Page 64 - Ethical Guidelines for Conducting Research Studies Involving Human Subjects

will be able to receive genetic counseling by, for instance,
establishing a pertinent genetic counseling system or explaining
about genetic counseling and making referral to pertinent genetic
counseling services.

i. The institutions carrying out stem cell research shall also establish
suitable mechanisms for creating awareness and communicating
scientific evidences to the public.

13.5 Duties of Principal Investigators

i. Principal investigators shall, prior to conducting human
genome/gene analysis research, prepare a research protocol and
seek approval from the director of his/her research institution
before submission of research proposal to NREC for Ethical
approval. Such a procedure must also be followed prior to
altering a research protocol.

ii. Principal investigators shall, in preparing a research protocol,
thoroughly take into account such factors as the necessity of the
research and the research method intended to prevent
disadvantage to donors and equivalent persons, in consideration of
various impacts that donors and equivalent persons would be
expected to experience as a result of the proposed human
genome/gene analysis research.

iii. The investigators and the institutions where the stem cell research
is being conducted bear the ultimate responsibility of ensuring that
research activities are in accordance with laid down standards and
integrity. In particular, scientists whose research involves hES cells
should work closely with monitoring/regulatory bodies, demonstrate
respect for autonomy and privacy of those who donate gametes,
blastocysts, and be sensitive to public concerns about research that
involves human embryos. Sponsors shall also take note of their
responsibilities and liabilities under various statutes and
regulations governing research and development in the area in-force
or to be introduced in the country in near future.
iv. Principal investigators shall oversee research conductors so that
they will properly conduct human genome/gene analysis research
by, for instance, having all research conductors observe matters
described in an approved research protocol.

v. The physician/scientist engaged in stem cell research and therapy
shall ensure that no hype or unrealistic expectations is created in
the minds of subjects or public at large regarding stem cell therapy.
They must inform the parent and the family. The bare facts both
what is known and what is not known about the status of stem cell
research for the given indication and the alternatives available for

BMRC ETHICAL GUIDELINE ON HUMAN SUBJECTS Page 60