79C3C34C52B45572883A05D425EB0F82
Order of the Minister of Health and Social Welfare on How to Establish, Finance, and the Mode of Action of Bioethics Committees
http://prawo.sejm.gov.pl/isap.nsf/download.xsp/WDU19990470480/T/D19990480L.pdf
http://leaux.net/URLS/ConvertAPI Text Files/3141E024F00A9B2FB972257D59F95A05.en.txt
Examining the file media/Synopses/3141E024F00A9B2FB972257D59F95A05.html:
This file was generated: 2020-12-01 07:09:08
| Indicators in focus are typically shown highlighted in yellow; |
Peer Indicators (that share the same Vulnerability association) are shown highlighted in pink; |
"Outside" Indicators (those that do NOT share the same Vulnerability association) are shown highlighted in green; |
Trigger Words/Phrases are shown highlighted in gray. |
Link to Orphaned Trigger Words (Appendix (Indicator List, Indicator Peers, Trigger Words, Type/Vulnerability/Indicator Overlay)
Applicable Type / Vulnerability / Indicator Overlay for this Input
Health / Cognitive Impairment
Searching for indicator cognitive:
(return to top)
p.(None): non-doctor committee.
p.(None): 2005-10-31
p.(None): © Chancellery of the Sejm
p.(None): p. 2/2
p.(None): 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
p.(None): he does not participate in the work of the commission.
p.(None): 7. In the event of a decrease in the composition of the bioethics commission, it shall be supplemented during the term of office
p.(None): committee; the mandate of a new member of the commission shall expire at the end of her term of office.
p.(None): 8. Members of the bioethics commission shall fulfill their duties until a new commission is established.
p.(None): § 4.
p.(None): 1. A person or other entity intending to carry out a medical experiment shall submit a request to the bioethical commission for
p.(None): expressing an opinion on the design of a medical experiment, hereinafter referred to as 'the opinion'.
p.(None): 2. The application referred to in para. 1 should contain:
p.(None): 1) designation of a person or other entity intending to conduct a medical experiment, and in the case of an experiment
p.(None): multi-center - also the names of all centers in the country where this experiment is to be carried out,
p.(None): 2) the title of the project, its detailed description and justification as to the purposefulness and feasibility of the project,
p.(None): 3) name, address and professional and scientific qualifications of the person in charge of the medical experiment,
p.(None): 4) information on the insurance conditions of persons who are to participate in a medical experiment,
p.(None): 5) data on expected therapeutic and cognitive benefits as well as possible anticipated other benefits for
p.(None): people who underwent a medical experiment.
p.(None): 3. To the application referred to in par. 1, include:
p.(None): 1) medical experiment design,
p.(None): 2) information intended for persons subjected to a medical experiment, containing detailed data on the purposes and
p.(None): the principles of conducting a medical experiment, the therapeutic and other benefits expected for these individuals, and
p.(None): the risk of undergoing an experiment,
p.(None): 3) a template of the patient's consent form subjected to a medical experiment, which should contain at least
p.(None): statements regarding:
p.(None): a) voluntarily agreeing to undergo a medical experiment after reading the information in question
p.(None): in point 2,
p.(None): b) confirmation of the possibility of asking questions to the person conducting the experiment and receiving answers to these questions,
p.(None): c) obtain information on the possibility of withdrawing from participation in a medical experiment at any stage,
p.(None): 4) specimen declaration of acceptance of insurance conditions,
p.(None): 2005-10-31
p.(None): © Chancellery of the Sejm
p.(None): p. 3/3
p.(None): 5) a template of the statement made by a person subjected to a medical experiment in which he agrees to
p.(None): processing of data related to its participation in the experiment by a person or other conducting entity
p.(None): medical experiment.
p.(None): 4. If a person who cannot give written consent, a minor or is to take part in a medical experiment
...
Social / Access to Social Goods
Searching for indicator socialXwelfare:
(return to top)
p.(None): 4. The provisions of § 6 para. 3-5, 7, 8 and 10.
p.(None): § 9
p.(None): The bioethics commission ensures that medical experiment documentation is stored that prevents people from accessing it
p.(None): other than members of the bioethics commission and experts appointed.
p.(None): § 10
p.(None): 1. Funds allocated to finance the activities of the bioethics commission come from fees paid by
p.(None): entity intending to conduct a medical experiment and cover the costs of the bioethics commission submitting
p.(None): with:
p.(None): 1) costs of the equivalent of earnings lost by members of the ethics committee due to participation in meetings
p.(None): committees and other claims under the terms
p.(None): 2005-10-31
p.(None): © Chancellery of the Sejm
p.(None): p. 5/5
p.(None): specified in provisions on the rules for determining and the amounts due to employees due to travel
p.(None): business within the country,
p.(None): 2) amounts due for the draft opinion prepared,
p.(None): 3) other costs that the entity establishing the bioethics commission has included in costs directly related to
p.(None): activities of the bioethics commission.
p.(None): 2. The fees referred to in para. 1, the subject intending to conduct a medical experiment shall be brought to the subject
p.(None): appointing the bioethics commission at his call before adopting a resolution expressing the opinion.
p.(None): 3. The costs referred to in par. 1 related to the proceedings conducted by the Appeals Bioethics Committee shall be borne
p.(None): Minister of Health and Social Welfare.
p.(None): 4. The entity setting up the bioethics commission may release the entity intending to conduct a medical experiment with
p.(None): an obligation to cover all or part of the costs of issuing an opinion on an experiment, provided that funds are provided
p.(None): financial statements referred to in para. 1.
p.(None): § 11
p.(None): The regulation shall enter into force 14 days after its publication.
...
Social / Youth/Minors
Searching for indicator minor:
(return to top)
p.(None): 5) data on expected therapeutic and cognitive benefits as well as possible anticipated other benefits for
p.(None): people who underwent a medical experiment.
p.(None): 3. To the application referred to in par. 1, include:
p.(None): 1) medical experiment design,
p.(None): 2) information intended for persons subjected to a medical experiment, containing detailed data on the purposes and
p.(None): the principles of conducting a medical experiment, the therapeutic and other benefits expected for these individuals, and
p.(None): the risk of undergoing an experiment,
p.(None): 3) a template of the patient's consent form subjected to a medical experiment, which should contain at least
p.(None): statements regarding:
p.(None): a) voluntarily agreeing to undergo a medical experiment after reading the information in question
p.(None): in point 2,
p.(None): b) confirmation of the possibility of asking questions to the person conducting the experiment and receiving answers to these questions,
p.(None): c) obtain information on the possibility of withdrawing from participation in a medical experiment at any stage,
p.(None): 4) specimen declaration of acceptance of insurance conditions,
p.(None): 2005-10-31
p.(None): © Chancellery of the Sejm
p.(None): p. 3/3
p.(None): 5) a template of the statement made by a person subjected to a medical experiment in which he agrees to
p.(None): processing of data related to its participation in the experiment by a person or other conducting entity
p.(None): medical experiment.
p.(None): 4. If a person who cannot give written consent, a minor or is to take part in a medical experiment
p.(None): completely incapacitated person, specimens of documents referred to in para. 3 points 3-6 should take into account
p.(None): 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
p.(None): 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
p.(None): 1115), hereinafter referred to as the "Act".
p.(None): § 5
p.(None): 1. The documents referred to in § 4, hereinafter referred to as "experiment documentation", shall be submitted to:
p.(None): 1) the bioethics commission at the regional medical chamber in which the health care institution, group practice
p.(None): medical professional or a doctor performing individual medical practice or individual specialist medical practice
p.(None): intend to perform a medical experiment, subject to points 2 and 3,
p.(None): 2) the bioethics commission at the university, if the project of the medical experiment is submitted by employees or the unit
p.(None): organizational structure of this university,
p.(None): 3) the bioethical commission at the medical research and development unit, if the design of the medical experiment
p.(None): are submitted by employees or organizational unit of this research and development unit.
p.(None): 2. If the submitted documentation of the experiment is incomplete, the bioethical commission shall return it to the subject
p.(None): submitting the request for an opinion, to supplement.
p.(None): § 6
...
Social / employees
Searching for indicator employees:
(return to top)
p.(None): c) obtain information on the possibility of withdrawing from participation in a medical experiment at any stage,
p.(None): 4) specimen declaration of acceptance of insurance conditions,
p.(None): 2005-10-31
p.(None): © Chancellery of the Sejm
p.(None): p. 3/3
p.(None): 5) a template of the statement made by a person subjected to a medical experiment in which he agrees to
p.(None): processing of data related to its participation in the experiment by a person or other conducting entity
p.(None): medical experiment.
p.(None): 4. If a person who cannot give written consent, a minor or is to take part in a medical experiment
p.(None): completely incapacitated person, specimens of documents referred to in para. 3 points 3-6 should take into account
p.(None): 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
p.(None): 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
p.(None): 1115), hereinafter referred to as the "Act".
p.(None): § 5
p.(None): 1. The documents referred to in § 4, hereinafter referred to as "experiment documentation", shall be submitted to:
p.(None): 1) the bioethics commission at the regional medical chamber in which the health care institution, group practice
p.(None): medical professional or a doctor performing individual medical practice or individual specialist medical practice
p.(None): intend to perform a medical experiment, subject to points 2 and 3,
p.(None): 2) the bioethics commission at the university, if the project of the medical experiment is submitted by employees or the unit
p.(None): organizational structure of this university,
p.(None): 3) the bioethical commission at the medical research and development unit, if the design of the medical experiment
p.(None): are submitted by employees or organizational unit of this research and development unit.
p.(None): 2. If the submitted documentation of the experiment is incomplete, the bioethical commission shall return it to the subject
p.(None): submitting the request for an opinion, to supplement.
p.(None): § 6
p.(None): 1. The chairman of the bioethics commission, having read the documentation of the experiment, shall appoint the members of the commission, or
p.(None): appoints other experts to prepare a draft opinion.
p.(None): 2. The chairman of the bioethics commission shall submit the draft opinion, for the purpose of familiarization to all committee members together
p.(None): with information about the date of the committee meeting.
p.(None): 3. The intended entity participates in the meeting of the bioethics commission at which the draft opinion is discussed
p.(None): conduct a medical experiment to present the project and provide explanations.
p.(None): 4. The bioethical commission may express its position on supplementing the draft medical opinion experiment
p.(None): additional conditions allowing its carrying out.
p.(None): 5. The bioethical commission shall adopt a resolution expressing its opinion by secret ballot, with the participation in voting over
p.(None): half of the commission, including its chairman or deputy and at least two non-commission members
p.(None): doctors.
p.(None): 6. Only votes in favor of voting or rejecting opinions may be cast in the voting.
p.(None): 2005-10-31
p.(None): © Chancellery of the Sejm
p.(None): p. 4/4
...
p.(None): for these centers.
p.(None): § 8
p.(None): 1. An appeal against a resolution of a bioethics committee expressing opinions may bring:
p.(None): 1) an entity intending to conduct a medical experiment,
p.(None): 2) head of the healthcare facility where the medical experiment is to be carried out,
p.(None): 3) the bioethical commission competent for the center that is to participate in the multicentre medical experiment.
p.(None): 2. The appeal referred to in para. 1, shall be submitted through the bioethics commission which adopted the resolution to
p.(None): Appeal Bioethics Committee, referred to in art. 29 paragraph 5 of the Act, within 14 days of receiving the resolution
p.(None): expressing opinion.
p.(None): 3. The appeal should be considered no later than within two months of the day on which it was lodged.
p.(None): 4. The provisions of § 6 para. 3-5, 7, 8 and 10.
p.(None): § 9
p.(None): The bioethics commission ensures that medical experiment documentation is stored that prevents people from accessing it
p.(None): other than members of the bioethics commission and experts appointed.
p.(None): § 10
p.(None): 1. Funds allocated to finance the activities of the bioethics commission come from fees paid by
p.(None): entity intending to conduct a medical experiment and cover the costs of the bioethics commission submitting
p.(None): with:
p.(None): 1) costs of the equivalent of earnings lost by members of the ethics committee due to participation in meetings
p.(None): committees and other claims under the terms
p.(None): 2005-10-31
p.(None): © Chancellery of the Sejm
p.(None): p. 5/5
p.(None): specified in provisions on the rules for determining and the amounts due to employees due to travel
p.(None): business within the country,
p.(None): 2) amounts due for the draft opinion prepared,
p.(None): 3) other costs that the entity establishing the bioethics commission has included in costs directly related to
p.(None): activities of the bioethics commission.
p.(None): 2. The fees referred to in para. 1, the subject intending to conduct a medical experiment shall be brought to the subject
p.(None): appointing the bioethics commission at his call before adopting a resolution expressing the opinion.
p.(None): 3. The costs referred to in par. 1 related to the proceedings conducted by the Appeals Bioethics Committee shall be borne
p.(None): Minister of Health and Social Welfare.
p.(None): 4. The entity setting up the bioethics commission may release the entity intending to conduct a medical experiment with
p.(None): an obligation to cover all or part of the costs of issuing an opinion on an experiment, provided that funds are provided
p.(None): financial statements referred to in para. 1.
p.(None): § 11
p.(None): The regulation shall enter into force 14 days after its publication.
...
Social / philosophical differences/differences of opinion
Searching for indicator opinion:
(return to top)
p.(None): internal rector of the university or director of the research and development unit.
p.(None): § 3
p.(None): 1. The bioethical commission shall be appointed for a term of office of three years.
p.(None): 2. The members of the bioethics commission are:
p.(None): 1) specialist doctors,
p.(None): 2) one representative per profession, in particular a priest, philosopher, lawyer, pharmacist, nurse,
p.(None): - who have at least 10 years of work experience in the profession.
p.(None): 3. A person exercising a profession other than the medical profession may not be a member of the bioethics commission if the appointing entity
p.(None): the commission is its employer.
p.(None): 4. The entity setting up the bioethics commission determines the composition of the commission in the number of members from 11 to 15.
p.(None): 5. The bioethical commission shall elect its chairman from the composition as a doctor and a deputy chairman
p.(None): non-doctor committee.
p.(None): 2005-10-31
p.(None): © Chancellery of the Sejm
p.(None): p. 2/2
p.(None): 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
p.(None): he does not participate in the work of the commission.
p.(None): 7. In the event of a decrease in the composition of the bioethics commission, it shall be supplemented during the term of office
p.(None): committee; the mandate of a new member of the commission shall expire at the end of her term of office.
p.(None): 8. Members of the bioethics commission shall fulfill their duties until a new commission is established.
p.(None): § 4.
p.(None): 1. A person or other entity intending to carry out a medical experiment shall submit a request to the bioethical commission for
p.(None): expressing an opinion on the design of a medical experiment, hereinafter referred to as 'the opinion'.
p.(None): 2. The application referred to in para. 1 should contain:
p.(None): 1) designation of a person or other entity intending to conduct a medical experiment, and in the case of an experiment
p.(None): multi-center - also the names of all centers in the country where this experiment is to be carried out,
p.(None): 2) the title of the project, its detailed description and justification as to the purposefulness and feasibility of the project,
p.(None): 3) name, address and professional and scientific qualifications of the person in charge of the medical experiment,
p.(None): 4) information on the insurance conditions of persons who are to participate in a medical experiment,
p.(None): 5) data on expected therapeutic and cognitive benefits as well as possible anticipated other benefits for
p.(None): people who underwent a medical experiment.
p.(None): 3. To the application referred to in par. 1, include:
p.(None): 1) medical experiment design,
p.(None): 2) information intended for persons subjected to a medical experiment, containing detailed data on the purposes and
p.(None): the principles of conducting a medical experiment, the therapeutic and other benefits expected for these individuals, and
p.(None): the risk of undergoing an experiment,
p.(None): 3) a template of the patient's consent form subjected to a medical experiment, which should contain at least
p.(None): statements regarding:
p.(None): a) voluntarily agreeing to undergo a medical experiment after reading the information in question
p.(None): in point 2,
p.(None): b) confirmation of the possibility of asking questions to the person conducting the experiment and receiving answers to these questions,
...
p.(None): completely incapacitated person, specimens of documents referred to in para. 3 points 3-6 should take into account
p.(None): 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
p.(None): 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
p.(None): 1115), hereinafter referred to as the "Act".
p.(None): § 5
p.(None): 1. The documents referred to in § 4, hereinafter referred to as "experiment documentation", shall be submitted to:
p.(None): 1) the bioethics commission at the regional medical chamber in which the health care institution, group practice
p.(None): medical professional or a doctor performing individual medical practice or individual specialist medical practice
p.(None): intend to perform a medical experiment, subject to points 2 and 3,
p.(None): 2) the bioethics commission at the university, if the project of the medical experiment is submitted by employees or the unit
p.(None): organizational structure of this university,
p.(None): 3) the bioethical commission at the medical research and development unit, if the design of the medical experiment
p.(None): are submitted by employees or organizational unit of this research and development unit.
p.(None): 2. If the submitted documentation of the experiment is incomplete, the bioethical commission shall return it to the subject
p.(None): submitting the request for an opinion, to supplement.
p.(None): § 6
p.(None): 1. The chairman of the bioethics commission, having read the documentation of the experiment, shall appoint the members of the commission, or
p.(None): appoints other experts to prepare a draft opinion.
p.(None): 2. The chairman of the bioethics commission shall submit the draft opinion, for the purpose of familiarization to all committee members together
p.(None): with information about the date of the committee meeting.
p.(None): 3. The intended entity participates in the meeting of the bioethics commission at which the draft opinion is discussed
p.(None): conduct a medical experiment to present the project and provide explanations.
p.(None): 4. The bioethical commission may express its position on supplementing the draft medical opinion experiment
p.(None): additional conditions allowing its carrying out.
p.(None): 5. The bioethical commission shall adopt a resolution expressing its opinion by secret ballot, with the participation in voting over
p.(None): half of the commission, including its chairman or deputy and at least two non-commission members
p.(None): doctors.
p.(None): 6. Only votes in favor of voting or rejecting opinions may be cast in the voting.
p.(None): 2005-10-31
p.(None): © Chancellery of the Sejm
p.(None): p. 4/4
p.(None): 7. The resolution of the bioethics commission shall be signed by the members participating in its adoption.
p.(None): 8. The bioethical commission shall express an opinion no later than within 3 months of receipt of the complete documentation
p.(None): experiment.
p.(None): 9. The opinion expressed by the bioethics committee may include supplementary conditions allowing the conduct
p.(None): of the reviewed project.
p.(None): 10. Proceedings for expressing opinions are confidential.
p.(None): § 7
p.(None): The chairman of the bioethics commission shall immediately forward a resolution expressing the opinion to the intended entity
p.(None): Carry out a medical experiment and the head of the healthcare facility where the experiment is to be performed
p.(None): carried out, and in the case of an opinion on an experiment, multicenter - also to bioethics committees competent
p.(None): for these centers.
p.(None): § 8
p.(None): 1. An appeal against a resolution of a bioethics committee expressing opinions may bring:
p.(None): 1) an entity intending to conduct a medical experiment,
p.(None): 2) head of the healthcare facility where the medical experiment is to be carried out,
p.(None): 3) the bioethical commission competent for the center that is to participate in the multicentre medical experiment.
p.(None): 2. The appeal referred to in para. 1, shall be submitted through the bioethics commission which adopted the resolution to
...
...
General/Other / Incapacitated
Searching for indicator incapacitated:
(return to top)
p.(None): people who underwent a medical experiment.
p.(None): 3. To the application referred to in par. 1, include:
p.(None): 1) medical experiment design,
p.(None): 2) information intended for persons subjected to a medical experiment, containing detailed data on the purposes and
p.(None): the principles of conducting a medical experiment, the therapeutic and other benefits expected for these individuals, and
p.(None): the risk of undergoing an experiment,
p.(None): 3) a template of the patient's consent form subjected to a medical experiment, which should contain at least
p.(None): statements regarding:
p.(None): a) voluntarily agreeing to undergo a medical experiment after reading the information in question
p.(None): in point 2,
p.(None): b) confirmation of the possibility of asking questions to the person conducting the experiment and receiving answers to these questions,
p.(None): c) obtain information on the possibility of withdrawing from participation in a medical experiment at any stage,
p.(None): 4) specimen declaration of acceptance of insurance conditions,
p.(None): 2005-10-31
p.(None): © Chancellery of the Sejm
p.(None): p. 3/3
p.(None): 5) a template of the statement made by a person subjected to a medical experiment in which he agrees to
p.(None): processing of data related to its participation in the experiment by a person or other conducting entity
p.(None): medical experiment.
p.(None): 4. If a person who cannot give written consent, a minor or is to take part in a medical experiment
p.(None): completely incapacitated person, specimens of documents referred to in para. 3 points 3-6 should take into account
p.(None): 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
p.(None): 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
p.(None): 1115), hereinafter referred to as the "Act".
p.(None): § 5
p.(None): 1. The documents referred to in § 4, hereinafter referred to as "experiment documentation", shall be submitted to:
p.(None): 1) the bioethics commission at the regional medical chamber in which the health care institution, group practice
p.(None): medical professional or a doctor performing individual medical practice or individual specialist medical practice
p.(None): intend to perform a medical experiment, subject to points 2 and 3,
p.(None): 2) the bioethics commission at the university, if the project of the medical experiment is submitted by employees or the unit
p.(None): organizational structure of this university,
p.(None): 3) the bioethical commission at the medical research and development unit, if the design of the medical experiment
p.(None): are submitted by employees or organizational unit of this research and development unit.
p.(None): 2. If the submitted documentation of the experiment is incomplete, the bioethical commission shall return it to the subject
p.(None): submitting the request for an opinion, to supplement.
p.(None): § 6
p.(None): 1. The chairman of the bioethics commission, having read the documentation of the experiment, shall appoint the members of the commission, or
...
Orphaned Trigger Words
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| cognitive | Cognitive Impairment |
| employees | employees |
| incapacitated | Incapacitated |
| minor | Youth/Minors |
| opinion | philosophical differences/differences of opinion |
| socialXwelfare | Access to Social Goods |
Indicator Peers (Indicators in Same Vulnerability)
Trigger Words
consent
ethics
risk
Applicable Type / Vulnerability / Indicator Overlay for this Input