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DOE Human Subjects Working Group Spring Workshop What New Policy/Guidance is Coming from OHRP? May 7, 2009

DOE Human Subjects Working Group Spring Workshop What New Policy/Guidance is Coming from OHRP? May 7, 2009. Julie Kaneshiro HHS Office for Human Research Protections Phone: 240-453-8293 Email: julie.kaneshiro@hhs.gov. Topics. What’s been issued recently What’s coming soon

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DOE Human Subjects Working Group Spring Workshop What New Policy/Guidance is Coming from OHRP? May 7, 2009

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  1. DOE Human Subjects Working GroupSpring WorkshopWhat New Policy/Guidance is Coming from OHRP? May 7, 2009 Julie Kaneshiro HHS Office for Human Research Protections Phone: 240-453-8293 Email: julie.kaneshiro@hhs.gov

  2. Topics • What’s been issued recently • What’s coming soon • What’s coming later

  3. Recent Policies/Guidance • Guidance on the Genetic Information Nondiscrimination Act: Implications for Investigators and IRBs • Advanced notice of proposed rulemaking on IRB Accountability • IRB Registration Rule • FAQs clarifying meaning of OHRP-registered IRB and OHRP-approved FWA

  4. Guidance on the Genetic Information Nondiscrimination Act of 2008 (“GINA”) (Issued April 7, 2009)

  5. What is GINA? • A federal law that prohibits discrimination in health coverage (coverage provided by either health insurers or by employment-based health plans) and employment based on an individual’s genetic information • The bill is intended to allow Americans to take advantage of the benefits of genetic testing without fear of losing their health insurance or their jobs

  6. Important Definitions

  7. An individual’s genetic tests (including genetic tests done as part of a research study) The genetic tests of the individual’s family members (dependents and up to and including 4th degree relative) Genetic tests of any fetus of an individual or family member who is pregnant, and genetic test of any embryo legally held by an individual or family member using assisted reproductive technology. Genetic Information means information about:

  8. The manifestation of a disease or disorder in family members of an individual (family history) Any request for, or receipt of, genetic services or participation in clinical research that includes genetic services (genetic testing, counseling, or education) by an individual or family member (NOTE: Genetic information does not include information about the age or sex of an individual.) Genetic Information means information about (cont):

  9. An analysis of human DNA, RNA, chromosomes, proteins, or metabolites that detect genotypes, mutations, or chromosomal changes Does not include tests such as CBCs, cholesterol tests, and liver-function tests that do not measure RNA, DNA, or chromosomal changes Does not include tests that analyze proteins or metabolites the results of which are directly related to a manifest disease, disorder, or pathological condition that could reasonably be detected by a health care professional with appropriate expertise and training in the field of medicine involved. Definition of Genetic Test

  10. What will GINA do?

  11. Requesting, requiring, or purchasing genetic information of an individual or an individual’s family members, except in limited specified circumstances Using genetic information for decisions regarding coverage, rates, or preexisting conditions Title I prohibit health insurers and health plan administrators from…

  12. Using genetic information in decisions regarding hiring, firing, promotion or any other terms of employment (e.g., benefits) Requesting, requiring, or purchasing genetic information of an individual or an individual’s family members, except in limited specified circumstances (e.g., when health or genetic services are offered by the employer as part of a wellness program) Disclosing genetic information concerning an employee, except in very limited circumstances. Retaliating against employees who file a complaint under GINA Title II prohibit most employers from…

  13. GINA’s limitations and exceptions

  14. What GINA will not do: • Health coverage provisions do not extend to life insurance, disability insurance, and long-term care insurance • Does not mandate coverage for any particular test or treatment • Employment provisions do not apply to employers with fewer than 15 employees

  15. What GINA will not do (cont): • In the individual health insurance market, does not prohibit the health insurer from determining eligibility or premium rates for an individual based on the manifestation of a disease or disorder in that individual. • In the group market (health coverage based on employment), the overall premium rate for an employer can be increased because of the manifestation of a disease or disorder of an individual enrolled in the plan, but the manifested disease or disorder of one individual cannot be used as genetic information about other group members to further increase the premium.

  16. What GINA will not do (cont): • Does not prohibit health insurers or health plan administrators from obtaining and using genetic test results in making health insurance payment determinations.

  17. “Research Exception” Under Title I • Allows health insurers and group plans engaged in research to request (but not require) that an individual undergo a genetic test, if the following conditions are met: • Request made pursuant to research that complies with 45 CFR 46, or equivalent regs., and any applicable state or local laws for protection of human subjects • Clear indication that participation is voluntary and that non-compliance will have no effect on enrollment status or premium or contribution amounts • Genetic information collected as part of the research may not be used for underwriting purposes • The health insurer or group health plan notifies the Federal government in writing of the research being conducted pursuant to the exception • The issuer complies with other conditions as the Secretary may by regulation require

  18. “Research Exception” Under Title II • Allows employers to disclose genetic information about an employee to an occupational or other health researcher if the research is conducted in compliance with 45 CFR part 46

  19. Implementation of GINA

  20. Effective Dates • Health coverage provisions (Title I) related to individual health insurers will take effect May 22, 2009 • Health coverage provisions (Title I) related to group health plans will take effect between May 22, 2009 and May 21, 2010 • Employer provisions (Title II) will take effect November 21, 2009

  21. GINA Rulemaking • Department of Labor issued an RFI notice in Federal Register soliciting comments in October 2008 regarding title I provisions • EEOC issued an NPRM on March 2, 2009 proposing regulations implementing Title II provisions (29 CFR part 1635); 60-day comment period

  22. OHRP’s Guidance on the Genetic Information Nondiscrimination Act: Implications for Investigators and Institutional Review Boards

  23. GINA and the Criteria for IRB Approval of Research • Risks to subjects are minimized (45 CFR 46.111(a)(1)) • Risks to subjects are reasonable in relation to anticipated benefits, if any, to the subjects and importance of knowledge that may reasonably be expected to result (45 CFR 46.111(a)(2)) • When appropriate, adequate provisions to protect privacy of subjects and confidentiality of data (45 CFR 46.111(a)(7))

  24. GINA and the Requirements for Informed Consent • A description of any reasonably foreseeable risks or discomforts to the subjects (45 CFR 46.116(a)(2)) • A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained (45 CFR 46.116(a)(5))

  25. OHRP Guidance on GINA: Implications for Investigators and IRBs: http://www.hhs.gov/ohrp/humansubjects/guidance/gina.pdf

  26. Advanced Notice of Proposed Rulemaking on IRB Accountability(Issued March 5, 2009)

  27. Meetings on Alternative IRB Models • Secretary’s Advisory Committee on Human Research Protections recommendation: OHRP, NIH, and FDA should consider holding a workshop focused on central IRB review mechanisms and that SACHRP use the workshop experience and other processes as a means of gathering information and moving forward toward future committee action (Fall, 2004).

  28. Meetings on Alternative IRB Models • OHRP co-sponsored meetings on alternative IRB models in November 2005 and November 2006 • Other sponsors were NIH, the Association of American Medical Colleges, and the American Society of Clinical Oncology

  29. Meetings on Alternative IRB Models • A key conclusion: Despite existing regulatory flexibilities some institutions remain reluctant to designate external IRBs and rely on cooperative review arrangements.

  30. Meetings on Alternative IRB Models • A key factor: OHRP currently holds institution engaged in human subjects research study accountable for noncompliance on the part of the external IRB designated on FWA to review the research.

  31. OHRP Proposal to Hold IRBs Accountable • Should OHRP revise 45 CFR part 46 to enable HHS to hold IRBs and IRB organizations (IORGs) directly accountable for compliance? • An Advanced Notice of Proposed Rulemaking published March 5, 2009

  32. Proposal to Hold IRBs Accountable Issues to consider: • FDA’s IRB regulations explicitly include compliance provisions (21 CFR part 56) • Is there sufficient need for HHS to pursue a regulatory change to 45 CFR part 46 to hold IRBs directly accountable?

  33. Proposal to Hold IRBs Accountable • Would such a regulatory change have the unintended effect of making IORGs less willing to have their IRB designated on other institutions’ FWAs? • How should the IRB authorization agreement be used to inform OHRP’s compliance oversight evaluations?

  34. Proposal to Hold IRBs Accountable • How should OHRP categorize the responsibilities of the IRB/IORG and FWA holding institution? Regulatory requirements seem to fall into three categories of responsibilities.

  35. Proposal to Hold IRBs Accountable • Categories of regulatory responsibilities: • Responsibilities unique to IRBs/IORGs; • Responsibilities unique to institution engaged in human subjects research; • Responsibilities that may be fulfilled by either IRBs/IORGs or institutions engaged in human subjects research. • Is there a category of responsibilities that are inherently shared by the IRBs/IORGs and engaged institutions?

  36. Proposal to Hold IRBs Accountable • Responsibilities that may be unique to IRBs/IORGs; a few examples: • Provisions regarding IRB membership (45 CFR 46.107) • Provision that identifies criteria for IRB approval of research (45 CFR 46.111) • Provision that permits IRB to alter or waive informed consent (45 CFR 46.116(c) and (d))

  37. Proposal to Hold IRBs Accountable • Responsibilities that may be unique to engaged institutions; a few examples: • Requirement that investigator obtain IRB review and approval before beginning non-exempt human subjects research (45 CFR 46.109(a)) • Requirement that no investigator conduct non-exempt human subjects research without obtaining and documenting subjects’ informed consent unless an IRB has waived these requirements (45 CFR 46.116 and 46.117).

  38. Proposal to Hold IRBs Accountable • Responsibilities that may be fulfilled by IRB/IORG or engaged institutions; a few examples: • Determining applicability of 45 CFR part 46 (e.g. exemptions) (45 CFR 46.101(b)) • Developing written IRB procedures which IRB will follow (45 CFR 46.103(b)(4)) • Fulfilling documentation and recordkeeping requirements associated with IRB activities (45 CFR 46.115)

  39. ANPRM on IRB Accountability: http://edocket.access.gpo.gov/2009/pdf/E9-4628.pdf *Comments due June 3, 2009

  40. IRB Registration Rule (Issued January 15, 2009)

  41. IRB Registration Rule • OHRP added a new subpart E requiring IRB registration for: • IRBs reviewing HHS-conducted or supported human subjects research; and • Designated on a Federal wide Assurance • FDA simultaneously issued IRB registration rule • Both rules become effective July 14, 2009

  42. IRB Registration Rule • First time registration required within 60 days of effective date (9/14/09) • Already registered IRBs as of 9/14/09 must re-register within 3-year expiration date or within 90 days of any changes regarding: • the contact person who provided the IRB registration information; or • the IRB chairperson

  43. IRB Registration RulesOHRP: http://edocket.access.gpo/gov/2009/E9-588.htmFDA: http://edocket.access.gpo/gov/2009/E9-682.htm

  44. FAQs on Meaning of OHRP-Registered IRB and OHRP-Approved FWA(Issued May 6, 2009)

  45. FAQs on IRB Registration/FWA • Clarify that IRB registration does not mean that an IRB is in full compliance with the HHS human subject protection regulations. • Clarify that OHRP-approved FWA does not mean that an institution is in full compliance with the HHS human subject protection regulations.

  46. FAQs: IRB Registration (see Question #14): http://www.hhs.gov/ohrp/IRBfaq.htmlFWA approval: (see Question #25): http://www.hhs.gov/ohrp/FWAfaq.html

  47. Policy/Guidance Coming Soon… • Guidance on discontinuation of participation in human subjects research (draft issued for public comment December, 2008) • Draft guidance on continuing review (will address several SACHRP recommendations) • Revised guidance on stem cell research (will update references to NIH’s guidelines for human stem cell research) • Notice to modify expedited review category 5 and/or 7 (notice issued for public comment October, 2007) • FAQs on IRBs (expected to send to Common Rule agencies for comment before issuance) • Guidance to clarify investigator is not prohibited from making exemption determinations.

  48. Policy/Guidance Coming Soon (Maybe) • Several possible modifications to the FWA—seeking comments from Common Rule Departments/Agencies: • Eliminate “check-box” • Eliminate requirement that all IRBs being relied upon by institution be designated on its FWA (e.g. internal IRBs only, or if none internal only the external IRB that reviews the most human subjects research) • Eliminate references to international standards on FWA for international institutions • Require electronic submission of FWA • Eliminate collection of HHS Institutional Profile File code and Federal Entity Identification number

  49. Policy/Guidance Coming Later… • Guidance on human biological specimens, repositories and databanks (SACHRP is addressing a subset of these issues) • Guidance on research involving children (taking into account SACHRP’s and IOM’s recommendations) • Possible NPRM to eliminate requirement for reporting IRB membership rosters to OHRP (responsive to a SACHRP recommendation)

  50. DISCUSSION

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