Viewpoint

Undue inducement in clinical research in developing countries: is it a worry?

A confused concern

There is something strange about this worry. Antiretroviral treatments for people with HIV are recognised as a tremendous benefit. They prolong and greatly improve quality of life, and they allow people to return to productive economic, social, and family lives. Proponents are tirelessly campaigning to secure these drugs for people in developing countries who cannot afford them. Critics seem to worry that although getting the drugs is clearly desirable and reasonable, receiving them as part of

Differentiating inducement from undue inducement

Not every inducement is undue. Classifying inducements as undue is logical only if there are inducements that are due or appropriate. Nor can an inducement that changes a person's action, making them do something they would otherwise not have done, be sufficient to make inducement undue. After all, the purpose of any inducement is to change behaviour. If all behaviour-changing inducements were by definition undue, there would only be attempted inducements and undue inducements, and no simple

When is inducement undue?

Although commonly invoked as an ethical transgression, including specific admonitions in the US Federal regulations on informed consent and many other ethical guidelines for research, undue inducement is rarely explicitly and precisely defined.5, 6, 7, 8 The main worry seems to be that individuals are offered some good that leads them to use poor judgment and assume substantial risks of harm that compromise their welfare.4, 6, 7, 8, 9, 10, 11, 12 As the Council for International Organizations

Differentiating undue inducement from coercion

Frequently, undue inducement is conflated with coercion, exploitation, injustice, deception, misunderstanding, and other ethical transgressions as if they were equivalent or interchangeable.11, 16 It is important to distinguish these violations not merely for philosophical fastidiousness, but because they entail distinct wrongs, and practically because they require different solutions (table).¹⁷ For instance, providing truthful information to avoid deception does not address exploitation, and

Differentiating undue inducement from exploitation

Undue inducement is often conflated with exploitation.15, 19 Exploitation requires unfair distribution of advantages from an interaction.¹⁵ A exploits B if, because of the interaction, B receives too little benefit or assumes too great a risk compared with the benefits A receives or the risks A assumes.15, 20 Exploitation entails a person getting too little, whereas undue inducement entails a person receiving too much, an excessive offer. Indeed, the distinction between exploitation and undue

Differentiating undue inducement from unfortunate circumstances

Many worry that poverty or otherwise compromised circumstances may force people to take an inducement that people in a better situation shun.1, 2, 6, 8, 16 Because of people's unfortunate circumstances, these tempting offers are said to undermine autonomy and voluntariness and, therefore, informed consent.¹

Distressing circumstances that create limited options do not necessarily compromise the autonomy and voluntariness of decisions.15, 18, 19, 20 A person suffering from terminal heart disease

Undue inducement in clinical research

Although it is a pervasive worry, undue inducement cannot happen in clinical research that fulfils basic ethical requirements. Independent review of clinical research by institutional review boards (IRBs) or ethics review committees (ERCs) should exclude trials exposing participants to substantial risks of serious harms. Thus, even if the participants exercise poor judgment, they are protected from research with unfavourable risk-benefit ratios.

To be ethical, a research study in a developing

Real concerns masquerading as undue inducement

Much of the concern about undue inducement seems to be a misguided worry that IRBs and ERCs are not functioning properly and are ineffective at assessing the risks and benefits of research studies, and hence are approving research with substantially unfavourable risk-benefit ratios. IRBs and ERCs are human institutions, and can make mistakes; they might approve clinical research trials that do not contribute social value, are not scientifically valid, or, most importantly, pose excessive risks

Undue inducement and HIV/AIDS research trials

Providing antiretroviral medications as part of an otherwise ethical research trial in a developing country in which such medications are not generally available—or are available only on a restricted basis—does not constitute undue inducement. The antiretroviral drugs might serve as an inducement, and their availability in the trial could lead some, maybe even many, to change their actions and judge that enrolling in the research trial is worthwhile. However, assuming the trial is otherwise

Conclusion

There are pervasive worries that clinical research in developing countries that offers payment or medical interventions generally not available to the participants creates ethically worrisome undue inducements. Too many people confuse any inducement that changes behaviour with an undue inducement. This notion is mistaken. Undue inducement requires offering something valuable that leads to both bad judgments and exposure to unreasonable risks. As long as the research is otherwise ethical,