Department:

UAMS Human Research Advisory Committee

Policy Number:

10.1

Section:

Principal Investigator Responsibilities

Effective Date:

July 31, 2002

Revision Date:

October 10,  2002

 SUBJECT:  Principal Investigator Training

Investigator Training.  Recognizing the complexity of the federal, state, and campus policies and regulations created to adequately protect the rights of human subjects in research, UAMS has adopted the mandatory education program outlined below for all HRAC members, Principal Investigators, and all key project staff (e.g. sub-investigators, study coordinators, study nurses) having contact with human subjects, human subject data, or biological specimens. 

Effective January 1, 2003, the UAMS HRAC office will not process any new research protocol application unless the Principal Investigator and all appropriate key project staff listed on the HRAC application for submission of new research studies have completed educational requirements.  These requirements can be fulfilled in two ways:

  1. Successful completion of a pre-approved web-based tutorial program (see HRAC Web Page) OR
  2. Attendance and successful completion of the seminar:  “Conduct of Human Subjects Studies” sponsored by UAMS, CAVHS, ACH, and affiliates. 

Re-certification every two years in human subject protections will be required for all research faculty, staff, and students directly involved in research with human subjects.  Institutional educational programs will be offered that will be customized and up-dated to ensure relevance to current needs (ex. HIPAA).  The Principal Investigator must keep  certificates of completion on file. 

Reminders of re-certification requirements will be sent to Principal Investigators approximately two (2) months prior to the re-certification date.

Deadlines: 

1.         All Principal Investigators and key project staff participating in a currently active, previously approved HRAC study must complete one of the accepted educational programs by January 1, 2003.  Successful completion of the CITI program is automatically registered with the Research Compliance Offices at UAMS and ACHRI.

2.          Beginning on January 1, 2003, new HRAC Protocol Applications will not be placed on the HRAC agenda if study personnel identified on the Application Form have not previously completed one of the human subjects training educational programs.

3.         Beginning on January 1, 2003, all Change in Principal Investigator Applications or Change in Procedure Applications that add research faculty who have not yet completed one of the accepted educational programs will not be processed by the HRAC Office until the research faculty have completed one of the human subjects training educational programs.

4.         Principal Investigators who do not meet re-certification requirements will not be able to submit new protocols to the HRAC.   

For More Information.  Questions concerning this policy should be directed to the UAMS Office of Research Compliance at (501) 526-6876.