Page 54 - Ethical Guidelines for Conducting Research Studies Involving Human Subjects

h. Research on living donors should be restricted to renewable
tissues like bone marrow, liver. In the cases of absolute
necessity under observance and approval of a ethical committee
of the Institute and NREC, one can use pair organs whose
removal will not greatly alter the physiologic functions, for
research purposes e.g. Kidney. But removal of eye shall not be
permitted in live donor as lost of binocular vision &
disfigurement.

i. The donor should be lifetime insured (Life and Medical) and all
of the related harms should be compensated by PI.

j. Surplus or waste tissues remained from diagnostic and
therapeutic procedures or surgeries, by considering
confidentiality and after approval of ethics committee, can be
used for transplantation research, unless prior notification of
owner's disagreement.

k. Financial incentives or special advantages should not be used
for encourage persons for organ donation in the transplantation
research with living donor. But only incidental expenses or
work loss may be compensated.

l. The children, mentally retarded or mentally disabled persons,
psychiatric patients and other special groups, who possibly have
not competence for informed decision making, should not be
tissue or organ donors in transplantation research.

m. The children mentally retarded or mentally disabled persons,
psychiatric patients, should only be recipient of tissue or organ
in transplantation research with direct therapeutic benefit for
them.

n. Confidentiality of the donation shall be maintained on both
sides. Recipient will not be informed the identity of donor and
donor family also will not informed who receive the donor
organ.

o. Under no circumstances should there be a conflict between
scientific content of a study and the best interests of the
patient. The experiment is be abandoned and the patient should
receive the best treatment possible.

p. The transplant research team should have high technical
expertise.
q. Adequate data management, tissue storage facilities, and
surveillance procedures should be available in a centre before it
is authorized to conduct research into transplantation.

BMRC ETHICAL GUIDELINE ON HUMAN SUBJECTS Page 50