Page 66 - Ethical Guidelines for Conducting Research Studies Involving Human Subjects

or equivalent person and/or intellectual property rights of
researchers.

xii. Principal Investigator shall be understood that while no bar is
placed in carrying out experiments which may lead to benefit to
humanity, but this should not take them down on the slippery road
to prohibited areas of research.
xiii. Once the cell line is established, it shall be registered with the
BMRC

13.6 Matters to be included

Matters to be included in explanatory documents for donors and proxy
consenters, etc. shall, in general, be as follows, but adjustments may be
made according to the details of the research:

• That the donation of human specimens is voluntary.

• That any person who has received a request for human specimen
donation will not be treated in a disadvantageous manner as a
result of not agreeing to donate a human specimen.

• That a donor or proxy consenter, etc. may revoke, in writing, the
informed consent they gave, at any time without suffering any
disadvantage (including, where necessary, the methods for
receiving requests for revocation).

• That, where consent has been revoked by a donor or proxy
consenter, etc., the human specimens and research results related
to the said revocation will be disposed of, unless, for instance, they
have been anonymized in an unlinkable fashion.

• The reasons for selection as a donor.

• The significance, objectives and method of research (the targeted
disorder, analytical methods and so forth; where future additions
and/or alterations are anticipated, a description to that effect; in the
case of a single-gene disorder or the like, the necessity of the
research, measures for preventing disadvantage and other items
worthy of special mention), the period of research.

• When personal information is used jointly with other institutions in
collaborative research: (i) the fact that it is collaborative, (ii) the
items of the personal information used jointly, (iii) the scope of the
joint users, (iv) the purpose for which the personal information is
used by them, and (v) the names of the persons responsible for the
management of the personal information.

BMRC ETHICAL GUIDELINE ON HUMAN SUBJECTS Page 62