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Human subjects protections is about respecting the rights and welfare of people who volunteer to help researchers by participating in their studies. Researchers come from colleges and universities, medical facilities and medical schools, and private and public research institutes. Regardless where in the United States a researcher is working, the ethical principles and fundamental regulations are the same.
Every institution that accepts public funding for research must abide by one of the three primary ethical guidelines: the Declaration of Helsinki, the Nuremberg Code, or the Belmont Report. MSU Denver is committed to upholding the ethical principles of the Belmont Report: Respect for Persons, Beneficence, and Justice.
In addition, each institution must have an Institutional Review Board (IRB) that is charged with reviewing human subjects research to ensure that it complies with ethical principles and the federal regulations that govern human subjects protections.
This “Guidance” section of the IRB/HSPP website is intended to provide information to researchers, participants, IRB members, and the general community on ethical issues in human subjects research and protections. Guidance on specific aspects of human subjects research, such as informed consent, may be helpful as researchers develop a submission package for IRB review or as individuals consider whether or not to participate in a research study.
The HSPP welcomes your questions, concerns, feedback, suggestions, and collaboration. If you need assistance, please contact us.
Before proceeding with any student-driven research activities, determine whether the project needs to be reviewed by the IRB or if it qualifies as a class project. Use the HRP-310 WORKSHEET: Human Research Determination to help you know if it qualifies as human subject research. If there is ANY doubt, please contact the HSPP for assistance.
Although many studies are developed and conducted primarily by student researchers, it is expected that human research activities are appropriately mentored by a faculty or staff adviser. MSU Denver’s IRB only reviews protocols where a faculty or staff member is identified as the Principal Investigator.
Student researchers are encouraged to take an active role in the development of the IRB submission package to learn about ethical conduct of human subject research and IRB oversight. The HRP-103: Investigator Manual and other researcher materials can be valuable resources in educating new researchers on IRB review and requirements. However, official IRB correspondence is limited to the Principal Investigator. Student researchers may register with IRBNet and submit materials to the IRB, but the faculty member must be listed as the Principal Investigator.
As Principal Investigator of student research projects, faculty/staff are expected to:
The Principal Investigator on any IRB-approved human research assumes primary responsibility for the ethical conduct of the research and for meeting all IRB requirements.
The HSPP and IRB are very cognizant of the need to support student research activities. However, student-driven research cannot be held to any different standard of ethical conduct or oversight. In order to support MSU Denver student research, the HSPP/IRB responds to all research review requests in a timely manner. Protocols that receive the fastest approval are those that provide clear and consistent information about all procedures involved and include all necessary supporting materials and documentation. Proposed research activities that are not fully explained and/or well designed cannot be approved by the IRB and will require additional information or revisions.
There have been times that students have run out of time and were not able to conduct their studies, which posed problems for both the students and faculty. It is worth the time and effort to complete the submission materials correctly the first time. In addition, for many students the first submission to the IRB can be an important opportunity to learn about the ethical requirements of human subjects research. This can carry through to future research endeavors. Student researchers and their faculty/staff mentors are encouraged to consult with the HSPP in the development of their submission package and throughout the IRB review process for guidance and assistance.
In general, investigators should plan to submit a complete application for IRB review at least two months prior to beginning low risk studies. Researchers planning studies with vulnerable populations or other greater than minimal risk research should plan to submit at least six months prior to beginning the study.
Submissions to the IRB are processed and reviewed on a first-come, first-served basis. Failure to plan for the IRB review process may delay your timeline for the initiation of the research. No research activities involving participants or identifiable data, including recruitment, may begin until final IRB approval or an exempt determination is granted.
Most studies are reviewed outside of the convened IRB (as exempt or expedited) and can be submitted at ANY time. Studies that are reviewed at scheduled IRB meeting involve greater than minimal risks to participants and need to submit well in-advance of a scheduled meeting to make that agenda. The level of review is determined by the HSPP/IRB based on your protocol and cannot be requested by the researchers.
Factors that influence the speed with which a protocol can be reviewed include the following:
Many protocols are not approved on the first review because there are questions or concerns about the content. After the initial review, the Principal Investigator will receive a notice via IRBNet. Investigators may receive a determination letter requesting modifications that must be re-reviewed before the protocol can be approved. The HSPP staff can answer questions about IRB requests for modifications or clarification and can offer guidance on how to revise your submission materials accordingly.
If you are new to the IRB review process or if you have any questions as you develop your submission materials, please contact the HSPP for assistance and answers at [email protected].
If your study may require full Board review, please take note of the meeting schedule and be advised that a complete submission would need to be received at least two weeks prior to the scheduled meeting date in order to make the meeting agenda. We recommend that you contact the IRB as soon as you believe you will undertake a project that may require a full board review.
Basic regulations governing the protection of human subjects in research supported or conducted by the Department of Health and Human Services (HHS, then the Department of Health, Education and Welfare) were first published at 45 CFR part 46 in 1974. In the United States, a series of highly publicized abuses in research led to the enactment of the 1974 National Research Act (Public Law 93-348), which created the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. One of the charges to the National Commission was to identify the basic ethical principles that should underlie the conduct of biomedical and behavioral research involving human subjects and to develop guidelines to assure that such research is conducted in accordance with those principles. In 1978, the Commission published “Ethical Principles and Guidelines for the Protection of Human Subjects of Research,” also known as the Belmont Report, named after the Belmont Conference Center where the Commission met when drafting the report. The Belmont Report identifies three fundamental ethical principles for all human subjects research: respect for persons, beneficence, and justice.
Based on the Belmont Report and other work of the National Commission, HHS revised and expanded its regulations in the late 1970s and early 1980s, requiring basic protections to human subjects involved in both biomedical and behavioral research conducted or supported by HHS. The statutory authority for the HHS regulations derives from 5 U.S.C. 301; 42 U.S.C. 300v-1(b); and 42 U.S.C. 289.
The current version of the regulations includes five subparts.
Subpart A is the basic set of protections for all human subjects of research conducted or supported by HHS, and was revised in 1981 and 1991, with technical amendments made in 2005.
Three of the other subparts provide added protections for specific vulnerable groups of subjects.
Subpart E, issued in 2009, requires registration of institutional review boards (IRBs) which conduct review of human research studies conducted or supported by HHS.
OHRP publishes a booklet that includes the text of the human subject protection regulations, the categories of research that an IRB may review through an expedited review procedure, the statutory basis for the regulations, and the departments and agencies that have published or follow the Common Rule.
The Food and Drug Administration (FDA) is an HHS agency that regulates clinical investigations of products under its jurisdiction, such as drugs, biological products, and medical devices. FDA regulations are published in title 21 of the CFR. FDA’s human subject protection regulations include:
21 CFR part 50, Protection of Human Subjects
21 CFR part 56, Institutional Review Boards
21 CFR part 312, Investigational New Drug Application
21 CFR part 812, Investigational Device Exemptions
21 CFR part 50 “Protection of human subjects,” issued in 1980, amended in 1981, 1989, 1990, 1991, 1996, 1997, 1999, 2006, and 2011, applies to informed consent by research subjects. Subpart D was added to 21 CFR part 50 in 2001 and provides additional protections for children involved in clinical investigations.
21 CFR part 56, issued in 1981 and amended in 1989, 1991, 1996, 1999 , 2000, 2001, 2002, and 2009, applies to IRBs.
Other FDA regulations that apply to clinical investigations include 21 CFR part 54, Financial Disclosure by Clinical Investigators.
The Common Rule
In 1991, the “Federal Policy for the Protection of Human Research Subjects,” informally known as the “Common Rule” was issued by 15 federal departments and agencies. The Common Rule was based on the HHS 45 CFR part 46 subpart A, and includes identical language in the separate regulations of those departments and agencies. Technical amendments were made to the Common Rule in 2005.
Three departments and agencies have not issued the Common Rule but apply all parts of 45 CFR part 46: The Central Intelligence Agency, the Social Security Administration, and the Department of Homeland Security.
Other departments and agencies have adopted one or more of the other HHS subparts and some have their own additional human subject protection regulations.
The informed consent process involves three key features: (1) disclosing to potential research subjects information needed to make an informed decision; (2) facilitating the understanding of what has been disclosed; and (3) promoting the voluntariness of the decision about whether or not to participate in the research. Informed consent must be legally effective and prospectively obtained. HHS regulations at 45 CFR 46.116 and 45 CFR 46.117 describe the informed consent requirements.
The informed consent process is the critical communication link between the prospective human subject and an investigator, beginning with the initial approach of an investigator to the potential subject (e.g., through a flyer, brochure, or any advertisement regarding the research study) and continuing until the completion of the research study. For the purposes of the HHS regulations at 45 CFR part 46, “investigators” are individuals who conduct human subjects research projects, including individuals directly involved in seeking the voluntary informed consent of potential subjects. Investigators can include physicians, scientists, nurses, administrative staff, teachers, and students, among others.
The informed consent process should be an active process of sharing information between the investigator and the prospective subject. The exchange of information between the investigator and prospective subjects can occur via one or more of the following modes of communication, among others: face-to-face contact; mail; telephone; video; or fax. Prospective subjects should be provided with ample opportunity to ask questions and seek clarification from the investigator. The prospective subjects should be in a position to freely decide whether to initially enroll in the research, or later, to withdraw or continue participating in the research. The informed consent process should ensure that all critical information about a study is completely disclosed, and that prospective subjects or their legally authorized representatives adequately understand the research so that they can make informed choices.
The procedures used in seeking and obtaining informed consent should be designed to communicate with the subject population in terms that they can understand. Information about a research project must be presented in such a way that enables each person to voluntarily decide whether or not to participate as a research subject. Thus, the information must be conveyed in language understandable to those being asked to participate as subjects in the research (45 CFR 46.116).
In addition to the information provided here, the Office for Human Research Protections (OHRP) has addressed a number of frequently asked questions about informed consent. The answers to the informed consent FAQs can be very helpful in developing a consent process for your research and understanding the requirements.
As you develop a consent process and form, consider reviewing the IRB members’ HRP-314 WORKSHEET: Criteria for Approval to ensure that you have addressed issues related to the consent process and have included required elements of consent.
The process of obtaining informed consent must comply with the requirements of 45 CFR 46.116 . The documentation of informed consent must comply with 45 CFR 46.117. Consider the following OHRP guidance:
Informed consent is legally effective if it is both obtained from the subject or the subject’s legally authorized representative and documented in a manner that is consistent with the HHS protection of human subjects regulations and with applicable laws of the jurisdiction in which the research is conducted. In general terms, the regulations stipulate that an investigator should seek consent only under circumstances that provide the prospective subject or the legally authorized representative sufficient opportunity to consider whether to participate and that minimize the possibility of coercion or undue influence. The information provided should be in language that is understandable to the subject or the representative. No informed consent, whether oral or written, may include any exculpatory language.
It is important to note that the informed consent requirements in the regulations are not intended to preempt any applicable federal, state, or local laws that require additional information to be disclosed for consent to be legally effective (45 CFR 46.116(e)).
“No informed consent, whether oral or written, may include any exculpatory language through which the subject is made to waive or appear to waive any of the subject’s legal rights, or releases or appears to release the investigator, the sponsor, the institution, or its agents from liability for negligence.” – 45 CFR 46.116
Examples of Exculpatory Language
By agreeing to this use, you should understand that you will give up all claim to personal benefit from commercial or other use of these substances.
I voluntarily and freely donate any and all blood, urine, and tissue samples to the U.S. Government and hereby relinquish all right, title, and interest to said items.
By consent to participate in this research, I give up any property rights I may have in bodily fluids or tissue samples obtained in the course of the research.
I waive any possibility of compensation for injuries that I may receive as a result of participation in this research.
Examples of Acceptable Language
Tissue obtained from you in this research may be used to establish a cell line that could be patented and licensed. There are no plans to provide financial compensation to you should this occur.
By consenting to participate, you authorize the use of your bodily fluids and tissue samples for the research described above.
This hospital is not able to offer financial compensation nor to absorb the costs of medical treatment should you be injured as a result of participating in this research. This hospital makes no commitment to provide free medical care or payment for any unfavorable outcomes resulting from participation in this research. Medical services will be offered at the usual charge.
What does it mean to minimize the possibility of coercion or undue influence?
The HHS regulations state that “An investigator shall seek such consent only under circumstances that provide the prospective subject or the representative sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion or undue influence” (45 CFR 46.116). This requirement applies to all nonexempt human subjects research not eligible for a waiver of the consent requirements.
Coercion occurs when an overt or implicit threat of harm is intentionally presented by one person to another in order to obtain compliance. For example, an investigator might tell a prospective subject that he or she will lose access to needed health services if he or she does not participate in the research.
Undue influence, by contrast, often occurs through an offer of an excessive or inappropriate reward or other overture in order to obtain compliance. For example, an investigator might promise psychology students extra credit if they participate in the research. If that is the only way a student can earn extra credit, then the investigator is unduly influencing potential subjects. If, however, she offers comparable non-research alternatives for earning extra credit, the possibility of undue influence is minimized.
In addition to undue influence that can arise with the offering of rewards, undue influence also can be subtle. For example, patients might feel obligated to participate in research if their physician is also the investigator, or students might feel pressure to participate in research if everyone else in the class is doing so. Because influence is contextual, and undue influence is likely to depend on an individual’s situation, it is often difficult for IRBs to draw a bright line delimiting undue influence. It is up to the IRB to use its discretion in determining which circumstances give rise to undue influence. For example, an IRB might consider whether the informed consent process will take place at an appropriate time and in an appropriate setting, and whether the prospective subject may feel pressured into acting quickly or be discouraged from seeking advice from others.
Because of their relative nature and lack of clear-cut standards on the boundaries of inappropriate and appropriate forms of influence, investigators and IRBs must be vigilant about minimizing the possibility for coercion and undue influence. Reasonable assessments can be made to minimize the likelihood of undue influence or coercion occurring. For example, IRBs may restrict levels of financial or nonfinancial incentives for participation and should carefully review the information to be disclosed to potential subjects to ensure that the incentives and how they will be provided are clearly described. Known benefits should be stated accurately but not exaggerated, and potential or uncertain benefits should be stated as such, with clear language indicating how much is known about the uncertainty or likelihood of these potential benefits.
The regulatory requirements for IRB review and approval also specify the need for the IRB — in order to approve research covered by the HHS regulations — to ensure that “When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons, additional safeguards have been included in the study to protect the rights and welfare of these subjects” (45 CFR 46.111(b)). Thus, inducements that would ordinarily be acceptable in some populations may become undue influences for these vulnerable subject groups.
When does compensating subjects undermine informed consent or parental permission?
The HHS regulations require that “An investigator shall seek such consent only under circumstances that provide the prospective subject or the representative sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion or undue influence” (45 CFR 46.116).
Paying research subjects in exchange for their participation is a common and, in general, acceptable practice. However, difficult questions must be addressed by the IRB. For example, how much money should research subjects receive, and for what should subjects receive payment — their time, inconvenience, discomfort, or some other consideration — IRBs must be sensitive to whether any aspect of the proposed remuneration will be an undue influence, thus interfering with the potential subjects’ ability to give voluntary informed consent. In no case should remuneration be viewed as a way of offsetting risks; that is, it should not be considered a benefit to be weighed against study risks. The level of remuneration should not be so high as to cause a prospective subject to accept risks that he or she would not accept in the absence of the remuneration. This same principle would apply to remuneration offered to parents whose children are prospective subjects.
Remuneration for participation in research should be just or fair. However, the specifics of each protocol will influence how those determinations are made. Both researchers and IRBs need to be familiar with the study population and the context of the research in order to make reasonable judgments about how compensation will affect participation. Wherever the remuneration is set, it will influence the decisions of some more than others. In particular, it will be more important to those for whom it will make a significant financial difference. Thus, IRBs should be cautious that payments are not so high that they create an “undue influence” or offer undue inducement that could compromise a prospective subject’s examination and evaluation of the risks or affect the voluntariness of his or her choices.
Protocols submitted to IRBs should indicate and justify proposed levels and purposes of remuneration, which also should be clearly stated in the accompanying consent forms. IRBs may need to request of the investigator some plan for monitoring subject recruitment to ensure that such inducements do not result in inequitable subject recruitment (e.g., recruiting only economically disadvantaged individuals).
Some institutions have adopted policies regarding the recruitment and payment of volunteers. IRBs and investigators should ensure that the consent process includes a detailed account of the terms of payment, including a description of the conditions under which a subject would receive partial or no payment (e.g., what will happen if he or she withdraws part way through the research or the investigator removes a subject from the study for medical or noncompliance reasons).
Finally, in studies of considerable duration or that involve multiple interactions or interventions, OHRP recommends that payment be prorated for the time of participation in the study rather than delayed until study completion, because the latter could unduly influence a subject’s decision to exercise his or her right to withdraw at any time. For example, if the study is conducted over a period of 6 months, there might be a monthly or bi-monthly payment. Or, if the study involves 12 sessions, there might be payment after every two sessions.
Can non-financial enrollment incentives constitute undue influence?
Yes, in certain circumstances. Non-monetary incentives (e.g., extra credit for students, access to services or programs) also can create undue influence on a potential subject’s decision about research participation. Informed consent always must be voluntary (45 CFR 46.116).
IRBs should ensure that non-financial incentives are not so great as to diminish the voluntariness of consent or cloud someone’s appreciation of risks or potential benefits that might be gained from participating in a study (45 CFR 46.116). Moreover, it must be clear that choosing to not participate will not adversely affect an individual’s relationship with the institution or its staff or the provision of services in any way (e.g., loss of credits or access to programs) (45 CFR 46.116(a)(8)).
Overt coercion (e.g., threatening loss of services or access to programs to which the potential subjects are otherwise entitled) is never appropriate. However, it might be permissible to provide incentives to participate that do not constitute undue influence. Using enrollment incentives to recruit subjects may be ethically permissible as long as the IRB has determined that, although they may be a factor in a subject’s decision to participate, they have not served to unduly influence the subject to participate. To make this determination, IRBs should know who the subject population will be, what incentives are being offered, and the conditions under which the offer will be made.
Department of Health and Human Services regulations for the protection of human subjects require that informed consent information be presented “in language understandable to the subject” and, in most situations, that informed consent be documented in writing (45 CFR §46.116 and §46.117).
Where informed consent is documented in accordance with §46.117(b)(1), the written consent document should embody, in language understandable to the subject, all the elements necessary for legally effective informed consent. Subjects who do not speak English should be presented with a consent document written in a language understandable to them. This procedure is strongly encouraged whenever possible.
Alternatively, §46.117(b)(2) permits oral presentation of informed consent information in conjunction with a short form written consent document (stating that the elements of consent have been presented orally) and a written summary of what is presented orally. A witness to the oral presentation is required, and the subject must be given copies of the short form document and the summary.
When this procedure is used with subjects who do not speak English, (i) the oral presentation and the short form written document (see HRP-507 TEMPLATE CONSENT DOCUMENT: Short Form ) should be in a language understandable to the subject; (ii) the IRB-approved English language informed consent document may serve as the summary; and (iii) the witness should be fluent in both English and the language of the subject.
At the time of consent, (i) the short form document should be signed by the subject (or the subject’s legally authorized representative); (ii) the summary (i.e., the English language informed consent document) should be signed by the person obtaining consent as authorized under the protocol; and (iii) the short form document and the summary should be signed by the witness. When the person obtaining consent is assisted by a translator, the translator may serve as the witness.
The IRB must receive all foreign language versions of the short form document as a condition of approval under the provisions of §46.117(b)(2). Expedited review of these versions is acceptable if the protocol, the full English language informed consent document, and the English version of the short form document have already been approved by the convened IRB.
It is the responsibility of the IRB to determine which of the procedures at §46.117(b) is appropriate for documenting informed consent in protocols that it reviews.
If you are proposing research that will involve subjects whose primary language is not English and need assistance developing a consent process and forms that meet these requirements, please contact the HSPP for assistance.
The IRB must determine, to the extent required by 45 CFR 46.116, that adequate provisions are made for soliciting the assent of the children — when in the judgment of the IRB the children are capable of providing assent — as well as the permission of the parents (45 CFR 46.408). Permission means the agreement of parent(s) or guardian to the participation of their child or ward in research (45 CFR 46.402(c)).
By regulatory definition, children are “persons who have not attained the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted” (45 CFR 46.402(a)). In the United States the legal age of adulthood is a matter of state and local law. This means that who is legally considered a child may vary from state to state; in a large majority of states 18 years of age is the legal age of adulthood, but this is not true in every state, locality, or territory. State law also may address specific circumstances in which a person younger than the age of adulthood is legally authorized to consent to medical procedures: for example, some states allow children younger than the legal age of adulthood to consent to the provision of contraceptive services. Certain states provide a mechanism for the emancipation of minors, through which a child younger than the legal age of adulthood may gain certain civil rights, which might include the legal ability to consent to research participation.
The definition of children also takes into account the particular interventions or interactions involved in the proposed research (e.g., surveys, blood tests). For example, in some places individuals who are 16 years of age may legally consent to certain clinical interventions or interactions. If the involvement of human subjects in a proposed research activity consists of these interventions or interactions, then those individuals may be considered as adults for that purpose. If a proposed activity includes an intervention or interaction for which the subject has not yet reached the legal age of consent, however, that person must be considered a child.
Under 45 CFR 408(b) the IRB may find that the permission of one parent is sufficient for research to be conducted under 45 CFR 46.404 or 45 CFR 46.405. Where research is conducted under 45 CFR 46.406 or 45 CFR 46.407, permission must be obtained from both parents unless one parent is deceased, unknown, incompetent, or not reasonably available, or when only one parent has legal responsibility for the care and custody of the child.
Although the regulations state that children are unable to provide legally effective informed consent to participate in research, some might be able to give their assent. Assent means a child’s affirmative agreement to participate in research. Mere failure to object should not, absent affirmative agreement, be construed as assent (45 CFR 46.402(b)).
If the IRB determines that the capability of some or all of the children is so limited that they cannot reasonably be consulted regarding assent, or that the intervention or procedure involved in the research holds out a prospect of direct benefit that is important to the health or well-being of the children, and is available only in the context of the research, the assent of the children is not a necessary condition for proceeding with the research. Even where the IRB determines that the subjects are capable of assenting, the IRB may still waive the assent requirement under certain circumstances in accord with 45 CFR 46.116 and 45 CFR 46.408(a).
In general, the HSPP recommends the following:
For children one month to 7 years of age, child assent is often waived or a simple verbal assent process may be provided. Simply failing to object does not mean that a child is providing assent, or agreement, to participate in a study. For some children in this age group, simple tasks or procedures of a study can be verbally explained in a way they might understand (e.g. “We are going to play a game about colors. Do you want to play?”). Then, the researchers can use verbal responses (“yes”, “no”, etc.) and/or non-verbal cues (joining the play group, pulling away from the play group, etc.) to appropriately assess assent. In general, researchers should defer to the responses of young children as to whether or not they want to engage in the research activities. Children should not be coerced into participation by the researchers or their parents.
In your submission packet: For children in the age group, the IRB would expect to see some discussion of whether or not there will be any assent process and your reasoning. If there will be a verbal assent process, please provide a copy of your verbal script for review (i.e. the language the researchers will use to explain the study procedures to children) and explain how, when, and where the assent process will occur in conjunction with the parental consent process.
For children 8 to 12 years of age, child assent should often be provided and may be verbal or written depending on the research procedures involved and the level of understanding of the targeted population. A verbal script or written form should be provided for IRB review. The IRB would expect that the language used in either the script or the written form would be appropriate for the targeted age group and would focus on the research tasks or procedures that the child will undertake in the study. There are a number of readability measures online that can help researchers assess the language being used in this process. Consider using a readability checker like http://www.read-able.com or a list of possible word substitutions (such as Wikipedia’s list of plain English words and phrases) to bring readability down to the appropriate level. In some studies, child assent in this age group may be documented with a written name/signature. For some procedures, children may feel more engaged in the process of assent by signing their name. However, researchers should ensure that this is not the only sign of agreement and they have appropriately discussed the research together with the child.
In your submission packet: For children in this age group, the IRB would expect an explanation of your proposed assent process in your research protocol. If assent will not be sought from participants, this should be appropriately explained and justified. The details of assent should be included, such as whether assent will be a verbal process or use a written form, whether or not assent will be documented and by whom, and how, when, and where assent will be conducted (e.g. with the parent or separately). Provide the IRB with a copy of any verbal script or written assent form for review.
For children 13 to 17 years of age, child assent should most often be provided. In many cases, children in this age group are able to read and discuss research participation provided that the information is presented in a way or at a level that they can best understand. When enrolling children across this age group, assent forms or scripts should be designed for the youngest potential participants (e.g. 13 years). Children in this age group can be provided with a separate assent form or can read and sign the consent form in conjunction with their parent/guardian if the consent form is at a reading level both parent and child can understand. Assent should be documented when appropriate for your study.
In your submission packet. For children in this age group, the IRB would expect an explanation of your proposed assent process in your research protocol. If assent will not be sought from participants, this should be appropriately explained and justified. The details of assent should be included, such as whether assent will be a verbal process or use a written form, whether or not assent will be documented, and how, when, and where assent will be conducted (e.g. with the parent or separately). Provide the IRB with a copy of your verbal script, written assent form, or combined consent/assent form for review.
This information is provided for general guidance and your proposed assent process should be tailored to your study and your targeted population. Some additional considerations:
Who are “investigators”? The HHS regulations at 45 CFR part 46 use the term “investigator” to refer to an individual performing various tasks related to the conduct of human subjects research activities, such as obtaining informed consent from subjects, interacting with subjects, and communicating with the IRB. Other terms such as “researcher,” “research team member,” or “research personnel” may also be used and have the same meaning as an investigator.
For the purposes of the IRB, an “investigator” is any individual who is involved in designing, conducting, or reporting human subjects research activities. Such involvement can include:
Investigators may include instructors, students, clinicians, scientists, coordinators, directors, and administrative staff, among others. Please contact the HSPP with any questions about who might be acting as an investigator in your research study.
In every study, one investigator should be designated as the “Principal Investigator” who assumes overall responsibility for the conduct of the study. MSU Denver’s IRB requires that the Principal Investigator be a member of the University’s faculty or staff. Multiple PIs are not allowed on an IRB submission. MSU Denver students may not serve as the Principal Investigator on a research study; this role should be assumed by the faculty or staff advisor.
In every human subjects research study, investigators have certain responsibilities regarding the ethical treatment of human subjects. Investigators play a crucial role in protecting the rights and welfare of subjects and are responsible for carrying out sound ethical research consistent with research plans approved by an IRB.
Along with meeting the specific requirements of a particular research study, investigators are responsible for ongoing requirements in the conduct of approved research that include, in summary:
The Principal Investigator and all members of the research team should review the HRP-103: Investigator Manual, HSPP Policies & Procedures, and MSU Denver’s Human Research Protection Plan .
The federal guidance clearly states that it is a conflict of interest for investigators to make the determination that their own research is exempt from requirements of the Common Rule. Therefore, like many other institutions, it is the IRB’s policy that any research involving human subjects or identifiable private data be submitted for to the HSPP for IRB review, and that the IRB will make the determination of exempt status, not the researcher.
The Word Exempt is Misleading
Investigators sometimes think the word “exempt” means that their protocol does not have to be submitted to the IRB for review and determination, but that is not the case. A determination of “exempt” means that the research protocol is exempt from regulatory requirements of the Common Rule (45 CFR 46), the federal regulations that govern the conduct of human subjects research. However, theses studies must still meet institutional standards. At MSU Denver all human subjects research must be reviewed by the IRB and is held to same standard of ethical conduct.
Studies that qualify for an exempt determination involve research activities that pose less than minimal risk to participants and fall within six defined categories in the Common Rule. Studies that are determined exempt do not require continuing or final review by the IRB. If modifications are proposed to exempt research, a modification application must be submitted for IRB review and approval prior to implementing any changes to the study.
The submission requirements are the same for all levels of IRB review, including exempt determinations. The reviewer(s) must be given sufficient information to assess risks to participants. Therefore, the quality and clarity of your submission materials will affect the reviewer’s ability to determine if your proposed research is exempt.
Please consult with the HSPP staff if you have any questions about the review process or whether your study may be exempt.
The vast majority of research protocols are reviewed through an expedited process. For IRB purposes, the term “expedited” refers to the process, not a timeline. Proposed research that poses no more than minimal risk to participants (i.e. no more than the risks that participants would encounter is their daily lives) can be reviewed by one or more IRB members and generally does not have to go to the full board for review.
When proposed research is determined to qualify for expedited review, the HSPP staff will assign one or more IRB reviewers to read and evaluate the submission materials. Each reviewer determines whether the research protocol requires minor or major modifications and subsequent review or if the protocol can be approved as is. Individual IRB members, including the Chair, cannot disapprove a proposed study and, if those concerns arise, the study would be assigned to the next convened board meeting. Each expedited reviewer returns his/her determination to the HSPP staff who will post a letter of determination to the Principal Investigator in IRBNet. This “round” of the review process typically takes a week to 10 days. However, given the complexity of the research and any concerns that arise in the review process, studies can go through several “rounds” of expedited review before receiving an approval.
Please be advised that the quality and clarity of the submission materials greatly impact the IRB reviewer’s ability to assess risks to participants and to make a determination in a timely manner. Poorly crafted research protocols and supporting materials will delay the process regardless of whether the study is reviewed by one or all IRB members.
Research protocols requiring review by the full board are those that involve greater than minimal risk to human participants. Common examples of research requiring full board review are studies involving prisoners, persons with undocumented status, research on illegal activities, incarcerated youth, among others. Whether a proposed research protocol will require full board review depends on the nature and context of the particular study. The level of review is determined by the HSPP/IRB, not by the investigators. In addition, some studies may begin review by one or two members (expedited review), but may be referred to the convened IRB at the discretion of the reviewer(s).
The full board meets about once a month, but approval may require modifications and subsequent review(s) by the convened IRB or by designated members. Researchers should allow sufficient time for the pre-review process to ensure that submission materials are adequate for IRB review. Only complete and consistent submission materials will be assigned to a meeting agenda for review, and the agendas are closed approximately one week prior to each meeting.
If your research may involve greater than minimal risk to subjects, you are advised to submit the study well before you intend to begin their research – our recommendation is six months prior to the planned start of the research. Communication with the HSPP manager can also ensure the timeliness of this process.
The DHHS Office of Human Research Protections dictates the procedures for convened IRB meetings. The content of the meeting minutes is also regulated by federal codes and guidelines, as well as institutional standards.
Convened IRB meetings are closed to the public. Researchers and outside consultants may be asked to participate in IRB discussions of specific studies, but only IRB members and authorized HSPP staff can be present in the room for votes on determinations.
There are several possible determinations that may be made for proposed research that is reviewed by the convened IRB:
In general, continuing reviews and amendments to studies originally approved by a convened IRB must also be reviewed and approved in the same manner. However, the IRB may determine at some point that a specific study may be handled through the expedited process – depending on the risks to participants and the current status of the research.
Please be advised that the quality and clarity of any proposed research materials submitted to the IRB will affect the board’s ability to assess risks to participants and to make a determination in a timely manner. Researchers who are developing study proposals that may involve greater than minimal risk to participants are encouraged to actively seek guidance and information from the HSPP prior to submission to avoid unnecessary delays in the review process.
HSPP staff will help facilitate the IRB review process and send appropriate correspondence to the Principal Investigator via IRBNet of any determination made by the IRB. The HSPP staff can offer guidance and assistance on the IRB review process and requirements. Please contact the HSPP with any questions or concerns at [email protected].
When MSU Denver students are the intended subjects of a research study, the researchers should carefully review and understand the concepts of coercion and undue influence.
OHRP provides guidance on this specific topic:
What constitutes coercion or undue influence when students are involved in research in a college or university setting?
The regulations require that the investigator seek consent only under circumstances that minimize the possibility of coercion or undue influence (45 CFR 46.116). The Office for Human Research Protections (OHRP) recommends that institutions have policies in place that clarify for students and faculty that any participation of students in research must be voluntary. Reasonable levels of extra credit or rewards may be offered for participating in research. If extra credit or rewards are offered for participation, students must be provided with and informed of non-research alternatives involving comparable time and effort to obtain the extra credit in order for the possibility of undue influence to be minimized. However, if participation in research is a course requirement, students must be informed of non-research alternatives involving comparable time and effort to fulfill those requirements in order for the possibility of undue influence to be minimized. Moreover, students must not be penalized for refusing to participate in research (45 CFR 46.116(a)(8)).
In addition, some research institutions use a so-called “student subject pool” to identify students who might be willing to participate in research, even when the exact nature of the research to be conducted has not yet been determined. Extra credits or other rewards are often offered as an incentive to encourage participation. Students who sign up for such pools have not legally consented to participate in a research study since they have not been provided with sufficient information concerning the exact study in which they would participate. Thus, signing up to be in a subject pool is only a first and preliminary step by which individuals can indicate their willingness to be considered for research participation. The student must also provide informed consent, unless the consent requirement is waived by an IRB once he or she is being considered for a specific study (45 CFR 46.116). Furthermore, individuals in the pool must be free to decline participation in any available research projects without penalty (45 CFR 46.116(a)(8)).
Please consider the following:
Research with one’s own students presents unique considerations with regard to human subjects protections. At the center of the issue is the inherent power difference between student and instructor. Regardless how well a faculty member presents the recruitment and option not to participate, students may feel as though they have to participate or risk having their non-participation impact their grade or relationship with the professor. In addition, the idea of ongoing voluntary participation is a potential issue if a student decides they want to discontinue their participation after initially consenting. Real coercion is rare is research, but the perception of coercion can be just a problematic in obtaining voluntary informed consent.
The MSU Denver IRB considers the following factors in support of proposed enrollment of subjects with potential status relationships with the researcher(s):
MSU Denver IRB often requires that faculty who are conducting research with their own students use a third party to distribute and collect consent and data – just as you would a course evaluation. The third party may be an individual from the department office, another faculty member, or a co-investigator, etc. who has no relationship to these students or the course (i.e. not a co-instructor, teaching assistant, or student teacher). There are many variations to using this approach depending on the timing and procedures involved. Here are some examples of processes that can help minimize coercion of undue influence:
EXAMPLE A: Data will be collected from students in a targeted class through an anonymous survey (no names or other identifying information will be included). The researcher, who is also the instructor of the course, has designed a simple written consent statement to describe the research and no signed consent forms will be collected. At the end of a class period, the instructor/researcher introduces and discusses the study with the students (using the approved recruitment script and consent statement), answers any questions, and then leaves. A third party would distribute the survey to students and collect any completed surveys. The surveys could be provided to the instructor after all were collected. Using this process, the students can be assured that the instructor does not know who provided which survey and who did or did not participate.
EXAMPLE B: The survey administered to a targeted class is not anonymous (student names and IDs are being collected). The survey data will be linked to participating students’ final exam scores and course grades. Here, the third party would be used the same as in the first example, but signed consent forms and identifiable surveys are collected and placed in a sealed envelope. The third party would keep the sealed envelope in a locked file cabinet until after the class grades were submitted. Only then are the completed consent forms and surveys provided to the instructor/researcher. The researcher will then know who has agreed to participate in the study and which survey they provided; but, the involvement of a third party and the timing provide students assurance that their participation, or lack thereof, has no impact on their grade or their standing in the class.
EXAMPLE C: An instructor proposes to use student work products (assignments, papers, quizzes, exams, etc.) as research data. Documented (signed) consent forms need to be collected from students who are willing to provide their data for the study. The instructor/researcher would present the study to the class and answer questions, as in the other examples. The third party would collect signed consent forms and keep them in a locked file cabinet until after the class grades have been submitted. Then, the faculty researcher could access the consent forms and collect and analyze only the work products of those students who had given permission to use for their data in the study. Again, in this process the students can be assured that their participation, or lack thereof, has no impact on their grade or their relationship with the instructor.
The specific role of the third party may or may not require them to be listed as a co-investigator on the IRB submission. Individuals who are tasked with obtaining consent (describing the study procedures, answering questions about the study, ensuring comprehension, etc.) are engaged in human research activities and are considered investigators by the IRB. Other individuals, like the third parties in the three example above, may only be tasked with collecting and temporarily holding documents for the investigators and generally are not themselves considered investigators on the study. How this process will work best for your study will depend on the procedures, the subject population, and other components of your specific research plan.
If you have questions on how to minimize the potential for coercion or undue influence in your research and who may be an investigator, please contact the HSPP staff for guidance.
Compensation to research subjects is not a benefit of research. Rather, compensation is meant to offset the time and inconvenience of participation, as well as to serve as an incentive to participate. The federal regulations do not set limits on compensation to participants. However, both researchers and the IRB are tasked with ensuring that research subjects provide voluntary, informed consent that is free from coercion or undue influence.
Compensation that is excessive or inappropriate in relation to the research procedures is problematic for a number of reasons. It can induce subjects to participate against their better judgment. In addition, excessive compensation incentives can encourage some individuals to lie or to withhold information in order to participate in the study when they don’t meet the eligibility criteria. This impacts not only the integrity of the research and the validity of the data, but can also compromise the safety of subjects. Inappropriate compensation can also create coercive situations when given to third parties. For example, a parent may coerce or pressure their child into participating in a study when payment is significant.
All potential research participants – and, in the case of children, their parent/guardian – should be able to make informed decisions about participation based on the true risks and benefits of the research, not on compensation.
The Form and Amount of Compensation:
Compensation can take on many forms and can include monetary (cash, gift cards, etc.) and/or non-monetary (gifts, course credit, extra credit, etc.) payments to subjects. Your protocol (research plan) should clearly specify what form(s) of compensation would be provided to participants in your study and the amount of payment. For non-monetary items, please provide an approximate value.
Compensation can also take the form of a drawing. When considering using a drawing or lottery form of compensation, researchers should ensure that there is a fair method for selecting winners and that the value of the prize divided by the number of subjects is reasonable in relation to the procedures involved.
Compensation may be awarded or accrued by participants in response to various tasks in a study. For example, compensation may be accrued in process of playing a game where certain decisions warrant an award. For these studies, participants should be informed of the minimum and maximum compensation amounts involved in participation.
For student subjects, reasonable levels of extra credit may be offered as compensation for participating in research. If extra credit is offered for participation, students must be provided with and informed of non-research alternatives involving comparable time and effort to obtain the extra credit in order for the possibility of undue influence to be minimized. (source)
Payments or compensation should not require subjects to spend their own money. For example, a gift card to a coffee shop would be acceptable if it was sufficient to purchase a drink or other items without spending further money. However, a 50%-off coupon for a coffee drink would not be an appropriate form of payment.
Proposed cash payments to research subjects must be appropriate for the study and subjects population and must be consistent with all Accounting Services policies and procedures.
Timing of Compensation:
In addition to the form and amount of compensation to subjects, researchers should give consideration to the timing of payments.
In many studies, the procedures occur only once in a short period of time (e.g., completion of a 15 minute survey). Making compensation contingent on completion may be appropriate if the procedures are short. However, subjects who are disqualified during the study or are unable to complete the research through no fault of their own should still receive compensation.
In other studies, participation involves tasks completed over time or through multiple interactions or interventions (e.g., a one-hour interview done once a month for three months). Making compensation entirely conditional on the completion of multiple procedures could undermine a participant’s ability to withdraw at any time. In most cases, payments should be prorated, and subjects who are not able to complete the research should receive compensation proportional to their participation, regardless of whether they withdraw or are withdrawn by the researchers. Prorating payments to subjects is required for FDA-regulated research. Researchers are allowed to withhold a portion of the payment until completion (e.g. a completion bonus), provided that the amount does not exceed more than 50% of the total compensation.
Compensation for Research-Related Injury:
If research-related injury (i.e., harm that is physical, psychological, social, financial, or otherwise) is possible in research that is more than minimal risk, an explanation must be given of whatever voluntary compensation and treatment will be provided. Note that the federal regulations do not limit injury to only physical injury. 45 CFR 46.102(g)
Information Collected for Accounting and Reporting Purposes:
It is the responsibility of the PI to maintain accurate payment records according to MSU Denver accounting standards and sponsor requirements. The IRB needs to be informed of any required collection of subject information (e.g., name, SSN, 900#, etc.) for accounting purposes.
At MSU Denver, reporting information on individual research subjects is not required for accounting purposes if the total compensation to each subject is $50 or less (monetary amount and/or value of non-cash items).
For compensation plans that exceed $50 to individual subjects, information must be collected to ensure that the University can fulfill any state or federal income tax reporting requirements that may apply. Please consult with Accounting Services for questions on accounting policies or the requirements for collecting and reporting research participant information.
When identifiable information is collected for accounting purposes, researchers are reminded to follow all appropriate standards to maintain the confidentiality of participant information.
Disclosure to Research Subjects:
Research subjects should be accurately informed through the consent process about any compensation for participation. The consent form should clearly state what form of payment will be provided, the amount or value of the payment, and the timing of compensation. If or when questions or complaints arise regarding compensation, the consent form becomes the source document for the information that was provided to participants. The information about compensation should be clear, detailed, and consistent with your protocol.
In the case of drawings or lottery compensation, potential participants need to be informed of the odds of winning (i.e., how many individuals are participating divided by the number of prizes), how participants can enter the drawing, how winners are chosen, and how winners are notified.
In any study where information is being collected from participants for accounting purposes, individuals need to be informed about what information will be requested (e.g., name, SSN, 900#, etc.) and how that information will be used and stored, including any reporting to the Internal Revenue Service. Some examples of consent form language include:
“Financial rules require us to have your 900 number [or name, SSN, address] in order to compensate you for your participation. This information and your payment amount will be kept secure and confidential in our research financial records, our department’s financial office and the University’s financial office. This information will not be associated with the study name or the research data you provide as a participant.”
“If you are paid a total of $600 or more as a research subject in a calendar year, the University is required to report the payment to the Internal Revenue Service as miscellaneous income. MSU Denver will send you a form (IRS form 1099) in January documenting the payment total. This form is also sent to the IRS to report any money paid to you. You can use the form with your income tax return, as appropriate.”
Based on your study and your subject population, this sample language should be modified and/or additional details can be provided during the consent process about how and where the information will be stored and who will have access to it.
Use the HRP-316 WORKSHEET: Payments to evaluate any proposed compensation or payments in the same way that the IRB reviewer will. Please contact the HSPP for any questions concerning compensation to research participants.
Vulnerable populations of human research participants are groups of people who have either historically been coerced or forced to participate in research or who may not have the language, education, or decision-making skills to decide for themselves whether to participate in research. For this reason, members of vulnerable populations are afforded additional layers of protection under Title 45 Section 46 of the Code of Federal Regulations.
However, the regulations do not limit considerations of vulnerability in research to only these three categories of subjects. Many other groups or individuals can be vulnerable to coercion or undue influence, may have limited autonomy to freely consent, or may not be fully able to understand the research and what participation entails. Some examples:
Even within a vulnerable group of subjects, some individuals may be more vulnerable than others. For example, children who are wards of the state may need additional protections when they are engaged in research as subjects than children who have a parent or guardian.
Vulnerability may also change over time and during the course of a research study. In a medical study, for example, a severely-ill hospitalized patient may not be able to understand what is being asked of him and a legally-authorized representative may be approved to be his decision-maker for participation in the research. However, when the patient recovers and regains his decision-making capacity, he can and should be given the opportunity to provide or withdraw his own consent.
The primary ethical considerations concerning research with children are described in the first section of the Belmont Report, respect for persons.Respect for persons incorporates at least two ethical convictions: first, that individuals should be treated as autonomous agents, and second, that persons with diminished autonomy are entitled to protection. The principle of respect for persons thus divides into two separate moral requirements: the requirement to acknowledge autonomy and the requirement to protect those with diminished autonomy. (Belmont Report, 1979)
Issues to consider regarding respect for persons in dealing with children is that there are many circumstances in which children are not considered autonomous. Adults make many decisions for children, which is generally very appropriate. With regard to research, however, ethics guidelines explicitly state that investigators must treat children as autonomous and respect their stated wishes whether they choose to participate in research or not.
The second ethical issue related to research with children is that they are considered persons with diminished authority. Because their developmental stage dictates that their decision-making skills are limited by their maturity, they are entitled to protections that are not afforded to adults who participate in research.
These two provisions conflict in very fundamental ways, which makes research with children a challenge. In a study protocol, the investigators should provide sufficient information to help the IRB understand how they plan to both respect the autonomy and protect the wellbeing of the children who participate in their research. The HSPP can provide guidance on the regulatory requirements for inclusion of children in proposed research. Please contact the HSPP with any questions at [email protected].
Title 19 of the Colorado Revised Statutes (C.R.S.) covers issues relating to the abuse and neglect of children. These statutes include provisions on persons who are required to report child abuse or neglect, which can be very relevant in some proposed research studies with children. Please review:
TITLE 19. CHILDREN’S CODE
ARTICLE 3. DEPENDENCY AND NEGLECT
PART 3. CHILD ABUSE OR NEGLECT
C.R.S. 19-3-304 (2012)
19-3-304. Persons required to report child abuse or neglect
(1) (a) Except as otherwise provided by section 19-3-307, sections 25-1-122 (4) (d) and 25-4-1404 (1) (d), C.R.S., and paragraph (b) of this subsection (1), any person specified in subsection (2) of this section who has reasonable cause to know or suspect that a child has been subjected to abuse or neglect or who has observed the child being subjected to circumstances or conditions that would reasonably result in abuse or neglect shall immediately upon receiving such information report or cause a report to be made of such fact to the county department or local law enforcement agency.
(b) The reporting requirement described in paragraph (a) of this subsection (1) shall not apply if the person who is otherwise required to report does not:
(I) Learn of the suspected abuse or neglect until after the alleged victim of the suspected abuse or neglect is eighteen years of age or older; and
(II) Have reasonable cause to know or suspect that the perpetrator of the suspected abuse or neglect:
(A) Has subjected any other child currently under eighteen years of age to abuse or neglect or to circumstances or conditions that would likely result in abuse or neglect; or
(B) Is currently in a position of trust, as defined in section 18-3-401 (3.5), C.R.S., with regard to any child currently under eighteen years of age.
(2) Persons required to report such abuse or neglect or circumstances or conditions include any:
(a) Physician or surgeon, including a physician in training;
(b) Child health associate;
(c) Medical examiner or coroner;
(i) Registered nurse or licensed practical nurse;
(j) Hospital personnel engaged in the admission, care, or treatment of patients;
(k) Christian science practitioner;
(l) Public or private school official or employee;
(m) Social worker or worker in any facility or agency that is licensed or certified pursuant to part 1 of article 6 of title 26, C.R.S.;
(n) Mental health professional;
(o) Dental hygienist;
(q) Physical therapist;
(s) Peace officer as described in section 16-2.5-101, C.R.S.;
(u) Commercial film and photographic print processor as provided in subsection (2.5) of this section;
(v) Firefighter as defined in section 18-3-201 (1), C.R.S.;
(w) Victim’s advocate, as defined in section 13-90-107 (1) (k) (II), C.R.S.;
(x) Licensed professional counselors;
(y) Licensed marriage and family therapists;
(z) Registered psychotherapists;
(aa) (I) Clergy member.
(II) The provisions of this paragraph (aa) shall not apply to a person who acquires reasonable cause to know or suspect that a child has been subjected to abuse or neglect during a communication about which the person may not be examined as a witness pursuant to section 13-90-107 (1) (c), C.R.S., unless the person also acquires such reasonable cause from a source other than such a communication.
(III) For purposes of this paragraph (aa), unless the context otherwise requires, “clergy member” means a priest, rabbi, duly ordained, commissioned, or licensed minister of a church, member of a religious order, or recognized leader of any religious body.
(bb) Registered dietitian who holds a certificate through the commission on dietetic registration and who is otherwise prohibited by 7 CFR 246.26 from making a report absent a state law requiring the release of this information;
(cc) Worker in the state department of human services;
(dd) Juvenile parole and probation officers;
(ee) Child and family investigators, as described in section 14-10-116.5, C.R.S.;
(ff) Officers and agents of the state bureau of animal protection, and animal control officers;
(gg) The child protection ombudsman as created in article 3.3 of this title;
(hh) Educator providing services through a federal special supplemental nutrition program for women, infants, and children, as provided for in 42 U.S.C. sec. 1786.
(2.5) Any commercial film and photographic print processor who has knowledge of or observes, within the scope of his or her professional capacity or employment, any film, photograph, video tape, negative, or slide depicting a child engaged in an act of sexual conduct shall report such fact to a local law enforcement agency immediately or as soon as practically possible by telephone and shall prepare and send a written report of it with a copy of the film, photograph, video tape, negative, or slide attached within thirty-six hours of receiving the information concerning the incident.
(3) In addition to those persons specifically required by this section to report known or suspected child abuse or neglect and circumstances or conditions which might reasonably result in abuse or neglect, any other person may report known or suspected child abuse or neglect and circumstances or conditions which might reasonably result in child abuse or neglect to the local law enforcement agency or the county department.
(3.5) No person, including a person specified in subsection (1) of this section, shall knowingly make a false report of abuse or neglect to a county department or local law enforcement agency.
(4) Any person who willfully violates the provisions of subsection (1) of this section or who violates the provisions of subsection (3.5) of this section:
(a) Commits a class 3 misdemeanor and shall be punished as provided in section 18-1.3-501, C.R.S.;
(b) Shall be liable for damages proximately caused thereby.
Research that proposes to involve prisoners as subjects requires special protections under the federal regulations because these individuals may not be free to make voluntary decisions about participation and may be subject to coercion or undue influence. Under the Common Rule (45 CFR 46, Subpart C), prisoner is defined as:
any individual involuntarily confined or detained in a penal institution. The term is intended to encompass individuals sentenced to such an institution under a criminal or civil statute, individuals detained in other facilities by virtue of statutes or commitment procedures which provide alternatives to criminal prosecution or incarceration in a penal institution, and individuals detained pending arraignment, trial, or sentencing.
Because the ethical requirements for a study that targets or includes prisoners as subjects can involve additional protections or safeguards, the IRB review process is often more stringent and lengthy. In addition, if IRB approval is granted, this approval may need to be certified at the federal level by the Office for Human Research Protections (OHRP). OHRP guidance on research with prisoners can be found here.
One very important note: The regulations and standards for research involving prisoners are not limited only to those studies that target prisoners, but can apply whenever any human subject in a research protocol becomes a prisoner at any time during the study. OHRP provides the following guidance:
What should be done when a subject becomes a prisoner after enrollment in a study which was not reviewed and approved by the IRB in accordance with the requirements of subpart C (research involving prisoners)?
When a previously enrolled research subject becomes a prisoner and the relevant research protocol was NOT reviewed and approved by the institutional review board (IRB) in accordance with the requirements of HHS regulations at 45 CFR part 46, subpart C, the principal investigator should promptly notify the IRB of this event. All research interactions and interventions with, and obtaining identifiable private information about, the now-incarcerated prisoner-subject must cease until the requirements of subpart C have been satisfied with respect to the relevant protocol. (source)
If a participant becomes incarcerated (or otherwise meets the definition of prisoner noted above) during the course of your research study, STOP all research-related interactions and data collection with that subject and contact the HSPP immediately for guidance. OHRP allows for only one exception to this rule and that exception must be determined by the IRB Chair.
In addition, an adolescent detained in a juvenile detention facility IS considered a prisoner. Therefore, in most cases, the requirements of both Subpart C and Subpart D must be met.
If you are developing a study that relates to prisoners or prison settings or involves participants that may become prisoners during the course of your research, please contact the HSPP for guidance. To allow sufficient time for the IRB review process and, if needed, federal certification, these kinds of studies should be submitted at least six months prior to your planned start date for the research.
Researchers should carefully consider the inclusion or the exclusion of potential participants who have limited literacy and/or English language skills. The ability to understand information about the research and provide voluntary consent is key to the autonomy of and respect for research subjects. The IRB is tasked with ensuring that the proposed research includes a consent process in the language most appropriate for the subjects.
If your potential participants speak English, but are unable to adequately read a consent document, a verbal consent process may be more appropriate. A verbal consent script (i.e. what information will be read to and discussed with the participant) should be submitted for IRB review. In addition, you may want to request a waiver of documentation of consent – that is, a consent process is occurring, but participants will give the researcher verbal consent, rather than signing a form. Alternatively, in some studies, a witness and a short form consent may be required to support this process (see below).
For participants whose native language is not English, the researcher must carefully consider how these individuals would be consented into the study. If the study targets non-English speakers or if the majority of the participants are expected to be non-English speakers, then the consent process should be conducted in the language appropriate to those participants. An English version and a fully translated version of the consent form should be submitted for IRB review. The IRB would also expect that the study instruments (e.g. survey questions, interview questions, etc.) would also be translated into the appropriate language. The IRB should be informed of the researchers ability and qualifications to conduct the consent and the research in a language other than English.
For research where only some or a few of the participants are non-English speakers, the researchers may consider using a translator and a short form consent process. The translator can act as an impartial witness to help ensure that participant understands the information about the research and is giving voluntary informed consent. A short form consent (HRP-507 TEMPLATE CONSENT DOCUMENT: Short Form ) is a translated form which identifies the information that should be provided in the consent process and is conveyed in the written English consent document or summary. Please consult the Researcher Materials page for a template of a short form consent.
For answers to questions and for guidance on the IRB review of research involving participants with limited English language skills, please contact the HSPP.
Occasionally faculty and staff are interested in obtaining feedback and information from the MSU Denver community or other individuals about their satisfaction with, ways to enhance, and/or future needs for existing or potential programs and services. This type of survey or assessment often falls under the category of “quality improvement” and does not meet the federal criteria for human research. Quality improvement activities do not need to be reviewed by the Institutional Review Board.
Typically, projects that are determined to be quality improvement are those:
Use the HRP-310 WORKSHEET: Human Research Determination to help you determine if your project can be considered human research. Contact the HSPP staff with any questions.
If you anticipate that your quality improvement project may yield data that could be analyzed and shared as research, be proactive in engaging the IRB. IRB approval cannot be granted retrospectively for research activities.
Federal Regulations governing the protection of human research participants defines research as:
§46.102(d) Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.
Student projects that are conducted solely for a course grade are not considered to be “designed to develop or contribute to generalizable knowledge” and are not subject to IRB oversight. Individuals who provide information or data for class projects should be informed of the purpose of the study and understand how their information may be used. Information or data collected for course projects are not meant to be shared with individuals outside of the class.
Student projects presented to anyone who is not on the official class roster may be considered to be “designed to develop or contribute to generalizable knowledge” and may require IRB approval before any participants can be recruited. Presentations outside the class roster include, but are not limited to, poster or oral presentations to people not enrolled in the class (including the Undergraduate Research Conference), public websites or electronic media, and publications.
Use the HRP-310 WORKSHEET: Human Research Determination to help you determine if your project is Human Research and requires IRB review and approval. The HSPP staff can also help you make this determination.
When Conducting Course Projects:
Students who are conducting projects for courses are bound by the ethics of their discipline, rules and guidelines determined by their instructor and department, and all federal, state, and local laws. The course instructor is responsible for ensuring that students are knowledgeable and follow all appropriate ethics, rules, guidelines, and laws.
To enhance student learning, the HSPP recommends that students conducting course projects that mimic research activities take advantage of available CITI training for human subjects research and the responsible conduct of research. CITI training is for educational purposes and is NOT equivalent to IRB review and approval.
There is no “retroactive” IRB approval of research. If professors and/or students believe that their class project may yield valuable data that could be presented or shared outside of the class, they should plan ahead to get IRB approval prior to data collection.
Please contact the Human Subjects Protection Program (HSPP) for clarification or questions.
The IRB has oversight over human research. Proposed projects or studies must meet both the federal definitions of research and human subjects.
Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities.
Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains (1) Data through intervention or interaction with the individual, or (2) Identifiable private information.
Intervention includes both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject or the subject’s environment that are performed for research purposes.
Interaction includes communication or interpersonal contact between investigator and subject.
Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects.
(source 45 CFR 46)
Your project plan should be carefully assessed to determine whether or not it meets these definitions before initiating any activities involving participants. Conducting human research without IRB approval may constitute noncompliance with institutional standards and federal regulations and may be reportable within and outside of the institution. Many sources for sharing and disseminating research results, such as peer-reviewed journals and academic conferences, require documentation of IRB oversight when it is applicable.
Use the HRP-310 WORKSHEET: Human Research Determination to help you determine if your project constitutes Human Research. The HSPP staff can also help you determine whether or not your study or project requires IRB oversight.
For IRB purposes, the term “expedited” refers to a process, not a timeline, where the review is conducted by, typically, only one IRB member and not the full board.
Studies that involve no more than minimal risk for participants (no greater than the risks we would encounter in our daily lives) generally do not have to be reviewed at a convened IRB meeting. Studies that involve more than minimal risk cannot be reviewed by this expedited process and must be assigned to the next available convened IRB meeting.
Keep in mind, though, that the quality and clarity of your protocol and submission materials will affect the reviewer’s ability to assess risks to participants and make a timely determination. Poorly crafted submissions, therefore, will take longer under any review process simply because the reviewers are not given the information they need to make a determination according to the regulatory requirements.
Yes. The federal regulations make no distinction between student and faculty research. All researchers are required to abide by the same ethical and regulatory standards, so MSU Denver requires all investigators to follow the same process. Student-driven research is not held to a lower standard and is evaluated the same by the IRB.
In the development and conduct of human subjects research, students are expected to be appropriately mentored by more experienced researchers. The IRB does NOT review studies submitted solely by student researchers. As a student, your faculty or staff advisor must be designated on the IRB submission as the Principal Investigator. The Principal Investigator should be involved in all aspects of the IRB review process and oversees the conduct of your research. You can engage with the HSPP and IRB to learn about this important process; but, submissions to the IRB and official correspondence must come from the Principal Investigator. Student are not allowed to register with or use IRBNet. This way the IRB is assured that the faculty or staff advisor is not being by-passed in this process and has had the opportunity to review materials being developed by the student.
Unfortunately, no. The IRB cannot give retrospective approvals for research and can only approve studies before any participant recruiting or data collection has begun.
If you are planning a project that may meet that definition of human subjects research, you should seek IRB approval before you begin any project activities. This leaves you the option of presenting or publishing the study results at a later time. If you collect data from individuals for a class project, a quality improvement project, or other non-research purposes, it can be difficult (and in some cases it would not be possible) to gain permission from individuals for use of their data later as research. To receive IRB approval for use of this data in research, you would either need to demonstrate a plan for gaining informed consent or meet the conditions for a waiver. Plan ahead, and consult with the HSPP if you are not sure about the IRB requirements.
External researchers who wish to recruit study participants from the MSU Denver student, staff, or faculty populations should consult with the HSPP. The HSPP can determine institutional engagement and whether or not MSU Denver’s IRB oversight is required in addition to your own institution. In some cases, our IRB can defer to the IRB of record, and we simply need to acknowledge that oversight and protections are appropriate. When MSU Denver IRB review is required, a MSU Denver faculty or staff member should act as a local PI. The local PI assumes responsibility of the ethical conduct of research for those activities conducted at MSU Denver.
Please be advised that even when MSU Denver’s IRB review is not required for your research, to access students, faculty, or staff through existing classes, programs, services, listservs, etc. you would need permission from the institutional official overseeing that class, program, service, listserv, etc. AND your proposal will need to be reviewed and approved by MSU Denver’s Senior Leadership Group under the direction of the Provost.
The HSPP can help facilitate that process with Senior Leadership. At a minimum, Senior Leadership would expect to see a copy of the IRB approval letter from your institution, copies of the approved study materials (protocol, consent form, etc.), and a cover letter describing the research activities that will take place on our campus and any local permissions you have already obtained.
If you would like to recruit study participants from the MSU Denver community (faculty, staff, or students) please contact the HSPP at 303-605-5282 or [email protected].
The Institutional Review Board (IRB) is seeing an increase in the request to use specific listservs for recruitment of participants into a research study. The IRB is trained and responsible for assessing the risk to human subjects of all research proposals including research design, recruitment and consent processes, data management and confidentiality according to the three principles contained in the Belmont Report and the Code of Federal Regulations (45 CFR 46). https://www.hhs.gov/ohrp/. Upon review and approval of a research proposal that intends to use any internal or external listservs for recruitment, the IRB requests that the Principal Investigator (PI) obtains permission from the owner of the listerv, to encourage responsible use. This step ensures that the IRB carries out its charge and responsibilities to protect human subjects, and also decreases administrative burden on offices who are not trained in assessing the risk to human subjects of research per federal regulations. PIs will be instructed that it is their responsibility to request permission to use a listserv prior to recruitment. The decision to approve this request is up to the individual unit, office, department, etc. that controls the listserv. Approval to use a listserv to distribute recruitment information does not change the PIs responsibility to the protection of the rights and welfare of subjects in human research, including obtaining informed consent of individual subjects.
A research study often requires a team of individuals to accomplish its goals, and individuals have a variety of roles in research (funding acquisition, protocol development, data collection, analysis, etc.). To the IRB, investigators are those individuals who interact with participants and/or have access to identifiable private information for the purposes of the research. This means anyone who gains informed consent, administers a survey, conducts an interview or focus group, collects data from individuals by other means, or is involved in data management or analysis where the data is identifiable to individual participants must be listed in your research protocol as an investigator. Individuals who only have access to de-identified data or results do not have to be listed as an investigator.
There are some exceptions. For example, individuals who distribute recruitment materials, interpreters, professional transcriptionists, etc. may not have to be listed as an investigator on your study. Please discuss the details of your proposed research with the HSPP staff to help determine who needs to be listed on the IRB application and, therefore, complete any IRB requirements for investigators.
For every study submitted to the IRB, one individual who is member of the MSU Denver faculty or staff must be designated as the Principal Investigator (PI). The PI has primary responsibility for the development and implementation of a research protocol and has ultimate accountability for the ethical conduct of the research. Investigators may be identified in the initial IRB application or added later to an approved study through an amendment application. It is the PI’s responsibility to ensure that no individual on their research team interacts with participants for the study or is given access to identifiable private data until they are approved by the IRB as an investigator.
The Collaborative Institutional Training Initiative (CITI) is an online training program developed and published by the University of Miami. All IRBs are tasked with ensuring that the investigators involved in a proposed study are qualified to conduct the research in an ethical manner. Like many institutions, MSU Denver subscribes to the CITI Program and requires investigators in human subjects research studies to complete training modules designated by our institution.
The HSPP has outlined required training modules for researchers involved in social and behavioral research or in biomedical studies. Every investigator (researchers involved with human subjects) listed in your Initial Review Form must complete the required basic course before the study will be reviewed. This basic course includes information on the history of human subjects research, the development of ethical guidelines, risks to participants, informed consent, and protecting privacy and confidentiality. Completion of the basic course is valid for three (3) years, and researchers have an opportunity to complete a refresher course to maintain their certification.
Collaborating researchers from other institutions may submit an alternate training to the MSU Denver CITI required modules. Alternate training must be equivalent to or exceed the MSU Denver required training and must be approved by the HSPP. MSU Denver faculty, staff, and student researcher should complete our training modules.
Maybe. Read the letter carefully for the specific IRB determinations and instructions, as IRB correspondence can reflect a variety of possible determinations. For new studies under review, an IRB determination letter sent to the Principal Investigator may reflect any of the following decisions:
You should also note that all official letters from the IRB regarding reviews and determinations are signed by the IRB Chair. However, the IRB Chair acts as the signatory authority for the Board, but may not be individually involved in the review of your study or involved in preparation of the determination letter. Determination letters are provided to the PI via email from the HSPP. If you have questions, concerns, need corrections on, or assistance with any IRB determination letter you receive, please contact the HSPP at [email protected] or 303-605-5282.
When your study undergoes IRB review, the IRB reviewer may ask for additional information or revisions to your submission materials before approval can be granted. When these are needed, the PI is sent a letter detailing the requests. The modification request letter will also specify that revisions must be submitted within 25 days of the date of the letter to remain under IRB consideration. Because of the high volume of submissions, reviews for studies cannot be pending indefinitely and researchers are expected to respond to IRB requests in a timely manner. If you receive a letter requesting clarifications or revisions to your submission and do not respond within 60 days, your study may be administratively withdrawn from the IRB review process and your materials will need to be re-submitted as a new study.
However, there may be circumstances where you need more time to address the IRB requests (for example, if you are collaborating with researchers from multiple institutions or you are awaiting specific documentation from another office or organization). If you anticipate that will need more time than the 25 day limit, please communicate with the HSPP staff to ensure that they are aware of your circumstances, so they can extend the deadline accordingly.
Identifiable information is any information that may reasonably be expected to identify, contact, or locate a single person, or to identify an individual in context. The most common identifier is a name; but, identifiers can also be birthdates, telephone numbers, biometric identifiers (like finger prints or voice prints), and full face photographic or video images. Numbers assigned to individuals are considered identifiers, including social security numbers, medical record numbers, certification/license numbers, and student ID numbers (900 numbers). For research involving the use of the internet to collect data, email addresses, Web Universal Resource Locators (URLs), and Internet Protocol (IP) address numbers are all identifiable information.
An individual’s title may be sufficient to identify them depending on how it is used or presented. For example, a quote attributed to the “MSU Denver IRB Chair” would be easily identifiable to an individual; where a quote from “an IRB Chair at a higher education institution” would not.
If you are collecting information about an individual’s age, all elements of dates (except year) are identifiable. So, if you ask an individual to provide his/her birthdate on a survey, you are collecting identifiable information. If you ask him/her to provide the year of their birth, their age in years, or to select an age category (e.g. 25 – 35 years of age), this information alone is not generally identifiable.
Information may be identifiable alone or in combination with other available information. When you are collecting detailed demographic information, you should carefully assess whether any combination of that information may be sufficient to identify an individual.
Data or information that is linked to identifiers through a coding system is also considered identifiable.
No. MSU Denver’s 900 numbers are considered identifiers and are protected under the Federal Education Right to Privacy Act (FERPA). No part of a 900 number may be used for the purpose of coding or linking research participants with their data.
900 numbers are treated the same as any identifier (names, birthdates, social security numbers, etc.) in a proposed research study. If you collect 900 numbers, the purpose and risks of collecting this information should be clearly explained in both your Investigator Protocol and in your consent information. Students would need to give written, signed permission for collection of this data. And, the researchers would need to put appropriate measures in place to protect the privacy of subjects and the confidentiality of the data.
You can find out more information on FERPA from the Office of the Registrar.
If your study is already approved by the IRB and you decide to make any changes or additions, you will need to complete and submit a modification (using HRP-213: Modification). This application form allows you to inform the IRB as to the current status of your study and to describe any proposed changes for review.
If your proposed changes involve your research protocol, you will need to include an updated protocol. Any revised supporting materials, such as consent forms, recruitment materials, or data collection instruments (e.g. surveys, questionnaires, etc.) should also be included in your amendment submission packet. When you revise your protocol or other materials, be sure that you are modifying the approved version (and not an earlier draft). Use track-changes, highlight revisions, and/or include a cover letter to direct the IRB reviewer to the modifications. No proposed changes can be implemented in your study until IRB approval is granted for the amendments.
This same application form is used if you need to add new investigators to your study. You will need to confirm with the HSSP that any new investigator has completed the required CITI training or you should provide a copy of the CITI completion certificate.
It depends. IRB oversight is required when the existing data (documents, records, specimens, etc.) is “identifiable private information.” That is, the dataset is not publicly available and subjects (the individual sources of the data) can be identified directly or indirectly by the researchers.
In reviewing a research proposal that involves identifiable private information, the IRB needs to be informed as to how the existing data was originally collected (e.g. for non-research purposes, from a previous research study, etc.) and under what conditions, if any, this information was provided. The researchers must demonstrate that they have the appropriate permissions to access and use this data for the proposed study. This can include secondary use of a researcher’s own data or specimens. Researchers must carefully outline a data management plan to inform the IRB how the data would be treated (e.g. de-identified, coded, etc.) during the analysis and dissemination of results.
If the existing dataset is publicly available or is not identifiable (either directly or indirectly) to individuals, no IRB oversight is required. Please contact the HSPP with any questions on IRB oversight and requirements for research using existing data sets.
The HSPP periodically evaluates the needs of the Institutional Review Board and seeks to add new members as needed. The Institutional Official, as head of the HSPP, is tasked with appointing IRB members and the IRB Chair. When a position becomes available the Institutional Official works with current IRB members and HSPP staff to identify faculty, staff, students, or community members who would meet the needs of the committee.
Federal regulations (45 CFR 46) require an Institutional Review Board to include:
In addition to the requirements for IRB membership by the federal guidelines, the HSPP is also interested in having representation from a variety of disciplines within the University. Members are provided ongoing education and professional development training in human subjects research oversight.
If you are interested in becoming a member of the IRB, please contact HSPP staff at [email protected] or (303) 605-5282.
ADVERSE EFFECT: An undesirable and unintended, although not necessarily unexpected, result of therapy or other intervention. Also referred to as an adverse event. See HRP-214 FORM: Reportable New Information .
AGENT: An institution’s employees or agents refer to individuals who: (1) act on behalf of the institution; (2) exercise institutional authority or responsibility; or (3) perform institutionally designated activities. This can include staff, students, contractors and volunteers, among others, regardless of whether the individual is receiving compensation. A student’s affiliation with an academic institution makes him/her an agent of that institution; and thus the academic institution is engaged in the research regardless of where the research takes place. See HRP-311 WORKSHEET: Engagement Determination and the Human Research Protection Plan .
ALLEGATION OF NON-COMPLIANCE: An unproved assertion of non-compliance. See HSPP Policies & Procedures.
ALTERNATE MEMBER: Alternate Institutional Review Board (IRB) committee members may be designated, as needed, for regular voting members. The appointment of alternate members should be based on expertise similar to that of the regular voting member. An alternate member may vote only when the regular voting member is absent.
AMENDMENT: Any change to an IRB-approved study protocol regardless of the level of review it receives initially. Also referred to as a modification. See HRP-103: Investigator Manual and HRP-213 FORM: Modification .
ANONYMITY: The condition achieved when the identities of subjects are unknown or when the researcher cannot link the data to the individual participant. With anonymity, the researcher does not know subjects’ names or any characteristics that might reasonably lead the researcher (or anyone else) to discover their identities. Compare to confidentiality.
ANONYMOUS DATA: Information that was recorded or collected without any identifiers and no code is assigned that would allow data to be traced to an individual. See identifiable information.
ASSENT: Agreement by an individual not competent to give legally valid informed consent (e.g., a child or adult who is cognitively impaired) to participate in research. See HSPP Policies & Procedures.
ASSURANCE: A formal written, binding commitment that is submitted to a federal agency in which an institution promises to comply with applicable regulations governing research with human subjects and stipulates the procedures through which compliance will be achieved. Also referred to as a federalwide assurance or FWA. See Human Research Protection Plan .
BELMONT REPORT: A statement of basic ethical principles governing research involving human subjects issued by the National Commission for the Protection of Human Subjects in 1978.
BENEFICENCE: An ethical principle discussed in the Belmont Report that entails an obligation to protect persons from harm. The principle of beneficence can be expressed in two general rules: (1) do not harm; and (2) protect from harm by maximizing possible benefits and minimizing possible risks of harm.
BENEFIT: A valued or desired outcome; an advantage.
CHILDREN: Persons who have not attained the legal age for consent to treatment or procedures involved in the research, as determined under the applicable law of the jurisdiction in which the research will be conducted [45 CFR 46.401(a)] . See HRP-416 CHECKLIST: Children .
CLINICAL TRIAL: A biomedical or behavioral research study of human subjects designed to answer specific questions about diagnostic procedures or therapeutic interventions (drugs, treatments, devices, or new ways of using known drugs, treatments, or devices). Clinical trials are used to determine whether new diagnostic procedures or therapeutic interventions are safe, efficacious, and effective.
CLOSURE: Continuing review and re-approval of a study is required so long as the project continues to involve human subjects. When research activities no longer involves subjects or their identifiable data, the study may be closed with the IRB. If the all of the following are true, a study may be closed:
See HRP-212 FORM: Continuing Review and HRP-103: Investigator Manual.
CODE OF FEDERAL REGULATIONS (CFR): Rules published in the Federal Register by the executive departments and agencies of the Federal Government. The CFR is divided into 50 titles that represent broad areas subject to Federal regulation. Each volume of the CFR is updated once each calendar year and is issued on a quarterly basis.
COGNITIVELY IMPAIRED: Having either a psychiatric disorder (e.g., psychosis, neurosis, personality or behavior disorders, or dementia) or a developmental disorder (e.g., mental retardation) that affects cognitive or emotional functions to the extent that capacity for judgment and reasoning is significantly diminished. Others, including persons under the influence of or dependent on drugs or alcohol, those suffering from degenerative diseases affecting the brain, terminally ill patients, and persons with severely disabling physical handicaps, may also be compromised in their ability to make decisions in their best interests.
COMPENSATION: Compensation is primarily a means to offset inconvenience, travel expenses and/or lost revenue due to participation in a research project, however, it may be structured to serve as a recruitment incentive as well. Alternate terms are payment, reimbursement, or remuneration. Compensation also refers to payments or treatments provided for research-related injury. See IRB Guidance on Compensation and HRP-316 WORKSHEET: Payments .
COMPETENCE: Technically, a legal term used to denote capacity to act on one’s own behalf; the ability to understand information presented, to appreciate the consequences of acting (or not acting) on that information, and to make a choice. See also incapacity and cognitively impaired.
CONFIDENTIALITY: Pertains to the treatment of information that an individual has disclosed in a relationship of trust and with the expectation that it will not be divulged to others in ways that are inconsistent with the understanding of the original disclosure, without permission. Compare to anonymity and privacy.
CONFLICTING INTEREST: An individual involved in research review is automatically considered to have a conflicting interest when the individual or the individual’s spouse, domestic partner, children, and dependents have any of the following interests in the sponsor, product or service being tested, or competitor of the sponsor held by the individual or the individual’s immediate family:
See HSPP Policies & Procedures.
CONSENT: See informed consent.
CONTINUING NON-COMPLIANCE: A pattern of non-compliance that suggests the likelihood that, without intervention, instances of non-compliance will recur, a repeated unwillingness to comply, or a persistent lack of knowledge of how to comply. See HSPP Policies & Procedures.
CONTINUING REVIEW: Periodic review of research activities at intervals appropriate to the degree of risk, but not less than once per year. The criteria for approval are defined by federal regulations. See HRP-212 FORM: Continuing Review and HRP-103: Investigator Manual.
DATA COLLECTION INSTRUMENTS: See study instruments.
DATA USE AGREEMENT: An agreement between an institution and the intended recipient of a limited data set that establishes the ways in which the information in the dataset may be used and how it will be protected.
DEBRIEFING: Giving subjects previously undisclosed information about the research following completion of their participation in research activities. Debriefing is often used as an extension of the informed consent process when incomplete disclosure or deception is used. Debriefing may also be used as an educational tool. (Note that this usage, which occurs within the behavioral sciences, departs from Standard English where debriefing is obtaining rather than imparting information.)
DECLARATION OF HELSINKI: A code of ethics for clinical research approved by the World Medical Association in 1964 and widely adopted by medical associations in various countries. It was revised in 1975 and 1989.
DE-IDENTIFIED DATA: Data that has been stripped of all identifiers so that the information cannot be traced back to an individual. De-identified data may also pertain to information that has been assigned and retains a code provided that:
DESIGNATED REVIEWER: The IRB Chair or an experienced IRB member designated to conduct non-committee reviews (e.g., expedited review).
DHHS: Abbreviation for the U.S. Department of Health and Human Services, a federal agency. Also, abbreviated simply as HHS. The DHHS regulations on the Protection of Human Subjects, 45 CFR part 46, include four subparts: subpart A, also known as the Federal Policy or the “Common Rule”; subpart B, additional protections for pregnant women, human fetuses, and neonates; subpart C, additional protections for prisoners; and subpart D, additional protections for children.
DOCUMENTATION: The act or an instance of furnishing or authenticating with documents. Documentation of informed consent includes use of a written consent form (approved by the IRB) and signed and dated by the subject or the subject’s legally authorized representative and, typically, by the person obtaining consent.
ELIGIBILITY CRITERIA: Requirements that must be met, or characteristics that he or she must have, for an individual to be included in a study. These include inclusion criteria and exclusion criteria. For example, a study might only accept participants who are above or below certain ages.
EMANCIPATED MINOR: A legal status conferred upon persons who have not yet attained the age of legal competency as defined by state law (for such purposes as consenting to medical care), but who are entitled to treatment as if they had by virtue of assuming adult responsibilities such as being self-supporting and not living at home, marriage, or procreation.
ENROLLMENT: Occurs when an eligible, prospective subject undergoes the initial informed consent process and voluntarily agrees to participate in a research project. The number of enrolled subjects includes withdrawals.
EQUITABLE: Fair or just; used in the context of selection of subjects to indicate that the benefits and burdens of research are fairly distributed.
EXCLUSION CRITERIA: The factors (or reasons) that prevent a person from participating in a research study.
EXEMPT: Certain categories of human research may be exempt from federal regulation but require IRB review. It is the responsibility of the institution, not the investigator, to determine whether human research is exempt from IRB review. See HRP-103: Investigator Manual and HSPP Policies & Procedures.
EXPEDITED REVIEW: Review of proposed research by the IRB Chair, a designated voting member, or group of voting members rather than by the convened IRB. Federal rules permit expedited review for certain kinds of research involving no more than minimal risk and for minor changes in approved research. See HRP-313 WORKSHEET: Expedited Review .
EXPIRED: When continuing review of the research does not occur prior to the end of the approval period specified by the IRB, IRB approval expires automatically. The study expires on the date specified on the approval letter and the consent document. No activities can occur after the expiration date. Also referred to as a lapsed study or protocol.
FAMILY EDUCATIONAL RIGHTS AND PRIVACY ACT OF 1974 (FERPA): Federal legislation in the United States that protects the privacy of students’ personally identifiable information (PII). The act applies to all educational institutions that receive federal funds. See HRP-331 WORKSHEET: FERPA Compliance .
FOOD AND DRUG ADMINISTRATION (FDA): An agency of the federal government established by Congress in 1912 and presently part of the Department of Health and Human Services. FDA regulations are published as part of chapter 21 of the CFR, and FDA’s human subject protection regulations are in parts 50, 56, 312 and 812.
FINDING OF NON-COMPLIANCE: Non-Compliance in fact.
FULL BOARD REVIEW: Review of proposed research at a convened meeting at which a majority of the membership of the IRB is present, including at least one member whose primary concerns are in nonscientific areas. For the research to be approved, it must receive the approval of a majority of those members present at the meeting.
GREATER THAN MINIMAL RISK: The research involves more than minimal risk to subjects. See minimal risk.
GUARDIAN: An individual who is authorized under applicable state or local law to give permission on behalf of a child to general medical care [45 CFR 46.402(3)].
HEALTH INSURANCE PORTABILITY AND ACCOUNTABILITY ACT (HIPAA): Sets standards and regulations to protect patients from inappropriate disclosures of their protected health information (PHI) that could cause harm to their insurability, employability and their privacy. Also known as “The Privacy Rule.”
HIPAA AUTHORIZATION: A customized document or form that gives permission to use specified protected health information (PHI) for a specific purpose, or to disclose PHI to a third party specified by the investigator other than for treatment, payment or health care operations.
HUMAN RESEARCH: Any activity that either:
See HRP-310 WORKSHEET: Human Research Determination .
HUMAN SUBJECT (as defined by DHHS): A living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual or (2) identifiable private information. See intervention, interaction, identifiable information, and private information.
HUMAN SUBJECT (as defined by FDA): An individual who is or becomes a subject in research, either as a recipient of the test article or as a control. A subject may be either a healthy human or a patient. A human subject includes an individual on whose specimen a medical device is used.
HUMAN SUBJECT IDENTIFIER: Any word, number, symbol, or combination of words, numbers or symbols that can be used by a third party to uniquely identify an individual, such as name, Social Security number, address or patient registration number that is provided for use in a research protocol. See also identifiable information, personally identifiable information, and protected health information.
IDENTIFIABLE INFORMATION: Information that can be linked to specific individuals by the investigator(s) either directly or indirectly through coding systems.
Identifiable information can include, but are not limited to:
Protected Health Information (PHI)
Personally Identifiable Information (PII)
|The Privacy Rule (HIPAA) protects all individually identifiable health information held or transmitted by a covered entity or its business associate, in any form or media, whether electronic, paper, or oral.
PHI is information, including demographic data, that relates to:
and that identifies the individual or for which there is a reasonable basis to believe it can be used to identify the individual. PHI identifiers include:
The Family Educational Rights and Privacy Act (FERPA) specifically defines PII as including, but not limited to:
(a) The student’s name;
(b) The name of the student’s parent or other family members;
(c) The address of the student or student’s family;
(d) A personal identifier, such as the student’s social security number, student number, or biometric record;
(e) Other indirect identifiers, such as the student’s date of birth, place of birth, and mother’s maiden name;
(f) Other information that, alone or in combination, is linked or linkable to a specific student that would allow a reasonable person in the school community, who does not have personal knowledge of the relevant circumstances, to identify the student with reasonable certainty; or
(g) Information requested by a person who the educational agency or institution reasonably believes knows the identity of the student to whom the education record relates.
|Source: HIPAA||Sources: US GSA, FERPA, NIST|
Many demographics (e.g. age, sex, ethnicity, etc.) on their own are not considered identifiable to individual subjects. However, researchers should be aware that a combination of demographic information may be sufficient to identify an individual within a group or a limited population.
Descriptions of personal and highly specific events may be sufficient to identify an individual in a known community even when typical identifiers, like names, are removed.
See also human subject identifier, personally identifiable information, and protected health information.
INCAPACITY: Refers to a person’s mental status and means inability to understand information presented, to appreciate the consequences of acting (or not acting) on that information, and to make a choice. Often used as a synonym for incompetence. See also competence and cognitively impaired.
INCLUSION CRITERIA: The factors (or reasons) that allow a person to participate in a research study.
INFORMED CONSENT: A person’s voluntary agreement, based upon adequate knowledge and understanding of relevant information, to participate in research or to undergo a diagnostic, therapeutic, or preventive procedure. In giving informed consent, subjects may not waive or appear to waive any of their legal rights, or release or appear to release the investigator, the sponsor, the institution or agents thereof from liability for negligence [45 CFR 46.116; 21 CFR 50.20 and 50.25]. In the review and conduct of human research, informed consent refers as much to the process as to any particular form or document. The goal of the informed consent process is to protect participants. It begins when a potential participant first asks for information about a study and continues throughout the study until the study ends. Because giving consent to participate in research is not a contract, participants can leave a study at any time. See HSPP Policies & Procedures and HRP-103: Investigator Manual.
INSTITUTION: 1) Any public or private entity or agency (including federal, state, and local agencies). Or, 2) a residential facility that provides food, shelter, and professional services (including treatment, skilled nursing, intermediate or long-term care, and custodial or residential care). Examples include general, mental, or chronic disease hospitals; inpatient community mental health centers; halfway houses and nursing homes; alcohol and drug addiction treatment centers; homes for the aged or dependent, residential schools for the mentally or physically handicapped; and homes for dependent and neglected children.
INSTITUTIONAL ENGAGEMENT: An institution becomes “engaged” in human research when its employees or agents 1) intervene or interact with living individuals for research purposes, or 2) obtain individually identifiable private information for research purposes. An institution is also considered engaged in human research when it receives a direct Federal award to support the research. See HRP-311 WORKSHEET: Engagement Determination . See also agent.
INSTITUTIONAL OFFICIAL: At MSU Denver, the Associate Vice President of Curriculum and Academic Effectiveness is designated as the Institutional Official and is the Signatory Authority on the University’s federalwide assurance (FWA) with OHRP. Also referred to as the Organizational Official. See Human Research Protection Plan .
INSTITUTIONAL REVIEW BOARD (IRB): A specially constituted review body established or designated by an entity to protect the welfare of human subjects recruited to participate in biomedical or social-behavioral research.
INSTITUTIONALIZED: Confined, either voluntarily or involuntarily (e.g., a hospital, prison, or nursing home).
INTERACTION: Communication or interpersonal contact between investigator and subject.
INTERVENTION: Physical procedures by which data are gathered (for example, venipuncture) or manipulations of the subject or the subject’s environment that are performed for research purposes.
INVESTIGATOR: An individual (researcher, member of the research team, etc.) who interacts or intervenes with subjects for the purposes of the research or who has access to identifiable private information for research purposes. In clinical trials, an individual who actually conducts an investigation [21 CFR 312.3]. See HRP-103: Investigator Manual. See also Principal Investigator.
IRB APPROVAL: The determination of the IRB that the research study has been reviewed and meets the criteria set forth by the IRB, the institution, and other federal, state, and local requirements. See HRP-103: Investigator Manual and HRP-314 WORKSHEET: Criteria for Approval .
IRB AUTHORIZATION AGREEMENT: A formal, written agreement in which the reviewing IRB agrees to serve as the IRB of record for a relying institution, including an academic institution. Agreements are generally used to cover a single research study, categories of research studies, or research studies within a research program.
JUSTICE: An ethical principle discussed in the Belmont Report requiring fairness in distribution of burdens and benefits; often expressed in terms of treating persons of similar circumstances or characteristics similarly.
LEGALLY AUTHORIZED REPRESENTATIVE (LAR): A person authorized either by statute or by court appointment to make decisions on behalf of another person. In human subjects research, an individual or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subject’s participation in the procedure(s) involved in the research. See HSPP Policies & Procedures.
LIMITED DATA SET: A limited data set allows retention of specific elements of identifying private information: geographic subdivisions, town, city, state, ZIP code, dates, age. Limited data sets are not considered to be de-identified information.
MATERIAL TRANSFER AGREEMENT (MTA): A contract that governs the transfer of tangible research materials between two organizations when the recipient intends to use the materials for his or her own research purposes.
MENTALLY DISABLED: See cognitively impaired.
MINIMAL RISK: The probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. [45 CFR 46.102(i)] See HSPP Policies & Procedures.
MODIFICATION: Any change to an IRB-approved study protocol regardless of the level of review it receives initially. Also referred to as an amendment. See HRP-103: Investigator Manual and HRP-213 FORM: Modification .
MONITORING: The collection and analysis of information or data as the project progresses to assure the appropriateness of the research, its design, and subject protections.
MULTICENTER RESEARCH: Research conducted at more than one location and under the jurisdiction of more than one IRB.
MULTI-SITE RESEARCH: Research conducted at more than one location and under the jurisdiction of only one IRB.
NATIONAL INSTITUTES OF HEALTH (NIH): A federal agency within the Public Health Service, DHHS, comprising 21 institutes and centers. It is responsible for carrying out and supporting biomedical and behavioral research.
NONAFFILIATED MEMBER: Member of an Institutional Review Board who has no ties (and whose immediate family has no ties) to the parent institution, its staff, or faculty. This individual is usually from the local community (e.g., minister, business person, attorney, teacher, homemaker).
NON-COMPLIANCE: Failure to follow the regulations, the requirements, and/or determinations of the IRB. See HSPP Policies & Procedures.
NUREMBERG CODE: A code of research ethics developed during the trials of Nazi war criminals following World War II and widely adopted as a standard during the 1950s and 1960s for protecting human subjects.
ORAL CONSENT: A spoken presentation of the elements of informed consent to the prospective subject or their legally authorized representative and received agreement (or refusal). The presentation may be based on information contained within an oral consent script or the written consent document. Oral consent is often associated with waiving the documentation of consent. Oral consent is usually documented in the research project files or, in some cases, may be audio or video recorded. Also referred to as verbal consent.
ORGANIZATIONAL OFFICIAL: See Institutional Official.
PAYMENT: See compensation.
PERFORMANCE SITE: A site where research is performed.
PERMISSION: The agreement of parent(s) or guardian to the participation of their child or ward in research [45 CFR 46.402(c)]. Permission may also be used more generally to refer to the consent of an adult participant or to the assent of a child participant.
PERSONALLY IDENTIFIABLE INFORMATION (PII): In US privacy and security laws, PII refers to information that can be used to distinguish or trace an individual’s identity, either alone or when combined with other personal or identifying information that is linked or linkable to a specific individual. The definition of PII is not anchored to any single category of information or technology. Rather, it requires a case-by-case assessment of the specific risk that an individual can be identified. In performing this assessment, it is important to recognize that non-PII can become PII whenever additional information is made publicly available that, when combined with other available information, could be used to identify an individual. See also identifiable information and FERPA.
PREGNANCY: The period of time from confirmation of implantation of a fertilized egg within the uterus until the fetus has entirely left the uterus (i.e. has been delivered). Implantation is confirmed through a presumptive sign of pregnancy such as missed menses or a positive pregnancy test [45 CFR 46.203(b)]. See HRP-412 CHECKLIST: Pregnant Women .
PRINCIPAL INVESTIGATOR (PI): For the IRB, the Principal Investigator is the individual who assumes overall responsibility for the ethical conduct of the study. MSU Denver’s IRB requires that the Principal Investigator be a member of the University’s faculty or staff. Multiple PIs are not allowed on an IRB submission. Students may not serve as the Principal Investigator on a research study. Submissions to the IRB must be made by the PI and IRB correspondence will be directed to the PI. See IRB Guidance on Investigator Responsibilities and HRP-103: Investigator Manual.
PRISONER: Any individual involuntarily confined or detained in a penal institution. The term is intended to encompass individuals sentenced to such an institution under a criminal or civil statute, individuals detained in other facilities by virtue of statutes or commitment procedures which provide alternatives to criminal prosecution or incarceration in a penal institution, and individuals detained pending arraignment, trial, or sentencing. [45 CFR 46.303(c)]. For Department of Defense (DOD) research the term includes military personnel in either civilian or military custody. See HRP-415 CHECKLIST: Prisoners .
PRIVACY: Control over the extent, timing, and circumstances of sharing oneself (physically, behaviorally, or intellectually) with others. Compare to confidentiality.
PRIVATE INFORMATION: 1) Information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place. Or, 2) information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). [45 CFR 46.102(f)]
PROGRESS REPORT: Details of the study activity during the last approval period. Often requested when submitting for continuation or closure of your active IRB research study. See HRP-212 FORM: Continuing Review and HRP-103: Investigator Manual.
PROTECTED HEALTH INFORMATION (PHI): Individually identifiable health information transmitted or maintained by a covered entity or its business associate [45 CFR 160.103]. PHI and its potential uses in research are described in more detail in the Health Insurance Portability and Accountability Act (HIPAA). See also identifiable information.
PROTOCOL: The written description of a research study. It includes the study’s objectives, design, and methods. It may also include relevant scientific background and statistical information. For IRB review, a protocol should include detailed information about the study population and components of human subjects protections (risks, benefits, recruitment, consent, etc.). See HRP-503a TEMPLATE PROTOCOL: Social-Behavioral .
PROTOCOL DEVIATION: A divergence (unintentional or intentional) from the IRB-approved protocol without significant consequences. A deviation generally (a) does not increase risk or decrease benefit, (b) does not have a significant effect on the subject’s rights, safety, or welfare, and (c) does not impact the integrity of the data. Deviations may result from the action of the subject or the researcher. May also be non-compliance. Protocol deviations should be noted in the research records, but often don not require reporting to the IRB. See HRP-214 FORM: Reportable New Information . See protocol violation.
PROTOCOL VIOLATION: A divergence (unintentional or intentional) from the IRB-approved protocol that (a) increases risk or decreases benefit, (b) affects the subject’s rights, safety, or welfare, or (c) impacts the integrity of the data. May also be non-compliance. See HRP-214 FORM: Reportable New Information . See protocol deviation. (Note: Deviation and violation may be used synonymously, but violation tends to be more serious.)
QUORUM: A majority of voting members of an IRB, including at least one member whose primary expertise is in a nonscientific area.
RE-CONSENTING: Process of notifying research subjects of changes (or new risks, problems, events, etc.) in the research, including documentation of the subject’s continued informed consent through signature on a revised written consent form.
RECRUITMENT: Recruitment, a component of the consent process, is the process of distributing or presenting information that describes the research project and eligibility criteria so that a prospective subject may consider enrollment.
RELATED: An event or issue (e.g., unanticipated problem, side effect, etc.) is “related” if in the opinion of the investigator it is likely to have resulted from participation in the research study.
REPORTABLE NEW INFORMATION: Categories of information that require immediate or timely reporting to the IRB for review and determination. Includes, but is not limited to, information that indicates a new or increased risk to subjects or others, non-compliance, audits, unresolved complaints, and other unanticipated problems, events, acts, or omissions. See also unanticipated problem involving risks to subjects or others. Refer to page two of the HRP-214 FORM: Reportable New Information for a comprehensive list.
RESEARCH (as defined by DHHS): A systematic investigation, including research development, testing and evaluation designed to develop or contribute to generalizable knowledge. [45 CFR 46.102(d)]
RESEARCH (as defined by FDA): Any experiment that involves a test article and one or more human subjects, and that meets any one of the following:
Note: FDA-regulation of research is not dependent on funding or funding sources.
RESEARCH MISCONDUCT: Any fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results. Research misconduct may or may not be non-compliance. See MSU Denver’s “Research Misconduct Policy and Procedures” available on the ASA Policy Manual webpage.
RESPECT FOR PERSONS: An ethical principle discussed in the Belmont Report requiring that individual autonomy be respected and that persons with diminished autonomy be protected.
RESTRICTED: Applies to investigators who are delinquent in meeting IRB requirements.
RISK: The probability of harm or injury (physical, psychological, social, or economic) occurring as a result of participation in a research study. Both the probability and magnitude of possible harm may vary from minimal to significant. Federal regulations define only “minimal risk.” See also minimal risk.
SERIOUS NONCOMPLIANCE: Noncompliance that adversely affects the rights and welfare of subjects. Serious noncompliance may also affect the subject’s willingness to participate in research or may affect the integrity of the data. In some cases, may also be research misconduct. See HSPP Policies & Procedures.
SHORT-FORM CONSENT PROCESS: A short form consent process is used with IRB approval when a subject or the subject’s legally authorized representative cannot read the standard written consent form. The short form consent document states the elements of consent that are presented orally and is translated into the appropriate language. The short form consent process requires a witness (and in some cases an interpreter or translator) and has specific requirements for documentation of consent. See HRP-317 WORKSHEET: Short Form of Consent Documentation .
STUDY INSTRUMENTS: Examples of study instruments include, but are not limited to:
Copies and/or detailed descriptions of all study instruments are required in the initial review, and submitted materials (and versions) are noted in the IRB approval. Proposed changes to approved study instruments must be submitted via a modification and must be reviewed and approved by the IRB before any changes are implemented. See HRP-103: Investigator Manual.
SUBJECTS: May also be referred to as participants. See human subjects.
SUSPENSION OF IRB APPROVAL: An action of the IRB, IRB designee, Organizational Official, or designee of the Organizational Official to temporarily or permanently withdraw IRB approval of some or all research procedures short of a Termination of IRB Approval. Suspended studies remain open and are subject to continuing review. See HSPP Policies & Procedures.
TERMINATION OF IRB APPROVAL: An action of the IRB, IRB designee, Organizational Official, or designee of the Organizational Official to permanently withdraw IRB approval of all research procedures. Terminated studies are permanently closed and no longer require continuing review. See HSPP Policies & Procedures.
UNANTICIPATED PROBLEM INVOLVING RISKS TO SUBJECTS OR OTHERS: Any information that is 1) unanticipated and 2) indicates that subjects or others are at increased risk of harm. See HSPP Policies & Procedures and HRP-214 FORM: Reportable New Information .
VERBAL CONSENT: See oral consent.
VOLUNTARY: Free of coercion, duress, or undue inducement. Used in the research context to refer to a subject’s decision to participate (or to continue to participate) in a research activity.
WARD: A child who is placed in the legal custody of the state or other agency, institution or entity, consistent with applicable federal, state or local law. See HRP-416 CHECKLIST: Children .
WITHDRAWAL: A subject who enrolled (i.e., consented to participate) but later withdrew from (i.e., discontinued his or her participation in) a study, either before, during, or after completing research procedures. For a variety of reasons, a subject enrolled in a research study may decide to withdraw from the research, or an investigator may decide to terminate a subject’s participation in research regardless of whether the subject wishes to continue participating (e.g., for non-compliance with research procedures). Withdrawals do not include individuals who failed initial eligibility screening.