Page 73 - Ethical Guidelines for Conducting Research Studies Involving Human Subjects

In seeking to satisfy itself and on the technical aspects of a proposal
for gene therapy or related technology, and to ensure that all
requirements have been met, the BMRC may need to consult with
the clinical trials, drug trials and bio safety committees of the
institution. (NHMRC, Australia)

13.8.2 Supervision of gene therapy

Expert supervisory body

Continuing supervision of gene therapy is necessary. No existing
body is constituted for this task. Therefore it is recommended that a
new, expert supervisory body be established. An example of such a
body is the British Human Fertilization and Embryo Authority.

The supervisory body should be of sufficient standing to command
the confidence of existing Research Ethics Committees and of the
public, the professions and Parliament. It should have a
responsibility for:

i. advising on the content of proposals including the details of
protocols for therapeutic research in somatic cell gene
modification;

ii. advising on the design and conduct of the research;

iii. advising on the facilities and service arrangements
necessary for the proper conduct of the research;

iv. advising on the arrangements necessary for the long term
surveillance and follow-up of treated patients;

v. receiving proposals from clinicians who wish to conduct
gene therapy in individual patients and making an
assessment of:

a. the clinical status of the patient;

b. the scientific quality of the proposal, with particular
regard to the technical competence and scientific
requirements for achieving therapy effectively and
safely;

c. whether the clinical course of the particular
disorder is known sufficiently well
■ for sound information, counseling and advice to
be given to the patient (or those acting on behalf of
the patient)
■ for the outcomes of therapy to be assessable;

d. the potential benefits and risks for the patient
of what is proposed;

BMRC ETHICAL GUIDELINE ON HUMAN SUBJECTS Page 69