Participant Recruitment
Section 4
Payments and Incentives
It is generally appropriate to provide payments and incentives to participants in clinical trials, particularly when those payments and incentives relieve burdens associated with participation. The consensus view is that offering payments to participants may be justified on 3 grounds: first, to offset incremental out-of-pocket expenses, such as extra transportation costs; second, to compensate for time or burden associated with participation; and third, to incentivize enrollment and adherence to the trial protocol (Dickert and Grady 1999; Gelinas et al 2018).
| Table. NIH Pragmatic Trials Collaboratory Trials Using Payments and Incentives | |
|---|---|
| Trial | Description |
| BackInAction | Patient-subjects receive $15 at baseline, scaling up to $30 at 12 months, plus $5 for each of the 9 monthly assessments. |
| BeatPain Utah | Patient-subjects receive payments for completing follow-up surveys. |
| FM-TIPS | Patient-subjects receive a free transcutaneous electrical nerve stimulation unit and $200; clinics receive $200 per patient-subject enrolled and bonuses for completing training. |
| GGC4H | Patient-subjects receive payments for completing a study survey (increased to $20 from $10). |
| OPTIMUM | Patient-subjects receive payments for responding to patient-reported outcome assessments. They are also loaned smartphones/tablets. |
| PRIM-ER | Clinicians receive gift cards and continuing medical education credit for completing study training. |
| STOP CRC | Institutions received approximately $20,000 per year. |
| TiME | The trial pilot-tested an incentive program for patient-subjects and facilities to improve adherence to the trial intervention. |
| TSOS | Patient-subjects received payments ranging from $20 to $50 for participation in baseline and follow-up interviews. |
Pragmatic clinical trials may use each of these approaches in principle, but special care must be taken to avoid undermining the pragmatic nature of the trial (Garland, Weinfurt, and Sugarman 2021). For example, if transportation costs are a barrier to trial participation, they may also be a barrier to effective implementation of the intervention in usual care. By offering to pay these costs, the trial may actually be studying the effect of the medical intervention plus the payment.
Compensation for extra time or burden may be appropriate, particularly when the study requires unusual, time-consuming treatments or activities (such as reporting instruments) that would not continue in usual care. One potential special form of payment in this category is compensation for the use of patient data. Patients have some ownership rights over their data, and it may seem appropriate to pay for access to it. Nonetheless, researchers should be aware that the act of offering payment may have unexpected effects, and some patients may not want their data to be used in this way, regardless of the payment amount.
Incentives can be ethically appropriate, but they may thwart the pragmatic aims of a pragmatic trial, except perhaps in trials where payment is the intervention. Incentives for starting or adhering to treatment are rare in usual care, and while they might yield improvements in health outcomes, and they might ordinarily be a legitimate means to recognize patient contributions, it will be rare for them to not jeopardize the pragmatic aims of the trial.
Paying participants also has administrative and organizational costs. The cost of the payments themselves, plus the administrative burden of issuing payments, may make large studies that would otherwise be feasible too expensive to conduct. By not offering compensation to those included in a large trial, the researchers treat those enrolled unequally. Yet some amount of unequal treatment may be justified when the social benefits of improved care for everyone are great enough. As research becomes more integrated into ordinary healthcare, it may be possible to mitigate some of the practical and administrative burdens associated with offering payments (Largent, Joffe, and Miller 2011).
SECTIONS
REFERENCES
Dickert N, Grady C. 1999. What's the price of a research subject? Approaches to payment for research participation. N Engl J Med. 341(3):198-203. doi: 10.1056/NEJM199907153410312. PMID: 10403861.
Garland A, Weinfurt K, Sugarman J. 2021. Incentives and payments in pragmatic clinical trials: scientific, ethical, and policy considerations. Clin Trials. 18(6):699-705. doi: 10.1177/17407745211048178. PMID: 34766524.
Gelinas L, Largent EA, Cohen IG, et al. 2018. A framework for ethical payment to research participants. N Engl J Med. 378(8):766-771. doi: 10.1056/NEJMsb1710591. PMID: 29466147.
Largent EA, Joffe S, Miller FG. 2011. Can research and care be ethically integrated? Hastings Cent Rep. 41(4):37-46. doi: 10.1002/j.1552-146x.2011.tb00123.x. PMID: 21845922.