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