Revised Common Rule UPDATE
In January 2017, 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.
Effective immediately, Metropolitan State University of Denver will adopt these changes to the review of research involving human subjects. If you have any questions, please contact the HSPP Manager, Mike Heathcote at 303-605-5282 or firstname.lastname@example.org.
The Human Subjects Protection Program (HSPP) at MSU Denver
The cornerstone of 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.
The 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.
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.
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 staff 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 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. The Associate Vice President of Curriculum and Academic Effectiveness, Dr. Chad Harris, is the signatory authority on the FWA and oversees the Human Subject Protection Program and the administrative support of the IRB.
HSPP staff members actively consult and collaborate 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.
Through the Federalwide Assurance (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: 05/12/2022
Each FWA must designate at least one IRB registered with OHRP. MSU Denver's Institutional Review Board is registered with HHS.
IORG #: IORG0004531 Expires 03/9/2019
HHS IRB Registration #: IRB00005388