| Department: |
UAMS Human Research
Advisory Committee |
|
Policy Number: |
8.2 |
|
Section: |
Change in Protocol |
|
Effective Date: |
July 31, 2002 |
|
Revision Date: |
|
SUBJECT: Change in Principle Investigator
The HRAC must be notified
within 30 days of a change in the principal investigator or the closure of the
study. When changing investigators,
please submit the following:
1. Protocol
Amendment/Modification Form (found on the UAMS HRAC website)
2. A
letter from the principal investigator indicating the change in responsibility
3. A
letter from the new investigator accepting the responsibility for the research.
Any
HRAC project associated with a Principal Investigator (PI) who has left the
University of Arkansas for Medical Sciences cannot continue without
modification. These projects must be closed or a new PI must be signed to take
full responsibility for the project and the subjects enrolled in the project. If
the study cannot be closed because of safety issues related to participant
involvement, it is mandatory that a local, affiliated investigator be named as
PI.
The
HRAC considers a change in PI to be a major revision, usually requiring a full
Board review before the change can be officially implemented. A change in
sub-investigators must also be reported to the HRAC. It is the responsibility of
the PI to notify the HRAC when a sub-investigator is dropped from a study and
when a new sub-investigator joins an HRAC-approved project. Sub-investigator
changes are considered minor revisions, but must also be approved before the
change can be implemented.