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HIPAA Combined Informed Consent/Authorization Template
A new version of the HIPAA Combined Informed Consent/Authorization Template (June 2011, Version 12) has been posted. All new and revised consent forms are required to be on this template as of August 1, 2011. Consent forms received after August 1, 2011 on an outdated template will be returned and the application will not be processed until the correct consent forms are submitted.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 12 Informed Consent Template.
Please note the following significant changes in the template:
Section 1: What you should know about this study.
An additional bullet has been added with information about www.ClinicalTrials.gov. This should be included in all consent forms.
Section 11: Why might we take you out of the study early?
A required sentence has been added that advises participants about the sharing of their health information if they are taken out of the study.
Section 12: How will your privacy be protected?
The Principal Investigator is required to provide his/her contact information (phone, address and fax numbers).
Section 19: What is a Genome-Wide Association Study?
The JHMIRB standard language has been revised.
Signature Page: Please note that the time as well as date is required for each signature.