A new version of the JHM IRB Combined Informed Consent/HIPAA Authorization Template (December 2018, Version 16) has been posted.
This new version of the template has been created to comply with the revisions to the federal human subjects research regulations, called the Common Rule, which take effect on January 21, 2019.
- New applications approved before 1/21/2019 will continue to follow the requirements of the current (“old”) Common Rule and should not convert to the new template (Version 15 must continue to be used).
- New applications approved after 1/21/2019 must comply with the new Common Rule and must use the new template (Version 16).
- If your application is submitted but not approved before 1/21/2019, it will be RETURNED after 1/21/2019 to adhere to the new rule requirements.
Please see the IRB’s website for deadlines related to this transition that may impact new applications you currently have under review.
Changes in Research
- Changes in Research (whether submitted before or after 1/21/2019) to a parent application that was approved under the current (“old”) Common Rule, should not convert to the new template (Version 15 must continue to be used).
- If you convert your consent form unnecessarily from Version 15 to Version 16, your application will be returned to you.
- Version 15 of the template will continue to be effective/acceptable to use for studies initially approved under the “old” Common Rule, before 1/21/2019.
- The new template (Version 16) should only be used for applications that will not be approved by 1/21/2019. If your study requires convened review and has not yet been submitted for review, please use the new template.
- For studies submitted between 12/20/2018 and 1/7/2019 that may qualify for expedited review, we suggest you start your application using the existing template [Version 15].
Please Also Note:
- The new version of the Combined Informed Consent/HIPAA Authorization Template now includes a statement on p. 1 that should be included when the research includes children.
- The new Combined Informed Consent/HIPAA Authorization Template will also serve as a Parental Permission form. A separate new Parental Template will not be posted.