9. Subject Considerations

9.1 Clinical trial subject recruitment: Are digital advertisements (including social media streams such as TikTok) allowed and, if so, what regulations govern them?

While the existing Polish regulations are silent on this matter, in recent years, Poland has seen a significant shift towards recruiting patients online, as well as through dedicated websites run by public institutions or private companies. Social media are becoming another important source of recruiting patients for trials, but these recruitment tools do not work in all centers (success depends largely on the type of trial).

The Medical Research Agency has published a training on “promotional activities and recruitment of patients in a clinical trial.” which provides additional tips on digital advertisement.

9.2 Vulnerable Subjects

It is not explicit within the Act of March 2023, however, the Medical and Dental Profession Act of 1996 refers to “minor patient, incapacitated patient or incapable of giving written informed consent”. 

Recital 15 of the EU CTR 536/2014 appears to make a positive case for including vulnerable groups in clinical trials:

“In order to improve treatments available for vulnerable groups such as frail or older people, people suffering from multiple chronic conditions, and people affected by mental health disorders, medicinal products which are likely to be of significant clinical value should be fully and appropriately studied for their effects in these specific groups, including as regards requirements related to their specific characteristics and the protection of the health and well-being of subjects belonging to these groups”.

The EU CTR 536/2014 further states that in Article 10:

1. "Where the subjects are minors, specific consideration shall be given to the assessment of the application for authorization of a clinical trial on the basis of pediatric expertise or after taking advice on clinical, ethical, and psychosocial problems in the field of pediatrics.
2. Where the subjects are incapacitated subjects, specific consideration shall be given to the assessment of the application for authorization of a clinical trial on the basis of expertise in the relevant disease and the patient population concerned or after taking advice on clinical, ethical, and psychosocial questions in the field of the relevant disease and the patient population concerned.
3. Where the subjects are pregnant or breastfeeding women, specific consideration shall be given to the assessment of the application for authorization of a clinical trial on the basis of expertise in the relevant condition and the population represented by the subject concerned.
4. If according to the protocol a clinical trial provides for the participation of specific groups or subgroups of subjects, where appropriate, specific consideration shall be given to the assessment of the application for authorization of that clinical trial on the basis of expertise in the population represented by the subjects concerned.
5. In any application for authorization of a clinical trial referred to in Article 35, specific consideration shall be given to the circumstances of the conduct of the clinical trial."

9.3 Pediatrics (including whether consent from a single parent is sufficient vs. requiring both parents to sign)

Based on Art 25 of the Medical and Dental Professions Act of 1996, both parents are required to sign consent.

Note that the Medical Research Agency has published a template of an ICF for minors (12-16 years), which includes the following clarification: “*The consent form for a minor participant does not replace the consent form signed by the child's parents or guardians. The consent of a minor participant is given in addition to the consent of parents/guardians and signals the child's willingness to cooperate in the study.”

9.4 Financial Disclosures

The EU CTR 536/2014 requires the following information to be submitted at the time of submission of the dossier. Please see - Annex I. P of EU CTR 536/2014: 

“69. A brief description of the financing of the clinical trial.

70. Information on financial transactions and compensation paid to subjects and investigator/site for participating in the clinical trial shall be submitted.

71. Description of any other agreement between the sponsor and the site shall be submitted.”

In addition, the European Federation of Pharmaceutical Industry Associations (EFPIA) Code provides for disclosures in relation to clinical studies, as follows (see Annex B on page 37 of the Code), in accordance with clauses 22 & 23.

Clause 23 provides that “Research and Development ToVs in each Reporting Period must be disclosed by each Member Company on an aggregate basis. Costs related to Events that are clearly related to activities covered in this section can be included in the aggregate amount under the “Research and Development Transfers of Value” category”.

Research and Development ToVs are defined in Section 15.01 of the HCP Code as: “Transfers of Value to HCPs or HCOs related to the planning or conduct of (i) non-clinical studies (as defined in OECD Principles on Good Laboratory Practice); (ii) clinical trials (as defined in Regulation 536/2014); or (iii) NIS that are prospective in nature and that involve the collection of patient data from or on behalf of individual, or groups of, HCPs specifically for the study”.

The Polish pharmaceutical trade association, Infarma, is a member of EFPIA, so the EFPIA code applies in Poland.

9.5 ICF translations – Are Certificates Required? 

The national law is silent on whether or not a translation certification is required. Under normal practice, Certificates of Translations (CoTs) are not required to be submitted. However, relevant CoTs should be filed within the Trial Master File.

9.6 Subject Compensation: Is there a need for a local sponsor to be listed on the insurance certificate, the insurance certificate to cover the duration of the study, and specific minimum amounts of coverage to be specified, both for individual events occurring and in aggregate?

Yes – see the Act of March 2023 which provides that:

“Art 39 

(1) “The conduct of a clinical trial shall not relieve the investigator and sponsor from civil liability arising from the conduct of the clinical trial.

(2) The sponsor and the investigator shall bear civil liability for causing damage to a clinical trial subject resulting from their acts or omissions.”

Art40 

(1) “The sponsor and the investigator by virtue of conducting a clinical trial shall be subject to compulsory liability insurance for damages caused in connection with the conduct of the clinical trial.

(2) In the case of a low-intervention clinical trial within the meaning of Article 2 (2) (3) of Regulation 536/2014, the sponsor shall not be required to take out liability insurance for damages caused in connection with the conduct of the clinical trial.

(3) The sponsor shall attach to the application for a clinical trial permit proof of insurance confirming the conclusion of the liability insurance contract referred to in paragraph (1) and payment of the deposit referred to in Article 42 (1).

(4) The civil liability insurance referred to in paragraph (1) shall cover the civil liability of the investigator and the sponsor for damage consisting in bodily injury, disorder of health, or death of the clinical trial participant, during the period of insurance coverage, caused in connection with the conduct of the clinical trial.

(5) The liability insurance referred to in paragraph (1) shall not cover damages:

1) consisting of damage, destruction, or loss of property;      

2) resulting from the development of addiction in a clinical trial participant, if the possibility of development of addiction was presented in writing to the clinical trial participant at the start of the clinical trial;

3) directly or indirectly caused by or related to asbestos;

4) involving an obligation to pay contractual penalties;

5) arising from acts of war, martial law, riot, and civil commotion, as well as acts of terror.

(6) The liability insurance referred to in paragraph (1) shall cover all damages within the scope referred to in paragraph (4), subject to paragraph (5), without the possibility of contractual limitation by the insurance company of the payment of damages.

(7) The obligation of liability insurance referred to in paragraph (1) shall arise no later than the date of submission of the application for a clinical trial permit.

(8) The minimum guarantee amount of the liability insurance referred to in paragraph 1 with respect to one event and all events, the consequences of which are covered by the contract of liability insurance for damage caused in connection with the conduct of a clinical trial, depends on the number of participants in the clinical trial and is equivalent in zlotys to:

1) up to 50 people - 2,000,000 euros [approx. USD 2,173,700 at current rates];

2) above 50 persons - 5,000,000 euros [approx. USD 5,434,250 at current rates].

(9) The minimum guarantee amount referred to in paragraph (8) is determined jointly with respect to the sponsor and all investigators participating in the clinical trial in question.

(10) The amounts referred to in paragraph 8, shall be calculated using the average euro exchange rate announced by the National Bank of Poland, for the first time in the year in which the insurance contract was concluded as referred in paragraph 1.”

An element of the compensation system in force in Poland is the Clinical Trials Compensation Fund, operating at the Ombudsman for Patients' Rights. This means that to give informed consent to participate in a clinical trial, the trial participant must be informed in advance of the right to benefit from financial support from the Compensation Fund (as well as of the mandatory civil liability insurance of the sponsor and the investigator for damage caused in connection with the conduct of the trial).

The Ombudsman for Patients' Rights has prepared a proposed wording of information on the Clinical Trials Compensation Fund. We recommend that you include the proposed clause as part of the information provided to participants before they decide to participate in the study, accompanying the informed consent form.