Required Language for fMRI/other imaging modalities For any studies without a certified radiologist on the study team, and that involve scans that could detect anomalies beyond what is specifically being looked at for the research study, the following language is required (per consultation with the Office of the General Counsel): You will be getting a scan for research purposes only. The research does not require health professionals to read the scan. The researchers are not qualified to interpret the images for healthcare purposes. Do not rely on the scan for clinical or diagnostic purposes. However, if the researchers have a question about something they see on the scan they will tell you, and ask you if you want the scan sent to a qualified health professional for review and any further medical treatment. You or your insurance company may have to pay for the review and any such treatment. If the study team does include a certified radiologist or other member who is qualified to interpret the test being done, please modify the language to reflect your plan for discussing incidental findings with the participants. Suggestion: You will be getting a scan for research purposes only. The research does not require the scan to be read for healthcare purposes. However, if the researchers are concerned about something they see on the scan they will tell you, and ask you if you want the scan to be reviewed for healthcare purposes (possibly by other clinicians), and you may then be referred for medical treatment. You or your insurance company may have to pay for the review for healthcare purposes, and for any such treatment. Studies under Risk Evaluation and Mitigation Strategies (REMS ): A Risk Evaluation and Mitigation Strategy () is a safety strategy to manage a or potential serious risk associated with a drug or biological product. A REMS will be required if the Food and Drug Administration (FDA) determines that a REMS is necessary to ensure the benefits of the drug or biological product outweigh its risks. A REMS can include a Medication Guide, Patient Package Insert, a communication plan, elements to assure safe use, and an implementation system. Click here for more information on REMS. Things to consider for the informed consent: Does the consent document describe REMS requirements for subjects? Does the subject have to register with a REMS program? Does the REMS apply to all subjects? Does REMS require subject counseling? Does REMS address reproductive risks?
Required Language for fMRI/other imaging modalities For any studies without a certified radiologist on the study team, and that involve scans that could detect anomalies beyond what is specifically being looked at for the research study, the following language is required (per consultation with the Office of the General Counsel): You will be getting a scan for research purposes only. The research does not require health professionals to read the scan. The researchers are not qualified to interpret the images for healthcare purposes. Do not rely on the scan for clinical or diagnostic purposes. However, if the researchers have a question about something they see on the scan they will tell you, and ask you if you want the scan sent to a qualified health professional for review and any further medical treatment. You or your insurance company may have to pay for the review and any such treatment. If the study team does include a certified radiologist or other member who is qualified to interpret the test being done, please modify the language to reflect your plan for discussing incidental findings with the participants. Suggestion: You will be getting a scan for research purposes only. The research does not require the scan to be read for healthcare purposes. However, if the researchers are concerned about something they see on the scan they will tell you, and ask you if you want the scan to be reviewed for healthcare purposes (possibly by other clinicians), and you may then be referred for medical treatment. You or your insurance company may have to pay for the review for healthcare purposes, and for any such treatment. Studies under Risk Evaluation and Mitigation Strategies (REMS ): A Risk Evaluation and Mitigation Strategy () is a safety strategy to manage a or potential serious risk associated with a drug or biological product. A REMS will be required if the Food and Drug Administration (FDA) determines that a REMS is necessary to ensure the benefits of the drug or biological product outweigh its risks. A REMS can include a Medication Guide, Patient Package Insert, a communication plan, elements to assure safe use, and an implementation system. Click here for more information on REMS. Things to consider for the informed consent: Does the consent document describe REMS requirements for subjects? Does the subject have to register with a REMS program? Does the REMS apply to all subjects? Does REMS require subject counseling? Does REMS address reproductive risks?
modular-consent-language.docx