Human gene therapy guideline proposals

The National Health and Medical Research Council (NHMRC) is inviting submissions on draft guidelines for the Writing of Human Gene Therapy Proposals. The draft guidelines have been developed by the NHMRC Gene and Related Therapies Research Advisory Panel (GTRAP).

GTRAP ensures that human gene therapy studies conform to the principles of the Declaration of Helsinki (Recommendations Guiding Physicians in Biomedical Research Involving Human Subjects - revised 1989) and the NHMRC National Statement on Ethical Conduct in Research Involving Humans (Commonwealth of Australia 1999).

Human Research Ethics Committees (HRECs) are required to consult GTRAP prior to approving studies involving gene therapy. The guidelines have been developed to assist clinicians, scientists, sponsors and HRECs in the design and submission of protocols to facilitate the review process.

The draft Guidelines for the Writing of Human Gene Therapy Proposals are available on the NHMRC web site.

Item provided courtesy of Science Industry