A S S O C I A T E S I R B
Research Oversight Jurisdiction
This form is requiredwhen conducting human subject research at selected primary and/or additional siteswhere oversight jurisdiction (external IRB reliance)must first be authorized or waived to Schulman IRB.Note: If oversight is authorized or waived by an existing contractor agreement with Schulman, this form may not be required. Contact the facility or Schulman if unsure.
Note:Include an IRB Authorization Agreement for research conducted under a Federal Wide Assurance (FWA).
- Facilitiesincludeinstitutions under the jurisdiction of an IRB/REB (Research Ethics Board)or human research protection program (HRPP), as well as other facilities that must authorize the conduct of research at the location.
- Research conduct mayincludeconsenting human subjects, housing or administering investigational products or devices, performing investigational procedures, and receiving an award through a grant (i.e. awardee institutions).
SECTION 1.0: Study Information
1. PI/QI Name: / 2. Sponsor: / 3. Protocol No.:
SECTION 2.0: Research Oversight Jurisdiction
This section must be signedby an authorized official responsible for human subject research oversight (e.g. IRB/REB Chairperson, Institutional Official, IRB Director, Compliance Officer, Sr. Research Administrator, or CEO).
1. Facility Name:
2.Select the appropriate IRB/REB or HRPP jurisdiction option that applies to your facility:
Option 1:Deferral of Oversight to Schulman
The facility is affiliated with an IRB/REB or HRPP that has jurisdiction over human subject research conducted at this location.
By checking here, I confirm that the facility’sIRB/REBor HRPP waives oversight jurisdiction and authorizes Schulman Associates Institutional Review Board, Inc. to be the reviewing IRB on the above referenced research study.
- OR-
Option 2:Not Affiliated
The facility is not affiliated with an IRB/REB or HRPP that has jurisdiction over human subject research conducted at this location.
By checking here, I confirm thatthefacility is aware that this research study may involve the use of an investigational drug, device or procedure.
- OR-
Option 3:Not Engaged In Research
The facility is affiliated with an IRB/REB or HRPP that has jurisdiction over human subject research conducted at this location. Part of the research will be conducted at this facility. Upon review of the proposed research, it was determined that the facility is not engaged in the research activities.
By checking here, I confirm that thefacility is aware that this research study may involve the use of an investigational drug, device or procedure.
3. Does your facility want to be notified when IRB documents are available via Schulman SiteAccess?
No / Yes Provide the contact information of the individual that should be notified:
Name: / Title:
Company: / Address:
City: / State/Province: / Phone:
Postal Code: / Country: / Email:
Authorized Facility Official– Signature / Signature Date (mm/dd/yyyy)
Authorized Facility Official– Print Name & Title
Version:March 6, 2015 / © 2015 Copyright SCHULMAN / Page 1 of 1