INSTRUCTIONS FOR SUBMITTING PROTOCOLS FOR REVIEW BY WESTERN by mikelbyington

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									                          INSTRUCTIONS FOR SUBMITTING PROTOCOLS FOR REVIEW BY
                                WESTERN INSTITUTIONAL REVIEW BOARD (WIRB)

                                             THE OHIO STATE UNIVERSITY


The Principal Investigator (PI) should work with the Office for Business and Industry Contracts (OBIC) and the
Office of Responsible Research Practices (ORRP) to be certain that the protocol qualifies for review by the
Western Institutional Review Board (WIRB).

The proposed research protocol must be industry-sponsored, industry-written and meet the National
Institutes of Health 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).”

The proposed research cannot involve planned emergency research, xenotransplantation, gene transfer, or
embryonic stem cell research.

Submit the following materials:

                         By e-mail to:                                            By mail or courier to:
WIRB Administrator:                                             WIRB Administrator
ebert.55@osu.edu                                                Office of Responsible Research Practices
                                                                Room 300, Research Foundation Building
                                                                1960 Kenny Road
                                                                Columbus, OH 43210-1063
     •    Application for Protocol Review by WIRB
     •    The Ohio State University Authorization – WIRB form (with signatures)
     •    One copy of the research protocol, including advertisements and solicitation scripts, if applicable
     •    One copy of the proposed consent form using the OSU/WIRB template
     •    One copy of the WIRB Initial Review Submission Form (including FDA 1572 if applicable)

NOTE: The Principal Investigator and all co-investigators will need to have a current Financial Disclosure
Screening Form on file with ORRP before authorization will be given to submit materials to WIRB.

•    ORRP will send to the PI (via fax or e-mail) the signed Authorization Form, after review and approval of the
     completed submission materials.

•    After ORRP authorization is given, the PI can submit the materials to WIRB, along with the signed OSU
     Authorization Form by mail to: WIRB, P.O. Box 12029, Olympia, Washington 98502. Alternatively, submission
     materials can be e-mailed to clientservices@wirb.com.

•    All materials submitted to ORRP will be retained in ORRP.

•    WIRB will notify PI of its decision and will provide copies of all regulatory documents to the PI, the sponsor, and
     ORRP.

If you have questions regarding OSU policies and procedures, please contact ORRP - 614-688-8457, e-mail –
wirbinfo@osu.edu or visit http://www.orrp.ohio-state.edu.

If you have questions regarding WIRB policies and procedures, please contact WIRB at 1-800-562-4789 or visit
http://www.wirb.com.


Rev. 12/20/2007
                                      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.”)

                  2. Is the protocol designed and written by the sponsor and without any scientific contribution by
                     OSU faculty?

                  3. 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

                  4. Planned emergency research?

                  5. Xenotransplantation?

                  6. Gene Transfer?

                  7. Embryonic stem cells?

                  8. 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

                  9. Do the Principal Investigator and/or any listed co-investigator have an ownership interest,
                     including stock and stock options, in the sponsoring entity/company? If so, please explain:



                  10. Do the Principal Investigator and/or co-investigators receive any gifts or donations from the
                      sponsoring entity/company? If so, please explain:



                  11. Do the Principal Investigator and/or co-investigators have a consulting agreement to perform
                      service for the sponsoring entity/company? If so, please explain:



**If the answer to any of the above questions 9 through 11 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.

Rev. 12/20/2007
THE OHIO STATE UNIVERSITY AUTHORIZATION -                                     ORRP Use Only:
WESTERN INSTITUTIONAL REVIEW BOARD
                                                                              Date Received:                          Time:


    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.

Signature of the Principal Investigator affirms that all co-investigators have reviewed the proposal and that
research will be conducted in compliance with applicable Ohio State University policies and federal regulations
governing the protection of human research subjects.
Principal Investigator:
OSU Faculty or approved PI status                        Typed Name                                       Signature

Academic Title:                                                   Phone No.:                              Fax No.:

College:                                                                            Department/No.:

Campus Address:                                                                          E-mail:

Co-Investigators:
                                             Typed Name                                                  Signature

                                 Typed Name                                      Signature
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: ______________________.
                  Radioactive Drugs or Unusual Exposure to External Radiation. Approval by the Medical Radionuclide
                  Committee (Phone: 292-0122) is required prior to activation.
                  Cancer-related Activities. Approval by the James Cancer Center Clinical Scientific Review Committee
                  (Phone: 293-4976) is required prior to submission.
                  Pregnant Women. Approval by Maternal-Fetal committee (Phone: 293-8736) is required prior to
                  activation.
Signature of the Department Chair(s) affirms that the research has been reviewed by the department(s) and found to be consistent with
University unit(s) objectives and standards, that suitable facilities are available, that the investigators are qualified to perform the
research and that the unit(s) will be solely responsible for all costs associated with review by WIRB that are not paid by the study
sponsor.
Department Chair(s) Endorsement:
                                                               Typed Name                                       Signature

                                                               Typed Name                                       Signature

Office of Responsible Research Practices:

    Approved for submission to WIRB                     Not approved for submission to WIRB
                                                      Reason:_______________________________________________


ORRP WIRB Contact                                         Date
Rev. 12/20/2007

								
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