Page 63 - Ethical Guidelines for Conducting Research Studies Involving Human Subjects

b. Director/Head of research institutions shall establish an ethics
review committee as an advisory board to review the propriety of
conducting human genome/gene analysis research etc. When,
however, it is difficult to set up an ethics review committee for
reasons such as the small size of a human specimen collecting
institution, an ethics review committee established by a
collaborative research institution, a public service corporation or an
academic society may be substituted for an internal one.

c. Director/Head of research institutions shall keep track of the
progress of human genome/gene analysis research by, for instance,
receiving a research progress report on a regular basis, at least
annually, and implementing an on-site investigation by qualified
external persons on a regular basis, at least annually, and shall
order the research altered or discontinued based on the ethics
review committee submitting the opinion of alteration or
discontinuation, or if necessary for any reason.

d. The regulatory bodies shall appreciate that stem cell research is a
nascent field. While there have been tremendous advances in
understanding the biology of stem cells, these are several elements
of unpredictability in the translation of research in this area. It is of
utmost importance that review of research in this field ensures
highest degree of scientific rigor and resolution of ethical concerns.
The members of the regulatory committee shall remain in constant
touch with advances in this field.

e. Director/Head of research institutions shall deliver to a personal
information custodian a copy of an approved research protocol, a
copy of regular reports regarding research progress and a copy of
on-site investigation results conducted by qualified external
persons.

f. Each institution should maintain a registry of its investigators who
are conducting stem cell research and ensure that all registered
users are kept up to date with changes in guidelines and
regulations regarding use of these cells. It shall also be the
responsibility of the institution to ensure that most current
standards are applied.

g. Director/Head of human specimen collecting institutions shall, in
principle, anonymize a human specimen when providing it to an
external institution, (When the human specimen collecting
institution also conducts human genome/gene analysis research, its
research division shall be considered to be an external institution).

h. Director/Head of human specimen collecting institutions shall, as
required, ensure that donors and their families or blood relatives

BMRC ETHICAL GUIDELINE ON HUMAN SUBJECTS Page 59