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 through IRB Forms and Templates.
(Can be in any order)
ITEMS
DESCRIPTION
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 breach 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 participant could opt for and mention they are allowed not to participate if desired.
Confidentiality
Confidentiality breach 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.