Accreditation of Human Research Protection Programs

A Brief History

  • AAHRPP founded in 2001 to accredit high-quality human research protection programs (HRPPs).
  • Response to research protection deficiencies, including the 1999 Jesse Gelsinger case.
  • IOM and National Bioethics Advisory Commission reports suggested accreditation as part of the solution.
  • AAHRPP standards released in 2002; first accreditations followed 14 months later.
  • As of September 2017, 247 organizations were AAHRPP accredited, including 46 outside the US.

Principles of Accreditation (AAHRPP)

  • Protecting research participants is the first priority.
  • Responsibility of everyone within the organization.
  • Meet or exceed federal requirements and seek new safeguards.
  • Standards are clear, specific, and applicable across settings.
  • Standards identify outcome measures for quality improvement.
  • Performance-based standards using objective criteria.
  • Clear pathway to achieve accreditation with AAHRPP assistance.
  • Collegial, educational, and interactive accreditation process.
  • Responsive to changes in federal regulations and evolving standards.

Human Research Protection Programs: The Shift to Shared Responsibility

  • Shift from IRBs/ECs to broader organizational responsibility.
  • AAU report (2000) recommended vigilance by senior management and training for all personnel.
  • IOM report (2001) advocated for a comprehensive HRPP with shared responsibilities.
  • AAHRPP requires a comprehensive, integrated program, even when outsourcing reviews.

Key Characteristics of High-Quality HRPPs

  • Commitment permeates the entire organization.
  • Communication and collaboration among researchers and IRB professionals.
  • High priority on protecting human research participants.
  • Advancing discovery by sharing new knowledge.
  • Ethical, comprehensive, and informative consent process.
  • Managing conflicts of interest.
  • Responsibility to the public through community outreach and education.
  • HRPP is efficient and effective.

The Accreditation Standards

  • Divided into three domains: Organization, IRB/EC, and Researcher/Research Staff.

Domain I: Organization

  • Focuses on overarching organizational policies.
  • Includes policies for financial disclosures, clinical trials, education, scientific review, community engagement, and quality improvement.
Key Standards
  • I-1: Systematic and comprehensive HRPP.
  • I-2: Sufficient resources to protect participants.
  • I-3: Transnational research activities meet equivalent protection levels.
  • I-4: Responding to concerns of research participants.
  • I-5: Measuring and improving compliance and HRPP quality.
  • I-6: Managing financial conflicts of interest.
  • I-7: Compliance with legal requirements for investigational articles.
  • I-8: Working with sponsors to apply HRPP requirements.
  • I-9: Protecting participants when sharing oversight with another organization.

Domain II: Institutional Review Board or Ethics Committee

  • Covers IRB/EC composition, review practices, documentation, and policies.
  • Includes policies for handling unanticipated problems and protecting vulnerable participants.
Key Standards
  • II-1: Appropriate structure and composition of the IRB/EC.
  • II-2: Evaluating research protocols to ensure participant protection.
  • II-3: Approving protocols based on applicable laws and regulations.
  • II-4: Providing additional protections for vulnerable individuals.
  • II-5: Maintaining documentation of activities.

Domain III: Researcher and Research Staff

  • Applies to researchers and staff, focusing on ethical standards, regulations, and reporting.
  • Focuses on overseeing research and responsiveness to participants’ concerns.
Key Standards
  • III-1: Adherence to ethical principles and standards.
  • III-2: Meeting requirements for conducting research and complying with applicable laws.

Steps to Accreditation

  • Self-assessment (gap analysis).
  • Step 1 Application (program overview and policies).
  • Step 2 Application (revised application).
  • Site visit by trained peers.
  • Council on Accreditation review.
  • Accreditation status: full accreditation, qualified accreditation, accreditation pending, or accreditation withheld.
  • Reevaluation required every 3 years (initial) and then every 5 years.

Value of Accreditation

  • Strengthening protections for research participants.
  • Improving regulatory compliance.
  • Comprehensive, systematic approach to research ethics.
  • Facilitating collaboration and a global infrastructure for ethical practices.
  • Most respondents reported that achieving AAHRPP-accreditation was “very important” to their organization.
  • 91% agreed that their overall HRPP has improved as a result of achieving AAHRPP accreditation.
  • Accreditation status is a signal to sponsors and colleagues for high-quality HRPPs.
  • Facilitates collaborative relationships among universities and institutions.