1. Jeffrey M. Cohen, Ph.D. CIP President HRP Associates, Inc.
Accreditation
Jeffrey M. Cohen, Ph.D. CIP
President
HRP Associates, Inc.
© HRP Associates, Inc.

2. Accreditation
Accreditation conducted by Association for the Accreditation of Human Research Protection Programs (AAHRPP)
AAHRPP is a non-profit organization founded in 2001 to ensure research compliance and to promote uniform standards for the protection of human research subjects
© HRP Associates, Inc.

3. Accreditation
It is the Association for the Accreditation of Human Research Protection Programs
NOT
Association for the Accreditation of IRBs
© HRP Associates, Inc.

4. HRPP
An HRPP is a comprehensive and organized system to ensure the protection of human volunteers participating in research.  The objective of this system is to assist the institution in meeting ethical principles and regulatory requirements for the protection of human subjects in research. 
© HRP Associates, Inc.

5. Components of an HRPP Institutional/Hospital Officials
IRB – Members/Chair
IRB Administrators
Investigators
Research Staff
Internal Others (RSA, DSMB, IDS, CRO
Subjects)
External (Sponsor, CRO, Regulatory Agency)
© HRP Associates, Inc.

6. HRPP Essential Elements
Education
Policies
Procedures
Protocol Review
Conduct of Study
Study Monitoring
Program Assessment
© HRP Associates, Inc.

7. Human Research Protections is a Shared Responsibility
HRPP Responsibility
Human Research Protections is a Shared Responsibility
Investigator/Researcher
IRB
Institution
© HRP Associates, Inc.

8. AHHRPP Accreditation
Accreditation is not just based on compliance with the regulations
Accreditation evaluates how well the HRPP works to protect the rights and welfare of human subjects
Based on ethical principles, regulations, Good Clinical Practice, best practices
© HRP Associates, Inc.

9. AAHRPP Standards Accreditation is based on HRPP standards
Standards are divided into five “domains”
Domain I: Organization
Domain II: Research Review Unit
Domain III: Investigator
Domain IV: Sponsor
Domain V: Participant
Each domain divided into individual standards
Each standard divided into elements
Total of 77 elements
© HRP Associates, Inc.

10. IRB Review
AAHRPP expects IRBs to ensure that the regulatory criteria for approval are met for all research
The IRB must have sufficient information from the investigators on each of the criteria
Application forms must ask specific questions regarding each of the criteria
© HRP Associates, Inc.

11. Criteria for IRB Approval
When appropriate:
data collection is monitored to ensure subject safety
privacy and confidentiality of subjects is protected
additional safeguards are included for vulnerable populations
Risks to subjects are minimized
Risks are reasonable in relation to anticipated benefits
Selection of subjects is equitable
Informed consent is appropriately sought
Informed consent is appropriately documented
© HRP Associates, Inc.

12. Criteria for IRB Approval
BENEFICENCE
JUSTICE
RESPECT FOR PERSONS
Subject selection
Inclusion/exclusion
Recruitment
Risk/Benefit Analysis Data Safety
Experimental Design
Qualifications of PI
Privacy & Confidentiality Vulnerable Populations
Informed consent
Surrogate consent
Assent
© HRP Associates, Inc.

13. Risk Responsibilities: Identify Risks
Determine that risks are minimized
Determine that “risks to subjects are reasonable in relation to anticipated benefits”
Determine that subjects are adequately informed about “any reasonably foreseeable risks or discomforts”
Comes from Common Rule Sections 111 (Criteria for IRB Approval of Research) and 116 (General Requirements for Informed Consent)
IRB cannot rely on the investigator to identify risk.
“Dr. Frankenstein”
Example - Achievement Motivation in Black Children
IRB can call on outside experts to advise on determinations.
© HRP Associates, Inc.

14. The Consent Process
Informed consent is not a single event or just a form to be signed -- rather, it is an educational process that takes place between the investigator and the prospective subject.
The basic elements of the consent process include:
full disclosure of the nature of the research and the subject's participation,
adequate comprehension on the part of the potential subjects, and
the subject's voluntary choice to participate.
Adequate Informed Consent. Only the subjects can evaluate the degree of risk in a given situation. The IRB must ensure that subjects are given sufficient information regarding the study to determine for themselves what the risks are and whether they want to assume those risks.
Must be understandable to subjects: Risks described in terms that the subjects can understand. Comparisons to everyday risks.
Avoid Bias and Creation of Negative Mindsets: Consent process should not increase the likelihood of harm.
© HRP Associates, Inc.

15. Procedures for Obtaining Consent
46.116
Subject has the legal and mental capacity to give consent
legally authorized representative;
Sufficient opportunity is provided to consider
The possibility of coercion or undue influence is minimized
Language understandable to the subject
No “exculpatory” language
© HRP Associates, Inc.

16. Summary
Lifespan’s HRPP is being accredited by AAHRPP, not just the IRB
The responsibility for protecting subjects is shared by the institution, the IRB, and investigators
The IRB must ensure that the criteria for approval are met for all research
Investigators will have to provide more detailed information on human research protections
© HRP Associates, Inc.