OHRP Guidance and Policy Development Process Secretary’s Advisory Committee on Human Research Protections Meeting October 27, 2008 Irene Stith-Coleman,

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Presentation transcript:

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Development, Review and Approval (Cond) HHS agency review and comment HSRS review and comment Revise, if necessary If draft guidance, issue Federal Register Notice, seeking public comments Revise document after considering public comments HHS and HSRS review and comment on revised document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 B. When finalized: Post on Policy Guidance [by Topics] webpage Post on FAQ webpage

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 ("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