OHR-12B

5/2013

TJU Office of Human Research - Adding Study Personnel

Directions: Use this form only to add study investigators and key personnel. Attach revised consent form as necessary for stamping.

For adding Affiliated Personnel: For TJU/TJUH, Rothman or Hand Center personnel, provide signatures for personnel, Department Chair(s), and Administrator(s) on attached signature page, and complete COI section for each personnel.

For adding Unaffiliated Personnel: Signatures not required for unaffiliated personnel. Include Unaffiliated Investigator agreement for each added personnel or IRB Authorization Agreement (IAA). 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 or 215-923-3613, in Office of University Counsel, for COI review.

Once personnel changes are approved, the first page 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:

Name of Added Personnel / Adding As:
(Check appropriate box) / Affiliated with TJU/ TJUH/Rothman/
Hand Center? / *If no, name of external affiliate (if applicable):
PI / Co-I / KP / Yes / No

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

J. Bruce Smith, M.D, CIP Kyle Conner, M.A., CIP Mary Rose Taft Patricia Oden

Director, OHR Associate Director, DHSP Executive Secretary, IRBs Admin. Sec’y, IRB

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:______TJU ID # ______
1.Do you or an immediate family member have any financial interests as defined in the TJU Conflicts of Interest Policy 107.03? / Yes___ / No___
2.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 either question 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.

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 ALL INDIVIDUALS being added to the project and their DEPARTMENT CHAIRPERSON and ADMINISTRATOR. The Principal Investigator agrees to accept responsibility for the conduct of the project according to the tenets of Good Clinical Practice (DHSP 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. All Key Personnel certify that, to the best of their knowledge, all information provided for Committee reviews is correct and in compliance with University policies

Please type all names below signature lines.

______

Principal Investigator Chairman Administrator

______

Co-Investigator Chairman Administrator

______

Co-Investigator Chairman Administrator

______

Key Personnel Chairman Administrator

______

Key Personnel Chairman Administrator

______

Dean, Jefferson School of Health Professions (for JSHP applications only)