Machine Translation of "RS 810.301 Order of 20 September 2013 on human research with the exception of clinical trials (Human Research Ordinance,..." (Switzerland)

Art. 1 Purpose

This order shall rule:

A.: The requirements for conducting human research projects with the exception of clinical trials; and
B.: The authorization and announcement procedures for research projects within the meaning of the let. A.

Art. 2 Applicable Provisions

The provisions on scientific integrity and scientific quality according to art. 3 and 4 of the Clinical Trials Order of September 20, 2013 (OClin) ¹ Are applicable by analogy.

¹ RS 810.305

Art. 3 Project Management and Project Management Responsibilities

¹ The project management is responsible for the practical implementation of the research project in Switzerland and the protection of the people involved in the research project at the place of realization.

² It is also responsible for the initiative of the research project, in particular the launch, management and financing in Switzerland, insofar as no other person or institution in Switzerland accepts responsibility (promoter).

Art. 4 Professional qualifications

¹ The direction of a research project must:

A.: Be entitled to exercise under its own responsibility the profession which gives it the qualifications specifically required to carry out the research project concerned;
B.: Justify the necessary training and experience in connection with the completion of the relevant research project;
C.: Have knowledge of the legal requirements applicable to a research project or be able to guarantee them through an expert.

² The other persons performing the research project must have the professional knowledge and experience necessary for the activity concerned.

Art. 5 Retention of personal data related to health and biological material

¹ Anyone who maintains personal health data for research purposes must ensure their protection through appropriate operational and organizational measures, including:

A.: Allow the use of personal health data only for those who need it to carry out their tasks;
B.: Prevent the publication, modification, deletion and copying of personal health data without authorization or inadvertence;
C.: Document all critical processing processes to ensure traceability.

² Any person who maintains biological material for research purposes shall include:

A.: Respect the principles within the meaning of para. 1;
B.: Ensure compliance with the technical requirements for the proper storage of biological material;
C.: Make available the necessary resources for conservation.

Section 1 General provisions

Art. 6 Research Project

A research project under this chapter is deemed to be a research project for which biological material is collected from a person or personal data related to his or her health is collected for the purpose of:

A.: Answer a scientific question; or
B.: Reuse biological material or health-related data for research purposes.

Art. 7 Classification

¹ A research project is Category A where the risks and constraints inherent in the planned measures for the collection of biological material or collection of personal data are minimal.

² A research project is Category B when the risks and constraints inherent in the planned measures are more than minimal.

³ The risks and constraints inherent in the collection of biological material or the collection of personal data related to health are minimal where the measures, in their intensity and quality, have only minimal impact and Temporary on the health of the person participating in the project, taking into account the vulnerability of the person involved in the project and the specific circumstances. In particular, minimum risks and constraints may be present:

A.: Questionnaires and observations;
B.: Venous or capillary peripheral blood samples and skin biopsies on a small surface;
C.: The collection or collection of bodily substances without invasive measures (including the saliva, urine or stool sample);
D.: Smears;
E.: Magnetic resonance tomography without contrast, ultrasound and electrograms;
F.: Examinations by means of medical devices with a mark of conformity without a contrast product or by authorised medicinal products capable of emitting ionising radiation, to the extent that the effective dose is less than 5 mSv By research project and by individual reviewed.

Art. 8 Information

¹ In addition to the information in Art. 16, para. 2, LRH, the data subject must receive the following information:

A.: The expenses and obligations arising from participation in the research project;
B.: The right to refuse or revoke consent without having to justify its decision;
C.: The consequences of revoking consent for the subsequent use of biological material collected before revocation and personal data collected before revocation;
D.: The right to receive information on other matters at any time;
E.: The right of the person to be informed of the results concerning her health or to refrain from receiving such information, or to designate a person who makes that decision for her;
F.: The arrangements made to cover possible damage to the research project, including the procedure for damage;
G.: The major sources of funding for the research project;
H.: Other elements necessary for the Commission to make its decision.

² If a re-use of the biological material collected or the personal data relating to the collected health is provided for in the research, the information contained in the art. 28 to 32 must be provided to the data subject.

³ The information can be done in successive stages. It may, in addition, be given otherwise than in the form of text.

⁴ It is ensured through appropriate measures, that the data subject understands the essential elements of the information.

Art. Exceptions to the written form

¹ Information and consent may take place and be documented in a form other than written form:

A.: When it is a Category A research project in accordance with this order, which is carried out with adults capable of discernment;
B.: When written information and consent are disproportionate because of the device of the project; and
C.: Where the exception to the written form is provided for in the application to the competent Committee on Research Ethics (Ethics Commission).

² In the present case, information and consent may take place in a form other than the written form:

A.: Where, for bodily or cognitive reasons, the data subject cannot read or write; and
B.: Where the project management provides evidence of information and consent, including through written evidence of witnesses or the recording of oral consent.

³ In the present case, the information may be given in a different form than the written form:

A.: Where the language knowledge of the data subject is such that information in writing is a disproportionate burden; and
B.: When, for verbal information, an independent and qualified translator is consulted and the translator confirms in writing that the information has taken place.

Art. 10 Consequences of revocation

¹ If the individual revoked his or her consent, biological material and personal health data must be anonymized after being analyzed.

² The anonymization of biological material or personal data is not required:

A.: Where the person concerned has expressly renounced it at the time of revocation; or
B.: When it is evident from the beginning of the research project that anonymization is not possible and that the person concerned has consented to participate in the project after being sufficiently informed of that circumstance.

³ A medical follow-up must be provided to the person who revoked his or her consent, to the extent necessary to protect his or her health.

Art. 11 Emergency research projects

Art. 15 to 17 OClin ¹ Apply mutatis mutandis to research projects carried out in an emergency situation.

¹ RS 810.305

Art. 12 Exceptions to Liability

Is relieved of liability within the meaning of s. 19, para. 1, LRH which proves that the damage:

A.: Has minimal health effects and is temporary; and
B.: Does not exceed the scope that is to be predicted according to the state of the science.

Art. 13 Warranty

¹ Are excluded from the obligation to guarantee within the meaning of s. 20 LRH Category A research projects.

² The amount of coverage for Category B research projects is set out in Appendix 1.

³ The guarantee must cover the damage that has occurred within ten years of the end of the research project.

⁴ In addition, s. 11, 13, para. 1, and 14 OClin ¹ Are applicable by analogy.

¹ RS 810.305

Section 2 Authorization procedure

Art. 14 Request

¹ The project management shall provide the documents of the required application within the meaning of Annex 2 to the ethics committee responsible for examination.

² The Ethics Commission may require additional information.

³ The proponent may file the application in place of the project management. In such a case, it shall assume the obligations of the project management under s. 17 to 23. The application documents are co-signed by the project management.

Art. 15 Audit Domains

The competent ethics committee shall verify:

A.

The application is complete;

B.

Classification in the requested category;

C.

The research plan with respect to:

1.: Scientific quality, to the extent that it is a research project under s. 6, let. A,
2.: The relationship between the risks and foreseeable constraints on the one hand and the expected utility on the other (art. 12, para. 2, LRH),
3.: The measures taken to minimise the risks and constraints of the persons involved in the research project and the measures taken to ensure their protection and medical follow-up (Art. 15 LRH), including protection measures for the processing of personal data,
4.: The need to include persons, particularly those who are particularly vulnerable (art. 11 LH),
5.: The criteria for selecting persons to participate in the research project,
6.: The planned flow of information and the obtaining of consent, including the setting of an appropriate period of reflection,
7.: Equitable remuneration of persons participating in the research project and compliance with the prohibition of marketing (art. 9 LRH), and
8.: Compliance with the requirements for scientific integrity;

D.

All documents relating to recruitment, information and consent, as well as their intelligibility, in particular with regard to the possible integration of particularly vulnerable persons;

E.

For Category B research projects, the guarantee of the right to compensation in the event of damage (art. 20 LRH);

F.

In addition, for examinations using radiation sources, compliance with the legislation on radiation protection and the estimation of the dose unless an opinion of the Federal Office of Public Health (FOPH) is to be sought in application of Art. 19, para. 2;

G

Professional qualifications of project management and other researchers;

H.

Compliance with the requirements for the conservation of biological material or personal health data under s. 5;

I.

The existence of appropriate infrastructure at the site of the research project;

J.

Funding of the research project and agreements between the sponsor, third parties and the investigator related to segregation of duties, remuneration and publication;

K.

Other areas to the extent necessary to assess the protection of the persons involved in the project.

Art. 16 Procedure and Time Limits

¹ The Ethics Commission confirms the receipt of the request to the project management within seven days and indicates the elements of the file that do not conform to the formal requirements.

² It shall make a decision within 30 days of the confirmation of receipt of the file in accordance with the formal requirements.

³ If the Ethics Commission requires additional information within the meaning of Art. 14, para. 2, the time limit shall be suspended until such documents are received.

Art. 17 Multicentre research projects

¹ The project management files the application for a multi-centre research project within the meaning of s. 47, para. 2, LRH with the lead committee.

² The lead committee confirms receipt of the request to the project management within seven days, indicating whether the file is in compliance with the formal requirements.

³ At the request of the Steering Committee, the project management shall provide the required documents within the meaning of Annex 2 in sufficient numbers to the relevant ethical commissions for the different places of completion of the research project (commissions Of ethics concerned). They examine whether local requirements are met and forward their opinions to the lead committee within 15 days.

⁴ The decision shall be made within 45 days of the confirmation of receipt of the application package in accordance with the formal requirements. It shall communicate its decision to the relevant ethics committees.

Art. 18 Amendments

¹ The essential changes to an authorized research project must be authorized by the Ethics Commission prior to their execution. The measures that must be taken immediately for the protection of the person participating in the trial are exempt from this obligation.

² The project management shall provide the Ethics Commission with the documents required for the purposes of Annex 2 which are affected by the amendment. At the same time, it informs the Commission of the reasons for the amendment.

³ The following are considered essential modifications:

A.: Changes that affect the safety and health of individuals involved in the research project and their rights and obligations;
B.: Changes to the research plan that relate to the objective or central issue of the research project, provided that it is a Category B project;
C.: A change in the place of realization or the addition of a place of realization; or
D.: The change in the direction of the project or proponent.

⁴ The Ethics Commission makes a decision on the essential changes within 30 days. Art. 16 shall apply mutatis mutandis.

⁵ Art. 17 shall apply mutatis mutandis to the authorisation procedure in the case of essential changes to an authorised multicentric research project.

Art. 19 Procedure for examinations using radiation sources

¹ For examinations using radiation sources, the project management shall provide the competent ethics committee with the additional documents required for the purposes of Annex 2, c. 2. The authorisation procedure is governed by Art. 14 to 18, subject to the following paragraphs.

² The project management also provides the FOPH with the required application documents within the meaning of Schedule 2, c. 3, and at the same time notify the Ethics Commission, where the effective dose is greater than 5 mSv per person per year, taking into account the uncertainty factor, and:

A.: A non-authorized radiopharmaceutical product in Switzerland is used;
B.: That a licensed radiopharmaceutical in Switzerland is used and that it is not a routine nuclear medicine examination; or
C.: Another sealed or unsealed radioactive source is used.

³ The FOPH issues an opinion to the Ethics Commission on compliance with the legislation on radiation protection and on the assessment of the dose.

⁴ The Ethics Commission grants the authorization, when:

A.: The requirements under s. 15 are respected; and
B.: OFSP has no objection to the research project.

⁵ In such a case, it shall make its decision within 45 days of the confirmation of receipt of the application file in accordance with the formal requirements. It communicates its decision to the OFSP.

Section 3 Announcements and report

Art. Security and protection measures announced

The project management shall notify the Ethics Commission within seven days of the safety and protection measures to be taken immediately during the conduct of a research project and the events which have made such measures Necessary.

Art. Serious Events

¹ If serious events occur on individuals involved in the research project during its completion, it must be discontinued.

² A serious event shall be considered to be a serious event which cannot be excluded from the collection of biological material or the collection of personal data relating to health which:

A.: Requires stationary treatment or extension while this is not provided for in the research protocol;
B.: Results in a disability or a lasting or serious disability;
C.: Puts life at risk or causes death.

³ If this is necessary to ensure the safety and health of the persons involved in the research project, other events must be designated as serious by the research protocol or at the request of the competent ethics committee.

⁴ The project management announces to the Ethics Commission serious events within seven days. It also establishes, for the purpose of the latter, a report on the link between the reported serious event and the collection of personal data related to health or the collection of biological material. At the same time, it presents proposals on the follow-up to be given.

⁵ If a serious event occurs during a test using a source of radiation for which the FOPH has provided an opinion under s. 19, this event must also be announced to the OFSP within seven days.

⁶ The Ethics Commission shall render its decision on the continuation of the research project within 30 days of receipt of the report.

Art. Announcement of termination or termination of the research project

The project management announces to the Ethics Commission the completion or termination of the research project within 90 days.

Art. Report on examinations with radiation sources

¹ The project management shall forward to the FOPH within one year of the end or termination of a research project which included examinations with radioactive sources sealed or unsealed a final report with all relevant indications on the Radiation protection, in particular a posterior estimate of the dose.

² No report within the meaning of para. 1 is not required for routine nuclear medicine examinations with licensed radiopharmaceuticals.

³ In the context of his opinion within the meaning of Art. 19 or on request, the FOPH may make other exceptions to the obligation to report.

Section 1 General provisions

Art. 24 ReuUsage

Any operation carried out for research purposes with biological material already collected or data already collected is considered to be a reuse of biological material or personal data related to health, in particular:

A.: Acquiring, consolidating or collecting biological material or personal health data;
B.: The registration or cataloguing of biological material or personal health data;
C.: Retention or seizure in biobanks or databases;
D.: Making available, making available, or communicating biological material or personal health data.

Art. 25 Anonymization

¹ In order to anonymize biological material and personal health data, all information that, in combination, restores the identity of the person without a disproportionate effort must be made permanently Unknowable or destroyed.

² Must be made unknowable or destroyed, in particular, the name, address, date of birth and characteristic identification numbers.

Art. 26 Encoding

¹ Biological material and personal health data are deemed to be properly coded within the meaning of s. 32, para. 2, and 33, para. 2, HRL when they are qualified anonymized from the perspective of a person who does not have access to the code.

² The code must be kept by a person who is designated in the application and is not involved in the research project, separately from biological material or personal data and in accordance with the principles set out in s. 5, para. 1.

Art. 27 Decoding conditions

Coded biological material and coded health-related personal data can only be decoded if:

A.: Decoding is necessary to prevent an immediate risk to the health of the data subject;
B.: A legal basis for decoding exists; or
C.: Decoding is necessary to guarantee the rights of the person concerned, in particular the right of revocation.

Section 2 Informed Consent and Information

Art. 28 Informed consent for the reuse of biological material and genetic personal data for a research project in an uncoded form

¹ The following information shall be provided to the person concerned in writing and orally:

A.: The nature, purpose, duration and conduct of the research project;
B.: The right at any time to refuse to participate in the research project or to revoke its consent without having to justify its decision;
C.: The consequences of revoking consent for biological material used prior to revocation and personal data used prior to revocation;
D.: The right to receive information at any time on matters relating to the research project;
E.: The right of the person to be informed of the results concerning her health or to refrain from receiving such information, or to designate a person who makes that decision for her;
F.: Measures to ensure the protection of biological material and personal data;
G.: The major sources of funding for the research project;
H.: Other elements necessary for the Commission to make its decision.

² Information may be provided other than in the form of text.

³ Consent shall be given in writing.

⁴ Art. 9 shall apply mutatis mutandis to exceptions to the written form.

Art. Informed consent for the reuse of biological material and genetic personal data for research purposes in coded form

¹ The following information must be provided to the person concerned in writing or orally:

A.: The intended reuse of coded biological material and genetic personal data coded for research purposes;
B.: The right, at any time, to refuse to participate in the research project or to revoke its consent without having to justify its decision;
C.: Measures to ensure the protection of biological material and personal data, in particular the management of the code;
D.: The possibility of transmitting biological material and genetic personal data to third parties for research purposes.

² The person concerned must give his or her written consent; s. 9 shall apply mutatis mutandis to exceptions.

Art. Information on the proposed anonymization of biological material and genetic personal data for research purposes

The following information must be provided to the person concerned in writing or orally:

A.: The proposed anonymization of biological material and genetic personal data for research purposes;
B.: The right to oppose it;
C.: The impact of anonymization on health outcomes;
D.: The possibility of transmitting biological material and data to third parties for research purposes.

Art. Informed consent for the reuse of non-genetic health-related personal data for research purposes in an uncoded form

¹ The following information must be provided to the person concerned in writing or orally:

A.: The intended reuse of non-genetic personal data related to health for research purposes;
B.: The right, at any time, to refuse to participate in the research project or to revoke its consent without having to justify its decision;
C.: The right of the person to be informed of the results concerning his or her health or to refrain from receiving such information;
D.: Measures to ensure the protection of personal data;
E.: The possibility of transmitting personal data to third parties for research purposes.

² The person concerned must give his or her written consent; s. 9 shall apply mutatis mutandis to exceptions.

Art. 32 Information on the proposed re-use of non-genetic personal data related to health for research purposes in a coded form

The following information must be provided to the person concerned in writing or orally:

A.: The intended reuse of health-related non-genetic personal data for research purposes;
B.: The right to oppose it;
C.: Measures to ensure the protection of personal data, including the management of the code;
D.: The possibility of transmitting personal data to third parties for research purposes.

Section 3 Authorization procedure and reporting requirements for research projects with biological material and personal health data

Art. 33 Research Project

Is considered to be a research project within the meaning of this section any project under which previously collected biological material or health-related personal data are reused to respond to A scientific problem.

Art. 34 Audit Domains

¹ The Ethics Commission shall verify:

A.: The application is complete;
B.: The conditions referred to in s. 32 and 33 HRL are completed;
C.: For research projects involving coded biological material and coded personal data related to health, accuracy and security of coding;
D.: Compliance with the requirements for the conservation of biological material or personal health data;
E.: The professional qualifications of the project management and others involved in the research project;
F.: Other areas to the extent necessary to assess the protection of the persons concerned.

² In so doing, it takes account of authorisations already issued by ethics committees for the biological material concerned or the personal data relating to the health concerned.

Art. 35 Applicable Provisions

The following provisions shall apply mutatis mutandis:

A.: For the filing of the application, s. 14;
B.: For procedure and time limits, s. 16;
C.: For multicentre research projects, s. 17.

Art. 36 Obligations to advertise

¹ The project management first announces a change in the direction of the project to the Ethics Commission.

² It announces the completion or termination of the research project to the Ethics Commission within 90 days.

Section 4 Authorization procedure and obligations to advertise for the reuse of biological material and personal health data for research purposes in the event of lack of consent or information within the meaning of s. 34 LRH

Art. Audit Domains

The Ethics Commission shall verify:

A.: The application is complete;
B.: The reasons for s. 34, let. A and b, LRH;
C.: The overriding interest of the purpose envisaged by the research project on that of the person concerned to decide on the reuse of his biological material and personal data related to his health;
D.: The circle of persons entitled to transmit biological material and personal data;
E.: Compliance with the requirements for the conservation of biological material or personal health data and the circle of persons authorized to access it;
F.: The professional qualifications of persons entitled to receive biological material and personal data;
G.: Other areas to the extent necessary to assess the protection of the persons concerned.

Art. 38 Applicable Provisions

The following provisions shall apply mutatis mutandis:

A.: For the filing of the application, s. 14;
B.: For procedure and time limits, s. 16;
C.: For the re-use or collection of biological material or personal data relating to health according to a uniform research protocol, but in different cantons, the procedure according to Art. 17.

Art. 39 Authorization

The authorization shall contain at least the following particulars:

A.: The purpose in which biological material and personal health data can be reused;
B.: The designation of biological material and personal health data included in the authorization;
C.: The circle of persons entitled to transmit biological material and personal health data;
D.: The circle of persons entitled to receive biological material and personal data.

Art. 40 Announcements

¹ The project management must inform the Ethics Commission in advance of any changes to the indications mentioned in the authorisation.

² It announces the end or stop of the collection to the Ethics Commission within 90 days.

Art. Audit Domains

The Ethics Commission shall verify:

A.: The application is complete;
B.: Scientific quality;
C.: Compliance with consent requirements (s. 36 LRH);
D.: For research projects on deceased persons placed under artificial respiration, the need to include them in the research project (art. 37, para. 2, LRH) and the independence of persons who participated in the finding of death (art. 37, para. 3, LRH);
E.: Compliance with the requirements for the conservation of biological material or personal health data;
F.: Compliance with the prohibition on marketing (s. 9 LRH);
G.: Professional qualifications of project management and other researchers.

Art. Applicable Provisions

The following provisions shall apply mutatis mutandis:

A.: For the filing of the application, s. 14;
B.: For procedure and time limits, s. 16;
C.: For multicentre research projects, the procedure according to Art. 17.

Art. 43 Announcements

¹ The project management must first announce the following changes to the research project to the Ethics Commission:

A.: The change in project direction;
B.: For research projects on deceased persons placed under artificial respiration, any essential modification of the research plan.

² It announces the completion or termination of the research project to the Ethics Commission within 90 days.

Art. 44 Informed consent

¹ For research projects on embryos and fetuses from interruptions in pregnancy and spontaneous abortions, including stillbirths, the following information shall be provided in writing and orally to the pregnant woman, respectively To the couple concerned:

A.: The use of the embryo or fetus for research purposes;
B.: The right at any time to refuse such use or to revoke their consent without having to justify their decision;
C.: Measures to ensure the protection of biological material and personal data;
D.: The treatment of embryos or fetuses after completion of the research.

² Information may be provided other than in the form of text.

³ Persons concerned must give their consent in writing. The consequences of revocation are governed by s. 10.

⁴ Art. 9 shall apply mutatis mutandis to exceptions to the written form.

Art. 45 Audit Domains

The Ethics Commission shall verify:

A.: The application is complete;
B.: Scientific quality;
C.: Compliance with information and consent requirements;
D.: For research projects on embryos and fetuses from terminations of pregnancy, compliance with the conditions set out in s. 39, para. 1, 2 and 4 HRL;
E.: Compliance with the prohibition on marketing (s. 9 LRH);
F.: Compliance with the requirements for the conservation of biological material or personal health data;
G.: Professional qualifications of project management and other researchers;
H.: Other areas to the extent necessary to assess the protection of the pregnant woman or the couple concerned.

Art. Applicable Provisions

The following provisions shall apply mutatis mutandis:

A.: For the filing of the application, s. 14;
B.: For procedure and time limits, s. 16;
C.: For multicentre research projects, the procedure according to Art. 17;
C.: For advertising obligations, s. 36.

Art. Updating annexes

The Federal Department of the Interior may update the annexes in accordance with international or technical developments. For updates that may constitute technical barriers to trade, it acts in consultation with the Federal Department of Economics, Training and Research.

Art. 48 Transitional provisions

¹ Research projects referred to in Chapter 2 that have been authorized before 1 ^Er January 2014 are deemed to be Category B research projects.

² The authority that authorized a research project before 1 ^Er January 2014 may file a research project in Category A upon request. In such cases, liability, guarantee and advertising obligations are governed by the new law.

³ The Ethics Commission makes its decision in accordance with para. 2 in simplified procedure according to Art. 6 of the organisation order concerning the HR of 20 September 2013 ¹.

⁴ The provisions of this Order shall apply to:

A.: Review of the essential changes made to the research projects referred to in Chapter 2;
B.: Announcements concerning research projects referred to in Chapters 3 to 5.

⁵ The competent Ethics Commission shall make a decision on the application for authorisation of a research project not subject to authorisation under the former right within the meaning of Art. 67, para. 2, LRH within six months of confirmation of receipt of the file in accordance with the formal requirements.

¹ RS 810.308

Art. Entry into force

This order shall enter into force on 1 ^Er January 2014.

(art. 13)

Coverage Amount

The amount of coverage for research projects on Category B persons is at least:

A.: 250 000 francs per person;
B.: 20,000 francs for property damage;
C.: 3 million francs for the entire research project.

State 1 ^Er January 2014

(art. 14, 17, 18 and 19)

Documents required for the procedure before the competent Ethics Commission

1: Documents required for research projects on persons linked to the collection of biological material and the collection of personal data related to health
1.1: Basic form including the summary of the research plan drawn up in the national language of the place of conduct of the research project and a statement of reasons for the application for classification in the category desired;
1.2: Research plan;
1.3: Information and consent forms, as well as recruitment documents, including advertisements or announcements;
1.4: Other documents provided to the individual involved in the research project;
1.5: Indications relating to the mode and amount of remuneration of persons participating in the research project;
1.6: For Category B research projects, the certificate of insurance or other assurance of possible damage;
1.7: Documentation concerning the safety of the processing of biological material and personal data, in particular their preservation;
1.8: Curriculum vitae of the project management including the certification of his/her knowledge and experience, as well as a list of other persons performing the research project, with their duties and knowledge Professional in the field;
1.9: Certification of the appropriateness and availability of the infrastructure at the site of the research project;
1.10: Agreements between project management and the proponent or third parties, including funding for the research project, compensation for project management and publication.
2: Additional documents required for research projects involving examinations using radiation sources
2.1: Data on the essential aspects of radiation protection, in particular a calculation or an estimate of the effective radiation dose, doses given to organs and possible tumour doses;
2.2: Authorizations required under s. 28 of the Radiation Protection Act of 22 March 1991 ¹.
3: Additional documents required for research projects involving examinations using sealed or unsealed radioactive sources and requiring advice from the FOPH under s. 19, para. 2
3.1: Data on radiopharmaceutical properties, including pharmacokinetics, quality, stability, radiochemical purity, and purity of the radionuclide;
3.2: For authorized radiopharmaceuticals, professional information;
3.3: For unauthorised radiopharmaceuticals, data on the manufacturing process and quality control of the product, the names of those responsible and information on their professional qualifications;
3.4: The names of persons responsible for the use of the radiopharmaceutical on human beings and information on their professional qualifications;
3.5: Data according to the OFSP form for research projects for radiopharmaceuticals or radiolabelled substances ².
4: Documents required for research projects involving the reuse of biological material and personal health data
4.1: Basic form including a summary of the scientific issue in the national language of the research project's location;
4.2: A description of the scientific issue;
4.3: Documentation of the origin of biological material and personal health data, as well as respect for the conditions of informed consent and information on the right of opposition within the meaning of s. 32 and 33 LRH;
4.4: For the re-use of biological material and personal data relating to health in coded form, the attestation of the security and the accuracy of their coding;
4.5: Documentation concerning the safety of the processing of biological material and personal data, in particular their preservation;
4.6: Curriculum vitae of the project management including the certification of his/her knowledge and experience, as well as a list of other persons performing the research project, with their duties and knowledge Professional in the field;
4.7: Indications of the infrastructure available at the site of the research project;
4.8: All authorisations issued by ethical commissions in Switzerland for the collection of biological material or the collection of personal data relating to health.
5: Documents required for the reuse of biological material and personal health data in the event of lack of consent and information within the meaning of s. 34 LRH
5.1: Basic form including a summary of the project written in the national language of the location of the research project;
5.2: Action plan;
5.3: A description of the proposed research goals that require the reuse of biological material or personal health data, including a discussion of the extent to which the interest of the research takes precedence over that of the persons concerned;
5.4: Designation of biological material or personal health data to be reused;
5.5: Designating the circle of persons entitled to transmit biological material or personal data relating to health;
5.6: Designation of persons entitled to receive biological material or personal health data;
5.7: Designating the persons responsible for ensuring the protection of the data communicated;
5.8: Designating the circle of persons entitled to access biological material or health-related data;
5.9: Documentation concerning the safety of the processing of biological material and personal data, in particular their preservation;
5.10: Indications relating to shelf life;
5.11: Curriculum vitae of the project management including the certification of his/her knowledge and experience, as well as a list of other persons performing the research project, with their duties and knowledge Professional in the field;
5.12: Indications of the infrastructure available at the site of the research project.
6: Documents required for research projects on deceased persons
6.1: Basic form including a summary of the research plan written in the national language of the site of the research project;
6.2: Research plan;
6.3: Certification of compliance with consent requirements within the meaning of s. 36 LRH;
6.4: Proof of the prior finding of death within the meaning of s. 37, para. 1, LRH;
6.5: For research projects on deceased persons who have been placed under artificial respiration, the rationale for why these persons should be included in the research project, and evidence of the independence of those who have Death;
6.6: Documents relating to possible remuneration;
6.7: Documentation concerning the safety of the processing of biological material and personal data, in particular their preservation;
6.8: Curriculum vitae of the project management including the certification of his/her knowledge and experience, as well as a list of other persons performing the research project, with their duties and knowledge Professional in the field;
6.9: Indications of the infrastructure available at the site of the research project;
6.10: Agreements between project management and third parties, in particular as regards the funding of the research project, the remuneration of the project management and publication.
7: Documents required for research projects on embryos and fetuses from interruptions in pregnancy and spontaneous abortions, including stillborn children
7.1: Basic form including a summary of the research plan written in the national language of the site of the research project;
7.2: Research plan;
7.3: Recruitment documents, including any advertisements, and information and consent forms;
7.4: Description of the measures planned to ensure compliance with the requirements for consent within the meaning of s. 39, para. 1, or 40, para. 1, LRH;
7.5: Description of the measures provided for in order to ensure compliance with the prior finding of death within the meaning of Art. 39, para. 3, respectively, s. 40, para. 2, LRH;
7.6: For research projects on embryos and fetuses resulting from terminations of pregnancy, proof of compliance with the conditions referred to in s. 39, para. 2 and 4, HRL;
7.7: Documents relating to possible remuneration;
7.8: Documentation concerning the safety of the processing of biological material and personal data, in particular their preservation;
7.9: Curriculum vitae of the project management including the certification of his/her knowledge and experience, as well as a list of other persons performing the research project, with their duties and knowledge Professional in the field;
7.10: Indications of the infrastructure available at the site of the research project;
7.11: Agreements between project management and third parties, in particular as regards the funding of the research project, the remuneration of the project management and publication.
8: Documents to be provided to relevant ethics boards for multicentre research projects
8.1: Basic form including a summary of the research plan written in the national language of the site of the research project;
8.2: Research plan;
8.3: For research projects on individuals or research projects on embryos and fetuses from terminations of pregnancy and spontaneous abortions, including stillborn children, information forms and Consent, as well as documents relating to recruitment, in particular the advertisement or the texts of the announcements, used at the place of implementation concerned;
8.4: For research projects involving deceased persons, the certification of compliance with consent requirements within the meaning of s. 36 LRH, as well as proof of the prior finding of death within the meaning of s. 37, para. 1, LRH at the relevant location;
8.5: Curriculum vitae of the person responsible for the research project at the site, including the certification of his or her knowledge and experience, as well as a list of other persons carrying out the research project at the site The implementation concerned, with their functions and their professional knowledge of the matter;
8.6: Attestation of the appropriateness and availability of the infrastructure at the site of the research project;
8.7: Agreements between the proponent and the person responsible for the research project at the place of performance concerned, in particular with regard to remuneration;
8.8: For research projects on persons in Category B, the certificate of insurance or other assurance of possible damage to the place of achievement concerned, including the agreements relating thereto between the promoter and the Person in charge at the site.

¹ RS 814.50
² This form can be obtained from the Federal Office of Public Health, Radiation Protection Division, 3003 Berne, or consulted on the website of the Office at the following address: www.bag.admin.ch > Topics > Radiation, radioactivity and sound.

State 1 ^Er January 2014

RS 810.301 Order of 20 September 2013 on human research with the exception of clinical trials (Human Research Ordinance, ORH)

Original Language Title: RS 810.301 Ordonnance du 20 septembre 2013 relative à la recherche sur l’être humain à l’exception des essais cliniques (Ordonnance relative à la recherche sur l’être humain, ORH)

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810.301

Human Research Order with the exception of clinical trials

(Human Research Ordinance, ORH)

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