Page 61 - Ethical Guidelines for Conducting Research Studies Involving Human Subjects

i. Optimum support and education should be provided for children
and families with genetic conditions.

j. Adopted children and others with biological relationships outside
the family should be able to receive information about their
biological relatives, under strict anonymity rules.

k. Research protocols should follow established procedures for review
and informed consent.

l. Protocols for experimental human gene therapy should receive
national review, with attention to the potential benefits or risks
arising from various approaches to therapy.

m. All institutions and investigators, both public and private, carrying
out research on human stem cells should be registered with the
BMRC.

n. All new human pluripotent stem cell lines, irrespective of the source
and methodology used, shall be created, and registered with BMRC
detailing on its source, development, passage number, identity and
movement.

o. All records pertaining to adult stem cell research must be
maintained for at least 5 years and those for hES/iPS cell research
for 10 years.

13.3 Basic Responsibilities of All Researchers

a. All researchers and equivalent persons shall conduct human
genome/gene analysis research for such purposes as elucidating life
phenomena, preventing diseases, improving diagnosis and
treatment protocols, and promoting health.

b. All researchers and equivalent persons shall ensure the societal
usefulness of their human genome/gene analysis research and shall
pay attention to guaranteeing the human rights of individuals by
prioritizing them over scientific or societal benefits.

c. All researchers and equivalent persons shall make it a basic
practice to conduct human genome/gene analysis research only
after obtaining the informed consent of donors or proxy consenters.

d. All researchers and equivalent persons shall not, in the absence of
any justifiable reason, divulge personal information obtained in the
course of their duties. This shall continue to apply after they resign
their position.

e. All researchers and equivalent persons shall endeavor to protect
personal information and shall also respond in good faith to

BMRC ETHICAL GUIDELINE ON HUMAN SUBJECTS Page 57