79C3C34C52B45572883A05D425EB0F82
Decree 23/2002 (V. 9.) of the Minister of Health on Biomedical Research on Human Beings
https://leaux.net/URLS/General/Hungary_2002_Decree_232002_V._9._of_the_Minister_of_Health_on_Biomedical_Research_on_Human_Beings.pdf
http://leaux.net/URLS/ConvertAPI Text Files/8D45A1736EA0B0444D9AA3275375BEC8.en.txt
Examining the file media/Synopses/8D45A1736EA0B0444D9AA3275375BEC8.html:
This file was generated: 2020-12-01 05:54:48
| 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
Political / Illegal Activity
Searching for indicator unlawful:
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p.000000: aa) *
p.000000: a 235/2009. (X. 20.) Government Decree § 17 (1) (b) (ba)
p.000000: HUF 370,000 in case of approval, HUF 80,000 in case of substantial modification;
p.000000: (ab) Regulation (EC) No 235/2009. (X. 20.) in the examination pursuant to Section 17 (1) (b) (bb) of the Government Decree
p.000000: HUF 200,000 in case of authorization, HUF 80,000 in case of amendment;
p.000000: b) *
p.000000: a 235/2009. (X. 20.) of the Government
p.000000: in the case of the authorization of a non - interventional study and the authorization of a substantial modification of the study plan
p.000000: 000 HUF;
p.000000: c) *
p.000000: in cases not falling under a) -b) HUF 294,000.
p.000000: (4) The fee shall be paid by the applicant in Annex 3 upon submission of the application
p.000000: to the indicated account by postal payment or transfer, or to the cashier of the bank account holder's institution
p.000000: pay.
p.000000: (5) *
p.000000: The fee is the revenue of the licensing authority providing the administrative service. THE
p.000000: 46% of the fee included in paragraph 3 (a) (aa) is OGYÉI, 54% is ETT TUKEB. THE 3)
p.000000: and a substantial modification of the test plan
p.000000: 80% of the fee paid for the licensing is ETT TUKEB, 20% is OGYÉI. Paragraph 3 (a) (aa)
p.000000: The fee for the modification referred to in point (a) shall be shared equally between the licensing authorities acting.
p.000000: The fee paid in appeal proceedings shall be reimbursed to the applicant if:
p.000000: the revised decision or measure to the detriment of the client has been found to be in breach of the law in whole or in part.
p.000000: (7) If, in appeal proceedings, the body acting at second instance is a body which has acted at first instance in whole or in part,
p.000000: unlawful decision
p.000000: (a) annul it at first instance without carrying out any special inquiries necessary to supplement the facts
p.000000: instructs the competent body to conduct a new procedure, it shall be obliged to pay the new procedure without paying a separate fee
p.000000: carried out;
p.000000: (b) by carrying out any special inquiries necessary to supplement the facts
p.000000: (ba) annul and instruct the body at first instance to conduct a new procedure,
p.000000: bb) changes,
p.000000: then the body of first instance to the body of second instance in the proceedings - the separate investigations
p.000000: reimburse the necessary costs incurred in carrying out the
p.000000: (8) *
p.000000: Itv.
p.000000: a) the provisions of Section 28, Paragraphs (2) - (3), the occurrence of the obligation to pay the fee,
p.000000: b) *
p.000000: In the first sentence of Section 31 (1) and in Section 31 (2), (4) - (6),
p.000000: and paragraph 8 to determine the range of persons liable to pay the fees,
p.000000: c) the provisions of Section 32 (1), the refund of the fee,
p.000000: d) the provisions of Section 86 of the statute of limitations
p.000000: shall apply mutatis mutandis by replacing the licensing authority with the licensing authority,
p.000000: a fee shall be construed instead of a fee.
p.000000: (9) For the recording and accounting of fees on the basis of the budget belonging to the general government subsystem
p.000000: existing legal requirements on the reporting and accounting obligations of economic entities
p.000000: apply.
p.000000: (10) *
p.000000: 20 / S. § *
p.000000: (1) *
p.000000: If the licensing authority conducts the investigation in accordance with Eütv.
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Health / Drug Usage
Searching for indicator drug:
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p.000000: University of Debrecen Medical and Health Sciences Center Regional Scientific
p.000000: and Research Ethics Committee
p.000000: University of Pécs Medical and Health Sciences Coordination Center Regional Science and Research Ethics
p.000000: Committee
p.000000: University of Szeged Szent-Györgyi Albert Medical and
p.000000: Health care institutions in Szolnok county, a
p.000000: With the exception of health care facilities specified in line 2
p.000000: 8. Health care institutions in Borsod-Abaúj-Zemplén, Heves and Nógrád counties
p.000000: 9. Health care institutions in Vas, Zala and Veszprém counties
p.000000: 10. Health care institutions in Győr-Moson-Sopron, Komárom-Esztergom and Fejér counties
p.000000: Regional Scientific and Research Ethics Committee of the Center for Pharmaceutical Sciences
p.000000: Borsod-Abaúj-Zemplén County Local Government Hospital
p.000000: Regional Scientific and Research Ethics Committee
p.000000: Vas County Lajos Markusovszky General, Rehabilitation and Spa Hospital,
p.000000: University Teaching Hospital Regional Scientific and Research Ethics Committee, Szombathely
p.000000: Győr-Moson-Sopron County Local Government Petz Aladár Hospital, Győr,
p.000000: Regional Scientific and Research Ethics Committee
p.000000: Annex 2 to Decree 23/2002. (V. 9.) EüM decree *
p.000000: Notification for non - interventional investigation
p.000000: Name of institution, health care provider:
p.000000: 1. Name of the study
p.000000: 2. In the case of a drug study, the name of the drug
p.000000: 3. *
p.000000: Type of test
p.000000: Drug study Retrospective study
p.000000: Non-drug study
p.000000: Prospective study
p.000000: The study is a prescribed pharmacovigilance study
p.000000: 4. Test site (s)
p.000000: Yes No
p.000000: Date: ................................................ ..
p.000000: .................................................. ................
p.000000: principal's signature
p.000000: Annex 3 to Decree 23/2002. (V. 9.) EüM decree *
p.000000: Organizations involved in the authorization process and their bank account numbers
p.000000: 1. *
p.000000: VENUE OF
p.000000: On the man
p.000000: Name of the body Health
p.000000: Account Number State
p.000000: medical research other than clinical trials with investigational medicinal products
p.000000: non - interventional studies,
p.000000: clinical trials with medical devices and non-interventional
p.000000: tests and Tests 2-11. cases specified in the order
p.000000: Scientific Council,
p.000000: Committees and Bureau of the Scientific Council for Health
p.000000: Health Care Center 10032000-
p.000000: 01490576-
p.000000: 00000000
p.000000: 2. *
p.000000: Semmelweis
p.000000: Semmelweis University
p.000000: 10032000-
p.000000: University and
p.000000: institutions, Pest County and the Minister of Health
p.000000: under the direct supervision of the headed ministry in the territory of the capital
p.000000: health care institutions
p.000000: Regional, Institutional Scientific and Research Ethics Committee
p.282819: 00282819
p.282819: 3. *
p.282819: Hungarian
p.282819: AEK Military Hospital,
p.282819: 10023002-
p.282819: Defense Forces, a
p.282819: health institutions of the Ministry headed by the Minister responsible for law enforcement,
p.282819: health care institutions
p.282819: 4. Other health care institutions based in Pest
p.282819: 5. Other health care institutions based in Buda
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Searching for indicator influence:
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p.000000: includes:
p.000000: a) identification of the research,
p.000000: (b) the name of the healthcare institution where the research is to be carried out,
p.000000: c) the name, position and position of the head of the research or the person providing the information
p.000000: Name,
p.000000: d) *
p.000000: identification data of the participant (name, mother 's name, place and time of birth, TAJ
p.000000: number, address), a minor with limited legal capacity and
p.000000: the exercise of related rights and a group of assets of a property nature
p.000000: in the case of a partially restricted or incapacitated participant, the legal representative giving the consent
p.000000: identification data,
p.000000: e) *
p.000000: a statement that the participant has limited legal capacity
p.000000: minors and their capacity to act in relation to the exercise of healthcare rights,
p.000000: and is partially restricted or
p.000000: in the case of an incapacitated participant, also the legal representative - in the research
p.000000: following the information provided for in paragraph 1,
p.000000: without influence, knowing that at any time, orally or in writing, without giving any reason
p.000000: revocable,
p.000000: f) the date of signature of the statement of consent,
p.000000: g) the signature of the research leader or information provider,
p.000000: (h) the signature of the person giving his consent and, in the case referred to in paragraph 7, of the witness.
p.000000: (6) *
p.000000: The person providing the information and the participant - to a limited extent
p.000000: the legal capacity of a minor and the exercise of health care rights in his or her capacity to act
p.000000: and in respect of a class of property of a limited nature or
p.000000: in the case of an incapacitated participant, the legal representative - also the written information pursuant to paragraph 4
p.000000: sign.
p.000000: (7) *
p.000000: If you want to be involved in the research, or to a limited extent
p.000000: the legal capacity of a minor and the exercise of health care rights in his or her capacity to act
p.000000: and in respect of a class of property of a limited nature or
p.000000: in the case of an incapacitated person, the legal representative cannot read the consent form
...
p.000000: (a) the identity of the research;
p.000000: (b) the name of the healthcare provider where the research is to be performed;
p.000000: c) the name, position and position of the head of the research or the person providing the information
p.000000: designation;
p.000000: d) *
p.000000: identification of the participant (name, place and date of birth),
p.000000: a minor with limited legal capacity and rights related to health care in his or her capacity to act
p.000000: and partially limited to a group of property cases
p.000000: or in the case of an incapacitated subject, the Eütv. The person entitled to make a declaration pursuant to § 16 (a
p.000000: hereinafter referred to as the "person entitled to make a declaration");
p.000000: e) *
p.000000: a statement that the participant has limited legal capacity
p.000000: minors and their capacity to act in relation to the exercise of healthcare rights,
p.000000: and is partially restricted or
p.000000: in the case of an incapacitated subject, the person entitled to make a statement - in the genetic test
p.000000: consent to participate in Article 4 / A. § or the information contained therein
p.000000: voluntarily, without influence, after resignation, in the knowledge that at any time,
p.000000: may be revoked orally or in writing without giving reasons;
p.000000: (f) the consent to the taking of a sample of the quantity and quality indicated in the prospectus and the identity of the participant
p.000000: use;
p.000000: (g) a statement as to how the samples will be handled, stating that it may decide on the sample to be provided
p.000000: biobank and the method of disposal, so that a sample is possible
p.000000: (ga) storage of personal data,
p.000000: gb) in encrypted form,
p.000000: gc) pseudonymised, ie in a form in which the
p.000000: the replacement code has been made available to the subject exclusively,
p.000000: (gd) anonymised, ie in a form where all the data relating to the subject are available
p.000000: personally identifiable information has been rendered unfit for identification;
p.000000: (h) a statement by the participant that the sample placed in the biobank is participating in further research; in this
p.000000: In this case, the participant must declare that his sample is the primary purpose of sampling
p.000000: diagnostic, for research purposes only, or any, ie diagnostic and research
p.000000: contributes to its use for its intended purpose;
p.000000: (i) the manner in which the result is to be communicated, even if the subject does not have access to it;
p.000000: (j) consenting to or excluding any future request;
p.000000: (k) the date of signature of the statement of consent;
p.000000: (l) the signature of the research leader or information provider;
p.000000: (m) the signature of the person giving his consent.
...
p.000000: 3. In the case of an oral statement of consent, the two witnesses shall certify that the subject is in accordance with paragraph 1.
p.000000: and the statement of consent referred to in paragraph 4 has been communicated to him and orally
p.000000: agreed.
p.000000: In addition to paragraph 1, the subject 's statement of consent shall in particular:
p.000000: shall include, as appropriate:
p.000000: (a) where the non - interventional examination is carried out by a health care provider, its health
p.000000: the name of the service provider where the test is to be performed;
p.000000: b) *
p.000000: the identity of the subject (name, place and date of birth),
p.000000: in the case of an incapacitated minor with limited legal capacity under the age of 16 a
p.000000: also the identification data of the person entitled to make a declaration;
p.000000: c) *
p.000000: a statement that the subject is incapacitated or
p.000000: in the case of a minor subject with limited legal capacity under the age of
p.000000: authorized person - his consent to participate in the investigation is set out in paragraph 1
p.000000: after giving information voluntarily, without influence, knowing that it is at any time, orally
p.000000: can be revoked in writing without giving reasons;
p.000000: (d) the date of signature of the statement of consent;
p.000000: (e) the signature of the study director or informant;
p.000000: (f) the signature of the person giving his consent.
p.000000: (5) *
p.000000: The person providing the information and the subject - are incapacitated
p.000000: In the case of a minor subject with limited legal capacity under the age of 16, to make a statement
p.000000: authorized person - also signs the written prospectus referred to in paragraph 1.
p.000000: (6) The information and consent shall be recorded in a separate sheet. The consent form
p.000000: and one original of each written information document shall be kept in the test documentation,
p.000000: and one original shall be handed over to the subject.
p.000000: (7) *
p.000000: If, in connection with a non-interventional investigation, such
p.000000: new relevant information becomes known which affects the contents of the written prospectus, the
p.000000: license modification should be initiated for human medical research, human
p.000000: clinical trials of the investigational medicinal products to be used and in humans
p.000000: clinical investigation of medical devices intended for clinical use
p.000000: 235/2009 on the rules for the authorization procedure (X. 20.) Government Decree 19.
p.000000: §. The subject of the amended written information shall be re-examined
...
Health / Healthy People
Searching for indicator healthy volunteers:
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p.000000: compliance with the conditions laid down in paragraphs 1 and 2 and with the requirements of this Regulation.
p.000000: (2) The research may not replace for the participant what is necessary from a medical-professional point of view, a
p.000000: examinations and interventions for the prevention, early detection and treatment of diseases.
p.000000: 3. Where research is intended to involve persons of reproductive age, the planning, authorization,
p.000000: in informing participants, special attention should be paid to research on fertility and fertility,
p.000000: pregnancy, embryonal / fetal health, which may occur at the time of inclusion in the research,
p.000000: impact.
p.000000: (4) Research should be designed and conducted in a manner that minimizes the person involved in the research
p.000000: possible damage, pain, fear and anxiety. The age of the person involved, health
p.000000: any foreseeable risks associated with the condition should be considered in the research
p.000000: planning and control.
p.000000: (5) The health status of the participant before the start of the research, continuously during the research
p.000000: and should then be carefully monitored and documented.
p.000000: (6) *
p.000000: As a participant in the research, primarily in the health care institution
p.000000: patients can be involved. A call to recruit participants - healthy
p.000000: with the exception of volunteers - can only be referred to doctors, according to the purpose and methods of the research, the
p.000000: with a precise indication of the number of participants to be selected. Recruiting healthy volunteers
p.000000: by means of a communication to the public, the invitation to recruit must clearly state that the
p.000000: involving healthy volunteers. The recruitment call may not be for advertising purposes. The call for recruitment
p.000000: the proposed text and a description of the recruitment method for the official approval of the research,
p.000000: or be accompanied by a request for a professional-ethical opinion. In the published recruitment notice, the
p.000000: reference to the existence of an official permit. In the event of a deviation from the permitted method and text of recruitment, the
p.000000: an amendment to the permit shall be initiated.
p.000000: (7) The loss of income related to the participation in the research and the travel expenses of the participant
p.000000: actually incurred and justified in this context
p.000000: - not covered by social security
p.000000: reimbursement is payable. Other benefits or fees for the participant
p.000000: - with the exception of research on healthy volunteers.
p.000000: Informing the participant, consent to the research
p.000000: § 4. (1) The person with legal capacity to be involved in the research shall be the head of the research or the person appointed by him / her.
p.000000: The doctor participating in the research shall inform the patient orally and in writing in Hungarian in a way that is comprehensible to the patient
p.000000: AH. 159 (3).
p.000000: 2. The person providing the information shall pay particular attention to verifying that he or she wishes to be involved
p.000000: whether the person is capable of acting. The findings in this regard are recorded in the medical records.
p.000000: (3) The information and consent shall be recorded in writing on a separate sheet. The written information and the
p.000000: a copy of the consent form shall be kept in the participant's medical records,
p.000000: and one copy shall be given to the participant.
p.000000: 4. The written information shall contain at least the following:
p.000000: a) identification of the research,
p.000000: (b) an indication of the experimental nature of the research, the purpose of the research, its expected duration,
p.000000: the number of persons to be involved, the course of the research, the nature and frequency of the planned interventions,
p.000000: (c) other agreed treatment options available to the participant and information thereon
p.000000: that research may mean the interruption of treatment that has already begun and that it has begun
p.000000: the consequences for the participant of the interruption of treatment,
p.000000: (d) a detailed description of the possible and expected consequences, risks and inconveniences, and
...
Searching for indicator volunteers:
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p.000000: taking into account.
p.000000: Protection of the person involved in the research
p.000000: § 3. (1) A person with legal capacity may be involved in research if the Eütv. Section 159 (1) - (3)
p.000000: compliance with the conditions laid down in paragraphs 1 and 2 and with the requirements of this Regulation.
p.000000: (2) The research may not replace for the participant what is necessary from a medical-professional point of view, a
p.000000: examinations and interventions for the prevention, early detection and treatment of diseases.
p.000000: 3. Where research is intended to involve persons of reproductive age, the planning, authorization,
p.000000: in informing participants, special attention should be paid to research on fertility and fertility,
p.000000: pregnancy, embryonal / fetal health, which may occur at the time of inclusion in the research,
p.000000: impact.
p.000000: (4) Research should be designed and conducted in a manner that minimizes the person involved in the research
p.000000: possible damage, pain, fear and anxiety. The age of the person involved, health
p.000000: any foreseeable risks associated with the condition should be considered in the research
p.000000: planning and control.
p.000000: (5) The health status of the participant before the start of the research, continuously during the research
p.000000: and should then be carefully monitored and documented.
p.000000: (6) *
p.000000: As a participant in the research, primarily in the health care institution
p.000000: patients can be involved. A call to recruit participants - healthy
p.000000: with the exception of volunteers - can only be referred to doctors, according to the purpose and methods of the research, the
p.000000: with a precise indication of the number of participants to be selected. Recruiting healthy volunteers
p.000000: by means of a communication to the public, the invitation to recruit must clearly state that the
p.000000: involving healthy volunteers. The recruitment call may not be for advertising purposes. The call for recruitment
p.000000: the proposed text and a description of the recruitment method for the official approval of the research,
p.000000: or be accompanied by a request for a professional-ethical opinion. In the published recruitment notice, the
p.000000: reference to the existence of an official permit. In the event of a deviation from the permitted method and text of recruitment, the
p.000000: an amendment to the permit shall be initiated.
p.000000: (7) The loss of income related to the participation in the research and the travel expenses of the participant
p.000000: actually incurred and justified in this context
p.000000: - not covered by social security
p.000000: reimbursement is payable. Other benefits or fees for the participant
p.000000: - with the exception of research on healthy volunteers.
p.000000: Informing the participant, consent to the research
p.000000: § 4. (1) The person with legal capacity to be involved in the research shall be the head of the research or the person appointed by him / her.
...
Health / Mentally Disabled
Searching for indicator disabled:
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p.000000: Non-interventional study in minors is described in 20 / G-20 / H. §-in
p.000000: may be carried out only if all of the following conditions are met:
p.000000: (a) the study is directly related to the clinical condition in which the minor suffers or is of a nature
p.000000: which can only be performed on minors;
p.000000: (b) in the case of a minor under the age of 16, the consent of the person entitled to make the declaration
p.000000: contains the probable will of a minor capable of forming an opinion and assessing the situation, and this a
p.000000: the declaration may be withdrawn at any time without the minor being adversely affected;
p.000000: (c) an investigator with experience in relation to minors shall, depending on his or her intellectual level,
p.000000: properly informed of the study, adverse and beneficial effects in a way that is comprehensible to him;
p.000000: (d) the investigator or study director takes full account of the
p.000000: a minor under the age of 16 who is able to assess the situation explicitly refuses to participate in the study, or
p.000000: that you wish to withdraw from the investigation at any time;
p.000000: e) *
p.000000: 20 / J. § *
p.000000: (1) *
p.000000: A non-interventional study shall not be included in a
p.000000: incapacitated or disabled minor; and
p.000000: the exercise of rights relating to healthcare, and
p.000000: a person who is partially restricted in the case of a group of property
p.000000: in its possession, it expressly excluded its participation in such investigations. Not for a particular study
p.000000: nor may he be involved who has previously refused consent in possession of his capacity to act
p.000000: for that study.
p.000000: (2) *
p.000000: Incapacitated or incapacitated with health care
p.000000: the exercise of related rights and a group of assets of a property nature
p.000000: partially restricted in adults 20 / G-20 / H. § only with proper application
p.000000: a non - interventional test may be carried out if - in paragraph 1
p.000000: all of the following conditions are met:
p.000000: (a) in the case of a person who is incapacitated, the consent of the person entitled to make the declaration
p.000000: it must contain the presumed will of the subject and this statement at any time
p.000000: can be withdrawn without prejudice to the subject;
p.000000: (b) the subject has been adequately informed of the study in a manner that is comprehensible to the subject, favorable and
p.000000: adverse effects;
...
Searching for indicator disability:
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p.000000: (c) cells, cell constituents, tissues, organs removed from a living human or dead body,
p.000000: done with a body part,
p.000000: d) epidemiological,
p.000000: (e) in the public health and epidemiological interest,
p.000000: f) *
p.000000: g) research on gametes and embryos.
p.000000: (2) - (3) *
p.000000: § 2. (1) For the purposes of this Decree
p.000000: the) *
p.000000: statement of consent: the person participating in the investigation has legal capacity
p.000000: person in the Eütv. 159 (1) e), or to a limited extent
p.000000: the legal capacity of a minor and the exercise of health care rights in his or her capacity to act
p.000000: and in respect of a class of property of a limited nature or
p.000000: in the case of an incapacitated person, the Eütv. A statement pursuant to Section 159 (4) (d);
p.000000: (b) research plan: the objectives, planned course, methods, statistical aspects of the research and
p.000000: documentation on its organizational issues prepared in advance in accordance with this Regulation;
p.000000: including further versions and modifications thereof;
p.000000: c) *
p.000000: (d) undesirable event: an adverse event in the research subject's state of health
p.000000: a change that does not necessarily result from the treatment applied;
p.000000: (e) "serious adverse event" means an adverse event that is life-threatening;
p.000000: requires or prolongs hospital treatment, is permanent
p.000000: causes damage to health, disability, congenital anomaly, birth defect or death;
p.000000: f) *
p.000000: (g) research coordinator: in the case of multi-center research, the researcher responsible for coordinating the research;
p.000000: h) *
p.000000: non-commercial research: industrial, commercial, service provider
p.000000: research carried out by researchers independent of business, which does not even indirectly serve the material of the sponsor
p.000000: profit and
p.000000: (ha) commissioned by an independent researcher or non-profit organization, in particular an educational organization
p.000000: institution, funded health care provider, publicly funded research institute, social
p.000000: organization,
p.000000: (hb) the research is planned and carried out by the sponsor in accordance with point (ha),
p.000000: (hc) the data resulting from the research become the property of the sponsor in accordance with point (ha),
p.000000: (hd) the results of the research are communicated by the sponsor in accordance with point (ha).
p.000000: i) *
p.000000: (2) *
p.000000: In addition to the provisions of paragraph 1, for the purposes of this Regulation,
p.000000: and the authorization procedure for medical research on human beings
p.000000: definitions contained in a separate legal act on the rules of
p.000000: taking into account.
p.000000: Protection of the person involved in the research
p.000000: § 3. (1) A person with legal capacity may be involved in research if the Eütv. Section 159 (1) - (3)
p.000000: compliance with the conditions laid down in paragraphs 1 and 2 and with the requirements of this Regulation.
...
Health / visual impairment
Searching for indicator blind:
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p.000000: 00000000
p.000000: 13. *
p.000000: Medical
p.000000: National Pharmaceutical
p.000000: 10032000-
p.000000: clinical trials and non-interventional trials
p.000000: and the Institute of Food Health
p.000000: 00290050-
p.000000: 00000000
p.000000: Annex 4 to Decree 23/2002. (V. 9.) EüM decree *
p.000000: Documents to be attached to the request for a non-interventional medical examination
p.000000: 1. Basic data of the study:
p.000000: a) title of the study in Hungarian, protocol number (if any),
p.000000: b) type of test,
p.000000: c) details and contact details of the sponsor of the study,
p.000000: d) the name and contact details (telephone, fax) and professional qualifications of the Hungarian leader of the study
p.000000: and academic degree, curriculum vitae, summary of professional work,
p.000000: e) the name and address of the healthcare provider (s) performing the examination,
p.000000: (f) planned date of commencement of the investigation,
p.000000: g) the planned duration of the study, the date of completion,
p.000000: (h) the intended location and address of the study.
p.000000: 2. Documentation of the medical device under investigation:
p.000000: a) the name, fancy name, serial number of the device,
p.000000: (b) documents proving the lawful placing on the market of the medical device (s) under investigation,
p.000000: c) instructions for use of the device (s) in Hungarian,
p.000000: (d) the technical documentation of the device (s).
p.000000: 3. Test plan including:
p.000000: a) a short summary in Hungarian;
p.000000: (b) a detailed test plan consisting of:
p.000000: (ba) the purpose of the investigation,
p.000000: bb) the name of the test device,
p.000000: (bc) a description of the test method (eg double-blind, randomized, etc.),
p.000000: (bd) a description of the test procedure related to the method,
p.000000: (be) determination of the number of participants in the study,
p.000000: (bf) the conditions for selecting or excluding study participants,
p.000000: (bg) the sample data sheet, algorithm, written instructions needed to evaluate the test,
p.000000: (bh) a follow-up plan,
p.000000: (bi) the scientific and medical justification for conducting the study,
p.000000: (bj) any other CE conformity marking not involved in the test
p.000000: documents proving the lawful placing on the market of medical devices
p.000000: (bk) the procedure to be followed in the event of an unforeseen event,
p.000000: (bl) the conditions for stopping the study,
p.000000: (bm) the package leaflet and the statement of consent,
p.000000: (bn) a risk-liability insurance contract concluded by the originator of the investigation
p.000000: Acknowledgment
p.000000: (bo) a statement from the healthcare provider receiving the study of consent to the study,
p.000000: bp) proof of payment of the administrative service fee.
p.000000: The wording of the second sentence was as follows: 35/2005. (VIII. 26.) EüM decree
p.000000: Section 25 (6). Amended by 52/2012. (XII. 27.) EMMI Decree § 4 a). Repealed by: 31/2009. (X. 20.) EüM
p.000000: Section 6 (2) a) of the Decree. Repealed: 21 X 2009.
p.000000: Repealed by: 31/2009. (X. 20.) EüM Decree § 6 (2) b). Repealed: 21 X 2009.
p.000000: Established: 31/2009. (X. 20.) EüM Decree § 1 (1). Modified: 16/2014. (III. 12.) EMMI Decree § 4 a).
p.000000: Repealed by: 31/2009. (X. 20.) EüM Decree § 6 (2) c). Repealed: 21 X 2009.
p.000000: Repealed by: 31/2009. (X. 20.) EüM Decree § 6 (2) c). Repealed: 21 X 2009.
...
Social / Access to Social Goods
Searching for indicator access:
(return to top)
p.000000: which affects the contents of the written prospectus, an amendment to the permit shall be initiated in Section 13
p.000000: in accordance with In accordance with the amended written information
p.000000: you must be informed again and your written consent must be sought to continue the research.
p.000000: 4 / A. § *
p.000000: (1) If specified in the special legislation during the research
p.000000: samples are taken for human genetic testing, the participant shall be informed separately. THE
p.000000: the information shall also include the right of the participant to be sampled separately
p.000000: in this case, the genetic data relating to him may no longer be anonymous
p.000000: to use. Rejection of sampling does not constitute a barrier to participant participation in further research
p.000000: section. Information on and agreement to sampling in a separate document
p.000000: must be booked.
p.000000: (2) Prior to sampling for human genetic testing, the participant shall be subjected to genetic counseling
p.000000: must be informed within
p.000000: (a) the purpose, quantitative and qualitative details of the sampling,
p.000000: (b) the benefits and risks of performing or not performing the study,
p.000000: (c) any possible outcome for the data subject and his or her close relatives
p.000000: consequences,
p.000000: (d) the methods and duration of storage of the genetic sample and data, the genetic data stored in different forms
p.000000: samples and the possibilities for identifying data,
p.000000: (e) unless otherwise stated by the participant, the genetic sample is in an archived collection
p.000000: the possible transfer of stored genetic samples,
p.000000: (f) that he or she is entitled to have access to the genetic data generated by the human genetic test; and
p.000000: (g) whether it may decide to place the sample it provides in a biobank;
p.000000: placement method so that a sample is possible
p.000000: (ga) storage of personal data,
p.000000: gb) in encrypted form,
p.000000: gc) pseudonymised, ie in a form in which the
p.000000: the replacement code has been made available to the subject exclusively,
p.000000: (gd) anonymised, ie in a form where all the data relating to the subject are available
p.000000: personally identifiable information has been rendered inoperable.
p.000000: (3) The participant shall also be informed that it may decide to add a sample to the biobank
p.000000: participation in research. In this case, the participant must declare that:
p.000000: for the primary purpose of sampling, for diagnostic purposes only, or
p.000000: whether it contributes to its use, ie for diagnostic and research purposes.
p.000000: 4 / B. § *
p.000000: (1) If the research is due to a human genetic test
p.000000: a separate statement of consent shall be drawn up.
p.000000: 2. The participant's statement of consent shall include at least the following:
p.000000: (a) the identity of the research;
p.000000: (b) the name of the healthcare provider where the research is to be performed;
p.000000: c) the name, position and position of the head of the research or the person providing the information
p.000000: designation;
p.000000: d) *
p.000000: identification of the participant (name, place and date of birth),
p.000000: a minor with limited legal capacity and rights related to health care in his or her capacity to act
...
p.000000: in the case of an incapacitated subject, the person entitled to make a statement - in the genetic test
p.000000: consent to participate in Article 4 / A. § or the information contained therein
p.000000: voluntarily, without influence, after resignation, in the knowledge that at any time,
p.000000: may be revoked orally or in writing without giving reasons;
p.000000: (f) the consent to the taking of a sample of the quantity and quality indicated in the prospectus and the identity of the participant
p.000000: use;
p.000000: (g) a statement as to how the samples will be handled, stating that it may decide on the sample to be provided
p.000000: biobank and the method of disposal, so that a sample is possible
p.000000: (ga) storage of personal data,
p.000000: gb) in encrypted form,
p.000000: gc) pseudonymised, ie in a form in which the
p.000000: the replacement code has been made available to the subject exclusively,
p.000000: (gd) anonymised, ie in a form where all the data relating to the subject are available
p.000000: personally identifiable information has been rendered unfit for identification;
p.000000: (h) a statement by the participant that the sample placed in the biobank is participating in further research; in this
p.000000: In this case, the participant must declare that his sample is the primary purpose of sampling
p.000000: diagnostic, for research purposes only, or any, ie diagnostic and research
p.000000: contributes to its use for its intended purpose;
p.000000: (i) the manner in which the result is to be communicated, even if the subject does not have access to it;
p.000000: (j) consenting to or excluding any future request;
p.000000: (k) the date of signature of the statement of consent;
p.000000: (l) the signature of the research leader or information provider;
p.000000: (m) the signature of the person giving his consent.
p.000000: Exercising a minor with limited legal capacity and rights related to health care in her capacity to act
p.000000: partially limited and incapacitated
p.000000: involvement of a person in research *
p.000000: § 5 (1) *
p.000000: If the research - the Eütv. Section 159 (4) and (5)
p.000000: subject to certain conditions - a minor with limited legal capacity and
p.000000: the exercise of rights relating to healthcare and of a pecuniary nature
p.000000: involving a partially restricted person in respect of a case group, both
p.000000: a minor with limited legal capacity and rights related to health care in his or her capacity to act
p.000000: and in respect of a group of property-type matters
p.000000: both the restricted person and his legal representative shall be informed in accordance with Section 4.
p.000000: (2) *
...
p.000000: b) *
p.000000: the Eütv. Person pursuant to Section 16, Paragraphs (1) - (2) - subject to the provisions of Art. 16th
p.000000: § (5) - or with limited legal capacity over the age of 16
p.000000: in respect of the exercise of rights in relation to a minor or a person with legal capacity,
p.000000: and a subject of partial investigation limited to a group of property - related matters
p.000000: gave his consent.
p.000000: 20 / Mon. § *
p.000000: 1. The subject of a non-interventional study shall be included in the study
p.000000: prior to the consent of the investigator or the investigator, orally and in writing in Hungarian - or
p.000000: in the subject's mother tongue or in another language indicated by the subject - known to the lay person
p.000000: orally and in writing
p.000000: (a) the voluntary nature of the participation in the study and the fact that the consent may be given at any time;
p.000000: (2) may be revoked orally or in writing without giving any reason and without adverse consequences;
p.000000: b) the essence, purpose, expected duration and place of the planned investigation, the persons to be involved
p.000000: the number or scope of the
p.000000: (c) the expected benefits and reimbursement to the subject of the investigation or to others, if
p.000000: It happens;
p.000000: (d) rules on the handling of, and access to, subject data;
p.000000: e) the name, position and job title of the person (s) responsible for the investigation;
p.000000: (f) the identity of the non-interventional study;
p.000000: g) the name and registered office of the applicant.
p.000000: 2. The subject shall obtain the written consent of the subject following the information referred to in paragraph 1
p.000000: add to the test. If the subject is unable to write in writing, or
p.000000: due to illiteracy, is not interested in two non-interventional
p.000000: oral consent in the joint presence of a witness is required for the investigation. In the case of oral consent a
p.000000: a statement must be made in writing certifying the verbal consent signed by the two witnesses
p.000000: took place. In the event of the subject's ability to recover, the statement of consent shall be issued by the
p.000000: confirm the written statement of consent before proceeding with the investigation, failing which
p.000000: shall be deemed to be withdrawn and the investigation may not be continued on the person concerned.
p.000000: 3. In the case of an oral statement of consent, the two witnesses shall certify that the subject is in accordance with paragraph 1.
p.000000: and the statement of consent referred to in paragraph 4 has been communicated to him and orally
p.000000: agreed.
...
Social / Age
Searching for indicator age:
(return to top)
p.000000: research carried out by researchers independent of business, which does not even indirectly serve the material of the sponsor
p.000000: profit and
p.000000: (ha) commissioned by an independent researcher or non-profit organization, in particular an educational organization
p.000000: institution, funded health care provider, publicly funded research institute, social
p.000000: organization,
p.000000: (hb) the research is planned and carried out by the sponsor in accordance with point (ha),
p.000000: (hc) the data resulting from the research become the property of the sponsor in accordance with point (ha),
p.000000: (hd) the results of the research are communicated by the sponsor in accordance with point (ha).
p.000000: i) *
p.000000: (2) *
p.000000: In addition to the provisions of paragraph 1, for the purposes of this Regulation,
p.000000: and the authorization procedure for medical research on human beings
p.000000: definitions contained in a separate legal act on the rules of
p.000000: taking into account.
p.000000: Protection of the person involved in the research
p.000000: § 3. (1) A person with legal capacity may be involved in research if the Eütv. Section 159 (1) - (3)
p.000000: compliance with the conditions laid down in paragraphs 1 and 2 and with the requirements of this Regulation.
p.000000: (2) The research may not replace for the participant what is necessary from a medical-professional point of view, a
p.000000: examinations and interventions for the prevention, early detection and treatment of diseases.
p.000000: 3. Where research is intended to involve persons of reproductive age, the planning, authorization,
p.000000: in informing participants, special attention should be paid to research on fertility and fertility,
p.000000: pregnancy, embryonal / fetal health, which may occur at the time of inclusion in the research,
p.000000: impact.
p.000000: (4) Research should be designed and conducted in a manner that minimizes the person involved in the research
p.000000: possible damage, pain, fear and anxiety. The age of the person involved, health
p.000000: any foreseeable risks associated with the condition should be considered in the research
p.000000: planning and control.
p.000000: (5) The health status of the participant before the start of the research, continuously during the research
p.000000: and should then be carefully monitored and documented.
p.000000: (6) *
p.000000: As a participant in the research, primarily in the health care institution
p.000000: patients can be involved. A call to recruit participants - healthy
p.000000: with the exception of volunteers - can only be referred to doctors, according to the purpose and methods of the research, the
p.000000: with a precise indication of the number of participants to be selected. Recruiting healthy volunteers
p.000000: by means of a communication to the public, the invitation to recruit must clearly state that the
p.000000: involving healthy volunteers. The recruitment call may not be for advertising purposes. The call for recruitment
p.000000: the proposed text and a description of the recruitment method for the official approval of the research,
p.000000: or be accompanied by a request for a professional-ethical opinion. In the published recruitment notice, the
p.000000: reference to the existence of an official permit. In the event of a deviation from the permitted method and text of recruitment, the
p.000000: an amendment to the permit shall be initiated.
p.000000: (7) The loss of income related to the participation in the research and the travel expenses of the participant
p.000000: actually incurred and justified in this context
p.000000: - not covered by social security
...
p.000000: (2) The subject and the Eütv. The person entitled to make a declaration pursuant to § 16 (a
p.000000: hereinafter referred to as "the person entitled to make a declaration")
p.000000: loss of income and costs related to participation in the investigation, in particular
p.000000: Reimbursement may be made for expenses actually incurred and justified in connection with the journey.
p.000000: No other benefits or fees may be granted to the subject and the person entitled to make a statement.
p.000000: 20 / G. § *
p.000000: (1) Non-interventional investigation of a person with legal capacity
p.000000: improvement of diagnostic, therapeutic, prevention and rehabilitation procedures only,
p.000000: development and evaluation of procedures, as well as the pathogenesis and pathogenesis of diseases
p.000000: and epidemiological and public health contexts.
p.000000: (2) A non-interventional investigation shall be performed on a minor or a person with incapacitated
p.000000: its capacity to exercise its rights in relation to healthcare, and
p.000000: in respect of a group of property of a partially limited nature, 20 / I-20 / J. §-in
p.000000: subject only to the coexistence of the following conditions
p.000000: can be performed in case of: *
p.000000: (a) the investigation may not be carried out on a person of comparable efficiency;
p.000000: b) *
p.000000: the Eütv. Person pursuant to Section 16, Paragraphs (1) - (2) - subject to the provisions of Art. 16th
p.000000: § (5) - or with limited legal capacity over the age of 16
p.000000: in respect of the exercise of rights in relation to a minor or a person with legal capacity,
p.000000: and a subject of partial investigation limited to a group of property - related matters
p.000000: gave his consent.
p.000000: 20 / Mon. § *
p.000000: 1. The subject of a non-interventional study shall be included in the study
p.000000: prior to the consent of the investigator or the investigator, orally and in writing in Hungarian - or
p.000000: in the subject's mother tongue or in another language indicated by the subject - known to the lay person
p.000000: orally and in writing
p.000000: (a) the voluntary nature of the participation in the study and the fact that the consent may be given at any time;
p.000000: (2) may be revoked orally or in writing without giving any reason and without adverse consequences;
p.000000: b) the essence, purpose, expected duration and place of the planned investigation, the persons to be involved
p.000000: the number or scope of the
p.000000: (c) the expected benefits and reimbursement to the subject of the investigation or to others, if
p.000000: It happens;
p.000000: (d) rules on the handling of, and access to, subject data;
p.000000: e) the name, position and job title of the person (s) responsible for the investigation;
p.000000: (f) the identity of the non-interventional study;
p.000000: g) the name and registered office of the applicant.
...
p.000000: a statement must be made in writing certifying the verbal consent signed by the two witnesses
p.000000: took place. In the event of the subject's ability to recover, the statement of consent shall be issued by the
p.000000: confirm the written statement of consent before proceeding with the investigation, failing which
p.000000: shall be deemed to be withdrawn and the investigation may not be continued on the person concerned.
p.000000: 3. In the case of an oral statement of consent, the two witnesses shall certify that the subject is in accordance with paragraph 1.
p.000000: and the statement of consent referred to in paragraph 4 has been communicated to him and orally
p.000000: agreed.
p.000000: In addition to paragraph 1, the subject 's statement of consent shall in particular:
p.000000: shall include, as appropriate:
p.000000: (a) where the non - interventional examination is carried out by a health care provider, its health
p.000000: the name of the service provider where the test is to be performed;
p.000000: b) *
p.000000: the identity of the subject (name, place and date of birth),
p.000000: in the case of an incapacitated minor with limited legal capacity under the age of 16 a
p.000000: also the identification data of the person entitled to make a declaration;
p.000000: c) *
p.000000: a statement that the subject is incapacitated or
p.000000: in the case of a minor subject with limited legal capacity under the age of
p.000000: authorized person - his consent to participate in the investigation is set out in paragraph 1
p.000000: after giving information voluntarily, without influence, knowing that it is at any time, orally
p.000000: can be revoked in writing without giving reasons;
p.000000: (d) the date of signature of the statement of consent;
p.000000: (e) the signature of the study director or informant;
p.000000: (f) the signature of the person giving his consent.
p.000000: (5) *
p.000000: The person providing the information and the subject - are incapacitated
p.000000: In the case of a minor subject with limited legal capacity under the age of 16, to make a statement
p.000000: authorized person - also signs the written prospectus referred to in paragraph 1.
p.000000: (6) The information and consent shall be recorded in a separate sheet. The consent form
p.000000: and one original of each written information document shall be kept in the test documentation,
p.000000: and one original shall be handed over to the subject.
p.000000: (7) *
p.000000: If, in connection with a non-interventional investigation, such
p.000000: new relevant information becomes known which affects the contents of the written prospectus, the
p.000000: license modification should be initiated for human medical research, human
p.000000: clinical trials of the investigational medicinal products to be used and in humans
p.000000: clinical investigation of medical devices intended for clinical use
p.000000: 235/2009 on the rules for the authorization procedure (X. 20.) Government Decree 19.
p.000000: §. The subject of the amended written information shall be re-examined
p.000000: be informed and consent must be sought for the investigation to continue. In the absence of this investigation, the
p.000000: cannot be continued on the person concerned.
p.000000: 20 / I. § *
p.000000: Non-interventional study in minors is described in 20 / G-20 / H. §-in
p.000000: may be carried out only if all of the following conditions are met:
p.000000: (a) the study is directly related to the clinical condition in which the minor suffers or is of a nature
p.000000: which can only be performed on minors;
p.000000: (b) in the case of a minor under the age of 16, the consent of the person entitled to make the declaration
p.000000: contains the probable will of a minor capable of forming an opinion and assessing the situation, and this a
p.000000: the declaration may be withdrawn at any time without the minor being adversely affected;
p.000000: (c) an investigator with experience in relation to minors shall, depending on his or her intellectual level,
p.000000: properly informed of the study, adverse and beneficial effects in a way that is comprehensible to him;
p.000000: (d) the investigator or study director takes full account of the
p.000000: a minor under the age of 16 who is able to assess the situation explicitly refuses to participate in the study, or
p.000000: that you wish to withdraw from the investigation at any time;
p.000000: e) *
p.000000: 20 / J. § *
p.000000: (1) *
p.000000: A non-interventional study shall not be included in a
p.000000: incapacitated or disabled minor; and
p.000000: the exercise of rights relating to healthcare, and
p.000000: a person who is partially restricted in the case of a group of property
p.000000: in its possession, it expressly excluded its participation in such investigations. Not for a particular study
p.000000: nor may he be involved who has previously refused consent in possession of his capacity to act
p.000000: for that study.
p.000000: (2) *
p.000000: Incapacitated or incapacitated with health care
p.000000: the exercise of related rights and a group of assets of a property nature
p.000000: partially restricted in adults 20 / G-20 / H. § only with proper application
p.000000: a non - interventional test may be carried out if - in paragraph 1
p.000000: all of the following conditions are met:
...
Social / Incarcerated
Searching for indicator restricted:
(return to top)
p.000000: (i) a warning that the consent is voluntary and unaffected,
p.000000: it may be withdrawn at any time, either orally or in writing, without giving any reason, without
p.000000: disadvantage,
p.000000: j) the rules for handling and accessing the participant's data,
p.000000: k) *
p.000000: giving the opinion of the competent authority necessary for the commencement of the research
p.000000: the name of the ethics committee, as well as the name of the chairman of IKEB and the independent doctor pursuant to Section 12 (5), and
p.000000: contact information.
p.000000: (5) The participant shall give his or her consent in writing. The statement of consent shall include at least:
p.000000: includes:
p.000000: a) identification of the research,
p.000000: (b) the name of the healthcare institution where the research is to be carried out,
p.000000: c) the name, position and position of the head of the research or the person providing the information
p.000000: Name,
p.000000: d) *
p.000000: identification data of the participant (name, mother 's name, place and time of birth, TAJ
p.000000: number, address), a minor with limited legal capacity and
p.000000: the exercise of related rights and a group of assets of a property nature
p.000000: in the case of a partially restricted or incapacitated participant, the legal representative giving the consent
p.000000: identification data,
p.000000: e) *
p.000000: a statement that the participant has limited legal capacity
p.000000: minors and their capacity to act in relation to the exercise of healthcare rights,
p.000000: and is partially restricted or
p.000000: in the case of an incapacitated participant, also the legal representative - in the research
p.000000: following the information provided for in paragraph 1,
p.000000: without influence, knowing that at any time, orally or in writing, without giving any reason
p.000000: revocable,
p.000000: f) the date of signature of the statement of consent,
p.000000: g) the signature of the research leader or information provider,
p.000000: (h) the signature of the person giving his consent and, in the case referred to in paragraph 7, of the witness.
p.000000: (6) *
p.000000: The person providing the information and the participant - to a limited extent
p.000000: the legal capacity of a minor and the exercise of health care rights in his or her capacity to act
p.000000: and in respect of a class of property of a limited nature or
p.000000: in the case of an incapacitated participant, the legal representative - also the written information pursuant to paragraph 4
p.000000: sign.
p.000000: (7) *
p.000000: If you want to be involved in the research, or to a limited extent
p.000000: the legal capacity of a minor and the exercise of health care rights in his or her capacity to act
...
p.000000: for the primary purpose of sampling, for diagnostic purposes only, or
p.000000: whether it contributes to its use, ie for diagnostic and research purposes.
p.000000: 4 / B. § *
p.000000: (1) If the research is due to a human genetic test
p.000000: a separate statement of consent shall be drawn up.
p.000000: 2. The participant's statement of consent shall include at least the following:
p.000000: (a) the identity of the research;
p.000000: (b) the name of the healthcare provider where the research is to be performed;
p.000000: c) the name, position and position of the head of the research or the person providing the information
p.000000: designation;
p.000000: d) *
p.000000: identification of the participant (name, place and date of birth),
p.000000: a minor with limited legal capacity and rights related to health care in his or her capacity to act
p.000000: and partially limited to a group of property cases
p.000000: or in the case of an incapacitated subject, the Eütv. The person entitled to make a declaration pursuant to § 16 (a
p.000000: hereinafter referred to as the "person entitled to make a declaration");
p.000000: e) *
p.000000: a statement that the participant has limited legal capacity
p.000000: minors and their capacity to act in relation to the exercise of healthcare rights,
p.000000: and is partially restricted or
p.000000: in the case of an incapacitated subject, the person entitled to make a statement - in the genetic test
p.000000: consent to participate in Article 4 / A. § or the information contained therein
p.000000: voluntarily, without influence, after resignation, in the knowledge that at any time,
p.000000: may be revoked orally or in writing without giving reasons;
p.000000: (f) the consent to the taking of a sample of the quantity and quality indicated in the prospectus and the identity of the participant
p.000000: use;
p.000000: (g) a statement as to how the samples will be handled, stating that it may decide on the sample to be provided
p.000000: biobank and the method of disposal, so that a sample is possible
p.000000: (ga) storage of personal data,
p.000000: gb) in encrypted form,
p.000000: gc) pseudonymised, ie in a form in which the
p.000000: the replacement code has been made available to the subject exclusively,
p.000000: (gd) anonymised, ie in a form where all the data relating to the subject are available
p.000000: personally identifiable information has been rendered unfit for identification;
p.000000: (h) a statement by the participant that the sample placed in the biobank is participating in further research; in this
p.000000: In this case, the participant must declare that his sample is the primary purpose of sampling
p.000000: diagnostic, for research purposes only, or any, ie diagnostic and research
p.000000: contributes to its use for its intended purpose;
p.000000: (i) the manner in which the result is to be communicated, even if the subject does not have access to it;
p.000000: (j) consenting to or excluding any future request;
p.000000: (k) the date of signature of the statement of consent;
p.000000: (l) the signature of the research leader or information provider;
p.000000: (m) the signature of the person giving his consent.
p.000000: Exercising a minor with limited legal capacity and rights related to health care in her capacity to act
p.000000: partially limited and incapacitated
p.000000: involvement of a person in research *
p.000000: § 5 (1) *
p.000000: If the research - the Eütv. Section 159 (4) and (5)
p.000000: subject to certain conditions - a minor with limited legal capacity and
p.000000: the exercise of rights relating to healthcare and of a pecuniary nature
p.000000: involving a partially restricted person in respect of a case group, both
p.000000: a minor with limited legal capacity and rights related to health care in his or her capacity to act
p.000000: and in respect of a group of property-type matters
p.000000: both the restricted person and his legal representative shall be informed in accordance with Section 4.
p.000000: (2) *
p.000000: Research can only be conducted on a minor with limited legal capacity and
p.000000: the exercise of rights relating to healthcare, and
p.000000: in the case of a group of property of a partially limited nature, if both the
p.000000: a minor with limited legal capacity and rights related to health care in his or her capacity to act
p.000000: and a group of assets of a property nature
p.000000: the consent of both a partially restricted person and his or her legal representative. The consent
p.000000: statement of both the minor with limited legal capacity and the capacity of the minor
p.000000: the exercise of rights relating to healthcare and of a pecuniary nature
p.000000: must be signed by both the person who is partially restricted in respect of the case and his or her legal representative.
p.000000: § 6 (1) *
p.000000: If the research - the Eütv. Section 159 (4) and (5)
p.000000: in accordance with the conditions laid down in paragraph 2, it is intended to involve an incapacitated person
p.000000: shall be in accordance with the provisions of
p.000000: (2) The Eütv. A person pursuant to Section 16 (1) - (2) shall comply with the provisions of Section 4
p.000000: be properly informed. In addition, a person who is incapacitated shall, in accordance with his or her judgment,
p.000000: be informed of all the research
p.000000: important circumstance, its risk and its positive or negative impact.
p.000000: A person with pedagogical experience should also be involved in informing the minor.
p.000000: (3) If the incapacitated person has understood the information, he or she can assess it and explicitly
p.000000: refuses to participate in the research or intends to withdraw from the research, this should be done to the research leader,
p.000000: or fully taken into account by the person conducting the research.
p.000000: (4) If the incapacitated person becomes able to act, as soon as possible
p.000000: be informed of the research and seek its consent to continue it. Failing this, the
p.000000: research may not be carried out on the person concerned.
...
p.000000: which can only be performed on minors;
p.000000: (b) in the case of a minor under the age of 16, the consent of the person entitled to make the declaration
p.000000: contains the probable will of a minor capable of forming an opinion and assessing the situation, and this a
p.000000: the declaration may be withdrawn at any time without the minor being adversely affected;
p.000000: (c) an investigator with experience in relation to minors shall, depending on his or her intellectual level,
p.000000: properly informed of the study, adverse and beneficial effects in a way that is comprehensible to him;
p.000000: (d) the investigator or study director takes full account of the
p.000000: a minor under the age of 16 who is able to assess the situation explicitly refuses to participate in the study, or
p.000000: that you wish to withdraw from the investigation at any time;
p.000000: e) *
p.000000: 20 / J. § *
p.000000: (1) *
p.000000: A non-interventional study shall not be included in a
p.000000: incapacitated or disabled minor; and
p.000000: the exercise of rights relating to healthcare, and
p.000000: a person who is partially restricted in the case of a group of property
p.000000: in its possession, it expressly excluded its participation in such investigations. Not for a particular study
p.000000: nor may he be involved who has previously refused consent in possession of his capacity to act
p.000000: for that study.
p.000000: (2) *
p.000000: Incapacitated or incapacitated with health care
p.000000: the exercise of related rights and a group of assets of a property nature
p.000000: partially restricted in adults 20 / G-20 / H. § only with proper application
p.000000: a non - interventional test may be carried out if - in paragraph 1
p.000000: all of the following conditions are met:
p.000000: (a) in the case of a person who is incapacitated, the consent of the person entitled to make the declaration
p.000000: it must contain the presumed will of the subject and this statement at any time
p.000000: can be withdrawn without prejudice to the subject;
p.000000: (b) the subject has been adequately informed of the study in a manner that is comprehensible to the subject, favorable and
p.000000: adverse effects;
p.000000: (c) in the case of an incapacitated person, the investigator and the investigator-in-charge shall take full
p.000000: the subject, who is able to form an opinion and assess the situation, expressly excludes from the study
p.000000: participation or wish to withdraw from the investigation at any time;
p.000000: d) *
p.000000: human medical research for human use
p.000000: clinical trials of investigational medicinal products and
p.000000: laying down rules for the authorization procedure for clinical trials on medical devices intended for clinical investigations
p.000000: 235/2009 (X. 20.) Government Decree [hereinafter: 235/2009. (X. 20.) Government Decree] Section 17 (1)
p.000000: (hereinafter referred to as the licensing authority) shall be the appropriate specialist for the disease in question
p.000000: decide on the authorization in the light of its opinion.
p.000000: (3) If the subject is able to act during the non-interventional investigation
...
Social / Linguistic Proficiency
Searching for indicator language:
(return to top)
p.000000: and epidemiological and public health contexts.
p.000000: (2) A non-interventional investigation shall be performed on a minor or a person with incapacitated
p.000000: its capacity to exercise its rights in relation to healthcare, and
p.000000: in respect of a group of property of a partially limited nature, 20 / I-20 / J. §-in
p.000000: subject only to the coexistence of the following conditions
p.000000: can be performed in case of: *
p.000000: (a) the investigation may not be carried out on a person of comparable efficiency;
p.000000: b) *
p.000000: the Eütv. Person pursuant to Section 16, Paragraphs (1) - (2) - subject to the provisions of Art. 16th
p.000000: § (5) - or with limited legal capacity over the age of 16
p.000000: in respect of the exercise of rights in relation to a minor or a person with legal capacity,
p.000000: and a subject of partial investigation limited to a group of property - related matters
p.000000: gave his consent.
p.000000: 20 / Mon. § *
p.000000: 1. The subject of a non-interventional study shall be included in the study
p.000000: prior to the consent of the investigator or the investigator, orally and in writing in Hungarian - or
p.000000: in the subject's mother tongue or in another language indicated by the subject - known to the lay person
p.000000: orally and in writing
p.000000: (a) the voluntary nature of the participation in the study and the fact that the consent may be given at any time;
p.000000: (2) may be revoked orally or in writing without giving any reason and without adverse consequences;
p.000000: b) the essence, purpose, expected duration and place of the planned investigation, the persons to be involved
p.000000: the number or scope of the
p.000000: (c) the expected benefits and reimbursement to the subject of the investigation or to others, if
p.000000: It happens;
p.000000: (d) rules on the handling of, and access to, subject data;
p.000000: e) the name, position and job title of the person (s) responsible for the investigation;
p.000000: (f) the identity of the non-interventional study;
p.000000: g) the name and registered office of the applicant.
p.000000: 2. The subject shall obtain the written consent of the subject following the information referred to in paragraph 1
p.000000: add to the test. If the subject is unable to write in writing, or
p.000000: due to illiteracy, is not interested in two non-interventional
p.000000: oral consent in the joint presence of a witness is required for the investigation. In the case of oral consent a
p.000000: a statement must be made in writing certifying the verbal consent signed by the two witnesses
...
Social / Occupation
Searching for indicator job:
(return to top)
p.000000: § (5) - or with limited legal capacity over the age of 16
p.000000: in respect of the exercise of rights in relation to a minor or a person with legal capacity,
p.000000: and a subject of partial investigation limited to a group of property - related matters
p.000000: gave his consent.
p.000000: 20 / Mon. § *
p.000000: 1. The subject of a non-interventional study shall be included in the study
p.000000: prior to the consent of the investigator or the investigator, orally and in writing in Hungarian - or
p.000000: in the subject's mother tongue or in another language indicated by the subject - known to the lay person
p.000000: orally and in writing
p.000000: (a) the voluntary nature of the participation in the study and the fact that the consent may be given at any time;
p.000000: (2) may be revoked orally or in writing without giving any reason and without adverse consequences;
p.000000: b) the essence, purpose, expected duration and place of the planned investigation, the persons to be involved
p.000000: the number or scope of the
p.000000: (c) the expected benefits and reimbursement to the subject of the investigation or to others, if
p.000000: It happens;
p.000000: (d) rules on the handling of, and access to, subject data;
p.000000: e) the name, position and job title of the person (s) responsible for the investigation;
p.000000: (f) the identity of the non-interventional study;
p.000000: g) the name and registered office of the applicant.
p.000000: 2. The subject shall obtain the written consent of the subject following the information referred to in paragraph 1
p.000000: add to the test. If the subject is unable to write in writing, or
p.000000: due to illiteracy, is not interested in two non-interventional
p.000000: oral consent in the joint presence of a witness is required for the investigation. In the case of oral consent a
p.000000: a statement must be made in writing certifying the verbal consent signed by the two witnesses
p.000000: took place. In the event of the subject's ability to recover, the statement of consent shall be issued by the
p.000000: confirm the written statement of consent before proceeding with the investigation, failing which
p.000000: shall be deemed to be withdrawn and the investigation may not be continued on the person concerned.
p.000000: 3. In the case of an oral statement of consent, the two witnesses shall certify that the subject is in accordance with paragraph 1.
p.000000: and the statement of consent referred to in paragraph 4 has been communicated to him and orally
p.000000: agreed.
p.000000: In addition to paragraph 1, the subject 's statement of consent shall in particular:
p.000000: shall include, as appropriate:
...
Social / Property Ownership
Searching for indicator property:
(return to top)
p.000000: and in accordance with the Declaration of Helsinki adopted by the World Medical Association,
p.000000: I order the following:
p.000000: § 1 (1) *
p.000000: The provisions of this Regulation shall apply to min (dhetntpe: m // blearenndivnéggz.ewttolte
p.000000: medical research (Section 157 of the Eütv., hereinafter: research). test
p.000000: In the case of a clinical trial of a medicinal product and a medical device, the provisions of this Regulation shall apply to
p.000000: prevail. It qualifies as medical research in particular
p.000000: utm_source = netjogta
p.000000: (a) to improve diagnostic, therapeutic, preventive and rehabilitative procedures, new
p.000000: procedures and a better understanding of the pathology and course of diseases,
p.000000: b) genetic,
p.000000: (c) cells, cell constituents, tissues, organs removed from a living human or dead body,
p.000000: done with a body part,
p.000000: d) epidemiological,
p.000000: (e) in the public health and epidemiological interest,
p.000000: f) *
p.000000: g) research on gametes and embryos.
p.000000: (2) - (3) *
p.000000: § 2. (1) For the purposes of this Decree
p.000000: the) *
p.000000: statement of consent: the person participating in the investigation has legal capacity
p.000000: person in the Eütv. 159 (1) e), or to a limited extent
p.000000: the legal capacity of a minor and the exercise of health care rights in his or her capacity to act
p.000000: and in respect of a class of property of a limited nature or
p.000000: in the case of an incapacitated person, the Eütv. A statement pursuant to Section 159 (4) (d);
p.000000: (b) research plan: the objectives, planned course, methods, statistical aspects of the research and
p.000000: documentation on its organizational issues prepared in advance in accordance with this Regulation;
p.000000: including further versions and modifications thereof;
p.000000: c) *
p.000000: (d) undesirable event: an adverse event in the research subject's state of health
p.000000: a change that does not necessarily result from the treatment applied;
p.000000: (e) "serious adverse event" means an adverse event that is life-threatening;
p.000000: requires or prolongs hospital treatment, is permanent
p.000000: causes damage to health, disability, congenital anomaly, birth defect or death;
p.000000: f) *
p.000000: (g) research coordinator: in the case of multi-center research, the researcher responsible for coordinating the research;
p.000000: h) *
p.000000: non-commercial research: industrial, commercial, service provider
p.000000: research carried out by researchers independent of business, which does not even indirectly serve the material of the sponsor
p.000000: profit and
p.000000: (ha) commissioned by an independent researcher or non-profit organization, in particular an educational organization
p.000000: institution, funded health care provider, publicly funded research institute, social
p.000000: organization,
p.000000: (hb) the research is planned and carried out by the sponsor in accordance with point (ha),
p.000000: (hc) the data resulting from the research become the property of the sponsor in accordance with point (ha),
p.000000: (hd) the results of the research are communicated by the sponsor in accordance with point (ha).
p.000000: i) *
p.000000: (2) *
p.000000: In addition to the provisions of paragraph 1, for the purposes of this Regulation,
p.000000: and the authorization procedure for medical research on human beings
p.000000: definitions contained in a separate legal act on the rules of
p.000000: taking into account.
p.000000: Protection of the person involved in the research
p.000000: § 3. (1) A person with legal capacity may be involved in research if the Eütv. Section 159 (1) - (3)
p.000000: compliance with the conditions laid down in paragraphs 1 and 2 and with the requirements of this Regulation.
p.000000: (2) The research may not replace for the participant what is necessary from a medical-professional point of view, a
p.000000: examinations and interventions for the prevention, early detection and treatment of diseases.
p.000000: 3. Where research is intended to involve persons of reproductive age, the planning, authorization,
p.000000: in informing participants, special attention should be paid to research on fertility and fertility,
p.000000: pregnancy, embryonal / fetal health, which may occur at the time of inclusion in the research,
p.000000: impact.
p.000000: (4) Research should be designed and conducted in a manner that minimizes the person involved in the research
p.000000: possible damage, pain, fear and anxiety. The age of the person involved, health
p.000000: any foreseeable risks associated with the condition should be considered in the research
p.000000: planning and control.
...
p.000000: the name and contact details of the liability insurer referred to in
p.000000: (h) the reimbursement, if any, of the costs incurred by the participant for participating in the research;
p.000000: (i) a warning that the consent is voluntary and unaffected,
p.000000: it may be withdrawn at any time, either orally or in writing, without giving any reason, without
p.000000: disadvantage,
p.000000: j) the rules for handling and accessing the participant's data,
p.000000: k) *
p.000000: giving the opinion of the competent authority necessary for the commencement of the research
p.000000: the name of the ethics committee, as well as the name of the chairman of IKEB and the independent doctor pursuant to Section 12 (5), and
p.000000: contact information.
p.000000: (5) The participant shall give his or her consent in writing. The statement of consent shall include at least:
p.000000: includes:
p.000000: a) identification of the research,
p.000000: (b) the name of the healthcare institution where the research is to be carried out,
p.000000: c) the name, position and position of the head of the research or the person providing the information
p.000000: Name,
p.000000: d) *
p.000000: identification data of the participant (name, mother 's name, place and time of birth, TAJ
p.000000: number, address), a minor with limited legal capacity and
p.000000: the exercise of related rights and a group of assets of a property nature
p.000000: in the case of a partially restricted or incapacitated participant, the legal representative giving the consent
p.000000: identification data,
p.000000: e) *
p.000000: a statement that the participant has limited legal capacity
p.000000: minors and their capacity to act in relation to the exercise of healthcare rights,
p.000000: and is partially restricted or
p.000000: in the case of an incapacitated participant, also the legal representative - in the research
p.000000: following the information provided for in paragraph 1,
p.000000: without influence, knowing that at any time, orally or in writing, without giving any reason
p.000000: revocable,
p.000000: f) the date of signature of the statement of consent,
p.000000: g) the signature of the research leader or information provider,
p.000000: (h) the signature of the person giving his consent and, in the case referred to in paragraph 7, of the witness.
p.000000: (6) *
p.000000: The person providing the information and the participant - to a limited extent
p.000000: the legal capacity of a minor and the exercise of health care rights in his or her capacity to act
p.000000: and in respect of a class of property of a limited nature or
p.000000: in the case of an incapacitated participant, the legal representative - also the written information pursuant to paragraph 4
p.000000: sign.
p.000000: (7) *
p.000000: If you want to be involved in the research, or to a limited extent
p.000000: the legal capacity of a minor and the exercise of health care rights in his or her capacity to act
p.000000: and in respect of a class of property of a limited nature or
p.000000: in the case of an incapacitated person, the legal representative cannot read the consent form
p.000000: the joint presence of two independent witnesses shall be ensured when providing the necessary information. Witnesses a
p.000000: by signing a statement of consent, they certify that the person to be included in the investigation is lawful
p.000000: provided with all possible information and the person and / or legal representative of the person to be involved
p.000000: gave its consent voluntarily and without interference.
p.000000: (8) If, in the course of the research, new relevant information becomes available in connection with the research,
p.000000: which affects the contents of the written prospectus, an amendment to the permit shall be initiated in Section 13
p.000000: in accordance with In accordance with the amended written information
p.000000: you must be informed again and your written consent must be sought to continue the research.
p.000000: 4 / A. § *
p.000000: (1) If specified in the special legislation during the research
p.000000: samples are taken for human genetic testing, the participant shall be informed separately. THE
p.000000: the information shall also include the right of the participant to be sampled separately
p.000000: in this case, the genetic data relating to him may no longer be anonymous
p.000000: to use. Rejection of sampling does not constitute a barrier to participant participation in further research
p.000000: section. Information on and agreement to sampling in a separate document
p.000000: must be booked.
...
p.000000: placement method so that a sample is possible
p.000000: (ga) storage of personal data,
p.000000: gb) in encrypted form,
p.000000: gc) pseudonymised, ie in a form in which the
p.000000: the replacement code has been made available to the subject exclusively,
p.000000: (gd) anonymised, ie in a form where all the data relating to the subject are available
p.000000: personally identifiable information has been rendered inoperable.
p.000000: (3) The participant shall also be informed that it may decide to add a sample to the biobank
p.000000: participation in research. In this case, the participant must declare that:
p.000000: for the primary purpose of sampling, for diagnostic purposes only, or
p.000000: whether it contributes to its use, ie for diagnostic and research purposes.
p.000000: 4 / B. § *
p.000000: (1) If the research is due to a human genetic test
p.000000: a separate statement of consent shall be drawn up.
p.000000: 2. The participant's statement of consent shall include at least the following:
p.000000: (a) the identity of the research;
p.000000: (b) the name of the healthcare provider where the research is to be performed;
p.000000: c) the name, position and position of the head of the research or the person providing the information
p.000000: designation;
p.000000: d) *
p.000000: identification of the participant (name, place and date of birth),
p.000000: a minor with limited legal capacity and rights related to health care in his or her capacity to act
p.000000: and partially limited to a group of property cases
p.000000: or in the case of an incapacitated subject, the Eütv. The person entitled to make a declaration pursuant to § 16 (a
p.000000: hereinafter referred to as the "person entitled to make a declaration");
p.000000: e) *
p.000000: a statement that the participant has limited legal capacity
p.000000: minors and their capacity to act in relation to the exercise of healthcare rights,
p.000000: and is partially restricted or
p.000000: in the case of an incapacitated subject, the person entitled to make a statement - in the genetic test
p.000000: consent to participate in Article 4 / A. § or the information contained therein
p.000000: voluntarily, without influence, after resignation, in the knowledge that at any time,
p.000000: may be revoked orally or in writing without giving reasons;
p.000000: (f) the consent to the taking of a sample of the quantity and quality indicated in the prospectus and the identity of the participant
p.000000: use;
p.000000: (g) a statement as to how the samples will be handled, stating that it may decide on the sample to be provided
p.000000: biobank and the method of disposal, so that a sample is possible
p.000000: (ga) storage of personal data,
p.000000: gb) in encrypted form,
p.000000: gc) pseudonymised, ie in a form in which the
p.000000: the replacement code has been made available to the subject exclusively,
p.000000: (gd) anonymised, ie in a form where all the data relating to the subject are available
...
p.000000: contributes to its use for its intended purpose;
p.000000: (i) the manner in which the result is to be communicated, even if the subject does not have access to it;
p.000000: (j) consenting to or excluding any future request;
p.000000: (k) the date of signature of the statement of consent;
p.000000: (l) the signature of the research leader or information provider;
p.000000: (m) the signature of the person giving his consent.
p.000000: Exercising a minor with limited legal capacity and rights related to health care in her capacity to act
p.000000: partially limited and incapacitated
p.000000: involvement of a person in research *
p.000000: § 5 (1) *
p.000000: If the research - the Eütv. Section 159 (4) and (5)
p.000000: subject to certain conditions - a minor with limited legal capacity and
p.000000: the exercise of rights relating to healthcare and of a pecuniary nature
p.000000: involving a partially restricted person in respect of a case group, both
p.000000: a minor with limited legal capacity and rights related to health care in his or her capacity to act
p.000000: and in respect of a group of property-type matters
p.000000: both the restricted person and his legal representative shall be informed in accordance with Section 4.
p.000000: (2) *
p.000000: Research can only be conducted on a minor with limited legal capacity and
p.000000: the exercise of rights relating to healthcare, and
p.000000: in the case of a group of property of a partially limited nature, if both the
p.000000: a minor with limited legal capacity and rights related to health care in his or her capacity to act
p.000000: and a group of assets of a property nature
p.000000: the consent of both a partially restricted person and his or her legal representative. The consent
p.000000: statement of both the minor with limited legal capacity and the capacity of the minor
p.000000: the exercise of rights relating to healthcare and of a pecuniary nature
p.000000: must be signed by both the person who is partially restricted in respect of the case and his or her legal representative.
p.000000: § 6 (1) *
p.000000: If the research - the Eütv. Section 159 (4) and (5)
p.000000: in accordance with the conditions laid down in paragraph 2, it is intended to involve an incapacitated person
p.000000: shall be in accordance with the provisions of
p.000000: (2) The Eütv. A person pursuant to Section 16 (1) - (2) shall comply with the provisions of Section 4
p.000000: be properly informed. In addition, a person who is incapacitated shall, in accordance with his or her judgment,
p.000000: be informed of all the research
p.000000: important circumstance, its risk and its positive or negative impact.
p.000000: A person with pedagogical experience should also be involved in informing the minor.
...
p.000000: in the case of non - interventional medical research (hereinafter together: non - interventional study) a
p.000000: 20 / B-20 / S. §.
p.000000: 20 / B. § *
p.000000: For the purposes of this Chapter:
p.000000: the) *
p.000000: sponsor: any natural or legal person who you are
p.000000: which initiates, conducts or finances a non-interventional investigation. The investigator and
p.000000: the principal may be the same person;
p.000000: (b) subject: a person participating in a non-interventional study who or to whom
p.000000: the data is used to continue the investigation or who participates in the investigation as a control person;
p.000000: (c) ‘investigator’ means a person charged with carrying out a non-interventional investigation in a
p.000000: test site;
p.000000: (d) principal investigator: the responsible leader of the team at a particular investigation site if the
p.000000: a non-interventional study is performed by a group of several investigators;
p.000000: (e) recruitment: the recruitment of a non-interventional study by the person who authorized the study;
p.000000: an authorized public call for the purpose of involving subjects in an investigation;
p.000000: f) non-commercial trial: from industrial, commercial, service companies
p.000000: research carried out by independent investigators which does not even indirectly serve the financial gain of the sponsor; and
p.000000: (fa) commissioned by an independent investigator or non-profit organization, in particular an educational organization
p.000000: institution, funded health care provider, publicly funded research institute, social
p.000000: organization,
p.000000: (fb) the investigation is planned and continued by the sponsor in accordance with point (fa),
p.000000: fc) the data resulting from the investigation become the property of the principal referred to in point (fa),
p.000000: (fd) the results of the test are communicated by the sponsor in accordance with point (fa);
p.000000: g) *
p.000000: coordinating study director: in the case of a multicenter study, the study
p.000000: responsible for the whole.
p.000000: h) *
p.000000: 20 / C. § *
p.000000: The following, in particular, shall be considered as non - interventional investigations:
p.000000: a) security,
p.000000: b) pharmacoeconomic,
p.000000: c) quality of life,
p.000000: d) epidemiological,
p.000000: e) compliance / persistence,
p.000000: f) observation cohort,
p.000000: g) retrospective case control,
p.000000: (h) other observational tests.
p.000000: 20 / D. § *
p.000000: 20 / E. § *
p.000000: 20 / F. § *
p.000000: (1) *
p.000000: The sponsor, the study director and the investigator, if the
p.000000: the purpose of the test cannot be achieved without recruitment or only with disproportionate difficulty, test
p.000000: you can recruit subjects in the press or on your own website
p.000000: by means of a published call. The text of the invitation to participate must state the purpose of the investigation,
p.000000: methods, marking the range of subjects to be selected, with the candidates
p.000000: any reimbursement to be made to the elected
p.000000: and the rules for processing the data of applicants. The call cannot be
p.000000: for advertising purposes. The published call must refer to the existence of a supporting professional ethics license. THE
p.000000: In the event of a deviation from the permitted method and text of recruitment, an amendment to the license shall be initiated.
p.000000: (2) The subject and the Eütv. The person entitled to make a declaration pursuant to § 16 (a
p.000000: hereinafter referred to as "the person entitled to make a declaration")
p.000000: loss of income and costs related to participation in the investigation, in particular
p.000000: Reimbursement may be made for expenses actually incurred and justified in connection with the journey.
p.000000: No other benefits or fees may be granted to the subject and the person entitled to make a statement.
p.000000: 20 / G. § *
p.000000: (1) Non-interventional investigation of a person with legal capacity
p.000000: improvement of diagnostic, therapeutic, prevention and rehabilitation procedures only,
p.000000: development and evaluation of procedures, as well as the pathogenesis and pathogenesis of diseases
p.000000: and epidemiological and public health contexts.
p.000000: (2) A non-interventional investigation shall be performed on a minor or a person with incapacitated
p.000000: its capacity to exercise its rights in relation to healthcare, and
p.000000: in respect of a group of property of a partially limited nature, 20 / I-20 / J. §-in
p.000000: subject only to the coexistence of the following conditions
p.000000: can be performed in case of: *
p.000000: (a) the investigation may not be carried out on a person of comparable efficiency;
p.000000: b) *
p.000000: the Eütv. Person pursuant to Section 16, Paragraphs (1) - (2) - subject to the provisions of Art. 16th
p.000000: § (5) - or with limited legal capacity over the age of 16
p.000000: in respect of the exercise of rights in relation to a minor or a person with legal capacity,
p.000000: and a subject of partial investigation limited to a group of property - related matters
p.000000: gave his consent.
p.000000: 20 / Mon. § *
p.000000: 1. The subject of a non-interventional study shall be included in the study
p.000000: prior to the consent of the investigator or the investigator, orally and in writing in Hungarian - or
p.000000: in the subject's mother tongue or in another language indicated by the subject - known to the lay person
p.000000: orally and in writing
p.000000: (a) the voluntary nature of the participation in the study and the fact that the consent may be given at any time;
p.000000: (2) may be revoked orally or in writing without giving any reason and without adverse consequences;
p.000000: b) the essence, purpose, expected duration and place of the planned investigation, the persons to be involved
p.000000: the number or scope of the
p.000000: (c) the expected benefits and reimbursement to the subject of the investigation or to others, if
p.000000: It happens;
p.000000: (d) rules on the handling of, and access to, subject data;
p.000000: e) the name, position and job title of the person (s) responsible for the investigation;
p.000000: (f) the identity of the non-interventional study;
p.000000: g) the name and registered office of the applicant.
p.000000: 2. The subject shall obtain the written consent of the subject following the information referred to in paragraph 1
p.000000: add to the test. If the subject is unable to write in writing, or
p.000000: due to illiteracy, is not interested in two non-interventional
...
p.000000: which can only be performed on minors;
p.000000: (b) in the case of a minor under the age of 16, the consent of the person entitled to make the declaration
p.000000: contains the probable will of a minor capable of forming an opinion and assessing the situation, and this a
p.000000: the declaration may be withdrawn at any time without the minor being adversely affected;
p.000000: (c) an investigator with experience in relation to minors shall, depending on his or her intellectual level,
p.000000: properly informed of the study, adverse and beneficial effects in a way that is comprehensible to him;
p.000000: (d) the investigator or study director takes full account of the
p.000000: a minor under the age of 16 who is able to assess the situation explicitly refuses to participate in the study, or
p.000000: that you wish to withdraw from the investigation at any time;
p.000000: e) *
p.000000: 20 / J. § *
p.000000: (1) *
p.000000: A non-interventional study shall not be included in a
p.000000: incapacitated or disabled minor; and
p.000000: the exercise of rights relating to healthcare, and
p.000000: a person who is partially restricted in the case of a group of property
p.000000: in its possession, it expressly excluded its participation in such investigations. Not for a particular study
p.000000: nor may he be involved who has previously refused consent in possession of his capacity to act
p.000000: for that study.
p.000000: (2) *
p.000000: Incapacitated or incapacitated with health care
p.000000: the exercise of related rights and a group of assets of a property nature
p.000000: partially restricted in adults 20 / G-20 / H. § only with proper application
p.000000: a non - interventional test may be carried out if - in paragraph 1
p.000000: all of the following conditions are met:
p.000000: (a) in the case of a person who is incapacitated, the consent of the person entitled to make the declaration
p.000000: it must contain the presumed will of the subject and this statement at any time
p.000000: can be withdrawn without prejudice to the subject;
p.000000: (b) the subject has been adequately informed of the study in a manner that is comprehensible to the subject, favorable and
p.000000: adverse effects;
p.000000: (c) in the case of an incapacitated person, the investigator and the investigator-in-charge shall take full
p.000000: the subject, who is able to form an opinion and assess the situation, expressly excludes from the study
p.000000: participation or wish to withdraw from the investigation at any time;
p.000000: d) *
p.000000: human medical research for human use
p.000000: clinical trials of investigational medicinal products and
p.000000: laying down rules for the authorization procedure for clinical trials on medical devices intended for clinical investigations
p.000000: 235/2009 (X. 20.) Government Decree [hereinafter: 235/2009. (X. 20.) Government Decree] Section 17 (1)
p.000000: (hereinafter referred to as the licensing authority) shall be the appropriate specialist for the disease in question
p.000000: decide on the authorization in the light of its opinion.
...
Social / Soldier
Searching for indicator armedXforces:
(return to top)
p.000000: within its website publishes the 20 / O. § information.
p.000000: 20 / T. § *
p.000000: Miscellaneous and transitional provisions
p.000000: § 21. (1) This Decree shall enter into force on the 15th day following its promulgation.
p.000000: shall apply to authorization procedures initiated after 1 July.
p.000000: (2) *
p.000000: This Regulation shall apply to medicinal products for human use
p.000000: Directive 2001/83 / EC of the European Parliament and of the Council on the pharmacovigilance
p.000000: Directive 2010/84 / EU of the European Parliament and of the Council of 15 December 2010 amending
p.000000: for compliance.
p.000000: (3) *
p.000000: This Regulation is laid down in Regulation (EC) No 726/2004 of the European Parliament and of the Council
p.000000: and pharmacovigilance as provided for in Directive 2001/83 / EC of the European Parliament and of the Council
p.000000: Commission Implementing Regulation (EU) No 520/2012 of 19 June 2012 on the implementation of
p.000000: lays down the provisions necessary for its implementation.
p.000000: Annex 1 to Decree 23/2002. (V. 9.) EüM decree *
p.000000: Area of competence of regional research ethics committees
p.000000: Name of the researcher or the committee
p.000000: the name of the licensing health institution
p.000000: 1. *
p.000000: Semmelweis University
p.000000: Semmelweis University Regional,
p.000000: and its institutions, the Ministry headed by Pest County and the Minister responsible for health
p.000000: health care institutions under the direct supervision of the capital
p.000000: Institutional Scientific and Research Ethics Committee
p.000000: 2. *
p.000000: Hungarian Armed Forces,
p.000000: Military Hospital-ÁEK Institutional and
p.000000: Health Institutions of the Ministry headed by the Minister responsible for law enforcement, Railway Health
p.000000: institutions
p.000000: 3. Other health care institutions based in Pest
p.000000: 4. Other health care institutions based in Buda
p.000000: 5. Health care institutions in Hajdú-Bihar and Szabolcs-Szatmár-Bereg counties
p.000000: 6. Health care institutions in Baranya, Somogy and Tolna counties
p.000000: 7. Csongrád, Bács-Kiskun, Békés and Jász-Nagykun-
p.000000: Regional Research Ethics Committee
p.000000: Metropolitan Municipality Uzsoki Street and Péterffy Sándor Street Hospitals Joint
p.000000: Regional Scientific and Research Ethics Committee
p.000000: Metropolitan Municipality of St. Imre and St. John Hospitals is a joint Regional Scientific
p.000000: and Research Ethics Committee
p.000000: University of Debrecen Medical and Health Sciences Center Regional Scientific
p.000000: and Research Ethics Committee
p.000000: University of Pécs Medical and Health Sciences Coordination Center Regional Science and Research Ethics
p.000000: Committee
p.000000: University of Szeged Szent-Györgyi Albert Medical and
p.000000: Health care institutions in Szolnok county, a
p.000000: With the exception of health care facilities specified in line 2
p.000000: 8. Health care institutions in Borsod-Abaúj-Zemplén, Heves and Nógrád counties
p.000000: 9. Health care institutions in Vas, Zala and Veszprém counties
...
Searching for indicator military:
(return to top)
p.000000: 20 / T. § *
p.000000: Miscellaneous and transitional provisions
p.000000: § 21. (1) This Decree shall enter into force on the 15th day following its promulgation.
p.000000: shall apply to authorization procedures initiated after 1 July.
p.000000: (2) *
p.000000: This Regulation shall apply to medicinal products for human use
p.000000: Directive 2001/83 / EC of the European Parliament and of the Council on the pharmacovigilance
p.000000: Directive 2010/84 / EU of the European Parliament and of the Council of 15 December 2010 amending
p.000000: for compliance.
p.000000: (3) *
p.000000: This Regulation is laid down in Regulation (EC) No 726/2004 of the European Parliament and of the Council
p.000000: and pharmacovigilance as provided for in Directive 2001/83 / EC of the European Parliament and of the Council
p.000000: Commission Implementing Regulation (EU) No 520/2012 of 19 June 2012 on the implementation of
p.000000: lays down the provisions necessary for its implementation.
p.000000: Annex 1 to Decree 23/2002. (V. 9.) EüM decree *
p.000000: Area of competence of regional research ethics committees
p.000000: Name of the researcher or the committee
p.000000: the name of the licensing health institution
p.000000: 1. *
p.000000: Semmelweis University
p.000000: Semmelweis University Regional,
p.000000: and its institutions, the Ministry headed by Pest County and the Minister responsible for health
p.000000: health care institutions under the direct supervision of the capital
p.000000: Institutional Scientific and Research Ethics Committee
p.000000: 2. *
p.000000: Hungarian Armed Forces,
p.000000: Military Hospital-ÁEK Institutional and
p.000000: Health Institutions of the Ministry headed by the Minister responsible for law enforcement, Railway Health
p.000000: institutions
p.000000: 3. Other health care institutions based in Pest
p.000000: 4. Other health care institutions based in Buda
p.000000: 5. Health care institutions in Hajdú-Bihar and Szabolcs-Szatmár-Bereg counties
p.000000: 6. Health care institutions in Baranya, Somogy and Tolna counties
p.000000: 7. Csongrád, Bács-Kiskun, Békés and Jász-Nagykun-
p.000000: Regional Research Ethics Committee
p.000000: Metropolitan Municipality Uzsoki Street and Péterffy Sándor Street Hospitals Joint
p.000000: Regional Scientific and Research Ethics Committee
p.000000: Metropolitan Municipality of St. Imre and St. John Hospitals is a joint Regional Scientific
p.000000: and Research Ethics Committee
p.000000: University of Debrecen Medical and Health Sciences Center Regional Scientific
p.000000: and Research Ethics Committee
p.000000: University of Pécs Medical and Health Sciences Coordination Center Regional Science and Research Ethics
p.000000: Committee
p.000000: University of Szeged Szent-Györgyi Albert Medical and
p.000000: Health care institutions in Szolnok county, a
p.000000: With the exception of health care facilities specified in line 2
p.000000: 8. Health care institutions in Borsod-Abaúj-Zemplén, Heves and Nógrád counties
p.000000: 9. Health care institutions in Vas, Zala and Veszprém counties
p.000000: 10. Health care institutions in Győr-Moson-Sopron, Komárom-Esztergom and Fejér counties
...
p.000000: 3. *
p.000000: Type of test
p.000000: Drug study Retrospective study
p.000000: Non-drug study
p.000000: Prospective study
p.000000: The study is a prescribed pharmacovigilance study
p.000000: 4. Test site (s)
p.000000: Yes No
p.000000: Date: ................................................ ..
p.000000: .................................................. ................
p.000000: principal's signature
p.000000: Annex 3 to Decree 23/2002. (V. 9.) EüM decree *
p.000000: Organizations involved in the authorization process and their bank account numbers
p.000000: 1. *
p.000000: VENUE OF
p.000000: On the man
p.000000: Name of the body Health
p.000000: Account Number State
p.000000: medical research other than clinical trials with investigational medicinal products
p.000000: non - interventional studies,
p.000000: clinical trials with medical devices and non-interventional
p.000000: tests and Tests 2-11. cases specified in the order
p.000000: Scientific Council,
p.000000: Committees and Bureau of the Scientific Council for Health
p.000000: Health Care Center 10032000-
p.000000: 01490576-
p.000000: 00000000
p.000000: 2. *
p.000000: Semmelweis
p.000000: Semmelweis University
p.000000: 10032000-
p.000000: University and
p.000000: institutions, Pest County and the Minister of Health
p.000000: under the direct supervision of the headed ministry in the territory of the capital
p.000000: health care institutions
p.000000: Regional, Institutional Scientific and Research Ethics Committee
p.282819: 00282819
p.282819: 3. *
p.282819: Hungarian
p.282819: AEK Military Hospital,
p.282819: 10023002-
p.282819: Defense Forces, a
p.282819: health institutions of the Ministry headed by the Minister responsible for law enforcement,
p.282819: health care institutions
p.282819: 4. Other health care institutions based in Pest
p.282819: 5. Other health care institutions based in Buda
p.282819: 6. Located in Hajdú-Bihar and Szabolcs-Szatmár-Bereg counties
p.282819: institutional
p.282819: and Regional
p.282819: Research Ethics Committee
p.282819: Metropolitan Municipality Uzsoki street
p.282819: and Péterffy Sándor Street Hospitals Joint Regional Scientific and
p.282819: Research Ethics Committee
p.282819: Metropolitan Municipality of St. Imre
p.282819: and St. John Hospitals Joint Regional Science and Research Ethics
p.282819: Committee
p.282819: University of Debrecen Medical
p.282819: and Health Sciences
p.290469: 00290469
p.290469: 11784009- p.15492674: 15492674 p.15492674: 11784009- p.15492564: 15492564 p.15492564: 10034002-
p.282981: 00282981
p.282981: health care institutions
p.282981: 7. Health care institutions in Baranya, Somogy and Tolna counties
p.282981: 8. Csongrád, Bács-
p.282981: Kiskun, Békés
p.282981: and health care institutions in Jász-Nagykun-Szolnok county, in the 3rd row
p.282981: with the exception of certain healthcare institutions
p.282981: 9. Health care institutions in Borsod-Abaúj-Zemplén, Heves and Nógrád counties
p.282981: 10. Health care institutions in Vas, Zala and Veszprém counties
p.282981: 11. Health care in Győr-Moson-Sopron, Komárom-Esztergom and Fejér counties
p.282981: Regional Scientific and Research Ethics Committee of the Center
...
Social / Youth/Minors
Searching for indicator minor:
(return to top)
p.000000: Additional Protocol to the Convention on the Prohibition of the Cloning of Human Beings
p.000000: and in accordance with the Declaration of Helsinki adopted by the World Medical Association,
p.000000: I order the following:
p.000000: § 1 (1) *
p.000000: The provisions of this Regulation shall apply to min (dhetntpe: m // blearenndivnéggz.ewttolte
p.000000: medical research (Section 157 of the Eütv., hereinafter: research). test
p.000000: In the case of a clinical trial of a medicinal product and a medical device, the provisions of this Regulation shall apply to
p.000000: prevail. It qualifies as medical research in particular
p.000000: utm_source = netjogta
p.000000: (a) to improve diagnostic, therapeutic, preventive and rehabilitative procedures, new
p.000000: procedures and a better understanding of the pathology and course of diseases,
p.000000: b) genetic,
p.000000: (c) cells, cell constituents, tissues, organs removed from a living human or dead body,
p.000000: done with a body part,
p.000000: d) epidemiological,
p.000000: (e) in the public health and epidemiological interest,
p.000000: f) *
p.000000: g) research on gametes and embryos.
p.000000: (2) - (3) *
p.000000: § 2. (1) For the purposes of this Decree
p.000000: the) *
p.000000: statement of consent: the person participating in the investigation has legal capacity
p.000000: person in the Eütv. 159 (1) e), or to a limited extent
p.000000: the legal capacity of a minor and the exercise of health care rights in his or her capacity to act
p.000000: and in respect of a class of property of a limited nature or
p.000000: in the case of an incapacitated person, the Eütv. A statement pursuant to Section 159 (4) (d);
p.000000: (b) research plan: the objectives, planned course, methods, statistical aspects of the research and
p.000000: documentation on its organizational issues prepared in advance in accordance with this Regulation;
p.000000: including further versions and modifications thereof;
p.000000: c) *
p.000000: (d) undesirable event: an adverse event in the research subject's state of health
p.000000: a change that does not necessarily result from the treatment applied;
p.000000: (e) "serious adverse event" means an adverse event that is life-threatening;
p.000000: requires or prolongs hospital treatment, is permanent
p.000000: causes damage to health, disability, congenital anomaly, birth defect or death;
p.000000: f) *
p.000000: (g) research coordinator: in the case of multi-center research, the researcher responsible for coordinating the research;
p.000000: h) *
p.000000: non-commercial research: industrial, commercial, service provider
p.000000: research carried out by researchers independent of business, which does not even indirectly serve the material of the sponsor
p.000000: profit and
p.000000: (ha) commissioned by an independent researcher or non-profit organization, in particular an educational organization
p.000000: institution, funded health care provider, publicly funded research institute, social
p.000000: organization,
...
p.000000: treatment, compensation and damages to be provided in case of violation of the right to privacy [Eütv. § 164
p.000000: (2)] and compensation [Eütv. 164 (1)], the Eütv. Section 164 (2)
p.000000: the name and contact details of the liability insurer referred to in
p.000000: (h) the reimbursement, if any, of the costs incurred by the participant for participating in the research;
p.000000: (i) a warning that the consent is voluntary and unaffected,
p.000000: it may be withdrawn at any time, either orally or in writing, without giving any reason, without
p.000000: disadvantage,
p.000000: j) the rules for handling and accessing the participant's data,
p.000000: k) *
p.000000: giving the opinion of the competent authority necessary for the commencement of the research
p.000000: the name of the ethics committee, as well as the name of the chairman of IKEB and the independent doctor pursuant to Section 12 (5), and
p.000000: contact information.
p.000000: (5) The participant shall give his or her consent in writing. The statement of consent shall include at least:
p.000000: includes:
p.000000: a) identification of the research,
p.000000: (b) the name of the healthcare institution where the research is to be carried out,
p.000000: c) the name, position and position of the head of the research or the person providing the information
p.000000: Name,
p.000000: d) *
p.000000: identification data of the participant (name, mother 's name, place and time of birth, TAJ
p.000000: number, address), a minor with limited legal capacity and
p.000000: the exercise of related rights and a group of assets of a property nature
p.000000: in the case of a partially restricted or incapacitated participant, the legal representative giving the consent
p.000000: identification data,
p.000000: e) *
p.000000: a statement that the participant has limited legal capacity
p.000000: minors and their capacity to act in relation to the exercise of healthcare rights,
p.000000: and is partially restricted or
p.000000: in the case of an incapacitated participant, also the legal representative - in the research
p.000000: following the information provided for in paragraph 1,
p.000000: without influence, knowing that at any time, orally or in writing, without giving any reason
p.000000: revocable,
p.000000: f) the date of signature of the statement of consent,
p.000000: g) the signature of the research leader or information provider,
p.000000: (h) the signature of the person giving his consent and, in the case referred to in paragraph 7, of the witness.
p.000000: (6) *
p.000000: The person providing the information and the participant - to a limited extent
p.000000: the legal capacity of a minor and the exercise of health care rights in his or her capacity to act
p.000000: and in respect of a class of property of a limited nature or
p.000000: in the case of an incapacitated participant, the legal representative - also the written information pursuant to paragraph 4
p.000000: sign.
p.000000: (7) *
p.000000: If you want to be involved in the research, or to a limited extent
p.000000: the legal capacity of a minor and the exercise of health care rights in his or her capacity to act
p.000000: and in respect of a class of property of a limited nature or
p.000000: in the case of an incapacitated person, the legal representative cannot read the consent form
p.000000: the joint presence of two independent witnesses shall be ensured when providing the necessary information. Witnesses a
p.000000: by signing a statement of consent, they certify that the person to be included in the investigation is lawful
p.000000: provided with all possible information and the person and / or legal representative of the person to be involved
p.000000: gave its consent voluntarily and without interference.
p.000000: (8) If, in the course of the research, new relevant information becomes available in connection with the research,
p.000000: which affects the contents of the written prospectus, an amendment to the permit shall be initiated in Section 13
p.000000: in accordance with In accordance with the amended written information
p.000000: you must be informed again and your written consent must be sought to continue the research.
p.000000: 4 / A. § *
p.000000: (1) If specified in the special legislation during the research
p.000000: samples are taken for human genetic testing, the participant shall be informed separately. THE
p.000000: the information shall also include the right of the participant to be sampled separately
p.000000: in this case, the genetic data relating to him may no longer be anonymous
...
p.000000: the possible transfer of stored genetic samples,
p.000000: (f) that he or she is entitled to have access to the genetic data generated by the human genetic test; and
p.000000: (g) whether it may decide to place the sample it provides in a biobank;
p.000000: placement method so that a sample is possible
p.000000: (ga) storage of personal data,
p.000000: gb) in encrypted form,
p.000000: gc) pseudonymised, ie in a form in which the
p.000000: the replacement code has been made available to the subject exclusively,
p.000000: (gd) anonymised, ie in a form where all the data relating to the subject are available
p.000000: personally identifiable information has been rendered inoperable.
p.000000: (3) The participant shall also be informed that it may decide to add a sample to the biobank
p.000000: participation in research. In this case, the participant must declare that:
p.000000: for the primary purpose of sampling, for diagnostic purposes only, or
p.000000: whether it contributes to its use, ie for diagnostic and research purposes.
p.000000: 4 / B. § *
p.000000: (1) If the research is due to a human genetic test
p.000000: a separate statement of consent shall be drawn up.
p.000000: 2. The participant's statement of consent shall include at least the following:
p.000000: (a) the identity of the research;
p.000000: (b) the name of the healthcare provider where the research is to be performed;
p.000000: c) the name, position and position of the head of the research or the person providing the information
p.000000: designation;
p.000000: d) *
p.000000: identification of the participant (name, place and date of birth),
p.000000: a minor with limited legal capacity and rights related to health care in his or her capacity to act
p.000000: and partially limited to a group of property cases
p.000000: or in the case of an incapacitated subject, the Eütv. The person entitled to make a declaration pursuant to § 16 (a
p.000000: hereinafter referred to as the "person entitled to make a declaration");
p.000000: e) *
p.000000: a statement that the participant has limited legal capacity
p.000000: minors and their capacity to act in relation to the exercise of healthcare rights,
p.000000: and is partially restricted or
p.000000: in the case of an incapacitated subject, the person entitled to make a statement - in the genetic test
p.000000: consent to participate in Article 4 / A. § or the information contained therein
p.000000: voluntarily, without influence, after resignation, in the knowledge that at any time,
p.000000: may be revoked orally or in writing without giving reasons;
p.000000: (f) the consent to the taking of a sample of the quantity and quality indicated in the prospectus and the identity of the participant
p.000000: use;
p.000000: (g) a statement as to how the samples will be handled, stating that it may decide on the sample to be provided
p.000000: biobank and the method of disposal, so that a sample is possible
p.000000: (ga) storage of personal data,
p.000000: gb) in encrypted form,
p.000000: gc) pseudonymised, ie in a form in which the
p.000000: the replacement code has been made available to the subject exclusively,
p.000000: (gd) anonymised, ie in a form where all the data relating to the subject are available
p.000000: personally identifiable information has been rendered unfit for identification;
p.000000: (h) a statement by the participant that the sample placed in the biobank is participating in further research; in this
p.000000: In this case, the participant must declare that his sample is the primary purpose of sampling
p.000000: diagnostic, for research purposes only, or any, ie diagnostic and research
p.000000: contributes to its use for its intended purpose;
p.000000: (i) the manner in which the result is to be communicated, even if the subject does not have access to it;
p.000000: (j) consenting to or excluding any future request;
p.000000: (k) the date of signature of the statement of consent;
p.000000: (l) the signature of the research leader or information provider;
p.000000: (m) the signature of the person giving his consent.
p.000000: Exercising a minor with limited legal capacity and rights related to health care in her capacity to act
p.000000: partially limited and incapacitated
p.000000: involvement of a person in research *
p.000000: § 5 (1) *
p.000000: If the research - the Eütv. Section 159 (4) and (5)
p.000000: subject to certain conditions - a minor with limited legal capacity and
p.000000: the exercise of rights relating to healthcare and of a pecuniary nature
p.000000: involving a partially restricted person in respect of a case group, both
p.000000: a minor with limited legal capacity and rights related to health care in his or her capacity to act
p.000000: and in respect of a group of property-type matters
p.000000: both the restricted person and his legal representative shall be informed in accordance with Section 4.
p.000000: (2) *
p.000000: Research can only be conducted on a minor with limited legal capacity and
p.000000: the exercise of rights relating to healthcare, and
p.000000: in the case of a group of property of a partially limited nature, if both the
p.000000: a minor with limited legal capacity and rights related to health care in his or her capacity to act
p.000000: and a group of assets of a property nature
p.000000: the consent of both a partially restricted person and his or her legal representative. The consent
p.000000: statement of both the minor with limited legal capacity and the capacity of the minor
p.000000: the exercise of rights relating to healthcare and of a pecuniary nature
p.000000: must be signed by both the person who is partially restricted in respect of the case and his or her legal representative.
p.000000: § 6 (1) *
p.000000: If the research - the Eütv. Section 159 (4) and (5)
p.000000: in accordance with the conditions laid down in paragraph 2, it is intended to involve an incapacitated person
p.000000: shall be in accordance with the provisions of
p.000000: (2) The Eütv. A person pursuant to Section 16 (1) - (2) shall comply with the provisions of Section 4
p.000000: be properly informed. In addition, a person who is incapacitated shall, in accordance with his or her judgment,
p.000000: be informed of all the research
p.000000: important circumstance, its risk and its positive or negative impact.
p.000000: A person with pedagogical experience should also be involved in informing the minor.
p.000000: (3) If the incapacitated person has understood the information, he or she can assess it and explicitly
p.000000: refuses to participate in the research or intends to withdraw from the research, this should be done to the research leader,
p.000000: or fully taken into account by the person conducting the research.
p.000000: (4) If the incapacitated person becomes able to act, as soon as possible
p.000000: be informed of the research and seek its consent to continue it. Failing this, the
p.000000: research may not be carried out on the person concerned.
p.000000: (5) Research may not be carried out with the involvement of an incapacitated person who, in his or her legal capacity, has excluded
p.000000: participation in research.
p.000000: (6) *
p.000000: A minor with limited legal capacity and capacity for action is
p.000000: the exercise of rights relating to healthcare and of a pecuniary nature
p.000000: partially limited and incapacitated person as a healthy volunteer for research
p.000000: cannot be involved.
p.000000: § 7 *
p.000000: § 8 *
p.000000: § 9 *
p.000000: § 10 *
p.000000: § 11 *
p.000000: The Institutional Research Ethics Committee and the Regional Research Ethics Committee
p.000000: § 12. (1) *
p.000000: All healthcare institutions where research is conducted use IKEB
p.000000: operate. In the healthcare institutions defined in Annex 1, the Regional Research Ethics Committee (a
p.000000: hereinafter referred to as RKEB).
p.000000: (2) Establishment of IKEB and RKEB, determination of their number - provisions of paragraph (4)
p.000000: the head of the health care institution.
p.000000: (3) In the health care institution where RKEB operates, it may also perform the tasks of IKEB.
p.000000: (4) IKEB and RKEB are listed in the Eütv. Shall be compiled in accordance with the provisions of Section 159 (6)
p.000000: provided that the number of members of the committee may not be less than five.
p.000000: (5) The protection of the interests of the participants in the research carried out in the institution by the President of IKEB shall be members of IKEB
p.000000: provided by an independent doctor not involved in the research. The designated doctor
...
p.000000: the purpose of the test cannot be achieved without recruitment or only with disproportionate difficulty, test
p.000000: you can recruit subjects in the press or on your own website
p.000000: by means of a published call. The text of the invitation to participate must state the purpose of the investigation,
p.000000: methods, marking the range of subjects to be selected, with the candidates
p.000000: any reimbursement to be made to the elected
p.000000: and the rules for processing the data of applicants. The call cannot be
p.000000: for advertising purposes. The published call must refer to the existence of a supporting professional ethics license. THE
p.000000: In the event of a deviation from the permitted method and text of recruitment, an amendment to the license shall be initiated.
p.000000: (2) The subject and the Eütv. The person entitled to make a declaration pursuant to § 16 (a
p.000000: hereinafter referred to as "the person entitled to make a declaration")
p.000000: loss of income and costs related to participation in the investigation, in particular
p.000000: Reimbursement may be made for expenses actually incurred and justified in connection with the journey.
p.000000: No other benefits or fees may be granted to the subject and the person entitled to make a statement.
p.000000: 20 / G. § *
p.000000: (1) Non-interventional investigation of a person with legal capacity
p.000000: improvement of diagnostic, therapeutic, prevention and rehabilitation procedures only,
p.000000: development and evaluation of procedures, as well as the pathogenesis and pathogenesis of diseases
p.000000: and epidemiological and public health contexts.
p.000000: (2) A non-interventional investigation shall be performed on a minor or a person with incapacitated
p.000000: its capacity to exercise its rights in relation to healthcare, and
p.000000: in respect of a group of property of a partially limited nature, 20 / I-20 / J. §-in
p.000000: subject only to the coexistence of the following conditions
p.000000: can be performed in case of: *
p.000000: (a) the investigation may not be carried out on a person of comparable efficiency;
p.000000: b) *
p.000000: the Eütv. Person pursuant to Section 16, Paragraphs (1) - (2) - subject to the provisions of Art. 16th
p.000000: § (5) - or with limited legal capacity over the age of 16
p.000000: in respect of the exercise of rights in relation to a minor or a person with legal capacity,
p.000000: and a subject of partial investigation limited to a group of property - related matters
p.000000: gave his consent.
p.000000: 20 / Mon. § *
p.000000: 1. The subject of a non-interventional study shall be included in the study
p.000000: prior to the consent of the investigator or the investigator, orally and in writing in Hungarian - or
p.000000: in the subject's mother tongue or in another language indicated by the subject - known to the lay person
p.000000: orally and in writing
p.000000: (a) the voluntary nature of the participation in the study and the fact that the consent may be given at any time;
p.000000: (2) may be revoked orally or in writing without giving any reason and without adverse consequences;
p.000000: b) the essence, purpose, expected duration and place of the planned investigation, the persons to be involved
p.000000: the number or scope of the
p.000000: (c) the expected benefits and reimbursement to the subject of the investigation or to others, if
p.000000: It happens;
p.000000: (d) rules on the handling of, and access to, subject data;
p.000000: e) the name, position and job title of the person (s) responsible for the investigation;
p.000000: (f) the identity of the non-interventional study;
p.000000: g) the name and registered office of the applicant.
...
p.000000: due to illiteracy, is not interested in two non-interventional
p.000000: oral consent in the joint presence of a witness is required for the investigation. In the case of oral consent a
p.000000: a statement must be made in writing certifying the verbal consent signed by the two witnesses
p.000000: took place. In the event of the subject's ability to recover, the statement of consent shall be issued by the
p.000000: confirm the written statement of consent before proceeding with the investigation, failing which
p.000000: shall be deemed to be withdrawn and the investigation may not be continued on the person concerned.
p.000000: 3. In the case of an oral statement of consent, the two witnesses shall certify that the subject is in accordance with paragraph 1.
p.000000: and the statement of consent referred to in paragraph 4 has been communicated to him and orally
p.000000: agreed.
p.000000: In addition to paragraph 1, the subject 's statement of consent shall in particular:
p.000000: shall include, as appropriate:
p.000000: (a) where the non - interventional examination is carried out by a health care provider, its health
p.000000: the name of the service provider where the test is to be performed;
p.000000: b) *
p.000000: the identity of the subject (name, place and date of birth),
p.000000: in the case of an incapacitated minor with limited legal capacity under the age of 16 a
p.000000: also the identification data of the person entitled to make a declaration;
p.000000: c) *
p.000000: a statement that the subject is incapacitated or
p.000000: in the case of a minor subject with limited legal capacity under the age of
p.000000: authorized person - his consent to participate in the investigation is set out in paragraph 1
p.000000: after giving information voluntarily, without influence, knowing that it is at any time, orally
p.000000: can be revoked in writing without giving reasons;
p.000000: (d) the date of signature of the statement of consent;
p.000000: (e) the signature of the study director or informant;
p.000000: (f) the signature of the person giving his consent.
p.000000: (5) *
p.000000: The person providing the information and the subject - are incapacitated
p.000000: In the case of a minor subject with limited legal capacity under the age of 16, to make a statement
p.000000: authorized person - also signs the written prospectus referred to in paragraph 1.
p.000000: (6) The information and consent shall be recorded in a separate sheet. The consent form
p.000000: and one original of each written information document shall be kept in the test documentation,
p.000000: and one original shall be handed over to the subject.
p.000000: (7) *
p.000000: If, in connection with a non-interventional investigation, such
p.000000: new relevant information becomes known which affects the contents of the written prospectus, the
p.000000: license modification should be initiated for human medical research, human
p.000000: clinical trials of the investigational medicinal products to be used and in humans
p.000000: clinical investigation of medical devices intended for clinical use
p.000000: 235/2009 on the rules for the authorization procedure (X. 20.) Government Decree 19.
p.000000: §. The subject of the amended written information shall be re-examined
p.000000: be informed and consent must be sought for the investigation to continue. In the absence of this investigation, the
p.000000: cannot be continued on the person concerned.
p.000000: 20 / I. § *
p.000000: Non-interventional study in minors is described in 20 / G-20 / H. §-in
p.000000: may be carried out only if all of the following conditions are met:
p.000000: (a) the study is directly related to the clinical condition in which the minor suffers or is of a nature
p.000000: which can only be performed on minors;
p.000000: (b) in the case of a minor under the age of 16, the consent of the person entitled to make the declaration
p.000000: contains the probable will of a minor capable of forming an opinion and assessing the situation, and this a
p.000000: the declaration may be withdrawn at any time without the minor being adversely affected;
p.000000: (c) an investigator with experience in relation to minors shall, depending on his or her intellectual level,
p.000000: properly informed of the study, adverse and beneficial effects in a way that is comprehensible to him;
p.000000: (d) the investigator or study director takes full account of the
p.000000: a minor under the age of 16 who is able to assess the situation explicitly refuses to participate in the study, or
p.000000: that you wish to withdraw from the investigation at any time;
p.000000: e) *
p.000000: 20 / J. § *
p.000000: (1) *
p.000000: A non-interventional study shall not be included in a
p.000000: incapacitated or disabled minor; and
p.000000: the exercise of rights relating to healthcare, and
p.000000: a person who is partially restricted in the case of a group of property
p.000000: in its possession, it expressly excluded its participation in such investigations. Not for a particular study
p.000000: nor may he be involved who has previously refused consent in possession of his capacity to act
p.000000: for that study.
p.000000: (2) *
p.000000: Incapacitated or incapacitated with health care
p.000000: the exercise of related rights and a group of assets of a property nature
p.000000: partially restricted in adults 20 / G-20 / H. § only with proper application
p.000000: a non - interventional test may be carried out if - in paragraph 1
p.000000: all of the following conditions are met:
p.000000: (a) in the case of a person who is incapacitated, the consent of the person entitled to make the declaration
p.000000: it must contain the presumed will of the subject and this statement at any time
p.000000: can be withdrawn without prejudice to the subject;
p.000000: (b) the subject has been adequately informed of the study in a manner that is comprehensible to the subject, favorable and
p.000000: adverse effects;
p.000000: (c) in the case of an incapacitated person, the investigator and the investigator-in-charge shall take full
...
Social / education
Searching for indicator educational:
(return to top)
p.000000: the legal capacity of a minor and the exercise of health care rights in his or her capacity to act
p.000000: and in respect of a class of property of a limited nature or
p.000000: in the case of an incapacitated person, the Eütv. A statement pursuant to Section 159 (4) (d);
p.000000: (b) research plan: the objectives, planned course, methods, statistical aspects of the research and
p.000000: documentation on its organizational issues prepared in advance in accordance with this Regulation;
p.000000: including further versions and modifications thereof;
p.000000: c) *
p.000000: (d) undesirable event: an adverse event in the research subject's state of health
p.000000: a change that does not necessarily result from the treatment applied;
p.000000: (e) "serious adverse event" means an adverse event that is life-threatening;
p.000000: requires or prolongs hospital treatment, is permanent
p.000000: causes damage to health, disability, congenital anomaly, birth defect or death;
p.000000: f) *
p.000000: (g) research coordinator: in the case of multi-center research, the researcher responsible for coordinating the research;
p.000000: h) *
p.000000: non-commercial research: industrial, commercial, service provider
p.000000: research carried out by researchers independent of business, which does not even indirectly serve the material of the sponsor
p.000000: profit and
p.000000: (ha) commissioned by an independent researcher or non-profit organization, in particular an educational organization
p.000000: institution, funded health care provider, publicly funded research institute, social
p.000000: organization,
p.000000: (hb) the research is planned and carried out by the sponsor in accordance with point (ha),
p.000000: (hc) the data resulting from the research become the property of the sponsor in accordance with point (ha),
p.000000: (hd) the results of the research are communicated by the sponsor in accordance with point (ha).
p.000000: i) *
p.000000: (2) *
p.000000: In addition to the provisions of paragraph 1, for the purposes of this Regulation,
p.000000: and the authorization procedure for medical research on human beings
p.000000: definitions contained in a separate legal act on the rules of
p.000000: taking into account.
p.000000: Protection of the person involved in the research
p.000000: § 3. (1) A person with legal capacity may be involved in research if the Eütv. Section 159 (1) - (3)
p.000000: compliance with the conditions laid down in paragraphs 1 and 2 and with the requirements of this Regulation.
p.000000: (2) The research may not replace for the participant what is necessary from a medical-professional point of view, a
p.000000: examinations and interventions for the prevention, early detection and treatment of diseases.
p.000000: 3. Where research is intended to involve persons of reproductive age, the planning, authorization,
p.000000: in informing participants, special attention should be paid to research on fertility and fertility,
p.000000: pregnancy, embryonal / fetal health, which may occur at the time of inclusion in the research,
p.000000: impact.
...
p.000000: Medicinal products for human use and other,
p.000000: Act XCV of 2005 amending the laws regulating the pharmaceutical market. Act (hereinafter: Gytv.)
p.000000: Non-interventional tests in accordance with Section 1 (8) and performed on humans
p.000000: intervention as defined in the legislation on the rules for the authorization of medical research
p.000000: in the case of non - interventional medical research (hereinafter together: non - interventional study) a
p.000000: 20 / B-20 / S. §.
p.000000: 20 / B. § *
p.000000: For the purposes of this Chapter:
p.000000: the) *
p.000000: sponsor: any natural or legal person who you are
p.000000: which initiates, conducts or finances a non-interventional investigation. The investigator and
p.000000: the principal may be the same person;
p.000000: (b) subject: a person participating in a non-interventional study who or to whom
p.000000: the data is used to continue the investigation or who participates in the investigation as a control person;
p.000000: (c) ‘investigator’ means a person charged with carrying out a non-interventional investigation in a
p.000000: test site;
p.000000: (d) principal investigator: the responsible leader of the team at a particular investigation site if the
p.000000: a non-interventional study is performed by a group of several investigators;
p.000000: (e) recruitment: the recruitment of a non-interventional study by the person who authorized the study;
p.000000: an authorized public call for the purpose of involving subjects in an investigation;
p.000000: f) non-commercial trial: from industrial, commercial, service companies
p.000000: research carried out by independent investigators which does not even indirectly serve the financial gain of the sponsor; and
p.000000: (fa) commissioned by an independent investigator or non-profit organization, in particular an educational organization
p.000000: institution, funded health care provider, publicly funded research institute, social
p.000000: organization,
p.000000: (fb) the investigation is planned and continued by the sponsor in accordance with point (fa),
p.000000: fc) the data resulting from the investigation become the property of the principal referred to in point (fa),
p.000000: (fd) the results of the test are communicated by the sponsor in accordance with point (fa);
p.000000: g) *
p.000000: coordinating study director: in the case of a multicenter study, the study
p.000000: responsible for the whole.
p.000000: h) *
p.000000: 20 / C. § *
p.000000: The following, in particular, shall be considered as non - interventional investigations:
p.000000: a) security,
p.000000: b) pharmacoeconomic,
p.000000: c) quality of life,
p.000000: d) epidemiological,
p.000000: e) compliance / persistence,
p.000000: f) observation cohort,
p.000000: g) retrospective case control,
p.000000: (h) other observational tests.
p.000000: 20 / D. § *
p.000000: 20 / E. § *
p.000000: 20 / F. § *
p.000000: (1) *
p.000000: The sponsor, the study director and the investigator, if the
p.000000: the purpose of the test cannot be achieved without recruitment or only with disproportionate difficulty, test
p.000000: you can recruit subjects in the press or on your own website
p.000000: by means of a published call. The text of the invitation to participate must state the purpose of the investigation,
p.000000: methods, marking the range of subjects to be selected, with the candidates
p.000000: any reimbursement to be made to the elected
p.000000: and the rules for processing the data of applicants. The call cannot be
p.000000: for advertising purposes. The published call must refer to the existence of a supporting professional ethics license. THE
...
Social / philosophical differences/differences of opinion
Searching for indicator opinion:
(return to top)
p.000000: in informing participants, special attention should be paid to research on fertility and fertility,
p.000000: pregnancy, embryonal / fetal health, which may occur at the time of inclusion in the research,
p.000000: impact.
p.000000: (4) Research should be designed and conducted in a manner that minimizes the person involved in the research
p.000000: possible damage, pain, fear and anxiety. The age of the person involved, health
p.000000: any foreseeable risks associated with the condition should be considered in the research
p.000000: planning and control.
p.000000: (5) The health status of the participant before the start of the research, continuously during the research
p.000000: and should then be carefully monitored and documented.
p.000000: (6) *
p.000000: As a participant in the research, primarily in the health care institution
p.000000: patients can be involved. A call to recruit participants - healthy
p.000000: with the exception of volunteers - can only be referred to doctors, according to the purpose and methods of the research, the
p.000000: with a precise indication of the number of participants to be selected. Recruiting healthy volunteers
p.000000: by means of a communication to the public, the invitation to recruit must clearly state that the
p.000000: involving healthy volunteers. The recruitment call may not be for advertising purposes. The call for recruitment
p.000000: the proposed text and a description of the recruitment method for the official approval of the research,
p.000000: or be accompanied by a request for a professional-ethical opinion. In the published recruitment notice, the
p.000000: reference to the existence of an official permit. In the event of a deviation from the permitted method and text of recruitment, the
p.000000: an amendment to the permit shall be initiated.
p.000000: (7) The loss of income related to the participation in the research and the travel expenses of the participant
p.000000: actually incurred and justified in this context
p.000000: - not covered by social security
p.000000: reimbursement is payable. Other benefits or fees for the participant
p.000000: - with the exception of research on healthy volunteers.
p.000000: Informing the participant, consent to the research
p.000000: § 4. (1) The person with legal capacity to be involved in the research shall be the head of the research or the person appointed by him / her.
p.000000: The doctor participating in the research shall inform the patient orally and in writing in Hungarian in a way that is comprehensible to the patient
p.000000: AH. 159 (3).
p.000000: 2. The person providing the information shall pay particular attention to verifying that he or she wishes to be involved
p.000000: whether the person is capable of acting. The findings in this regard are recorded in the medical records.
p.000000: (3) The information and consent shall be recorded in writing on a separate sheet. The written information and the
p.000000: a copy of the consent form shall be kept in the participant's medical records,
p.000000: and one copy shall be given to the participant.
p.000000: 4. The written information shall contain at least the following:
p.000000: a) identification of the research,
p.000000: (b) an indication of the experimental nature of the research, the purpose of the research, its expected duration,
p.000000: the number of persons to be involved, the course of the research, the nature and frequency of the planned interventions,
p.000000: (c) other agreed treatment options available to the participant and information thereon
p.000000: that research may mean the interruption of treatment that has already begun and that it has begun
p.000000: the consequences for the participant of the interruption of treatment,
p.000000: (d) a detailed description of the possible and expected consequences, risks and inconveniences, and
p.000000: an indication that the research may involve undesirable events which are unforeseeable,
p.000000: (e) a description of the reasonably foreseeable benefits or, if no benefit is expected from the research for the participant
p.000000: communication of the fact,
p.000000: f) the percentage probability of random assignment to each treatment group,
p.000000: g) *
p.000000: the occurrence of research - related damage to the participant, or
p.000000: treatment, compensation and damages to be provided in case of violation of the right to privacy [Eütv. § 164
p.000000: (2)] and compensation [Eütv. 164 (1)], the Eütv. Section 164 (2)
p.000000: the name and contact details of the liability insurer referred to in
p.000000: (h) the reimbursement, if any, of the costs incurred by the participant for participating in the research;
p.000000: (i) a warning that the consent is voluntary and unaffected,
p.000000: it may be withdrawn at any time, either orally or in writing, without giving any reason, without
p.000000: disadvantage,
p.000000: j) the rules for handling and accessing the participant's data,
p.000000: k) *
p.000000: giving the opinion of the competent authority necessary for the commencement of the research
p.000000: the name of the ethics committee, as well as the name of the chairman of IKEB and the independent doctor pursuant to Section 12 (5), and
p.000000: contact information.
p.000000: (5) The participant shall give his or her consent in writing. The statement of consent shall include at least:
p.000000: includes:
p.000000: a) identification of the research,
p.000000: (b) the name of the healthcare institution where the research is to be carried out,
p.000000: c) the name, position and position of the head of the research or the person providing the information
p.000000: Name,
p.000000: d) *
p.000000: identification data of the participant (name, mother 's name, place and time of birth, TAJ
p.000000: number, address), a minor with limited legal capacity and
p.000000: the exercise of related rights and a group of assets of a property nature
p.000000: in the case of a partially restricted or incapacitated participant, the legal representative giving the consent
p.000000: identification data,
p.000000: e) *
p.000000: a statement that the participant has limited legal capacity
p.000000: minors and their capacity to act in relation to the exercise of healthcare rights,
...
p.000000: cannot be involved.
p.000000: § 7 *
p.000000: § 8 *
p.000000: § 9 *
p.000000: § 10 *
p.000000: § 11 *
p.000000: The Institutional Research Ethics Committee and the Regional Research Ethics Committee
p.000000: § 12. (1) *
p.000000: All healthcare institutions where research is conducted use IKEB
p.000000: operate. In the healthcare institutions defined in Annex 1, the Regional Research Ethics Committee (a
p.000000: hereinafter referred to as RKEB).
p.000000: (2) Establishment of IKEB and RKEB, determination of their number - provisions of paragraph (4)
p.000000: the head of the health care institution.
p.000000: (3) In the health care institution where RKEB operates, it may also perform the tasks of IKEB.
p.000000: (4) IKEB and RKEB are listed in the Eütv. Shall be compiled in accordance with the provisions of Section 159 (6)
p.000000: provided that the number of members of the committee may not be less than five.
p.000000: (5) The protection of the interests of the participants in the research carried out in the institution by the President of IKEB shall be members of IKEB
p.000000: provided by an independent doctor not involved in the research. The designated doctor
p.000000: continuously monitors the progress of the research and maintains regular contact with the
p.000000: with the persons involved in the investigation, provides them with information and professional assistance.
p.000000: (6) *
p.000000: (7) *
p.000000: The task of the RKEB is to carry out the research specified in a separate legal act
p.000000: forming an ethical opinion in the case of.
p.000000: ! (8) *
p.000000: In the case of IKEB, it contains the composition and operating rules
p.000000: rules of procedure shall be approved by the territorially competent RKEB. The composition of the RKEB is the Health
p.000000: Scientific Council Committee under the Ministerial Decree on the Health Scientific Council
p.000000: approve.
p.000000: § 13. *
p.000000: § 14. (1) *
p.000000: It is funded at least in part by the Health Fund
p.000000: the head of the health care institution shall declare to the health insurer before the start of the research
p.000000: additional costs.
p.000000: (2) *
p.000000: About the date of commencement of the research by the health care institution
p.000000: the head shall notify the ethics committee.
p.000000: Exemption from payment of procedural fees *
p.000000: § 15. *
p.000000: Non-commercial research as well as Eütv. Section 159 (5)
p.000000: The authorization procedure for research under this Regulation shall be free of charge.
p.000000: § 16 *
p.000000: § 17 *
p.000000: § 18 *
p.000000: § 19. (1) *
p.000000: The National Health Insurance Fund Manager (hereinafter: NEAK)
p.000000: verifies that the additional costs recorded in the declaration pursuant to Section 14 (1)
p.000000: and that health insurance is provided exclusively for research
p.000000: are not used at their expense.
p.000000: (2) *
p.000000: (3) *
p.000000: If the audit finds that it is exclusively research
p.000000: the NEAK initiates the research
p.000000: suspension.
p.000000: Reporting obligation
p.000000: § 20 *
p.000000: The research leader is every second from the start of the research
p.000000: at the end of the year and within 15 days of the completion of the research, send a report to the licensor on ethical
...
p.000000: and one original of each written information document shall be kept in the test documentation,
p.000000: and one original shall be handed over to the subject.
p.000000: (7) *
p.000000: If, in connection with a non-interventional investigation, such
p.000000: new relevant information becomes known which affects the contents of the written prospectus, the
p.000000: license modification should be initiated for human medical research, human
p.000000: clinical trials of the investigational medicinal products to be used and in humans
p.000000: clinical investigation of medical devices intended for clinical use
p.000000: 235/2009 on the rules for the authorization procedure (X. 20.) Government Decree 19.
p.000000: §. The subject of the amended written information shall be re-examined
p.000000: be informed and consent must be sought for the investigation to continue. In the absence of this investigation, the
p.000000: cannot be continued on the person concerned.
p.000000: 20 / I. § *
p.000000: Non-interventional study in minors is described in 20 / G-20 / H. §-in
p.000000: may be carried out only if all of the following conditions are met:
p.000000: (a) the study is directly related to the clinical condition in which the minor suffers or is of a nature
p.000000: which can only be performed on minors;
p.000000: (b) in the case of a minor under the age of 16, the consent of the person entitled to make the declaration
p.000000: contains the probable will of a minor capable of forming an opinion and assessing the situation, and this a
p.000000: the declaration may be withdrawn at any time without the minor being adversely affected;
p.000000: (c) an investigator with experience in relation to minors shall, depending on his or her intellectual level,
p.000000: properly informed of the study, adverse and beneficial effects in a way that is comprehensible to him;
p.000000: (d) the investigator or study director takes full account of the
p.000000: a minor under the age of 16 who is able to assess the situation explicitly refuses to participate in the study, or
p.000000: that you wish to withdraw from the investigation at any time;
p.000000: e) *
p.000000: 20 / J. § *
p.000000: (1) *
p.000000: A non-interventional study shall not be included in a
p.000000: incapacitated or disabled minor; and
p.000000: the exercise of rights relating to healthcare, and
p.000000: a person who is partially restricted in the case of a group of property
p.000000: in its possession, it expressly excluded its participation in such investigations. Not for a particular study
p.000000: nor may he be involved who has previously refused consent in possession of his capacity to act
p.000000: for that study.
p.000000: (2) *
p.000000: Incapacitated or incapacitated with health care
p.000000: the exercise of related rights and a group of assets of a property nature
p.000000: partially restricted in adults 20 / G-20 / H. § only with proper application
p.000000: a non - interventional test may be carried out if - in paragraph 1
p.000000: all of the following conditions are met:
p.000000: (a) in the case of a person who is incapacitated, the consent of the person entitled to make the declaration
p.000000: it must contain the presumed will of the subject and this statement at any time
p.000000: can be withdrawn without prejudice to the subject;
p.000000: (b) the subject has been adequately informed of the study in a manner that is comprehensible to the subject, favorable and
p.000000: adverse effects;
p.000000: (c) in the case of an incapacitated person, the investigator and the investigator-in-charge shall take full
p.000000: the subject, who is able to form an opinion and assess the situation, expressly excludes from the study
p.000000: participation or wish to withdraw from the investigation at any time;
p.000000: d) *
p.000000: human medical research for human use
p.000000: clinical trials of investigational medicinal products and
p.000000: laying down rules for the authorization procedure for clinical trials on medical devices intended for clinical investigations
p.000000: 235/2009 (X. 20.) Government Decree [hereinafter: 235/2009. (X. 20.) Government Decree] Section 17 (1)
p.000000: (hereinafter referred to as the licensing authority) shall be the appropriate specialist for the disease in question
p.000000: decide on the authorization in the light of its opinion.
p.000000: (3) If the subject is able to act during the non-interventional investigation
p.000000: shall be informed of the test as soon as possible and 20 / H. With the appropriate application of the provisions of §
p.000000: your consent must be obtained to proceed. Failure to do so will result in an investigation of the person concerned
p.000000: cannot be continued.
p.000000: 20 / Tues § *
p.000000: 20 / L. § *
p.000000: 20 / M. § *
p.000000: 20 / N. § *
p.000000: During an approved non - interventional test:
p.000000: subjects and persons entitled to make a statement, investigators, study directors,
p.000000: the head of the health care provider conducting the examination or the sponsor may file a complaint with the
p.000000: to the licensing authority if they consider the test in the license or test
p.000000: continue as provided for in the plan.
p.000000: 20 / O. § *
p.000000: 1. Except as provided in paragraph 2, no intervention
p.000000: Within 90 days of the completion of the investigation, the sponsor shall notify the licensing authority of the investigation
p.000000: completion, the number of patients involved,
p.000000: within one hundred and eighty days of the completion of the investigation
p.000000: given answer.
p.000000: In the case of a post - authorization pharmacovigilance study:
p.000000: reporting on the pharmacovigilance of medicinal products for human use
p.000000: shall be complied with in accordance with a ministerial decree.
p.000000: (3) *
p.000000: The National Institute of Pharmacy and Food Health (a
p.000000: hereinafter referred to as ‘OGYÉI’) shall send copies of the non-interventional
p.000000: For ETT TUKEB.
p.000000: 20 / Fri. § *
p.000000: (1) A non-interventional test is an authorized test
...
General/Other / Incapacitated
Searching for indicator incapacitated:
(return to top)
p.000000: I order the following:
p.000000: § 1 (1) *
p.000000: The provisions of this Regulation shall apply to min (dhetntpe: m // blearenndivnéggz.ewttolte
p.000000: medical research (Section 157 of the Eütv., hereinafter: research). test
p.000000: In the case of a clinical trial of a medicinal product and a medical device, the provisions of this Regulation shall apply to
p.000000: prevail. It qualifies as medical research in particular
p.000000: utm_source = netjogta
p.000000: (a) to improve diagnostic, therapeutic, preventive and rehabilitative procedures, new
p.000000: procedures and a better understanding of the pathology and course of diseases,
p.000000: b) genetic,
p.000000: (c) cells, cell constituents, tissues, organs removed from a living human or dead body,
p.000000: done with a body part,
p.000000: d) epidemiological,
p.000000: (e) in the public health and epidemiological interest,
p.000000: f) *
p.000000: g) research on gametes and embryos.
p.000000: (2) - (3) *
p.000000: § 2. (1) For the purposes of this Decree
p.000000: the) *
p.000000: statement of consent: the person participating in the investigation has legal capacity
p.000000: person in the Eütv. 159 (1) e), or to a limited extent
p.000000: the legal capacity of a minor and the exercise of health care rights in his or her capacity to act
p.000000: and in respect of a class of property of a limited nature or
p.000000: in the case of an incapacitated person, the Eütv. A statement pursuant to Section 159 (4) (d);
p.000000: (b) research plan: the objectives, planned course, methods, statistical aspects of the research and
p.000000: documentation on its organizational issues prepared in advance in accordance with this Regulation;
p.000000: including further versions and modifications thereof;
p.000000: c) *
p.000000: (d) undesirable event: an adverse event in the research subject's state of health
p.000000: a change that does not necessarily result from the treatment applied;
p.000000: (e) "serious adverse event" means an adverse event that is life-threatening;
p.000000: requires or prolongs hospital treatment, is permanent
p.000000: causes damage to health, disability, congenital anomaly, birth defect or death;
p.000000: f) *
p.000000: (g) research coordinator: in the case of multi-center research, the researcher responsible for coordinating the research;
p.000000: h) *
p.000000: non-commercial research: industrial, commercial, service provider
p.000000: research carried out by researchers independent of business, which does not even indirectly serve the material of the sponsor
p.000000: profit and
p.000000: (ha) commissioned by an independent researcher or non-profit organization, in particular an educational organization
p.000000: institution, funded health care provider, publicly funded research institute, social
p.000000: organization,
p.000000: (hb) the research is planned and carried out by the sponsor in accordance with point (ha),
p.000000: (hc) the data resulting from the research become the property of the sponsor in accordance with point (ha),
p.000000: (hd) the results of the research are communicated by the sponsor in accordance with point (ha).
p.000000: i) *
p.000000: (2) *
...
p.000000: (i) a warning that the consent is voluntary and unaffected,
p.000000: it may be withdrawn at any time, either orally or in writing, without giving any reason, without
p.000000: disadvantage,
p.000000: j) the rules for handling and accessing the participant's data,
p.000000: k) *
p.000000: giving the opinion of the competent authority necessary for the commencement of the research
p.000000: the name of the ethics committee, as well as the name of the chairman of IKEB and the independent doctor pursuant to Section 12 (5), and
p.000000: contact information.
p.000000: (5) The participant shall give his or her consent in writing. The statement of consent shall include at least:
p.000000: includes:
p.000000: a) identification of the research,
p.000000: (b) the name of the healthcare institution where the research is to be carried out,
p.000000: c) the name, position and position of the head of the research or the person providing the information
p.000000: Name,
p.000000: d) *
p.000000: identification data of the participant (name, mother 's name, place and time of birth, TAJ
p.000000: number, address), a minor with limited legal capacity and
p.000000: the exercise of related rights and a group of assets of a property nature
p.000000: in the case of a partially restricted or incapacitated participant, the legal representative giving the consent
p.000000: identification data,
p.000000: e) *
p.000000: a statement that the participant has limited legal capacity
p.000000: minors and their capacity to act in relation to the exercise of healthcare rights,
p.000000: and is partially restricted or
p.000000: in the case of an incapacitated participant, also the legal representative - in the research
p.000000: following the information provided for in paragraph 1,
p.000000: without influence, knowing that at any time, orally or in writing, without giving any reason
p.000000: revocable,
p.000000: f) the date of signature of the statement of consent,
p.000000: g) the signature of the research leader or information provider,
p.000000: (h) the signature of the person giving his consent and, in the case referred to in paragraph 7, of the witness.
p.000000: (6) *
p.000000: The person providing the information and the participant - to a limited extent
p.000000: the legal capacity of a minor and the exercise of health care rights in his or her capacity to act
p.000000: and in respect of a class of property of a limited nature or
p.000000: in the case of an incapacitated participant, the legal representative - also the written information pursuant to paragraph 4
p.000000: sign.
p.000000: (7) *
p.000000: If you want to be involved in the research, or to a limited extent
p.000000: the legal capacity of a minor and the exercise of health care rights in his or her capacity to act
p.000000: and in respect of a class of property of a limited nature or
p.000000: in the case of an incapacitated person, the legal representative cannot read the consent form
p.000000: the joint presence of two independent witnesses shall be ensured when providing the necessary information. Witnesses a
p.000000: by signing a statement of consent, they certify that the person to be included in the investigation is lawful
p.000000: provided with all possible information and the person and / or legal representative of the person to be involved
p.000000: gave its consent voluntarily and without interference.
p.000000: (8) If, in the course of the research, new relevant information becomes available in connection with the research,
p.000000: which affects the contents of the written prospectus, an amendment to the permit shall be initiated in Section 13
p.000000: in accordance with In accordance with the amended written information
p.000000: you must be informed again and your written consent must be sought to continue the research.
p.000000: 4 / A. § *
p.000000: (1) If specified in the special legislation during the research
p.000000: samples are taken for human genetic testing, the participant shall be informed separately. THE
p.000000: the information shall also include the right of the participant to be sampled separately
p.000000: in this case, the genetic data relating to him may no longer be anonymous
p.000000: to use. Rejection of sampling does not constitute a barrier to participant participation in further research
p.000000: section. Information on and agreement to sampling in a separate document
p.000000: must be booked.
p.000000: (2) Prior to sampling for human genetic testing, the participant shall be subjected to genetic counseling
p.000000: must be informed within
...
p.000000: (ga) storage of personal data,
p.000000: gb) in encrypted form,
p.000000: gc) pseudonymised, ie in a form in which the
p.000000: the replacement code has been made available to the subject exclusively,
p.000000: (gd) anonymised, ie in a form where all the data relating to the subject are available
p.000000: personally identifiable information has been rendered inoperable.
p.000000: (3) The participant shall also be informed that it may decide to add a sample to the biobank
p.000000: participation in research. In this case, the participant must declare that:
p.000000: for the primary purpose of sampling, for diagnostic purposes only, or
p.000000: whether it contributes to its use, ie for diagnostic and research purposes.
p.000000: 4 / B. § *
p.000000: (1) If the research is due to a human genetic test
p.000000: a separate statement of consent shall be drawn up.
p.000000: 2. The participant's statement of consent shall include at least the following:
p.000000: (a) the identity of the research;
p.000000: (b) the name of the healthcare provider where the research is to be performed;
p.000000: c) the name, position and position of the head of the research or the person providing the information
p.000000: designation;
p.000000: d) *
p.000000: identification of the participant (name, place and date of birth),
p.000000: a minor with limited legal capacity and rights related to health care in his or her capacity to act
p.000000: and partially limited to a group of property cases
p.000000: or in the case of an incapacitated subject, the Eütv. The person entitled to make a declaration pursuant to § 16 (a
p.000000: hereinafter referred to as the "person entitled to make a declaration");
p.000000: e) *
p.000000: a statement that the participant has limited legal capacity
p.000000: minors and their capacity to act in relation to the exercise of healthcare rights,
p.000000: and is partially restricted or
p.000000: in the case of an incapacitated subject, the person entitled to make a statement - in the genetic test
p.000000: consent to participate in Article 4 / A. § or the information contained therein
p.000000: voluntarily, without influence, after resignation, in the knowledge that at any time,
p.000000: may be revoked orally or in writing without giving reasons;
p.000000: (f) the consent to the taking of a sample of the quantity and quality indicated in the prospectus and the identity of the participant
p.000000: use;
p.000000: (g) a statement as to how the samples will be handled, stating that it may decide on the sample to be provided
p.000000: biobank and the method of disposal, so that a sample is possible
p.000000: (ga) storage of personal data,
p.000000: gb) in encrypted form,
p.000000: gc) pseudonymised, ie in a form in which the
p.000000: the replacement code has been made available to the subject exclusively,
p.000000: (gd) anonymised, ie in a form where all the data relating to the subject are available
p.000000: personally identifiable information has been rendered unfit for identification;
p.000000: (h) a statement by the participant that the sample placed in the biobank is participating in further research; in this
p.000000: In this case, the participant must declare that his sample is the primary purpose of sampling
p.000000: diagnostic, for research purposes only, or any, ie diagnostic and research
p.000000: contributes to its use for its intended purpose;
p.000000: (i) the manner in which the result is to be communicated, even if the subject does not have access to it;
p.000000: (j) consenting to or excluding any future request;
p.000000: (k) the date of signature of the statement of consent;
p.000000: (l) the signature of the research leader or information provider;
p.000000: (m) the signature of the person giving his consent.
p.000000: Exercising a minor with limited legal capacity and rights related to health care in her capacity to act
p.000000: partially limited and incapacitated
p.000000: involvement of a person in research *
p.000000: § 5 (1) *
p.000000: If the research - the Eütv. Section 159 (4) and (5)
p.000000: subject to certain conditions - a minor with limited legal capacity and
p.000000: the exercise of rights relating to healthcare and of a pecuniary nature
p.000000: involving a partially restricted person in respect of a case group, both
p.000000: a minor with limited legal capacity and rights related to health care in his or her capacity to act
p.000000: and in respect of a group of property-type matters
p.000000: both the restricted person and his legal representative shall be informed in accordance with Section 4.
p.000000: (2) *
p.000000: Research can only be conducted on a minor with limited legal capacity and
p.000000: the exercise of rights relating to healthcare, and
p.000000: in the case of a group of property of a partially limited nature, if both the
p.000000: a minor with limited legal capacity and rights related to health care in his or her capacity to act
p.000000: and a group of assets of a property nature
p.000000: the consent of both a partially restricted person and his or her legal representative. The consent
p.000000: statement of both the minor with limited legal capacity and the capacity of the minor
p.000000: the exercise of rights relating to healthcare and of a pecuniary nature
p.000000: must be signed by both the person who is partially restricted in respect of the case and his or her legal representative.
p.000000: § 6 (1) *
p.000000: If the research - the Eütv. Section 159 (4) and (5)
p.000000: in accordance with the conditions laid down in paragraph 2, it is intended to involve an incapacitated person
p.000000: shall be in accordance with the provisions of
p.000000: (2) The Eütv. A person pursuant to Section 16 (1) - (2) shall comply with the provisions of Section 4
p.000000: be properly informed. In addition, a person who is incapacitated shall, in accordance with his or her judgment,
p.000000: be informed of all the research
p.000000: important circumstance, its risk and its positive or negative impact.
p.000000: A person with pedagogical experience should also be involved in informing the minor.
p.000000: (3) If the incapacitated person has understood the information, he or she can assess it and explicitly
p.000000: refuses to participate in the research or intends to withdraw from the research, this should be done to the research leader,
p.000000: or fully taken into account by the person conducting the research.
p.000000: (4) If the incapacitated person becomes able to act, as soon as possible
p.000000: be informed of the research and seek its consent to continue it. Failing this, the
p.000000: research may not be carried out on the person concerned.
p.000000: (5) Research may not be carried out with the involvement of an incapacitated person who, in his or her legal capacity, has excluded
p.000000: participation in research.
p.000000: (6) *
p.000000: A minor with limited legal capacity and capacity for action is
p.000000: the exercise of rights relating to healthcare and of a pecuniary nature
p.000000: partially limited and incapacitated person as a healthy volunteer for research
p.000000: cannot be involved.
p.000000: § 7 *
p.000000: § 8 *
p.000000: § 9 *
p.000000: § 10 *
p.000000: § 11 *
p.000000: The Institutional Research Ethics Committee and the Regional Research Ethics Committee
p.000000: § 12. (1) *
p.000000: All healthcare institutions where research is conducted use IKEB
p.000000: operate. In the healthcare institutions defined in Annex 1, the Regional Research Ethics Committee (a
p.000000: hereinafter referred to as RKEB).
p.000000: (2) Establishment of IKEB and RKEB, determination of their number - provisions of paragraph (4)
p.000000: the head of the health care institution.
p.000000: (3) In the health care institution where RKEB operates, it may also perform the tasks of IKEB.
p.000000: (4) IKEB and RKEB are listed in the Eütv. Shall be compiled in accordance with the provisions of Section 159 (6)
p.000000: provided that the number of members of the committee may not be less than five.
p.000000: (5) The protection of the interests of the participants in the research carried out in the institution by the President of IKEB shall be members of IKEB
p.000000: provided by an independent doctor not involved in the research. The designated doctor
p.000000: continuously monitors the progress of the research and maintains regular contact with the
p.000000: with the persons involved in the investigation, provides them with information and professional assistance.
p.000000: (6) *
p.000000: (7) *
p.000000: The task of the RKEB is to carry out the research specified in a separate legal act
...
p.000000: you can recruit subjects in the press or on your own website
p.000000: by means of a published call. The text of the invitation to participate must state the purpose of the investigation,
p.000000: methods, marking the range of subjects to be selected, with the candidates
p.000000: any reimbursement to be made to the elected
p.000000: and the rules for processing the data of applicants. The call cannot be
p.000000: for advertising purposes. The published call must refer to the existence of a supporting professional ethics license. THE
p.000000: In the event of a deviation from the permitted method and text of recruitment, an amendment to the license shall be initiated.
p.000000: (2) The subject and the Eütv. The person entitled to make a declaration pursuant to § 16 (a
p.000000: hereinafter referred to as "the person entitled to make a declaration")
p.000000: loss of income and costs related to participation in the investigation, in particular
p.000000: Reimbursement may be made for expenses actually incurred and justified in connection with the journey.
p.000000: No other benefits or fees may be granted to the subject and the person entitled to make a statement.
p.000000: 20 / G. § *
p.000000: (1) Non-interventional investigation of a person with legal capacity
p.000000: improvement of diagnostic, therapeutic, prevention and rehabilitation procedures only,
p.000000: development and evaluation of procedures, as well as the pathogenesis and pathogenesis of diseases
p.000000: and epidemiological and public health contexts.
p.000000: (2) A non-interventional investigation shall be performed on a minor or a person with incapacitated
p.000000: its capacity to exercise its rights in relation to healthcare, and
p.000000: in respect of a group of property of a partially limited nature, 20 / I-20 / J. §-in
p.000000: subject only to the coexistence of the following conditions
p.000000: can be performed in case of: *
p.000000: (a) the investigation may not be carried out on a person of comparable efficiency;
p.000000: b) *
p.000000: the Eütv. Person pursuant to Section 16, Paragraphs (1) - (2) - subject to the provisions of Art. 16th
p.000000: § (5) - or with limited legal capacity over the age of 16
p.000000: in respect of the exercise of rights in relation to a minor or a person with legal capacity,
p.000000: and a subject of partial investigation limited to a group of property - related matters
p.000000: gave his consent.
p.000000: 20 / Mon. § *
p.000000: 1. The subject of a non-interventional study shall be included in the study
p.000000: prior to the consent of the investigator or the investigator, orally and in writing in Hungarian - or
p.000000: in the subject's mother tongue or in another language indicated by the subject - known to the lay person
p.000000: orally and in writing
p.000000: (a) the voluntary nature of the participation in the study and the fact that the consent may be given at any time;
...
p.000000: add to the test. If the subject is unable to write in writing, or
p.000000: due to illiteracy, is not interested in two non-interventional
p.000000: oral consent in the joint presence of a witness is required for the investigation. In the case of oral consent a
p.000000: a statement must be made in writing certifying the verbal consent signed by the two witnesses
p.000000: took place. In the event of the subject's ability to recover, the statement of consent shall be issued by the
p.000000: confirm the written statement of consent before proceeding with the investigation, failing which
p.000000: shall be deemed to be withdrawn and the investigation may not be continued on the person concerned.
p.000000: 3. In the case of an oral statement of consent, the two witnesses shall certify that the subject is in accordance with paragraph 1.
p.000000: and the statement of consent referred to in paragraph 4 has been communicated to him and orally
p.000000: agreed.
p.000000: In addition to paragraph 1, the subject 's statement of consent shall in particular:
p.000000: shall include, as appropriate:
p.000000: (a) where the non - interventional examination is carried out by a health care provider, its health
p.000000: the name of the service provider where the test is to be performed;
p.000000: b) *
p.000000: the identity of the subject (name, place and date of birth),
p.000000: in the case of an incapacitated minor with limited legal capacity under the age of 16 a
p.000000: also the identification data of the person entitled to make a declaration;
p.000000: c) *
p.000000: a statement that the subject is incapacitated or
p.000000: in the case of a minor subject with limited legal capacity under the age of
p.000000: authorized person - his consent to participate in the investigation is set out in paragraph 1
p.000000: after giving information voluntarily, without influence, knowing that it is at any time, orally
p.000000: can be revoked in writing without giving reasons;
p.000000: (d) the date of signature of the statement of consent;
p.000000: (e) the signature of the study director or informant;
p.000000: (f) the signature of the person giving his consent.
p.000000: (5) *
p.000000: The person providing the information and the subject - are incapacitated
p.000000: In the case of a minor subject with limited legal capacity under the age of 16, to make a statement
p.000000: authorized person - also signs the written prospectus referred to in paragraph 1.
p.000000: (6) The information and consent shall be recorded in a separate sheet. The consent form
p.000000: and one original of each written information document shall be kept in the test documentation,
p.000000: and one original shall be handed over to the subject.
p.000000: (7) *
p.000000: If, in connection with a non-interventional investigation, such
p.000000: new relevant information becomes known which affects the contents of the written prospectus, the
p.000000: license modification should be initiated for human medical research, human
p.000000: clinical trials of the investigational medicinal products to be used and in humans
p.000000: clinical investigation of medical devices intended for clinical use
p.000000: 235/2009 on the rules for the authorization procedure (X. 20.) Government Decree 19.
p.000000: §. The subject of the amended written information shall be re-examined
p.000000: be informed and consent must be sought for the investigation to continue. In the absence of this investigation, the
p.000000: cannot be continued on the person concerned.
p.000000: 20 / I. § *
p.000000: Non-interventional study in minors is described in 20 / G-20 / H. §-in
p.000000: may be carried out only if all of the following conditions are met:
p.000000: (a) the study is directly related to the clinical condition in which the minor suffers or is of a nature
p.000000: which can only be performed on minors;
p.000000: (b) in the case of a minor under the age of 16, the consent of the person entitled to make the declaration
p.000000: contains the probable will of a minor capable of forming an opinion and assessing the situation, and this a
p.000000: the declaration may be withdrawn at any time without the minor being adversely affected;
p.000000: (c) an investigator with experience in relation to minors shall, depending on his or her intellectual level,
p.000000: properly informed of the study, adverse and beneficial effects in a way that is comprehensible to him;
p.000000: (d) the investigator or study director takes full account of the
p.000000: a minor under the age of 16 who is able to assess the situation explicitly refuses to participate in the study, or
p.000000: that you wish to withdraw from the investigation at any time;
p.000000: e) *
p.000000: 20 / J. § *
p.000000: (1) *
p.000000: A non-interventional study shall not be included in a
p.000000: incapacitated or disabled minor; and
p.000000: the exercise of rights relating to healthcare, and
p.000000: a person who is partially restricted in the case of a group of property
p.000000: in its possession, it expressly excluded its participation in such investigations. Not for a particular study
p.000000: nor may he be involved who has previously refused consent in possession of his capacity to act
p.000000: for that study.
p.000000: (2) *
p.000000: Incapacitated or incapacitated with health care
p.000000: the exercise of related rights and a group of assets of a property nature
p.000000: partially restricted in adults 20 / G-20 / H. § only with proper application
p.000000: a non - interventional test may be carried out if - in paragraph 1
p.000000: all of the following conditions are met:
p.000000: (a) in the case of a person who is incapacitated, the consent of the person entitled to make the declaration
p.000000: it must contain the presumed will of the subject and this statement at any time
p.000000: can be withdrawn without prejudice to the subject;
p.000000: (b) the subject has been adequately informed of the study in a manner that is comprehensible to the subject, favorable and
p.000000: adverse effects;
p.000000: (c) in the case of an incapacitated person, the investigator and the investigator-in-charge shall take full
p.000000: the subject, who is able to form an opinion and assess the situation, expressly excludes from the study
p.000000: participation or wish to withdraw from the investigation at any time;
p.000000: d) *
p.000000: human medical research for human use
p.000000: clinical trials of investigational medicinal products and
p.000000: laying down rules for the authorization procedure for clinical trials on medical devices intended for clinical investigations
p.000000: 235/2009 (X. 20.) Government Decree [hereinafter: 235/2009. (X. 20.) Government Decree] Section 17 (1)
p.000000: (hereinafter referred to as the licensing authority) shall be the appropriate specialist for the disease in question
p.000000: decide on the authorization in the light of its opinion.
p.000000: (3) If the subject is able to act during the non-interventional investigation
p.000000: shall be informed of the test as soon as possible and 20 / H. With the appropriate application of the provisions of §
p.000000: your consent must be obtained to proceed. Failure to do so will result in an investigation of the person concerned
p.000000: cannot be continued.
p.000000: 20 / Tues § *
p.000000: 20 / L. § *
p.000000: 20 / M. § *
p.000000: 20 / N. § *
p.000000: During an approved non - interventional test:
p.000000: subjects and persons entitled to make a statement, investigators, study directors,
p.000000: the head of the health care provider conducting the examination or the sponsor may file a complaint with the
p.000000: to the licensing authority if they consider the test in the license or test
...
General/Other / Relationship to Authority
Searching for indicator authority:
(return to top)
p.000000: the number of persons to be involved, the course of the research, the nature and frequency of the planned interventions,
p.000000: (c) other agreed treatment options available to the participant and information thereon
p.000000: that research may mean the interruption of treatment that has already begun and that it has begun
p.000000: the consequences for the participant of the interruption of treatment,
p.000000: (d) a detailed description of the possible and expected consequences, risks and inconveniences, and
p.000000: an indication that the research may involve undesirable events which are unforeseeable,
p.000000: (e) a description of the reasonably foreseeable benefits or, if no benefit is expected from the research for the participant
p.000000: communication of the fact,
p.000000: f) the percentage probability of random assignment to each treatment group,
p.000000: g) *
p.000000: the occurrence of research - related damage to the participant, or
p.000000: treatment, compensation and damages to be provided in case of violation of the right to privacy [Eütv. § 164
p.000000: (2)] and compensation [Eütv. 164 (1)], the Eütv. Section 164 (2)
p.000000: the name and contact details of the liability insurer referred to in
p.000000: (h) the reimbursement, if any, of the costs incurred by the participant for participating in the research;
p.000000: (i) a warning that the consent is voluntary and unaffected,
p.000000: it may be withdrawn at any time, either orally or in writing, without giving any reason, without
p.000000: disadvantage,
p.000000: j) the rules for handling and accessing the participant's data,
p.000000: k) *
p.000000: giving the opinion of the competent authority necessary for the commencement of the research
p.000000: the name of the ethics committee, as well as the name of the chairman of IKEB and the independent doctor pursuant to Section 12 (5), and
p.000000: contact information.
p.000000: (5) The participant shall give his or her consent in writing. The statement of consent shall include at least:
p.000000: includes:
p.000000: a) identification of the research,
p.000000: (b) the name of the healthcare institution where the research is to be carried out,
p.000000: c) the name, position and position of the head of the research or the person providing the information
p.000000: Name,
p.000000: d) *
p.000000: identification data of the participant (name, mother 's name, place and time of birth, TAJ
p.000000: number, address), a minor with limited legal capacity and
p.000000: the exercise of related rights and a group of assets of a property nature
p.000000: in the case of a partially restricted or incapacitated participant, the legal representative giving the consent
p.000000: identification data,
p.000000: e) *
p.000000: a statement that the participant has limited legal capacity
p.000000: minors and their capacity to act in relation to the exercise of healthcare rights,
...
p.000000: the exercise of related rights and a group of assets of a property nature
p.000000: partially restricted in adults 20 / G-20 / H. § only with proper application
p.000000: a non - interventional test may be carried out if - in paragraph 1
p.000000: all of the following conditions are met:
p.000000: (a) in the case of a person who is incapacitated, the consent of the person entitled to make the declaration
p.000000: it must contain the presumed will of the subject and this statement at any time
p.000000: can be withdrawn without prejudice to the subject;
p.000000: (b) the subject has been adequately informed of the study in a manner that is comprehensible to the subject, favorable and
p.000000: adverse effects;
p.000000: (c) in the case of an incapacitated person, the investigator and the investigator-in-charge shall take full
p.000000: the subject, who is able to form an opinion and assess the situation, expressly excludes from the study
p.000000: participation or wish to withdraw from the investigation at any time;
p.000000: d) *
p.000000: human medical research for human use
p.000000: clinical trials of investigational medicinal products and
p.000000: laying down rules for the authorization procedure for clinical trials on medical devices intended for clinical investigations
p.000000: 235/2009 (X. 20.) Government Decree [hereinafter: 235/2009. (X. 20.) Government Decree] Section 17 (1)
p.000000: (hereinafter referred to as the licensing authority) shall be the appropriate specialist for the disease in question
p.000000: decide on the authorization in the light of its opinion.
p.000000: (3) If the subject is able to act during the non-interventional investigation
p.000000: shall be informed of the test as soon as possible and 20 / H. With the appropriate application of the provisions of §
p.000000: your consent must be obtained to proceed. Failure to do so will result in an investigation of the person concerned
p.000000: cannot be continued.
p.000000: 20 / Tues § *
p.000000: 20 / L. § *
p.000000: 20 / M. § *
p.000000: 20 / N. § *
p.000000: During an approved non - interventional test:
p.000000: subjects and persons entitled to make a statement, investigators, study directors,
p.000000: the head of the health care provider conducting the examination or the sponsor may file a complaint with the
p.000000: to the licensing authority if they consider the test in the license or test
p.000000: continue as provided for in the plan.
p.000000: 20 / O. § *
p.000000: 1. Except as provided in paragraph 2, no intervention
p.000000: Within 90 days of the completion of the investigation, the sponsor shall notify the licensing authority of the investigation
p.000000: completion, the number of patients involved,
p.000000: within one hundred and eighty days of the completion of the investigation
p.000000: given answer.
p.000000: In the case of a post - authorization pharmacovigilance study:
p.000000: reporting on the pharmacovigilance of medicinal products for human use
p.000000: shall be complied with in accordance with a ministerial decree.
p.000000: (3) *
p.000000: The National Institute of Pharmacy and Food Health (a
p.000000: hereinafter referred to as ‘OGYÉI’) shall send copies of the non-interventional
p.000000: For ETT TUKEB.
p.000000: 20 / Fri. § *
p.000000: (1) A non-interventional test is an authorized test
p.000000: the provisions of the plan are considered to be an occupational rule.
p.000000: (2) *
p.000000: (3) *
p.000000: If the principal is related to some or all of the investigation
p.000000: entrusts another natural or legal person with the performance of his duties, in which case the principal shall also be liable
p.000000: for compliance with the provisions on testing laid down in this Regulation and in specific legislation.
p.000000: 20 / Q. § *
p.000000: In the case of a retrospective study, 235/2009. (X. 20.) Government Decree
p.000000: 17 / A. § (1) c) and d) of the 20 / G. § (2) b), the 20 / H.
p.000000: §, a 20 / I. § b) -d), 20 / J. § (1), second sentence, (2) a) -c),
p.000000: and paragraph 3 shall not apply.
p.000000: 20 / R. § *
p.000000: (1) *
p.000000: For the authorization procedures set out in this Chapter,
p.000000: with the exception of non-commercial investigations, to the licensing authority for the administrative services of the applicant
p.000000: is required to pay a fee.
p.000000: (2) *
p.000000: The applicant
p.000000: (a) the authorization referred to in paragraph 3 (a) for the first instance and for the purpose of an amendment
p.000000: the amount specified therein,
p.000000: (b) the appeal referred to in points (b) to (c) of paragraph 3
p.000000: the same amount as set out therein
p.000000: is required to pay a fee.
p.000000: (3) The amount of the fee:
p.000000: the) *
p.000000: and Gytv. In the case of a non-interventional investigation pursuant to Section 1 (8)
p.000000: aa) *
p.000000: a 235/2009. (X. 20.) Government Decree § 17 (1) (b) (ba)
p.000000: HUF 370,000 in case of approval, HUF 80,000 in case of substantial modification;
p.000000: (ab) Regulation (EC) No 235/2009. (X. 20.) in the examination pursuant to Section 17 (1) (b) (bb) of the Government Decree
p.000000: HUF 200,000 in case of authorization, HUF 80,000 in case of amendment;
p.000000: b) *
p.000000: a 235/2009. (X. 20.) of the Government
p.000000: in the case of the authorization of a non - interventional study and the authorization of a substantial modification of the study plan
p.000000: 000 HUF;
p.000000: c) *
p.000000: in cases not falling under a) -b) HUF 294,000.
p.000000: (4) The fee shall be paid by the applicant in Annex 3 upon submission of the application
p.000000: to the indicated account by postal payment or transfer, or to the cashier of the bank account holder's institution
p.000000: pay.
p.000000: (5) *
p.000000: The fee is the revenue of the licensing authority providing the administrative service. THE
p.000000: 46% of the fee included in paragraph 3 (a) (aa) is OGYÉI, 54% is ETT TUKEB. THE 3)
p.000000: and a substantial modification of the test plan
p.000000: 80% of the fee paid for the licensing is ETT TUKEB, 20% is OGYÉI. Paragraph 3 (a) (aa)
p.000000: The fee for the modification referred to in point (a) shall be shared equally between the licensing authorities acting.
p.000000: The fee paid in appeal proceedings shall be reimbursed to the applicant if:
p.000000: the revised decision or measure to the detriment of the client has been found to be in breach of the law in whole or in part.
p.000000: (7) If, in appeal proceedings, the body acting at second instance is a body which has acted at first instance in whole or in part,
p.000000: unlawful decision
p.000000: (a) annul it at first instance without carrying out any special inquiries necessary to supplement the facts
p.000000: instructs the competent body to conduct a new procedure, it shall be obliged to pay the new procedure without paying a separate fee
p.000000: carried out;
p.000000: (b) by carrying out any special inquiries necessary to supplement the facts
p.000000: (ba) annul and instruct the body at first instance to conduct a new procedure,
p.000000: bb) changes,
p.000000: then the body of first instance to the body of second instance in the proceedings - the separate investigations
p.000000: reimburse the necessary costs incurred in carrying out the
p.000000: (8) *
p.000000: Itv.
p.000000: a) the provisions of Section 28, Paragraphs (2) - (3), the occurrence of the obligation to pay the fee,
p.000000: b) *
p.000000: In the first sentence of Section 31 (1) and in Section 31 (2), (4) - (6),
p.000000: and paragraph 8 to determine the range of persons liable to pay the fees,
p.000000: c) the provisions of Section 32 (1), the refund of the fee,
p.000000: d) the provisions of Section 86 of the statute of limitations
p.000000: shall apply mutatis mutandis by replacing the licensing authority with the licensing authority,
p.000000: a fee shall be construed instead of a fee.
p.000000: (9) For the recording and accounting of fees on the basis of the budget belonging to the general government subsystem
p.000000: existing legal requirements on the reporting and accounting obligations of economic entities
p.000000: apply.
p.000000: (10) *
p.000000: 20 / S. § *
p.000000: (1) *
p.000000: If the licensing authority conducts the investigation in accordance with Eütv.
p.000000: 164 / A. § (2), publishes on its website 235/2009. (X. 20.) Government Decree 17 / A. §
p.000000: Information referred to in points (a) and (c) of paragraph 3.
p.000000: (2) *
p.000000: The licensing authority shall comply with Article 20 / O. § 15 days after notification
p.000000: within its website publishes the 20 / O. § information.
p.000000: 20 / T. § *
p.000000: Miscellaneous and transitional provisions
p.000000: § 21. (1) This Decree shall enter into force on the 15th day following its promulgation.
p.000000: shall apply to authorization procedures initiated after 1 July.
p.000000: (2) *
p.000000: This Regulation shall apply to medicinal products for human use
p.000000: Directive 2001/83 / EC of the European Parliament and of the Council on the pharmacovigilance
p.000000: Directive 2010/84 / EU of the European Parliament and of the Council of 15 December 2010 amending
p.000000: for compliance.
p.000000: (3) *
p.000000: This Regulation is laid down in Regulation (EC) No 726/2004 of the European Parliament and of the Council
p.000000: and pharmacovigilance as provided for in Directive 2001/83 / EC of the European Parliament and of the Council
p.000000: Commission Implementing Regulation (EU) No 520/2012 of 19 June 2012 on the implementation of
p.000000: lays down the provisions necessary for its implementation.
p.000000: Annex 1 to Decree 23/2002. (V. 9.) EüM decree *
p.000000: Area of competence of regional research ethics committees
p.000000: Name of the researcher or the committee
p.000000: the name of the licensing health institution
p.000000: 1. *
p.000000: Semmelweis University
p.000000: Semmelweis University Regional,
p.000000: and its institutions, the Ministry headed by Pest County and the Minister responsible for health
p.000000: health care institutions under the direct supervision of the capital
p.000000: Institutional Scientific and Research Ethics Committee
p.000000: 2. *
p.000000: Hungarian Armed Forces,
...
General/Other / declaration of helsinki
Searching for indicator helsinki:
(return to top)
p.000000: Status of the legislation in force today (14/04/2020). THE ! "signs past and future changes in paragraphs
p.000000: represent.
p.000000: This document contains website 1 of the legislation. To print the entire legislation, select it in the header
p.000000: found print icon!
p.000000: 23/2002. (V. 9.) EüM decree
p.000000: on human medical research
p.000000: CLIV of 1997 on health. § (hereinafter: Eütv.)
p.000000: Pursuant to Article VI (2) (o) and (p), in accordance with promulgated by law,
p.000000: to the Council of Europe on the human rights and dignity of the human being in biology and medicine
p.000000: the Oviedo Convention for the Protection of Human Rights and Fundamental Freedoms
p.000000: Additional Protocol to the Convention on the Prohibition of the Cloning of Human Beings
p.000000: and in accordance with the Declaration of Helsinki adopted by the World Medical Association,
p.000000: I order the following:
p.000000: § 1 (1) *
p.000000: The provisions of this Regulation shall apply to min (dhetntpe: m // blearenndivnéggz.ewttolte
p.000000: medical research (Section 157 of the Eütv., hereinafter: research). test
p.000000: In the case of a clinical trial of a medicinal product and a medical device, the provisions of this Regulation shall apply to
p.000000: prevail. It qualifies as medical research in particular
p.000000: utm_source = netjogta
p.000000: (a) to improve diagnostic, therapeutic, preventive and rehabilitative procedures, new
p.000000: procedures and a better understanding of the pathology and course of diseases,
p.000000: b) genetic,
p.000000: (c) cells, cell constituents, tissues, organs removed from a living human or dead body,
p.000000: done with a body part,
p.000000: d) epidemiological,
p.000000: (e) in the public health and epidemiological interest,
p.000000: f) *
p.000000: g) research on gametes and embryos.
p.000000: (2) - (3) *
p.000000: § 2. (1) For the purposes of this Decree
p.000000: the) *
p.000000: statement of consent: the person participating in the investigation has legal capacity
p.000000: person in the Eütv. 159 (1) e), or to a limited extent
p.000000: the legal capacity of a minor and the exercise of health care rights in his or her capacity to act
p.000000: and in respect of a class of property of a limited nature or
...
General/Other / oviedo
Searching for indicator oviedo:
(return to top)
p.000000: Status of the legislation in force today (14/04/2020). THE ! "signs past and future changes in paragraphs
p.000000: represent.
p.000000: This document contains website 1 of the legislation. To print the entire legislation, select it in the header
p.000000: found print icon!
p.000000: 23/2002. (V. 9.) EüM decree
p.000000: on human medical research
p.000000: CLIV of 1997 on health. § (hereinafter: Eütv.)
p.000000: Pursuant to Article VI (2) (o) and (p), in accordance with promulgated by law,
p.000000: to the Council of Europe on the human rights and dignity of the human being in biology and medicine
p.000000: the Oviedo Convention for the Protection of Human Rights and Fundamental Freedoms
p.000000: Additional Protocol to the Convention on the Prohibition of the Cloning of Human Beings
p.000000: and in accordance with the Declaration of Helsinki adopted by the World Medical Association,
p.000000: I order the following:
p.000000: § 1 (1) *
p.000000: The provisions of this Regulation shall apply to min (dhetntpe: m // blearenndivnéggz.ewttolte
p.000000: medical research (Section 157 of the Eütv., hereinafter: research). test
p.000000: In the case of a clinical trial of a medicinal product and a medical device, the provisions of this Regulation shall apply to
p.000000: prevail. It qualifies as medical research in particular
p.000000: utm_source = netjogta
p.000000: (a) to improve diagnostic, therapeutic, preventive and rehabilitative procedures, new
p.000000: procedures and a better understanding of the pathology and course of diseases,
p.000000: b) genetic,
p.000000: (c) cells, cell constituents, tissues, organs removed from a living human or dead body,
p.000000: done with a body part,
p.000000: d) epidemiological,
p.000000: (e) in the public health and epidemiological interest,
p.000000: f) *
p.000000: g) research on gametes and embryos.
p.000000: (2) - (3) *
p.000000: § 2. (1) For the purposes of this Decree
p.000000: the) *
p.000000: statement of consent: the person participating in the investigation has legal capacity
p.000000: person in the Eütv. 159 (1) e), or to a limited extent
...
Orphaned Trigger Words
p.282819: health institutions of the Ministry headed by the Minister responsible for law enforcement,
p.282819: health care institutions
p.282819: 4. Other health care institutions based in Pest
p.282819: 5. Other health care institutions based in Buda
p.282819: 6. Located in Hajdú-Bihar and Szabolcs-Szatmár-Bereg counties
p.282819: institutional
p.282819: and Regional
p.282819: Research Ethics Committee
p.282819: Metropolitan Municipality Uzsoki street
p.282819: and Péterffy Sándor Street Hospitals Joint Regional Scientific and
p.282819: Research Ethics Committee
p.282819: Metropolitan Municipality of St. Imre
p.282819: and St. John Hospitals Joint Regional Science and Research Ethics
p.282819: Committee
p.282819: University of Debrecen Medical
p.282819: and Health Sciences
p.290469: 00290469
p.290469: 11784009- p.15492674: 15492674 p.15492674: 11784009- p.15492564: 15492564 p.15492564: 10034002-
p.282981: 00282981
p.282981: health care institutions
p.282981: 7. Health care institutions in Baranya, Somogy and Tolna counties
p.282981: 8. Csongrád, Bács-
p.282981: Kiskun, Békés
p.282981: and health care institutions in Jász-Nagykun-Szolnok county, in the 3rd row
p.282981: with the exception of certain healthcare institutions
p.282981: 9. Health care institutions in Borsod-Abaúj-Zemplén, Heves and Nógrád counties
p.282981: 10. Health care institutions in Vas, Zala and Veszprém counties
p.282981: 11. Health care in Győr-Moson-Sopron, Komárom-Esztergom and Fejér counties
p.282981: Regional Scientific and Research Ethics Committee of the Center
p.282981: University of Pécs Medical and Health Sciences Coordination Center Regional
p.282981: Scientific and Research Ethics Committee
p.282981: University of Szeged Albert Szent-Györgyi Medical and Pharmaceutical Science Center Regional
p.282981: Scientific
p.282981: and Research Ethics Committee
p.282981: Borsod-Abaúj-Zemplén County Local Government Hospital of Regional Science and
p.282981: Research Ethics Committee
p.282981: Vas County Lajos Markusovszky General, Rehabilitation and Spa
p.282981: Hospital, Regional Teaching and Research Ethics Committee of the University Teaching Hospital,
p.282981: Szombathely
p.282981: Győr-Moson-Sopron County Municipality Petz Aladár Hospital, Győr, Regional
p.282981: 10024003-
p.283236: 00283236
p.283236: 10028007-
p.282802: 00282802
p.282802: 11994002- p.6066651: 06066651 p.6066651: 11747006- p.15420026: 15420026 p.15420026: 10200249- p.33018597: 33018597 p.33018597: institutions p.33018597: Scientific and Research Ethics Committee p.33018597: 12. * p.33018597: medicine p.33018597: National Pharmaceutical p.33018597: 10032000- p.33018597: non-interventional studies are those for human use p.33018597: clinical trials of medicinal products and p.33018597: clinical trials of medical devices intended for clinical trials licensing p.33018597: in the cases specified in the Government Decree on the Rules of Procedure p.33018597: and Food Health Institute (OGYÉI) p.33018597: 00290050-
p.000000: 00000000
p.000000: 13. *
p.000000: Medical
p.000000: National Pharmaceutical
p.000000: 10032000-
p.000000: clinical trials and non-interventional trials
p.000000: and the Institute of Food Health
p.000000: 00290050-
p.000000: 00000000
p.000000: Annex 4 to Decree 23/2002. (V. 9.) EüM decree *
p.000000: Documents to be attached to the request for a non-interventional medical examination
p.000000: 1. Basic data of the study:
p.000000: a) title of the study in Hungarian, protocol number (if any),
p.000000: b) type of test,
p.000000: c) details and contact details of the sponsor of the study,
p.000000: d) the name and contact details (telephone, fax) and professional qualifications of the Hungarian leader of the study
p.000000: and academic degree, curriculum vitae, summary of professional work,
p.000000: e) the name and address of the healthcare provider (s) performing the examination,
p.000000: (f) planned date of commencement of the investigation,
p.000000: g) the planned duration of the study, the date of completion,
p.000000: (h) the intended location and address of the study.
p.000000: 2. Documentation of the medical device under investigation:
p.000000: a) the name, fancy name, serial number of the device,
p.000000: (b) documents proving the lawful placing on the market of the medical device (s) under investigation,
p.000000: c) instructions for use of the device (s) in Hungarian,
...
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| access | Access to Social Goods |
| age | Age |
| armedXforces | Soldier |
| authority | Relationship to Authority |
| blind | visual impairment |
| disability | Mentally Disabled |
| disabled | Mentally Disabled |
| drug | Drug Usage |
| educational | education |
| healthy volunteers | Healthy People |
| helsinki | declaration of helsinki |
| incapacitated | Incapacitated |
| influence | Drug Usage |
| job | Occupation |
| language | Linguistic Proficiency |
| military | Soldier |
| minor | Youth/Minors |
| opinion | philosophical differences/differences of opinion |
| oviedo | oviedo |
| property | Property Ownership |
| restricted | Incarcerated |
| unlawful | Illegal Activity |
| volunteers | Healthy People |
Indicator Peers (Indicators in Same Vulnerability)
| Indicator | Peers |
|---|
| armedXforces | ['military'] |
| disability | ['disabled'] |
| disabled | ['disability'] |
| drug | ['influence'] |
| healthy volunteers | ['volunteers'] |
| influence | ['drug'] |
| military | ['armedXforces'] |
| volunteers | ['healthyXvolunteers'] |
Trigger Words
capacity
consent
ethics
protection
risk
volunteer
Applicable Type / Vulnerability / Indicator Overlay for this Input