Page 67 - Ethical Guidelines for Conducting Research Studies Involving Human Subjects

• In the case of long-term, ongoing research, the research institution’s
point of view regarding the organization and systems necessary for
conducting the ongoing research.

• Where obtaining the informed consent of donors is difficult, the
importance of the research and the reasons why the research
cannot be realized without the donation of human specimens from
donors.

• The predicted research results and any predicted risks and/or
disadvantages to a donor, etc. (including any disadvantages in
social life, such as social discrimination).

• That a donor or proxy consenter, etc. may, upon request, obtain or
inspect documents on the research protocol and research method to
the extent that doing so does not impede the protection of personal
information of other donors, etc. or the securing of research
originality.

• Whether a donated human specimen or the genetic information
derived there from will be anonymized in a linkable or unlikable
fashion and the specific method of anonymization; when
anonymization is not possible, a description to this effect and the
reasons for this.

• Whether or not a human specimen or the genetic information
derived there from can be provided to other institutions; and if so,
that the ethics review committee would review the handling of
personal information, the names of the receiving institutions, and
that the purposes of use at the receiving institutions are
appropriate.

• The anonymization method, etc. when part of the research is
entrusted.

• Matters regarding the disclosure of genetic information (if not
disclosed, the reasons there for).

• Matters regarding the disclosure of personal information (including
where and how requests for disclosure are received, the method for
confirming that a person is a donor or proxy consenter, etc., and if
charges are incurred for disclosure, a description to this effect).

• That research outcomes might generate intellectual property rights,
such as patent rights, in the future; the names of any envisaged
organizations to which such intellectual property rights, such as
patent rights, would belong, were they to be generated.

BMRC ETHICAL GUIDELINE ON HUMAN SUBJECTS Page 63