1. Improving Human Research Protections At MMC through Accreditation

2. Why were accreditation programs developed? In the late 1990s and in early 2000, non- compliance with federal regulations for the protection of human subjects became front page news through stories such as the suspension of research at Duke University, John Hopkins and University of Pennsylvania. The most influential case that prompted changes in human subjects research was the death of Jesse Gelsinger at the University of Pennsylvania.

3. AAHRPP Accreditation Process Submission of written accreditation application Site visit by AAHRPP to review program operations Determination of accreditation status by Accreditation Council

4. Accreditation Model Voluntary – MMC elected to achieve accreditation of its Human Research Protection Program Peer-driven Educational model – interactive, emphasis on learning and improvement

5. Who are the site visitors? AAHRPP retains a pool of expert site visitors Site visit teams are assembled based on expertise and the research setting Efforts are undertaken to tailor the site visit team to the needs of the organization. Site visitors generally represent four perspectives: –Experience advocating for public and participants –Experience with human research protection programs –Experience conducting human subjects research –Experience in institutional administration A site visitor may represent more than one perspective.

6. Ethical principles – Belmont Report Federal Common Rule and its Subparts – 45 CFR 46 Food and Drug Administration Regulations – 21 CFC 50 & 56 [and Parts 11, 312 & 812, as appropriate] International Conference on Harmonization – Good Clinical Practice Guidelines Best practices among top research institutions Accreditation standards are based on:

7. AAHRPP Site Visit Philosophy Accreditation, not auditing – no penalties attached to participation Outcomes-based Driven by peer standards Validation of MMC HRPP program Confidential and voluntary

8. What organizations have been accredited to date? As of March 2011: –231 organizations have received accredited –Several others in-process Examples of accredited institutions include: –Lehigh Valley Health Network –Harvard School of Public Health –Dana Farber/Harvard Cancer Center –Baystate Medical Center –Children’s Hospital Boston –Mayo Clinic –Newton-Wellsley Hospital –Johns Hopkins Medical Institutions –Yale

9. What are the categories of accreditation? Full AAHRPP accreditation Qualified AAHRPP accreditation Accreditation-pending Accreditation withheld

10. Benefits of accreditation Improves human research protection program (HRPP) Assists in achieving compliance Facilitates research integrity Improves research quality Instills confidence in sponsors Builds public trust