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Regulatory Compliance Update: OHRP

Administrative Structure. Office for Human Research Protections. Division of ComplianceOversight. . . . Division of Policy and Assurances. Division of Education and Development. . International Activities Unit. . . HHS - Office for Public Health

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Regulatory Compliance Update: OHRP

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    1. Regulatory Compliance Update: OHRP Freda E. Yoder Division of Education & Development Office for Human Research Protections (OHRP) Department of Health and Human Services (HHS) NCURA Washington, DC November 5, 2007

    3. Human Subject Protections Background OHRP Activities & Guidance Secretarys Advisory Committee on Human Research Protections (SCHRP) Initiatives Resources

    4. Regulation for Protection of Human Subjects

    5. Regulation for Protection of Human Subjects, contd

    6. OHRP Activities & Guidances

    7. Recent OHRP Activities and Guidance Frequently Asked Questions (FAQs) Informed Consent Prisoners in Research Investigator Responsibilities Request for comments Engagement of Institutions in Research Research Involving Adults with Impaired Decision Making Capacity

    8. Impaired Decision Making Request for Information Joint notice with FDA Comment period open through December 4, 2007 Notice available at http://www.hhs.gov/ohrp/documents/20070905.pdf

    9. Recent OHRP Guidance, contd Reviewing and Reporting Unanticipated Problems Involving Risks to Subjects or Others and Adverse Events Use of investigational in vitro diagnostic (IVD) devices

    10. Guidance on Reviewing and Reporting Unanticipated Problems Involving Risks to Subjects or Others and Adverse Events OHRP final guidance at: http://www.hhs.gov/ohrp/policy/AdvEvntGuid.htm FDA draft guidance at: http://www.fda.gov/OHRMS/DOCKETS/98fr/07d-0106-gdl0001.pdf

    11. Relevant Regulation, among others Institutions will have written procedures for ensuring prompt reporting of Any unanticipated problems involving risks to subjects or others Any serious or continuing noncompliance with HHS Regulations or determinations of the IRB Any suspension or termination of IRB approval 46.103(b)(5)

    12. Definitions Unanticipated Problem (UP) - incident, experience, or outcome that is unexpected related or possibly related AND suggests greater risk of harm Adverse Event (AE) - any untoward or unfavorable medical occurrence in a human subject temporally associated with participation in research

    13. UPs vs. AEs

    15. Guidance on Investigational Use of IVD Devices Applicability of 45 CFR part 46 to Clinical Investigations Conducted Under FDA's Interim Final Rule at 21 CFR 50.23(e) http://www.hhs.gov/ohrp/humansubjects/guidance/invitrodev.html FDA Rule: "Medical Devices; Exception From General Requirements for Informed Consent http://www.fda.gov/ohrms/dockets/98fr/03n-0355-nir0001.pdf

    16. Investigational IVD Devices, contd Not engaged if used only to identify potentially life-threatening chemical, biological, radiological, or nuclear agent facilitate the treatment of individuals exposed to such agents, and/or report test results to a public health authority Engaged if use identifiable private information to evaluate performance properties of device IRBs often will find informed consent can be waived under 46.116

    17. OHRP Initiatives & Guidances - in Progress Engagement of Institutions Informed Consent for Non-English Speaking Subjects What is Research? Frequently Asked Questions Other Recent Announcements http://www.hhs.gov/ohrp/news/index.html#recentann

    18. Engagement Of Institutions in Research Key Differences between old and new relate to: Providers of identifiable private information Employees or agents of institutions not selected as research sites administering certain clinical trial related medical services

    19. Secretarys Advisory Committee on Human Research Protections (SACHRP) Initiatives New Chair: Dr. Sam Tilden, Univ. of Alabama

    20. SACHRP Activities - Completed Recommendations on Subparts C and D guidance from OHRP HRPP Accreditation Harmonization of HIPAA and the Common Rule Greater Involvement of IOs in the HRPP Workshop and Conference on IRB Review Models http://www.aamc.org/research/irbreview/start.htm International Research

    21. SACHRP Activities - Ongoing Recommendations on Subpart A OHRP Guidance on Adverse Event Reporting Subcommittee on Inclusion of Individuals with Impaired Decision Making Capacity Responsibilities and Training of Investigators SACHRP Web page http://www.hhs.gov/ohrp/sachrp

    22. OHRP Resources

    23. Frequently Asked Questions Posted Assurance Process IRB Registration Process 45 CFR 46 Research with Children Investigator Responsibility Prisoner Research Informed Consent

    24. Resources, contd Guidance by topic at: http://www.hhs.gov/ohrp/policy/index.html#topics Compliance Oversight Procedures http://www.hhs.gov/ohrp/compliance/ohrpcomp.html Reporting Incidents to OHRP http://www.hhs.gov/ohrp/policy/incidreport_ohrp.html

    25. OHRP Resources & Contact Information OHRP Web page: http://www.hhs.gov/ohrp Join Listserv: http://www.hhs.gov/ohrp/news/distributionlist.html Contact OHRP: Phone: (240) 453-6900, (866) 447-4777 E-mail: ohrp@hhs.gov

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