Page 55 - Ethical Guidelines for Conducting Research Studies Involving Human Subjects

r. At any time, a patient can refuse to take part as a participant
for a research project, it should in no way interfere with his or
her right to receive treatment of the best quality, which the
team is capable of providing.

12.2 Guidelines on Stem Cell for Transplantation Research

a. Research related to human germ line genetic engineering or
reproductive cloning is prohibited till the formulation of any Stem
Cell Research Act by Government of Bangladesh.

b. Any in vitro culture of intact human embryo or any organized
cellular structures that have the potential of developing into
human, human organs and tissues, regardless of the method of its
derivation beyond 6 days restricted to approval.

c. Transfer of human Blastocysts generated by any means including
somatic cell nuclear transfer (SCNT) or parthenogenetic or
androgenetic techniques into a human or nonhuman uterus
restricted to approval.

d. Any research involving implantation of human embryo into uterus
after in vitro manipulation, at any stage of development in humans
or primates restricted to approval.

e. Creation of a human zygote by In vitro fertilization (IVF) or any
other method with the specific aim of deriving a human embryonic
stem cells cell line for therapeutic or research purpose may be
performed with a approval of the BMRC and GOB.

f. The import of Biological materials for research and development
should be regulated by GOB. Clinical trials using cells after major
manipulation or those sponsored by multinationals involving stem
cell products imported from abroad shall require prior approval of
the BMRC and Health Ministry.

g. Animals in which any of human stem cells have been introduced at
any stage of development should not be allowed to breed.

h. Studies on established fetal/adult stem cells, may be carried out
with approval of BMRC and provided the cell line is registered with
the GOB.

i. Once the cell line is established, it shall be registered with the
BMRC and GOB.

j. Establishment of Umbilical Cord stem cell bank may be done with
prior approval of GOB.

k. All clinical trials on stem cells shall be registered with GOB and
BMRC.

BMRC ETHICAL GUIDELINE ON HUMAN SUBJECTS Page 51