Office for Protection from Research Risks (OPRR)

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Office for Protection from Research Risks (OPRR)

• Department of Health and
• Human Services
• National Institutes of Health

OPRR Dissolved June, 2000
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Office for Human Research 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 Responsibilities

• Implementation and interpretation of federal
  regulations and policy
• Educational programs
• Negotiation of assurances
• Evaluation of compliance

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OHRP Electronic Access

• E-mail ohrp_at_osophs.dhhs.gov
• Web Site http//ohrp.osophs.dhhs.gov

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Federal 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, 1991
• Departments 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 Administration

• Regulations
• IRB - 21 CFR 56
• Informed Consent - 21 CFR 50

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OHRP 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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• Education

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Education

• Presentations and Training Programs
• Workshops and Town Meetings
• For further information on both of the above
  contact Darlene Ross (dr20a_at_nih.gov)
• Educational Materials
• IRB Guidebook http//ohrp.osophs.dhhs.gov/irb/ir
  b_guidebook.htm
• Videotape Series "Protecting Human Subjects
  http//ohrp.osophs.dhhs.gov/references/resource.ht
  m

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OHRP/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 Quality Improvement

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OHRP Federalwide Assurance

• Single Assurance Document - Federalwide Assurance
  (FWA)
• MPAs, CPAs, SPAs, CAs, IIAs, AIIs, NIAs
  eliminated
• FWAs will cover all of the institutions
  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 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 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 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 Education

• Recommended Features
• Ongoing
• One-time presentations inadequate
• Broad based
• Institutional Officials
• IRB members
• Investigators
• Staff
• Not voluntary

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IRB/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 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 Oversight

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Compliance 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 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 Process

• OHRP evaluates institutional response
• OHRP issues a report of findings
• OR
• OHRP performs site visit

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Compliance 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 Concerns

• OPRR Compliance Activities Common Findings and
  Guidance
• http//ohrp.osophs.dhhs.gov/references/findings.p
  df

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• Overarching Concerns

• 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?