NOTE: THIS GUIDANCE DOCUMENT HAS BEEN ARCHIVED BECAUSE THE DEPARTMENT OF HEALTH AND HUMAN SERVICES DOES NOT CONDUCT OR SUPPORT SUCH RESEARCH UNDER CURRENT APPROPRIATIONS STATUTES.

  Number 94-03 
  Human Subject Protections 

OPRR Reports
NIH PHS HHS 

July 22, 1994

Subject: In Vitro Fertilization of Human Ova--Prior Review by the Ethical Advisory Board No Longer Required for HHS Funding

Dear Colleague:

This letter is being forwarded to Institutional officials and Institutional Review Board (IRB) Chairs throughout the country. Its purpose is to inform you of legislative action which has nullified the regulatory requirement for review and advice from an ethical advisory board prior to the initiation of Health and Human Services- (HHS-) conducted or funded research involving human in vitro fertilization (IVF).

The National Institutes of Health Revitalization Act of 1993 (P.L. 103-43; June 10, 1993) nullified the provisions of section 204(d) of part 46 of title 45 of the Code of Federal Regulations (45 CFR 46.204 (d)). The provisions--which are now void--read: 

  "No application or proposal involving human in vitro fertilization may be funded by the Department until the application or proposal has been reviewed by the Ethical Advisory Board and the Board has rendered advice as to its acceptability from an ethical standpoint." 

The practical effect, on you, of this nullification is that research applications and proposals involving in vitro fertilization of human ova may now be submitted to and funded by HHS components without the prior review and advice of a national advisory body. Institutional Review Board (IRB) review and approval continues to be required in accord with 45 CFR 46.205

This OPRR REPORTS and the enclosed Federal Register Notice of June 1, 1994 (59FR28276) are for your information only and no action on your part is required at this time. If you have further questions, however, please contact OPRR at 301-496-7005. 
  Gary B. Ellis, Ph.D. 
Director
Office for Protection from Research Risks

Enclosure