Compensation and Reimbursement

3. How Much Compensation?

Pandya and Desai give an accurate description of the currently existing models for setting the amount of compensation (1):

‘There are several proposed models of making payment to subjects for trial participation. Some of the ways are more ethically acceptable than the others. The common models are:

The market model is based on the principle of supply and demand, which decides when and what is to be paid to the research subjects for a particular study in a particular location. This means that compensation is paid to the subjects for the studies that offer little or no benefits or the studies for which the target population is difficult to reach. Also, this implies that in case of studies that offer benefits or have a huge target population, little or no compensation is paid. This model has advantages like targeted number of subject recruitment achieved in the required time frame, decreased financial sacrifice by the subjects and high completion bonus ensures protocol compliance. However, on the flip side, this model leads to very high compensation in few of the hard-to-find-subject studies, which could serve as undue inducement and could unnecessarily commercialize the research participation. High payment can lead to subjects not paying attention to the risks involved in the study, as well as leading them to hide important data that could deem them ineligible for the study. It could also create situations where the investigators are competing for subjects by paying higher amounts.

The wage model is based on the concept that research participation requires little or no skill, but it does involve consideration of the time and effort of the subject and also discomfort that is faced by subjects. The model is in alignment with egalitarianism. This model suggests that the subjects engaged in similar activities be paid similarly. Thus, here, the subjects are paid on a scale parallel with that of the unskilled but essential jobs. The advantages of this model could include minimization of the issue of undue inducement, reduced inter-study competition as seen in the market model that would also encourage investigators to minimize the risks involved, decreased financial sacrifice by the subjects and prevention of discrimination between high-income and low-income groups (like the reimbursement model described below) as subjects of the same study receive equal compensation. However, it creates difficulty in achieving the targeted number of subject recruitment in the required time frame and it usually attracts the low-income population. It views subject's research participation as an unskilled job and many believe it to be inappropriate commercialization of the research participation.

The reimbursement model is also in alignment with the egalitarianism principle. This model suggests that compensation should only recover the costs incurred by the subject for participating in the trial. Also, the time spent away from work can be reimbursed proportional to their earning capacity. This model helps in resolving the issue of undue inducement to a certain extent. Subjects are less likely to hide information or overlook the risks involved in the study. The model also decreases the financial sacrifice by the subjects. On the other hand, the issues with this model could be difficulty in achieving the targeted number of subject recruitment in the required time span. Also, different subjects have different earning capacities based on their qualifications, which leads to either preference for the low-income group or high cost of study if subjects from the high-income group are selected.

The appreciation model suggests compensation at the time of study completion as a token of gratitude or appreciation. This has no impact on the study recruitment as it is given at the end of the study. However, this model could have an impact on subject retention and may act as an inducement to prevent a patient from discontinuing. It needs to be used along with one of the above-mentioned models. The researcher needs to carefully weigh the pros and cons of each of the above models and decide which one is best suited for the study on hand. It is also best to decide and document the mode of compensation before the trial is initiated, taking the stakeholders and the Ethics Committee in confidence and with the mandatory approval obtained from these.’