Page 74 - Ethical Guidelines for Conducting Research Studies Involving Human Subjects

e. the ethical acceptability of the proposal; and

f. the informed consent documents.

In the light of this assessment the expert supervisory body should
make a recommendation on whether the proposal should be
approved, and if so on what, if any, conditions.

The supervisory body should also have a responsibility for:

vi. acting in co-ordination with existing Research Ethics
Committees;

vii. acting as a repository of up-to-date information on
research in gene therapy internationally;

viii. setting up and maintaining a confidential register of
patients who have been the subjects of gene therapy;

ix. oversight and monitoring of the research; and

x. providing advice to Appropriate authority, on scientific
and medical developments which bear on the safety and
efficacy of human gene modification.

It is recommended that any proposal for gene therapy be approved by this
body as well as by NREC.

13.9 Stem Cell Research

Human embryonic stem cell (HESC) research offers much hope for
alleviating the human suffering brought on by the ravages of disease and
injury. HESCs are characterized by their capacity for self-renewal and
their ability to differentiate into all types of cells of the body. The main
goal of HESC research is to identify the mechanisms that govern cell
differentiation and to turn HESCs into specific cell types that can be used
for treating debilitating and life-threatening diseases and injuries.

Scientists recently succeeded in converting adult human skin cells into
cells that appear to have the properties of HESCs by activating four genes
in the adult cells. The reprogrammed cells - “induced pluripotent stem
cells” (iPSCs) - could ultimately eliminate the need for HESCs. However,
at present, the consensus in the scientific community is that both HESC
and iPSC research should be pursued, as we do not yet know whether
iPSCs have the same potential as HESCs or whether it is safe to
transplant them into humans. Thus, the controversies around HESC
research will continue, at least in the near-term.

While the principal source of the controversy surrounding HESC research
lies in competing views about the value of human embryonic life, the scope
of ethical issues in HESC research is broader than the question of the
ethics of destroying human embryos. It also encompasses questions about,
among other things, whether researchers who use but do not derive

BMRC ETHICAL GUIDELINE ON HUMAN SUBJECTS Page 70