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

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.

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

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.

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.

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

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

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.

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.

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.

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.

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.

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.

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.

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.

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.