Changed guidance on payment for study participants puts them at higher risk of harm, group says

A change in a guidance document concerning payment for participating in research undermines protection for human participants, a US consumer advocacy group has said.1

At issue is how much study participants can be paid without causing them to accept risks that they wouldn’t otherwise have accepted.

Under current US policy, payment is allowed to remunerate participants for their time, inconvenience, and discomfort, for example, but should not be so large that it induces them to accept risks they wouldn’t accept if it were not for the money. The concern is that such payments could be used to exploit poor people who might agree to participate in high risk studies because of their need for money.

The changes that sparked the controversy appear in a document of frequently asked questions about informed consent, issued by the US Office for Human Research Protections (OHRP). …