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A new version of the HIPAA Combined Informed Consent/Authorization Template (January 2010, Version 11) has been posted on this website. All new and revised consent forms are required to be on this template as of April 1, 2010. Consent forms received after April 1, 2010 on an outdated template will be returned and the application will not be processed until the correct consent forms are submitted. NOTE: Continuing reviews do not require submission of consent form(s) and do not require the transfer of the approved consent form(s) to the Version 11 Informed Consent Template.
Please note the following significant changes in the template:
There is new required language for Section 8 “Will it cost you anything to be in this study?” and for Section 16 “What treatment costs will be paid if you are injured in this study?”
There are Optional bullets available in Section 1 “What you should know about this study.” The new options are applicable to:
- research that will be conducted at Anne Arundel Medical Center;
- research that involves collection of genetic information and data to be shared with a National Institutes of Health Genome-Wide Association Study (GWAS) repository.
There is standard language applicable to the Genetic Information Nondiscrimination Act (GINA), a new federal law that became effective in 2009. The language is provided in Section 3: “What will happen if you join this study?” and in Section 4 “What are the risks or discomforts of the study?” This information should be included in all consent documents of studies where genetic testing will be done.