Page 56 - Ethical Guidelines for Conducting Research Studies Involving Human Subjects

l. No research on stem cell will be ethical if it involve direct or in
direct unethical financial interest.

m. Stem cell research center should be established in the in the
academic centers or universities with approval of GOB and BMRC.

12.3. Human fetal tissue Transplantation

Human fetal tissue could be used in transplantation research for a
wide range of purposes. The use of fetal tissue will minimize the
chance of rejection.
a. The transplantation research on tissues or organs of embryo or
fetus should be approved by the “BMRC” in keeping with the
national guidelines.

b. Such researches are only permitted in the public universities or
research centre’s those who have authorized standard research
laboratory on this regards and under surveillance of the Ministry of
Health and BMRC.

c. For using the organs and tissues of fetus in the transplantation
research, scientific approval of the research and follow up, control
and subsequent assessments by the research institute, BMRC and
related authorities are necessary.

d. For prevention of misconduct in using fetal tissues, specialists who
approve abortion should not be the member of the research group or
the organization who subsequently uses the embryonic or fetal
tissues. Any attempt of creation of human beings for
transplantation purposes has been banned.

e. Financial relationship between the donor and the recipient in the
research on transplantation of organs and tissues of embryo or fetus
is forbidden.
f. Abortion of live fetus is restricted for research purpose.

g. Tissue for transplantation or research may be obtained from dead
embryos or foetuses, their death resulting from legally induced or
spontaneous abortion. Death of an intact embryo or foetus is
defined as absence of respiration and heart beat.

h. Voluntary, informed, written consent will be obtained from the
mother in two stages - first for the abortion, next for the donation of
tissue from the foetus.

i. Termination of pregnancy should not be sought with a view to
donate foetal tissue in return for possible financial or therapeutic
benefits.

j. The mother’s decision to donate foetal tissue is sufficient for the use
of the tissue unless the father objects in writing. In cases of incest
or rape, the father’s objection carries no significance.

BMRC ETHICAL GUIDELINE ON HUMAN SUBJECTS Page 52