Page 50 - Ethical Guidelines for Conducting Research Studies Involving Human Subjects

capable of giving informed consent understanding the implications of the
study. With large segments of our population, given their level of
education, the full understanding in the sense of industrialized countries
may not be achievable. How the principle of “do no harm” is ensured under
such circumstances without being paternalistic is a major issue that has to
be taken into consideration in ethical guidelines. In cohort or survey
techniques for incidence and prevalence of various diseases, a major issue
that has to be considered is how much of intervention is justified and
whether one is justified in withholding interventions. For example, if you
are looking at longitudinal morbidity in a population group, should you
give them health education that is well established with regard to
preventive aspects, or should you leave them alone so that the natural
evolution of the disease can be studied? Health education or other
interventions including non-health interventions can be quite expensive.
An alternate strategy that may be followed is to make curative therapy
available to the population at their own request. This usually involves
running a clinic, which is readily accessible to the population without any
other intervention. However, it is generally considered unethical to
withhold intervention or services.

11.4 SPECIFIC PRINCIPLES

I. Informed Consent: Individual included as participants in
epidemiological studies, should be explained the purpose & general
objectives of the study to the participant as the way that they can
easily understand with ensuring the privacy. The role of
investigator is crucial and he / she should remain vigilant and
conscious of his / her obligations towards the participants / patients,
all through the course of the studies.

II. In most epidemiological research it would be necessary to have the
consent of the community to include the community members in the
research. It could be the Union Parishad Chairman / School Head /
Municipality Chief / Ward Commissioner etc, who are considered to
be gate keepers of the society / community. After getting consent
from the community, consent of the individual participants should
also have to be there. One cannot coerce a participant if he / she
denied to be a participant even after his community gives consent.

III. Inducement is not only unethical but also harmful as in vulnerable
or dependent subjects inducement may strongly influence their
consent. Researcher could pay for loss of wages / health related
expenditure as a compensation.

IV. In epidemiological study researcher must explain all risk including
risk of loss of privacy to the participant.

V. It is absolutely essential to maintaining confidentiality of the
epidemiological data. In issues like national security, is essential to

BMRC ETHICAL GUIDELINE ON HUMAN SUBJECTS Page 46