Page 10 - Ethical Guidelines for Conducting Research Studies Involving Human Subjects

1.8. Vulnerable population (Special attention should be
provided by the investigator in development of research studies
when the study involves the following category of subjects):

 Children

 Pregnant and Nursing Women

 Mentally ill and mentally defective persons
 Other vulnerable social and ethnic groups

 Subjects in rural communities

 Prisoner

02. International Guidelines on Ethics in Health Research

In 1947, the Nuremberg Code the first International document on the
ethics of medical research using human subjects was formulated. The
Code was developed as a consequence of the trial of physicians who had
conducted cruel experiments on prisoners and detainees during the
Second World War. The code emphasized on voluntary consent. The
Nuremberg Code is annexed (Annex-I).

Universal Declaration of Human Rights adopted by the United Nations
General Assembly expressed concern about involuntary maltreatment. In
1966, the International Covenant on Civil and Political Rights stated, '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'. (Article-7).

The Declaration of Helsinki is considered as the fundamental
document in the field of ethics in medical research. This document was
adopted by the World Medical Association in 1964 and subsequently
amended in1975, 1983, 1989, 1996 and 2000. The Declaration made an
important distinction between therapeutic and non-therapeutic
research and it made informed consent a central requirement for ethical
research, and allow for surrogate consent when the research participant
is minor and incompetent of giving consent. The Declaration of Helsinki is
appended (Annex-2).

In 1979, the National Commission for the Protection of Human Subjects of
Biomedical and Behavioral Research wrote their report, "Ethical
Principles and Guidelines for the Protection of Human Subjects of
Research", commonly called the Belmont Report. In this report the
Commission identified and described the basic ethical principles that
underlie research and protect the certain vulnerable research
participant’s e.g. pregnant women, prisoners and children. The
Commission considered the boundaries between biomedical and

BMRC ETHICAL GUIDELINE ON HUMAN SUBJECTS Page 6