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U-M HRPP Fully Re-accredited as of June 2021!
AAHRPP has officially re-accredited U-M's Human Research Protections Program (HRPP). Thank you to everyone who participated in the 2021 AAHRRP Re-accreditation site visit. The AAHRPP determination reconfirms the U-M HRPP's dedication to continual program improvement to protect human research participants and to facilitate the regulatory oversight of human research at U-M.
AAHRPP is an independent accrediting organization that uses a peer-driven evaluation and education process to ensure institutional Human Research Protection Programs, such as U-M's HRPP, establish and maintain rigorous standards of protections for human research participants.
AAHRPP accreditation is a signal to our research community, our worldwide collaborators, and our research sponsors that U-M strives to protect human research participants through the continual improvement of the ethical and professional conduct of research.
U-M's 2021 AAHRPP re-accreditation process is complete with the HRPP earning Full Accreditation! This effort, organized by the Office of Research Compliance Review (ORCR), involved a select representation of U-M Principal Investigators and study team personnel, the U-M IRBs, and the U-M HRRP component units.
U-M's HRPP has maintained AAHRPP accreditation since 2008. Re-accreditation demonstrates to AAHRPP and to ourselves that we provide superior protection to the human participants of U-M research!
AAHRPP Council granted full re-accreditation to the U-M HRPP in June 2021. In its review of the site visit report on our strengths and suggestions for improvements, the Council determined that the U-M HRPP:
- Met all of the AAHRPP's evaluation criteria;
- Demonstrated appropriate documentation of its self-assessment activities; and
- Is not required to submit subsequent progress reports to AAHRPP.
AAHRPP Site Visit
The site visit was conducted through a series of interviews designated to evaluate how well U-M practices the ethical and regulatory-required human subjects protections as outlined in the Common Rule, the HRPP Operations Manual, the IRB standard operating procedures, and other federal, state or local guidelines.
Dates: March 23 and 24, 2021
Location & Time: Virtual site visit using Zoom videoconferencing. Each interviewee received a meeting link with video/audio call directions. Each interview was scheduled at a specific time.
Results: Due in the summer of 2021
Preliminary Site Visit Outcome
Site visit observations help U-M to continuously improve its HRPP processes and guidelines. While U-M awaited the official findings and accreditation notification from the AAHRPP Council, we started to build upon the site visitor's preliminary insights into our HRPP strengths and areas of improvement.
- Commitment and support for our HRPP, as evidenced through the knowledge, dedication, and professionalism of our researchers, research staff, HRPP unit representatives, and U-M leadership;
- IRB Office resources;
- Online training resources for the continuing education of human research protections;
- High level of engagement by the HRPP Component Units; and
- Strong, well-developed ancillary review committees
Opportunities for Improvement
One minor observation was noted related to the documentation of the HRPP’s self-assessment activities. Efforts are underway to address and strengthen this area.
Site Visit Preparation & Re-accreditation Process
January - March
Early preparation for the site visit was key to our success! The AAHRPP re-accreditation team encouraged the research community to start by:
Re-familiarizing yourself with the updated HRPP Operations Manual.
Downloading and reviewing the preparation materials and interview guidance for your role(s) from M+Box. See the References & Resources section below for links.
More resources and preparation guidance will be made available on this webpage and in the M+Box folders throughout the re-accreditation process. Revisit this webpage frequently for updates.
April - June and Beyond
Continue to follow HRPP policy and guidance to protect the human participants of your research.
As official findings from the site visit are released, the AAHRPP re-accreditation team will provide information on its improvement efforts through this and other applicable HRPP webpages.
AAHRPP, the Association for the Accreditation of Human Research Protection Programs, Inc., is an independent organization that reviews and accredits institutions engaged in human subjects research to protect the rights and welfare of the research participants.
AAHRPP accreditation bolsters the university’s reputation as a leader in human subjects research. Research sponsors and other research partners increasingly consider AAHRPP accreditation before pursuing collaborations, or providing funding, for research.
February 2021. The AAHRPP re-accreditation team will announce the interview schedule for the March site visit and send out meeting invitations to the selected participants in February.
AAHRPP is a peer-driven review process. The site visitors will be human subjects researchers and institutional officials from peer institutions assembled by AAHRPP based on their expertise and experience in a similar research setting.
Biographies of the site visitors for U-M's 2021 re-accreditation are available on M+Box (UMICH login required).
The U-M Human Research Protection Program (HRPP) is an an integrated university-wide program that supports all those who are involved in human subjects research in some way at U-M - from study coordinators to the Vice President for Research.
The HRPP's central central charges are:
- To protect the rights and welfare of human research participants by promoting compliance with ethical and regulatory standards promulgated by the:
- Belmont Report
- The Federal Policy for the Protection of Human Subjects (aka "Common Rule")
- Office of Human Research Protections (OHRP)
- Food and Drug Administration (FDA)
- Good Clinical Practice Guidelines (GCP)
- To facilitate U-M human subjects research by providing resources, support, and education.
For details visit the HRPP website at: https://research-compliance.umich.edu/human-subjects.
The University of Michigan Office of Research (UMOR) coordinates the U-M Human Research Protections Program (HRPP) with collaboration from the following offices and more:
- U-M IRB offices
- Office of Research Compliance Review (ORCR)
- Office of Research and Sponsored Programs (ORSP)
- Michigan Institute for Clinical and Health Research (MICHR)
For a complete list, see the HRPP Operations Manual, Part 2 - Organization