Page 20 - Ethical Guidelines for Conducting Research Studies Involving Human Subjects

consent from the legal guardian should be taken after the person is
well informed about the study, need for participation, risks and
benefits involved and the privacy and confidentiality procedures.
The entire consent process should be properly documented;

d. Involvement of participants such as prisoners, students,
subordinates, employees, and service personnel etc. who have
reduced autonomy as research participants, since the consent
provided may be under duress or various other compelling reasons
required adequate justification.

06. POST - TRIAL ACCESS

Helsinki Declaration of the World Medical Assembly (WMA), 2000
states that at the end of the trial every participant should be assured of
access to the best proven prophylactic, diagnostic and therapeutic
methods identified by the study. This Declaration led to a lot of debate
globally on account of lack of even basic drugs in most of the developing
countries. The Declaration of the WMA in 2004 reaffirmed “its position
that it is necessary during the study planning process to identify post-trial
access by study participants to prophylactic, diagnostic and therapeutic
procedures identified as beneficial in the study or access to other
appropriate care. Post-trial access arrangements or other care must be
described in the study protocol so the ethical review committee may
consider such arrangements during its review.”

Therefore, whenever possible NREC should consider such an arrangement
in the a priori agreement. Sometimes more than the benefit to the
participant, the community may be given benefit in indirect way through
improving their living conditions, establishing counseling centers, clinics
or schools, and giving education on maintaining good health practices. For
smaller scale or student projects post trial benefit to the participants may
not be feasible but keeping in mind the post trial responsibility conscious
efforts should be made by the guides and the institution to initiate steps
to continue to support and give better care to the participants. (ICMR-
2006)

07. INTERNATIONAL COLLABORATION / ASSISTANCE IN BIO-
MEDICAL / HEALTH RESEARCH

Research in biomedical and health areas has gained greater momentum
only by the second half of the 20th Century, especially since the 1960s, the
scope of international co-operation and collaboration assumed such
proportions as to have exploitative connotations with commercial and
human dimensions. On the other hand, collaboration in medical research

BMRC ETHICAL GUIDELINE ON HUMAN SUBJECTS Page 16