1 Developed by: U-MIC To start the presentation, click on this button in the lower right corner of your screen. The presentation will begin after the screen changes and you press enter.

THE ASSOCIATION FOR THE ACCREDITATION OF HUMAN RESEARCH PROTECTION PROGRAMS (AAHRPP) Developed by: U-MIC University of Michigan IRB Collaborative

AAHRPP 3 Developed by: U-MIC Association for the Accreditation of Human Research Protection Programs (AAHRPP) reviews/accredits HRPPs international independent nonprofit AAHRPP accreditation voluntary designed to ensure excellent, ethically sound research

AAHRPP 4 Developed by: U-MIC Association for the Accreditation of Human Research Protection Programs (AAHRPP) accredits public/private entities engaged in human subjects research academic institutions hospitals government agencies private corporations independent IRBs has accredited over 215 organizations 46 US states other countries University of Michigan AAHRPP-accredited institution since 2008 currently seeking reaccreditation

AAHRPP 5 Developed by: U-MIC Association for the Accreditation of Human Research Protection Programs (AAHRPP) Accreditation of UM HRPP affirms UM’s commitment to excellence in human subjects research helps establish framework for a high-quality HRPP Sponsors/other research partners consider AAHRPP accreditation before pursuing research collaborations providing research funding

AAHRPP 6 Developed by: U-MIC Association for the Accreditation of Human Research Protection Programs (AAHRPP) examines policies, procedures, and practices within three categories of HRPP responsibility: institutional leadership institutional review boards (IRBs) researchers and research staff within these categories, applies fifteen standards numerous elements derived from federal regulatory requirements key ethical principles international guidelines best practices

AAHRPP 7 Developed by: U-MIC Association for the Accreditation of Human Research Protection Programs (AAHRPP) Category 1: Institutional leadership AAHRPP considers HRPP’s integrated structure/function HRPP resources Category 2: IRBs AAHRPP evaluates the functioning of IRBs ethical requirements regulatory requirements Are there processes in place to ensure the appropriate review of all research protocols involving human subjects? Do policies and procedures safeguard the rights and welfare of human subjects in accordance with AAHRPP standards? Category 3: Researchers and research staff ethical/regulatory responsibilities Are researchers and research staff aware of the ethical and regulatory requirements that apply to their research? Do they have sufficient education and training regarding human subjects protections?

AAHRPP 8 Developed by: U-MIC Association for the Accreditation of Human Research Protection Programs (AAHRPP) UM’s most recent reaccreditation process initiated June 2015 self-assessment updates: HRPP Operations Manual IRB Standard Operating Procedures

AAHRPP 9 Developed by: U-MIC Association for the Accreditation of Human Research Protection Programs (AAHRPP) AAHRPP site visit AAHRPP typically selects 100+ individuals to interview anyone whose duties relate to human subjects research institutional leadership IRB members/staff principal investigators/research staff others

AAHRPP 10 Developed by: U-MIC Association for the Accreditation of Human Research Protection Programs (AAHRPP) AAHRPP site visit If you are selected for an AAHRPP interview, you will be notified in advance by UM site visit coordinators receive additional information be asked by AAHRPP about human subjects protections Be prepared for your AAHRPP interview. You represent UM HRPP. You play a critical role in UM’s efforts toward reaccreditation. Make sure you understand HRPP structure your role within that structure

AAHRPP 11 Developed by: U-MIC Association for the Accreditation of Human Research Protection Programs (AAHRPP) AAHRPP site visit Re-familiarize yourself with human subject protections–related policies/procedures that apply to your role. Ensure you are familiar with practices related to recruitment and informed consent noncompliance and adverse event reporting including unanticipated problems involving risk to subjects or others (UaP/UPIRSO) privacy/confidentiality vulnerable subjects conflicts of interest

AAHRPP 12 Developed by: U-MIC Association for the Accreditation of Human Research Protection Programs (AAHRPP) AAHRPP site visit Be prepared to describe your education and training PEERRS information on IRB and HRPP websites IRB’s / other units’ courses seminars consultations Review IRB website HRPP Operations Manual PEERRS modules UM’s AAHRPP reaccreditation website AAHRPP website

For more information about AAHRPP accreditation 13 Developed by: U-MIC

Thank you. Sana Shakour Avery Avrakotos University of Michigan AAHRPP Accreditation Committee Judy Birk Cindy Shindledecker Brian Seabolt University of Michigan Institutional Review Boards 14 Developed by: U-MIC