Reimbursement for clinical trial participants is always a hot topic. Especially for healthy volunteers in early phase trials who do not get any additional benefits for participating in clinical trials and accept potential study risks. Monetary reimbursement is a strong motivator deciding whether to participate in a clinical trial or not. Evidence suggests that although there are often multiple motivations, healthy volunteers are primarily motivated by financial reward. Thus, it is not surprising that more money might influence their decisions.

Although a financial reward is a primary motivation to participate in clinical trials for healthy volunteers, financial motivations are not the only ones. Contribution to science or the health of others, accessing ancillary healthcare benefits, scientific interest, or interest in the goals of the study, as well as meeting people and curiosity motivates the healthy volunteers too (2). The diagram below demonstrates that not always money matter, some percentage of responders’ care about progress in medicine as well.

Source: Grady, C., Bedarida, G., Sinaii, N., Gregorio, M. A., & Emanuel, E. J. (2017). Motivations, enrollment decisions, and socio-demographic characteristics of healthy volunteers in phase 1 research. Clinical Trials, 14(5), 526–536.​

Legislation Changes in Lithuania

Let’s take a look at how legislation on reimbursement for clinical trial participants changed in Lithuania during the last five years.

The biggest changes in clinical trial reimbursement rules in Lithuania took place when a new revision of Law on Ethics of Biomedical Research entered into force on 01 January 2016 (3). Please, see below the changes at a glance:

The amount of reimbursement is defined in Order No. V-15 (08 January 2016) of the Minister of Health of the Republic of Lithuania (4). According to this Order, the terms and conditions of reimbursement should be clearly outlined in a written agreement, i.e., in the approved Informed Consent Form. For the period between 08 January 2016 and 11 September 2018 the amount of reimbursement for the time spent was calculated according to the minimum hourly earnings approved by the Government of the Republic of Lithuania, taking into account the time actually spent on biomedical research (time spent at the biomedical research centre and time for travelling), but not more than 8 hours a day. Since 11 September 2018, the reimbursement amount was increased up to the amount of average hourly gross earnings of the Republic of Lithuania (5). Also, the cap of 8 hours per day was removed. You can see how the average maximum hourly reimbursement amount increased in 2018-2020 due to gross average monthly earnings growth:

The amendment of Law on Ethics of Biomedical Research provided a better reimbursement scheme for trial participants since 01 January 2016. This is a fair and transparent way to reimburse clinical trial participants in Lithuania, especially, to healthy volunteers or subjects in early phase trials where some visits last up to two days or even longer. Thus, the changes in subject reimbursement scheme gave better chances to Lithuanian trial sites to be competitive in early phase trials and achieve recruitment targets.

Saulenė Kudarauskaitė, MD

Quality Assurance Manager

BIO1 Early Phase Unit

References:

1. Phase 1 healthy volunteer willingness to participate and enrollment preferences.
2. More than the money: A review of the literature examining healthy volunteer motivations.
3. Republic of Lithuania Law Amending Law No VIII-1679 on Ethics of Biomedical Research.
4. Dėl Patirtų išlaidų ir sugaišto laiko dėl dalyvavimo biomedicininiame tyrime kompensacijos apskaičiavimo ir mokėjimo tvarkos aprašo patvirtinimo.
5. Dėl Lietuvos Respublikos sveikatos apsaugos ministro 2016 m. sausio 8 d. įsakymo Nr. V-15 „Dėl Patirtų išlaidų ir sugaišto laiko dėl dalyvavimo biomedicininiame tyrime kompensacijos apskaičiavimo ir mokėjimo tvarkos aprašo patvirtinimo“ pakeitimo.