AAHRPP ACCREDITATION Association for the Accreditation of Human Protection Programs

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AAHRPP ACCREDITATION(Association for the
Accreditationof Human Protection Programs)
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AAHRPP 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

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Advantages of Accreditation

• Builds public trust
• Self regulation
• Attracts research and researchers
• Fosters alliances with accredited organizations
• Improves the Research Program

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Academic Institutions That Have Been Accredited

• University of Iowa
• Full accreditation
• University of Minnesota
• Qualified accreditation
• Vanderbilt University
• Full accreditation
• Washington University at St. Louis
• Full accreditation
• www.aahrpp.org

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The Review Process

• Self assessment Evaluation Instrument
• Pre Review
• Site Visit
• Consideration and Decision by the Council

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Potential Outcomes

• Full AAHRPP Accreditation
• Qualified AAHRPP Accreditation
• Accreditation Pending
• Accreditation Withheld

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Accreditation 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

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Accreditation Domains

• The Institution
• The IRB
• The investigators
• The sponsors
• The participants

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The 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

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Units Within The Institution

• Senior Leadership
• The IRB
• Clinical Trials Contracting Office
• Office of Sponsored Programs
• Conflict of Interest Committee
• Biosafety and Radiation Safety
• Pharmacy

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The IRB

• Evaluating risks to participants
• Scientific Merit
• Protection of confidentiality
• Informed consent
• Conflict of Interest
• Oversight of sites outside the institution

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The Investigator

• Employs ethical and regulatory principles in
  research
• Demonstrated Competency
• Standardized policies
• Designs studies to protect participants
• Adequate resources/facilities
• Minimizes risk
• Scientifically sound
• Data safety monitoring
• Responds to concerns of participants

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The Sponsor

• The Institution negotiates ethical research with
  sponsors
• Monitors conflicts of interest
• Accurately reports results

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The Participant

• Educate the public about research
• Provide a mechanism for feedback from
  participants
• Respond to their concerns

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UCs Human Subject Research

• Clinical Approved by IRBs 1 and 2
• Social and Behavioral IRB, Margaret Miller, Chair
• Federally sponsored
• Non federally sponsored, including pharmaceutical
  companies and foundations
• University sponsored

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Major Tasks

• Commitment of the University to
  protection of human research subjects
• University Rule
• Compliance Plan
• HRP Website
• www.medcenter.uc.edu/hrp

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Major Tasks (cont.)

• Identifying the appropriate Research Units.
• Written policies for each Research Unit.
• Administering standard policies across Research
  Units.

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Major Tasks (cont.)

• Communicating policies to researchers
• Monitoring approved research
• Commitment to training researchers and research
  staff
• Communicating to potential participants in
  research

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Involvement of Researchers

• Review draft policies
• Assist AAHRPP Oversight Committee
• Participate in the site visit

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Definitions

• 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

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Policies

• 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?
  ID222
• Categories of Review
• Research Which is Exempt From Continuing Review
• Research Which is Expedited
• Review at a Convened Meeting.

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AAHRPP 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