Healthy Volunteers in Device FIH Studies: What Ethics Committees Allow on Compensation in Costa Rica, El Salvador, Panama and Chile

Short answer: The four countries take different positions. Costa Rica’s research law says participants are not paid and only their expenses may be reimbursed; the one payment exception is for bioequivalence studies, which the regulation defines around pharmaceutical products. Panama’s 2026 research decree allows first-in-human (FIH) participants to receive compensation in proportion to time, effort and discomfort, with prior approval from the bioethics committee. El Salvador’s national ethics committee reviews the amount and method of any payment and requires that payments not depend on finishing the study. Chile’s device-trial guide allows reimbursement of direct expenses such as transport, as long as it is not an undue incentive; we found no Chilean rule on paying for time. In every country, what you plan to pay goes in the consent form and needs ethics committee approval.

Why healthy volunteers come up in device FIH studies

Some device FIH studies enroll healthy volunteers rather than patients. Examples include skin-contact and wearable devices, sensors, and products where the first question is tolerability or usability rather than treatment effect. Healthy volunteers get no therapeutic benefit, so ethics committees look closely at two things: whether the risk is justified, and whether the payment could push someone to accept a risk they otherwise would not.

The international reference point is Guideline 13 of the Council for International Organizations of Medical Sciences (CIOMS). It says participants “should be reasonably reimbursed for costs directly incurred during the research, such as travel costs, and compensated reasonably for their inconvenience and time spent,” that compensation “must not be so large as to induce potential participants to consent to participate in the research against their better judgment,” and that “a local research ethics committee must approve reimbursement and compensation” (CIOMS International Ethical Guidelines, 2016, Guideline 13). National law can be stricter than CIOMS, and in Latin America it sometimes is.

Costa Rica: reimbursement only, with a narrow exception

Article 5 of Ley 9234, the Biomedical Research Regulation Law, is titled “Gratuidad”. It says participation “siempre deberá ser voluntaria, por lo que no se remunerará a los participantes. Solo podrán reintegrarse los gastos en que eventualmente incurra un sujeto por su participación en la investigación.” It then makes one exception: “En el caso de los estudios de bioequivalencia, además del reconocimiento de gastos, se permitirá la remuneración al participante por su participación voluntaria,” with payment approved in advance by the scientific ethics committee (CEC, comité ético científico) (Ley 9234, Art. 5, La Gaceta, 25 Apr 2014).

Has that changed? The legislation index of the National Health Research Council (CONIS, Consejo Nacional de Investigación en Salud) lists one amendment to the law: the repeal of Article 18, published in La Gaceta in September 2020 (CONIS legislation page). Article 5 was not touched.

The implementing regulation, as amended in 2023, defines bioequivalence studies as studies in healthy volunteers “a los que se les administra un producto farmacéutico” and says that, because they lack therapeutic benefit, use healthy volunteers and are paid, they are classified as Phase I (Reglamento 39061-S as amended by DE 44033-S, Art. 3 def. 31, La Gaceta Alcance 111, 2023). The same regulation defines medical devices separately, as equipo y material biomédico (EMB) (def. 28). Our reading is that a device study does not fall under the bioequivalence exception, so healthy volunteers in a Costa Rican device study can have their expenses reimbursed but cannot be paid for participating. Confirm the treatment of any specific item with the CEC that will review the study.

Practical consequences: budget for documented expenses (transport, meals during long visits, and similar costs), describe exactly what will be reimbursed in the consent form, and do not advertise the study as a “paid” trial in Costa Rica.

Panama: compensation allowed for FIH studies, with committee approval

Panama’s Executive Decree 21 of 23 April 2026 regulates health research under Ley 84 of 2019. Article 61 says participants and their companions “no deben incurrir en ningún gasto por participar en un estudio de investigación”, and that any planned compensation must be in the informed consent and in the documents approved by the bioethics committee. Article 62 is specific to FIH studies: “Los participantes de los estudios clínicos por primera vez en humanos podrán recibir una compensación en proporción al tiempo, esfuerzo e incomodidad, previa aprobación del comité de bioética. El comité de bioética en el proceso de revisión deberá velar por que no se convierta en un incentivo indebido para la participación” (Decreto Ejecutivo 21 of 2026, Arts. 61 and 62, Gaceta Oficial Digital 30510 C).

Article 62 does not distinguish between drug and device FIH studies, and it does not set an amount. The bioethics committee decides whether the proposed compensation is proportionate. Build the proposal around the actual burden of the protocol: number and length of visits, procedures and any discomfort.

El Salvador: the national ethics committee reviews amount and method

The operating manual of the National Health Research Ethics Committee (CNEIS, Comité Nacional de Ética de la Investigación en Salud) does not ban payment. It requires review. The CNEIS “debe revisar tanto la cantidad como el método de pago a las personas para asegurarse que no existan problemas de coerción o mal influencia”, and “los pagos a la persona deberán ser asignados y no depender de que el sujeto termine el estudio.” The CNEIS must also make sure the methods, amounts and schedule of payment are set out in the written consent form (Manual de funcionamiento del CNEIS, Acuerdo 382 of 2017, section on functions, items (j) and (k)). A March 2026 reform of the manual changed the committee’s composition and removal rules, not these provisions (Acuerdo 838 BIS, 3 Mar 2026).

The key design point is proration. A schedule that pays only at the final visit conflicts with the manual. Pay per completed visit or per study phase.

Chile: reimbursement of direct expenses

The clinical investigation guide for medical devices issued by the Instituto de Salud Pública (ISP) through its Agencia Nacional de Dispositivos Médicos (ANDIM) department addresses this directly. It says it is appropriate to reimburse participants for “los gastos directos derivados de su participación (ej. transporte), bajo la figura de asignación por gastos de traslado”, and that this allowance must not be so large that it becomes an undue incentive or affects the participant’s right to withdraw early (ISP / ANDIM, Guía de Investigación Clínica de Dispositivos Médicos, May 2026, section 5.3).

We did not find a provision in Chilean law or regulation that addresses payment for time or inconvenience in device studies. Device trials in Chile also need ISP special authorization (Código Sanitario, Art. 111 A). Whether a CEC will accept compensation beyond the travel allowance should be confirmed per study.

Side by side

If the data will support a US submission

Sponsors planning a US submission sometimes ask whether FDA expects payment. It does not require it. The US Food and Drug Administration (FDA) guidance on payment says paying research subjects “is a common and, in general, acceptable practice”, that payment “is not considered a benefit” in the risk-benefit assessment, that credit “should accrue as the study progresses and not be contingent upon the subject completing the entire study”, and that the amount and schedule should be in the consent document (FDA, Payment and Reimbursement to Research Subjects, January 2018). That guidance is written for US institutional review boards; in each Latin American country the local law and ethics committee decide.

Building a compensation plan that passes review

1. Start from the local rule, not from a US or European template. In Costa Rica that means reimbursement only.
2. List every participant cost the protocol creates, visit by visit, and decide which will be reimbursed and how receipts or allowances will work.
3. Where payment for time is allowed, tie it to the burden of the protocol and explain the reasoning to the committee.
4. Prorate. Pay per visit or per phase so a participant who withdraws is not penalized, as El Salvador’s manual and FDA’s guidance both expect.
5. Put the amounts, method and schedule in the consent form in plain language, and keep recruitment materials consistent with it.
6. Keep compensation separate from compensation for research-related injury, which is a different obligation covered by insurance and by Article 61 in Panama.

Where bioaccess® fits

bioaccess® runs first-in-human and early feasibility medical device studies in Latin America. We help sponsors build participant reimbursement and compensation plans that match each country’s rules and the reviewing committee’s expectations, and keep the consent form, budget and recruitment materials aligned.

Related reading

• Microneedle Patches: Device, Combination Product, or Cosmetic? Planning Your First Human Study
• Running a First-in-Human Dermatology or Aesthetic Device Trial in Latin America: Sites, PIs and Outpatient Clinics
• 10 Startup Mistakes That Delay a Latin America FIH Study (and How to Avoid Them)
• Healthy volunteers in Phase 1 drug studies in Latin America
• Costa Rica FIH activation calendar: CONIS and CEC
• Subject injury vs third-party liability in FIH studies
• Clinical trial insurance for FIH studies in Panama
• First-in-human medical device trials in Chile
• Latin America FIH patient recruitment and feasibility

FAQ

Can healthy volunteers be paid in a device study in Costa Rica?

Ley 9234 says participants are not paid and only their expenses may be reimbursed. The only payment exception is for bioequivalence studies, which the regulation defines around pharmaceutical products. Our reading is that device studies are not covered by the exception, so plan for reimbursement only and confirm details with the reviewing ethics committee.

Does Panama allow compensation for first-in-human participants?

Yes. Article 62 of Executive Decree 21 of 2026 says first-in-human participants may receive compensation in proportion to time, effort and discomfort, with prior approval from the bioethics committee, which must make sure it does not become an undue incentive.

What does El Salvador require for participant payments?

The national ethics committee manual says the committee reviews both the amount and the method of payment, that payments must not depend on the participant finishing the study, and that methods, amounts and schedule must appear in the written consent form.

Can participants in a Chilean device trial be reimbursed?

Yes. The ISP device clinical investigation guide says direct expenses such as transport can be reimbursed as a travel allowance, as long as the amount is not an undue incentive and does not affect the right to withdraw. We found no Chilean rule on paying for time, so confirm per study.

Should payment depend on completing the study?

No. El Salvador’s ethics committee manual says payments must not depend on completion, and FDA guidance says credit for payment should accrue as the study progresses. Paying per visit or per phase is the safer design in every country.

Where should compensation be described?

In the informed consent form, with the amounts, method and schedule, and in the documents submitted to the ethics committee. Panama, El Salvador and CIOMS all expect the committee to review and approve it.