The Common Rule is a federal policy regarding Human Subjects Protection that applies to 17 Federal agencies and offices.  As of 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.

New Guidelines/Policies related to the Revised Common Rule

• 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
• Consent-Waiver of Documentation of Consent

Revised Guidelines/Policies related to the Revised Common Rule

• Informed Consent Document for Research Participants Who Do Not Speak English (Short Form)
• Instructions - Short Form Consent Process For Non-English Speakers
• 101.1 Organization Policy on Exempt Research
• Exempt Research Studies Involving Human Subjects
• 102.1 Organization Policy on Determinations of “Human Subject Research”
• 102.2 Organization Policy on the Definition of Research As It Applies to Clinical Practice and Public Health Activities
• 109.6(b) Organization Policy on Continuing Review of Approved Research
• 109.7 Organization Policy on Expiration of JHM IRB Approval for Studies Requiring Continuing Review
• 110.1 Organization Policy on Expedited Review of Proposed Research
• Continuing Review of JHM IRB Approved Studies
• Posting of Consent Forms for Federally-Funded Clinical Trials

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 (March 2023, Version 17) - 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.
• Open Access Data Sharing Consent Form Language
• 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.
• Waiver of Documentation of Consent Script

Request a Consult

If you require a more comprehensive discussion (e.g. you need assistance in protocol planning), please request a consult by clicking on this link. A virtual meeting with an appropriate member of our staff will be will be scheduled using MS Teams.