Page 71 - Ethical Guidelines for Conducting Research Studies Involving Human Subjects

7. Physicians should disclose all clinically relevant findings to
the woman or couple, including the full range of variability
in the manifestations of the condition under discussion
(autonomy).
8. The woman's and/or couple's choices in a pregnancy with an
affected fetus should be respected and protected, within the
framework of the family and of the laws, culture and social
structure of the country. The couple, not the health
professional, should make the choice (autonomy). (WHO,
2003, ICMR, 2006, India)

The following points should be noted and reflected in
guidelines:

a. Prenatal sex determination will not be allowed.

b. Termination of pregnancy for a genetic cause has to be
restricted by strict medical supervision.
c. BMRC should be aware for any uncertain future
developments and research applications in these fields.

d. Genetic manipulation to modify the genes of a fetus or
pre-embryo will not be allowed.

13.8 GENE THERAPY

The term “gene therapy”, when it is used subsequently, will mean somatic
cell gene therapy only. BMRC would not be expected to receive, and should
not approve, research proposals for the introduction of DNA and RNA into
germ (reproductive) cells or embryos. “Gene therapy” will also refer to
research protocols with either therapeutic or non-therapeutic aims.
Therapeutic research is conducted with the intent of providing a direct
benefit to research participants, while non-therapeutic research is
conducted with the intent to derive knowledge and not to be of direct
benefit to research participants (More on Gene therapy ANNEXURE-B).

A research proposal must be evaluated based on medical, scientific, ethical
and safety aspects. The proposal must be first approved by the concern
institutional biosafety committee before submitting to NREC of BMRC.
The following also need to be taken into account when protocols for gene
therapy are being considered by BMRC:

a. The balance of potential risks and benefits associated with the gene
therapy experiment. Diseases for which gene therapy is being
considered should be those which impose a severe burden on
affected individuals and for which there is no treatment or only
inadequate treatment. There is accumulating evidence that gene
therapy is relatively safe for humans, but the choice of diseases for

BMRC ETHICAL GUIDELINE ON HUMAN SUBJECTS Page 67