Exclusion of Vulnerable Populations - Making Sense of the Regulations and Guidelines

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When sites seek our advice (or ask our opinion as monitors) about whether they should steer clear of including vulnerable populations in their studies, what shall we say? Should we give them the opinion that there are a number of regulations and guidelines in place that may make working with a vulnerable population group challenging and time-consuming, should we give the opinion that these population groups can assist us in our research as much, or more, than the general population and that those regulations and guidelines are put in place more to protect the vulnerable populations, and not to prevent them from participating in research. The regulations exist to ensure that these groups of people are not exploited or put at unfair risk, and to enable their participation in the development of potentially life-saving or quality-of-life improving drugs or treatments.
So, vulnerable populations; what do the regulations tell us? We can all hazard a guess that this includes children, prisoners, pregnant women, handicapped or mentally disabled persons per the 21 CFR 56.107 and 45 CFR 46.107.In addition to the above, 45 CFR 46 includes economically or educationally disadvantaged persons.
In addition to the regulations above though, it is also necessary to take into account that a number of guidelines exist and it may be required, or it may be a matter of best practice, for these to be followed. Take a look at the Belmont Report, ICH-GCP, CIOMS and the Declaration of Helsinki for a more detailed view.
Once again, there is more; depending on what country you live in, it may be necessary to take into account local country regulations or guidelines. Let us use South Africa as an example; South African Good Clinical Practice (SA-GCP) includes a more extensive list of groups that they consider to be vulnerable.
Now that we have done a fly-by visit of which regulations and guidelines we need to consider, what do we do once we have made the decision to include one or more vulnerable population in our research study? Like most aspects of research, there is no single solution for all groups. Your decision on how to act has to be based on our discussions above as well as on your protocol and of course, which population group you are dealing with.
Keep watching this space; over the next few weeks, I will be posting snippets about some obvious and some easy to forget tips when dealing with illiteracy; pregnant women/foetuses and neonates; prisoners; children and immature or mentally incompetent persons; and please, do let me know the challenges you are facing, or the strategies you have implemented to assist in overcoming these challenges. And finally, I wouldn’t want to give everything away, but watch out for further ponderings on the term within SA-GCP; and what those could be, and what challenges those may bring.