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OHRP Guidance and Policy Development Process

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.

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OHRP Guidance and Policy Development Process

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  1. 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

  2. Outline • Interdivisional Policy Coordinating Committee • Selection of Topics • Guidance Document Development, Review and Approval • Communicating Completion/Posting of Guidance Documents

  3. Interdivisional Policy Coordinating Committee (IPCC) • Established January 2002 • Chaired by DPA Director • Representatives from each Division and OD • Meet weekly as needed

  4. Selection of Topics • OHRP mailbox queries • SACHRP recommendations • Update existing guidance documents • Requests from HHS agencies

  5. Guidance Document Development, Review and Approval • Initial draft developed by a lead writer • IPCC workgroup review/revision • IPCC deliberation • OHRP division review

  6. 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Review and Approval (Cond) • HHS agency review and comment • HSRS review and comment • Revise, if necessary • If draft guidance, issue Federal Register Notice, seeking public comments • Revise document after considering public comments • HHS and HSRS review and comment on revised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

  7. 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

  8. 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

  9. 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

  10. Frequently Asked Questions (FAQs) • Informed Consent • Prisoner Research • Research with Children • Assurance Process • IRB Registration Process • Investigator Responsibilities • 45 CFR 46 • Prisoner Research

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