AAHRPPAAHRPP ACCREDITATION ACCREDITATION

(Association for the Accreditation(Association for the Accreditationof Human Protection Programs)of Human Protection Programs)

AAHRPP FoundersAAHRPP Founders

Association of American Medical Colleges

Association of American Universities

Consortium of Social Science Associations

Federation of American Societies for Experimental Biology

National Association of State Universities and Land Grant Colleges

National Health Council

Public Responsibility in Medicine and Research

Advantages of AccreditationAdvantages of Accreditation

Builds public trust

Self regulation

Attracts research and researchers

Fosters alliances with accredited

organizations

Improves the Research Program

Academic Institutions That Academic Institutions That Have Been AccreditedHave Been Accredited

University of IowaFull accreditation

University of MinnesotaQualified accreditation

Vanderbilt UniversityFull accreditation

Washington University at St. LouisFull accreditation

www.aahrpp.org

The Review ProcessThe Review Process

Self assessment – Evaluation Instrument

Pre Review

Site Visit

Consideration and Decision by the Council

Potential OutcomesPotential Outcomes

Full AAHRPP Accreditation

Qualified AAHRPP Accreditation

Accreditation Pending

Accreditation Withheld

Accreditation PrinciplesAccreditation Principles

The Institution is the unit being accredited

Emphasis on education and communication, not penalties

Applicable across the range of human subjects’ research

Promotes development of outcome measures

Accreditation DomainsAccreditation Domains

The Institution

The IRB

The investigators

The sponsors

The participants

The InstitutionThe Institution

Commitment to protecting human subjects

Appropriate leadership

Adequate resources

Standardizing policies across the “Research Unit”

Monitoring approved research

Managing conflict of interest

Training

Integration of all units that affect human subjects

Units Within The InstitutionUnits Within The Institution

Senior Leadership

The IRB

Clinical Trials Contracting Office

Office of Sponsored Programs

Conflict of Interest Committee

Biosafety and Radiation Safety

Pharmacy

The IRBThe IRB

Evaluating risks to participants

Scientific Merit

Protection of confidentiality

Informed consent

Conflict of Interest

Oversight of sites outside the institution

The InvestigatorThe Investigator

Employs ethical and regulatory principles in research

Demonstrated Competency

Standardized policies

Designs studies to protect participantsAdequate resources/facilities

Minimizes risk

Scientifically sound

Data safety monitoring

Responds to concerns of participants

The SponsorThe Sponsor

The Institution negotiates ethical research with sponsors

Monitors conflicts of interest

Accurately reports results

The ParticipantThe Participant

Educate the public about research

Provide a mechanism for feedback from participants

Respond to their concerns

UC’s Human Subject ResearchUC’s Human Subject Research

Clinical – Approved by IRB’s 1 and 2

Social and Behavioral IRB, Margaret Miller, Chair

Federally sponsored

Non federally sponsored, including pharmaceutical companies and foundations

University sponsored

Major TasksMajor Tasks

Commitment of the University to protection of human research subjects

University Rule

Compliance Plan

HRP Website

www.medcenter.uc.edu/hrp

Major Tasks Major Tasks (cont.)(cont.)

Identifying the appropriate “Research Units.”

Written policies for each “Research Unit.”

Administering standard policies across “Research Units.”

Major Tasks Major Tasks (cont.)(cont.)

Communicating policies to researchers

Monitoring approved research

Commitment to training researchers and research staff

Communicating to potential participants in research

Involvement of ResearchersInvolvement of Researchers

Review draft policies

Assist AAHRPP Oversight Committee

Participate in the site visit

DefinitionsDefinitions

Research: a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.

Human subject: a living individual about whom an investigator conducting research obtains:

Data through intervention or interaction with the individual, or

Identifiable private information

PoliciesPolicies

IRB Review of Research

All research at the university involving human subjects shall be submitted to the IRB for review. See: http://www.uc.edu/trustees/rules/RuleDetail.asp?ID=222

Categories of Review

– Research Which is Exempt From Continuing Review

– Research Which is Expedited:– Review at a Convened Meeting.

AAHRPP InitiativesAAHRPP Initiatives

Written policies in the Office of the Vice President for Research

HRP website for review and comment of new policies

Competency Testing for Researchers

Training Programs

QA/QI for approved research and the IRB