Bioethics committee

 

The Bioethics Committee at Lazarski University was established by the Order of the Rector of Lazarski University No. 23/2021 dated 7.12.2021, as amended, and operates in accordance with the Regulations.

Composition of the Bioethics Committee

During the three-year term of office lasting from 7.12.2021 to 6.12.2024, the composition of the Bioethics Committee at Lazarski University as amended is as follows:

  • Chairperson: Prof. Anna Wilmowska-Pietruszyńska, M.D., Ph.D. (specialist physician)
  • Deputy Chairperson: Małgorzata Mazur, M.D.
  • Members:
    • Dr. habil. Marek Czarkowski, MD (specialist physician)
    • Dr. Elżbieta Makomaska-Szaroszyk, MD (specialist physician)
    • Dr. habil. Marek Stańczyk, MD (specialist physician)
    • Prof. Dr. habil. Ewelina Zawadzka-Bartczak, MD (specialist physician)
    • Rev. Piotr Woszczyk, MA (clergyman)
    • Dr. Wojciech Lewandowski, PhD (philosopher)
    • Łukasz Jankowski, MA (physician)
    • Monika Nawłoka, MA (pharmacist)
    • Joanna Stefek, MA (nurse)

Secretariat of the Bioethics Committee:

Ewelina Kruczyńska
e-mail: e.kruczynska@lazarski.edu.pl
tel: (+48) 22 54 35 330; (+48) 690 407 387

Accepting applications:
e-mail: komisja.bioetyczna@lazarski.pl

For technical and substantive issues, contact:
e-mail: anna.sulek@lazarski.pl
Tel: (+48 ) 690 407 383

 

Submission of proposals:

Research

Clinical trials

  • Cover Letter,
  • Application form,
  • A copy of the clinical trial protocol approved by the sponsor with any amendments,
  • Summary of the clinical trial protocol,
  • A copy of the investigator's brochure in case the investigational medicinal product is not authorized in the territory of any ICH member state,
  • A power of attorney granted by the sponsor to the submitter to act on behalf of the sponsor with a translation by a sworn translator, if applicable,
  • A copy of the agreement with the person or organizational unit conducting the clinical trial for the contract in case of transfer of some or all of the sponsor's responsibilities or activities, together with a translation prepared by a sworn translator,
  • Formof informed consent of the Participant/Patient for participation in the study,
  • Form of information for the Participant/Patient, prepared in accordance with the guidelines
  • Templateof consent form for processing of personal data of the Participant/Patient of the clinical trial related to his/her participation in the clinical trial,
  • Model clinical observation sheet,
  • Signed curriculum vitae of the investigator with a description of his/her scientific and professional activities,
  • A statement by the sponsor or the organizational unit conducting the clinical trial under contract, or the investigator regarding the rules for recruiting clinical trial participants, if not included in the clinical trial protocol,
  • Statement of the unit where the clinical trial will be conducted agreeing to conduct the trial there,
  • A statement by the investigator regarding the equipment of the clinical trial site to the extent necessary to conduct the clinical trial and information regarding the qualifications of the personnel who will participate in the conduct of the clinical trial,
  • A brief description of the financing of the clinical trial,
  • A copy of a document confirming that the sponsor and investigator have entered into a mandatory liability insurance contract, covering the entire duration of the clinical trial, for damages caused in connection with the conduct of the clinical trial,
  • Information on the amount of compensation or indemnification provided for any injury or death caused by participation in the clinical trial,
  • Information on financial transactions and compensation paid to participants and investigators or research centers where the clinical trial is conducted for participation in the clinical trial,
  • Description of any other agreements between the sponsor and the research center where the clinical trial is conducted,
  • A template of the recruitment notice for Clinical Trial Participants.