[Insert the short title of the study] – Main Section–[Insert date]

Request for participation in a research project

[Remove the highlighted text and the parentheses and insert your own text.Use at least a 12 point font size.]

“[Insertthe title of the study]”

Background and purpose

This is a request for you to participate in a research study that intends to[Insert informationon the purpose of the study, on why the person has been selected for this request and on the company or agency that is responsible. The informationshould be brief and readily understandable.]

What does the study entail?

[Insertthe general outline of what is to happen in the study, whether samples, examinations, interviews, filming, etc, will be conducted,whether contact with a third party will be established and how this will be transacted. If relevant, state the usual form oftreatmentthat will be administered if the person being askeddoes not wish to participate in the study; refer toChapter A for details, if necessary,. The informationmust be short and to the point!]

Potential advantages and disadvantages

[Insertinformationabout any potential advantages, disadvantages, discomforts, extra examinations, risks and expected activity for the participantthat might be experienced as a burdenif he or she participates in the study. In case it is not known whether the study entails any advantages, or if it is uncertain whether the study entails discomfort, information should be given about this.]

What will happen to the samples and the information aboutyou?[Remove “the samplesand” if such samples are not taken. The same applies to the text below.]

The samplesand data that are registered about you will only be used in accordance with the purpose of the studyas described above. All the data and sampleswill be processed without name, ID number or other directly recognisable type of information. A code number links you to your data and samplesthrough a list of names. [This means that the information isde-identified. Any deviation from this policy must be stated in the text.]

Only authorised project personnel will have access to the list of names and be able to identify you.[Stateanylinkstootherregistries;each single registrymust be stated, and also, if relevant,information that is obtained from other medical records, etc. A date must be stated for whenthe accumulated information and samplewill be deleted.]

It will not be possible to identify you in the results of the study when these are published. [The previous sentence must be reformulated if the selection is smalland/or the amount or type of informationin themselves might reveal the participant’s identity. In such a case it must be expressed that, as far as possible, an attempt shall be made to publish the results in such a manner that the participants’ identities are not disclosed.]

Voluntary participation
Participation in the study is voluntary. You can withdraw your consent to participate in the study at anytime and without stating any particular reason. This will not have any consequences for your further treatment. If you wish to participate, sign the declaration of consent on the final page. If you agree to participateat this time, you may later on withdraw your consent without your treatmentbeing affected in any way.If you later on wish to withdraw your consent or have questions concerning the study, you may contact[Insertthe name and phone number of the project leader or another permanent contact person].

Furtherinformationon the study can be found in Chapter A–Further elaboration of what the study entails.

Furtherinformationabout biobank, privacy and insurance can be found inChapter B – Privacy, biobank, funding and insurance.

The declarationof consent follows Chapter B.

[Insert the short title of the study] – Chapters A and B –[Insertdate]

Chapter A –Further elaboration of what the study entails

[The following aspects should be elaborated on to the extent that they are relevant and necessary to specify, and they should also be suitably grouped, if necessary with their own headings:

  • Criteria for participation
  • Background informationabout the study
  • Alternative procedures or treatment the patient receives if he or she chooses not to participate in the study
  • Examinations, blood samples, etc, that the participant must undergo
  • Schedule – what happens and when does it happen?
  • Potential advantages
  • Potentialadverse events
  • Potential discomforts ordisadvantages
  • The patient’s/study participant’s responsibility
  • That the patient/study participantor guardian will be informed as soon as possible in case new information becomes available that might influence the patient’s/test subject’s/participant’s willingness to participate in the study
  • That the patient/study participantwill be informed about potential decisions/situations that entail that their participation in the study might be ended earlier than planned
  • If relevant, possible compensation for and reimbursement of expenses for the participants]

Chapter B –Privacy, biobank, funding and insurance


Information thatis registered about you is [Explain in a generalway the type of data that will be registered. If there is a need for linking the data tolaw-regulatedregistries, medical records in other agencies or other registries, describe this by stating each registry. What type of data that is necessary to obtain from such registries or medical records, etc, must be explained (e.g.the Cancer Registry, the Birth Registry, the Cause of Death Registry, or by obtainingdata from a medical record from the person’s regular doctor or another hospital/treatment centre/agency).]

[Insertin casethe authorities or others have a right to access relevant parts of the medical record. If this is not relevant, delete the entire paragraph.] The purpose is to control that the study data correspond with the equivalent data in your medical record. Anyone who has access to this data is bound to secrecy.

[If external researchers have access to the data, this must be described to the extent that it is relevant.]

[The name of the agency], represented byitsmanaging director,isresponsible for the data processing.

Biobank[If a biobank is not going to be established, delete the entire section.]

The [Insertsample type]samplesthat are takenwill be stored in a biobank, established for research purposes, at[Inserttheagency in charge]. If you agree to participate in the study, you also consent to the biological material and samplesbeing included in the biobank. [Statethe person in charge of the biobank]is in charge of the biobank. The biological material can only be used by approval of the Regional Committees for Medical and Health Research Ethics (REC).

Releasing material and data to other parties

If you agree to participate in the study, you also consent to samples and de-identified data being released to [Insertthe agency and country. If de-identified data are to be sent to countries outside the EU/EEA, insert “These countries might have laws that do not meet the requirements of European legislature on privacy.”].

Right toaccess and right to deleteyour dataand samples

If you agree to participate in the study, you are entitled to have accessto what information is registered about you. You are further entitled to correct any mistakes in the information we have registered. If you withdraw from the study, you are entitled to demand that the collected samples and data are deleted, unless the data have already been incorporated in analyses or used in scientific publications.

Funding and the role of [Insertthe name of the SPONSOR]

[Account forethical and practical challenges linked to funding.]

The study and the biobank are funded by research grants from [Insert SPONSORor the hospital, depending on what is relevant.]. [Account forthe role of the sponsor, financial contributions and possible conflicts of interest].


[Statewhat insurance schemes that apply when participating in the study.]

Informationabout the outcome of the study

[Inform the participants that they are entitled to receive information about the outcome/result of the study.]

Consent for participationin the study

I am willing to participate in the study.


(Signed by the project participant, date)

Proxy consent when this is warranted, either in addition to or in place of the participant’s consent.


(Signed by representative, date)

[Remove the text concerning proxy consent if proxy consent is not warranted]

I confirm that I have given informationabout the study.


(Signed, role in the study, date)