Below are tools created to facilitate returning IRR in compliant and respectful ways. Each tool is meant as a starting point and should be tailored to fit the details and plans of each study.
Please contact us if there are additional tools, templates, or resources we can create to further these efforts.
TOOL
DESCRIPTION
LINK TO DOWNLOAD
IRB Approval Checklist for Returning IRR
A checklist to assist IRB members and Ethics Committees in reviewing return of IRR plans, based around the U.S. regulatory criteria for IRB approval.
Healthcare Provider Contact Form Template
A template for obtaining permission to contact a participant’s healthcare provider or doctor about individual research results, along with their contact information.
IRR Information Sheet for Participants Template
A template for supporting the decision and discussion around a participants’ choice to receive results, which should be adapted to reflect the plan of the study and the types of results that a participant has the option to receive, along with their decisions to receive them.
Informed Consent Sample Language
Sample language to use in informed consent forms when explaining the different types of individual results that will be generated/returned to participants in a study.
Resources for Participants
Page for supporting research participants in deciding whether or not to receive results, considering genetic results, and asking questions about individual results