HHS Waives Regulations on Medicaid Research, Proposes New ExemptionsAuthor(s): Carol LevineSource: IRB: Ethics and Human Research, Vol. 4, No. 4 (Apr., 1982), p. 10Published by: The Hastings CenterStable URL: http://www.jstor.org/stable/3564381 .

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10

ruary 22, 1982, pp. 7699-7701) does not specifically mention research projects, presumably it would cover any adoles- cent research subject who is receiving prescription drugs or devices.*

A recent statutory amendment of the Public Health Service Act requires family planning projects to "encourage family participation in the provision of services by the projects, to the extent practical." The Secretary proposes to implement this amendment by making family notification mandatory. In addi- tion, where state law requires family planning providers to provide Title X services to unemancipated minors only with notification or consent of their parents, projects would be required to comply with that law.

The rule would require that minors be told, before services are provided, that their parents will be notified. The only exceptions would be cases in which notification will result in physi- cal harm to the minor by the parents or guardian. The project would also have to verify the notifications, keep records on them, and also on the number of ex- emptions for potential physical abuse. These records must be supplied to the Secretary on request.

Comments on the proposed rule should be submitted in writing before April 23 to Marjory Mecklenburg, Act- ing Deputy Assistant for Population Af- fairs, HHS, Room 725H, 200 Independ- ence Ave. SW, Washington DC 20201.

*For a case study on this subject, see Roberta Herceg-Baron, "Parental Consent and Family Planning Research Involving Minors," IRB: A Re- view of Human Subjects Research (November 1981, pp. 5-7); and in the same issue a commen- tary by Carol Levine, "Teenagers, Research, and Family Involvement," p. 8; as well as the "Letters section" of IRB, February 1982, pp. 10-11).

CALENDAR

APRIL 23-24: Understanding, communicating and implementing the content of all regulations governing Institutional Review Boards (IRBs) and using them to work effectively within parent institutions will be the focus of the eleventh PRIM&R conference, entitled "The Ethical, Legal and Regulatory Dilemmas in Research with Human Subjects, and the Impact of the New Federal Regulations," to be held at the Shamrock Hilton in Houston, Texas.

The PRIM&R meeting will discuss the new HHS and FDA regulations in a forum of diverse and experienced speakers and workshop leaders, including representatives from the fields of research, regulation, industry, and bioethics. Conference participants will have the opportunity to participate in topical workshops and plenary sessions covering such issues as differences between the two sets of regulations, clarifications in the doctrine of informed consent, and, in general, the roles, rights, and responsibilities of the government, the institution, the IRB, the researcher, and the subject.

PRIM&R has set aside a limited number of scholarships for those persons demonstrating need; a limited number of spaces have also been reserved for the press. For a complete program and further information, contact Joan Rachlin, Executive Director, or Melissa Apperson, Administrative Assistant, at (617) 367-4992, or 367-2829.

MAY 3-4: A workshop on the "Protection of Humans as Experimental Re- search Subjects," cosponsored by the University of Illinois at the Medical Cen- ter, and the Office for Protection from Research Risks, NIH, will be held at the Radisson Chicago Hotel in Chicago. The conference is designed to provide technical assistance to grantee institutions, their staffs, and the research per- sonnel and members of their Institutional Review Boards. For further infor- mation contact: University of Illinois at the Medical Center, Office of Continuing Education Services, 912 South Wood Street, 2 North, Chicago, IL 60612; (312-996-8025).

MAY 21-22: A Northwest Regional Conference on Research Involving Human Subjects, cosponsored by the National Institutes of Health, U.S. Food and Drug Administration, and the Kaiser-Permanente Medical Care Program, will be held in Portland, Oregon. Topics will include problems experienced by in- vestigators and IRBs, ethical principles behind regulation of research involv- ing human subjects, and an overview of federal and state regulations for the protection of research subjects. For more information, write Kaiser-Perma- nente Education and Conference Center, 3425 N. Montana Ave., Portland, OR; or call 503-233-5631, ext. 10.

JULY 11-17: The Hastings Center will sponsor a "Workshop on Institutional Review Boards and Human Subjects Research" to be held at Colorado College, Colorado Springs. The purposes of the workshop are to provide an opportunity for the analysis and discussion of basic ethical principles underlying research involving human subjects, and to encourage understanding of federal regula- tions and IRB procedures, through discussion of practical problems in pro- tocol review. The workshop format will include lectures, small-group discussions, meetings of topics of special interest (deception, fraud in re- search, monitoring, randomized clinical trials, etc.) and opportunities for par- ticipants to meet and discuss mutual problems. The workshop director is Robert J. Levine. Faculty members are Albert R. Jonsen, John A. Robertson, Thomas H. Murray, and Thomas A. Shannon; many guest speakers will also attend. For a brochure, contact Workshops, The Hastings Center, 360 Broad- way, Hastings-on-Hudson NY 10706; (914) 478-0500.

HHS Waives Regulations on Medicaid Research, Proposes New Exemptions

Effective immediately, DHHS an- nounced on March 4 (Federal Register, Vol. 47, No. 43, p. 9208) that it is waiv- ing the requirements relating to the protection of human subjects in the case of demonstration projects which test the use of cost-sharing, such as de- ductibles, copayment, and coinsurance in the Medicaid program. The waiver is appropriate, according to the Secre- tary, since it will "facilitate the timely efficient operation" of these demon- stration projects.

The waiver applies only to the spe- cific case cited, but DHHS has also pro- posed a more general rule change

(Federal Register, March 22, 1982, Vol. 47, No. 55, pp. 12276-77) that would specifically exempt federally sponsored research and demonstration projects designed to study "certain public bene- fit or service programs, the procedures for obtaining benefits or services under those programs, and possible changes or alternatives to those programs or procedures, including changes in meth- ods or levels of payment." In effect, the Department stated, it would restore to the regulations an exemption included

in the initial notice of rulemaking (Au- gust 14, 1979). IRB review would, the agency claims, only duplicate the efforts of other officials and would be burdensome to state and local agen- cies.

Comments on the proposed rule should be submitted by April 21 to F. William Dommel, Jr., Assistant Direc- tor, OPRR, 5333 Westbard Ave., Room 3A-18, Bethesda, MD 20205; phone 301-496-7163.

Carol Levine

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