HHS HUMAN RESEARCH SUBJECT PROTECTION REGULATIONS PERTAINING TO INVITRO FERTILIZATION (IVF) OF HUMAN OVA MODIFIED BY THE NIH

REVITALIZATION ACT



NIH GUIDE, Volume 22, Number 32, September 3, 1993



P.T. 34



Keywords:

  Human Subjects Policy 

  Abortion (Induced) 

  Biological Resources 



National Institutes of Health



The National Institutes of Health Revitalization Act of 1993 (P.L. 103-

43) 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 of this nullification is that research

applications and proposals involving in vitro fertilization (IVF) of

human ova may be conducted or funded by HHS and its components without

the prior review and advice of a national advisory body.  IRB

(Institutional Review Board) review and approval continues to be

required in accord with 45 CFR 46.205.  It is anticipated that

applications and proposals involving certain types of human IVF

research will still be subject to special review on a case-by-case

basis, at the discretion of the Department and its components.



INQUIRIES



For further information, contact



F. William Dommel, Jr., J.D.

Senior Policy Advisor

Office for Protection from Research Risks

Building 31, Room 5B63

Bethesda, MD  20892

Telephone:  (301) 496-7005



.


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