HHS Publishes Regulations on Research Involving ChildrenAuthor(s): Carol LevineSource: IRB: Ethics and Human Research, Vol. 5, No. 2 (Mar. - Apr., 1983), p. 11Published by: The Hastings CenterStable URL: http://www.jstor.org/stable/3563800 .

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FDA Issues New Information Sheets

The Office of Health Affairs, Food and Drug Administration, has devel- oped the following new information sheets of interest to Institutional Re- view Boards, sponsors, investigators, and others concerned with clinical re- search and the protection of research subjects:

Acceptance of Foreign Data and IRB and Informed Consent Require- ments Continuing Review Cooperative Research FDA District Offices FDA Regulations Which Relate to IRB Activities Non-Local IRB Review Sponsor-Clinical Investigator-IRB Interrelationship

Information sheets on the following subjects have been available for some time:

A Suggested Self-Evaluation Guide: Human Subject Protection; Institu- tional Review Boards Clinical Investigators Unaffiliated with an Institution with an IRB Emergency Use of a Test Article Investigational Use of Marketed Products IRB Information Sheet Significant Differences in HHS and FDA Regulations for IRBs and In- formed Consent Waiver of IRB Requirements

Any questions regarding FDA pol- icies on IRBs and informed consent may be directed to Stuart L. Night- ingale, M.D., Associate Commissioner

for Health Affairs, Dr. Halyna Breslawec, or Ms. Bonnie Lee (301-443-1382). Copies of the informa- tion sheets may be obtained by writing to: Food and Drug Administration, Of- fice of Health Affairs, HFY-20, 5600 Fishers Lane, Rockville, Maryland 20857.

March/April 1983

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OMB's Changing Proposals on B~anin 'Political Advocacy'

On January 24, 1983, the Office of Management and Budget proposed sweeping new regulations that would have prohibited any institution that re- ceived a federal grant or contract from engaging in "political advocacy" (Federal Register, Vol. 48, No. 16, pp. 3348-51). The proposal was designed, the notice said, "to balance the First Amendment rights of federal grantees and contractors with the legitimate governmental interests of ensuring that the government does not subsidize directly or indirectly the political advo- cacy activities of private groups or in- stitutions."

Under the proposed rules, organiza- tions could not charge the government for any part of their rental costs if 5% or more of the building or office space was devoted to political advocacy. Em- ployees whose salaries were paid in part by federal funds could not engage in any form of political activity. The definition of "political advocacy" was very broad, encompassing not only tra- ditional categories such as election campaigns but also any attempts to in- fluence government policy through the regulatory process or the legislative process, or through litigation as an am- icus curiae.

OMB now concedes that its proposal "went way too far" (Chronicle of Higher Education, March 9, 1983, p. 11). Responding to heavy criticism from businesses, social service organizations and nonprofit institutions, Deputy Di- rector Joseph R. Wright, Jr. said at a House Government Operations sub- committee hearing that the agency would probably narrow its definition of "political advocacy" and might also liberalize other portions of the pro- posal.

The revised proposal is expected to be issued by March 11; the public will have 45 days to respond.

HIIHS Publishes Regulations on Research Involving Children

The long-awaited HHS regulations on research involving children were published March 8, 1983 (Federal Reg- ister, Vol. 48, No. 46, pp. 9814-9820). Secretary Richard Schweicker signed the regulations just before he left office.

The department's proposed regula- tions were published July 21, 1978, in response to the recommendations of the National Commission for the Pro- tection of Human Subjects of Bio- medical and Behavioral Research, is- sued in 1977.

IRB will report more fully on the regulations in a forthcoming issue.

Carol Levine

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