[Insert Project Title, Date and Version number here]
PARTICIPANT INFORMATION SHEET TEMPLATE FOR ADULTS
This is not offered as a rigid template, but rather as a flexible framework.
We have suggested headings which you may decide are appropriate to use, or not, depending on the type of study you are planning and what is involved.
[Place your logo here]
invitation to participate in a research project
[TITLE OF YOUR PROJECT]
You are invited to participate in a research project[insert information regarding the purpose of the study, why the person has been selected for possible participation, and information about the institution that is responsible for the research project.]
What IS THE STUDY ABOUT?
[Describe the main features of what the study entails, if tests will be taken, examinations, interviews, filming, etc., if there is likely to be any contact with a third-party and how it will be implemented. Describe how participation in the project may deviate from regular treatment. Give an approximate timeframe. The information given here will need to be short and concise.]
The study will collect and recordpersonal information about you. [Explain what type of information will be recorded. If the information is going to be compiled (linked to other data or registers), the type of source (e.g. personal health records, data from questionnaires, blood-test results) and type of register will need to be specified.]
POSSIBLE BENEFITS AND EXPECTED DISADVANTAGES OF TAKING PART
[Insert information regarding the expected advantages, risks, disadvantages, side-effects and discomfort from participating in the study. If the research is going to be combined with standard treatment, a clear explanation will need to be given, detailing the advantages and disadvantages in relation to the treatment received if they take part in the research project in comparison to the standard treatment.]
Voluntary participation and the possiblity to withdraw consent (Opt-out)
Participation in the study is voluntary. If you wish to take part, you will need to sign the declaration of consent on the last page. You can, at any given time and without reason withdraw your consent. This will not have any consequences for any future treatment [This last sentence can be deleted if the participant is not recruited by virtue of being a patient.] If you decide to withdraw participation in the project, you can demand that your tests and personal health data be deleted, unless however, the personal health data and tests have already been analysed or used in scientific publications. If you at a later point, wish to withdraw consent or have questions regarding the project, you can contact [Insert name, telephone number and project managers e-mail address, and if necessary another permanent project member/contact person.]
What will happen to YOUR HEALTH information?
The information that is recorded about you will only be used as described in the purpose of the study. You have the right to access which information is recorded about you and the right to stipulate that any error in the information that is recorded is corrected.
All information will be processed and used without your name or personal identification number, or any other information that is directly identifiable to you. [Any deviations from this process will need to be specified here.]
The Project Manager has the responsibility for the daily operations/running of the Research Project and that any information about you will be handled in a secure manner. Information about you will be anonymised or deleted a maximum of 5 years after the project has ended. [Any deviations from this must be reflected in the text]
what will happen to the tests you have taken?[only include this section if it is applicable to the study]
The tests that are taken from you will be stored in a Research Biobank. [Describe which tests will be stored, the name of the Research Biobank, its location, and the person in charge of the Research Biobank.]
The Research Biobank will be terminated after the research project has ended.
[You will need to give further details if: a) the tests are going to be sent to another country,b) if other researchers will have access to the biological material, or c) if the tests will be stored in a biobank for later studies.]
Genetic testing[only include this section if it is applicable to the study]
what kind of information can we obtain from genetic testing?
[Explain in lay terms which type of genetic analysis (simple gene analyses, genome-wide, genome-typing analyses, and genome-sequencing) will be performed, as well as a short summary of what it/they entail(s). It should be specified whether the participant will contacted in regard to any findings, or not.]
- Genetic Counselling
[Specify if counselling will be given verbally and/or in written form, and by whom. Give information outlining what kind of counselling will be given, before, during and after the genetic analyses are completed.] - Incidental findings
[If incidental findings are made - you will need to inform the participant as to whether they will be contacted and be given a referral - should you coincidentally uncover a genetic defect where the participant has a high chance of developing a serious illness which can be prevented or treated.] - Possible re-identification
[You will need to inform the participant that, even though their name and personal identification number is removed, the genome-sequencing is so unique that it can in theory never be regarded as completely anonymous.]
Insurance [describe as applicable]
[You will need to provide information regarding what type of insurance cover is applicable, in most instances the Patient Injuries Act(pasientskadeloven),theProduct Liability Act (produktansvarsloven)is applicable]
transfer of information to others[only include this section if it is applicable to the study]
By agreeing to participate in the study, you are also consenting to thatyour information [state which information (including genetic data if applicable)]can be transferred to another country. [If de-identified data is sent to a country outside of the EU/EEC, state which country.]This can be a country with laws that do not have the same standards as European Data Protection Law. The identifier code that connects you and your personal health data will not be transferred.
Follow-up study[only include this section if it is applicable to the study]
[You will need to inform the participant if they are likely to be contacted again for any follow-up studies.]
finance [only include this section if it is applicable to the study]
[You will need to account for any possible ethical and/or other challenges in relation to finance (e.g. if the participant will receive a travel allowance). If the Project/Biobank receives any financial support from a sponsor, you will need to inform the participant about the sponsor’s role, financial benefits, and any conflicts of interest.]
Approval
The Project is approved by the Regional Committee for Medical and Health Research Ethics[insert reference number from REC (20xx/yyyy)].
consent for participating in the research project
i am willing to participate in the research project
[Remove the parts which are not applicable]
City/Town and date / Participant’s SignatureParticipant’s Name (in BLOCK LETTERS)
[If a project includes a child or adolescent under the age of 16 years, initially both parents/guardians will need to sign the][Remove any text/sentences which are not applicable.]
As parents/guardians of______(Full name),we consent for him/her to participate in the Research Project
City/Town and date / Parent’s/Guardian’s SignatureParent’s/Guardian’s (in BLOCK LETTERS)
City/Town and date / Parent’s/Guardian’s Signature
Parent’s/Guardian’s (in BLOCK LETTERS)
Consent on behalf of a representative[Delete the following sentences if it has not been applied for or if it is notrequired/applicable]
As next of kin for______(Full name)I hereby consent to that he/she can participate in the research project.
Place and date / Next of kin signatureNext of kin name (IN BLOCK LETTERS)
I confirm that I have given information about the research project [You can include this sentence if you wish, only in the instances where the information is given face to face.]
Place and date / SignatureRole in the research project
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