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Home IRB Lab Consent Form

Consent Form

IRB provides a range of resources about consenting participants and consent process models. Consent is an important part of research and you can find more resources on the IRB website.

Download the printable and clickable checklist here.

(Can be in any order) Background: Information on the consent process including a short description of the study. Study procedures: Explain who is being recruited for the study, what is expected of the participant, and their time commitment. Risks: Risks are inherent in any study, ensure to include a statement about any risks including breech of confidentiality. Benefits: Mention how this study might better the scientific world, do not include compensation as a benefit. Alternative procedures: Clarify if there are any alternative procedures the participants could opt for and mention they are allowed not to participate if desired. Confidentiality: Confidentiality breech is a risk in any study, locate where the data can be accessed and how your research team plans to keep it confidential IRB Contact: Add the contact information for the IRB if they have any questions, complaints, or concerns. Research participant advocate: List the contact information for a research participant advocate if one is required for participants. Voluntary participation: Participants may not want to be a part of the study, explain how to go about opting out of the study at any point. Costs and Compensation: Some studies might have costs to participate or compensation for completion of the study. State costs or compensation to the participants. New Information: A statement about what will occur if new information is available that can affect their medical care and participation in the study. Number of Participants: Include information about how many participants are expected to be enrolled in the study. Authorization for use of your PHI (CLINICAL): Inform participants that signing this document indicates their PHI can be used for this study and what PHI can be collected. Deciding to unenroll in the study: Explain what participants should do if they do not want to participate after signing the consent form and if they have to re-enroll. Consent/signatures: Ensure participants have read the document and had a chance to ask questions, include a copy of the form for them to keep.

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