DECLARATION OF HELSINKI: World Medical Association drew up a Code of Ethics on human experimentation in 1964 which was revised in 1975.
(1) Basic Principles
Bio-medical research involving human subjects must conform to the moral and scientific principles that justify medical research, which should be based on scientifically established facts and animal and laboratory experiments. It must be conducted by qualified medical and other personnel and should be preceded by careful assessment of inherent risks in comparison to expected advantages to the subject or others. Particular care should be taken in research liable to lead to personality changes.
(2) Clinical work Combined with Professional Care
The doctor must be free to use a new therapeutic measure which is likely to save a patient’s life, re-establish health or alleviate suffering and may be continued if justified by its therapeutic value for the patient, provided consent has been taken of the patient or his legal guardian.
(3) Non-Therapeutic Clinical research
A doctor’s duty is to remain the protector of the life and health of a person, and as such, in a purely scientific clinical research, the involved risks should be explained and a free written consent should be taken from him or his legal guardian, with a proviso of his right to withdraw from the investigations whenever he likes. The right of parents or guardian to give consent is being questioned.
Human experimentation may be:
(1) THERAPEUTIC human experimentation is concerned primarily with improving the condition of a particular patient under treatment.
(2) RESEARCH experiment is concerned primarily with using a human subject as a means of expanding scientific knowledge for the benefit of humanity.
(3) INNOVATIVE experiments are therapeutic procedures that have not yet earned a place in medical practice.
Experimental procedures should not vary too radically from accepted methods, and they must be tried only after the failure of customary methods. The innovator must show that he possessed sufficient prior knowledge of the probability of success of the medical technique and of its collateral risks. He must know whether the probable success of the technique outweighs its collateral risks.
Extensive animal research is an absolute pre-requisite to the use of an innovative technique in the treatment of human beings. The most difficult innovative cases will be those in which prior animal study is impossible or would be uninformative.
Any appraisal of an innovative technique’s propriety must be made in the light of the patient’s interests. The treatment should be given cautiously and its after-effects should be noted and appreciated. Experiment on volunteers can only be justified if they do no significant harm to the subject and the results are likely to be beneficial.
It would be unethical to do something merely by way of human experimentation, i.e. which is not strictly related to the cure of the patient’s illness. There must also be no great risk in the proposed experimentation, even if the patient consents to run the great risk.
A new experiment should not be undertaken merely to find out its efficacy, if there is already a treatment which is equally efficient. The human experimentation should be stopped as soon as ill-effect is noted which should be immediately remedied. In considering whether a new treatment is as efficacious as an old one, side-effects of the two treatments and their cost should be considered.
ICMR GUIDELINES FOR HUMAN RESEARCH, 1995
The ICMR has laid down certain ethical guidelines for biomedical research on human subjects. It states that medical and related study using human beings should necessarily ensure that:
(1) Purpose of such research is directed towards the increase of knowledge about human condition in relation to its social and natural environment.
(2) Study is conducted under such conditions that the subjects are dealt with in a manner conducive to and consistent with their dignity and well being.
(3) Study must be subjected to a regimen of evaluation at all stages.
General Principles of human experimentation
(i) Principle of essentiality: Whereby the research is considered absolutely essential after a due consideration of all factors and options involved.
(ii) Principle of voluntariness, informed consent and community agreement: Whereby, the subjects are fully apprised of the study and the impact and risks to him and others; and he retains the right to abstain from further participation in the study irrespective of any obligation they may have entered, subject to only minimal restitutive obligations of any advance consideration received.
(iii) Principle of non-exploitation in human experimentation: Whereby as a general rule the study subjects are remunerated for their involvement in the research or experiment.
(iv) Principle of privacy and confidentiality: Whereby, the identity and records of the subjects are kept confidential as far as possible.
(v) Principle of precaution and risk minimization: Whereby, due care and caution is taken at all stages of a research to ensure that the subjects are put to minimum risk and generally benefit from the experiment.
(vi) Principle of professional competence: Whereby, the study is conducted at all times by competent and qualified persons who act with total integrity and impartiality and who have been made aware of the ethical considerations.
(vii) Principle of accountability and transparency: Whereby, the research experiment will be conducted in a fair, honest, impartial and transparent manner after full disclosure or all aspects of their interest.
(viii) Principle of maximization of public interest and of distributive justice: Whereby the study or experiment and its subsequent applicative use are conducted and used to benefit all humankind.
(ix) Principle of institutional arrangement : 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 study and its subsequent use or application are duly made in a transparent manner.
(x) Principle of public domain whereby, the research is brought into public domain so that its results are generally made known through scientific and other publications.
(xi) Principle of totality of responsibility: Whereby, the professional and moral responsibility, for the due observance of all the principles, guidelines and prescriptions rests with all those involved in conducting the experiment.
(xii) Principle of compliance in human experimentation: Whereby, there is a general and positive duty on all persons, conducting with any research entailing the use of a human subject to ensure that these guidelines are adhered in letter and spirit.