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Report No. 271

Chapter -II

Ethical Framework

2.1 The ethical framework for human subject's protection has its origins in the ancient Hippocratic Oath, which specified that a primary duty of a physician was to avoid harming the patient. However, this oath was not necessarily respected in human experimentation and most advances in protection for human subjects came as a response to abuse inflicted on human subjects. Conducting research on human subjects essentially involves certain binding ethics and standards to be followed in a humane and culturally sensitive manner.

2.2 The Declaration of Helsinki, 1964, set the guidelines adopted by the 18th World Medical Association General Assembly. It contains 32 principles, which stress on informed consent, confidentiality of data, vulnerable population and requirement of a protocol, including the scientific reasons of the study, to be reviewed by an Ethics Committee. The Universal Declaration of Human Rights 1948 adopted by the United Nations General Assembly expressed concern about rights of human beings against involuntary maltreatment.

The International Covenant on Civil and Political Rights, 1966 (ICCPR) has provided that "No one shall be subjected to torture or to cruel, inhuman or degrading treatment or punishment. In particular, no one shall be subjected without his consent to medical or scientific treatment". It also refers to various "minimum guarantees" in Article 14(3)(g) such as, 'everyone has a right not to be compelled to testify against himself or to confess guilt'.

2.3 In 1988, the Human Rights Committee (HRC), a group of independent experts who issue authoritative interpretations of the ICCPR, released General Comment 16 on the right to privacy (Art. 17). In this General Comment, the HRC noted that 'the right to privacy is not absolute'.

2.4 The Indian Research Fund Association (IRFA) was founded 1911. This was re-named as Indian Council of Medical Research (ICMR), in 1949, under the Ministry of Health and Family Welfare to develop research culture and infrastructure to foster community support. In the year 1980, ICMR released a document called "Policy Statement on Ethical Considerations involved in Research on Human Subjects". This was the first policy statement giving official guidelines for the establishment of Ethics Committees (ECs) in all medical colleges and research centres.

2.5 Comprehensive Ethical Guidelines for Biomedical Research on Human Subjects were finalised by ICMR in the year 2000, which researchers in India have to follow while conducting research on human subjects. The Drugs and Cosmetics Act, 1940 and the Medical Council of India Act, 1956 (Amended in 2002 provide that all clinical trials in India should follow these guidelines. These guidelines were revised in the year 2006, influenced by the Belmont Report and have the same three basic ethical principles:

Respect for person, Beneficence, and Justice. These ethical principles are fortified by inducting the following twelve general principles of:

(i) essentiality;

(ii) voluntariness, informed consent and community agreement;

(iii) non-exploitation;

(iv) privacy and confidentiality;

(v) precaution and risk minimisation;

(vi) professional competence;

(vii) accountability and transparency;

(viii) maximisation of the public interest and of distributive justice;

(ix) institutional arrangements;

(x) public domain;

(xi) totality of responsibility; and

(xii) compliance.

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