Submission Templates & Checklists
Informed Consent
See our list of Medical Terms in Lay Language for use in Informed Consent Forms
Forms & Applications
IRB Initial Review Application (IRA) Forms
For all new initial applications submitted to WRG-HS, a supplemental IRB Initial Review Appication (IRA) must be attached. Please select and fill in the applicable IRB Initial Review Application (IRA) linked below. Once complete, please upload it to WRG as part of your new submission.
Biomedical IRA: Use this IRB Initial Review Application if you have completed the Therapeutic Studies JCTO Protocol template and/or have a study which will use a device/drug or implement a clinical trial.- Biorepository IRA: This IRB Initial Review Application template is only to be used for the establishment of a biorepository (storage and maintenance) for potential future use, not testing and research.
- SBER and Records IRA: Use this IRB Initial Review Application if you have completed the Non-Therapeutic Studies or Tissue Use/Chart Review JSTO template, the Education Protocol Template and/or have a study which will use conduct social, behavioral, or educational research.
Supplemental Forms
- Drug Form: Used for any study involving drugs/dietary supplements
- Device Form: Used for any study involving medical devices (as defined by the FDA)
- Specimen Form: Used for any study collecting or using Human biological specimens for research (e.g., organ tissue, plasma, urine, feces, cells). This may include specimens collected as part of routine care for use as part of the research. This includes medical waste.
Guidance Documents
Assessing Capacity to Consent in Adults: Guidance for Researchers- The Cold-Calling Recruitment Method: Guidance for Researchers
Decisions Trees & Flowcharts
DECISION TREE: Do I Need A Key Information Section?
Documents currently under revision
- Standalone HIPAA Authorization template document, for use with the NCI CIRB Boilerplate ICF Template (version: 01/2021).
- CIRB-approved boilerplate language (version: 09/2020), to be inserted into the CIRB-approved consent form(s) by the Investigator.
- Template to report protocol deviations at the time of IRB Continuing Review.
- Form to document study details when using an existing reliance agreement.
- Form for use of the SMART IRB Master Agreement for federally funded cooperative research.
- Local template reliance document for multisite studies not utilizing federal funding or existing agreements.
- For completion when research will use or disclose the PHI of decedents.
- For use in the event of unexpected enrollment of a non-English speaking subject.
- Informed consent and HIPAA Authorization template document.
- Assent template document for enrolling children ages 7-11 or 12-17.
- Informed consent template document for research involving genetic testing.
- A table for reporting adverse events to the IRB at the time of Continuing Review.
