OHR-12B 7/8/2015 TJU Office of Human Research - Adding Study Personnel
Use this form to add study investigators and key personnel to a study.
For adding Affiliated Personnel: For TJU/TJUH, Hand Center, Rothman and Wills Eye personnel, provide signatures for personnel, Department Chair(s), and Administrator(s) on attached signature page, and complete COI section for each added personnel.
For JKCCN: Include signed “Addendum to IRB Authorization Agreement” (IAA). Provide signatures for added personnel only, and complete COI section for each added personnel.
For adding Unaffiliated Personnel: Signatures not required for unaffiliated personnel. Include Unaffiliated Investigator agreement for each added personnel or IRB Authorization Agreement (IAA) if a site is being added. Also, submit COI disclosure Attachment D form for each non-affiliated personnel to Office of University Counsel, Scott Bldg, 6FL. These forms are downloadable on the IRB forms page at http://www.jefferson.edu/human_research/irb/forms/index.cfm
Also, please email or fax a copy of this OHR-12B to [email protected] or 215-923-3613, in Office of University Counsel, for COI review.
Once personnel changes are approved, this form will be signed by an IRB Official and faxed to the contact person identified below. This constitutes your approval letter.
IRB Control #: Department: PI:
Study Title:
Sponsor:
Contact Person: Phone/Fax/Email:
Directions: Please complete table for each study personnel being added. Duplicate table as necessary. To activate drop-down menu, click on “Choose an item.” (If you cannot access drop-down menus, go to Word toolbar, click on File > Convert button>OK in dialogue box. This should enable the drop-down menus. If you still cannot use them, type responses.)
NAME STUDY ROLE AFFILIATION* CAMPUS KEY Choose an item. Choose an item. *If Affiliation is “Other” or “Unaffiliated/Private Practice”, please explain: DEPARTMENT DIVISION ONCOLOGY EMAIL Choose an item. Choose an item. Choose an item.
Signature of Principal Investigator Date Telephone/pager/e-mail
Do not fill out the section below – For IRB Use The signature below indicates that this amendment has been approved by the Thomas Jefferson University IRB.
______IRB Official Date of Approval
Walter Kraft, M.D. Kyle Conner, M.A., CIP Patricia Oden Director, OHR Associate Director, OHR Admin. Coord., OHR OHR-12B 7/8/2015 CERTIFICATION OF CONFLICTS OF INTEREST (See TJU Policy 107.03, Conflicts of Interests for Employees” attachment 2 for more detailed information)
THIS CERTIFICATION MUST BE COMPLETED AND ALL THE REQUIRED SIGNATURES MUST BE OBTAINED BEFORE THIS PROTOCOL/RESEARCH PROJECT MAY BE ADMINISTRATIVELY PROCESSED.
Each Investigator and all Key Personnel must answer the following questions in relation to this proposal. The TJU ID# requested can be found in the box on the left side of your pay stub. For non-Jefferson employees, this section should be left blank.
Copy as necessary for each individual being added. Please print names. Signatures not required here.
This study personnel is (check appropriate box): TJU TJUH JUP student volunteer contract staff other
Name:______
1. Do you have a current Conflicts of Interest Disclosure on file with the University? _____Yes _____No _____Not Sure
2. Do you or an immediate family member have any financial interests as defined in the TJU Conflicts of Interest Policy 107.03? _____Yes _____No
3. Do you or an immediate family member have a significant financial interest that may pose a conflict of interest as defined in the TJU Conflicts of Interest Policy 107.03? _____Yes _____No
If you checked “yes” to question 2 or 3 above, describe the financial interest below and any steps planned to prevent the financial interest from interfering with the design, conduct, or reporting of the research, including interfering with the protection of participants. Attach separate sheet if needed.
Check appropriate boxes in the table below.
Significant financial interest in the sponsor or subcontractor, i.e., paid consultancy, stock, stock options, ownership, etc. Intellectual property rights (patents, pending patents, copyrights, trademarks, licensing agreement, royalties) Honoraria, speaker’s fees, paid authorship Gifts Trips Service on Board Paid expert testimony Compensation for employment (by other than TJU/TJUH) Other None
How do you plan to manage the conflict?
Reduce ______Manage _____ Eliminate _____ OHR-12B 7/8/2015 If you identified a potential conflict of interest on this form that is not known to the TJU COI Committee, contact Janyce Lingo at 215-503-0758 or [email protected].
If you are a TJU employee or faculty member, or a TJUH employee you must have submitted an up-to-date Disclosure of Conflicts of Interest to University Counsel. If you have not, please complete an on-line Disclosure that can be accessed via the Pulse homepage or a hard copy that may be obtained on the Office of University Counsel website. If you are not a TJU employee, TJUH employee, nor a TJU faculty member, you must file a Disclosure Statement for Non TJU/TJUH Employees Conducting Research indicating either the nature of the conflict of interest, if any, or certifying that you do not have a conflict of interest in a financially interested company with regard to this proposal.
Signatures
This form must be signed by the Principal Investigator, and the Chair and Business Administrator of his/her department. All other investigators and research personnel on the study must be listed below. Signatures for these personnel are not required. However, if personnel from a department other than that of the PI are involved in the study, the chair and business administrator of that department also must sign below.
The Principal Investigator agrees to accept responsibility for the conduct of the project according to the tenets of Good Clinical Practice (OHR Policy GA 124, “Good Clinical Practice for Investigators”) and to provide the required progress reports if a grant/contract results from application/proposal. Department Chairs certify that the project meets Departmental standards with respect to scientific validity and that the project is consistent with Departmental goals. Administrators certify that the project meets applicable federal fiduciary requirements.
Principal Investigator Departmental Chair Business Administrator
Sign above and print name here Sign above and print name here Sign above and print name here
Co-Investigators/Key Personnel Departmental Chair Business Administrator (List names below – signatures not (Signature required if department differs (Signature required if department differs req’d) from that of PI) from that of PI)