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The IRB review process takes time and research protocols are reviewed on a first-come, first-serve basis. The IRB’s ability to conduct a timely review of your research is very dependent on the quality and clarity of your submission. Please plan accordingly and develop a clear and detailed research plan.
Documents required for review include:
-Review form (ex: HRP 211)
-Survey/Questionnaire and/or Qualtrics link
-Recruitment Materials (email, flyers, etc.)
The Principal Investigator and members of the research team are required to complete the CITI Program training.
If the CITI training requirement is not complete for all research personnel involved with human subjects in your study, your application is deemed incomplete and cannot be processed for IRB review.
This includes any researcher who:
• obtains information about living individuals by intervening or interacting with them for research purposes
• obtains identifiable private information about living individuals for research purposes
• obtains the voluntary informed consent of individuals to be subjects in research; and/or
• is studying, interpreting, or analyzing identifiable private information or data for research purposes.
To submit materials for IRB review, the Principal Investigator must register with IRBNet.org, the online document management system used by the HSPP to receive and process IRB submissions and reviews. At MSU Denver, the Principal Investigator must be a member of the faculty or staff.
Detailed instructions on how to use IRBNet for project submissions is available further down this page.
Once you register with IRBNet, you can access the library for submission materials, including application forms and templates. These materials are also available on this webpage. For any new project, the best place to start is the HRP-103: Investigator Manual. This manual will guide you on the requirements for submissions. For a new project, your submission packet is comprised of the HRP-211 FORM: Initial Review , your research protocol, and all relevant and requested supplements (informed consent forms, study instruments, recruitment materials, grant information, etc.).
Will you be conducting research at a school, public or private agency, or collaborating with an organization?
A letter of cooperation, authorization, or support to conduct research may be required. In many cases, the IRB needs documentation that the researchers have permission to conduct the study in a specific setting. These documents can sometimes take time to get, so plan ahead. Some organizations or institutions may also require their own ethics or IRB review process in addition to MSU Denver’s IRB review and approval. Multiple review processes can occur concurrently in many cases.
Are you proposing to recruit students from MSU Denver classrooms or student organizations?
Classes or student groups that are targeted for recruitment must be directly relevant to the proposed research and not simply a matter of convenience for the investigators. In some studies, the IRB may request documentation of permission from the course instructor or faculty or staff advisor that he/she is aware of the study and what is being asked of the students. As there are specific considerations of potential coercion or undue influence with recruiting students into a study, researchers are advised to clearly outline the measures they are taking to minimize this risk in their submission materials.
Use of Listservs
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.
Many researcher questions will be answered in the Investigator Manual, by completing the required CITI training, and by reviewing the information on the IRBNet training webpage. If you are unsure what information to include in your protocol, how to create a good consent form for your study, or need guidance on the submission process, please ask. The HSPP staff welcomes your questions and can provide assistance before and throughout the IRB review process!
Researchers (faculty, staff, and students) can make an appointment with HSPP staff to consult on their IRB application prior to submission or during the IRB review process. Please email the HSPP with questions or for a consultation ([email protected]). This is a great opportunity to learn about the requirements for IRB approval and will make subsequent applications to the IRB easier.
All requests for IRB review should be submitted through IRBNet.
Submissions will NOT be accepted through the HSPP email or any other method other than via IRBNet.
Submission materials should be complete and documents should be clearly titled. Instructions for submitting materials for IRB review can be found in the Investigator Manual and on the IRBNet Training page.
A note on HSPP application forms that require a “signature”: There is no requirement to provide a hand-signed, scanned copy on any IRB submission materials. Your ‘electronic’ signature (typed name) is sufficient for all application materials in the submission process.
CITI courses are intended to provide researchers (faculty, staff, and students) with an overview of human subjects research and protections. The CITI training is the minimum requirement for researchers who are submitting materials for IRB review. Basic course trainings are valid for 3 years from completion.
Are you new to the CITI program?
1. Go to the CITI website (www.citiprogram.org) and register as a new user.
2. To complete CITI training, you must be affiliated with a participating institution. Please select “Metropolitan State University of Denver” from the participating institutions dropdown list.
3. You will need to create a user name and password. Keep track of this information as it will allow you to log in and out of the program and complete the training modules at your own pace.
4. The program will ask you if you will be requesting CME/CEU credits for the course(s) you are about to complete. Choose “No” for this question, so the training is free.
5. Fill out all the required fields, including your institutional email address (@msudenver.edu).
6. When you select your curriculum, in Question 1 for Human Subjects Research learner groups (see below), most researchers at MSU Denver are conducting social and behavioral research and should select that learner group. The course that you will complete is the “Social & Behavioral Research – Basic/Refresher”, unless you are conducting biomedical research.
If you have any questions on the type of research you may be conducting and what CITI training modules would best apply to your studies, please contact the HSPP.
7. For ALL other questions under the curriculum choices (Questions 2- 6), select “Not at this time” or simply leave the choices unchecked when “Not at this time” is not an option.
Please Note: Researchers are welcome to add and complete other courses and training in the CITI program, but only the basic course in Human Subjects Research is required for IRB submissions. Once you register for the CITI program, you can always change learner groups or additional modules later. This is helpful for researchers who may need to complete additional training in CITI for other MSU Denver offices or programs. It is recommended that ALL researchers complete a Responsible Conduct of Research course which includes a training module on Conflicts of Interest.
8. The program will ask you if you want to register with another institution (besides Metropolitan State University of Denver), please select “No.”
9. The Basic Course should appear under your course list in the Main Menu. Follow the link to access the individual modules. The Main Menu will show you the status of the training and allow you to access a completion report when the training is complete. You may log out of the training at any time and the program will keep track of the modules you have already completed. The optional modules are optional and do not count towards your completion report.
10. Once you have completed all the required modules in the training (including quizzes), you will be granted a completion report. The CITI basic course training is valid for 3 years.
As a courtesy, the CITI program will alert you to expiring training via email and provide access to a refresher course as you near the expiration date.
It is your responsibility to ensure that the required training is complete and current when submitting to the IRB and conducting human subjects research.
Accessibility: According to the CITI Program website, the course modules are compatible to screen readers. In addition to English, many of the courses are available in the following languages: Chinese, French, Korean, Japanese, Portuguese, Russian, Spanish, and Thai.
Who needs to complete the required training?
The Principal Investigator and ALL research personnel involved with human subjects in your study. This includes any researcher who:
For research teams that involve external investigators (from other institutions or community members), the PI may provide alternate, comparable training for HSPP consideration.
CITI Human Subjects Research Learner Groups for MSU Denver include:
Social & Behavioral Research Investigators: This Human Subjects Research basic course is required for all members of a research team when submitting a social-behavioral research protocol to the MSU Denver Institutional Review Board. MOST researchers at MSU Denver fall into this learner group.
Biomedical Research Investigators: This Human Subjects Research basic course is required for all members of a research team when submitting a biomedical research protocol (e.g., clinical trial, drugs, devices) to the MSU Denver Institutional Review Board.
Research with Biomedical Data or Laboratory Specimens ONLY: This Human Subjects Research basic course is required for all members of a research team when submitting a protocol involving data repository or laboratory specimen research to the MSU Denver Institutional Review Board.
IRB Members: These training modules are required for all members of the Institutional Review Board.
CITI Training Affiliation
Please Take Note: As you register for the CITI program, make sure your affiliation is with “Metropolitan State University of Denver” and not simply “Metropolitan State University.”
If you are not associated with the correct institution, you cannot access MSU Denver’s required training modules.
This manual outlines the submission process throughout the life cycle of a study and should be referred to when you have questions.
HRP-211 FORM: Initial Review This form is REQUIRED for a new study submission for IRB review.
HRP-212 FORM: Continuing Review This form is REQUIRED for all continuing review and final review (closure) submissions.
HRP-213 FORM: Modification This form is REQUIRED for all modifications/amendments to IRB-approved studies.
HRP-214 FORM: Reportable New Information This form is REQUIRED for any new information submission to the IRB, such as a report of an unanticipated problem or adverse event. Refer to page two of the form for specific examples.
A note on HSPP application forms that require a “signature”: There is no requirement to provide a hand-signed, scanned copy on any IRB submission materials. Your typed name is sufficient for all application materials in the submission process, and the form is associated with your (the Principal Investigator’s) unique profile and access in IRBNet.
A note on multiple requests for the same study: For approved research, a modification request, continuing review, and new information report require separate IRB review processes and different forms. Modifications and Continuing Review applications must be submitted as separate packages in IRBNet for processing and review.
Templates are tools that may be used to develop materials for your study. There is no requirement to use these exact formats for your submission. However, all researchers are encouraged to review the templates for content and language that may be relevant to your research and may be considered during IRB review.
HRP-503a TEMPLATE PROTOCOL: Social-Behavioral This template can help you build a research protocol that includes information considered by the IRB during the review process. Your research protocol is the key document in your submission package that should be supported by all supplemental materials.
UNIVERSAL CONSENT TEMPLATE This template should be utilized by most research studies performed at MSU. This can be used for anonymous surveys, as well as when collecting identifiable data. This template can be adapted to best fit your research and subject population.
HRP-502c TEMPLATE CONSENT DOCUMENT: Release Form for Images and Recordings For some studies, a separate release form may be appropriate to gain specific permissions for data collection through photography, video-recording, and/or audio-recording. This template may be edited to fit your research. In other studies, the researchers may integrate language and permissions for this type of data collection into their consent form.
HRP-502d TEMPLATE CONSENT DOCUMENT: Assent Templates This template provides guidance on drafting verbal scripts and/or written assent forms for gaining permission from child participants.
HRP-502e TEMPLATE CONSENT DOCUMENT: Parental Consent For studies that involve child participants, this template can be used to develop a consent document for parents.
HRP-502f TEMPLATE CONSENT DOCUMENT: Adult Unable to Consent For studies that involve adult participants who are unable to consent, this template may be used to develop a consent document for legally authorized representatives (LAR).
HRP-507 TEMPLATE CONSENT DOCUMENT: Short Form A short form is required when gaining consent from subjects who cannot read an English consent form.
***If you do not see a consent template that you think will best suit your needs, please contact HSPP for further assistance.
HRP-504 TEMPLATE LETTER: School Permission to Conduct Research This templates provides example language for permission to conduct research in a school setting.
IRB forms and templates are also available in the IRBNet Library.
Please Note: The IRB website and IRBNet library contains forms and templates most commonly used by MSU Denver investigators, primarily for social-behavioral research. The HSPP staff can provide you with forms and templates for biomedical research (clinical trials, research with drugs or devices, etc.) if needed.
To access IRBNet, go to www.irbnet.org.
A note on Training & Credentials for IRB submissions: The IRB requires the Principal Investigator to provide a current curriculum vitae (CV) or résumé with submissions. This can be simply uploaded to your profile and submitted to the IRB. Your CITI completion report can also be uploaded to your profile and submitted. Researchers can also review this information, IRBNet: How to Upload CV & CITI Training, for specific questions on managing training and credentials in IRBNet.
When you build submission packages in IRBNet, create and upload your study materials as distinct documents within your submission package (e.g., research protocol, consent form, questionnaire, etc.). Clearly title each document and keep track of version numbers (or version dates).
TIP#1: Once a study is created in IRBNet, follow the guidance for managing submitted projects to add subsequent packages for further activities (continuing reviews, modifications, etc.). The idea is to keep the same six-digit assigned IRBNet number for the study. The submission package is noted each time following the six-digit number. For example, your new study can be assigned the number 654321-1. A subsequent revision would receive the number 654321-2. Then a continuing review would receive the next package number 654321-3. And so on…
TIP#2: Each activity that requires an IRB form (initial review, continuing review, modification, reportable new information) also requires a separate submission package in IRBNet. If you are submitting for continuing review and proposing a modification at the same, these activities should be submitted in IRBNet as two separate submission packages for the same project.
TIP#3: To better manage study documents in IRBNet, create and upload your study materials as distinct documents within your submission package. Clearly title each document and keep track of version numbers (or version dates). This way, you can more easily make requested or needed revisions to documents and manage your approved materials. An example: