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AAHRPP Re-Accreditation

AAHRPP Site Visit concluded!   Thank you to everyone who participated in the 2021 AAHRRP Re-accreditation site visit.  Preliminary feedback from the site visitors was complimentary to our research community's engagement in, and dedication to, the protection of human research participants.  Official accreditation results are expected this summer.
AAHRPP March 2021 Site Visit Dates

AAHRPP Accreditation

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 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 now underway!  This effort, organized by the Office of Research Compliance Review (ORCR), involves 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 Site Visit 

The site visit is 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. 

AAHRPP accreditation sealKey Information

DatesMarch 23 and 24, 2021

Location & Time:  Virtual site visit using Zoom videoconferencing.  Each interviewee will receive a meeting link with video/audio call directions.  Each interview will be scheduled at a specific time.  

Results:  Due in the summer of 2021

Preliminary Outcome

Site visit observations help U-M to continuously improve its HRPP processes and guidelines.  While U-M awaits the official findings and accreditation notification from the AAHRPP Council this summer, we can start to build upon the site visitor's preliminary insights into our HRPP strengths and areas of improvement.  

Strengths

  • 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 is key to success!  Start by:

Number 1 icon

Refreshing your knowledge of the U-M HRPP and the HRPP policies and guidance.

Number 2 iconRe-familiarizing yourself with the updated HRPP Operations Manual.

Number 3 iconReviewing the IRB process information on our websites:  IRB-HSBSIRBMED, U-M Dearborn, and U-M Flint

Number 4 iconDownloading 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.

FAQs

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:

For a complete list, see the HRPP Operations Manual, Part 2 - Organization

References and Resources

All Interviewees

  • All Interviewees - AAHRPP Site Visit Guidance Link to M+Box folder containing general resources for all U-M interviewees participating in the AAHRPP site visit interviews.  U-M login (Level 1) required.
  • HRPP U-MIC Download the University of Michigan IRB Collaborative (U-MIC) presentation (with audio) describing U-M's Human Research Protection Program (HRPP) ~ 3 minutes.
  • AAHRPP U-MIC Download the University of Michigan IRB Collaborative (U-MIC) presentation (with audio) describing the AAHRPP re-accreditation process (~ 6 minutes).  Last Updated:  November 2020
  • AAHRPP Re-accreditation: All You Need to Know! Webinar slides outlining the AAHRPP accreditation process, tips on what to expect during the site visit and preparation resources.  The webinar (recorded 01/26/2021) can be viewed at: https://sites.google.com/umich.edu/frankel-c3rg/past-seminar-schedule.

Principal Investigators

Research Staff

  • Research Staff - AAHRPP Site Visit Guidance Link to M+Box folder containing guidance and other prepatory materials for Research Staff participating in the AAHRPP site visit interviews.  U-M login (Level 1) required. 

IRB Members & Staff

  • IRB Members & Staff - AAHRPP Site Visit Guidance Link to M+Box folder containing interview guidance and other prepatory materials for IRB Board Members and IRB Staff participating in the AAHRPP site visit interviews.  U-M login (Level 1) required.

HRPP Support Units

  • HRPP Support Units - AAHRPP Site Visit Guidance Link to M+Box folder and sub-folders containing guidance for eight HRPP Component Units (supporting units) participating in the AAHRPP Site Visit interviews.  There is a sub-folder for each support unit.  U-M login (Level 1) required.

Questions?

If you have additional questions about the site visit, please contact AAHRPPsitevisit@umich.edu