Institutional Review Board & Human Subjects Protection Program

The Human Subject Protection Program (HSPP) provides professional support to MSU Denver’s Institutional Review Board (IRB).  IRB oversight is an essential component of human subjects protection.  The Review Board is composed of members of the MSU Denver faculty and staff and the community at-large.  Members of the IRB are tasked with protecting the rights and welfare of participants in research studies.

The IRB reviews and makes determinations on proposed human subjects research that is conducted by or in collaboration with MSU Denver faculty, staff, and/or students.  The IRB follows regulatory requirements and the ethical principles of Respect for Persons, Beneficence, and Justice in reviewing research that involves participants and/or identifiable private information.

If your research project is conducting a systematic investigation with human subjects and you hope to disseminate your findings to outside parties, you should consult the HSPP beforehand regarding the IRB process.

Please contact [email protected] with any IRB related questions, we are here to support your research!

The cornerstone of the Human Subject Protection Program (HSPP) efforts is the establishment of MSU Denver’s Human Research Protection Plan, signed by former President Jordan on September 19, 2014.

The University’s HRP Plan is a comprehensive system to ensure the protection of the rights and welfare of subjects in Human Research.  The protection of human subjects relies on ALL individuals at this University, along with key individuals and committees, to fulfill their roles and responsibilities described in this plan.  The Human Subjects Protection Program (HSPP) serves as the administrative unit of this institutional plan to ensure that it functions effectively.

WE ARE HERE TO HELP YOU CONDUCT RESEARCH AT MSU!!!

The HSPP serves as a resource for MSU Denver researchers (faculty, staff, and student investigators), for research participants or for individuals considering participation in research, and for members of the Institutional Review Board (IRB).  Through the HSPP, individuals can learn about the ethical conduct of human subjects research, understand and implement regulatory requirements and standards in their studies, and successfully navigate the IRB review process and requirements throughout the life of their study.

The HSPP receives all submissions to the IRB, assigns studies for review, and facilitates the process for both researchers and IRB reviewers.

Researchers are encouraged to consult with the HSPP during the development of their IRB submission and to engage with the HSPP during the review process for any assistance needed.

Please visit our Researcher Materials & Resources page for access to templates to help you complete your submission.

The HSPP also coordinates outreach activities and provides workshops to train and inform researchers on the ethical conduct of human subjects research and the IRB process.  Please contact us if you are interested in holding a workshop or training for your class or department!

IRB Virtual Office Hours

The HSPP offers IRB Q&A sessions via Teams every other Friday from 11:30am until 12:30pm.  Please drop in at any time during this hour to ask anything IRB related.

Questions about Cayuse?  Not sure how to consent students properly in a classroom setting?  Want to know how long it will take to obtain approval?  Or maybe it will be your first IRB submission and you just don’t know where to start…IMMEDIATE answers are here!

CLICK HERE TO JOIN

Spring ’26 Virtual Office Hour begins Friday, January 16th.  Please join us every other Friday for IRB related help.

The HSPP works to ensure that the review and conduct of human subjects research is in compliance with regulations and standards.  These tasks include developing, implementing, and evaluating policies and procedures that meet the terms of our Federalwide Assurance (FWA).  The FWA is the institution’s agreement with the federal government on the conduct and oversight of human subjects research.  Our OSRP Director, Laneika Musalini, serves as the signatory authority on the FWA and oversees the Human Subject Protection Program and the administrative support of the IRB.

The HSPP actively consults and collaborates with University departments, programs, and offices to ensure that the IRB and researchers comply with institutional policies, sponsor requirements, and federal regulations that govern the conduct of human subjects research.  The HSPP and the IRB take a collaborative approach with researchers to ensure that any concerns of noncompliance are appropriately addressed, that corrective actions are developed to protect current and future participants, and that reporting requirements are met both within and outside of the institution.

Federalwide Assurance (FWA) & HHS IRB Registration

Through the FWA, an institution commits to the U.S. Department of Health and Human Services (HHS) that it will comply with the requirements in the HHS Protection of Human Subjects regulations at 45 CFR part 46.

MSU Denver’s FWA#: FWA00010020   

Expires: 09/16/2027

Each FWA must designate at least one IRB registered with OHRP.  MSU Denver’s Institutional Review Board is registered with HHS.

IORG #: IORG0004531   

Expires 03/12/2028

HHS IRB Registration #:  IRB00005388

Definition/Purpose

A Data Use Agreement (DUA) is a contractual document between a “Data User” (usually the MSU Denver investigator requesting access to information) and the “Data Set Source” (the organization or institution providing the data) describing the provisions associated with the transfer of confidential, protected , or restricted-use data. Examples include records from governmental agencies or corporations, student records information, existing human research subjects data, and limited data sets.

DUAs address important issues such as limitations on use of the data, liability for harm arising from the use of the data, publication, and privacy rights that are associated with transfers of confidential or protected data. The DUA also assures that Data Users are using the data in accordance with applicable law (e.g. HIPAA, FERPA) and prevents the inappropriate use of protected or confidential data that could cause harm to the investigator, the University, or individuals whose data is part of the data set.

In general, a Data Use Agreement includes:

• What data will be released or shared
• Who has ownership of the data
• What, if any, identifiers will be included
• The purposes for which the data may be used
• With whom, if anyone, the data may be shared
• Data security and safeguards
• To whom violations of the agreement should be reported
• The term of the agreement
• The disposition of the data at the end of the agreement
• Any indemnification or insurance requirements

IRB & Human Subjects Research

DUAs are commonly used when a researcher wishes to access archives or restricted data sets that may contain identifiable information about individuals for the purpose of conducting such projects. The IRB must be contacted if the use of the archived protected health data falls under the IRB’s definition of “research.”

When a DUA is a part of the project submitted to the IRB, a draft version must be included in the protocol application. The IRB may provide conditional approval of a protocol if it is needed in order to get a DUA signed, but final IRB-approval will not be granted until a copy of the signed DUA is submitted to the IRB.

For more information on the connections between DUAs & IRB/Human Subject Research, please contact us at [email protected].

In January 2019, the U.S. Department of Health and Human Services (HHS), and 15 other federal agencies, issued a final rule to update regulations that safeguard individuals who participate in research.

The new rule strengthens protections for people who volunteer to participate in research, while ensuring that the oversight system does not add inappropriate administrative burdens, particularly to low-risk research. It also allows more flexibility in keeping with today’s dynamic research environment.

The final rule will now generally expect consent forms to include a concise explanation – at the beginning of the document – of the key information that would be most important to individuals contemplating participation in a particular study, including the purpose of the research, the risks and benefits, and appropriate alternative treatments that might be beneficial to the prospective subject.

The final rule also removes the requirement to conduct continuing review of ongoing research studies in certain instances where such review does little to protect subjects.

Metropolitan State University of Denver has adopted these changes to the review of research involving human subjects. If you have any questions, please contact the HSPP Manager at 303-605-5282 or [email protected].