Nih Proposes Tough Rules for Human Experimentation (Science & Government Report)

Page 1

NTH Proposes Tough Rules for Human Experimentation raises for consideration new regulations governing the use of children, prisoners, and the mentally infirm a s experimental subjects. The regulations, published in the Nov. 16 Federal Register. (Part 11, p. 31737) seem to go a long way toward tightening up practices that have recently come under serious criticism. They provide, fcexample, that each HEW agency establish an Ethical respiration and heart beat may not be undertaken.” And it goes on to recommend that “This policy and these protections apply with equal force to the products of spontaneous abortion.” The proposals for prisoners notes that “While it is important that prisoners have the opportunity to participate in research, it is equally important that they not feel compelled to.” It recommends the establishment of an Organizational Review Committee by the prison institution Of the SpOnSOrhg agency, plus a Protection Committee, consisting of at least five members, up to one-third of them scientists mittee for the same purpose. or physicians, plus at least one prisoner “or a r e p As far a s research on children is concerned, the resentative of an organization concerned with ing research activities which expose children to risk Also. “A child may not be included a s a subject in must document, as part of the application for s u p research involving risk if he is detained in an instiport, that the information to be gained can be ob- tutional setting pursuant to a Court order. whether tained in no other way. n e investigator must also or not the parents and the child have consented to stipulate eiher that the risk to the subjects will be the childsparticipation.” insignificant, or that although some risk exists, the p o t e n ~ a lbeoefit is significant and far outweighs ongoing reviews by the agency Ethical Review that risk. In no case will research activities be a p Board, plus reviews by Protection Comnittees at proved which entail substantial risk, except in the each institution. case of clearly therapeutic procedures in which the It also proposes that HEW-supported research benefit to &e patient signrficandy outweighs the abroad be subject to the same ethical standards as possible ham.” are employed domestically, and in regard to In regard. to fetal research, the draft suggests that research not s p o m r e d by HEW. it ~~comm8nds the r e d a t i o n s be allowed Some flexibility to ac- that, if HEW standards are not met, the institution commodate new technologies, but it also states flatly be barred from eligibility for HEW support until it that “Ln order to insure that research considera- falls in line with the standards. tions do not influence decisions a s to timing, method, These are tough re,dations that should meet the or extent of a procedure to terminate a pregnancy, approval of virtually all who have felt distressed no investigator engaged in the research on the about the ethical standards governing a great deal abortus may take part in these decisions. These of human research. It may also be anticipated that decisions are to be made by the woman and her phy- many researchers will regard the regulations a s SO sician.” It adds that “If the physician detE:mines stringent and wra ped up in red tape that a lot of maintain heart beat or respiration artificially in the HEW invites interested parties to comment on the abortus for the purpose of research. Experimental regulations by writing to Director, NIH,9 W Rockprocedures which of thamselves will terminate ville Pike, Bethesda, Md., 20014 For the past two years the President has vetoed all HEW appropriations bills sent to him on the ground Congress Passed a 1974 appropriations bill that again called for far more spending than the President desired ($32.9 billion instead of the President’s budget request of $31.5 billion). But as part of a deal worked out with the White House, bngressbnal conferees agreed that the Administration total appropriatsd. provided that no single program make certain that ths Admiiistration doesn’t cancel entire Programs by impourdment. Even if the Admlnistratlon holds back the full $403 nillioc, the fiEW budget will still be almost $1 bilsoq highor than Nimn wanted. on Dee. 5, and the Senate by a5 to 3 on EX. 7, Bo:h In regard to the mentally infirm, the draft caIls for 2 that the fetus is not viable, it is not acceptable to useful research wirl come to a halt. REP*RT *5*1973 that they called for excessjve spending. Last week NIH Gets Substantial Boost in Budget boost of $500 million to $500 million under a camHouse over the fiscal 1974 appropriations bill for the The National hstitutes of Health will get a budget promise reached between Congress and the ’rVhite Department of Health. Education and Welfare. The compromise, which ends two years of warring OvsT the HEW appropriations bill, will give NM at least $2.46 billion, and possibly a s much as $2.57 biliion, for fiscal 1974 (the cwren: year]. compared could refrain from spending up to $400 million of the is cut more than 5 psr cent, a provision designed to