APPLICATION FOR PROTOCOL REVIEW BY

WESTERN INSTITUTIONAL REVIEW BOARD (WIRB)

THE OHIO STATE UNIVERSITY

Principal Investigator:
Protocol Title:
Sponsor:

YES

/

NO

  1. Does this research meet the NIH definition of a clinical trial? (“A prospective biomedical or behavioral research study of human subjects that is designed to answer specific questions about biomedical or behavioral interventions (drugs, treatments, devices, or new ways of using known drugs, treatments, or devices.”)

  1. Is the protocol designed and written by the sponsor and without any scientific contribution by Ohio State faculty?

  1. Is the sponsor of the research a for-profit entity/company?

**If the answer to any of the above is “no”, the protocol cannot be reviewed by WIRB.**

Does the proposed research involve:

YES

/

NO

  1. Planned emergency research?

  1. Xenotransplantation?

  1. Gene Transfer?

  1. Embryonic stem cells?

  1. Research funds from a federal or other not-for-profit funding agency?

**If the answer to questions 4 through 8 is “yes”, the protocol cannot be reviewed by WIRB.**

YES

/

NO

  1. Does any Ohio State investigator (including principal or co-investigator), key personnel, or their immediate family members have a financial interest (including salary or other payments for services, equity interests, or intellectual property tights) that would reasonably appear to be affected by the research, or a financial interest in any entity whose financial interest would reasonably appear to be affected by the research?

All Ohio Stateinvestigators and key personnel must have a current COI disclosure form (updated as necessary for the proposed research) filed before IRB review. Examples of financial interested that must be disclosed include (but are not limited to) consulting fees or honoraria; stocks, stock options or other ownership interests; and patents, copyrights and royalties from such rights. For more information, see Office of Research Compliance COI Overview and eCOI.

**If the answer to question 9 is “yes”, the protocol may be reviewed by WIRB following full disclosure of the above information to the University’s Conflict of Interest Officer at the Office of Research Compliance.

THE OHIO STATE UNIVERSITY AUTHORIZATION - WESTERN INSTITUTIONAL REVIEW BOARD

All persons affiliated with the Ohio State University or intending to use its facilities or personnel who desire to initiate programs involving human research subjects are responsible for ensuring appropriate committee review and for knowing and complying with requirements set forth in applicable university policies and guidelines. Research may not begin until written IRB approval has been received.

Electronic signatures of the principal investigator, co-investigator(s) and department chair will be obtained electronically through IRB Submit.

Principal Investigator:
Name
Co-Investigators:
Name / Name
Name / Name
Name / Name

Name

/

Name

Name

/

Name

PROTOCOL TITLE:
SPONSOR:

Proposed Research Involves:

YES / NO
Investigational Drug(s) or investigational use of marketed drugs(s). If yes, provide:
IND Number / Issued to / Generic Name:
Investigational Devices(s). If yes, indicate NSR ______; or SR ______;
If SR, provide: IDE Number ______; Issued to: ______.
Radiologic Procedures for research purposes (e.g., non-clinical care X-rays, DEXA or CT scans, nuclear medicine procedures). Approval by the Human Subject Radiation Committee (HSRC)is required prior to authorization for submission to WIRB.
Cancer-related Activities. Approval by the Comprehensive Cancer Center (CCC) Clinical Scientific Review Committee (CSRC)is required prior to submission.
Pregnant Women. Approval by Maternal-Fetal Welfare Committee is required prior to activation.
Office of Responsible Research Practices:
Approved for submission to WIRB / Not approved for submission to WIRB
Reason:
ORRP WIRB Contact / Date

Revised 3/20/2014