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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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1-Draft: Consultative Document on Ethical Guidelines on Biomedical Research involving Human Subjects Statement of General Principles on Ethical Considerations involving human subjects in Medical Research

This "Statement of Ethical Considerations involved in Biomedical Resarch on Human Subjects" shall be known as the ICMR Code and shall consist of the -

(a) Statement of General Principles on Research using Human Subjects in Biomedical Research

(b) Statement of Specific Principles on Research using Human Subjects in specific areas of Biomedical Research

These Statements of General and Specific Principles may be varied, amended, substituted and added from time to time.

BACKGROUND

In the aftermath of the Second World War (1939-45), there was an intensified concern about the use of the human subjects for medical research. The first international statement on the ethics of medical research using human subjects was the Nuremberg Code of 1947, which emphasised consent and voluntariness. The Nuremberg Code was evolved in the aftermath of the trial of medical practitioners accused of conducting experiments in medical research without their consent and in conditions where the human subjects were put to grave risks resulting in their deaths and permanent impairment to their faculties. In 1948, Universal Declaration of Human Rights (adopted by the General Assembly of the United Nations) expressed human rights concern about human beings being subject to involuntary maltreatment. In 1966, the International Covenant on Civil and Political Rights specifically stated,"No one shall be subjected to torture or to cruel, inhuman or degrading treatment or punishment. In particular, no one shall be subjected to without his consent to medical or scientific treatment".

Following preliminary efforts by the Council for International Organisations of Medical Sciences (CIOMS) the World Medical Association formulated the Declaration at Helsinki in 1964 which was revised from time to time and which laid down general principles on using human subjects in medical research in addition to specific prescriptions for biomedical research. In February 1980, the Indian Council of Medical Research released a "Policy Statement on Ethical Considerations involved in Research on Human Subjects" for the benefit of all those involved in clinical research in India. In 1982, the World Health Organisation (WHO) and the CIOMS issued Proposed International Guidelines for Biomedical Research involving Human Subjects. Subsequently the CIOMS issued "International Guidelines for Ethical Review of Epidemiological studies" in 1991 and "International Ethical Guidelines for Biomedical Research involving Human subjects" in 1993. Over the years, various bodies in national jurisdictions have also laid down general and specific principles in respect of medical research generally and in specific areas of scientific research entailing the use of human beings as a subject. These 'national' Codes (drawn from the international codes and the universal principles underlying them) outline 'guidelines' to be followed in their respective jurisdictions.

GENERAL STATEMENT

Medical and related research using human beings as subjects must necessarily ensure that -


  1. The PURPOSE, of such research is that it should be directed towards the increase of knowledge about the human condition in relation to its social and natural environment, mindful that the human species is one of the many species in a planet in which the well being of all species is under threat - no less from the human species as any other; and that such research is for the betterment of all, especially the least advantaged.
  2. Such research is CONDUCTED under conditions that no person or persons become a mere means for the betterment of others and that human beings who are subject to any medical research or scientific experimentation are dealt with in a manner conducive to and consistent with their dignity and well being under conditions of professional competence, fair treatment and transparency; and, after ensuring that the subject is placed at no greater risk, other than such risk commensurate with the well being of the subject in question in the light of the object to the achieved.
  3. Such research must be subjected to a regime of EVALUATION at all stages of the proposal i.e., research design and experimentation, declaration of results and use of the results thereof; and, that each such evaluation shall bear in mind the objects to be achieved, the means by which they are sought to be achieved, the anticipated benefits and dangers, the potential uses and abuses of the experiment and its results and, above all, the premium that civilised society places on saving and ensuring the safety of each human life as an end in itself.

STATEMENT OF GENERAL PRINCIPLES

Any research using the human beings as subjects of medical or scientific research or experimentation shall bear in mind the following principles -



  1. Principles of essentiality whereby, the research entailing the use of human subjects is considered to be absolutely essential after a due consideration of all alternatives; in the light of the existing knowledge in the proposed area of research and after the proposed research has been duly vetted and considered by an appropriate and responsible body of persons who are external to the research and who, after careful consideration, come to the conclusion that the said research is necessary for the advancement of knowledge and for the benefit of all members of the human species and for the ecological and environmental well being of the planet.
  2. Principles of voluntariness, informed consent and community agreement whereby, research subjects are fully apprised of the research and the impact and risk of such research on the research subject and others; and, whereby the research subjects retain the right to abstain from further participation in the research irrespective of any legal or other obligation that may have been entered into by such human subjects or someone on their behalf, subject to only minimal restitutive obligations of any advance consideration received and outstanding. Where any such research entails treating any community or group of persons as a research subject, these principles of voluntariness and informed consent shall apply, mutatis mutandis, to the community as a whole and to each individual member who is the subject of the research or experiment.
  3. Where the human subject is incapable of giving consent and it is considered essential that research or experimentation be conducted on such a person incompetent to give consent, the principle of voluntariness and informed consent shall continue to apply and such consent and voluntariness shall be obtained and exercised on behalf of such research subjects by someone who is empowered and under a duty to act on their behalf.
  4. The principles of informed consent and voluntariness are cardinal principles to be observed throughout the research and experiment, including its aftermath and applicative use so that research subjects are continually kept informed of any and all developments in so far as they affect them and others. However, without in any way undermining the cardinal importance of obtaining informed consent from any human subject involved in any research, the nature and form of the consent and the evidentiary requirements to prove that such consent was taken, shall depend upon the degree and seriousness of the invasiveness into the concerned human subject's person and privacy, health and life generally, and, the overall purpose and the importance of the research.
  5. Principle of non-exploitation whereby, as a general rule, research subjects are remunerated for their involvement in the research or experiment; and, irrespective of the social and economic condition or status, or literacy or educational levels attained by the research subjects kept fully apprised of all the dangers arising in and out of the research so that they can appreciate all the physical risks as well as moral implications of the research whether to themselves or others, including those yet to be born.
  6. Such human subjects should be selected so that the burdens and benefits of the research are distributed without arbitrariness, discrimination or caprice.
  7. Each research shall include an inbuilt mechanism for compensation for the human subjects either through insurance cover or any other appropriate means to cover all foreseeable and unforseeable risks by providing for remedial action and comprehensive after-care, including treatment during and after the research or experiment, in respect of any effect that the conduct of research or experimentation may have on the human subject and to ensure that immediate recompense and rehabilitative measures are taken in respect of all affected, if and when necessary.
  8. Principles of privacy and confidentiality whereby, the identity and records of the human subjects of the research or experiment are as far as possible kept confidential; and, that no details about identity of said human subjects, which would result in the disclosure of their identity, are disclosed, without sound scientific reasons which may be essential for the purposes of therapeutics or other interventions,without the specific consent in writing of the human subject concerned, or someone authorised on their behalf; and, after ensuring that the said human subject does not suffer from any form of hardship, discrimination or stigmatisation as a consequence of having participated in the research or experiment.
  9. Principles of precaution and risk minimisation whereby, due care and caution is taken at all stages of the research and experiment (from its inception as a research idea, its subsequent research design, the conduct of the research or experiment and its applicative use) to ensure that the research subject and those affected by it are put to the minimum risk, suffer from no irreversible adverse effects and, generally, benefit from and by the research or experiment; and that requisite steps are taken to ensure that both professional and ethical reviews of the research are undertaken at appropriate stages so that further and specific guidelines are laid down, and necessary directions given, in respect of the conduct of the research or experiment.
  10. Principles of professional competence whereby, the research is conducted at all times by competent and qualified persons who act with total integrity and impartiality and who have been made aware of, and are mindful of, the ethical considerations to be borne in mind in respect of such research or experiment.
  11. Principles of accountability and transparency whereby, the research or experiment will be conducted in a fair, honest, impartial and transparent manner after a full disclosure is made by those associated with the research or experiment of each aspect of their interest in the research, and any conflict of interest that may exist; and whereby, subject to the principles of privacy and confidentiality and the rights of the researcher, full and complete records of the research inclusive of data and notes are retained for such reasonable period as may be prescribed or considered necessary for the purposes of post-research monitoring evaluation of the research, conduting further research (whether by the initial researcher or otherwise) and in order to make such records available for scrutiny by the appropriate legal and administrative authority, if necessary.
  12. Principle of the maximisation of the public interest and of distributive justice whereby, the research or experiment and its subsequent applicative use are conducted and used to benefit all human kind and not just those who are socialy better off but also the least advantaged; and, in particular, the research subject themselves.
  13. Principle of Institutional Arrangements whereby, there shall be a duty on all persons connected with the research to ensure that all the procedures required to be complied with and all institutional arrangements required to be made in respect of the research and its subsequent use or application are duly made in a bonafide and transparent manner; and to take all appropriate steps to ensure that research reports, materials and data connected with the research are duly preserved and archived.
  14. Principle of public domain whereby, the research and any further research, experimentation or evaluation in response to,and emanating from such research is brought into the public domain so that its results are generally made known through scientific and other publications subject to such rights as are available to the researcher and those associated with the research under the law in force at that time.
  15. Principle of totality of responsibility whereby, the professional and moral responsibility, for the due observance of all the principles, guidelines or prescriptions laid down generally or in respect of the research or experiment in question, devolves on all those directly or indirectly connected with the research or experiment - including the researchers, those responsible for funding or contributing to the funding of the research, the institution or institutions where the research is conducted and the various persons, groups or undertakings who sponsor, use or derive benefit from the research, market the product (if any) or prescribe its use - so that, inter alia, the effect of the research or experiment is duly monitored and constantly subject to review and remedial action at all stages of the research and experiment and its future use.
  16. Principle of Compliance whereby, there is a general and positive duty on all persons conducting, associated or connected with any research entailing the use of a human subject to ensure that both the letter and the spirit of these guidelines, as well as any other norms, directions and guidelines which have been specifically laid down or prescribed and which are applicable for that area of research or experimentation, are scrupulously observed and duly complied with.

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