In a large proportion of clinical trials, whether for drugs or for other procedures, participants are given compensation in return for their involvement. Sometimes this is a cash payment but it may be in the form of services. Participants are commonly reimbursed for travel, food, or other costs.
Defining reimbursement in clinical trials
Reimbursement expenses are expenses related to participating in a clinical trial. All eligible trial participants (or their representatives) receive reimbursement. Reimbursement expenses must be documented prior to the start of the trial. Examples include travel costs, accommodation, food, and any loss of income due to the time they spend participating in the trial.
Defining compensation in clinical trials
There are two meanings to compensation in the context of scientific studies. Compensation can refer to benefits, monetary or otherwise, received by trial participants as a reward (compensation for participation). It may also refer to compensation due to harm or injury suffered as a result of the trial.
Compensation for participation is quite common in some regions. It may be desirable for clinical research organizations to advertise compensated trials as a way of recruiting more participants. In the United States, for example, there is a standard tariff for such compensation set by the National Institutes of Health.
Legislation, guidelines, and practice relating to compensation vary significantly depending on the regions where the trials are held. Typically, compensation for participation in clinical trials will be reviewed by a relevant ethics committee to ensure that it complies with legal obligations and regulations, as well as internal ethical standards. Restrictions often exist as to who can be offered compensation for participation. For example, minors and incapacitated persons may be excluded from such incentives, as may pregnant women. It is always crucial that participants are made aware of any risks.
IRBs (institutional review boards) exist in some regions to oversee trials involving human subjects. These boards help to ensure that all trials comply with the law and that volunteers’ rights are respected. An investigator will review the study and the organization and determine whether it’s in compliance.
In some clinical trials, there is a distinct risk to the subject. For example, if the purpose of a trial is to collect data on the effectiveness of a new medicine against a particular disease, a participant may suffer harm if the treatment is ineffective. In some regions, such as the EU, it may be necessary to obtain insurance to cover compensation in the event that harm is suffered by participants. This might not be applicable where clinical trials pose no additional risk. If there is a risk to patients, the responsible research body may need to obtain insurance to cover any compensation that they are obliged to pay.
Participants who register for a clinical trial will typically need to sign an Informed Consent Form or ICF. This will contain information on compensation schemes and the insurance that is offered to cover any harms, injuries, or deaths suffered by people participating in the trial. The ICF needs to include specific details on how the subjects can contact the insurance company directly in case of harm resulting from their participation. This is so that participants and representatives do not have to rely on the CRO, sponsor, or personnel engaged in the study if they need to obtain compensation later on, which may present difficulties for injured participants.
Ethical considerations
There are a number of ethical considerations and concerns surrounding compensation for clinical trials. The principal concerns are focused on the possibly coercive effect of such payments for vulnerable participants. As stated above, minors and other persons who might be less able to make informed decisions about entering a trial are generally excluded from compensation. Even so, it is possible that people may be induced to take part in riskier trials if there is compensation available than they would otherwise, particularly in cases where the amount of compensation is high.
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