Page 80 - Ethical Guidelines for Conducting Research Studies Involving Human Subjects

Coded Samples: Sometimes termed “linked” or “identifiable,”
these samples are supplied by repositories to investigators from
identified specimens with a code rather than with personally
identifying information such as a name or other identifying
number.

Identified Samples: These samples are supplied by repositories
from identified specimens with a personal identifier (such as a
name of person/patient number) that would allow the researcher to
link the biological information derived from the research directly to
the individual from whom the material was obtained. (ICMR, 2006,
India)

❑ Guidelines for using repository samples:

a) Primary use:

By primary use it is meant that the biological material will be
used for the intended purpose as described in the protocol
submitted for approval from Ethics Committee. Ownership of the
sample lies with the individual, family or community as the case
may be. Local Ethics Committee should consider following points
for approving primary use:

i. consent should be in written form, given voluntarily by the
donor who has the capacity to do so. The use of the samples
shall be reserved for the defined purpose only;

ii. participants have the right to withdraw at any time. This
does not apply to anonymized samples;

iii. if sample is inadequate or contaminated re-contact is
necessary for fresh and specific consent. This should be
incorporated in the prior consent form;

iv. while obtaining data/samples from vulnerable subgroups
with reduced autonomy, Ethics Committee should ensure
that informed consent be obtained from legally authorized
representatives in the presence of impartial witness. The
risks and benefits should be adequately explained;

v. when samples have to be obtained for specific research from
participants belonging to specified communities, permission
of the group leader/local leader/authorities must also be
obtained. However individual consent should never be
compromised even if permission of the gatekeepers/village
panchayat.

vi. group consent of the population/community should be
obtained through its culturally appropriate authorities

BMRC ETHICAL GUIDELINE ON HUMAN SUBJECTS Page 76