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Forms & Applications
IRB Review Application (IRA) Forms
For all new initial applications submitted to WRG-HS, a supplemental IRB Review Application (IRA) must be attached. Please select and fill in the applicable IRB Review Application (IRA) linked below. Once complete, please upload it to WRG as part of your new submission.
- Biomedical IRA: Use this IRB 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 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.
- Medical Education IRA: Use this IRB Review Application if your study is minimal risk and qualifies under exempt category 1 only: Research, conducted in established or commonly accepted educational settings, that specifically involves normal educational practices that are not likely to adversely impact students’ opportunities to learn required educational content or the assessment of educators who provide instruction.
- Social-Behavioral and Educational Research (SBER) and Records IRA: Use this IRB Review Application if you have completed the Non-Therapeutic Studies or Tissue Use/Chart Review JCTO template, the Education Protocol Template and/or have a study which will use conduct social, behavioral, or educational research.
- 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.
Submission Templates & Checklists
- As of May 17th, 2023, the ICF Templates available on our Informed Consent Templates page replaces all previously released templates.
- Deviation Log Template
- Adverse Event & IND Safety Reporting Cumulative Table
- Amending an Existing Protocol vs. Submitting a New One
- Assessing Capacity to Consent
- Assessing Capacity to Consent in Adults (Flowchart)
- The Cold-Calling Recruitment Method
- CT.gov Informed Consent Form Posting Guidance
- Determining Engagement
- Do I Need a Key Information Section? (Decision Tree)
- Informed Consent Writing Guidance: How to Prepare a Readable Consent Form
- Lapses in IRB Approval: Continuing Reviews and PAM-AR
- NewYork-Presbyterian Personnel and WRG Access
- Not Human Subjects Research (NHSR) Guidance
- Protocol Deviations Guidance