Research Carried Out in Developing Countries

In one line

A trial is cheapest where oversight is lightest and participants have fewest alternatives, and the population that carries the risk is usually not the population that will be able to buy the result.

In the wording a student can write in an exam: transnational research raises the problem of double standards, in which a study is conducted in a host country under conditions that would not be approved in the sponsoring country; the instruments answer it by requiring ethical review in both the host State and the State where the funder is located under article 21(2), by requiring research to be responsive to the needs of host countries under article 21(3), by requiring agreement on the benefits of research with equal participation under article 21(4), and, most usefully for a lawyer, by placing on the State of origin the duty to guarantee the rights and obligations of all parties under paragraph 22 of General Comment 25.

Why the incentives point one way

The structure of the problem should be stated plainly, because every rule in this chapter is a response to it.

Cost. A trial is cheaper where wages, facilities and regulatory compliance cost less.

Speed. Recruitment is faster where the condition is prevalent and where potential participants have no alternative source of treatment, so enrolment is quick and withdrawal rare.

Oversight. Where the regulator is under-resourced, review is lighter and the study proceeds sooner.

Liability. Where the practical ability of a participant to obtain a remedy is limited, the expected cost of an injury is lower.

Each of those makes the host country attractive for a reason that is simultaneously a reason for concern. That is the same inverse relation identified in [Human Experimentation Before Nuremberg]: the features that make a population available are the features that make its consent and its protection problematic.

And the benefit runs the other way. The product is priced for markets that can pay, so the population that bore the risk is frequently not the population that will obtain the result. That is the benefit-sharing failure taken in [Access to Medicines and Patents].

The double standard

The specific ethical objection has a name and a precise content. A double standard exists where research is conducted in a host country to a standard lower than would be required of the same sponsor at home: a placebo control where the standard treatment would be required in the sponsoring country, a consent process that would not be accepted there, an ethics review that would not pass there, or no provision for the participant after the trial.

The Declaration of Helsinki forecloses the argument directly through two provisions taken elsewhere in this module. The comparator is the best proven intervention, not the intervention locally available, which is the point in [The Declaration of Helsinki]. And an ethics committee must take national and international norms into account but these must not be allowed to reduce or eliminate any of the protections for research participants set out in the Declaration, which is the point in [Research Ethics Committees].