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Sounding Board

Indian Pediatrics 2001; 38: 514-517  

Ethical Issues in Biomedical Research on Human Beings


K.R. Thankappan
Richard A. Cash*

From the Achutha Menon Center for Health Science Studies, Sree Chitra Tirunal Institute for Medical Sciences and Technology, Thiruvananthapuram, Kerala 695 011, India and *Harvard School of Public Health, 665 Huntigton Avenue SPH1-1106 C, Boston MA 02115, USA.

Correspondece to: Dr. K.R. Thankappan, Associate Professor, Achutha Menon Center for Health Science Studies, Sree Chitra Tirunal Institute for Medical Sciences and Technology, Thiruvananthapuram, Kerala 695 011, India.

E-mail: thank@sctimst.ker.nic.in

Biomedical and social research are essential for the development of better interventions to prevent and treat illnesses. The amount and level of this research will increase within India as globalization accelerates. For biomedical research to be accepted by both the scientific community and by the public (an equal partner in all research endeavors), it must conform to certain ethical guidelines. The Indian Council of Medical Research (ICMR) has recently updated its own "Ethical Guide-lines for Biomedical Research on Human Subjects", after four years of thoughtful discussion and dialogue. As stated by the former chief justice of India, Justice M.N. Venkatachaliah, in the guidelines foreword, "...any system of ethical guidelines on research needs to be cognizant of, and informed by, a sensitive balance of the risks and benefits(2). The National Committee for Ethics and Social Science Research in Health (NCESSRH) has also published the first "Ethical Guidelines for Social Science Research in Health" for India(2). To further a dialogue on ethical issues in health research in South Asia, the Achutha Menon Center for Health Science Studies of the Sree Chitra Tirunal Institute for Medical Sciences and Technology, Thiru-vananthapuram, recently organized a four-day workshop on "Ethical Issues in Health Research in South Asia" during the week of January 29, 2001. Researchers, funders of research and ethicists from South Asia and other Asian countries were brought together to share their experiences and to discuss ethical guidelines. In the workshop, extensive use was made of cases to illustrate principles articulated in earlier lectures. We would like to share with the readers of ‘Indian Pediatrics’, some of the important issues discussed in the workshop and to suggest ways that the quality of research ethics might be improved.

General Principles of Biomedical Research Involving Human Subjects

In the updated ICMR guidelines a number of general principles were identified as forming the basis of ethical research. These are the principles of essentiality; voluntariness, informed consent and community agreement; non-exploitation; privacy and confidentiality; precaution and risk minimization; professional competence; accountability and transparency; maximization of the public interest and distributive justice; institutional arrangements; public domain; totality of responsibility; and compliance. Some of these issues are self-explanatory but many need to be further discussed so that a better understanding emerges. We will focus on those issues that have particular relevance to research on children.

Informed Consent

A major principle in all ethical guidelines is that informed consent should be obtained from all study participants except where the subject is incapable of giving consent. This latter group includes children, however defined by a society. One problem in countries like India is the presence of a large number of illiterate and poor who cannot give written consent. This problem should actually be seen as an opportunity to clearly explain the study to the participant. The focus should be on ‘understood’ consent rather than informed consent. How can the investigator be certain that subjects fully comprehand the study? What information is essential for understanding? At what age should a child decide whether or not to participate? The NCESSRH Guidelines use 14 years as the age that separates children from adults(2). The WHO definition of children extends to age 18. Should there be one age for all societies or does it depend on the responsibility of a child in each society? Who should take the decisions on whether consent is valid? Should the researcher who wants to enroll subjects (and therefore has a ‘conflict of interest’) be the one who seeks consent? Though the answers to these questions are not easy, there are some principles of informed consent. Informed consent is essential to protect the participants, not the researchers or the institutions. The purpose of the research, identity of the researchers, how and why the participants are selected for the study and harms and benefits of the study, should be understood by all participants no matter what their level of literacy. The right of participants to withdraw from the study is essential, as is their right to health care for complications related to the study.

Additional Concern

Other areas of concern include genetic research (including genetic engineering), rights of the human embryo, genetic counsel-ing, prenatal diagnostic techniques, and stem-cell research. Drug testing will clearly become a major research topic and source of funding. Conflict of interests of the researcher and funder (especially if it is a pharmaceutical company) must be acknowledged and dis-cussed. Should an investigator be allowed to conduct research on products for which he/she stands to gain a financial benefit? If so should there be requirement that all financial holdings with the company be disclosed? When the outcome of research is not beneficial to a sponsoring company should it be allowed to prevent the investigator from publishing the findings? When do incentives to participate in a study become so excessive as to be coercive? Who should benefit from the results of a study? What responsibilities does the researcher have to the individual participant or community? How do we even define a community if it is to benefit? Lastly, what standard of care should be available to those who are in the control group? The best in the world or the best available and accessible in the community or country? This latter issue has led to major disputes within the research community.

Ethical Review Boards

The establishment of ethical review boards (ERBs) to review research proposals is essential for the conduct of biomedical and social research. Should ERBs only review the ethics of a proposal or should they also review study design? Any study improperly designed, it is argued, is by definition unethical. At some point in the review process the scientific validity of a study must be determined. A major problem in countries like India is the establishment of functioning Ethical Review Boards in all institutions sponsoring research. Though, there are some excellent ERBs, a disturbing number of institutions conducting research do not have ERNs or have them in name only. The WHO through the Tropical Disease Research program has recently published "Operational Guidelines for Ethics Committees that Review Biomedical Research"(3) which provides an excellent roadmap as to how to establish an ERB and make it a viable and functioning unit. Clearly, there is a great need for training in how to develop an ERB and to review relevant issues that will likely come before the ERBs. The guidelines address questions such as: Who should be the members of the review boards? How many members should there be and what should they do? How can they be protected against the economic and political interests of the investigator, the host institution, or the country? What should be the process by which proposals are reviewed? What should be the training of members of the Ethical Review Board? How long should members serve? Many ERBs need funds to support their work. How will ERBs be financially supported? Should ERBs assess a fee for reviewing each study and does this cause it’s own ethical dilemmas? Again, the most important principle for ERBs is that they are "....responsible for acting in the full interest of potential research participants and concerned communities, taking into account the interests and needs of the researchers, while having due regard for the requirements of relevant regulatory agencies and applicable laws(3).

Need for Including Ethics in the Medical Curriculum

A clear recommendation of the workshop was to include and improve the teaching of medical ethics and research ethics to medical students, nurses, and any other professionals, including social scientists, who might be engaged in health related research. Students need to know that they first and foremost must serve the best interest of their patients and study participants. At present there are only a handful of schools that have courses on medical ethics and fewer still that require all students to take such courses. Curriculum development and the training of teachers should be given priority. Exposure to medical and research ethics must continue throughout their training, including house-manship/internship at all levels. In addition some faculty who have been exposed to many of the contemporary issues in medical ethics could benefit from continuing education in health research ethics. The role of professional associations, such as the Indian Academy of Pediatrics, will be critical in the teaching and dissemination of ethical principles for research to its widespread membership.

Acknowledgements

The authors are thankful to the Harvard School of Public Health, Boston, World Health Organization, Geneva and the Indian Council of Medical Research, New Delhi for their sup-port in organizing the workshop on "Ethical Issues in Health Research in South Asia".

Key Messages

  • Health researchers and those approving this research should know the basic principles and contemporary issues in research ethics.

  • A number of useful guidelines for biomedical and social science health research have been developed in India and internationally.

  • Institutions approving research must have ethical review boards whose members have had some training in health related research ethics and are aware of current issues.

  • Teaching in research ethics should begin at the medical schools and other professional institutions and should continue throughout one’s career. Professional associations have an important role to play in this educational process.

 

References
  1. Indian Council of Medical Research. Ethical Guidelines for Biomedical Research on Human Subjects. ICMR, New Delhi 2000.

  2. National Committee for Ethics in Social Science Research in Health (NCESSRH). Ethical Guidelines for Social Science Research in Health. Cehat, Mumbai, November 2000.

  3. Operational Guidelines for Ethics Commit-tees That Review Biomedical Research, Tropical Disease Research Program, World Health Organization, Geneva, 2000.

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