Frequently asked questions on application

Questions about the application

1. 1. What is to be notified to the regional committee on biomedical research ethics?

   • Any biomedical research project shall be notified to the regional committee on biomedical research ethics, cf. section 8 of the Committee Act.

     A biomedical research project is an activity planned according to research methods which aim at producing new, valuable knowledge about human biological and psychological processes, either in relation to healthy persons or for the purpose of prevention, recognition, relief, treatment or cure of disease, symptoms and pain, including affecting bodily functions.

     Clinical trials on human biological material must be notified whether the material is identifiable with a person or it is ”anonymous”. Data are identifiable with individual subjects if it is possible to identify such subjects either by name or by code.  If just one subject has the "key", the material is identifiable with a subject and is not "anonymous”. Questionnaire-based examinations and interview examinations shall be notified only if the project will include examination of human biological material or examination of individuals.

     Clinical trials involving medicinal products and clinical investigations of medical devices, regardless of whether the device are CE approved or not, shall also be notified to the relevant committee. However non-intervention trials involving medicinal products shall not be notified to the committee system as the patient is not exposed to any special harm or risk, and the primary aim of prescribing the medicinal product is treatment. The medicinal product is prescribed in the usual manner in accordance with the terms of the marketing authorisation and the decision to prescribe the medicinal product is clearly separated from the decision to include the patient in a study.

     For more information see, Guidelines about Notification etc. of a Biomedical Research Project to the Committee System on Biomedical Research Ethics, 2.0.

2. 2. Notification to other authorities?
   

   • The Danish Data Protection Agency exercises surveillance over processing of data to which the Act on Processing of Personal Data applies, see the act or contact the Data Protection Agency for further information www.datatilsynet.dk

     Clinical trials involving medicinal products and clinical investigations of medical devices shall be notified to the Danish Medicines Agency: www.laegemiddelstyrelsen.dk

     If information from patients' records is to be used – in register research projects without the use of biological material – an application for such approval shall be submitted to the National Board of Health, cf. S. 46 (2) of the Health Act, see the National Board of Health.: www.sundhedsstyrelsen.dk

3. 3. What are the requirements for informed consent from trials subjects?
   

   • An informed consent is a decision to participate in a research project which has been made upon due information on the nature, significance, implications and risks of the project and receipt of suitable documentation. The decision is made voluntarily by a person who is capable of giving his or her consent. The consent shall be in writing, dated and signed or provided using an electronic signature. The trial protocol shall be accompanied by one of the ready-printed declarations of the committee system concerning informed consent.

     Guidelines for communicating oral information to participants shall be attached to the trial protocol. The requirements for written information is described in Guidelines about Notification etc. of a Biomedical Research Project to the Committee System on Biomedical Research Ethics.

4. 4. How is informed consent obtained from vulnerable subjects?

   • Surrogate consent is needed when the trial involves subjects who because of age or reduced physical or mental abilities due to depression, age, mental deficiencies or similar conditions are incapable of giving informed consent to participation in a trial. 

     Surrogate consent shall mean a decision in writing, dated and signed, or in electronic form along with an electronic signature, cf. the Act on Electronic Signatures, to take part in a biomedical research project, such decision being made by the closest relatives and the general practitioner, alternatively the medical officer of health or the holder of custody or the guardian following satisfactory information about the nature, significance, implications and risk of the project and receipt of suitable documentation.

5. 5. How is the regulation in emergency situations?

   • If the nature of the project means that it can only be implemented in emergency situations where the trial subject is unable to give his/her informed consent and it is impossible to obtain surrogate consent, the project may be implemented if it may in the long term improve the health of the subject. The investigator shall as soon as possible thereafter attempt to obtain informed consent or surrogate consent. However this shall not apply to clinical research with medicinal products.

     If a project involves medicinal products and if the nature of the trial means that it can bee implemented only in emergency situations where the trial subject is unable to give his/her informed consent and it is impossible to obtain surrogate consent from the guardian, the holder of custody or from the closest relatives and the general practitioner – alternatively the medical officer of health – the project may bee implemented if surrogate consent has been obtained from the trial guardian.

     In generel research in emgency situations may be made only if the physical/mental condition making it impossible to obtain informed consent or a surrogate consent is a necessary characteristic element of the research project. It is normally trials involving individuals who are temporarily incapacitated, e.g.  unconscious. It is a requirement that there is reason to assume that the trial subject's health can be improved in the long term.

6. 6. Is the trial subjects general rights described?

   • Yes the document “The rights of a trial subject in a biomedical research project” describes the general rights.

7. 7. How are the trial subjects insured?
   

   • The Danish Patient Insurance Act does cover most indemnities. Compensation is being paid to patients in case of injury in Denmark. Persons taking part in biomedical trials that do not form part of the diagnosis or treatment of their illness shall also be regarded as patients. The same shall apply to donors from whom tissue and other biological material are taken, se the conditions for paying compensation in the act, Section 1. See also www.patientforsikringen.dk  

     The system is supplemented by private compensation and reimbursement schemes.

8. 8. Can trial subjects get remuneration?

   • In general a distinction is made between compensation for documented loss of earnings or for documented transportation costs and inconvenience compensation, which relates to the invasiveness, duration, pain and discomfort of the trial. Healthy trial subjects may receive all this types of remuneration.

     Trial patients, who participate in a trial because they have a disorder or condition which is required for participation in the trial, cannot be offered inconvenience compensation.

     However model trial patients may receive the same types of remuneration as healthy trial subjects. These trial subjects is patients but there must be no possible treatment benefit in participating in the trial. See, Guidelines for remuneration or other payment for voluntary trial subjects, Appendix 6 in the Guidelines about Notification etc. of a Biomedical Research Project to the Committee System on Biomedical Research Ethics.

9. 9. How do ECs deal with SUSAR reports and Annual Safety Reports?

   • In all kinds of clinical trials the sponsor or the chief investigator shall once every year during the entire trial period submit to the committee a list of all serious adverse reactions and all serious events encountered during the period and shall provide information about the safety of the trial subjects.  

     In trials without medicinal products the investigator shall immediately inform the regional Committee if serious adverse reactions or serious events are encountered during the project. The notification shall include comments on any consequences for the trial. This goes for clinical trials with medicinal devices to.

10. 10. Who is responsible for submitting the request for ethical review to the competent ethics committee for single-site and for multi-site clinical trials?

    • The investigator is responsible

11. 11. Which committee is the relevant regional committee?

    • The notification is going to be sent to the committee in the region, where the investigator works.

12. 12. Applications in multi-site studies?

    • The co-ordinating chief investigator submits an application for a multi-site study to the regional scientific ethical committee for the area in which he/she is operating. This regional committee must make its decision, which forms the basis for an opinion, and then inform the other regional committees and the Danish National Committee for Biomedical Research Ethics for the investigators at the other sites involved.

       

13. 13. What are the timeline for getting an opinion?

    • The committee shall decide on the approval of the project within 60 days of receiving the duly formulated application, cf. section 10 of the Committee Act. The 60-calendar-day period starts from the time when the committee has received a duly formulated application. A valid application shall mean an application which contains the information which the committee system must receive in order to make a research ethical evaluation in accordance with Chapter 4 of the Act.

      The time-limit of 60 calendar days may be interrupted once by the committee as the committee may request information in supplement to the otherwise duly formulated application, cf. section 10(2) of the Committee Act. The time-limit is interrupted until the committee has received the supplementary information.

      In the event of a request for amendment of an approved biomedical research project, the committee shall decide on any approval of the amendment within 35 days of the receipt of a duly formulated application for amendment.

14. 14. Are there exceptions from the normal timelines?
    

    • Yes, the normal time limit shall be extended by 30 days if the processing concerns an application for the approval of trials involving gene therapy or somatic cell therapy or medicinal products containing genetically modified organisms. The 90-day deadline shall be further extended by 90 days in case of consultation of public boards or commissions.

      No time limit shall apply to the authorisation period regarding the processing of an application for the approval of xenogenic cell therapy.

      7. What is the time limit for an appeal?

      If the application for the approval has been declined the chief investigator may bring the decision before the Danish National Committee on Biomedical Research Ethics not later than 30 days from receipt of the decision from the regional committee. The National Committee is the final administrative complaint board.

      For more information about the complaints procedure see Guidelines about Notification etc. of a Biomedical Research Project to the Committee System on Biomedical Research Ethics, 10.0.

      8. Do the committees charge fees?

      The regions finance the operation of the regional committees and they lay down a fee per project notified by the research institutions, etc. and by private undertakings and hospitals. The regions own institutions are excepted.

      It has been agreed that the fee for notifying a project shall be DKK 4000 and for a supplementary protocol, DKK 1500.  

15. 15. What is the time limit for an appeal?

    • If the application for the approval has been declined the chief investigator may bring the decision before the Danish National Committee on Biomedical Research Ethics not later than 30 days from receipt of the decision from the regional committee. The National Committee is the final administrative complaint board.

      For more information about the complaints procedure see Guidelines about Notification etc. of a Biomedical Research Project to the Committee System on Biomedical Research Ethics, 10.0.

16. 16. Do the committees charge fees?

    • The regions finance the operation of the regional committees and they lay down a fee per project notified by the research institutions, etc. and by private undertakings and hospitals. The regions own institutions are excepted.

      It has been agreed that the fee for notifying a project shall be DKK 4000 and for a supplementary protocol, DKK 1500.

17. 17. Which language does the committee accept in an application?
    

    • Generally, reports may be submitted in both Danish and English and that they can be submitted electronically.