>6.6 Indian Code on Human Genetics and Reproductive Technology

pp. 102-103 in Bioethics and the Impact of Human Genome Research in the 21st Century

Author: Ishiwar C. Verma (Sanger Ram Hospital, India)

Editors: Norio Fujiki, Masakatu Sudo, and Darryl R. J. Macer
Eubios Ethics Institute

Copyright 2001, Eubios Ethics Institute All commercial rights reserved. This publication may be reproduced for limited educational or academic use, however please enquire with the author.
In 1980 the Indian Council of Medical Research (ICMR) had published a "Policy statement on ethical considerations involved in research on human subjects" which has been widely used by scientists in India. With the ushering in of the era of biotechnology and genomic studies medical procedures and therapeutics have undergone a tremendous change. In order to make this document contemporarily relevant a central Ethical Committee on Human Research was constituted under the chairmanship of Hon'ble Justice Mr. M.N. Venkatachaliah. Subcommittees were appointed to draw guidelines for the following areas (i. Clinical evaluation of drugs, devices, vaccines and herbal medicines; ii. Epidemiological research; iii. Human genome research; iv. Trans-plantation research; and v. Assisted reproduction techno-logies). A Draft Consultative Document was prepared and widely circulated for discussion. Public debates (four regional and one national) were organized to reflect ethnic differences. The final draft is awaiting approval and adoption.

The document provides a background of various international documents on ethics (Nurenberg code, Helsinki declaration, CIOMS guidelines). It states 12 general principles of ethics, discusses the ethical review process and makes recommendations regarding institutional ethical review committees. There is a detailed discussion of informed consent. It recommends that pregnant or nursing women should in no circumstance be subjects of research unless the research carries no more than minimal risk to the fetus. It states that children should not be involved in research that might be carried out equally well in adults. It recommends that persons who are economically or socially disadvantaged should not be used for research to benefit those who are better off.

Regarding international collaboration it states that the developing countries should function as equal partners with sponsors. Community representatives should be involved in a sustained manner in all phases of the research. The dignity, safety and welfare of the participants should be protected. Rules and regulations of all countries participating in collaborative research should be respected. The researchers should follow the Govt. of India notification on" Exchange of Human Biological Material for Biomedical Research (1997)."

It presents guidelines for drug and vaccine trials, and emphasizes that permission of the Drug Controller of India is essential. Regarding herbal medicines it makes the interesting point that no clinical trials are required if these are used by practitioner of ayurveda, but trials would be necessary if these drugs are used by doctors practicing western system of medicine. It states the ethical principles for different forms of epidemiological studies.

Under genetic research it makes the point that harm from genetic counselling and technologies may not only be physical but psycho-social producing anxiety and depression. When commercial companies are involved in research it is necessary to protect researchers and subjects from possible coercion /inducement to participate in the study. It makes special mention of the privacy and confidentiality of the data. Family members are not entitled to know each other's diagnosis. However confidentiality of information is not absolute, and may be disclosed if it is in the public interest, or if required by a court of law. It permits somatic cell gene therapy, but disallows germ line therapy. Gene therapy for enhancement and eugenic genetic engineering is prohibited.

Regarding DNA banking it recommends that normally the samples should be used for the primary purpose only. The review committee shall examine every request for a secondary purpose to ensure that the proposed use does not transgress the original consent given earlier.

With regard to reproductive technologies informed consent shall include information regarding use of spare embryos \ to be preserved for later use, to be used for research or implanted in another woman. Investigators should clarify the ownership of the embryos \ whether they belong to the biological mother or the laboratory. There is no ethical objection at the moment for IVF or any other related procedure for research or for clinical application. Respect for embryos is to be shown by accepting limits on what can be done, limiting the time for research to 14 days i.e. when the primitive streak appears. Prenatal diagnosis of sex, or pre-conceptional or preimplantation sex selection is prohibited except for detecting sex specific genetic disorders. A child born through ART is presumed to be the legitimate child of the couple, and the donor of sperm or egg has no right over the child. Regarding surrogate motherhood it accepts the universal consensus \ the woman who carries the child is its mother, she has the right to retain the baby if she so desires, the intending parents should have a preferential right to adopt the child subject to 6 weeks of postpartum delay for necessary maternal consent, and all expenses are to be borne by the intending couple.

There is a detailed discussion on transplantation. Donation from a live donor is restricted to renewable tissues like bone marrow or paired organs, while removal of an eye is not permitted because it will compromise binocular vision. The interest of the donor should always take priority over those of the recipient. The donor should have the legal capacity to give consent, and be in a position to exercise free power of choice without the slightest element of force, duress or coercion. It encourages cadaver transplants, and suggests making of living wills. In the absence of such a direction the person in lawful possession of the body will make the decision to use the organs or not. It allows tissue for transplantation to be obtained from dead embryos or fetuses after abortion, but disallows deliberate conception or abortion for the sake of obtaining tissues for transplantation. Those participating in the termination of pregnancy will not, in any way, be a party to subsequent usage of embryonic or fetal tissue. However no research is permitted on a live aborted fetus. Use of tissue or organs from dead anencephalic fetus or neonate is permitted. Transplantation of fetal tissues into man will only be permitted when certain specific criteria are met. Xenotransplantation is permitted only between different animal species, but not yet from animal to man.

Please send comments to Email < asianbioethics@yahoo.co.nz >.

To contents page
To Eubios book list
To Eubios Ethics Institute home page