IRB – Consent Changes 5/29/14

Consent Changes Font = Calibri Clarification and addition to instructions in several sections (Header, Randomization, Voluntary Participation and Withdrawal, Signatures) Addition of Sponsor Protocol No. to header when applicable

Consent Changes Clarification of Sample Randomization Paragraph Randomization: If your protocol involves randomization, include a paragraph on risks of randomization. Ensure the risks of all study arms are described in detail in this section, even if the procedures in those arms would be standard of care if the participant was not in the study. An example paragraph is below; however, you should revise as applicable to your study.  You will be assigned to a group by chance, which may prove to be less effective or to have more side effects than the other study group(s) or alternatives NOTE: customize this to your project

Consent Changes Clarification of Confidentiality Section The results of the treatment may be published for scientific purposes. These results could include your [ONLY INCLUDE APPLICABLE] lab tests and X-rays. However, your identity will not be given out. Now reads: The information from the research may be published for scientific purposes; however, your identity will not be given out.   

Consent Changes Clarification of Billing Compliance Language in Confidentiality Section Information relating to this study, including your name, medical record number, date of birth and social security number, may be shared with the billing offices of [UAB/Children’s] so that claims may be appropriately submitted to the study sponsor or to your insurance company for clinical services and procedures provided to you during the course of this study. Now reads: Information relating to this study, including your name, medical record number, date of birth and social security number, may be shared with the billing offices of [UAB/Children’s] so that the costs for clinical services can be appropriately paid for by either the study account or by the patient/patient’s insurance.   

Consent Changes Addition of Clinical Trial Indicator in Medical Records for Confidentiality Section   Clinical Trials: Include the following language for all clinical trials. Click here to determine if your protocol meets UAB’s definition of clinical trial. Your medical record will indicate that you are on a clinical trial and will provide the name and contact information for the principal investigator.    NOTE: coverage for PowerTrials

Consent Changes Addition of Class B Medical Device Language in Cost of Participation Section   Category B Medical Devices: If a Category B medical device is used in the study, include the following statement: Your insurance company may or may not pay for the device(s) used in this study. Blue Cross Blue Shield of Alabama will not pay for Category B medical devices. Other insurance companies may also decline to cover these types of devices. Therefore, it is very important that you provide your current health insurance information to UAB and that you check with your insurance company about the costs of participation.

Consent Changes Lots of Changes to Guidance in the Signatures Section   Reminder that these are guidelines There is no way to provide all the scenarios Bottom Line: it needs to reflect the process

Consent Changes HIPAA Authorization Form – Can I Cancel the Authorization?   You may cancel this Authorization at any time by notifying the Director of the IRB, in writing, referencing the Research Protocol and IRB Protocol Number. Now reads: You may cancel this Authorization at any time by notifying the Principal Investigator, in writing, referencing the Research Protocol and IRB Protocol Number.