Elyse I Summers J D President and CEO

Elyse I. Summers, J. D. President and CEO CAREB 2014 National Conference Montreal, Quebec April 23 – 26, 2014 Copyright © 2013 AAHRPP® All rights reserved

Outline § Who is AAHRPP? Que est AAHRPP? § What is AAHRPP’s role? Quel est le rôle de AAHRPP? § What we do/Ce que nous faisons § Questions/Questions

We are AAHRPP!!

AAHRPP Global non-profit organization founded in 2001 – Contract research organizations, hospitals, independent REBs/IRBs, research institutes, sponsors, universities and government agencies – Small (fewer than 20 protocols) and large (greater than 6, 000 protocols) institutions – Clinical and non-clinical research programs – The world’s largest research-based pharmaceutical company

AAHRPP-Accredited organizations § As of March 2014, 196 organizations representing over 600 entities § Truly global – AAHRPP-accredited organizations in Canada, China, India, Korea, Mexico, Saudi Arabia, Singapore, Taiwan, United States § Other countries with organizations in the application process, include: Brazil, Belgium, Lebanon, Spain, Thailand

The focus of AAHRPP accreditation § Organization § REB or IRB § Researchers and Research staff } Human Research Protection Program Protecting research participants is a shared responsibility

Human Research Protection Program Education Programs Conflict of Interest Researcher and Research Staff Compliance Oversight Organizational Plan Pharmacy Services Contracts and Grants Communications System IRB or REB

AAHRPP Accreditation standards § Relevant Country laws, codes and guidelines § Based on ICH-GCP Guideline (E 6) § If organization conducts research under U. S. federal regulations for conducting human research: U. S. Department of Health and Human Services (45 CFR part 46); U. S. Food and Drug Administration (21 CFR parts 50, 56)

AAHRPP Accreditation standards § Human Research Protection Program Domain 1: Organization Domain 2: REB or IRB Domain 3: Researchers and Research Staff

AAHRPP Accreditation standards AAHRPP process is outcomes-based approach many possible avenues to achieve shared goal: Protection of the health and welfare of research volunteers, whose participation makes the whole enterprise possible.

What is accreditation of a human research protection program? § Accreditation of an Organization: – is voluntary – is flexible – is based on outcome-based standards • consistent regulatory, legal, and ethical requirements • allows a proportionate risk management approach – – evaluates structures, processes, and outcomes is not an audit of ethics decisions is not an audit of individual studies focuses on quality

Benefits of Accreditation § Assures highest level of protection afforded to participants § Increases public trust and participation in research § Meet uniform worldwide standards § Signals high standards of performance to sponsors § Facilitates collaborations across institutions

Benefits of Accreditation, cont’d. § Attract and retain high level researchers § Improves science – facilitates acceptance to prestigious journals § Fewer findings on FDA inspections § Fewer findings in OHRP compliance cases

AAHRPP’s Goals § One set of Standards Worldwide § Promote Organization-wide commitment to protecting participants in clinical research § Reinforce high standards and continuous quality improvement of HRPPs § Explore ways to improve efficiency 15

The AAHRPP Advantage: Rigorous and Accessible HRPP Accreditation Rigoureuse et accessible HRPP Accréditation

Oh, Canada: Canada Le moment est venu The time is right

Contact AAHRPP Elyse I. Summers, J. D. President and CEO esummers@aahrpp. org Sarah Giannakopoulos Director of Operations sgiannakopoulos@aahrpp. org Sarah Kiskaddon, J. D. Director of Global Business Development and Public Affairs skiskaddon@aahrpp. org 202. 783. 1112