Page 72 - Ethical Guidelines for Conducting Research Studies Involving Human Subjects

clinical trials or research remains critical. There should be good
reason to believe that clinical outcomes will be improved.

b. The objectives and rationale of the proposed gene therapy or
research should be clear, based on a sound understanding of the
biological system being studied and where possible and appropriate,
based on prior studies in animals.

c. The structure and characteristics of the DNA or RNA, and of the
vector (carrier of the DNA or RNA), to be used for gene transfer
must be known.

d. It should be possible to measure the effects of treatment and
research.

e. Procedures should be in place which ensures the long-term follow-
up of those studied or treated.

f. How consent to participation is obtained, and on what information
it is to be based should be carefully considered.

13.8.1 Basic Requirement of a proposal for gene therapy

When reviewing a proposal for gene therapy, or introduction
of DNA or RNA into humans for research purposes, BMRC
should also be satisfied that:

(a) The research team has the necessary knowledge of, and
experience in, molecular biology and the disease being
treated.

(b) The research team has appropriate facilities in order to
carry out the research.

(c) Research on Gene therapy will be restricted to public
academic Institution.

(d) The purity of the material to be administered and the
methods of handling it during its preparation and
distribution are in accordance with current guidelines.

(e) Experiments in vitro and/or in animal models have
demonstrated that the inserted DNA or RNA:

(i) will not enter the germ cells;
(ii) is likely to have the intended effect in humans;
(iii) is unlikely to cause undesirable side effects in
humans.

(f) The potential risks have been assessed, taking into
consideration the patient, the patient’s family, the health
professionals involved in treatment and its evaluation and
the community.

BMRC ETHICAL GUIDELINE ON HUMAN SUBJECTS Page 68