Page 25 - Ethical Guidelines for Conducting Research Studies Involving Human Subjects

SECTION – B

10. INTERVENTIONAL STUDIES

The importance of clinical studies has been increasing with the advances
in science and technology and these studies designed to improve methods
of preventing, diagnosing, and treating diseases, for better understanding
of the etiology and pathophysiology of individual diseases, and to improve
the quality of life of patients. Research on human participants is necessary
to discover better medical and therapeutic modalities and it is contributed
hugely to human good. However, such research on healthy participants
and patients is associated with some degree of risk to the individual
concerned. These guidelines have been framed to carry out the evaluation
of drugs, vaccines, devices and other diagnostic materials on human
participants including herbal remedies, in accordance with the basic
ethical principles. These guidelines are important for the protection of
research participants against any avoidable risk, guide the researchers in
the preparation of research proposals/ protocols and facilitate ethical
committees (ECs) to review and approve such studies and also to protect
the researcher. For the clinical evaluation of proposed research
intervention, the framework of guidelines is provided for the following
areas:

1. Drug trials (including nutritional substances)
2. Vaccine trials
3. Surgical procedures / medical devices
4. Diagnostic agents - with special reference to use of
radioactive materials and X-rays
5. Trials with herbal remedies

GENERAL PRINCIPLES

These guidelines follow the four basic principles of research involving
human participants namely autonomy (respect for individual rights),
beneficence (do good), non-maleficence (do no harm) and justice. A
researcher is the key person who is responsible for the research trial and
for protection of the rights, health and welfare of the participants included
in the study. The researcher should have qualification and capability to
pursue clinical research appropriately and should be aware of and meet all
requirements of the study protocol as described under the General
Principles and General Issues in these guidelines.

BMRC ETHICAL GUIDELINE ON HUMAN SUBJECTS Page 21