Page 62 - Ethical Guidelines for Conducting Research Studies Involving Human Subjects

questions, complaints, etc. concerning the handling of personal
information.

f. All researchers and equivalent persons shall, when any serious
concerns arise in terms of guaranteeing the human rights of donors,
etc., such as an unexpected divulgence of personal information,
immediately report this to the director / head of their research
institution and.

g. All researchers and equivalent persons shall conduct human
genome/gene analysis research properly in compliance with these
Guidelines and with respect for human dignity and human rights
by, for instance, conducting research in accordance with a research
protocol as authorized by the ethics review committee and approved
by the director/head of their research institution.

h. All researchers and equivalent persons shall endeavor to guarantee
the transparency of their research through, for instance, ensuring
due process when conducting research, on-site investigations by
outside experts, appropriate responses to inquiries from donors,
etc. regarding the progress of research, and the release of research
results into the public domain.

i. All researchers and equivalent persons shall, in consideration of the
fact that the donation of human specimens is based on goodwill,
make efforts to minimize the amount of human specimens donated
from people by, for instance, properly preserving and utilizing
specimens already provided.

j. No researchers and equivalent persons shall, when conducting
human genome/gene analysis research, acquire personal
information or human specimen by deception or other wrongful
means.

13.4 Responsibilities of Director/Head of Research Institutions

a. Director/Head of research institutions, such as human specimen
collecting institutions, that handle personal information shall
designate a personal information custodian for the purpose of
protecting personal information in human genome/gene analysis
research.

Director/Head may, as required, also designate, upon specifying a
chain of command, a co-custodian or an assistant who conducts
actual operations under the supervision of a personal information
custodian.

BMRC ETHICAL GUIDELINE ON HUMAN SUBJECTS Page 58