Bulgaria CTIS Part II Healthy Volunteer Consent Requirements

When a healthy-volunteer variation is needed

Mandatory when the trial enrolls healthy volunteers. Use participant information written for people who are not being treated for the condition under study. Do not reuse a patient ICF that implies therapeutic need, clinical benefit or treatment alternatives that do not apply.

The Bulgaria participant-facing documents must be in Bulgarian, together with the Bulgaria version in English. The standard written consent and signature requirements apply.

What the healthy-volunteer document set should contain

The exact number of documents depends on the protocol. A typical set includes:

• Bulgarian healthy-volunteer PIS and ICF
• corresponding Bulgaria English version
• any separate optional consent for future data or biological sample use
• recruitment advertisements or other volunteer-facing recruitment material in Bulgarian
• any participant diary, instruction or procedure information provided before the decision to participate when it forms part of the consent package

No separate Bulgaria national healthy-volunteer consent form was identified in the current BDA Part II list.

Main differences from a patient PIS and ICF

Expected benefit

Mandatory. Explain whether the healthy volunteer can expect any direct clinical benefit. In many healthy-volunteer studies there is no expected therapeutic benefit. Bulgarian Good Clinical Practice requires participants to be told when clinical benefit is not expected.

Avoid language suggesting that trial participation is treatment or that the investigational medicinal product is expected to improve the volunteer's health.

Procedures and burden

Describe confinement periods, fasting, dosing, blood draws, ECGs, imaging, sampling, restrictions and follow-up in participant language. If the protocol has intensive sampling or repeated invasive procedures, the practical burden should be easy to understand before consent.

Risks

Explain known and reasonably foreseeable risks, including uncertainty associated with the investigational product. If reproductive restrictions or pregnancy risks are relevant, explain them in the healthy-volunteer context rather than copying patient wording.

Payment and reimbursement

Mandatory. Bulgaria's Part II document list specifically includes financial and other arrangements with principal investigators, healthcare institutions and healthy volunteers. The dossier must describe participant compensation and relevant financial arrangements. The BDA points sponsors to the EudraLex participant-compensation template.

The PIS and ICF should state the payment or reimbursement structure in language that agrees with the Part II financial document. Explain whether payment is linked to completed visits, time, inconvenience or reimbursable expenses. If payment changes after early withdrawal, explain the rule clearly.

Payment should not be presented as a benefit of the investigational product. The consent decision must remain voluntary.

Consent and signature process

Mandatory during trial conduct. Written informed consent is obtained before enrollment. The volunteer and the person conducting the consent interview sign and date the ICF. The volunteer receives a copy of the signed and dated consent and written information.

If the volunteer cannot read or cannot write, do not improvise a signature workaround. Use the Bulgaria impartial witness consent guide.

If the study uses emergency enrollment, it is unlikely to fit the usual healthy-volunteer setting. Any use of the Article 35 emergency exception must be justified by the actual emergency medical condition and protocol, not by operational convenience.

Insurance and injury information

Bulgarian law requires insurance covering sponsor and principal investigator liability for trial-related material and non-material harm. The participant-facing document should explain trial-related injury, compensation or treatment in a way that matches the current insurance and Part II documentation.

Do not insert policy details that may change unless they are needed for the participant. The consent text should remain accurate for the authorised insurance arrangement.

Samples, data and optional future research

Conditional. If healthy volunteers provide samples for storage or future use, state the purpose and storage plan clearly. When future scientific use is optional and outside the main protocol, separate that decision from the main trial consent. The Bulgaria secondary use consent guide explains the optional-consent structure.

Recruitment materials

Conditional. If healthy volunteers are recruited through advertising, the BDA requires copies of the recruitment materials and a description of the response-handling process. Recruitment materials must be in Bulgarian. Keep payment statements, eligibility claims and study-burden wording consistent with the PIS and ICF.

For the complete country guide library, return to the Bulgaria CTIS hub.