What the US Presidential Commission for the Study of Bioethical Issues Doesn't Say

The Presidential Commission for the Study of Bioethical Issues (PCSBI) has just published a report commissioned as a result of the 'discovery' of the Guatemala syphilis experiment in the 1940s, which involved infecting unsuspecting people with syphilis and other diseases for the purpose of scientific research. A lot of people were infected and many died as a result. Some of those running the Guatemalan study later took part in the Tuskegee Syphilis experiment, which continued into the 1070s.

The PCSBI wanted "assurance that the rules governing federal research today adequately guard against the abuses perpetrated by the U.S. Public Health Service" and "that current rules protect people from harm or unethical treatment, no matter where in the world U.S.-supported research occurs.". The assurance is forthcoming, in a rather limited sense, and there are many recommendations that still need to be met.

As a Public Library of Science blog notes, the report is about federally funded research, not research carried out by Big Pharma or other industries, nor even that carried out by NGOs, which probably constitute the biggest proportion of trials involving human subjects. Therefore the report is not really very reassuring at all. Outrages such as those that occurred in Guatemala and Tuskegee might occur elsewhere; they could even be occurring right now, with the knowledge of the US and other governments.

I attended part of a training course to teach rural albinos and carers of albinos about income generation schemes, planning, budgeting, etc, and becoming involved in community level savings and loans schemes. It's interesting how much effort the trainer needed to put into starting off with very basic concepts and repeating them throughout the week. Many had only a few years of primary school and had rarely used their reading or writing skills since leaving school.

So I always wonder when I hear terms like 'informed consent' and how they work in such a setting. What level of understanding do people have of complex drug regimes and other matters if they have little or no basic literacy? Many drugs come with instructions that presuppose a level of literacy that may not have been attained by all, or even most participants in some types of research. Is it enough to have a set of signatures from people involved, even if the form they are signing is written in their mother tongue?

I have blogged elsewhere about the Rebecca Project, which has published a damning report on non-consensual research in African countries, showing that such things may not happen in the circumstances described by the PCSBI report but they do still happen. David Gisselquist of the Don't Get Stuck With HIV website and blog has also written a comprehensive review of unethical and illegal research that has taken place in African countries.

It's a pity the PCSBI kept their brief so narrow because now we have no idea who, if anyone, will carry out similar research into non-federally funded research and when this might happen. The last thing we need is for the industry to fund the research itself. Given what is available to us about their ethical standards, we can be forgiven for not expecting much better from that which is unavailable.