Version 1.0 - February 2017

Guidelines on the Remuneration of Trial Participants

1. About Remuneration for Trial Participants

1.1 General on Remuneration of Voluntary Trial Participants

It's important that when a trial participant consents to partake in a health science research project, their decision is based on voluntary acceptance. Consequently, remuneration or other benefits must not motivate participation in the trial. The committee law stipulates that the remuneration or benefits must not be “likely to influence the decision to consent”.

Four types of remuneration are recognized in relation to a trial participant’s involvement in a health science research project:

  • Remuneration for inconvenience
  • Remuneration for documented lost earnings
  • Remuneration for documented transportation expenses
  • Other benefits

Additionally, specific rules apply based on whether the participant is a healthy volunteer or a trial patient.

More information about remuneration for trial participants can be found in Appendix 1 (PDF).

1.2 Remuneration for Healthy Trial Participants

“Healthy trial participants” refers to individuals either completely healthy with no known acute or chronic illness or those with a known condition that is irrelevant to the research project (for instance, a tennis elbow patient participating in a diabetes project).

1.2.1 Remuneration for Inconvenience

Healthy trial participants derive no benefit from participating in a health science research project. Hence, they can be remunerated for inconvenience. The amount of remuneration should be based on a specific assessment of the trial, including its invasive nature, duration, pain, and discomfort.

1.2.2 Remuneration for Transportation and Lost Earnings

Moreover, remuneration for documented lost earnings and transportation expenses can be granted. Regarding lost earnings, full remuneration is permissible for individuals in paid employment. As for transportation costs, they are covered to a reasonable extent, usually favoring the most economical means of transport unless exceptional circumstances apply.

1.2.3 Other Benefits

In some cases, healthy trial participants might receive benefits other than remuneration. These could be benefits integral to the health science research project and necessary for its execution (e.g., free diet for half a year in diet-related projects or distribution of plasters in a wound healing project) or benefits offered post-trial (like cinema tickets, bottles of wine, mp3 players, etc.) When assessing the appropriateness of such benefits, distinctions should be made between necessary project components and benefits akin to remuneration. The assessment should mirror the considerations used for inconvenience remuneration.

1.3 Remuneration for Trial Patients

“Trial patients” are individuals with a condition or illness necessary for project participation. Their participation might be part of their diagnostic or therapeutic treatment at a hospital, potentially offering diagnostic or therapeutic benefits. Alternatively, they might participate solely due to their illness, unrelated to their current treatment. Even if the patient is well-managed for the illness, their contribution can be considered valuable and relevant.

1.3.1 Remuneration for Inconvenience

Since trial patients might benefit from the project, they usually cannot receive inconvenience remuneration. However, if participation is deemed to offer no treatment benefit, inconvenience remuneration may still be granted.

1.3.2 Remuneration for Transportation and Lost Earnings

Remuneration for documented transportation expenses and lost earnings is possible if the patient’s participation is due to their illness and not part of their regular treatment. If participation coincides with regular hospital visits, no remuneration is provided. However, additional costs incurred beyond normal treatment (like multiple visits or prolonged hospital stays) can be compensated.

1.3.3 Other Benefits

Trial patients, like healthy participants, may receive benefits other than remuneration. These can either be integral to the research project (like free diet in nutrition studies or plasters in wound healing projects) or post-trial benefits (cinema tickets, wine, mp3 players, etc.) The assessment of these benefits should follow the same principles as for inconvenience remuneration, considering whether the patient experiences inconvenience or gains benefit from project participation.

1.4 Special Considerations for Children and Adults Without Decision-Making Capacity

Initially, it should be noted that the rules for approving health science research involving children and adults without decision-making capacity are more stringent. More information about these rules can be found in Information for Researchers and on the topic page about Guidelines for Emergency Trials outside of the CTR and the MDR.

1.4.1 Children and Adolescents Under 18 Years

Children and adolescents under 18 years cannot consent to participate in a health science research project on their own, hence consent must be provided by their legal guardians.

The same rules for compensation for transportation and lost earnings apply to children/adolescents participating in research as for adult participants. Often, it's the parents who incur expenses due to the child's/adolescent's participation, and they can then be compensated for transport costs and lost earnings. No compensation is provided if these costs are already covered under other legislation, like the service law.

1.4.2 Adults Without Decision-Making Capacity

By "adults without capacity to act," we mean individuals who are unable to give informed consent to participate in a research project due to a lack of physical or mental functionality (e.g., because of mental state, age, developmental disability, or similar). Adults without the capacity to act will often be represented by a guardian or the closest relative.

The committee law does not distinguish between individuals who are permanently without the capacity to act (e.g., individuals with severe dementia) and those who are temporarily without the capacity to act (e.g., unconscious individuals who subsequently regain their capacity). However, there is a difference in the research project. If it concerns an so-called acute trial, involving participants who suddenly lose their capacity to act, special rules apply. See the Guidelines for Emergency Trials outside of the CTR and the MDR for more information.

The same rules apply regarding compensation for transportation costs and lost earnings for adults without the capacity to act who participate as trial participants in a research project, as for other adult trial participants.

1.5 Requirements for Protocol and Participant Information

The size of the remuneration, including the possibility of compensation for transportation, lost earnings, and/or inconvenience allowance, should be clearly stated in the protocol and participant information.

It should be outlined what payout will occur if the participant chooses to withdraw from the trial prematurely or is excluded based on the decision of the trial organizer. Participant information should also clarify whether the benefits are taxable.

Frequently Asked Questions

Compensation for lost earnings and for pain and discomfort (inconvenience allowance) in a health science research project is taxable. However, the part of the compensation that covers documented expenses related to participation, e.g., transportation costs, is not taxable.

It is the responsibility of the trial leader to report the entire compensation to the tax authorities. The trial participant must report the income in their tax return. What needs to be reported is the part of the compensation that exceeds the trial participant's documented expenses for participation. The trial participant can contact the trial leader or the tax authorities if they are unsure about what is taxable.

Please refer to the guide's  Appendix 1: Guidelines for compensation or other benefits for voluntary research participants. There is no set limit for the size of the compensation, but it should be appropriate in relation to the intervention or the inconvenience the research participant is subjected to.

The compensation is taxable and must be reported to the tax authorities by the person responsible for the research. The research participant must declare the income themselves.

Last updated 01-02-2024

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