Page 82 - Ethical Guidelines for Conducting Research Studies Involving Human Subjects

taking them out with clear reasons. Third parties must be
allowed to take samples only after approval from Repository
ethics committee.
5. The identity of the Repository from which samples were
obtained must be revealed in all reports, patents or
copyrights arising out of these samples.

6. Due intellectual property rights should be given while
granting access to samples, through a contractual
agreement.

7. For any publication resulting out of research from samples
taken from repository, appropriate acknowledgement should
be given to the original contributor of samples, sponsors of
research, repository, donors and participants. (ICMR, 2006,
India)

13.10.3 Biobank ethical issues:

The key event which arises in biobanking is when a researcher
wants to collect a human specimen for research. When this
happens, some issues which arise include the following: right
to privacy for research participants, ownership of the specimen and
its derived data, the extent to which the donor can share in
the return of the research results, and the extent to which a donor
is able to consent to be in a research study.

❑ Governance

There is no internationally-accepted set of governance guidelines
which are designed to work with biobank. Biobanks typically try to
adapt to the broader recommendations of guidelines which are
internationally accepted for human subject research, and use
changing guidelines as they become accepted. Biobanks need
ethical oversight from an independent reviewer and the governance
process is intended to be public. Institutional review boards
typically enforce standards set by their own institutes following
government regulations.

❑ Informed consent

Because donating a specimen involves consideration of many issues,
different people will have different levels of understanding of what
they are doing when they donate a specimen. Since it is difficult to
explain every issue to everyone, problems of giving informed
consent arise when researchers take samples. Researchers support
biobanking despite risk to participants because the benefit is high,
it pays respect to people's wishes to involve themselves in research,
current practices and culture support this kind of research, and
consensus is that the risk of participation is low.

BMRC ETHICAL GUIDELINE ON HUMAN SUBJECTS Page 78