Yet another example is that ICH-GCP contains practically no language on justice and fairness, whereas the Declaration of Helsinki, CIOMS, and TCPS2 do.
Similarly, ICH-GCP is mainly directed at those researchers and sponsors who might contemplate submission of trial data to regulatory authorities for product licensure.
ICH-GCP policies emerge from a setting in which sponsors have substantial resources, and significant financial incentives to portray their drugs in the most favourable light possible.
In recent years, many academic trialists have protested the stifling effect of applying ICH-GCP requirements to all clinical research.
Tools like ICH-GCP and 45 CFR 46 are first and foremost regulatory instruments, and only indirectly moral policies.
It would be difficult to imagine an administrative policy like ICH-GCP making the following statement (from Belmont):
But then, their ends on applying a policy like ICH-GCP can only be indirectly moral because such policies capture only those expressions of morality that can be administered by central authorities.
The ICH-GCP begins by enumerating some general principles, such as the primordial importance of respecting the rights and well-being of research subjects and the need for a careful weighing of risks and potential benefits of clinical trials.
The legal status of the ICH-GCP in Canada is ambiguous, since it is not part of the formal regulations enacted by the government.
And yet, although the ICH-GCP rules with respect to REB review can be used to determine whether an REB is acting in accordance with good clinical practice, there is no clear regulatory power to hold these REBs accountable for violations of these rules.
The regulatory impact statement refers to good clinical practice guidelines, and Health Canada has introduced the ICH-GCP guidelines as a guidance document, but it is not part of a directly enforceable regulatory structure.