Indian Council Proposes Guidelines on Human ExperimentationAuthor(s): Carol LevineSource: IRB: Ethics and Human Research, Vol. 3, No. 3 (Mar., 1981), p. 10Published by: The Hastings CenterStable URL: http://www.jstor.org/stable/3564088 .

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the records to defend itself or its em- ployees in cases that may arise in con- nection with these research programs and;

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OTA Report Suggests Ways to Compensate Injured Vaccine Victims

The swine flu epidemic of 1976 never materialized, but it was followed by a rash of lawsuits seeking damages for injuries that resulted from the mass ad- ministration of the vaccine. No federal program to compensate the injured ex-. ists; but a technical memorandum, "Compensation for Vaccine-Related In- juries," recently issued by the Office of Technology Assessment (OTA) offers some recommendations toward formu- lating a federal policy for future mass immunization programs (Science, Vol. 211, February 27, 1981, pp. 906-908).

The report outlines options for Con- gress to consider to replace the current adversarial system that involves long and expensive lawsuits. According to Lawrence Miike, staff director for the report and a lawyer and physician, "The legal system ... takes years to get a settlement and only a few who push their cases get anything." Yet, the re- port asserts, "Society has the obliga- tion to minimize the consequences" when injury occurs as part of a na- tional immunization program.

Drug manufacturers would like a federal compensation program to cover all vaccines. They refused to produce the swine flu vaccine until the govern- ment agreed to handle liability suits that did not result from company negli- gence. The OTA proposal does not go as far as the drug companies might like, recommending that only those chil- dren harmed by mandatory vaccines should be covered. Under this plan, persons who volunteer for inoculations such as swine flu would not be compen- sated for injury. David Banta, OTA's health program manager, makes this distinction: "What we're saying [now] is 'tough luck' to the child who be- comes ill after taking a [required] vac- cine. With the flu vaccine, a person is making a choice." Furthermore, the re- port recommends that the federal gov- ernment should compensate only for serious injuries, defined by the medical

expenses and/or degree of disability. The report describes other compen-

sations programs now in effect-in Cal- ifornia, Denmark, and Japan. Califor- nia has a maximum award of $25,000 for medical expenses; but in Japan an injured child can receive, in addition to medical expenses, an annuity for the person responsible for his or her care, a disability pension, and even a funeral grant. In Denmark a lump sum is awarded for disabilities of 5 to 50 per- cent; an annuity is given for more se- rious injury.

Where will the money for such a compensation program come from? Not from a surcharge on vaccines, the report says. This method was sug- gested in an earlier court decision on compensation, but it would be ineffec- tive in lowering the rate of injury and would only be an added cost to the ma- jor purchaser of vaccines-the govern- ment. The funds would probably come from general tax revenues.

The OTA report was requested by former Rep. Harley Staggers (D.-W. Va.), who was chairman of the House Committee on Interstate and Foreign Commerce, but he retired at the end of the last session of Congress. The report was completed too late for action at that session, and its future is uncertain.

President's Commission Developing Plans for IRB Studies Despite Budget Uncertainties

The President's Commission for the Study of Ethical Problems of Medicine and Biomedical and Behavioral Re- search, like many other federal agen- cies, expects to undergo budget cuts. However, according to Barbara Mish- kin, a Commission staff member, it is "definitely not going out of business." In fact, she says, the Office of Manage- ment and Budget has been "quite rea- sonable with respect to budget re- quests." But until Congress votes the actual budget, it is not clear how much money will be available, especially for large studies. Alexander Capron, Ex- ecutive Director, and Morris B. Abram, Chairman, testified before the House HHS Appropriations Subcommittee on February 6 and a Senate committee on March 11. The budgetary process will probably continue for some time.

Although the Commission will have to absorb budget cuts in its various programs, IRB studies remain very much on the agenda. As part of its bi- ennial report to the Congress, due at the end of 1981, the Commission must

report on the "uniformity and ade- quacy of rules, policies, guidelines and regulations of all Federal agencies re- garding the protection of human sub- jects of research, and of their actual implementation." The preparation of this report is complicated by the shift to new regulations in July so the Com- mission may first study, through a lim- ited questionnaire, some aspects of the new regulations that are not affected by the changed regulations. One study now under development will aim at de- veloping dependable indices for eval- uating IRBs on site visits. The Commis- sion would also like to set up regional workshops for IRBs, but travel is one budget item that is likely to be cut.

Indian Council Proposes Guidelines on Human Experimentation

The Indian Council of Medical Re- search (ICMR) has formulated guidelines for conducting medical re- search involving human subjects (Na- ture, January 15, 1981, p. 113). The guidelines, prepared by the ICMR Cen- tral Ethical Committee, are aimed at protecting the rights and welfare of subjects participating in clinical trials and ensuring that the benefits of the re- search outweigh the risks to the indi- vidual. Informed consent should be obtained from each individual before the start of the trial, the guidelines state, although the specifics are left to individual ethics committees. The ICMR is also concerned that each in- vestigator is competent to conduct the trial.

The ICMR also recommends that in- stitutions form ethics committees, con- sisting of five to seven clinicians and nonmedical persons, to give advice on ethical and legal matters. The commit- tees would review proposals on the ba- sis of a nine-point code. Since it will take some time to set up these commit- tees, the ICMR has offered to provide interim consultation services to evalu- ate the proposals. This will make it possible for institutions that do not yet have ethics committees to apply for funding from international agencies such as the World Health Organization which require an ethics committee's approval.

- The guidelines have been sent to the Indian government with the recom- mendation that they be followed by all institutions engaged in clinical re- search. By law the Drugs Controller of India must approve all clinical trials on new drugs. Carol Levine

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