What to consider when deciding whether to reimburse and/or compensate research participants in clinical research
Overview
The practice of offering reimbursement and compensation to research participants in clinical research is widespread. Nevertheless, such payment remains the source of substantial debate, in particular about the extent to which offers of payment are ethically sound and acceptable, and do not constitute a coercion of, and/or undue inducement, for individuals to participate. Understanding what is ethically admittable in terms of offers of payment is not easy. Taking into account the legal framework and balancing different ethical principles is the way to follow, in order to establish fair, equitable, proportionate reimbursement and compensation policies, which consider all the interests and issues at stake. A general ethical principle embedded in different sources of the law at the international, EU and national level is the principle of “fiscal or financial neutrality”, which means to reimburse and/or compensate donors to cover expenses or losses without providing financial gain.
In terms of terminology:
- “payment” is the overarching term that encompasses all forms of financial and non-financial support provided to research participants;
- “payment” is divided into:
- “recompense”, which is consists of “reimbursement” (covering direct financial expenses for participation in research, such as costs of travel, accommodation, meals, childcare) and “compensation” referring to both indirect financial expenses (e.g. and loss of wage for taking unpaid leave from work) and financial and non-financial losses resulting from injuries as a direct consequence of participation in research;
- “remuneration”, which refers to any payment provided to individuals for their service as research participants, bringing a monetary gain or profit to them. It depends on time devoted to research, risks involved in research, etc. Remuneration is usually considered as an incentive to research.
Key Ethical, Legal and Societal Issues
Lack of Consensus on Compensation
Some ethicists view any form of financial incentive as unethical. Others distinguish between reimbursement, compensation, and incentives, evaluating them based on intent and impact. Different legal and ethical sources would lead to distinguish among:
- Reimbursement for actual expenses: Widely accepted and ethically permissible.
- Compensation for time and effort: Often accepted, but should be based on fair and transparent criteria.
- Tokens of appreciation: Ethically acceptable when small and offered post-consent.
- Financial incentives to encourage participation: Ethically sensitive; may lead to undue inducement, threatening voluntariness and autonomy.
Undue Inducement
Large payments may influence individuals to participate against their better judgment, compromising informed consent and autonomy.
Principle of Social Beneficence
Compensation can be ethically justified to promote participation and support scientific progress, benefiting society. However, this doesn’t justify unlimited or disproportionate payments.
Equity and Justice
Payments must be fair and equitable, not reinforcing income inequality. For example, compensating based on lost wages may disadvantage low-income or unemployed individuals.
Vulnerability and Exploitation
Vulnerable groups (e.g., students, unemployed) may be unduly influenced even by modest payments. Ethical compensation must avoid both exclusion and exploitation.
Equality Principle
Similar contributions should receive similar compensation. However, different treatment may be justified with appropriate reasoning (e.g., offering non-monetary benefits to reduce coercion).
Role of Research Ethics Committees (RECs)
Research Ethics Committees can serve as critical gatekeepers for research ethics, including reviewing compensation rules. However, questions arise about potential conflicts of interest when REcs are situated within the same institutions collecting samples for research. This is a key structural issue. Indeed, institutional RECs may have implicit pressure to approve protocols that benefit their institution.
Relevant EU Legislation
- EU Clinical Trials Regulation (536/2014): it only mentions (art. 31, 32 and 33) the possibility of “compensation for expenses and loss of earnings directly related to the participation in the clinical trial” in case of clinical trials on incapacitated subjects, on minors and on pregnant or breastfeeding women. There is a section devoted to compensation for any damage suffered by a subject resulting from participation in a clinical trial (art. 76). Then, information on financial transactions and compensation paid to subjects and investigator/site for participating in the clinical trial shall be provided by the Sponsors (Annex I).
- Regulation (EU) 2024/1938 on standards of quality and safety for substances of human origin (SoHO) intended for human application allows compensation as long as it guarantees financial neutrality and does not constitute an incentive that would cause a SoHO donor to disclose medical data or donate in any way that could pose health risks. The principle of voluntary and unpaid donation is central (see art. 54), and donation should be based on transparent criteria. Compensation (through financial and non-financial means) can consist of the reimbursement of expenses incurred in connection with SoHO donation or of making good of any losses, preferably based on quantifiable criteria, associated with the donation of SoHO. Whatever the form of compensation, it cannot result in competition between SoHO entities for SoHO donors (especially between public and private sectors). The Regulation recommends using “quantifiable criteria” to determine the compensation amounts and suggests delegating the fixing of such criteria to independent bodies.
- Directive 2002/98/EC setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components, in OJ L 33, 8.2.2003, p. 30–40
- Directive 2004/23/EC on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells, in OJ L 102, 7.4.2004, p. 48–58
- Directive 2010/53/EU on standards of quality and safety of human organs intended for transplantation, in OJ L 207, 6.8.2010, p. 14–29
BBMRI Resources
The below resources have been developed by those included in the BBMRI network:
- The Austrian national node has explored the issue of financial gain related to samples: Legal Q&A: Can human biological samples be sold? – BBMRI.at
External Resources
- UZ Leuven, Ethics Committee Research, Frequently asked questions EC Research, https://www.uzleuven.be/en/ethics-committee-research/frequently-asked-questions
- Belgian Association of Research Ethics Committees (BAREC), Guidance on fair compensation of subjects for their participation in clinical research in Belgium, November 2023, https://barec.be/guidance-on-compensation-of-clinical-research-participants
- UK NHS, Health Research Authority (HRA), United Kingdom, Payments and Incentives in Research, 5 Dec 2024, https://www.hra.nhs.uk/about-us/committees-and-services/nreap/payments-and-incentives-research
- Nuffield Council on Bioethics, Human bodies: donation for medicine and research, 2011, nuffieldbioethics.org/wp-content/uploads/Human-bodies-donation-report.pdf
Relevant Publications
- What’s in a name? Subjects, volunteers, participants and activists in clinical research
By Corrigan O., Tutton R.
Clinical Ethics. 2006;1(2):101-104. doi:10.1258/147775006777254524
- Citizen Science Terminology Matters: Exploring Key Terms. Citizen Science: Theory and Practice
By Eitzel, M.V. et al.
2017, 2(1): 1, pp. 1–20, doi: https://doi.org/10.5334/cstp.96
- A framework for ethical payment to research participants.
By Gelinas L, Largent E, Glenn Cohen I, Kornetsky S, Bierer B, Fernandez Lynch H
The New England Journal of Medicine, 2018, 378 (8): 766–771
- Payment of clinical research subjects
By Grady C.
The Journal of Clinical Investigation 2005, 115 (7): 1681–1687.
- The ethical anatomy of payment for research participants
By Różyńska J.
The Med Health Care and Philos 25, 449–464 (2022). https://doi.org/10.1007/s11019-022-10092-1
