1. Elyse I. Summers, J.D. President and CEO
CAREB-ACCER 2019 National Conference
Winnipeg, Manitoba, Canada
Friday, April 12
Copyright © 2013 AAHRPP® All rights reserved

2. True, equal partners:
AAHRP Accreditation is complementary and congruent with all Canadian initiatives currently under consideration or operational.
In short,
AAHRPP 7

3. AAHRPP Global non-profit organization founded in 2001
Contract research organizations, hospitals, independent ECs/IRBs, research institutes, sponsors, universities and government agencies (e.g., NIH, NCI, VA, State Departments of Health)
Small (fewer than 20 protocols) and large (greater than 6,000 protocols) institutions
Clinical and non-clinical research programs
The world’s premier research organization (NIH)
The world’s largest research-based pharmaceutical company (Pfizer) 8

4. AAHRPP-Accredited organizations
As of March 2019, more than 250 organizations representing over 600 entities
Truly global – AAHRPP-accredited organizations in Belgium, Brazil, Canada, China, India, Korea, Mexico, Saudi Arabia, Singapore, South Africa, Taiwan, Thailand, United States
Other countries with organizations in the pipeline, include: Australia, Japan, Jordan 9

5. Human Research Protection Program
Education
Programs
Researcher and Research Staff
Conflict
of Interest
Organizational
Plan
Compliance
Oversight
Pharmacy Services
Contracts
and Grants
Communications
System
IRB or REB 11

6. The focus of AAHRPP accreditation
Organization (Domain I)
REB or IRB (Domain II)
Researchers and
Research staff (Domain III)
Protecting research participants is a shared responsibility
Human
Research
Protection
Program } 10

7. AAHRPP Accreditation standards
Relevant Country laws, codes and guidelines (e.g., TCPS2)
Based on ICH-GCP Guideline (E6)
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) 12

8. Sincerest form of flattery...

9. Sincerest form of flattery, part deux…

10. The time is right Le moment est venu
Oh, Canada:
The time is right Le moment est venu 18

11. Contact AAHRPP 202.783.1112 Elyse I. Summers, J.D. President and CEO
Michelle Feige, MSW, LCSW-C
Executive Vice President
Robert Hood, Ph.D.
Director of Accreditation
Kate Vulakovich
Director of Operations 19