NOTE: THIS GUIDANCE DOCUMENT HAS BEEN ARCHIVED BECAUSE SUBPART B HAS BEEN REVISED AND CAN BE FOUND AT http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm#subpartb.

Number 98-02
Human Subject Protections

OPRR REPORTS

June 30, 1998

Subject: Proposed Revision of Title 45, Code of Federal Regulations, Part 46, Subpart B

Dear Colleague:

This letter informs Institutional Officials and Institutional Review Board (IRB) Chairs of a Notice of Proposed Rulemaking (NPRM) concerning 45 CFR Part 46, Subpart B, “Additional DHHS Protections Pertaining to Research, Development, and Related Activities Involving Fetuses, Pregnant Women, and Human In Vitro Fertilization.” The existing regulations date from 1975 and were last revised in 1978.

The NPRM appears in the May 20, 1998 Federal Register (63:27793-27804). A copy of the notice is also available from OPRR by FAX, by calling 301-594-0464 and requesting document #3.

The proposed rule change institutes a policy of presumed inclusion of pregnant women in research, with certain exceptions--rather than a policy of presumed exclusion. Specific proposed revisions include the following:

• The pregnant woman would have to be fully informed regarding the reasonably foreseeable impact of the research on her fetus (or resultant child).

• For research that is designed to meet the health needs of the fetus, the consent of the mother, rather than both parents, would be required.

• Six categories of research that present benign risk, such as innocuous survey research, would be exempt from regulation. (These exemptions have applied since 1981 to research involving nonpregnant women.)

• Consultation with experts and a public meeting would be required should waiver of any of the regulatory protections be considered by the Secretary of Health and Human Services. (This requirement replaces the requirement for a standing ethical advisory board to advise the Secretary.)

Ms. Carol Y. Wigglesworth
Senior Policy Analyst
Office for Protection from Research Risks
6100 Executive Boulevard, Suite 3B01 MSC 7507
Rockville, MD 20892-7507

The comment period ends on August 18, 1998. fr20my98-23

Sincerely,

Gary B. Ellis, Ph.D.	J. Thomas Puglisi, Ph.D.
Director	Director
Office for Protection from Research Risks	Division of Human Subject Protections