Slovenia CTIS Healthy Volunteer Consent Requirements

When the healthy-volunteer variation is needed

Mandatory when applicable. Use an adapted document set when the protocol recruits healthy volunteers, including first-in-human, pharmacokinetic, bioavailability, bioequivalence, food-effect, drug-interaction, or other non-therapeutic cohorts.

Do not reuse patient language that suggests treatment or disease benefit. If a protocol contains both patients and healthy volunteers, prepare separate or clearly population-specific documents so each group receives an accurate explanation.

Required healthy-volunteer documents

• A Slovenian healthy-volunteer Patient Information Sheet and Informed Consent Form.
• Slovenian recruitment advertisements and screening invitations.
• Any Slovenian screening consent if invasive procedures or identifiable health-data collection begins before main consent.
• Slovenian instructions for confinement, fasting, diet, activity, medicines, alcohol, nicotine, contraception, donation restrictions, driving, or follow-up.
• A separate optional consent when future data or sample use is not required for the trial.
• Pregnancy-risk or partner information when the investigational product creates reproductive or teratogenic risk.

Submit clean, blank, versioned forms. Future participants and investigators do not sign them at CTIS submission.

Differences from the standard patient PIS and ICF

No therapeutic benefit

State plainly that the person is healthy for the trial's purpose and is not receiving treatment for an illness. Explain that direct medical benefit is not expected unless the protocol supports a narrow, accurate statement. Screening tests may identify a finding, but that possibility is not a promised benefit.

First exposure and uncertainty

For first-in-human or limited-experience products, explain the degree of uncertainty, the basis for the starting dose, sentinel dosing where used, dose escalation, stopping rules, monitoring, and emergency arrangements. Avoid implying that preclinical or previous human data eliminate unknown risk.

Procedures and restrictions

Describe screening, cannulation, blood volumes, biopsies, lumbar puncture, imaging, drug administration, confinement, overnight stays, repeated dosing, washout, follow-up, and restrictions in practical terms. State the total expected time and which activities can be uncomfortable or burdensome.

Payment and expense reimbursement

Separate reimbursement of expenses from compensation for time, inconvenience, and burden. State the amount, calculation, schedule, tax or payment conditions where relevant, and treatment after screen failure or early withdrawal.

KME RS guidance supports reimbursement of direct participation-related costs and states that payment must not induce participation. Avoid large completion bonuses or wording that makes the person feel financially unable to withdraw. The institution conducting the research should manage the participant compensation agreement under the published national guidance.

Reproductive and donation restrictions

Explain contraception, pregnancy testing, sperm or egg donation restrictions, breastfeeding restrictions, and the duration of each requirement. Where teratogenic risk exists, KME RS guidance calls for written pregnancy and fetal-risk information, contraception instructions, and a signed acknowledgment. The same warning should be provided to healthy female partners of male participants when relevant. Use the Slovenia pregnancy follow-up guide for pregnancy reporting and partner follow-up.

Incidental findings and medical care

Explain how clinically relevant screening or research findings will be handled, who decides whether they are disclosed, and what follow-up the trial will or will not provide. State how trial-related injury is managed and how ordinary medical care remains separate.

Recruitment and screening QC

Recruitment claims must match the approved PIS and financial document. Do not describe the trial as a job, guaranteed income, free health check, or risk-free opportunity. State the main participation burden and payment without making payment the dominant message.

If screening involves only a brief eligibility contact, explain what data are collected and retained. If screening includes blood draws, imaging, genetic testing, washout, or other material procedures, obtain the consent approved for those procedures before they occur.

Screening failures should receive the information promised about results, reimbursement, sample handling, and data retention. The right to withdraw should remain clear throughout screening, confinement, dosing, and follow-up.

Consent and signature process

The person conducting the interview must give the volunteer enough time to decide and check understanding. The volunteer and interviewer sign and date the approved consent record when consent is obtained. KME RS guidance asks for two signed copies, one for the volunteer and one for the research archive.

If the person can consent but cannot write, apply the approved Slovenia impartial witness procedure. Healthy status does not reduce the consent standard and does not justify emergency or legal-representative enrollment.

No separate national healthy-volunteer template

No current Slovenia-specific CTIS healthy-volunteer consent template was identified on the JAZMP or KME RS pages. Use the main CTR and KME RS consent expectations, adapted to the healthy-volunteer protocol. The KME RS generic consent form is a reference only and does not replace a full trial-specific PIS and ICF.

Return to the Slovenia CTIS hub for the document checklist and all consent variations.