Information about the PAM Bioethics Commission
Key information
Below you will find the most important information from the Bioethics Committee of the Poznań Medical University about its principles of operation, submitting applications and meeting dates.
About the Bioethics Commission
General Information
The composition and functioning of the bioethics commission are specified in Article 29 of the Act of 5 December 1996 on the medical and dental professions and in the Regulation of the Minister of Health of 26 January 2023 on the bioethics commission and the Appeal Bioethics Commission.
The Bioethics Committee at the Poznań Academy of Applied Medical Sciences named after Prince Mieszko I was established by Order No. 13/2022/2023 of the Rector of the Academy of Applied Sciences named after Prince Mieszko I in Poznań (currently the Poznań Academy of Applied Medical Sciences named after Prince Mieszko I).
Composition of the Commission
- Prof. Dr. Hab. Krzysztof Szyfter (genetics)
- Rev. Dr. Hab. Mieczysław Michalski (priest)
- Prof. Dr. Hab. n. med. Andrzej Oko (internal medicine, nephrology)
- Prof. Dr. Hab. n. med. Mieczysław Komarnicki (internal medicine, hematology)
- Prof. Dr. Hab. Bolesław Andrzejewski (philosophy)
- Prof. Dr. Hab. n. med. Małgorzata Bruska (pediatric surgery)
- Prof. Dr. Hab. n. med. Maria Borszewska-Kornacka (pediatrics, neonatology)
- Prof. Dr. Hab. n. med. Krzysztof Drews (gynecology and obstetrics)
- Prof. Dr. Hab. Michał Umbreit (Pharmacy)
- Dr. hab. n. med. Michał Gaca (anasthesiology, intensive care)
- Dr. n. med. Jadwiga Wigowska-Sowińska (neurology)
- Alla Rejniak, M.A. (nursing)
- Katarzyna Zych-Wachowiak, M.A., attorney (law)
- Emilia Banaszak, M.A. (administrative support)
- Teresa Dłużewicz (administrative support)
Term of office of the Commission: 1 October 2023 to 30 September 2026.
Tasks of the commission
The purpose of the commission
The bioethics committee is appointed to express an opinion on the design of a medical experiment.
In accordance with the assumptions adopted in the regulation on the bioethics committee and the Appeal Bioethics Committee, an entity intending to conduct a medical experiment submits to the relevant bioethics committee an application for an opinion on the medical experiment project, together with the necessary documents.
Tasks of the commission
- verification of applications in formal terms,
- expressing opinions on medical experiment projects, taking into account ethical criteria and the feasibility and feasibility of the project,
- adopting resolutions,
- keeping records of accepted applications and adopted resolutions,
- periodic review of the implementation of long-term research projects.
Legal regulations
- Act of 5 December 1996 on the professions of physician and dentist,
- Regulation of the Minister of Health of 26 January 2023 on the bioethics committee and the Bioethics Appeal Committee,
- Regulation of the Minister of Finance, Funds and Regional Policy of 30 December 2020 on mandatory civil liability insurance of the entity conducting a medical experiment,
- Act of 13 January 2023 on clinical trials of medicinal products for human use,
- Act of 6 September 2001 – Pharmaceutical Law,
- Regulation of the Minister of Finance of 30 April 2004 on mandatory civil liability insurance for researchers and sponsors (Journal of Laws of 2004, No. 101, item 1034, as amended),
- Regulation of the Minister of Health of 30 April 2004 on the method of conducting clinical trials involving minors,
- Regulation of the Minister of Health of 30 April 2004 on reporting unexpected serious adverse reactions to medicinal products,
- Regulation of the Minister of Health on fees for medical devices of July 26, 2022,
- Act of 7 April 2022 on medical devices (Journal of Laws of 2022, item 974, as amended),
- Regulation of the Minister of Finance of 2 December 2022 on mandatory insurance of the sponsor and researcher in connection with conducting a clinical trial of a device or a performance study of an in vitro diagnostic medical device,
- Act of 18 March 2011 on the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products,
- Regulation of the Minister of Health of 2 May 2012 on Good Clinical Practice,
- Regulation of the Minister of Health of 12 October 2018 on the templates of documents submitted in connection with a clinical trial of a medicinal product and the fees for submitting an application to commence a clinical trial,
- The Declaration of Helsinki of the World Medical Association (WMA) – containing ethical principles for conducting medical research involving human subjects and ICH GCP regulations.
Office tasks
- verification of documentation submitted to the Commission in terms of formal requirements;
- organizing and coordinating the proper conduct of Commission meetings;
- participating in the meetings of the Commission, taking minutes of their proceedings and preparing draft opinions and decisions adopted by the Commission;
- ongoing contact with external applicants for commercial clinical trials;
- cooperation with competence departments and external companies in the financial field;
- cooperation with external institutions in the scope of reviewed projects, including the Bioethics Appeal Committee;
- preparation of civil law contracts for members of the Commission and external reviewers;
- preparation of internal acts regulating the organization and work of the Commission.
Conclusions
Information on submitting an application
The application should be submitted to the Office of the Bioethics Committee in the following version:
- paper – to the address of the Bioethics Commission Office
- electronically – via email
Below you will find required attachments, a list of special requirements, and other information for sponsored and unsponsored medical research studies.
Sponsored experiment
General information
- The documentation must be prepared in Polish.
- The application should be submitted to the Office of the Bioethics Committee in paper or electronic form.
- Application attachments should be prepared using the templates available below.
Application attachments
- Study protocol with reference list (with version number and date).
- Information for the study participant (with version number and date).
- Participant informed consent form (marked with version number and date).
- Personal data processing consent form (marked with version number and date).
- Declaration of acceptance of the terms of third party liability insurance by the participant (marked with version number and date).
- Applicant’s scientific CV (dated and handwritten).
- Consent of the head of the entity in which the medical experiment is planned to be conducted.
- Copy of document confirming insurance for the study.
- Declaration for issuing an accounting note by the Bioethics Committee for issuing an opinion.
- Sample questionnaire/survey for research using them.
Special requirements
- In the case of multi-centre medical experiments, a list of centres in Poland where the study is planned to be conducted should be attached, along with the addresses of the relevant bioethics committees, CVs of the Principal Investigators from the individual centres, declarations signed by the Principal Investigators on the appropriate qualifications of the research team members, the appropriate equipment of the centre enabling the study to be conducted, and the Principal Investigator’s commitment to conduct the study in accordance with the approved protocol and to inform the Study Coordinator (Applicant) of any adverse events and study progress at a given centre,
- Additional requirements apply to research involving minors.
If the situation allows it (e.g. the study does not involve direct participation of participants to whom specific forms would be addressed), a declaration should be submitted that there is no need to attach part of the documentation, i.e. (1) information for the participant, (2) the participant’s informed consent form, and (3) the consent form for the processing of personal data.
Researcher Responsibilities
- Conducting the study in accordance with the opinion obtained from the Bioethics Committee, reporting to the Committee any changes that may affect the course of the study,
- Reporting of adverse events,
- Submission of periodic reports, submission of the final report or information on early termination of the study.
Researcher Downloadable Forms
- Amendment submission – for consideration by the Committee – for the information of the Committee only.
- Interim/final report on the implementation of a medical experiment.
- Reporting an adverse event to the Commission.
Unsponsored experiment
General information
- The documentation must be prepared in Polish.
- The application should be submitted to the Office of the Bioethics Committee in paper or electronic form.
- Application attachments should be prepared using the templates available below.
Application attachments
- Study protocol with reference list (with version number and date).
- Information for the study participant (with version number and date).
- Participant informed consent form (marked with version number and date).
- Personal data processing consent form (marked with version number and date).
- Declaration of acceptance of the terms of third party liability insurance by the participant (marked with version number and date).
- Applicant’s scientific CV (dated and handwritten).
- Consent of the head of the entity in which the medical experiment is planned to be conducted.
- Declaration on the implementation of the project as part of research work.
- Sample questionnaire/survey for research using them.
Special requirements
- in the case of multi-centre medical experiments, a list of centres in Poland where the study is planned to be conducted should be attached, along with the addresses of the relevant bioethics committees, CVs of the Principal Investigators from the individual centres, declarations signed by the Principal Investigators on the appropriate qualifications of the research team members, the appropriate equipment of the centre enabling the study to be conducted, and the Principal Investigator’s commitment to conduct the study in accordance with the approved protocol and to inform the Study Coordinator (Applicant) of any adverse events and study progress at the given centre,
- In the case of research involving minors, additional requirements apply.
If the situation allows it (e.g. the study does not involve direct participation of participants to whom specific forms would be addressed), a declaration should be submitted that there is no need to attach part of the documentation, i.e. (1) information for the participant, (2) the participant’s informed consent form, and (3) the consent form for the processing of personal data.
Researcher Responsibilities
- Conducting the study in accordance with the opinion obtained from the Bioethics Committee, reporting to the Committee any changes that may affect the course of the study,
- Reporting of adverse events,
- Submission of periodic reports, submission of the final report or information on early termination of the study.
Researcher Downloadable Forms
Contact
Office of the Bioethics Committee at the Poznań Academy of Medical Applied Sciences named after Prince Mieszko I
Street. Bułgarska 55
60-320 Poznań, Rector’s Office
rektorat@pam.poznan.pl
61 64 60 267
Office hours:
Tuesday – Saturday
7:30 a.m. – 3:30 p.m.