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STATEMENT OF SPECIFIC PRINCIPLES FOR CLINICAL EVALUATION OF DRUGS/DIAGNOSTICS/VACCINES/HERBALREMEDIES ETC.
Human studies designed to evaluate the safety, effectiveness, or usefulness of an intervention include research on therapeutics, diagnostic procedures and preventive measures including vaccines. The type of experimental procedures that a patient is submitted to has become more complex and varied as the complexities of medical research have increased. It is clearly accepted that it is essential to carry out research on human subjects to discover better medical and therapeutic modalities for the benefit of mankind. It is equally clear that such research on normal subjects and patients is associated with some degree of risk to the individual concerned. The guidelines have been framed to carry out the evaluation of drugs, vaccines, devices and other diagnostic materials on human subjects including herbal remedies, in accordance with basic ethical principles. These guidelines are important for the protection of research subjects against any avoidable risk and to guide the researchers in the preparation of research proposals/protocols.
For the evaluation of proposed research intervention the framework of guidelines is as follows:

A. General Ethical Principles

B. Special Ethical concerns related to

  1. Drug Trials
  2. Vaccine Trials
  3. Medical Devices
  4. Diagnostic agents - with special reference to use of Radioactive Materials and X-rays
  5. Trials with Herbal remedies.

A. GENERAL ETHICAL PRINCIPLES

All the research involving human subjects should be conducted in accordance with three basic ethical principles, namely respect for person/subject, beneficience and justice. The guidelines laid down are directed at application of these basic principles to research involving human subjects.
An investigator is the person responsible for the clinical trial and for the rights, health and welfare of the subjects recruited for the study. He/she should have qualification and competence in clinical trial research methods for proper conduct of the trial and should be aware of and comply with the legal and ethical requirements of the study protocol
1. Informed Consent of Subject:

1.1 Individual Informed Consent
For all biomedical research involving human subjects, the investigator must obtain the informed consent of the prospective subject or, in the case of an individual who is not capable of giving informed consent, the consent of a legal guardian.

1.2 Essential information for prospective research subjects
Before taking the informed consent of subject, the investigator must provide the individual with the following information in the language he or she is able to understand -

1.3 Obligations of investigators regarding informed consent The investigator has          duty to:

1.4 Inducement to participate
Subjects may be paid for the inconvenience and time spent, and should be reimbursed for expenses incurred, in connection with their participation in research. They may also receive free medical services. However, payments should not be so large or the medical services so extensive as to induce prospective subjects to consent to participate in research against their better judgement (inducement). All payments, reimbursement and medical services to be provided to research subjects should be approved by the Ethical Committee.

2. Selection of Research Subjects:

2.1 Equitable distribution of burdens and benefits
Effort may be made that individuals or communities invited for research should be selected in such a way that the burdens and benefits of the research should be equally distributed. Special justification is required for inviting vulnerable subjects, whose rights and welfare must be protected.
Vulnerable subjects:- Equitable distribution of the burdens and benefits of research participation is generally more difficult when the intended subjects include vulnerable individuals or groups. These subjects are children, persons with mental or behavioural disorders, who are incapable of giving informed consent and prisoners, students, subordinates service personnel etc. who have reduced autonomy. Adequate justification of their involvement as research subjects is required.
The quality of the consent of certain social groups requires careful consideration, as their agreement to volunteer may be unduly influenced by the Investigator.

2.2 Selection of pregnant or nursing women as research subjects:-
As a general rule, pregnant and nursing (breast feeding) women should not be subjects of any clinical trials except such trials which are designed to protect or advance the health of pregnant or nursing women or fetuses or nursing infants, and for which drugs can be tested only in pregnant women.
The justification of participation of these women in clinical trials would be that they should not be deprived arbitrarily of the opportunity to benefit from investigations, drugs, vaccines or other agents that promise therapeutic or preventive benefits. Example of such trials are, to test the efficacy and safety of a drug for reducing perinatal transmission of HIV infection from mother to child, trials for detecting fetal abnormalities, trials of therapies for conditions associated with or aggravated by pregnancy etc.
Women should not be encouraged to discontinue nursing for the sake of participation in research and in case she decides to do so, harm of cessation of breast feeding to the nursing child should be properly assessed.
Research related to termination of pregnancy:- Pregnant women who desire to undergo Medical Termination of Pregnancy (MTP) could be made subjects for research relating to termination of pregnancy, as per The Medical Termination of Pregnancy Act, 1971.
Research related to pre-natal diagnostic techniques:- In pregnant women research on prenatal diagnostic techniques should be limited to detect the fetal abnormalities. Such research should take the consideration of The Prenatal Diagnostic Techniques (Regulation and Prevention of Misuse) Act, 1994.

2.3 Research involving children
Before undertaking children as subjects for clinical trial, the investigator must ensure that

3. Confidentiality of Data:

3.1 Safeguarding confidentiality
The investigator should safeguard the confidentiality of research data, which might lead to the identification of individual subjects.
Data of individual subjects can be disclosed only in a court of law under the orders of the presiding judge or in some cases may be required to communicate to drug registration authority or industrial sponsor of research or in cases of certain communicable diseases to health authority. Therefore, the limitations in maintaining the confidentiality of data should be anticipated and assessed.

4. Compensation of Research Subjects from Accidental Injury:

4.1 Right of subjects to compensation
Research subjects who suffer physical injury as a result of their participation are entitled to financial or other assistance to compensate them equitably for any temporary or permanent impairment or disability. In case of death, their dependents are entitled to material compensation.

Obligation of the sponsor to pay:- The sponsor whether a pharmaceutical company, a government, or an institution, should agree, before the research begins, to provide compensation for any physical injury for which subjects are entitled to compensation.

5. Ethical Review Committee:

All trials involving human subjects must be submitted for scientific review and approval of ethical review committee of institute before starting such research.
All the medical colleges and research institutions/centres involved in clinical research should form scientific and ethical committees which may be either combined or be two independent committees. The scientific evaluation will assess the technical excellence of the proposed clinical trial.

5.1 Composition of the Ethical Committee
The ethical committee should be able to provide complete and adequate review of the research proposals submitted to them. The committee should be headed by a chairman, who should not be head of the same institution. Other members should be - one pharmacologist preferably clinical pharmacologist if available, one pathologist, two clinicans, one or more members of non-clinical departments, one person having knolwedge of law (preferably a Judge or Lawyer) and a social scientist or philosopher. The member secretary should be from the Institute concerned.
The number of persons in an ethical committee be kept fairly small (5-7 members). The ethical committee at any institution should not hesitate to have as its members, individuals from other institutions or communities if required. If the Investigator is a member of the Institutional Ethical Committee, he/she should not be present when his/her own project is discussed.

5.2 Basic responsibilities
The ethical committee should meet periodically (at least twice a year) and review all research proposals and their progress reports. Ethical approval through circulation of research proposal among members should not be resorted to. The basic responsibilities of ethical committee are -

5.3 Assessment of research proposal
The ethical committee should review every research proposal on human subjects. It should observe that the research proposal is scientifically sound, the possible risks to the subjects are justified by the expected benefits, informed consent is satisfactory and procedures for selection of subjects are equitable and properly documented.

The protocol should include -

The role of ethical committee is not only to permit the initiation of research but also to review research during the course of study. When there is anticipation of likely injury or detection of adverse events during the course of study the termination of study should be recommended.

6. Externally Sponsored Research:
The externally sponsored research entails two ethical obligations:-



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