Law Medical-Scientific Research In Humans

Original Language Title: Wet medisch-wetenschappelijk onderzoek met mensen

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Law of 26 February 1998, laying down of medical-scientific research in humans (law medical-scientific research in humans) we Beatrix, by the grace of God, Queen of the Netherlands, Princess of Orange-Nassau, etc. etc. etc.
All who read this will see or hear, greetings! do: So We have considered, that, also in connection with articles 10 and 11 of the Constitution, it is desirable to arrange for medical-scientific research in humans;
So it is, that we heard, the Council of State, and with agreement of the States-General of the Netherlands, as we find good goedgevonden and have understood and understand this: paragraph 1. General provisions article 1 1 In this Act and the provisions based thereupon, the following definitions shall apply: a. the Minister: the Minister of health, welfare and Sport;
b. scientific research: medical-scientific research which is part subjecting persons to acts or requiring to persons of a certain conduct;
c. test subject: the person, referred to in subparagraph (b);
d. research protocol: the complete description of a proposed scientific research including the objectives, design, methodology, statistical considerations and organisation of scientific research;
e. facilities management institution: institution or company where acts pursuant to a scientific research;
f. the one scientific research carried out: a person, company, institution or organisation which takes responsibility for the initiation, management or financing of the scientific research;
g. the one who carries out scientific research: a doctor or a person referred to in article 3 (e), which is responsible for the implementation of scientific research in a particular location. If the actual implementation will be carried out by an employee or another person, help is the one that this person uses identified as the one who performs the research;
h. Commission: a Commission approved under article 16;
i. Central Committee: the Committee referred to in article 14;
j. College: the medicines evaluation board, referred to in article 2, paragraph 1, of the medicines Act;
k. other Member States: Netherlands than other Member States of the European Union;
l. the European Agency for the evaluation of medicinal products: the European Agency for the evaluation of medicinal products established by Regulation No 136/66/EEC. (EEC) 2309/93 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 evaluation of medicinal products (OJ L 214), monitoring;
m. spread performed scientific research: scientific research that according to one particular protocol by more than one researcher is carried out on different locations;
n. scientific research with medicines: scientific research on medicinal products aimed at the clinical, pharmacological or other pharmacodynamic effects of one or more investigational medicinal products to fix or to confirm whether any side effects of one or more investigational medicinal products to signal or the absorption, distribution, metabolism and excretion of one or more investigational medicinal products in order to study the safety or efficacy of these medicines;
o. investigational medicinal product: a pharmaceutical form of an active substance or a placebo that came with a scientific investigation with medicines is being investigated or if reference is used, including a medicinal product for which a marketing authorisation has been issued but that another way is used or synthesized, formulated or packaged than the authorised form , for an is used or is being used for further information on a permitted use;
p. investigator's brochure: the whole of the clinical and non clinical data on the investigational medicinal product or that are relevant to the study of the medicine or the investigational medicinal products in people;
q. adverse event: a harmful phenomenon at a test subject that not necessarily with scientific research related;
r. side effect: all untoward and unintended responses to an investigational medicinal product related to any dose administered;
s. serious adverse event: any untoward occurrence that is fatal, life-danger to the test subject, hospital admission or for the renewal of the recording, persistent or significant disability or incapacity for work caused or in a birth defect or deformity;
t. serious adverse reaction: an adverse reaction which is fatal or life-threatening results, hospital admission or for the renewal of the recording, persistent or significant disability or incapacity for work caused or in a birth defect or deformity;
you. unexpected adverse reaction: an adverse reaction, the nature and gravity do not match the information about the product as included in the investigator's brochure for an investigational medicinal product for which no licence has been issued or in the case of a medicinal product for which a market authorization has been granted, in the package leaflet contained the summary of product characteristics;
v. written consent: informed, written, dated and signed permission to to a scientific research.
2 subjecting persons to acts and impose to persons of a certain conduct solely for the purposes of the assistance to them is under the first paragraph, under b, not understood.
3 this Act does not apply to scientific research for which a permit is required on the basis of the population screening Act and, with the exception of articles 7 and 9 and articles 8, 11 and 33, in so far as they concern article 7, on the embryo law scientific research whose research protocol following a positive opinion from the Committee responsible pursuant to article 3 of the Embryo.

Article 2 1 scientific research shall be carried out in accordance with a special research protocol.
2 about this research protocol must be a positive opinion obtained: a. a Commission which is competent to do so, when part b, under 2 °, 3 ° and 4 °, does not apply;
b. of the Central Committee, when it concerns: 1 °. a decision on administrative appeals;
2 °. a scientific research referred to in the second sentence of article 4, paragraph 1, that the person concerned can benefit and where his trial State intentionally;
3 °. a scientific research of which the assessment pursuant to article 19 by the Central Committee is based;
4 °. other order in Council designated forms of scientific research which review by the Central Committee is desired considering the research connected to social, ethical or legal aspects.
3 The review by the respective committees shall be made on the basis of paragraphs 2 and 3 and articles 9, 10, 11 and 12 and, as far as scientific research with medicinal products, paragraph 5a.

Article 2a spread performed scientific research, including scientific research, is rated by one competent Commission designated by the person who carried out the research.

Paragraph 2. Rules for scientific research with subjects Article 3 pursuant to article 2, paragraph 2, The Committee responsible may only give a positive opinion about a research protocol, if: a. reasonably likely that the scientific research to the establishment of new insights in the field of medical science;
b. reasonably likely that the establishment, referred to in point (a), not by other forms or methods of scientific research than scientific research with subjects or by conducting research of less intrusive nature can be made;
c. reasonably likely that the with to serve the research interest of the test subject and other current or future patients in proportional relationship to the objections and the risk for the test subject;
d. the research meets the requirements of a proper methodology of scientific research;
e. the research is carried out in appropriate institutions and by or under the direction of persons who are experts in the field of scientific research and at least one of which is an expert in the field of operations for the implementation of the research regarding the test subject;
f. reasonably likely that pass the test person to pay fees not disproportionately affect giving permission for participation in the research;
g. the one that performs scientific research and the institution where this research takes place, receive compensation that does not exceed an amount that is in reasonable proportion to the nature, extent and purpose of scientific research;
h. in the research protocol clearly indicated the extent to which the scientific research at the trial concerned person can benefit;
i. in the research protocol on scientific research tailored to the criteria for the recruitment of subjects;

j. the results of the investigation by the Central Commission will be made publicly accessible, unless object is created by the one that the scientific research carried out;
k. the study also incidentally meets to requirements reasonably.

Article 3a 1 A Commission may by her given approval of a research protocol suspension or revocation if there are substantial grounds for believing that continuation of the scientific research would lead to unacceptable risks for the test subject.
(2) if there are reasonable grounds to believe that the continuation of scientific research would lead to unacceptable risks for the test subject, the Central Committee or the Minister, in the case of paragraph 5 of article 13i, the implementation of the scientific research until a Committee has given a further positive opinion about this research protocol. The Central Committee or the Minister, in the case of paragraph 5 of article 13i applies, the suspension of the implementation of the research to the Commission, which has given a positive opinion on the last research protocol and to the one who carried out the scientific research and the one that carries out the investigation.
3 Except in the event of imminent danger, the Commission, the Central Committee or the Minister, in the case of paragraph 5 of article 13i applies, before it considers to suspend or withdraw any positive, or the implementation of the scientific research, the one that the scientific research or scientific research, the opportunity to express its views within one week.
4 If a Commission given by her decision a positive opinion about a research protocol on scientific research with medicines to suspend or withdraw, it shall inform the Central Committee or our Minister, where article 13i, fifth paragraph, apply, and notify the College, under giving reasons.
5 the College establishes, under giving reasons the European Agency for the evaluation of medicinal products and the European Commission immediately aware of the suspension or revocation of a given approval of a research protocol on a scientific research with medicines.

Article 4 1 it is prohibited to conduct scientific research with subjects who the age of eighteen have not yet reached or who are unable to a reasonable appreciation of their interests in this area. This prohibition does not apply to scientific research that inform the subjects concerned can benefit themselves and on scientific research that not then with the cooperation of subjects from the category to which the person belongs, can be carried out and whose trial for them the risk is negligible and the objections are minimal.
2 If the test subject itself at a in the first paragraph, second sentence, referred to scientific research opposition to an act to which he is subjected or against an imposed to him conduct, research finds no place with that test subject.

Article 5 it is prohibited to conduct scientific research with subjects who should reasonably be assumed that they given the actual or legal relation to the one that the research subjects or run or the person who recruits, not able to decide on participation in freedom. This prohibition does not apply to scientific research that inform the subjects concerned can benefit themselves and on scientific research that not then with the cooperation of subjects from the category to which the subject belongs, can be carried out.

Article 6 1 it is prohibited to carry out scientific research: a. If the test subject is of legal age, and part c does not apply: without the written consent of the person concerned;
b. If the test subject is a minor but has reached the age of twelve years and part c does not apply: without the written consent of the person concerned as well as that of the parents who exercise authority or of his guardian;
c. If the test person twelve years old or older and is not able to a reasonable appreciation of his interests in the matter: without the written consent of the parents who exercise or the authority of the guardian or if he is an adult, by the legal representative of the data subject or, failing these, the person authorized in writing for that purpose by the person concerned or , in the absence of such person, by the spouse, registered partner or other life companion of the data subject or, failing these, the parents of the person concerned or, if they are missing, the reasonably accessible adult children or, if they also are missing, the reasonably accessible adult brothers and sisters of the person concerned;
d. If the test subject has not reached the age of twelve years: without the written consent of the parents who exercise authority or of his guardian.
2 If the person concerned is unable to write, the permission can be given orally in the presence of at least one witness.
3 the permission of a in the first paragraph, under (c) and (d) persons gives the presumed will of the test subject.
4 If the scientific research can only be performed in emergency situations that the authorisation required under paragraph 1 cannot be given, and benefit the person looking into that emergency situation, implementing acts can take place without that permission as long as the circumstance that the foreclosure of giving consent forms, occurs.
5 Before authorization is requested, the one who performs the research ensure that the person whose consent is required, in writing and, if desired, in a prior consent to the maintenance is informed of: a. the purpose, type and duration of the research;
b. the risks that the research for the health of the test subject would bring with itself;
c. the risks that the interim termination of the research for the health of the test subject would bring with itself;
d. the objections that the search for the test subject with itself might bring.
6 The information shall be provided in such a way that is reasonably sure that the person concerned has understood this to its content. He gets such a cooling-off period that he on the basis of this information a carefully considered decision on the requested permission. A ministerial order may further demands are placed on the data subject information to be provided.
7 the one who carries out scientific research, shall ensure that subjects who have not yet reached the age of twelve years or who are unable to a reasonable appreciation of their interests in this field, about the research are informed by an educated person in a way that suits their comprehension.
8 the way in which the implementation of the provisions of this article shall be specified in the research protocol.
9 the test subject pursuant to this article or, if this is not competent to give consent, the one who is competent in his place, the consent at any time, without giving reasons, withdraw. He is liable to pay compensation in respect of the withdrawal does not.

Paragraph 3. Liability and insurance Article 7 1 The scientific research is carried out only if, at the time when the investigation begins, a insurance that the order in Council designated by the damage caused by death or injury investigation of the test subject. The insurance need not cover the injury suffered on the basis of the nature of the research sure if virtually certain was that this would arise.
2 On the obligation of the insurer to make good damage, referred to in the first paragraph, of section 6.1.10 of the Civil Code articles 95, 96, 97, 100, first paragraph to 105 to 102, 107a, paragraph 1, and 108 shall apply mutatis mutandis.
3 be by or pursuant to order in Council in respect of the insurance and with regard to the scope of coverage of the insurance terms. Pursuant to order in Council to set rules concerning only changes in that measure included money amounts which, by their nature, regularly in need of change. The order in Council does not occur earlier than eight weeks after the date of issuance of the Official Gazette, in which he is placed. The placement shall be immediately notified to the two rooms.
4 the insurance covers only the damage of natural persons.
5 If, in the opinion of the Commission charged with assessing the research protocol, to scientific research for the test subject after his kind no risk in approval of the research protocol the provider at his request, grant a derogation from the obligation of insurance.

6 in an investigation that aims in the circle of professional enjoyed usual forms of handling in the field of medicine to compare with each other, the Commission charged with assessing the research protocol, by a positive assessment the provider on his request, grant a derogation from the obligation of insurance if the investigation as a result of the comparative character in the view of the Commission for the subjects after their kind at most negligible risk.
7 the way in which the implementation of the first and ninth member is logged in the research protocol.
8 Is the one that performs scientific research be liable for the damage caused by death or injury of the test subject, then the responsible scientific research. As far as implementing a scientific research operations take place in a facility setting, rest this liability, even if the research not by those setting is performed or executed, partly on that setting.
9 scientific research has also been carried out only if, at the time when the investigation begins an insurance to cover the risk of the liability referred to in the eighth paragraph of the one who performs the investigation or of the person who carried out the research, or otherwise sufficient to ensure that their obligations in respect of their liability can be met.
10 the first and ninth paragraph shall not apply in respect of the performance of scientific research by services, institutions or companies of the Central Government that have been designated by the Minister. The injured person has in respect of a service, institution or company of the Government that no insurance as referred to in the first paragraph has closed the rights which he would have otherwise opposite the insurer in accordance with this article.
11 the liability of the performer or, in the case referred to in the eighth paragraph of the one that the scientific research of the facility or institution, cannot be limited or excluded.

Paragraph 4. Obligations of those who carry out or perform scientific research Article 8 1 the obligation to ensure the fulfilment of articles 2, paragraphs 1 and 2, and 7 rest on the one that the scientific research.
2 the obligation to ensure the implementation of article 2, first and second paragraph, rest in the case referred to in article 7, paragraph 5, second sentence, partly on the facility setting.

Article 9 the one scientific research carried out shall ensure that the test subject itself for information and advice concerning the examination can turn to a doctor who is not in the research protocol to designate in the implementation of the research is concerned or other expert who must be regarded as the test subject of adequate information and advice concerning the examination and who are not in the implementation of the research is concerned.

Paragraph 5 article 10 1 the one that performs scientific research, shall report all serious adverse events, with the exception of the serious adverse events in accordance with the research protocol no immediate reporting by the person who performs scientific research, is required, immediately to the person who carried out the research. The immediate reporting is followed by detailed written reports, in which the subjects with code number.
2 the one that the scientific research is carried out, shall report all serious adverse events, with the exception of those serious adverse events in accordance with the research protocol no reporting is required, to the competent Committee in accordance with article 2, paragraph 2, and, if this is not the Central Committee is, in copies to the Central Committee.
3 Unless other terms are provided in the research protocol, the reporting referred to in the second paragraph, as soon as possible and: (a) within seven days after the one that the scientific research has taken notice of the events, if the events which have led to the death of a test subject or lead, which is an additional period of eight days within which relevant information is presented on the aftermath of the incident;
b. within fifteen days after the one that the scientific research has taken notice of the events, if the other occurrences.
4 If during the scientific research has reasonable grounds to believe that the continuation of scientific research would lead to unacceptable risks for the test subject, apron the one scientific research carried out on the implementation of the research to a further positive opinion has been obtained from the competent Commission, pursuant to article 2, paragraph 2.
5 reasons does the scientific research carried out pursuant to article 2, paragraph 2, to the competent Committee: a. immediately communication of a decision to suspend the research;
b. within 15 days of the communication of a decision to early termination of the study.
6 for the purposes of this article, serious adverse event include such occurrence in a test subject that is in the opinion of the person who carries out scientific research during the investigation would have been able to develop into a serious adverse event, but where this serious adverse event as a result of intervention has not accomplished.
7 the Central Commission shall report each calendar year based on the number of serious adverse events in the preceding calendar year, with the exception of those serious adverse events in accordance with the research protocol no reporting is required.

Article 11 1 the one that performs scientific research shall ensure that the test subject is informed in good time about: a. the provisions of articles 6, paragraph 6, second sentence, and ninth Member, 7, 9 and 12; and b. the conduct of research, including in any case be understood situations referred to in article 10, paragraph 4.
2 the information provided shall be supplemented.
3 The obligations referred to in paragraphs 1 and 2, also apply with respect to the other persons whose consent is required under article 6.

Article 12 the one who carries out scientific research shall ensure that the privacy of the test subject is protected as much as possible.

Article 13 the one who carries out scientific research shall ensure that, before the implementation of a research occupational begin, those whose cooperation is needed in the implementation of the research, about the nature and purpose of the research are informed.

Paragraph 5a. Additional rules for scientific research on medicinal products Article 13a On scientific research with medicines is in addition to the provisions of paragraphs 1 to 4, the provisions of this section apply.

Article 13b 1 scientific research with medicines, including research into the bio-availability and bio-equivalence, in terms of design, implementation and reporting in accordance with the principles of good clinical practice.
2 by order in Council be rules on good clinical practice.

Article 13 c it is prohibited in the context of gene therapy with medicines to carry out scientific research aimed at modification of the germ line genetic identity of the test subject.

Article 13d without prejudice to the provisions of paragraph 2, the Committee responsible pursuant to article 2, paragraph 2, only a positive opinion about a research protocol that covers scientific research on medicinal products if: a. the person who carries out scientific research or his legal representative on the territory of the European Union;
b. the investigational medicinal products or, where appropriate, the tools for Administration, except if the scientific research with free registered medicinal products, to be made available by the one that the scientific research carried out;
c. a on the basis of the Act on professions in the individual health care registered doctor or dentist, working in health care, is responsible for the medical care and medical decisions about the test subject.

Article 13 without prejudice to the provisions of paragraph 2, scientific research with drugs in minor subjects be carried out only if: (a) the research is essential in order to be able to confirm the results of scientific research on medicinal products with people who can give their consent according to this law or by other research methods and research any direct benefit for the Group of patients;
b. the relevant laid down by the European Agency for the evaluation of scientific guidance;
c. the risk referred to in article 4, and the degree of distress be specifically defined and permanently be controlled;
d. the Committee responsible pursuant to article 2, paragraph 2, has expertise in the field of Pediatrics or pediatric advice on the clinical, ethical and psychosocial aspects of the research;

e. the interests of the patient always prevail over those of science and society.

Article 13f without prejudice to the provisions of paragraph 2, scientific research with drugs in adult subjects who are unable to a reasonable appreciation of their interests in this area, only be conducted if: a. the research is essential in order to be able to confirm the results of scientific research with drugs in individuals who can give their consent in accordance with this law , or by other research methods, and it is directly related to a clinical condition that is life-threatening or debilitating, and in which the test subject is;
b. the risk referred to in article 4, and the degree of distress be specifically defined and permanently be controlled;
c. the Committee responsible pursuant to article 2, paragraph 2, has expertise in the relevant disease and the relevant population or advice on the clinical, ethical and psychosocial aspects of the disease and population;
(d) the interests of the patient always prevail over those of science and society;
e. the reasonable expectation that the benefits of administration of the investigational medicinal product for the patient in question outweigh the risks or that the Administration at all any risk.

Article 13 g 1 The Committee responsible pursuant to article 2, paragraph 2, gives her opinion in the investigator's brochure and decides on an application to obtain a positive opinion about a research protocol with respect to scientific research with medicines within 60 days of receipt of the request.
2 during the period within which the application shall be treated in accordance with article 2, paragraph 2, the competent Committee once further information to supplement the information already provided by the applicant.
(3) the time limit referred to in paragraph 1 may, by means of scientific research with gene therapy medicinal products and somatic cell therapy and all medicinal products containing genetically modified organisms, be extended by a maximum of 30 days.
4 The periods referred to in the first and third paragraphs do not apply to the assessment of scientific research on medicinal products for xenogeneic cell therapy.

Article 13 h 1 an application for a judgement of a competent pursuant to article 2, paragraph 2, on a scientific research on medicinal products must comply with a ministerial order stipulated rules. These rules concern the form of the request and the documents which must be submitted, in particular with regard to the information provided to subjects is provided, and ensure that there are adequate safeguards to protect personal information.
(2) if the request referred to in the first paragraph relates to scientific research with registered drugs, needs the application only the summary of product information such as that when registration is determined to be provided. If there is a different dosage form in relation to the registration, indication, patient group or dosage is the summary of the product information for the relevant research supplemented by the relevant additional information.

Article 13i 1 scientific research on medicinal products may only be carried out as far as the Central Committee not opposed within the time limit referred to in the third paragraph motivated objections.
2 before the implementation of the scientific research on medicinal products begins, set the one that research, the Central Committee accompanied by the investigator of the investigation.
3 the Central Commission may, at the latest within fourteen days of receipt of the notification referred to in the second paragraph the research inform her grounds for non-acceptance to the one that the research. In this case, once this change in the proposed research protocol in order to make the objections of the Central Committee. The person who makes the research of that possibility no use, then it may not begin research.
4, the notification referred to in the second paragraph covers scientific research on medicinal products for gene therapy, somatic cell therapy, xenogenic cell therapy or medicinal products containing genetically modified organisms, the implementation of the research only commence if the Central Committee or the Minister, if the fifth member applies, expressly stated to have no objection to the research. In this case, the period referred to in the third paragraph be extended for not more than thirty days, except that under this Act No term applies to making known of motivated objections to research medicinal products for xenogeneic cell therapy.
5 by way of derogation from paragraphs 1 and 2, if the assessment of the research Protocol pursuant to article 2, paragraph 2, point (b), 2 °, 3 ° or 4 ° takes place by the Central Commission, the notification referred to in the second paragraph reported to our Minister and decides this with analogous application of this article.
6 a ministerial order lays down rules concerning the form and content of the notification referred to in the second paragraph, to submit the supporting documents, the form and content of a proposal for substantial changes to the protocol are made and the statement that the investigation has ended.
7 may a ministerial order rules on the amounts for the costs involved with the implementation of this article by the Central Committee or the Minister, in the case of paragraph 5 of article 13i applies, can be charged to the person who has made the notification referred to in the second paragraph.

Article 13 years 1 the Central Committee or the Minister, in the case of paragraph 5 of article 13i applies, makes motivated objection if in the European database already side effects of the medicine for research that lead to unacceptable risks for the test subject or if there are otherwise indications that the scientific research leads to unacceptable risks for the test subject.
2 The health care Inspectorate checks at the request of the Central Committee or by the Minister, in the case of paragraph 5 of article 13i applies, or scientific research on medicinal products is expected to be take place in accordance with this law. Article 5:12, 5:15 and 5:15 to 5:20 of the General Administrative Law Act shall apply mutatis mutandis.

Article 13 k 1 after starting the investigation the person who carried out the research, the research protocol on scientific research with medicines.
2 If the change was substantial and effect it can have on the safety of subjects or may lead to a different interpretation of the scientific documents that substantiate the course of the investigation or if the change is significant, otherwise the one that carried out the research protocol change only if: a. He the Committee responsible pursuant to article 2, paragraph 2, in article 13i, first or fifth member, referred to and, where appropriate, the competent authority of another Member State, which has given its opinion, as the last of the reasons and the content of the proposed amendment;
b. the Committee responsible pursuant to article 2, paragraph 2, a positive assessment on the proposal to amend the protocol and c. in article 13i, first or fifth member, no grounds for non-acceptance referred to the proposed amendment to the protocol has brought in.
3 in the event the in article 13i, first or fifth member, referred to or the competent authorities of other Member States motivated objections to the amendments to the protocol have inserted, can the research only proceed where the person serving the scientific research, the proposed amendment to the protocol adapts to the objections made.
4 under article 2, paragraph 2, The Committee shall assess the modification of the protocol, decide within a period of thirty-five days after receipt of the proposal to amend the protocol.
5 in article 13i, first or fifth member, makes no later than within thirty-five days of receipt referred to of the proposal to amend the protocol against this motivated objections.

Article 13 l 1 the one that the research carried out pursuant to article 2, paragraph 2, shall inform the relevant Committee referred to in article 13i, first or fifth member, referred to and, where appropriate, the competent authority of another Member State within 90 days of the end of a scientific research with medicines that the investigation shall be terminated.
2 when the investigation should be stopped early, set the one who carried out the research in article 13i, first or fifth member, referred to and, where appropriate, the competent authority of another Member State within 15 days after the cessation under giving reasons.

Article 13 m 1 The first paragraph and in article 13i, paragraph 5, the Agency shall inform referred to by or pursuant to order in Council designated data concerning scientific research with medicines, that takes place in Netherlands, made available to the College.

2 the College shall be responsible for the introduction of this information in a European database accessible only to the College, the Central Committee or the Minister, in the case of paragraph 5 of article 13i applies, the health care Inspectorate, the competent authorities of other Member States, the European Agency for the evaluation of medicinal products and for the European Commission. By or pursuant to order in Council rules can be set with regard to the confidentiality of the data entered in the European database.
3, further to a reasoned request from another Member State, the European Agency for the evaluation of medicinal products or the European Commission shall provide the Member in article 13i, first and fifth member, referred to any additional information concerning a scientific research with medicines, which is not already in the European database.
4 a ministerial order may further rules on the methods of electronic data exchange.

Article 13n If the Central Committee or our Minister, where article 13i, paragraph 5 applies, has objective grounds for considering that the one scientific research carried out or run with medicines or any other person involved in the test no longer fulfil his obligations, the Central Commission or our Minister this thereof, indicating the course of action and said person need to follow in order to correct the said situation. The Central Committee or our Minister, where article 13i, fifth paragraph, apply, shall immediately inform the Committee responsible pursuant to article 2, paragraph 2, who last gave its opinion on the scientific research with medicines, the competent authorities of other Member States and the European Commission of that course of action.

Article 13o 1 adverse events or abnormal laboratory values which, according to the protocol for the safety assessment of crucial importance, within the time limit set in the protocol to the one who carried out the research, reported.
2 the one that performs scientific research, provided to the one that the scientific research, and to the Committee responsible pursuant to article 2, paragraph 2, who last gave its opinion, any additional information requested for reported deaths.
3 the one who carried out the research, keep detailed records of all adverse events which made him by the person who performs scientific research, are reported. This information will be transferred to the Dutch health care Inspectorate and the Central Committee or the Minister if article 13i, fifth paragraph, applies, and the competent authorities of the Member States in whose territory the scientific research is carried out.

Article 13p 1 the one that carries out scientific research on medicinal products shall ensure that all relevant information about suspected unexpected serious adverse reactions to research that have led to the death of a test subject or lead, is recorded and as soon as possible but no later than seven days after he has taken note of, is reported to the College , the Central Committee, the relevant competent authorities of other Member States and the Committee responsible pursuant to article 2, paragraph 2, and that relevant information about the aftermath in another eight days shall be communicated to the said authorities.
2 all other suspected serious unexpected adverse reactions than in the first paragraph of investigational medicinal products as soon as possible but no later than fifteen days after the one who carried out the research, has taken note, reported to the College, the Central Committee, the relevant competent authorities of other Member States and the Commission pursuant to article 2, paragraph 2, competent.
3 the one who carried out the research, informs all others who conduct research.
4 the College shall be responsible for the introduction of all reported suspected unexpected serious adverse reactions to an investigational medicinal product in a European database, as referred to in article 13, paragraph 2.

Article 13q During the entire duration of the scientific research on medicinal products provided the one who carried out the research, once a year a list of all suspected serious adverse reactions to research, located in that year and a report on the safety of the subjects to: a. the Central Committee or the Minister if article 13i, fifth Member , applies;
(b) the competent authorities of the other Member States in whose territory the scientific research on medicinal products is carried out;
c. under article 2, paragraph 2, the Committee responsible.

Article 13r a ministerial order may require the reporting referred to in articles 13p, 13o and 13q.

Section 6. The committees Article 14 1 There is a Central Committee for medical research. It has not more than fifteen members. Independent administrative authorities is the framework law on the Central Commission to apply, with the exception of article 22 of this law, in so far as the decisions that the Central Commission shall, for the application of this Act and the articles 10, 16 and 19 of the Embryo.
2 the Central Committee exists in each case from one or more doctors, and from people who are experts in the field of embryology, pharmacology, pharmacy, nursing, behavioural science, legal science, the methodology of scientific research and ethics, as well as a person who assesses scientific research specifically from the point of view of the test subject.
3 for each Member an alternate member appointed.
4 The members, including the Chairman, and the alternate members of the Central Committee are appointed for a maximum period of four years. The Minister shall designate a person who can attend as observers the meetings of the Committee.
5 the Central Committee designates from among its members one or more alternates for the Chairman.
6 reappointment of members and alternate members can twice and each time for a maximum of four years.
7 the Central Committee regulates its method at a rules of procedure. The rules of procedure contains a provision under which a member or an alternate member of the Central Committee does not participate in the assessment of a research protocol if it is involved in the conduct or perform to assess the scientific research.

Article 15 the Central Committee has a secretariat, whose officials heard by our Minister, the Central Committee, are appointed, suspended and dismissed.

Article 16 1 the Central Commission may recognize committees, which are responsible for the review of research protocols in accordance with the provisions in or under this Act or the Embryo.
2 for recognition is only eligible: a. a Commission which in each case consists of one or more doctors and from persons who are experts in the field of legal science, the methodology of scientific research and ethics, as well as a person who assesses scientific research specifically from the point of view of the test subject and that in case of assessment of scientific research with medicines also consists of persons who are experts in the field of Pharmacy and the Clinical Pharmacology;
b. whose members meet by the Central Committee to determine further requirements for training and experience;
c. whose members are appointed for a period not exceeding four years and reappointment of members can take place twice each time for a period not exceeding four years;
d. in whose rules well is provide for co-operation by other experts with a view on the nature of its research protocols submitted for review;
e. from whose rules of procedure shows for which post she worked;
f. in whose rules well is provide for the independence of the organization that the Commission has set up;
g. welker rules provides for a fair settlement of its method and that among other things contains a provision under which a member or an alternate member does not participate in the assessment of a research protocol if it is involved in the conduct or perform to assess scientific research;
h. which reasonably likely that research protocols will be submitted for review to her until at least the number of drawn up for that purpose by the Central Committee.

Article 17 1 the Central Committee brings a recognition referred to in article 16, paragraph 1, at once in knowledge of our Minister.
2 approval referred to in article 16, paragraph 1, by the care of the Minister be notified in the Official Gazette.

Article 18 A Commission of an amendment to its rules and its removal in writing communication to the Central Committee.

Article 19 1 within six weeks of the submission of a protocol on a scientific research referred to in the second sentence of article 4, paragraph 1, in which the State of the test subject not intentionally changed the assessment thereof, the Commission may decide to transfer to the Central Committee. The Commission is the one who has submitted the protocol, communication from the transfer.

2 the Central Committee may determine that the assessment of protocols on a by her preferred form of scientific research as referred to in paragraph 1 shall be made by her.

Article 20 as compensation for the costs involved with the assessment the Commission and the Central Committee to the person who submits a research protocol for review, an amount of the booking.

Article 21 1 At order in Council can be determined on the basis of article 16 that the recognised committees assess whether to designate at the measure forms of scientific research available to the relevant Committee has given its opinion pursuant to article 2, take that create major a gradient for the test subject is less favourable than in the research protocol. In that event the Commission may give a further assessment of the research protocol. Article 10, paragraph 4, shall apply.
2 by order in Council can further rules concerning the way in which the committees the task referred to in the first paragraph.
3 paragraphs 1 and 2 shall apply mutatis mutandis with regard to the Central Committee, in so far as such under article 2, paragraph 2, subparagraph (b), under 2 °, 3 ° and 4 °, shall be responsible for the assessment of research protocols.

Article 22 1 the Commission shall forward to the Central Commission copy of any judgement pursuant to this law as well as of the research protocol or the main points thereof within seven days after the day on which the judgement is given. Furthermore, the Commission referred to in article 10, paragraph 5, part b, within seven days after receipt of the communications referred to the Central Committee.
(2) the Commission shall submit an annual report of its work before 1 april in the last calendar year. This report is sent to the Central Committee and is, moreover, the Commission, against payment of costs, available for everyone.
3 the Commission grants the Central Committee any assistance that is reasonably necessary for the performance of its task.

Article 23 Against a judgment given by a Commission can an interested administrative appeal to the Central Committee.

Article 24 the Central Committee oversees the work of the committees. They can establish guidelines in respect of the work to be carried out by them in accordance with this law. Such guidelines are submitted by the care of our Minister announced in the Government Gazette.

Article 25 1 the Central Committee granted recognition to a Committee in a draw if: a. the Commission no longer fulfils one of the in article 16, paragraph 2, (a) to (g), with a view to recognition conditions;
b. the Commission the obligations resulting from this law, insufficient to fulfil her;
c. amendment of the rules of procedure of the Commission by a proper exercise of the work with which it is charged under this law, no longer is reasonably assured.
2 the Central Commission may also revoke a recognition if identified by the Commission in the last two calendar years, a smaller number of research protocols is rated than the number referred to in article 16, paragraph 2 (h). 3 A decision to withdraw recognition shall not taken until the Commission by the Central Committee is heard.
4 of any withdrawal shall be notified to the Commission. Article 17, paragraph 2, shall apply mutatis mutandis.

Article 26 [expired per 01-07-2011] article 27 each time within a period of five years thereafter, the Central Committee a report to the Minister, in which the task fulfilment of the Central Committee, must be examined and proposals for desired changes. Our Prime Minister takes his views on this report in the report referred to in article 39, paragraph 1, of the framework law independent administrative bodies and adds the report at that report.

Section 7. Further provisions article 27a a ministerial order may provide for transmission of information, which under this Act must be provided to the Central Committee, to the Minister where article 13i, fifth paragraph, apply, and in addition to the Commission, the College or the health care Inspectorate, shall be made electronically. In addition, rules on the form in which this must be made.

Article 28 1 ensuring compliance with the provisions in or under this Act have been charged the officials appointed by decision of the Minister of the State supervision of public health.
2 of a decision as referred to in the first paragraph shall be notified by placement in the Government Gazette.
3 by or pursuant to order in Council can further rules on the supervision of the compliance with the provisions in or under this Act in relation to scientific research with medicines.

Article 29 1 as concerns scientific research on medicinal products is of the inspection referred to in article 28, paragraph 1, produced a report that is made available to the scientific research. As far as the report personal data as referred to in Chapter 2, paragraph 2, of the data protection act, continues to be included in the report, unless thereby apparently non-infringement on privacy.
2 the report shall be in addition to a reasoned request and only made available to Member States of the European Union, the Central Committee, the Commission and the European Agency for the evaluation of medicinal products.

Article 30 the application of this law by the committees shall take place with due respect for the national applicable national and international rules to protect data confidentiality by the interest of the State or of its allies is advised.

Article 31 1 without prejudice to articles 7, paragraph 1, and 8, paragraph 1, of the Coördinatiewet States of exception, in cases where exceptional circumstances make this necessary may, by Royal Decree, on the recommendation of our Prime Minister, article 32.
2 when the decision referred to in paragraph 1, shall be a draft law sent to the lower House about the continuation of the operation of the provision operated by that decision.
3, the draft law rejected by the States General, by Royal Decree, on the recommendation of our Prime Minister, the provision which, under the first paragraph has been switched on, immediately inactivated.
4 by Royal Decree, on the recommendation of our Prime Minister, the provision which, under the first paragraph has been switched on, out of action, as soon as conditions allow this in our opinion.
5 the decision, mean in the first, third and fourth member, is published on the manner determined therein. It shall enter into force immediately after the announcement.
6 the decision referred to in the first, third and fourth paragraph shall in any case published in the Official Gazette.

Article 32 [shall enter into force on a date to be determined] this part is (still) not entered into force; see the overview of amendments to paragraph 8. Penal provisions Article 33 1 with imprisonment not exceeding one year or a fine of the fourth category is punished the person who intentionally or unintentionally contravenes a prohibition contained in article 6, paragraph 1.
2 with imprisonment of up to six months or a fine of the fourth category is punished the person who contravenes the obligation to ensure compliance with article 2, paragraph 1 or paragraph 2, or 7 or in breach of any obligation contained in articles 10, 11, 12 and 13 and paragraph 5a, or in violation of any course of conduct referred to in article 13n. Punished with the same penalty is the one who contravenes a prohibition contained in articles 4, 5 and 13 c, the one who carries out scientific research without a protocol on which a positive assessment is obtained, or fight with it, and the one that carries out scientific research while the Commission given by her positive opinion on the research protocol has suspended or revoked or the Central Committee or our Minister , where the fifth paragraph of article 13i applies, has suspended the implementation of the research.
3 The offences in the first paragraph are crimes; the offences are offences in the second paragraph.

Paragraph 9. Final provisions article 34 [Red: modifies the Coördinatiewet exception situations.]

Article 35 [Red: modifies this law.]

Article 36 [Red: modifies this law.]

Article 37 1 the Minister shall, within 4 years after the entry into force of this law, and then every 5 years, to the States General a report on the effectiveness and effects of this law in practice.
2 The report referred to in article 39, paragraph 1, of the framework law self-government, is part of the report referred to in the first paragraph.

Article 38 The articles of this law shall enter into force at a time determined by Royal Decree, that for the various articles or parts thereof may be made differently.

Article 39 this Act is cited as: law medical-scientific research in humans.
Charges and recommend that this in the Official Gazette will be placed and that all ministries, authorities, bodies and officials whom it may concern, to the exact implementation will keep the hand.

The Hague, 26 February 1998 given Beatrix the Minister of health, welfare and Sport, e. Borst-Eilers the Minister of Justice, w. Sorgdrager issued the 26th March 1998 the Minister of Justice, w. Sorgdrager

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