Division of Policy and Assurances Processes

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					  OHRP Guidance and Policy
    Development Process

Secretary’s Advisory Committee on Human Research
                 Protections Meeting
                  October 27, 2008

            Irene Stith-Coleman, Ph.D.
     Director, Division of Policy & Assurances
     Office for Human Research Protections

   Interdivisional Policy Coordinating Committee
   Selection of Topics
   Guidance Document Development, Review and
   Communicating Completion/Posting of Guidance
    Interdivisional Policy Coordinating Committee

   Established January 2002
   Chaired by DPA Director
   Representatives from each Division and OD
   Meet weekly as needed
                 Selection of Topics

   OHRP mailbox queries
   SACHRP recommendations
   Update existing guidance documents
   Requests from HHS agencies
         Guidance Document Development,
               Review and Approval

   Initial draft developed by a lead writer
   IPCC workgroup review/revision
   IPCC deliberation
   OHRP division review
        Guidance Document Development,
           Review and Approval (Cond)

   HHS agency review and comment
   HSRS review and comment
   Revise, if necessary
   If draft guidance, issue Federal Register Notice,
    seeking public comments
   Revise document after considering public comments
   HHS and HSRS review and comment on revised
   Finalize document after considering all comments
   Request ASH approval to post
        Communicating Completion/Posting
            of Guidance Documents

A. In concert with FR publication:
  List Serv Announcement (more than 6,000 subscribers)
  Post on Requests for Comment webpage
B. When finalized:
  Post on Policy Guidance [by Topics] webpage
  Post on FAQ webpage
                  Requests for Comment

   Implementation of Human Subjects Protections Training and
    Education Programs
   Categories of Research That May be Reviewed By an IRB
    Through An Expedited Review Procedure
   Draft Engagement of Institutions in Human Subjects Research
   Research that Involves Adult Individuals with Impaired Decision-
    making Capacity
                 Guidance Documents
   Guidance on Reporting and Reviewing Adverse Events and
    Unanticipated Problems Involving Risks to Subjects or Others
   Informed consent requirements for In Vitro Medical Device
    Clinical Investigations Conducted Under FDA’s Interim Final Rule
    at 21 CFR 50.23(e)
   Children Involved as Subjects in Research: Guidance on the
    HHS 45 CFR 46.407 ("407") Review Process
   Guidance on Reporting Incidents to OHRP
           Frequently Asked Questions

   Informed Consent
   Prisoner Research
   Research with Children
   Assurance Process
   IRB Registration Process
   Investigator Responsibilities
   45 CFR 46
   Prisoner Research

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