Transcript Introductions & Recognitions

Improving Human Research
Protections At MMC through
Accreditation
Why were accreditation programs
developed?
• In the late 1990s and in early 2000, noncompliance 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.
AAHRPP Accreditation Process
• Submission of written accreditation application
• Site visit by AAHRPP to review program
operations
• Determination of accreditation status by
Accreditation Council
Accreditation Model
• Voluntary – MMC elected to achieve
accreditation of its Human Research Protection
Program
• Peer-driven
• Educational model – interactive, emphasis on
learning and improvement
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.
Accreditation standards are based on:
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
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
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
What are the categories of
accreditation?
• Full AAHRPP accreditation
• Qualified AAHRPP accreditation
• Accreditation-pending
• Accreditation withheld
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