Kindly note that the following text is under revision.
Please be careful to choose correct application form. Application may be submitted in Icelandic or English. If submitted in English please enclose also Icelandic translations of items 1 and 3 of the application.
It should also be observed that it is mandatory that all documents and other communication with participants be in Icelandic.
An application for approval of a general research protocol shall include the following information.Please note that the numbers listed below refer to numbered items of the application form.
A. General information
- Full title of project in Icelandic and English (as applies)
- Type of research: A study with active participation or a retrospective study without contact wit subjects.
- The objective of the study in Icelandic (mandatory) and English, as applies (e.g. key objectives, methodology, participants, scientific relevance, benefits to participants, etc.).
- Name of the Principal Investigator who is responsible for carrying out the study in accordance with the approved protocol. Please bear in mind that the PI is the contact link with the NBC, he is als responsible for all handling and processing of health information, incl. biosamples. Please provide information on place of work and contact details.
- Name of other researchers involved, their place of work, positions and contact details.
- Name and address of other collaborators/sponsors (e.g. institutions or companies and indicate the type of their contribution to the project).
- The division of labour (who is doing what)?
- Interests. Are ther economic, financial conflicts of interest, familial affinities or workplace hierarcies which might cause partiality or bias?
B. Research data
Health related information is defined as medical records, health information, biological samples and information from health information collections including samples and information from previous studies.
- Identify the population to be recruited for participation in the study. Number of participants and selection criteria for participation, inclusion and exclusion. Account for whether an informed consent will be obtained or if those concerned will otherwise be informed that data on them is being processed for the study.
- Collection of information. Indicate what information will be collected and processed, eg age, gender, test results and diagnosis. In general research data shall be anonymous. List all collections from which information will be collected. Please indicate if other information will be collected, including directly from the participants.
- Identification/encryption/coding: Do you get access to personally identifiable data and for how long? Will such information be marked with a research code or participant number - when and how? If so account for security measures and how to protect the key between personal data and participant numbers?
- Processing of genetic information. Will genetic information/data be processed in the study? If that is the case please account for the processing, and how will infirmation/data be transfered between the site for processing and the research site?
- Please account for if there exists an agreement on the processing of identifiable personal information and confidentiality is kept?
- Accsess to, retention and destruction of research data. Who will get access to the data and how will its security be controlled? Where and how will data be kept during the study? If it is intended to retain research data after the conclusion of the study for future research, the data must be kept in a health data collection which has been approved by the Ministry of Health.
- Is it planned to export data og biosamples? If so to which country and institution/company and who will be responsible for the data at the receiving instance? Account for the objective for exporting data and what kind of processing will take place. Will the data and remaining samples be destroyed abroad or returned? How will the samples or data be marked and security ensured?
- Data sharing and joint data processing. Do you intend to get access to data and samples from previous studies? If so please account for the names of these studies, their NBC-number and who is/are the PI/PIs. In case of joint processing of files please account for which files and if personal identifiers will be coded.
C. Scientific and ethical issues (in progress)
- Research methodology: Describe methodology and explain adequately what participants are expceted to do. Specify what sort of statistical analysis, i.a. power analysis, has been carried out in preparing the study.If questionaires or tests will be used please account for their accuracy, reliability and validity and an if permit for using these insturments has been obtained.
- Scientific issues pertain to all scientific studies in the health sector. These issue may concern justification for doing a study, risk for participants and benefit, confidentiality in handling sensitive information, economic interdependecies or familial/jobrelated relationships, belonging to a vulnerable group, etc. Account for the ethical issues involved with the project.
- Please account for risk and benefits. On the one hand scientific and on the other practical benefits accruing from the study.
- Please describe the State of the Art in the research field and the theoretical and clinical background for the study. Please keep in mind that this is the scientific rationale for the study.
- Please indicate start of the study and its estimated conclusion. Please nothe that it is not permitted to start a study before all necessary permissions are in hand, The approval of the NBC or a HREC expires on the day of estimated conclusion of the study.
- As a general rule the NBC and HREC´s request that all results are made available or published, regardless of the results are confirming or refuting the working thesis of the study.
D. Participants (Chapter D applies if there is direct communication between researchers and participants)
- Account for age, gender and number of participants, as well as inclusion and exclusion criteria. Please note that particular justification is requested for involving children or persons in vulnerable situation in the study, including those not in a position to give their informed consent.
- Informed consent must be obtained from those participating in a biomedical study. There are two types of consent: a) Limited consent for participation in a single study, or b) Open consent for approving participation in a particular study and the use of data, including bio-samples, medical records, etc., in subsequent studies approved by the NBC or HREC. Using limited consent entails that research data must not be kept longer than necessary for the purpose of the study and shall be destroyed upon the conclusion of the study. Responding to a questionnaire equals the signing of a limited consent.
- How and by whom is informed consent obtained or completion of a questionnaire requested.Note that a parental or custodial consent is mandatory for minors under 18. Children as of the age of 12 must receive information adequate for their age and shall, themselves, sign a consent form.
- Account for possible risks and benefits for those participating in the study.
- If there is a risk of emotional indisposition following the participation in a study, it is requested that there will be an opportunity to meet a counsellor once without cost.
- a) Is there an insurance policy covering personal damage because of participating in the study. If yes – how are the participants insured, what is covered by the policy. Name the insurance company. It is mandatory that participants can claim their rights before domestic court. b) Is the health of the participants particularly monitored during the course of the study? If so by whom and how.
Reinbursement/remuneration for participation: a) Are expences of the participants reimbursed? If yes, please account for which expenses are covered. b) Is the a remuneration to participants? If yes, indicate form and amount of reimbursement for participation.
Form or amount of reimbursement must not encourage participants to take risks they otherwise would not have taken.
- According to the provisions of 2nd paragraph of Article 19 of Act of law No 44/2014 the PI in each study is obliged to inform those giving informed consent to participate in a study about ongiong studies by the PI.
E. Other remarks by the applicant.
F. Enclosures. Please list all enclosed permits and other enclosures.
G. The obligations of the Principal Investigator. By submitting a completed application to the NBC or a HREC, the PI confirms that the research protocol approved will be followed to detail, that copies of all necessary permits have been enclosed with the application and that all researchers – assistants have signed a declaration of confidentiality.
The Principal Investigator is responsible for all data of the study and processing of this data. All intended amendments must be submitted to the NBC for approval.