Department:

UAMS Human Research Advisory Committee

Policy Number:

7.2

Section:

Procedures for Study Review

Effective Date:

July 31, 2002

Revision Date:

 

SUBJECT:  Investigator and Sub-Investigator Qualifications

1.         All human subjects research that is conducted by or under the direction of any employee, faculty, staff, student or agent of University of Arkansas for Medical Sciences in connection with his or her institutional responsibilities must be reviewed by the HRAC.

2.         Student Conducted Research.  All activities that meet the definition of research with human subjects and that are conducted by students for a class project or for work toward a degree must be reviewed by the HRAC.  For example, activities that must be reviewed and approved by the HRAC include:

a.   All masterís theses and doctoral dissertations that involve human subjects; and

b.   All projects that involve human subjects and for which findings may be published or otherwise disseminated.

                                     i.  Oversight by Faculty/Advisor.  All students/fellows applying for HRAC review must obtain the signature of their faculty advisor on the Signature Page of their application.

3.         Conflict of Interest.  The protection of human subjects requires objectivity in communicating risks, selecting subjects, promoting informed consent, and gathering, analyzing and reporting data.  Therefore, the HRAC Committees should consider conflict of interest issues in their deliberations of applications.

a.   All investigators must reveal on their application to the HRAC whether they or any other person responsible for the design, conduct, or reporting of the research has an economic interest in, or acts as an officer or a director of any outside entity whose financial interests would reasonably appear to be affected by, the research.

b.   When appropriate, the informed consent document should state that all clinical investigators are required to comply with University of Arkansas for Medical Sciencesí Conflict of Interest Guidelines or an affiliate institutional policy  (see HRAC policy 3.3).