towards an international ethic for research with human beings

Towards an International Ethic for Research with Human BeingsAuthor(s): Judith MillerSource: IRB: Ethics and Human Research, Vol. 10, No. 6 (Nov. - Dec., 1988), pp. 9-11Published by: The Hastings CenterStable URL: http://www.jstor.org/stable/3564201 .

Accessed: 16/06/2014 15:14

Your use of the JSTOR archive indicates your acceptance of the Terms & Conditions of Use, available at .http://www.jstor.org/page/info/about/policies/terms.jsp

.JSTOR is a not-for-profit service that helps scholars, researchers, and students discover, use, and build upon a wide range ofcontent in a trusted digital archive. We use information technology and tools to increase productivity and facilitate new formsof scholarship. For more information about JSTOR, please contact [email protected].

.

The Hastings Center is collaborating with JSTOR to digitize, preserve and extend access to IRB: Ethics andHuman Research.

http://www.jstor.org

This content downloaded from 188.72.126.55 on Mon, 16 Jun 2014 15:14:35 PMAll use subject to JSTOR Terms and Conditions

http://www.jstor.org/action/showPublisher?publisherCode=hastings

http://www.jstor.org/stable/3564201?origin=JSTOR-pdf

http://www.jstor.org/page/info/about/policies/terms.jsp


November/December 1988

Towards an International Ethic for Research with Human Beings by Judith Miller

Rapid progress in bioscience and the growing interdependence of nations have created an urgent need for con- tinuing development of national and international ethics standards. The fourth international summit symposia devoted to bioethics, hosted by Canada in 1987, focused on the priority area of ethics review of research with human beings.

Twenty-six scientists, philosophers, and lawyers, nominated by the heads of state of the Economic Summit nations, by the European Economic Community, and by the World Health Organization, worked together "Towards an International Ethic for Research with Human Beings." Partic- ipants addressed not only the underlying principles, but more specifically the practices and procedures to carry them out. At the subsequent Economic Summit meeting, the Prime Minister of Canada encouraged his fellow heads of state to implement the delegates' recommendations.

Delegates deliberated upon a wide variety of subjects. These included: the structure and function of multidisciplinary ethics review committees, protection of vulnerable subjects, manage- ment of risks of research, public participation in ethics review, control of research with embryos and fetuses, review mechanisms for pilot studies and novel therapies, ethics issues in industrial research, selection of research topics, the transferability of ethics standards among nations, and the expansion of transnational standards.

Delegates unanimously affirmed the importance of multidisciplinary research ethics committees to implement the widely endorsed underlying principles of respect for individuals, contribution to the well being of society and the equitable distribution of potential risks and benefits throughout society.

They made recommendations to improve protection of subjects of

research throughout the world. A key recommendation is that "a nation should not allow or support, in other countries, research which does not conform to ethics review standards at least equivalent to those in force within the nation."

In the highly sensitive area of research with embryos, the delegates linked research with therapy and called for "the supervision and control of centres offering in vitro fertilization, of related treatments for infertility and of those conducting embryo research. Procedures should be regulated according to appropriate guidelines administered by a competent authority."

With regard to the special problem of ethics review of preliminary studies of medical innovations, delegates recommended that "they should be subject to the same ethical judgements that apply to all research protocols."

While accepting the necessity for animal studies to precede research with human beings, the delegates urged that "governmental agencies continuously modernize their own regulatory requirements to ensure that they do not demand test results of safety and toxicology which are no longer relevant or which can be replaced by satisfactory alternatives requiring fewer animals."

Delegates stressed the vital role of education in medical ethics for all involved, be they physicians, investiga-

tors, medical students, the media, or the public. Such education underlies informed participation in and review of health sciences research.

The significance of individual recommendations differs according to the system in place within each country. It can be argued that the standards of ethics among western democracies are generally comparable, but that the processes for ethics review vary widely.

From a Canadian perspective, the general tenor of the deliberations reinforces the approach already in place, i.e., review through local research ethics boards founded upon national guidelines. Steps are now in process to improve the monitoring of the function- ing of these boards in accord with the thinking of the Summit Conference. The systematic inclusion of pilot studies in such review is an innovation in the Medical Research Council "Guidelines for Research Involving Human Sub- jects," issued subsequent to the Bio- ethics Summit Conference. The Inter- national Development Research Council fosters an awareness of ethical principles among health researchers of the Third World and reviews all research it supports in other countries to assure that the research meets comparable ethics standards to those for research conducted in Canada.

Canada, like other nations, would benefit from the continued international dialogue advocated by the delegates. Such international exchange both promotes constructive reflection on current practices and helps to develop common attitudes and standards that may improve international agreement and cooperation.

Excerpts from the Summary Report of the International Conference on Bloethics

Research with Embryos The integrity and uniqueness of

human life in its earliest embryonic stages of formation must be accorded great respect. Generally, current forms of control of research procedures and manipulation of human embryos are not legislative in nature. In fact, in the almost total absence of legislation, research on the embryo is presently, for the most part, governed by the self-regulatory efforts of scientific and professional bodies, the centres themselves, and the review by ethics committees, local and national. Voluntary licensing control exists, for example in England, but there was

consensus on the need to regulate the current anarchic proliferation and operaton of in vitro fertilization centres in some countries as an interim measure while acquiring the experience necessary for effective legislation. Thus the delegates recommended the need to keep in balance the professional liberty for clinical treatment and for scientific inquiry in the interest of progress in medical knowledge and skill while upholding regard for the human interest in the embryo. To this end, the delegates recommend the supervision and control of centres offering in vitro fertilization, of related treatments for

Judith Miller is Bioethics Summit Conference Coordinator, Medical Research Council of Canada The ideas expressed are those of the author and not necessarily those of the Medical Research Council Free copies of the Summary Volume (in English or in French) are available from Ms. Judith Miller, Bioethics Summit Conference Coordinator, Medical Research Council of Canada, Ottawa, Ontario, Canada K1A OW9.

9



luo

infertility and of those conducting embryo research. Procedures should be regulated according to appropriate guidelines administered by a competent authority.

All delegates recognized the pre- ciousness of the human embryo. Nevertheless, different positions were taken with respect to the possibility of permitting research on the human embryo.

Several questions were raised with respect to the applicability of legal concepts of "ownership" (more prop- erly discussed in terms of legitimate interest in) and control of human embryos during storage or after the death of the donors. Questions were also raised concerning penal sanction as opposed to professional regulation.

Considering the experimental nature of in vitro fertilization, its low success rate and the unknown long term effect of these procedures, which though "therapeutic" in nature for the infertile have implications for the manipulation and control of human life, any work with embryos even as a treatment for infertility should be regarded as devel- opmental procedures that are experimental in nature and therefore should be closely monitored.

Pilot Studies and the Introduction of Novel Therapies

Delegates debated the special problem of ethics review of pilot studies or preliminary studies of medical innovations. Such studies were viewed as a phase between the initial obser- vations on one or a few patients and the start of a full fledged protocol- based program.

Delegates recognized that it is often not easy to be sure whether an intervention by a physician should be regarded as a treatment undertaken only in the patient's best interest, or whether it is guided also by an intent to gain scientific knowledge.

The decision on when a research intent is present in therapy is a determination to be made by the physician. It was the opinion of the delegates that, if the health professional has any doubt whether the intervention is in fact research, the issue would best be brought to the attention of the ethics committee.

In reviewing the novel therapy of research, delegates recommended that they should be subject to the same ethical judgements that apply to all research protocols. Special consider- ation should be given to limiting the number of subjects entered into pilot studies and to monitoring closely and frequently.

In ethics review of pilot studies as in that of other proposed research, the delegates agreed that provision should be made for a mechanism to reexam- ine a research project rejected by a research ethics committee if the investigator should request it. Such a mechanism should be of a sort which would not invite the overriding of local decisions by a higher or distant authority. It should maintain the collaborative nature of the relationship between the researcher and the ethics committee, rather than encour- age an adversarial relationship. It was also agreed that there should be a greater exchange of information between research ethics committees.

Industrial Research Industries are a major source of

medical innovation. Also much of their research is mandated by national standards for licensing drugs or devices. This research involves both animals and human beings and is often carried out in a number of countries. For that reason, the inter- actions between industries, govern- ments and sometimes universities are of great concern.

Differences in the way ethics standards are interpreted and imple- mented can have direct economic effects. Lack of consistency can adversely affect national and com-

mercial interests as well as the safety of research subjects. Delegates recommended that, at the very least, a nation should not allow or support, in other countries, research which does not conform to ethics review standards at least equivalent to those in force within the nation. Nations and industries should develop international accords which strive for common attitudes and the exchangeability of standards and for mutual trust. Nations and industries should also identify emerging technologies to foster early discussion of the ethical concerns. Such interaction might help the equitable distribution of effort in research and development.

Delegates also discussed the ethical concerns raised by the growing pace of commercialization of biomedical products. The increasingly close links between university-based and industry-based research mean that academic physicians or institutions may have financial interests in the outcome of the research; any such potential conflicts of interest should be declared in the research ethics review process. Moreover, it was the opinion of some delegates that we should develop and implement values which integrate ethics and economic interests.

Delegates also discussed the effects of confidentiality, and of compensa-

CALENDAR

JANUARY 24-25, 1989: This workshop on the Humane Care and Use of Laboratory Animals sponsored by NIH will be held in San Antonio, Texas. For information on this meeting, please contact Ms. Molly Greene, Institutional Animal Care Program, University of Texas Health Science Center at San Antonio, 7713 Floyd Curl Drive, San Antonio, TX 78284-3717. FEBRUARY 2-3: Ethical Issues Surrounding the Use of Human Subjects in Research, a regional workshop sponsored by the Office for Prevention from Research Risks and Arizona State University, will be held in Tempe, Arizona. The workshop will focus on panel speakers and group participation will enable an exchange of ideas to assist in resolving challenging issues that are presented to IRBs. Viewpoints will be presented by faculty from ASU and other universities. This workshop will focus on specific issues such as use of vulnerable populations, cooperative research with institutions not under university regulations, the use of deception in research, and legal issues. The workshop is to be held at the Sheraton Tempe Mission Palms Hotel in Tempe. For further information contact: Carol Jablonski, Human Subjects Coordinator, Arizona State University, (602) 965-2170. FEBRUARY 9-10: The location of this workshop on the Humane Care and Use of Laboratory Animals is Salt Lake City, Utah. Contact Joan Provost, Conferences and Institutes, University of Utah, Salt Lake City, UT 84112, (801) 581-5809 for information.



November/December 1988

tion of research subjects. The confidentiality of commercially sensitive material may not be consistent with the requirements for ethics review. In addition, payment can induce subjects, especially those of more limited means, to participate in research, and may lead to financial competition for research subjects. With respect to both industrial and other research, concern was expressed over whether patients will be compensated for adverse effects which may on rare occasions arise from research...

The Selection of Research Topics and Directed Research

Researchers consider many scientific, social and other factors when choosing research topics: choices are also made in the context of national policies and systems of support as well as national policies and practices in respect to ethics. In some instances, this results in an apparent imbalance between the research topics being chosen and major global needs for research in fields such as fertility regulation and tropical diseases.

International research programs can provide a successful mechanism to promote and carry out research in those areas which are neglected, sensitive and/or economically unat- tractive to national researchers. These programs can make extensive use of the international scientific community and can apply high standards of scientific and ethical review to carry out research in the areas of high global priority which are difficult to address on a national basis. Those nations with the means to support research have an obligation to devote some of those resources to the research needs of nations without such means.

The group recommended that research should focus upon the development of knowledge in broad fields of science with the aim of achieving a fundamental understanding of biological processes, even those which might not appear to have direct application over the short or longer term. It is seen as a scientific infra- structure of further advance. It was also recommended that the results of research should be applied as rapidly and as effectively as possible.

Large scale support for narrowly focussed research on specific diseases without the necessary foundation of scientific knowledge was seen as rarely, if ever, successful Also the failure to implement the results of research for the benefit of mankind has, in itself, serious ethical implications...

? NNOTATIONS

AAAS-ABA National Conference of Lawyers and Scientists. Project on Scientific Fraud and Misconduct. Report on Workshop Number One. Washington, DC: American Association for the Advancement of Science, 1988. [*AAAS, Office of Public Sector Pro- grams, 1333 H Street, NW, Washington, DC 20005].

Rosemary Chalk, Patricia K Woolf, Warren Schmaus, and Barbara Mishkin contribute papers from a September 1987 conference on legal and scientific dimensions of fraud in science. Issues include a definition of fraud, the extent of deception in research, harm to patients or to public policy, ways institutions handle allegations of fraud, recent incidents and their consequen- ces, deterrents, and due process and its application to misconduct in science.

Johnstone, James M. "Treatment IND Safety Assessment: Potential Legal and Regulatory Problems." Food Drug Cosmetic Law Journal 43(3) (May 1988), 533-40 [J.M. Johnstone, Wiley, Rein and Fielding, 1776 K Steet, NW, Washington, DC 20006].

In discussing the FDA's November 1987 regulations concerning adverse drug reactions (ADRs) Johnstone focuses on the tension between drug manufacturers' incentives and safe- guards imposed by the regulations. He describes the practical and legal problems of ADR reporting and of product liability and concludes that the safe- guards may outweigh the incentives.

Kimmel, Allan J. Ethics and Values in Applied Social Research. Newbury Park, CA: Sage Publications, 1988. $19.95; $9.95 paper.

Kimmel's text offers an overview of the ethical problems encountered by social science researchers and includes discussions of informed consent, assign- ment of research subjects, confidentiality, the role of values, and investigators' responsibilities regarding the use of scientific data generated by their research.

Mishkin, Barbara. "Responding to Scientific Misconduct: Due Process and Prevention." Journal of the American

Please enter my subscription to IRB: A Review of Human Subjects Research

L INSTITUTIONAL $200 annually (20 copies mailed to the same address)

Additional copies included in same mailing @ $10 each annually (number)

O LIBRARY $45 annually (single copy) 0 INDIVIDUAL $30 ($25 if paid by personal check, for new

subscribers) Prepayment is appreciated. Please make checks payable to: The Hastings Center, IRB L My check for is enclosed. If you enclose payment, we

wll extend your subscription to include one free issue. (Please detach the subscription form and mail with check in an envelope, addressed to: The Hastings Center, IRB, 255 Elm Road, Briarcliff Manor, NY 10510.)

El Please bill. LI Please change my individual subscription to an institutional sub-

scription.

Name

Title

Institution

Address

City/State/Zip

I11



towards an international ethic for research with human beings

Documents