Regarding the offer of financial benefits to participants in clinical trials with medicines, clinical investigations with medical devices and performance studies with in vitro diagnostic products

Considering

  1. Articles 28(1)(h), 31(1)(c), 32(1)(d) and 33(d) of Regulation (EU) 536/2014,
  2. Articles 62 par. 4 par. k), 64 par. 1 par. d), 65 par. 1 par. d) and 66 par. c) of Regulation (EU) 745/2017,
  3. Articles 58(5)(k), 60(1)(d), 61(1)(d) and 62(d) of Regulation (EU) 746/2017,
  4. ensures document "Part II Document Harmonization Guidance" (Eudralex, 2020/1),
  5. the Questions and Answers document regarding the CTR (Eudralex, 2022), and specifically in Question 9.1.,
  6. Article 9 para. 7, 15 and 20 Government Gazette B 4131/2016,

The following are clarified following questions:

  1. Participation in a clinical trial, clinical research or performance study is voluntary and arises from the free will of the participant and his/her desire to contribute to the public good. Therefore, it should be free from undue influence of any nature, including financial. Parallel, it is not allowed to cause financial burden to participants due to their participation in the clinical trial, clinical research or performance study and care should be taken to redress it. Undue influence is defined as “the offering of an excessive, unjustified, inappropriate or improper reward or other inducement”, which constitutes undue influence in the sense that it may adversely affect a prospective participant’s ability to consider and assess risks and undermine their freedom of will and the validity of their free consent.
  2. In light of the above, it is acceptable the reimbursement to the participant of the actual cost of the expenses incurred and are associated with his participation. In particular, these are expenses related to the procedures, which required by the research protocol, including the diagnosis and remediation of any adverse reactions and must be provided completely free of charge by the sponsor. The same category includes expenses for all types of travel, for food, accommodation and childcare, as well as expenses related to habits and behaviors, which are required for the participant due to his participation in a clinical trial, such as, for example, the use of contraceptives, the use of sunscreen, the cryopreservation of reproductive material, the consumption of specific foods, etc. In the same context, it is acceptable, compensation for lost income or revenue or for lost profit of the participant, directly related to the participation of.
  3. In addition, compensation for loss of time is acceptable, for any burden, discomfort or inconvenience directly related to participation in the clinical trial, clinical research or performance study. In this case, a reasonable lump sum may be paid as compensation.
  4. A distinct, but equally acceptable category is the a practical sign of gratitude that can be expressed through items, goods and services of low or higher value, such as cinema or amusement park tickets, gift cards, subscriptions to music or television platforms, gaming applications, games, provision of medicines or medical devices after the completion of a clinical trial, clinical research or performance study.
  5. On the contrary, the payment of financial incentives, which extend beyond the financial benefits of points 2, 3 and 4 and aim to motivate participation and stay in a clinical trial, clinical research or performance study or to reward the willingness of participants, is not acceptable., as contributions to science and research must be inspired by altruism and based on the voluntary will of the participants.
  6. No other financial benefits are permitted for vulnerable categories of incapacitated or minor participants and pregnant or breastfeeding women, except for reimbursement of expenses and compensation for lost income or profits, loss of time, burden, discomfort or inconvenience directly related to participation in the clinical trial, clinical research or performance study. On the contrary, a small sample of assessment is considered acceptable in these categories of participants after approval by the National Ethics Committee.
  7. Any financial benefit to participants in a clinical trial should be described and adequately documented in the application file (CTR Annex I, P(70)), and is assessed by the ADR. as to its type (monetary or non-monetary), its amount or value, its method of payment (e.g. by cash, bank deposit, gift card, bank check or prepaid card, per session or over longer periods of time) and its justification, in order to ensure that no undue influence is exerted, taking into account the type and duration of the clinical trial, clinical research or performance study, the burden, the need for rehabilitation resulting from participation for the body or health.

National Ethics Committee for Clinical Studies (NEC)

Athens, 22.07.2026