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DRAFT: CONSULTATIVE DOCUMENT ON ETHICAL GUIDELINES ON BIOMEDICAL RESEARCH INVOLVING HUMAN SUBJECTS
( By Indian Council of Medical Research New Delhi )

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Why the Debate?

Why the Debate?

Biomedical research is essential for enhancing human health and well being. Development of a therapeutic drug is a complex process. At times it involves Research over 2 to 3 decades and may cost crores of rupees. It is mandatory that any drug before being marketed is evaluated for its toxicology and efficacy in controlled trials in human sunjects. The type of experimental protocol or procedure that a human volunteer or a patient may be exposed to will vary with the complexity of the medical intervention and is often associated with a certain amount of risk. The cardinal guiding principle of ethics in drug-research involving human subjects is that the benefit of intervention should far out-weigh the risks and the adverse effects should be minimal, transitory and should disapper on withdrawal of the drug. Similar considerations also apply to studies on subjects designed to evaluate newly developed diagnostic agents, medical devices and vaccines.

Basic Tenets of Ethics: The main pillars of ethics in biomedical research are : Essentiality of the proposed research - valid information would not have become available otherwise, voluntariness of the subject, informed-consent, confidentiality of the identity/personal data of individual subjects, non-exploitation of subjects' situational or circumstantial position, treatment of research subjects with respect and dignity, professional competence of the investi-gator (s) or medical team, accountability and transparency of all transactions between the researcher(s), research-institution and the volunteer, and finally - the public domain, that is, the findings should be made public domain, that is, the findings should be made public for the benefit of the society. The guidelines in biomedical research are formulated to ensure universal compliance of the basic tenets of ethics. The guidelines are not a permanent feature. They need revision to cope with changes in dynamics of the society induced by rapid advances in science.


Formulation of Ethical Guidelines:

The Indian Council of Medical Research (ICMR) is a nodal agency that co-ordinates biomedical research involving human subjects across the country. In 1980, the ICMR Ethics Committee under the Chairmanship of Justice H.R. Khanna released a document entitled "Policy statement on ethical considerations involved in research on human subjects" This document has been extensively used by scientists of ICMR and other agencies. The document now needs to be updated in view of recent developments in modern biology and other branches of medical science so that it can serve as a useful guide to all scientists and agencies involved in research on human subjects.

Genetic Research :

Uprecedented advances in the fields of biotechnology and genetic engineering and the ready availability of molecular biology tools have brought man to the realm of elucidating the human genome, possibility of gene-therapy for genetic-defects and cancers and the production of life-saving drugs, hormones and vitamins by DNA-recombinant technology. Genetic variability among population accounts for variation in body traits such as susceptibility to environmental stress, genetic-diseases, intelligence, height, blood pressure, etc.

Knowing the genomic make-up of an individual is like knowing the blue-print of a facility - laying bare the possibilities for up-gradations or down-gradations. Biomedical researchers similarly can manipulate the genome to eradicate untold miseries of mankind or, like "cloning of Dolly" they may sanction eugenic genetic engineering for personality, character, formation of body organs, fertility, intelligence, and physical, mental, and emotional characteristics. Is the time ripe for society to intervene to regulate the recent trends in biomedical researches involving human beings?


Assisted Reproductive Technology :

Assisted reproductive technology (ART) primarily involves manipulation of oocyte (egg) outside the body and then transfer of either the fertilized egg (embryo) or gametes (sperm/egg) into the would-be mother. The availability of "micromanipulator" as a tool has added a new dimension to ART. A sperm can be introduced under the zona pellucida of the oocyte (SUZI), or into the cytoplasm of the oocyte (ICSI). Micromanipulator can also be used to assist embryo-hatching by drilling a hole in the zona-pellucida prior to embryo transfer into the mother. The micromanipulator is also being used to manipulate the embryo for diagnosis of genetic defects before implantation (pre-implantation-diagnosis), gene-therapy and sex-determination. After the birth of the first test-tube baby, Louise Brown, ART has reached a stage where one may have to re-define the term "Infertility". Interventions have become possible in those cases of infertility which were considered "impossible" or "hopeless" a decade back. The availability of ICSI in particular has revolutionized the field of male infertiltiy. Individuals with complete azoospermia (no sperm in the semen ejaculate), asthenozoospermia (immotile sperm in the ejaculate), or teratozoospermia (sperms with abnormal morphology in semen) have been able to father a child.

Man has gained phenomenal insight into the delicate mechanisms that control the fertilization of ovum by sperm, early changes in the development of conceptus, embryo and aspects of early pregnancy. It has become possible to diagnose sex and genetic-defects before the establishment of clinical pregnancy. Human embryos can be maintained under laboratory conditions. What then are the implications of such medical progress on the society and in what manner should the society react to these developments? What are the types of experiments that can be conducted without sacrificing human values and dignity?

Ethical issues raised in day-to-day practice of ART are :


  • Should an infertile couple be encouraged to use a donor egg or a donor sperm to bear a biological child who in genetic-terms is not wholly theirs? Is such a child entitled to know the pedigree of genetic father or mother?
  • Who bears the consequences if the child inherits genetic defect from either the genetic father or mother?
  • Should an elderly infertile couple be exposed to assisted reproductive technology to bear a child?
  • Who should donate sperm/egg and how many times?
  • Should the donor of sperm/egg be financually rewarded or compensated?
  • What should be upper- and lower-age limit for donation of egg/sperm?
  • Should gamete donors be screened for genetic defects, sexually transmitted diseases, etc. and who should bear the cost of such screenings?
  • Should inter-community, inter-racial donation of sperm/egg be encouraged?
  • How long should sperm/oocyte be cryopreserved?
  • Should society promote surrogacy or hiring of wombs for the growth of a genetically alien embryos?
  • Could a surrogate mother undergo abortion on health grounds or otherwise if she opts to?
  • How many embryos should be transferred in one sitting to avoid multiple pregnancies?
  • Who is the owner of spare embryos?
  • Should spare embryos de destroyed or donated to compromised eligible couples?
  • How long should embryos be cryopreserved?
  • Could spare embryos be used for biomedical research?
  • Who would authorise the use of spare embryos for biomedical research?

The list continues

Tissue Transplants:

Tissue for transplantation may be from a live donor or human cadaver. A major issue involved in tissue transplantation is the rejection of the donated organ or tissue by the host due to uncompromised immunological sequelae. The use of human foetal tissue is one of the means to eliminate the chances of rejection. Foetal cells, in the early weeks after conception, are not fully differentiated, grow fast and adapt easily to messages from surrounding tissue in a host. They grow, differentiate and integrate to form a part of the host organ. Foetal tissues are therefore sought for transplantation. But is the transplantation of foetal tissue to adult host justifiable? What could be the source of foetal tissue? Would it be an expelled or delivered foetus that exhibits no heart beat or spontaneous breathing? Would society abhor or promote abortions induced specifically for transplantation? A whole range of ethical issues arise which need to be addressed rationally and objectively.

Organ replacement:

Paucity of organs from humans for transplantation into other humans has led to search for other sources such as animals (xeno-transplantation). Pigs are currently the animals of choice as the size of their organs and the anatomical and physiological loads they must carry are similar to those in man. Attempts are on to engineer pigs which possess genetic material similar to that in man. This is done by replacing pig (porcine) genes by human genes into the cell that will form the pig embryo. It is hoped that tissues and organs from such transgenic pigs when transplanted into patients will not be rejected. Problems would still remain in using pig tissue or organs in human transplantation. Of great concern is the possibility of transferring germs and viruses peculiar to pigs into man through transplanted tissues. The existence of species-specific infective diseases that limit themselves to that species is well known. Under special circumstances - as after transplantation - such organisms may leap from one species to another and cause untold havoc in the new species, previously unexposed to these organisms and which hence has no immunity against them. The apprehension that tissues or organs transplanted from animal to man may convey infection or unwanted genetic abnormalities has prompted most countires, to ban all research on transplanting animal organs to human beings till this issue has been satisfactorily addressed. Measures proposed include the breeding of successive generations of animals and studying them for all known and possible unknown organisms that can cause disease. Only those animals certified free from disease could be considered for transplantation. Would we in India be able to enforce such a code of conduct for research?

Measures against misuse:

Though recent biomedical innovations have brought great solace and benefic to mankind, grave concerns have been raised at different levels on the unwitting misuse and exploitation of human subjects. There is thus a need to bridle and guide the biomedical research involving human subjects. ICMR took the onus to lead the way in the Golden Jubilee year of our Independence.

ICMR constituted a Central Ethics Committee on Human Research (CECHR) under the Chairmanship, National Human Rights Commission, New Delhi) to consider various issues related to the ethical, legal and social aspects of research on human beings. The committee met on 10th September 1996 and identified following five major areas and the sub-committees for drawing up detailed guidelines on:


  • Human Genetics Research
  • Transplantation research including fetal tissue transplantation
  • Clinical evaluation of Drugs/Devices/Vaccines/Herbal remedies
  • Epidemiological research
  • Assisted Reproductive Technology

The CECHR met on 10th August 1997 to consider the draft reports prepared by all the five groups and following detailed discussions released a draft of "Consultative Document on Ethical Guidelines on Biomedical Research involving Human Subjects" for circulation and subsequent national debate. The draft is intended to be finalized after incorporating all view points of the public after a national debate.

Terms of Reference of the document are:


  • To review ethical, legal, social and other issues of research involving/affecting human subjects.
  • To formulate general principles for such research.
  • To formulate guidelines on specific areas of such research.
  • To examine the possibilities of setting up machinery and mechanism to monitor, implement and review the general and specific guidelines so formulated, and to further formulate such guidelines as may be necessary from time to time.
  • To consider and review the guidelines, machinery and mechanisms so formulated in the light of experience gained from time to time
  • To consider the wider implications of biomedical and health research and suggest ways and means in which interdisciplinary and inter-agency discussion and consultations can take place on an ongoing basis.
  • To consider ways and means in which these guidelines for research can be disseminated to increase awareness amongst researchers, concerned persons, institutions and the community. In order to achieve the desired goal,

Director General, ICMR, has proposed to conduct four regional debates at Hyderabad, Mumbai, Calcutta and New Delhi in the months of August-September, 1998. The public are encouraged to participate in the debate and give biomedical researches involving human subjects a mandate and its seal of sanctity and authority. A committee has been set up under the Chairmanship of Dr. Sunil Pandya, an Eminent Neurosurgeon and Dr. H.S. Juneja, Director, Institute for Research in Reproduction (IRR), Mumbai as member-secretary to organize the debate at Mumbai. Copies of the draft document are available for study by interested individuals or agencies from Director General, ICMR or Director, IRR, Mumbai.

The debate in Mumbai will be held on Sunday, September 20, 1998 in Dr. S.M. Merchant Auditorium, Bai Jerbai Wadia Children's Hospital, Acharya Donde Marg, Parel, Mumbai - 400 012. At least five different sessions of one-and a half hour each covering different topics, with regular-breaks, will be held from 9.00 a.m. onwards. The discussion from the floor will be encouraged. It will be open to all and is expected to be of one hour duration in each session.


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