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Revised Common Rule
The Common Rule is a federal policy regarding Human Subjects Protection that applies to 17 Federal agencies and offices. On January 21, 2019, all new federally funded human subjects research studies must comply with the revisions to the U.S. Department of Health and Human Services (DHHS) human subjects research regulations, the Revised Common Rule. In addition, all research conducted in Maryland must follow the Revised Common Rule.
In preparation for implementation of the Revised Common Rule, the JHM IRB is using the following timeline for new applications not granted final IRB approval before January 21, 2019.
- New applications submitted after 12/15/2018, but not reviewed by the IRB, will be returned to study teams after 01/21/2019 with any pre-review issues. Study teams will see some sections of the application have changed to be in compliance with the Revised Common Rule. Study teams should address all pre-review issues, complete any new required questions and resubmit the application for review.
- New applications reviewed by the IRB, but not approved prior to 01/21/2019, will be returned to study teams after 01/21/2019 and include the IRB review issues. Study teams will see some sections of the application have changed to be in compliance with the Revised Common Rule. Study teams should address all IRB review issues, complete any new required questions and resubmit the application for review.
Guidelines & Policies
- What You Need to Know About the Revised Common Rule
- FAQ related to the Revised Common Rule
- Guidance for Preparing an eIRB Application that will be Reviewed and Approved
under the Revised Common Rule
- Public Health Surveillance Activities
Forms, Tools, and Templates Related to the Revised Common Rule
- Key Information Guidance - This guidance is designed to assist researchers in addressing the new Revised Common Rule requirement that “Key Information” be presented first.
- Biospecimen testing language - If your study includes gene sequencing, creation of cell lines, genome/exome sequencing, or creation of pluripotent stem cells please use the suggested language in this document in your consent form.
- Exempt Determination Worksheet
- Informed Consent General Guidance - Please refer to this guidance for general information and instructions for preparing the JHM IRB Combined Informed Consent/HIPAA Authorization document.
- JHM IRB Combined Informed Consent/HIPAA Authorization Template (December 2018, Version 16) - For use when submitting new applications on or after 12/15/2018. Please click HERE for more details regarding the use of this new template.
- Informed Consent Document for Research Participants Who Do Not Speak English (Short Form)
- MRI language - If your study includes research imaging in an MRI scanner, the language options outlined in this document should be included in the consent form.
Public Health Surveillance Determination Worksheet - This form is required where the study team believes their project, or a component of the project, qualifies as a public health surveillance activity. If applicable, complete the determination worksheet and upload it in Section 1 of the eIRB application.
IRB Office Hours:
The IRB will hold open office hours to help study teams with questions about new applications affected by the Revised Common Rule. IRB staff will be available in Reed Hall conference room B102G to help answer your questions. In order to provide specific guidance, we will need the number for the application you are working on. Staff will be available at the following times:
Tuesday 1/22/2019 through Thursday 1/24/2019 – 12:00 – 3:00
Monday 1/28/2019* through Thursday 1/31/2019 – 1:00 – 3:00
If you are not able to attend on one of these days, you may request an appointment by emailing the eIRB help desk at email@example.com.
* This session will be held in Reed Hall conference room 102.