Page 65 - Ethical Guidelines for Conducting Research Studies Involving Human Subjects

the same. Their responsibility is to generate robust scientific
evidence through controlled trials which may be applied for the
benefit of the patients.

vi. The basic scientists engaged in stem cell research from human
sources shall be vigilant to safeguard human rights and human
dignity of those from where samples have been obtained. The
biological material should be treated with utmost respect and care
in all experiments. The use of human embryos shall be restricted.

vii. Principal investigators shall, with regard to the progress of human
genome/gene analysis research, report to the Director/Head of their
research institution & NREC in writing on a regular basis, at least
annually.

viii. Principal investigator shall, in principle, conduct human
genome/gene analysis research by using anonymized human
specimens or genetic information. When a donor, proxy consenter or
equivalent person agrees and, at the same time, a research
protocol authorized by the ethics review committee and approved
by the director/head of a research institution allows not to
anonymize human specimens or genetic information,
anonymization is not required.

ix. Principal investigators shall not, in principle, provide an
unanonymized human specimen or genetic information to an
external institution. When a donor, proxy consenter or equivalent
person agrees to provision without anonymization and, at the same
time,a research protocol authorized by the ethics review committee
and approved by the director/head of a research institution allows
not anonymizing human specimens or genetic information, it is
permitted to provide unanonymized human specimens or genetic
information to an external institution.

x. Principal investigators shall, in contracting out a part of work in
human genome/gene analysis research, in principle, anonymize
human specimens or genetic information to be provided to the
contractor concerned. When a donor, proxy consenter or equivalent
person agrees and, at the same time, a research protocol authorized
by the ethics review committee and approved by the director/head of
a research institution allows not to anonymize human specimens or
genetic information, anonymization is not required.

xi. Principal investigators shall, both on a regular basis and in
response to a request from parties including donors, explain clearly
or release into the public domain the progress and results of human
genome/gene analysis research. This shall not, however, apply to a
part that is essential for the protection of human rights of a donor

BMRC ETHICAL GUIDELINE ON HUMAN SUBJECTS Page 61