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Sample Consent Changes

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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.
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