An investigator requesting review of a new study for a protocol that has never been reviewed by Schulman must submit:
Note: If submitting a Canadian study, please refer to our Research in Canada page.
- Single Site Study Submission Form or Minimal Risk Single Site Submission Form
- Template Informed Consent Document(s) (Microsoft Word format required)
- Curriculum Vitae (CV) of Principal Investigator/Qualified Investigator (PI/QI) and each *Sub-Investigator (Sub-I), if not already on file – CVs must reflect experience, be signed and dated within the past 2 years.
- * Sub-I CVs are not generally required for site submissions on studies that have been qualified by the Board as minimal risk and/or non-interventional.
And, if applicable:
- Copy of the Principal Investigator’s current medical/professional license (Mississippi and Puerto Rico only)
- Drug Information (e.g., Investigator’s Brochure or Package Insert) or Device Information
- Recruitment/Study-Related Materials
- Request for Alteration or Waiver of Informed Consent or Request for Waiver of Documentation of Informed Consent
- Request for Alteration or Waiver of Authorization or Request for Partial Waiver of Authorization for Recruitment Purposes
Schulman IRB has IRB meetings every day of the business week, with special submission deadlines for Phase I and Canadian-based research.
- Please review Phase I Research to learn more about Schulman’s accelerated review timelines.
- Please review Research in Canada to learn more about review timelines.
Full Board Review Submission Deadlines
Submission deadline is one week prior to intended meeting.
Assignment to a Board meeting is dependent upon the complete and accurate submission of all required documents. Refer to Federally Funded/FWA Study, Submitting a Device Study and Transfer of IRB Oversight for Study for additional requirements for these types of study submissions.
Please note: Full Board review of studies with Canadian sites are reviewed only at Friday Board meetings.