Division of Policy and Assurances Processes

Document Sample
Division of Policy and Assurances Processes Powered By Docstoc
					  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
                       Outline

   Interdivisional Policy Coordinating Committee
   Selection of Topics
   Guidance Document Development, Review and
    Approval
   Communicating Completion/Posting of Guidance
    Documents
    Interdivisional Policy Coordinating Committee
                         (IPCC)

   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   If draft guidance, issue Federal Register Notice,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
    document
   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
http://www.hhs.gov/ohrp/requests/
B. When finalized:
  Post on Policy Guidance [by Topics] webpage
http://www.hhs.gov/ohrp/policy/index.html
  Post on FAQ webpage
http://www.hhs.gov/ohrp/faq.html
                  Requests for Comment
                         Notices

   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
                     (FAQs)

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

				
DOCUMENT INFO
Shared By:
Categories:
Tags:
Stats:
views:19
posted:11/27/2010
language:English
pages:10