Fillable Adverse Reaction (AR) And Unexpected Event (UE) Form (Wayne State University)

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Adverse Reaction (AR) And Unexpected Event (UE) Form (Wayne State University)

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The Adverse Reaction (AR) And Unexpected Event (UE) Form (Wayne State University) form is 3 pages long and contains:

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  • 23 check-boxes
  • 17 other fields

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PI Electronic Signature & Attestation 3/16/2020
WSU IRB Submission Principal Investigator Attestation and Signature
This completed attestation must be included with applications that are submitted electronically.
One Attestation & Signature per submission (Non eProtocol submissions)
Principal Investigator’s Submission Attestation IRB#
As the principal investigator for this study, my signature below indicates that I have carefully reviewed the
information for the noted submission type and agree that the information provided is complete and accurate.
Submission Type (Select ONLY One):
Expedited Amendment (stop see updated 3/2020 form)
Key Personnel (stop see updated 3/2020 form)
Change in PI (new PI must complete the conflict of interest question & signature on next page)
Full Board Amendment (stop see updated 3/2020 form)
Continuation Submission (the conflict of interest question & signature on next page)
HIPAA Summary Form
Coordinating Center Form
Administrative Application
Unanticipated Problem Report: Date of Occurrence indicated for question#11 of UP form:
Administrative Application
Other:
External IRB Requests Initial Submission WIRB CIRB Other
(the conflict of interest question must be completed below for new submissions & PI Change)
External IRB Requests Modification WIRB CIRB Other
Above Form’s completed date of submission: (this date should match what is indicated on the above selected form)
Only one Attestation and Signature can be provided per submission. This form cannot be applied to multiple submissions
__________________________________________________ ____________________
Signature of Principal Investigator ONLY Date
__________________________________________________
Name of Faculty Supervisor/Mentor (if applicable)
__________________________________________________ ____________________
Signature of Faculty Supervisor/Mentor (if applicable) Date
For Change in PI Amendments, Initial External IRB Requests, Continuations, New VA submissions
continue to next page for conflict of interest statement (if not applicable this form is complete)
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PI Electronic Signature & Attestation 3/16/2020
Conflict of Interest (For Continuation & New VA Submissions) IRB#
This question applies to the Principal Investigator only: Do you, your spouse or domestic partner, or any of your dependent children have a
potential and/or real financial conflict of interest with the sponsor of this project, including all secondary sources? Yes No
Signature
If yes, a “Financial Conflict of Interest Detailed Disclosure Form” must be submitted to the FCOIC annually or when a change occurs.
The form and more information are available at: www.research.wayne.edu/coi. For additional information, contact the Conflict of Interest
Coordinator at 313-577-9064.
If “yes,” the FCOI committee communication must be included with the submission.
Endorsements and Financial Conflict of Interest Disclosure:
Objectivity in research is a key component of any research project. One method for maintaining objectivity is to have all individuals involved in
research design, development, or data evaluation/analysis disclose any potential and/or real financial conflict of interest.
Examples of relevant relationships for potential conflict of interest include but are not limited to:
(1) receiving past, current, or expecting future income in the form of salary, stock or stock options/warranties, equity, dividends, royalties, profit
sharing, capital gain, forbearance or forgiveness of a loan, interest in real or personal property, or involvement in a legal partnership with
the sponsor
(2) receiving past, current, or expecting future income in the form of consulting fees, honoraria, gifts, gifts to the University, or payments
resulting from seminars, lectures, or teaching engagements, or service on a non-federal advisory committee or review panel
(3) serving in a corporate or for-profit leadership position, such as executive officer, board member, fundraising officer, agent, member of a
scientific advisory board, member of a scientific review committee, or member of a data safety monitoring committee, regardless of
compensation
(4) inventor on a patent or copyright involving technology/processes/products licensed or expected to be licensed to the sponsor.
Change in PI for IRB#
New Principal Investigator FCOI & Signature:
For students or individuals without a WSU faculty appointment, a WSU faculty supervisor/sponsor or authorized signatory (official from DMC, KCI, etc.) is required. The full
change in PI form must be completed. This document is only for signature documention.
1) Do you, your spouse or domestic partner, or any of your dependent children have a potential and/or real financial conflict of interest
NO
YES - see instructions above and attach correspondence
with the sponsor of this project, including all secondary sources?
2) In signing the description of this research project, the PI agrees to accept primary responsibility for the scientific and ethical conduct of
the research, as approved by the IRB, and abide by the IRB’s policies and procedures. The PI change does not take effect until the
investigator has received documentation of IRB review and final approval.
PI Signature:
Title: Date:
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PI Electronic Signature & Attestation 3/16/2020
Dean/Department Chair/Authorized Signatory IRB#
(the following should be completed for Change in PI Amendments, Initial External IRB Requests, & new VA
Submissions)
Department Chair, Dean or Authorized Signatory Official FCOI and Certification:
1) Do you, your spouse or domestic partner, or any of your dependent children have a potential and/or real financial conflict of interest with the
sponsor of this project, including all secondary sources? NO YES - see instructions above and attach correspondence
2) In signing the submission of this research project, the Department Chairperson, Dean, Institute/Center Director, or other authorized signatory
certifies that (1) appropriate support will be provided for the research project including adequate facilities and staff;(2) appropriate scientific and
ethical oversight has been and will be provided; and (3) the research uses procedures consistent with sound research design; (4) the research
design is sound enough to yield the expected knowledge. Any comments or feedback related to this certification should be in writing and accompany
this research proposal submission.
Signature of Chair/Dean of the WSU Faculty or authorized signatory Title Date
____________________________
Print name of the person signing above
If PI is a student or an individual without a WSU faculty appointment, the above signature must be that of a Chair or Dean of the WSU Faculty or
authorized signatory (official from DMC, KCI, etc.). If Change in PI submission, this is also authorization of the PI Change.
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Adverse Reaction (AR) And Unexpected Event (UE) Form (Wayne State University)

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Completed 21 July 2020

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