Key Benefits:
Law of 26 February 1998, dealing with medical and scientific research with human beings (Medical and Scientific Research Act with People)
We Beatrix, at the grace of God, Queen of the Netherlands, Princess of Orange-Nassau, etc. etc. etc.
All of them, who will see or hear these, saluut! do know:
In particular, we have taken into consideration that, in connection with the Articles 10 and 11 of the Constitution , to regulate in relation to medical scientific research with human beings,
In this way, we, the Council of State, and with the mean consultations of the States-General, have been well-regarded and understood to be right and to be understood by the following:
1 The following shall be understood in this Act and the provisions which are based thereon:
a. Our Minister: Our Minister of Health, Welfare and Sport;
b. Scientific research: medical-scientific research, part of which is the subjectmatter of persons to acts or the imposition of a certain behavioural manner;
c. test subject: the person referred to in point (b);
d. research protocol: the complete description of a proposed scientific research, including the objectives, design, methodology, statistical aspects and organisation of scientific research;
e. Facilities institution: institution or establishment where acts are carried out for the purpose of carrying out a scientific investigation;
(f) the person carrying out the scientific research: a person, undertaking, institution or organisation which assumes responsibility for the initiation, management or financing of scientific research;
g. the person carrying out the scientific research: a doctor or an in Article 3 (e) , the person referred to, who is responsible for carrying out the scientific research in a given location. If the actual execution is carried out by an employee or other auxiliary, the person taking advantage of that person shall be qualified as the person carrying out the investigation;
h. Commission: a Article 16 recognised committee;
i. Central commission: the commission referred to in Article 14 ;
j. College: the College for the Evaluation of Medicinal Products, named in Article 2, first paragraph, of the Pharmaceutical Act ;
k. other Member States: other Member States of the European Union than the Netherlands;
(l) the European Agency for the Evaluation of Medicinal Products: the European Agency for the Evaluation of Medicinal Products established by Regulation No (EEC) 2309/93 of the Council of 22 July 1993 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Development of Medicinal Products for the Development of pharmacovigilance, (PbEG L 214);
m. conducted scientific research: scientific research carried out by more than one researcher in a number of locations according to a single protocol;
n. scientific research with medicinal products: scientific research with medicinal products designed to determine or to determine the clinical, pharmacological or other pharmacodynamic effects of one or more medicinal products for the purpose of research Confirm that any adverse reactions to one or more investigational medicinal products or to detect the resorption, distribution, metabolism and excretion of one or more investigational medicinal products in order to ensure safety or efficacy of the medicinal products for the study to establish the efficacy of these medicinal products;
o. investigational medicinal product: a pharmaceutical form of an active substance or a placebo which is examined in a scientific study with medicinal products or used as a reference, including a medicinal product for which a medicinal product is permit for placing on the market but otherwise used or composed, formulated or packed than the authorised form, for an unauthorised indication, or used for further information. to obtain an authorised application;
p. 'investigator' dossier: the whole of the clinical and non-clinical data on the medicinal product or investigational medicinal products which are relevant for the study of the medicinal product or investigational medicinal products of humans;
q. adverse event: a harmful phenomenon in a test-person not necessarily related to the scientific investigation;
r. adverse reaction: a harmful and undesired response to a drug for examination, regardless of the dose administered;
s. serious adverse event: an adverse event which is fatal, endangering the subject, hospitalisation or renewal is necessary, permanent or significant disability or incapacity for work Causes or causes a congenital defect or malformation;
Serious adverse reaction: a lethal adverse event, life endangering the subject, hospitalisation or prolongation is necessary, permanent or significant disability or incapacity for work than is out in a congenital defect or malformation;
u. unexpected adverse reaction: a side effect of which the nature and severity do not correspond to the information about the product included in the investigator's file for a medicinal product for which no authorisation has been granted or in the Case of a medicinal product for which a market authorisation has been granted, the summary of product characteristics contained in the package leaflet;
v. written consent: informed, written, diaries, and signed consent to participate in a scientific investigation.
2 The subjectmatter of persons to acts and the imposition of a certain type of behaviour solely for the purpose of providing assistance to them is not covered by paragraph 1 (b).
3 This Act does not apply to scientific research for performing which is required by virtue of the Population survey law and, with the exception of the Articles 7 and 9 and the Articles 8 , 11 and 33 , to the extent that they relate to Article 7 , on scientific research whose research protocol is based on the Embryowet has received a positive opinion from the following Article 3 of Embryolaw competent committee.
1 Scientific research shall be carried out in accordance with a research protocol to this effect.
2 On this research protocol, a positive judgment must be obtained:
a. of a committee responsible for this purpose, where subparagraph (b), 2 °, 3 ° and 4 °, does not apply;
(b) of the Central Commission when it is concerned:
1 °. a decision on an administrative appeal;
2 °. a scientific study as intended in the Second sentence of Article 4, first paragraph , which cannot benefit the test subject in question and which intentionally changes the condition of the test person;
3 °. a scientific study of which the assessment is based on Article 19 lies with the Central Commission;
4. other forms of scientific research, other by general management, of which assessment by the Central Committee is desirable having regard to the social, ethical or legal aspects related to the investigation.
3 The assessment shall be made by the respective committees on the basis of the paragraphs 2 and 3 and the Articles 9 , 10 , 11 and 12 and, in so far as scientific studies on medicinal products are concerned, Paragraph 5a .
Scientific research, including conducted scientific research, shall be evaluated by a single competent committee appointed by the person carrying out the investigation.
The following Article 2, second paragraph , the competent committee may only give a favourable opinion on a research protocol if:
a. It is reasonably likely that scientific research will lead to the adoption of new findings in the field of medical science;
b. It is reasonably likely that the determination referred to in point (a) cannot be considered by other forms or methods of scientific research than scientific studies with test subjects or by carrying out research of less radical nature. take place;
c. It is reasonable to assume that the trial person's interest and other current or future patients should be proportional to the risk and risk to the test person;
d. the research meets the requirements of a correct methodology of scientific research;
(e) the investigation shall be carried out in suitable institutions and by or under the direction of persons qualified in scientific research and at least one competent in the field of operations carried out in the field of scientific research; conduct of the test in relation to the test subject;
f. reasonably plausible that fees payable to the test-person do not have a disproportionate influence on the consent to participate in the investigation;
g. the person carrying out the scientific investigation and the institution where this examination is carried out received a fee not exceeding an amount reasonably proportionate to the nature, extent and purpose of scientific research; research;
(h) the examination protocol clearly indicates the extent to which scientific research can benefit the test subject in question;
i. included in the research protocol the criteria for the recruitment of test subjects tailored to the scientific research;
j. the results of the examination shall be made publicly available by the Central Board unless objections are objected to by the person carrying out the scientific investigation;
k. The investigation also satisfies reasonably reasonably requirements.
1 A committee may suspend or revoke a favourable opinion on a research protocol if there are reasonable grounds to believe that continuation of scientific research would lead to unacceptable risks for the future of the Community. the test subject.
2 If there are reasonable grounds to believe that continuation of scientific research would lead to unacceptable risks to the test person, the central commission or our Minister may, in the case of the fifth member of the Article 13i apply, the implementation of the scientific investigation has been suspended until a committee has given a positive opinion on this research protocol. The central committee or our Minister, in case the fifth paragraph of Article 13i applies, reports the suspension of the conduct of the inquiry to the committee which, as the last, has given a positive opinion on the research protocol and to the person carrying out the scientific investigation and the person carrying out the investigation.
3 Except in the event of imminent danger, the Commission, the Central Commission or Our Minister shall, in the case of the fifth member of Article 13i is applicable, before suspending or withdrawing the positive opinion, or suspending the execution of scientific research, the person carrying out the scientific investigation or the scientific investigation shall be able to present its views within a period of one week.
4 If a committee decides to suspend or revoke a positive assessment of a research protocol on scientific research with medicinal products, it shall inform the Central Commission or Our Minister, in the case of: Article 13i, fifth paragraph , applies to, and the College is informed thereof, under a statement of reasons.
5 The College shall, on grounds of reason, immediately inform the European Agency for the Evaluation of Medicinal Products and the European Commission of the suspension or withdrawal of a given positive opinion on a research protocol on an evaluation of the medicinal products and for the evaluation of the medicinal products. Scientific research with medicinal products.
1 It shall be prohibited to carry out scientific studies in subjects who have not reached the age of 18 years or who are unable to reasonably appreciate their interests in this respect. This prohibition shall not apply to scientific research which may be of benefit to the subjects concerned and to scientific research which does not, with the collaboration of subjects from the category to which the test person is subject, can be studied. may be carried out and for which the risks are negligible and the objections are minimal.
2 If, by a scientific inquiry referred to in the second sentence of the first paragraph, the test person concerned is opposed to an act to which he is subject or to an act imposed on him, the investigation shall not take place on the basis of a That test person.
It shall be prohibited to carry out scientific investigations with subjects who are reasonably expected to be regarded as having the actual or legal relation to the person carrying out or the carrying out of the study or the person who carried out the study. It is not possible to decide on participation in freedom of participation. This prohibition shall not apply to scientific research which may be of benefit to the subjects concerned and to scientific research which does not, with the collaboration of subjects from the category to which the test person is subject, can be studied. is, can be performed.
1 It shall be prohibited to carry out scientific investigations:
a. if the subject is of majority age, and section c is not applicable: without the written consent of the person concerned;
b. if the subject is underage but has reached the age of 12 years and is not subject to part c: without written consent of the person concerned, and that of the parents exercising the authority or of his guardian;
c. if the test person is 12 years of age or older and is unable to reasonably appreciate his interests in this respect: without the written consent of the parents exercising the authority or of the guardian or if he is of the age of majority; of the legal representative of the person concerned or, if this is missing, of the person empowered to do so by the person concerned in writing or, in the absence of such person, of the spouse, registered partner or other person parent of the person concerned or, if the person is missing, the parents of the person concerned or, if so missing, the reasonably reachable adult children or, if they are also absent, the reasonably accessible adult siblings of the person concerned;
d. if the test subject has not reached the age of 12 years: without the written consent of the parents exercising the authority or of his guardian.
2 If the person is unable to write, consent may be given orally in the presence of at least one witness.
3 The replacement consent of the persons mentioned in paragraph 1 (c) and (d) above indicates the suspected will of the test person.
4 If scientific research can only be carried out in emergency situations where the consent required under the first paragraph cannot be given, and may benefit the person who is in that emergency. acts for their execution take place without such permission as long as the condition which is preventing the giving of consent presents itself.
5 Before consent is requested, the person carrying out the investigation shall ensure that the person whose consent is required is informed in writing and, if he so wishes, in a prior maintenance consent, of:
a. the purpose, nature and duration of the investigation;
b. the risks that the study would bring to the health of the test person;
c. the risks that the interim termination of the study would bring to the health of the test person;
d. the objections that the study could bring to the test person.
6 The information shall be provided in such a way as to ensure that it is reasonably certain that the person concerned has understood it. He shall be given a period of reflection in such a way as to enable him to give a carefully considered decision on the requested consent on the basis of this information. In the case of ministerial arrangements, further requirements may be made to the information which is provided to the person concerned.
7 The person carrying out scientific research shall ensure that subjects who have not reached the age of 12 years or who are unable to reasonably appreciate their interests in the matter are to be examined. informed by a qualified person in a manner appropriate to their comprehension capacity.
8 The manner in which implementation is given to the provisions of this Article shall be laid down in the research protocol.
9 The test person or, if this is not authorised under this Article, to give consent, the person empowered to do so in his place, may withdraw the consent at any time, without justification. He shall not be liable for damages in respect of revocation.
1 The scientific investigation shall only be carried out if an insurance has been concluded at the time the investigation begins, which is the result of the injury caused by the investigation by reason of the death or injury caused by the investigation. the test subject is covered. The insurance does not have to cover the damage which, on the basis of the nature of the investigation, was certain or almost certain that it would occur.
2 The insurer's obligation to compensate for the damage, referred to in the first member, shall be Section 6.1.10 of the Civil Code The Articles 95 , 96, first paragraph , 97 , 100 to 102 , 105 to 107a, first paragraph , and 108 applicable mutatis mutandis.
3 In the case of, or under general management, detailed rules shall be laid down for insurance and in respect of the extent of the coverage of the insurance. The rules to be adopted on a general basis concern only changes to the amounts of money included in that measure, which are, by their nature, subject to regular change. The general measure of management shall not take effect sooner than eight weeks after the date of issuance of the Official Gazette, in which he is placed. Notice of the placement shall be communicated without delay to the two Chambers of the States-General.
4 The insurance covers only the damage of natural persons.
5 If, in the opinion of the committee responsible for the assessment of the relevant research protocol, no risk is attached to scientific research for the test person, it may, in the case of a positive opinion, be the research protocol waivers the provider on his request from the obligation to conclude an insurance policy.
6 In the case of a study aimed at comparing the usual acts of medicine in the field of medicine, the committee responsible for the assessment of the relevant research protocol may, in the case of a study, be carried out by the a positive assessment of the obligation on the provider to grant an exemption from the obligation to conclude an insurance scheme if, as a result of the comparative nature of the investigation, the investigation has been carried out in the opinion of the Commission for the subjects Its nature is at high risk of negligible risk.
7 The manner in which implementation is given to the first and ninth member shall be laid down in the research protocol.
8 Is the person carrying out scientific research liable for the damage caused by the death or injury of the test person, then the person responsible for carrying out the scientific investigation shall be liable. To the extent that the conduct of a scientific investigation is carried out in a facility setting up facilities, such liability shall, even if the investigation is not carried out or carried out by that institution, also take place in such an institution.
9 The scientific investigation shall also be carried out only if, at the time of commencement of the investigation, an insurance has been entered in order to cover the risk of the liability of the person referred to in the eighth paragraph of the investigation carry out or otherwise adequately ensure that their obligations in respect of their liability can be fulfilled.
10 The first and ninth members shall not apply in respect of the provision of scientific research by the authorities or agencies of the state government designated by Our Minister. The injured party shall have the rights which he otherwise would have against the insurer in accordance with the provisions of this Article vis-vis a service, institution or company of the State's State which does not have insurance as referred to in the first paragraph.
11 The liability of the performer or, in the case referred to in paragraph 8, of the person conducting the scientific investigation or of the facility, cannot be restricted or excluded.
1 The obligation to ensure compliance with Articles 2, first and second paragraphs, and 7 rests on the person carrying out the scientific investigation.
2 The obligation to comply with Article 2, first and second paragraphs, shall in the case provided for in the second sentence of Article 7, second sentence, including the facility provided for in Article 7, paragraph 2.
The person carrying out the scientific research shall ensure that the subject is able to contact a doctor in the research protocol for information and advice relating to the investigation, who is not in the course of the implementation of the scientific research programme. studies are concerned or another expert who should be considered able to provide the subject with appropriate information and advice on the investigation and who is not involved in the conduct of the investigation.
1 The scientific investigation shall report all serious adverse events, except for serious adverse events which, according to the research protocol, are not immediate reporting by the person who is the subject of scientific research. carrying out scientific research is required, immediately to the person carrying out the scientific investigation. The immediate reporting is followed by detailed written reports, in which the subjects are identified by code number.
2 The scientific study shall report all serious adverse events, except those serious adverse events which are not subject to reporting according to the research protocol, to the following: Article 2, second paragraph , competent committee and, where this is not the central committee, in copy to the central committee.
3 Unless other time limits have been specified in the research protocol, the reporting referred to in paragraph 2 shall be reported as soon as possible and shall:
a. Within seven days of the knowledge of the occurrence of the occurrence of the occurrence of the occurrence of the occurrence of the occurrence of the occurrence of the occurrence of the occurrence of the occurrence of the occurrence of the occurrence of the occurrence of the occurrence of a test, eight days within which relevant information about the aftermath of the occurrence is presented;
b. Within 15 days of the occurrence of occurrence of the occurrence of the occurrence of the occurrence, if any other occurrence, of the scientific investigation.
4 If there are reasonable grounds to believe that continuation of scientific research would lead to unacceptable risks to the test person, the person who is the subject of scientific research shall be considered to have been justified. carry out the examination until a further favourable opinion has been obtained from the following Article 2, second paragraph -The committee responsible.
(5) Subject to the reasons for which the scientific investigation has been carried out, Article 2, second paragraph , competent committee:
(a) immediately notice of a decision to suspend the investigation;
(b) within 15 days of a notice of a decision to terminate the investigation in a timely way.
6 For the purposes of this Article, serious adverse events shall include such phenomena in a test-person who, in the opinion of the person carrying out the scientific investigation, may have been present during the investigation. develop into a serious adverse event, but where this serious adverse event has not materiated as a result of intervention.
7 The central committee shall report each calendar year on the number of serious adverse events occurring during the previous calendar year, with the exception of those serious adverse events which have not been reported under the terms of the research protocol is required.
1 The person carrying out the scientific research shall ensure that the subject is informed in good time about:
a. the provisions of the Article 6, sixth paragraph, second sentence, and ninth member , 7 , 9 and 12 ; and
b. the conduct of the investigation, including in any case, understood situations as referred to in Article 10, fourth paragraph .
2 The information supplied shall be supplemented on request.
3 The obligations referred to in paragraphs 1 and 2 shall also apply to the other persons of whom, on the basis of Article 6 Consent is required.
The person carrying out the scientific research shall ensure that the privacy of the subject is protected as much as possible.
The person carrying out scientific research shall ensure that, prior to the commencement of an investigation, those whose professional cooperation is necessary in carrying out the investigation shall, on the nature and purpose of the investigation, be responsible for the conduct of the research. Have been notified.
In scientific studies with medicinal products, in addition to the (1) to (4) the provisions of this paragraph shall apply.
1 Scientific research with medicinal products, including bioavailability and biological equivalence studies, is in design, implementation and reporting in accordance with the principles of good clinical experience. practices.
2 In the case of or under general management measure, rules on good clinical practice shall be established.
It shall be prohibited to carry out scientific research with medicinal products intended for modification of the germ membrane and the genetic identity of the test person established in the context of gene therapy.
Without prejudice to: Section 2 can be the following Article 2, second paragraph , the committee responsible only gives a favourable opinion on a research protocol which concerns scientific research with medicinal products where:
(a) the person carrying out the scientific investigation or his legal representative established in the territory of the European Union;
(b) the medicinal products for examination or, where appropriate, devices for administration, except where scientific studies on registered medicinal products are concerned, shall be made available free of charge by the person who scientific research;
c. on the basis of the Law on the professions in individual health care registered physician or dentist, working in health care, is responsible for medical care and medical decisions about the trial subject.
Without prejudice to: Section 2 scientific studies of medicinal products for underage subjects may only be carried out if:
a. The investigation is essential in order to confirm the results of scientific research with medicinal products with persons who may, under this law, give their consent or of other research methods and the research directly benefit the affected group of patients;
(b) the relevant scientific guidelines adopted by the European Agency for the Evaluation of Medicinal Products are respected;
c. the risk, specified in Article 4 , and the load rate is specifically defined and permanently controlled;
d. the following Article 2, second paragraph , having expertise in the field of pediatrics or paediatric advice, has gained expertise in the clinical, ethical and psychosocial aspects of research;
e. the interests of the patient always prevail over those of science and society.
Without prejudice to: Section 2 Clinical trials with medicinal products in adult subjects who are not capable of reasonable appreciation of their interests in this respect may only be carried out if:
a. The research is essential to confirm the results of scientific research with medicinal products in persons who may, under this law, give their consent, or of other research methods, and direct it. related to a clinical condition that is life-threatening or undermines health, and where the subject is subject to the test;
b. the risk, specified in Article 4 , and the load rate is specifically defined and permanently controlled;
c. the following Article 2, second paragraph , competent committee has expertise in the area of the disease concerned and has gained the population or advice concerned on the clinical, ethical and psychosocial aspects of the disease and population concerned;
d. the interests of the patient always prevail over those of science and society;
e. the reasonable expectation is that the benefits of administration of the drug for examination for the patient in question outweVe the risks or that the administration is at no risk associated with the administration at all.
1 The following Article 2, second paragraph The committee responsible shall give its opinion, having regard to the research dossier, and shall decide on an application for a positive opinion on a research protocol on scientific research with medicinal products within 60 years of age. days after receipt of the application.
2 During the period within which the application is to be treated, the Article 2, second paragraph , once further information is requested from the competent committee in addition to the information already provided by the applicant.
3 The period referred to in paragraph 1 may be extended by a maximum of 30 days in the case of scientific research with medicinal products for gene therapy and somatic cell therapy and any medicinal product containing genetically modified organisms.
4 The time limits set out in paragraphs 1 and 3 shall not apply to the assessment of scientific research with medicinal products for xenogenic cell therapy.
1 An application for a judgment of an appropriate Article 2, second paragraph , the committee responsible for scientific research with medicinal products must comply with the rules laid down by ministerial rules. These rules concern the form of the request and the documents to be presented, in particular as regards the information supplied to subjects, and the adequate safeguards for the protection of personal data.
2 If the application referred to in paragraph 1 relates to scientific research with registered medicinal products, only the summary of the product information, as established at the time of registration, need to be taken into account in the application. shall be provided. If an application form, indication, patient group or dosage may be different from the registration, indication, patient group or dose, the summary of the product information shall be supplemented by additional information relevant to the relevant examination.
1 Scientific examination of medicinal products may be carried out only in so far as the central committee has not expressed any objections to such objection within the time limit laid down in the third paragraph.
2 Before the completion of scientific research with medicinal products, the person carrying out the examination shall inform the Central Commission, on presentation of the investigator's file, of the examination.
3 The central committee may, at the latest within 14 days of receipt of the notification referred to in the second paragraph, inform the applicant of the examination of its reasoned objections to the investigation. In such a case, it may amend the proposed research protocol in order to accommodate the objections of the Central Commission. If the person who carries out the investigation does not make use of that possibility, the investigation shall not commence.
4 The notification referred to in paragraph 2 relates to scientific research with medicinal products for gene therapy, somatic cell therapy, xenogenic cell therapy, or medicinal products containing genetically modified organisms, the only if the central committee or our Minister, if the fifth member is applicable, expressly stated in writing not to have any objection to the investigation. In such cases, the period referred to in the third paragraph may be extended for a period not exceeding 30 days, except that under this law no time limit shall apply to the making of reasoned objections to the examination of medicinal products for Xenogenic cell therapy.
5 By way of derogation from the first and second paragraphs, if the assessment of the examination protocol is based on: Article 2, second paragraph, point (b), 2 °, 3 ° or 4 ° by the Central Committee, the notification referred to in paragraph 2 has been notified to our Minister and shall decide on this matter by analogy with the provisions of this Article.
6 By ministerial arrangements, rules shall be laid down concerning the form and content of the notification provided for in paragraph 2, the supporting documents to be submitted, the form and content of a proposal for substantial amendments to be made to the Commission. protocol shall be affixed and the declaration that the investigation has been terminated.
7 By ministerial arrangement rules may be laid down concerning the amounts which the central committee or our Minister, in the case of the fifth paragraph of Article 13i applies, for the costs of the implementation of this Article, may be taken into account in be able to be taken into account by the person who has made the notification provided for in paragraph 2.
1 The central committee or our minister, in case the Fifth paragraph of Article 13i is subject to justification if adverse reactions to the investigational medicinal product are already included in the European database which result in unacceptable risk to the test person or if there is otherwise evidence that the scientific investigation leads to unacceptable risks to the test subject.
2 The Health Care Inspecting Inspect at the request of the Central Commission or of Our Minister, in case it Fifth paragraph of Article 13i apply, or scientific research with medicinal products may be expected to take place in accordance with this Act. The provisions of Article 5:12 , 5:13 and 5:15 to 5:20 of the General Administrative Law Act shall apply mutatis mutandis.
1 Upon the start of the study, the person carrying out the scientific research may amend the research protocol on scientific research with medicinal products.
2 If the modification is substantial and may have an effect on the safety of subjects or may result in a different interpretation of the scientific documents that substantiate the course of the study or if the change is otherwise be significant, the person conducting the investigation may only change the protocol if:
a. He the following Article 2, second paragraph , the competent committee, the Article 13i, first or fifth member , referred to as the body and, where appropriate, the competent authority of another Member State, which gave its final opinion, of the reasons and content of the proposed amendment,
b. the following Article 2, second paragraph (i) a favourable opinion on the proposal for amendment of the Protocol and
c. the Article 13i, first or fifth member , that authority has not raised any reasoned objections to the proposed amendment of the Protocol.
3 In case the Article 13i, first or fifth member Where the said authority or the competent authorities of other Member States have raised reasoned objections to the amendment of the Protocol, the examination may only be carried out if the person carrying out the scientific investigation is to proceed with the examination of the any proposed amendment to the Protocol adapts to the objections raised.
4 The following Article 2, second paragraph , the competent committee shall assess the amendment of the Protocol within thirty days of receipt of the proposal for a modification of the Protocol.
5 The Article 13i, first or fifth member The said authority shall, at the latest within thirty days of receipt of the proposal for amendment of the Protocol, raise objections to that effect.
1 The person carrying out the examination shall draw up the following information: Article 2, second paragraph , the competent committee, the Article 13i, first or fifth member , referred to as the body and, where appropriate, the competent authority of another Member State, within 90 days of the end of a scientific study of medicinal products, informed that the investigation has been terminated.
2 When the investigation is to be discontinued prematurely, the person conducting the investigation shall inform the Article 13i, first or fifth member The authority referred to above and, where appropriate, the competent authority of another Member State, shall be informed of such termination within 15 days of the end of the period of cessation of reasons.
1 The in Article 13i, first paragraph and fifth paragraph The said authority shall make available to the College, at the College, the data on scientific research with medicinal products designated by or on the basis of a general measure of management.
2 The College shall ensure the introduction of this information in a European database accessible only to the College, the Central Commission or our Minister, in the event of a Fifth paragraph of Article 13i The Health Care Inspectorate, the competent authorities of other Member States, the European Agency for the Evaluation of Medicinal Products and the European Commission shall apply. Rules governing the confidentiality of the information contained in the European database may be laid down or under general management measures.
3 On a reasoned request from another Member State, the European Agency for the Evaluation of Medicinal Products or the European Commission shall provide the Article 13i, first paragraph and fifth paragraph , as a body, all additional information relating to a scientific research with medicinal products which are not yet included in the European database.
4 The methods of electronic data exchange may be subject to detailed rules by ministerial arrangements.
If the Central Commission or Our Minister, in the case of: Article 13i, fifth paragraph apply, has objective reasons to believe that the person carrying out or performing the scientific research with medicinal products or any other person involved in the trial is no longer fulfilling its obligations, the plant shall The Commission or our Minister immediately inform them of this and give notice of the behaviour that the person named in order to correct in order to correct the situation. The Central Commission or Our Minister, in the event of Article 13i, fifth paragraph , applies, immediately fixes the following: Article 2, second paragraph The competent committee which, as the last, gave its opinion on the relevant scientific research with medicinal products, informed the competent authorities of other Member States and the European Commission of a code of conduct.
1 Undesirable events or laboratory abnormalities that are crucial according to the safety assessment protocol shall be addressed to the person carrying out the scientific examination within the time limit specified in the Protocol, reported.
2 The person carrying out the scientific investigation shall provide the person carrying out scientific research and the following to the person responsible for carrying out scientific research. Article 2, second paragraph , competent committee which gave its final opinion, all requested additional information on reported deaths.
3 The person carrying out the scientific investigation shall keep detailed records of all adverse events reported to him by the person carrying out the scientific investigation. This information will be transferred to the Healthcare and Central Commission or Our Minister if requested, upon request if Article 13i, fifth paragraph , applies to and the competent authorities of the Member States within the territory of which the scientific investigation is carried out.
1 The person carrying out scientific research with medicinal products shall ensure that all relevant information about suspicions of unexpected serious adverse reactions to investigational medicinal products which have resulted in the death of a test person be registered and as soon as possible, but no later than seven days after he has taken note of it, shall be reported to the College, the Central Commission, the competent authorities of other Member States concerned and the following Article 2, second paragraph , competent committee and relevant information on its aftermath shall be communicated to the said authorities within a further eight days.
2 All suspected unexpected serious adverse reactions to investigational medicinal products referred to in paragraph 1 shall be notified as soon as possible, but not later than 15 days after the person carrying out the investigation has been informed of any unexpected serious adverse reactions. taken, reported to the College, the Central Commission, the relevant competent authorities of other Member States and the following Article 2, second paragraph -The committee responsible.
3 The person carrying out the scientific investigation shall inform all the others who carry out the investigation.
4 The College shall ensure the introduction of all the reported suspicions of unexpected serious adverse reactions to a medicinal product for research in a European database, as referred to in Article 4 (2) of the EC Treaty. Article 13m, second paragraph .
Throughout the duration of the scientific research with medicinal products, the person carrying out the study shall, once a year, provide a list of all suspected serious adverse reactions to investigational medicinal products, which are to be considered during the year. have occurred and a report on the safety of the subjects to:
a. The Central Commission or Our Minister if Article 13i, fifth paragraph , applicable;
(b) the competent authorities of the other Member States within the territory of which the scientific research with medicinal products is carried out;
c. the following Article 2, second paragraph -The committee responsible.
Ministerial arrangements may require reporting, which is to be reported in the Articles 13o , 13p and 13q .
1 There is a central committee for medical-scientific research. It has a maximum of 15 members. The Framework Law on self-employed administrative bodies shall apply to the Central Board, with the exception of: Article 22 of that Act , in so far as decisions are taken by the Central Commission for the implementation of this Law and the Articles 10 , 16 and 19 of Embryolaw .
2 The central committee shall be composed of one or more doctors, and persons with competence in the fields of embryology, pharmacology, pharmacy, nursing, behavioural sciences, legal science, the methodology of the doctors, etc. scientific research and ethics, as well as a person who specifically assesses the scientific research from the angle of incidence of the test subject.
3 A substitute member shall be appointed for each member.
4 The members, including the Chairman, and alternate members of the Central Commission shall be appointed for a maximum period of four years. Our Minister shall designate a person who may attend the meetings of the committee as an observer.
5 The central committee shall appoint one or more alternates for the chairman from among its members.
6 Reappointment of members and alternate members may take place twice and for a maximum of four years.
7 The central committee shall regulate its operation in the case of a regulation. The Regulation contains a provision on the basis of which a member or an alternate member of the Central Commission does not participate in the assessment of a research protocol if it is involved in the performance or execution of the research protocol. Evaluation of scientific research.
The central committee shall have a secretariat, the officials of which shall be appointed by our Minister, shall be appointed, suspended and dismissed.
1 The central committee may recognize commissions, which are in charge of review of research protocols in accordance with or under this law or the Embryowet .
2 For recognition, only a committee shall:
a. Consisting, in each case, of one or more doctors and persons with competence in the field of legal science, the methodology of scientific research and ethics, as well as a person specific to the scientific investigation assess, from the point of view of the test subject, and that in the case of the assessment of scientific research with medicinal products, it shall also include persons who are competent in pharmacy and clinical pharmacology;
(b) whose members comply with further requirements concerning training and experience, to be defined by the Central Committee;
(c) whose members are appointed for a period of not more than four years and the reappointment of the members may take place twice for a period of not more than four years;
d. satisfactorily provide for the cooperation of other experts with a view to the nature of the research protocols submitted to it by other experts;
e. whose circle is to be worked out in respect of which the circle is to be employed;
f. in whose rules of procedure are satisfied with the independence of the organisation which the committee has set up;
g. Welker Rules provides for a proper arrangement of its operation and includes, inter alia, a provision under which a member or an alternate member does not take part in the assessment of a research protocol if it is involved when performing or carrying out the scientific research to be assessed;
h. of which it is reasonable to assume that its research protocols will be submitted for evaluation to at least the number determined by the Central Committee.
1 The central committee shall forthwith inform our Minister of a recognition as referred to in Article 16, first paragraph.
2 Of a recognition as referred to in Article 16, first paragraph, shall be communicated by the care of Our Minister in the Official Gazette.
A committee shall make a written communication to the central committee of the amendment of its rules of procedure and of its abolition.
1 Within six weeks of the submission of a Protocol concerning a scientific examination as referred to in the second sentence of Article 4, first paragraph, where the condition of the subject is not intentionally altered, the Commission may decide to to transfer its assessment to the Central Commission. The Commission shall inform the person who has submitted the Protocol of the transfer.
2 The central committee may provide that the assessment of protocols relating to a form of scientific research designated by it as referred to in the first paragraph shall be carried out by it.
The Commission and the Central Commission may, as a fee for the assessment, pay an amount to the applicant who submits a research protocol.
1 In the case of a general measure of management, it may be determined that the Article 16 recognised committees verify that the measure constitutes a form of scientific research on which the relevant committee is under consideration, as a result of the action taken Article 2 has given its opinion, taking a course which is, to a significant extent, less favourable to the test person than provided for in the research protocol. In such a case, the committee may give a further opinion on the research protocol. Article 10, fourth paragraph , is applicable.
2 In the case of a general measure of management, detailed rules may be laid down concerning the manner in which the commissions exercise the task referred to in the first paragraph.
3 The first and second paragraphs shall apply mutatis mutandis to the Central Commission, in so far as they apply to the Central Commission. Article 2 (2) (b) (2), (3) and (4) , it is responsible for the assessment of research protocols.
1 The Commission shall forward to the central committee copies of any judgment given pursuant to this Act as well as of the relevant research protocol or main cases within seven days of the day on which the judgment is given. In addition, the Commission of the Article 10, fifth paragraph, part b Those communications shall be notified to the central committee within seven days of receipt of such communications.
2 The Commission shall report annually before 1 April of its activities in the last calendar year. This report shall be sent to the central committee and, by the way, shall be made available by the committee for the payment of costs, to each one.
3 The Commission shall provide the central committee with all the cooperation which is reasonably necessary for the performance of its task.
An interested administrative profession may be brought by a committee to the central committee against a judgment given by a committee.
The Central Commission shall monitor the work of the committees. It may lay down directives in respect of activities which they shall carry out in accordance with that law. Such guidelines are made public by the care of Our Minister in the State Gazette.
1 The central committee shall withdraw approval granted to a committee if:
a. The commission no longer meets any of the Article 16, second paragraph, points (a) to (g) , terms and conditions laid down for the purpose of recognition;
(b) the commission fails to comply with the obligations arising out of this law for its implementation;
By amending the Commission's rules of procedure, it is no longer reasonable to ensure that the work with which it has been entrusted pursuant to this Act is not reasonably ensured.
2 The central committee may also withdraw recognition if a smaller number of research protocols has been assessed by the committee in the last two calendar years than the number of research protocols referred to in the Article 16, second paragraph, point (h) .
3 A decision to revoke a recognition shall not be taken after the committee has been heard by the Central Commission.
4 The repeal shall be communicated in writing to the Commission. Article 17, second paragraph , shall apply mutatis mutandis.
Each time within a period of five years, the central committee shall report to our Minister, in which the task of the central committee shall be subject to examination and proposals may be made for any changes which may be required. Our Minister is responsible for his views on this report in the report, which is intended to be Article 39 (1) of the Framework Law on independent administrative bodies and adds the report to that report.
Ministerial arrangements may provide for the transmission of information to be transmitted to the Central Commission pursuant to this Law to our Minister, in the case of: Article 13i, fifth paragraph , applies, and also to the Committee, the College or the Health Care Inspectorate, to be done electronically. Rules governing the form in which it is to be taken may be laid down.
1 With the supervision of compliance with or under this law, the officials of the State Supervision designated by the decision of Our Minister shall be responsible for public health.
2 Of a decision referred to in paragraph 1 shall be communicated by the State Official Gazette.
3 In the case of, or under general management, detailed rules may be laid down for the supervision of compliance with or under this Law with regard to scientific research with medicinal products.
1 In the case of scientific research with medicinal products of the inspection, Article 28, first paragraph , drawn up in a report made available to the person carrying out scientific research. In so far as the report concerns personal data as intended Chapter 2, Section 2, of the Personal Data Protection Act , the inclusion of this report is omitted, unless it appears that it does not infringe the privacy of the private sector.
2 The report shall also be made available to Member States of the European Union, the Central Commission, the Commission and the European Agency for the Evaluation of Medicinal Products on a reasoned request.
The application of this Law by the committees shall be subject to the national and international rules applicable to the State Department in order to ensure the protection of information which is confidential through the interests of the State or its allies. Commands.
1 Without prejudice to: Articles 7, 1st paragraph , and 8, first paragraph, of the Coordination Act of Exceptions in the event of exceptional circumstances, may, in the case of exceptional circumstances, be brought into force by Royal Decree, on the proposal of Our Minister-President, Article 32.
2 Where the decision referred to in paragraph 1 has been taken, a proposal for a law shall be forwarded to the Second Chamber forthwith, on the continuation of the operation of the provision in force for that decision.
If the proposal is rejected by the States-General, a royal decree, on the proposal of our Minister-President, shall without delay delay the provision which has been brought into force under paragraph 1.
4 By royal decree, upon the proposal of Our Prime Minister, the provision which has been brought into force under paragraph 1 shall be excluded as soon as the circumstances permit it to be considered.
5 The decision, in the first, third and fourth paragraphs, shall be published in accordance with the procedures to be determined therein. It shall enter into force immediately after the publication.
6 The decision, referred to in the first, third and fourth paragraphs, shall be placed in each case in the Official Journal.
This part has not (yet) entered into force; see the summary of changes
1 imprisonment of a maximum of one year or a fine of the fourth category shall be punished by the person, whether intentionally or not, in breach of a prohibition, which is contained in Article 6, first paragraph .
2 imprisonment of up to six months or a fine of the fourth category shall be punished by the person who acts in breach of the obligation to ensure the fulfilment of the obligations imposed by the Commission. Article 2, first paragraph or second paragraph , or 7 but contrary to an obligation, contained in the Articles 10 , 11 , 12 and 13 and Paragraph 5a , or contrary to a code of conduct intended in Article 13n . With the same penalty penalty is punished the one who acts in violation of a ban, contained in the Articles 4 , 5 and 13c , the person carrying out scientific research without a protocol on which a favourable opinion has been obtained or in contraa with that and the person carrying out scientific research while the committee has taken a favourable opinion on the subject. has suspended or revoked the research protocol or the central commission or Our Minister, in the case of the fifth member of Article 13i applies, the conduct of the investigation has been suspended.
3 The offences referred to in paragraph 1 are offences; the offences referred to in the second paragraph are offences.
1 Our Minister shall, within 4 years of the entry into force of this Law, and thereafter every five years thereafter, send to the States-General a report on the effectiveness and effects of this law in practice.
2 The report referred to in Article 39 (1) of the Framework Law on independent administrative bodies , shall be part of the report referred to in paragraph 1.
The articles of this Law shall enter into force on a date to be determined by royal decree, which may be made different for the various articles or parts of such articles.
This law is cited as: Law medical-scientific research with people.
Burdens and orders that it will be placed in the Official Gazette, and that all ministries, authorities, colleges and officials who so concern will keep their hands on the precise execution.
Issued at Gravenhage, 26 February 1998
Beatrix
The Minister for Health, Welfare and Sport,
E. Borst-Eilers
The Minister of Justice,
W. Sorgdrager
Published on the 26th March 1998The Minister of Justice,
W. Sorgdrager
