There is much to commend the newest version. There are also a number of disappointments. I won't dwell on these here, however. Instead, I will focus on Tricouncil's revised language on phase 1 and gene transfer research.
The revised Tricouncil contains a definition of phase 1 that, in my view, is somewhat outmoded and not much of an improvement on the old version. Both emphasize the role of phase 1 in toxicity and dose determination, but do not encompass the many other purposes to which phase 1 trials are put (e.g. for deciding whether to pursue phase 2, for gathering evidence of biological effects, etc.). On the other hand, the new Tricouncil requires prospective registration of all trials– including phase 1. And it contains a lengthy discussion of "therapeutic misconception," which it defines as "the tendency of trial participants to believe that the primary intention of research tests and interventions is to provide a therapeutic benefit to the patient-participant." The document urges research ethics boards and researchers to "emphasize which specific elements of a clinical study are required for research purposes, as well as the differences between research and the standard clinical care they might otherwise receive." Bravo.
The new Tricouncil also, for the most part, replaces the old language of "gene therapy" with the more neutral "gene transfer." In a section on "Gene Transfer," the new draft warns about therapeutic misconception. It shrinks from any ethical statement on germline modification by deferrinng to Canada's Assisted Human Reproduction Act. The remainder of the text notes the irreversibility of genetic alterations (not quite accurate), the potentially latent nature of gene transfer risks (a point I agree with), and states that research and ethical debate is evolving rapidly (a point I mostly agree with). Somewhat disappointingly, there is no mention of the need for centralized, transparent, or specialized review of such protocols.
On balance, these two sets of modifications are pretty good, though rather than anticipate the issues that are likely to arise in the next 5-10 years while this draft is in force, I worry a little that instead the draft represents a policy that I and others wish we might have had in the previous 5-10 years. Onwards and upwards! (photo credit: Studiolit 2006)