Page 83 - Ethical Guidelines for Conducting Research Studies Involving Human Subjects

❑ Privacy for research participants

There is broad consensus that when a person donates a specimen
for research then that person has a right to privacy thereafter. To
this end, researchers balance the need for specimens to
be anonymous or de-identified from protected health
information with the need to have access to data about the
specimen so that researchers can use the sample without knowing
the identity of the donor

❑ Ownership of specimens

When a person donates a specimen to a researcher it is not easy to
describe what the participant is donating because ownership of the
specimen represents more rights than physical control over the
specimen.

The specimens themselves have commercial value, and research
products made from specimens can also. Fundamental research
benefits all sectors, including government, non-profit, and
commercial, and these sectors will not benefit equally. Specimens
may be subject to biological patenting or research results from
specimen experimentation may lead to the development of products
which some entity will own. The extent to which a specimen donor
should be able to restrict the way their specimen is used is a matter
of debate.

❑ Return of results

There is broad consensus that participants in clinical research have
a right to know the results of a study in which they participated so
that they can check the extent to which their participation delivered
beneficial results to their community.

❑ Incidental finding
Participant shell let know if there are any incidental finding that is
beneficial for the participant.

❑ System of disposal of material.

❑ Donor discrimination

Biobanks should prevent donor communities from facing
discrimination as a result of participating in a biobank project.

❑ Commercialization

Different aspects of biobank serve public, private, commercial, and
noncommercial interests. Set guidelines to fairly balance public,
private, commercial, and noncommercial interests. Who owns
biological specimens and data derived there from? When biobank

BMRC ETHICAL GUIDELINE ON HUMAN SUBJECTS Page 79