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March 2012 New Version of HIPAA Combined Informed Consent Authorization Template
A new version of the HIPAA Combined Informed Consent/Authorization Template (March 2012, Version 13) has been posted. All new and revised consent forms are required to be on this template as of June 1, 2012. Consent forms received after June 1, 2012 on an outdated template will be returned and the application will not be processed until the correct consent forms are submitted.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 13 Informed Consent Template.
Please note the following significant changes in the template:
Title Page: The Principal Investigator’s name, address, phone and fax numbers must be included.
Section 1: What you should know about this study:
- The language for www.ClinicalTrials.gov should be included exactly as it appears in the template.
- An optional bullet for medical record information has been provided. Include this language in the consent form if clinical tests will be included in the medical record.
Section 9: Will you be paid if you join this study?
JHMIRB standard language has been provided to advise participants:
- they may be required to provide their Social Security number
- that payments exceeding $600 per year must be reported to the Internal Revenue Service
Section 12: How will your privacy be protected?
The JHMIRB HIPAA privacy language has been revised.
Section 16: What treatment costs will be paid if you are injured in this study?
The following sentence has been added to JHMIRB standard language: “You will not give up your right to seek compensation for harm by signing this form.”
Page 3 of Instructional Template: Information has been added for studies that will also include creation of cell lines or pluripotent cells.