A bioethics commission is an independent institution that checks that clinical trial projects are conducted with respect for human dignity. Medicinal products, before they reach pharmacies, must undergo numerous tests, including tests involving humans. Ethical committees watch over the protection of people participating in them, as well as care for their welfare, dignity and safety. No clinical trial will begin without their consent.
Contents :
- Bioethics committee: competences
- Bioethics commission: composition
- Bioethics committee: tasks
- Bioethics commission: research requiring an ethical opinion
- Bioethics committee: how does it work?
Bioethics committee: competences
Clinical trials on medicinal products have been conducted in Poland since the early 1990s. Currently, they must be conducted in accordance with the adopted law and ethical standards. To ensure that this process was carried out properly, bioethical committees and the Central Register of Clinical Trials were established - renamed the Office for Registration of Medicinal Products, Medical Devices and Biocidal Materials (URPL).
For research to begin, approval must be given by both the Ethics Committee and the President of the URLP who controls the clinical trials.
In turn, bioethical committees, of which there are over 50 in Poland, check whether a given study is justified, how it will be performed, what its plan is, and analyze whether it is needed, and what benefits and risks it brings. On the basis of the collected data, they give an opinion whether a given study can start and control its course. Bioethics committees operate at universities or medical research institutes and at Medical Chambers.
Bioethics committee: composition
The bioethics committee is composed of 11 to 15 people. Its members may be specialist doctors, in particular psychiatrists and paediatricians, and one representative of another profession (e.g. a clergyman, lawyer, pharmacist, nurse) who have at least 10 years of experience in the profession.
Members of the bioethical commission are appointed by the district medical council in the area of its activity. In the case of a commission operating at a university or medical research institute, it is appointed by the rectoruniversity or director of a research institute. The term of office of the selected commission is three years.
The members of the bioethics committee must be guided in their work primarily by ethical standards and applicable legal regulations. A REC is independent of sponsors, funders, research, and all influences and pressures (e.g., political, institutional, professional, or commercial) and operates transparently. In this way, it can be ensured that the well-being of the research participants is paramount.
Bioethics committee: tasks
The responsibilities of the REC include:
- caring for the well-being, safety and protection of people participating in the medical trial,
- approval and verification of applications, including determining the credibility of the entity conducting clinical trials,
- expressing an opinion on clinical trials that takes into account both the ethics and the purposefulness of the research undertaken,
- adopting resolutions,
- collecting a list of motions and resolutions adopted,
- periodic control of the implementation of research projects,
- receiving information on possible side effects and possibly suspending research if necessary,
- storage of the provided documentation of medical experiments and supplementary materials provided during their implementation,
- cooperation with other ethics committees,
- taking care of the substantive preparation of committee members to give opinions on medical experiment projects.
Bioethics commission: research requiring an ethical opinion
All human research must be assessed by an ethics committee before being recruited for potential participants. This also applies to research carried out using personal data (i.e. medical records) or human tissues and genetic material. Research using human gametes (ie sperm or ova), embryos and fetal tissue also requires prior ethical review. For certain studies, the need to obtain an ethical review may be excluded, for example, if there is no foreseeable risk or discomfort, and the study is likely to inconvenience participants at most. The same also applies to research using existing datasets or registers that only contain data that do not identify individuals (e.g. public registers, archives or publications).
Bioethics committee: how does it work?
Meetings of the bioethical commission are held at least once a month. The commission takesdecisions to proceed with clinical trials in meetings in the presence of a quorum. The opinion is issued within 60 days from the moment of submitting the application together with the documentation. The decision of the bioethics committee may be appealed. This can be done by reporting to the Appeal Bioethics Committee operating at the Ministry of He alth. The Appeals Bioethics Committee examines the appeals within 2 months.
Bioethical commissions in Poland - a historical outlineThe latest report of the Bioethics Committee at the District Medical Chamber in Warsaw for 2015-2022 shows that a total of 182 resolutions were adopted on medical experiment projects, of which 46 positive resolutions were issued conditionally, stipulating the need to introduce significant changes in the manner of implementation of a medical experiment project and / or introducing changes to insurance policies.
(…) In Poland, the discussion on the legitimacy of establishing ethical committees began in the second half of the seventies. The experiences of other countries were mainly used. Professor Kornel Gibiński together with prof. Jan Nielubowicz were the first in 1977 to postulate the creation of a network of ethical committees for research on humans.
At the Medical University of Gdańsk, the Team for Deontological Assessment of Scientific Research was appointed by the Rector, prof. Z. Brzozowski as early as 1979. It was probably the first Polish ethics committee.
In response to the appeal of professors Gibiński and Nielubowicz, the Minister of He alth and Social Welfare published the Order on the Supervision Commission for Human Research 3. The network of committees established at that time initially included only medical academies.
In November 1982. The Ethics Committee for Experimental Clinical Research at the Medical University of Krakow was established, and the first ethical committee to review medical experiments at the Medical University of Silesia was established in 1983. During this period, an ethics committee at the Medical University of Poznań was also established. Later, committees were also established at some departmental institutes and scientific institutes of the Polish Academy of Sciences. These committees collaborated with the Central Commission appointed by the Minister of He alth. The way in which these committees operated, especially in the initial period, was very diverse. The ethics committees were composed almost exclusively of representatives of the medical community (…) ".