Page 53 - Ethical Guidelines for Conducting Research Studies Involving Human Subjects

12. TISSUE TRANSPLANTATION AND RELATED SUBJECTS

The medical advancements in science and technology related to
transplantation have raised new ethical issues that need to be addressed.
There is also a need for careful evaluation of these new methods and their
outcomes through research. The inevitable necessity of standardized
ethical guidelines for research on human subjects is universally
recognized.

Tissue and organ transplant like other medical issues will make a rapid
progress in this country and review of the guideline of ethical issues will be
needed. The objective of the BMRC guideline is to promote ethical
research.

12.1 Ethical Guidelines of Transplantation Research

Systematic control and strengthening research ethics committees all over
the country would pave the way for achieving the goals in the coming
years. This guideline mentions essential ethical principles, which should
be considered in the research on tissue and organ transplantation.

12.1.1 Organ and tissue Transplantation

a. All transplantation research on tissues or organs should be
done according to the Human tissue transplantation act Law-
5, April-13, 1999, of Bangladesh.

b. Purpose of research in any Transplant should be scientific
advancement and in accordance with goals of national health
system and should not be for financial or commercial purposes.

c. For using the tissues or organs of foreigners in transplantation
research, the approval of NREC required.

d. In view of the risk involved, the voluntary consent of the donor
is absolutely essential. The donor should be informed of all
possible risks in a manner easily understood by the participant
before the consent is taken.

e. For using tissues and organs stored in the banks, the donor
should mention his / her consent for this kind of use.

f. The system of obtaining consent for using the organs of
deceased persons for research in Bangladesh already
formulated by Human tissue transplantation act 1999. The
consent of person before death or a donor card or the consent of
his/her next to kin (decision maker) is necessary.

g. During the time of removal of tissues or organs from deceased
person until the time of burying the deceased, observance of all
customary and spiritual respects to cadaver and the removed
tissues or organs is essential.

BMRC ETHICAL GUIDELINE ON HUMAN SUBJECTS Page 49