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OJ 1999 No. 47 item 480
REGULATION OF THE MINISTER OF HEALTH AND SOCIAL CARE
of May 11, 1999
on the detailed principles of appointing and financing as well as the mode of operation of bioethics committees.
Based on Article. 29 paragraph 6 of the Act of December 5, 1996 on the medical profession (Journal of Laws of 1997 No. 28, item 152 and No.
88, item 554 and from 19998. No. 106, item 668 and No. 162, item 1115) the following shall be ordered:
§ 1
The provisions of the regulation apply to bioethical commissions appointed at the regional medical chamber, higher
medical university or university with a medical faculty, hereinafter referred to as "the university", and at the medical unit
research and development.
§ 2
1. The bioethical commission at the regional medical chamber is appointed by way of a resolution of the regional medical board.
2. The bioethical commission at the university or at the medical research and development unit are appointed by way of an ordinance
internal rector of the university or director of the research and development unit.
§ 3
1. The bioethical commission shall be appointed for a term of office of three years.
2. The members of the bioethics commission are:
1) specialist doctors,
2) one representative per profession, in particular a priest, philosopher, lawyer, pharmacist, nurse,
- who have at least 10 years of work experience in the profession.
3. A person exercising a profession other than the medical profession may not be a member of the bioethics commission if the appointing entity
the commission is its employer.
4. The entity setting up the bioethics commission determines the composition of the commission in the number of members from 11 to 15.
5. The bioethical commission shall elect its chairman from the composition as a doctor and a deputy chairman
non-doctor committee.
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6. The entity setting up the bioethics commission may dismiss a member of the commission before the end of his term at his request or when
he does not participate in the work of the commission.
7. In the event of a decrease in the composition of the bioethics commission, it shall be supplemented during the term of office
committee; the mandate of a new member of the commission shall expire at the end of her term of office.
8. Members of the bioethics commission shall fulfill their duties until a new commission is established.
§ 4.
1. A person or other entity intending to carry out a medical experiment shall submit a request to the bioethical commission for
expressing an opinion on the design of a medical experiment, hereinafter referred to as 'the opinion'.
2. The application referred to in para. 1 should contain:
1) designation of a person or other entity intending to conduct a medical experiment, and in the case of an experiment
multi-center - also the names of all centers in the country where this experiment is to be carried out,
2) the title of the project, its detailed description and justification as to the purposefulness and feasibility of the project,
3) name, address and professional and scientific qualifications of the person in charge of the medical experiment,
4) information on the insurance conditions of persons who are to participate in a medical experiment,
5) data on expected therapeutic and cognitive benefits as well as possible anticipated other benefits for
people who underwent a medical experiment.
3. To the application referred to in par. 1, include:
1) medical experiment design,
2) information intended for persons subjected to a medical experiment, containing detailed data on the purposes and
the principles of conducting a medical experiment, the therapeutic and other benefits expected for these individuals, and
the risk of undergoing an experiment,
3) a template of the patient's consent form subjected to a medical experiment, which should contain at least
statements regarding:
a) voluntarily agreeing to undergo a medical experiment after reading the information in question
in point 2,
b) confirmation of the possibility of asking questions to the person conducting the experiment and receiving answers to these questions,
c) obtain information on the possibility of withdrawing from participation in a medical experiment at any stage,
4) specimen declaration of acceptance of insurance conditions,
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5) a template of the statement made by a person subjected to a medical experiment in which he agrees to
processing of data related to its participation in the experiment by a person or other conducting entity
medical experiment.
4. If a person who cannot give written consent, a minor or is to take part in a medical experiment
completely incapacitated person, specimens of documents referred to in para. 3 points 3-6 should take into account
confirmation of the data resulting from the circumstances specified in art. 25 paragraph 1, 2 and 4 of the Act of December 5, 1996 on
medical profession (Journal of Laws of 1997, No. 28, item 152 and No. 88, item 554 and of 19998, No. 106, item 668 and No. 162, item
1115), hereinafter referred to as the "Act".
§ 5
1. The documents referred to in § 4, hereinafter referred to as "experiment documentation", shall be submitted to:
1) the bioethics commission at the regional medical chamber in which the health care institution, group practice
medical professional or a doctor performing individual medical practice or individual specialist medical practice
intend to perform a medical experiment, subject to points 2 and 3,
2) the bioethics commission at the university, if the project of the medical experiment is submitted by employees or the unit
organizational structure of this university,
3) the bioethical commission at the medical research and development unit, if the design of the medical experiment
are submitted by employees or organizational unit of this research and development unit.
2. If the submitted documentation of the experiment is incomplete, the bioethical commission shall return it to the subject
submitting the request for an opinion, to supplement.
§ 6
1. The chairman of the bioethics commission, having read the documentation of the experiment, shall appoint the members of the commission, or
appoints other experts to prepare a draft opinion.
2. The chairman of the bioethics commission shall submit the draft opinion, for the purpose of familiarization to all committee members together
with information about the date of the committee meeting.
3. The intended entity participates in the meeting of the bioethics commission at which the draft opinion is discussed
conduct a medical experiment to present the project and provide explanations.
4. The bioethical commission may express its position on supplementing the draft medical opinion experiment
additional conditions allowing its carrying out.
5. The bioethical commission shall adopt a resolution expressing its opinion by secret ballot, with the participation in voting over
half of the commission, including its chairman or deputy and at least two non-commission members
doctors.
6. Only votes in favor of voting or rejecting opinions may be cast in the voting.
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7. The resolution of the bioethics commission shall be signed by the members participating in its adoption.
8. The bioethical commission shall express an opinion no later than within 3 months of receipt of the complete documentation
experiment.
9. The opinion expressed by the bioethics committee may include supplementary conditions allowing the conduct
of the reviewed project.
10. Proceedings for expressing opinions are confidential.
§ 7
The chairman of the bioethics commission shall immediately forward a resolution expressing the opinion to the intended entity
Carry out a medical experiment and the head of the healthcare facility where the experiment is to be performed
carried out, and in the case of an opinion on an experiment, multicenter - also to bioethics committees competent
for these centers.
§ 8
1. An appeal against a resolution of a bioethics committee expressing opinions may bring:
1) an entity intending to conduct a medical experiment,
2) head of the healthcare facility where the medical experiment is to be carried out,
3) the bioethical commission competent for the center that is to participate in the multicentre medical experiment.
2. The appeal referred to in para. 1, shall be submitted through the bioethics commission which adopted the resolution to
Appeal Bioethics Committee, referred to in art. 29 paragraph 5 of the Act, within 14 days of receiving the resolution
expressing opinion.
3. The appeal should be considered no later than within two months of the day on which it was lodged.
4. The provisions of § 6 para. 3-5, 7, 8 and 10.
§ 9
The bioethics commission ensures that medical experiment documentation is stored that prevents people from accessing it
other than members of the bioethics commission and experts appointed.
§ 10
1. Funds allocated to finance the activities of the bioethics commission come from fees paid by
entity intending to conduct a medical experiment and cover the costs of the bioethics commission submitting
with:
1) costs of the equivalent of earnings lost by members of the ethics committee due to participation in meetings
committees and other claims under the terms
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specified in provisions on the rules for determining and the amounts due to employees due to travel
business within the country,
2) amounts due for the draft opinion prepared,
3) other costs that the entity establishing the bioethics commission has included in costs directly related to
activities of the bioethics commission.
2. The fees referred to in para. 1, the subject intending to conduct a medical experiment shall be brought to the subject
appointing the bioethics commission at his call before adopting a resolution expressing the opinion.
3. The costs referred to in par. 1 related to the proceedings conducted by the Appeals Bioethics Committee shall be borne
Minister of Health and Social Welfare.
4. The entity setting up the bioethics commission may release the entity intending to conduct a medical experiment with
an obligation to cover all or part of the costs of issuing an opinion on an experiment, provided that funds are provided
financial statements referred to in para. 1.
§ 11
The regulation shall enter into force 14 days after its publication.
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