In the last year, the Human Subjects Protection Program (HSPP) has made great strides in ensuring that the conduct and oversight of MSU Denver research involving human subjects is ethical and in compliance with federal regulations. The protection of research participants relies on the efforts of everyone involved in this process – the researchers, the Institutional Review Board (IRB), and the University. This summer, the HSPP adopted and developed new resources for both researchers and IRB members to make the IRB review process more efficient and effective.
Beginning August 25th, a comprehensive set of HSPP policies and procedures will be posted on the IRB website. This IRB “toolkit” contains new forms, worksheets, and checklists that are designed to work efficiently together and to keep us in compliance with federal regulations. Beginning next week, previous versions of IRB forms will not be accepted for review. Prior to developing a new study or project, researchers should refer to the IRB website for the most current requirements for submission.
In addition, the HSPP is now subscribing to IRBNet, an online document management system that will be used to receive submissions and document reviews in a confidential and efficient manner. We are currently integrating the IRB toolkit with this online system and will ‘go live’ with IRBNet on Monday, August 25th. Beginning next week, submissions will no longer be accepted via the HSPP email. Instructions for registering with and using IRBNet will be available on the IRB website on Monday. As submissions to the IRB are to be made only by a faculty or staff Principal Investigator, students will not be allowed to register or submit through IRBNet.
Anyone who needs assistance during this transition should contact the HSPP at email@example.com. Thank you for your patience and cooperation in this transition.
The Human Subjects Protection Program (HSPP) at MSU Denver
The HSP Program serves three primary functions...
The HSPP provides professional support to the 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.
Resources and Administrative Support:
The HSPP serves as a resource for MSU Denver faculty, staff, and student researchers. 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. HSPP staff receive submissions to the IRB, assign studies for review, and facilitate the process for both researchers and IRB reviewers. Researchers are encouraged to consult with the HSPP Coordinator in the development of their IRB submission packets and to engage with the HSPP staff during the review process for any assistance needed. 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.
The HSP Program 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. The Associate Vice President of Curriculum and Academic Effectiveness, Dr. Rae Shevalier, is the signatory authority on the FWA and oversees the HSP Program and the administrative support of the IRB. The HSPP and 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.
Contact the Human Subjects Protection Program at firstname.lastname@example.org or 303-352-7330.
Metropolitan State University of Denver
Federalwide Assurance (FWA) for the Protection of Human Subjects
FWA#: FWA00010020 Expires: 11/05/2018
U.S. Department of Health and Human Services (HHS) Registration of an Institutional Review Board
IORG #: IORG0004531 Expires 03/31/2017