office for protection from research risks (oprr) department of health and human services national...
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Office for Protection from Office for Protection from Research Risks (OPRR)Research Risks (OPRR)
Department of Health and
Human Services
National Institutes of Health
OPRR Dissolved June, 2000OPRR Dissolved June, 2000
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Office for Human Research Office for Human Research Protections (OHRP)Protections (OHRP)
Department of Health and
Human Services
Office of Public Health and Science
Director: Greg Koski, Ph.D. M.D.
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OHRP ResponsibilitiesOHRP Responsibilities
Implementation and interpretation of federal regulations and policy
Educational programs Negotiation of assurances Evaluation of compliance
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OHRP Electronic AccessOHRP Electronic Access
E-mail: [email protected]
Web Site: http://ohrp.osophs.dhhs.gov
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Federal Regulations and PolicyFederal Regulations and Policy
45 CFR 46 - Basic DHHS Policy for Protection of Human Research Subjects - Subpart A
Originally adopted January 13, 1981 Revised June 18, 1991
“The Common Rule” - Federal Policy for the Protection of Human Subjects June 18, 1991Departments of Agriculture, Energy, Commerce, HUD, Justice,
Defense, Education, Veterans Affairs, Transportation, and HHS. NSF, NASA, EPA, AID, Social Security Administration, CIA, and the Consumer Product Safety Commission.
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Food and Drug AdministrationFood and Drug Administration
Regulations: IRB - 21 CFR 56 Informed Consent - 21 CFR 50
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OHRP OrganizationOHRP Organization
Office of the Director• Greg Koski – Director• Melody Lin – Deputy Director
– Division of Education• Jeffrey Cohen – Director
– Division of Assurance Support & Quality Improvement
• George Gasparis – Acting Director
– Division of Compliance Oversight• Michael Carome - Director
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EducationEducation
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EducationEducation
Presentations and Training Programs Workshops and Town Meetings
– For further information on both of the above contact Darlene Ross ([email protected])
Educational Materials– “IRB Guidebook”
http://ohrp.osophs.dhhs.gov/irb/irb_guidebook.htm
– Videotape Series: "Protecting Human Subjects“ http://ohrp.osophs.dhhs.gov/references/resource.htm
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OHRP/FDA/VA WorkshopsOHRP/FDA/VA Workshops
"Current Human Research Issues & Solutions: Regulatory Overview & Investigator/Institutional Sponsor Partnerships ", May 10-11, 2001, Newark, NJ.
"Evolving Concern for Protection of Human Subjects“, June 8, 2001, St. Louis MO. (Town Meeting)
"Current Human Research Issues & Solutions: Regulatory Overview & Hot Topics", June 21-22, 2001, Charleston, SC
"Current Human Research Issues & Solutions: Regulatory Overview & Social/Behavioral Research" July 16-17, 2001, Los Angeles, CA.
"Current Human Research Issues & Solutions: Regulatory Overview & TBD", September 20-21, 2001, Minneapolis, MN.
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Assurance Support & Assurance Support & Quality ImprovementQuality Improvement
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OHRP Federalwide AssuranceOHRP Federalwide Assurance
Single Assurance Document - Federalwide Assurance (FWA)– MPAs, CPAs, SPAs, CAs, IIAs, AIIs, NIAs
eliminated– FWAs will cover all of the institution’s
Federally-supported human subject research.
– No OHRP review of individual applications, protocols, consent documents
http://ohrp.osophs.dhhs.gov/irbasur.htm
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OHRP Federalwide AssuranceOHRP Federalwide Assurance
Each legally separate institution will need its own FWA
International Standards OK All Institutions Eligible – no longer limited to
those receiving Federal funds Web-Based Application Process IRB Registration Rely on own institutional IRB, other
institutional IRB, commercial
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OHRP Federalwide AssuranceOHRP Federalwide Assurance
Current Status– Currently in pilot phase– FWA is voluntary– OHRP will continue to accept SPAs and
CPAs– All MPAs extended until FWA becomes
mandatory
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OHRP Federalwide AssuranceOHRP Federalwide Assurance
Required completion of OHRP Assurance Training Modules
– The Institutional Signatory Official– The Human Protections Administrator (e.g.,
Human Subjects Administrator or Human Subjects Contact Person)
– IRB Chairperson(s) Institutions must establish education
programs for IRB members and investigators– Completion by investigators must be documented
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URL: ohrp-ed.nih.gov
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IRB/Investigator EducationIRB/Investigator Education
Recommended Features: Ongoing
– One-time presentations inadequate Broad based
– Institutional Officials– IRB members– Investigators– Staff
Not voluntary
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IRB/Investigator EducationIRB/Investigator Education
Content: Ethical principles of human subject research Requirements of the Federal regulations Applicable state law Provisions of Institutional Assurance Institutional policies and procedures for the
protection of human subjects
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Quality ImprovementQuality Improvement
Consultation to improve institutional programs of human subjects protections– Voluntary– Separate from Compliance Oversight
Multiple methodologies– Self evaluation tools– Teleconference/Videoconference
consultations– Site visits
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Compliance OversightCompliance Oversight
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Compliance ProcessCompliance Process
OHRP discovers or receives an allegation or indication of non-compliance
• COMPLAINT(S)– PI, IRB MEMBER, SUBJECT, PRIVATE CITIZEN, ETC.
• SELF REPORTING– INSTITUTION, PI
• MEDIA• OTHER INCIDENT REPORT
– FDA INSPECTION– NIH PSV REPORT– COOPERATIVE GROUP AUDIT
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Compliance ProcessCompliance Process
OHRP determines if it has jurisdiction OHRP notifies institution and requests
institutional response (may include additional documentation, institutional investigation and report, etc.)
OHRP may take immediate action if protection of human subjects warrants
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Compliance ProcessCompliance Process
OHRP evaluates institutional response
OHRP issues a report of findings
OR OHRP performs site visit
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Compliance ProcessCompliance Process
Most compliance oversight evaluations can be resolved through correspondence with the institution and do not require an on-site review or a formal report of findings.
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Compliance ConcernsCompliance Concerns
OPRR Compliance Activities: Common Findings and
Guidance
http://ohrp.osophs.dhhs.gov/references/findings.pdf
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Does the institution support and respect the IRB and its mission?
Is there a “culture of compliance”?Are IRB members and investigators
knowledgeable about regulatory requirements?
Is there adequate documentation of IRB findings and actions?