Add/Remove/Change Study Personnel

ADD/REMOVE/CHANGE STUDY PERSONNEL

Version October 11, 2016

Use this form to request addition, removal or change in the role of personnel on an IRB approved study.
Study Information
Current Principal Investigator: / Click here to enter text. /
IRB Study #: / Click here to enter text. /
Protocol Title: / Click here to enter text. /
Primary Contact/Person Completing Form: / Click here to enter text. /
Add Personnel
Name and Degree: / Click here to enter text. /
Role on Project: / ☐Primary Investigator ☐Sub-Investigator ☐Research Staff
☐Regulatory Coordinator ☐Research Coordinator ☐Authorized Personnel (HUD)
Employer: / Click here to enter text. /
Department: / Click here to enter text. /
Email: / Click here to enter text. /
Phone: / Click here to enter text. /
Responsibilities on Project: / ☐Obtain consent from participants ☐Provide access to patient population
☐Other (describe):Click here to enter text.
Supporting Documentation: / Human Subjects Protections Training: / ☐Attached
☐Already on file with IRB
CV:
Investigators only / ☐Attached
☐Already on file with IRB
Medical License:
Investigators only / ☐Attached
☐Already on file with IRB
Humanitarian Use Device:
(if applicable) / Is the HDE holder (sponsor/manufacturer) required to provide training on the use of the device prior to use? / ☐Yes, Date of Completion ______or provide certificate of training.
☐No, Physician’s is qualified to use the device based on clinical experience.
☐N/A, Please explain ______.
Remove Personnel
Name and Degree: / Click here to enter text. /
Change Personnel Role
Name and Degree: / Click here to enter text. /
Previous Role: / ☐Primary Investigator ☐Sub-Investigator ☐Research Staff
☐Regulatory Coordinator ☐Research Coordinator ☐Authorized Personnel (HUD)
New Role: / ☐Primary Investigator ☐Sub-Investigator ☐Research Staff
☐Regulatory Coordinator ☐Research Coordinator ☐Authorized Personnel (HUD)
Documents
Indicate the documents requiring revision due to the change in personnel. Attach a version with tracked changes and a clean version of each document.
☐ / Consent Form
☐ / Recruitment materials
☐ / Other (describe): Click here to enter text.
Conflicts of Interest
Federal Guidelines emphasize the importance of assuring there are no conflicts of interest in research projects that could affect the welfare of human subjects. Reporting of financial interests is required from all individuals responsible for the design, conduct or reporting of the research. If this study involved or presents a potential conflict of interest, additional information will need to be provided to the IRB.
Examples of conflicts of interests may include, but are not limited to:

• Researcher participating in research in technology, process or product owned by a business in which the researcher or family member holds a significant interest or a business interest.
• Researcher participating in research on a technology, process, or product developed by that researcher or family member.
• Researcher or family member assuming an executive position in a business engaged in commercial or research activities related to the researcher’s institutional responsibilities.
• Researcher receiving consulting income from a business that funds his or her research
• Researcher receiving consulting income from a business that could benefit from the results of research sponsored by a federal agency.

Do the personnel change on this study change the status of conflict(s) of interest previously reported to the IRB or created a new conflict of interest? ☐Yes ☐No
If Yes, describe: / Click here to enter text. /
Signature of Current Principal Investigator
Name / Date