Researcher’s institutional letterhead
Participant Information Sheet for Case Report[version number] [date]
PARTICIPANT INFORMATION SHEET for CASE REPORT
Title of Project:
Chief Investigator:
Associate Investigators:
Dear [Patient Name]
1.Invitation
Provide the patient with an introduction to your study. For example, “We are writing to ask your permission to use your medical records to write a case report for a journal article submission. This case report will be based on your condition and subsequent treatment.”
2.What is the purpose of this study?
Describe the aim of your study. For example “The purpose of this study is to review your case and the treatment you received.”Also, what do you aim to achieve by publishing this case report (e.g. we believe that this information will be of benefit to medical practitioners in the area of…). Include (if available) information about where you intend to publish this case report (i.e. in the X Journal, at X conference).
3.Why have I been invited to participate?
Explain the basis for your selection the patient.
Include reasons why you are intending to write a case report on this patient’s condition and treatment (e.g. that it is a rare condition; the treatment was unusual).
Patient should be informed that their involvement is voluntary, that there are no consequences if they decide not to participate and that this will not affect, for example, their relationship with the their treating doctor.
4.What will I be asked to do?
Explain that this document contains information about a research project based on this patient’s condition/ treatment and that you are asking for their consent to use their medical records to obtain information in order to publish a case report on their condition/treatment. Indicate that once they understand what is being asked of them they will be asked to sign the Consent Form. Let the patient know that they are free to ask you any question that they may have and that they are also welcome to go away and think about what is being asked of them and to talk to over with a family member/friend.
5.Are there any possible benefits from participation in this study?
Inform the patient that they are unlikely to benefit in any direct way from the publication of this case report. However, this case may help you and other practitioners learn how to benefit patients in the future.
6.Are there any possible risks from participation in this study?
Inform the patient that there are no direct risks associated with participating in this study. However, there may be a risk that due to the uniqueness of their condition/treatment they may be able to be identified from the information contained in the publication.
7.Confidentiality
Inform the patient that besides the named investigators, no one will have access to their medical information. Inform the patient that neither their name nor their identity will be used for the publication. That ever effort will be made to ensure that the information published is anonymous.
Finish by inviting patient to contact you should they have any queries about this study.
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