New applications submitted on or after June 5, 2023 must ensure all written consent forms use the Version 17 template.
The major changes to the new template language include:
- The addition of a required paragraph explaining that research-related information may be included in the Electronic Medical Record (EMR). This language is required for ALL studies with a PRA and/or when inclusion of information in EMR is planned.
- Links have been incorporated to new template language available for studies that involve the following:
- Use of Biospecimens: For studies that involve genomic sequencing, creation of cell lines or creation of pluripotent stem cells, new template language is available.
- Data Sharing: New template language is available to describe special sharing plans including sharing for future general research use and sharing via open access.
- A new signature page is available for adults unable to sign the consent. Please see the link for instructions.
In addition, the following minor changes have been incorporated into the JHM IRB Version 17 template:
- Section 3: Removed “Maryland” under “communicable diseases” to account for reporting in other states
- Section 3: Added HIV reporting language
- Section 4: Added definition of xenotransplantation
- Documentation of Physician Consent Process signature page: Revised “Mid-level Provider” with “Advanced-Practice Provider”
Please contact Senior Consent Form Specialist Lucas Szylow at email@example.com.