As a sponsor, what do the regulations say about paying research subjects? What are acceptable practices for compensating subjects for participating in a clinical trial?
The FDA and other federal regulations on human subjects protections do not specifically address payment. The regulations do require that informed consent must be obtained under circumstances “that minimize the possibility of coercion or undue influence.” OHRP guidance states: “Paying research subjects is a common, and in general, acceptable practice.”
“Paying research subjects is a common, and in general, acceptable practice.” In fact, it is common for subjects to be paid for their participation in research. Sponsors, researchers and Institutional Review Boards (IRBs) may consider the following as acceptable practices for compensating subjects:
Reimbursement of Study-Related Expenses
Research participation should be cost-neutral. This helps to ensure the principle of distributive justice, and that the risks and benefits of research participation are fairly distributed. A number of different models for covering out-of-pocket expenses are acceptable including collection of receipts and reimbursement in cash or check; vouchers for taxis, parking or meals; pre-funded debit cards; or providing a per-diem amount based on average and expected expenses.
Compensation for Time and Effort
Participants may be compensated for their time and effort including study visits, tasks outside study visits (completing surveys or diaries), and even travel time to clinical sites. Some ethicists have proposed payment amounts based on local minimum wages,1 although others have pointed out that compensating at minimum wages may attract only lower-paid persons to participate in research.
In some cases, a sponsor may wish to pay a certain amount of money to ensure that they were able to enroll the study with the necessary number of participants and in a reasonable amount of time. An IRB may consider and approve an incentive plan.
For more detailed information, see our white paper Compensating Participants in Clinical Research: Current Thinking.
1 What’s the Price of a Research Subject? Approaches to Payment for Research Participation, Neal Dickert and Christine Grady in Ethical and Regulatory Aspects of Clinical Research, The Johns Hopkins University Press, 2003.
ASK THE EXPERTS
Our experts answer your research ethics and oversight questions, and share the (anonymized) answers as a resource for our industry.