Department:

UAMS Human Research Advisory Committee

Policy Number:

4.6

Section:

Committee Operations

Effective Date:

July 31, 2002

Revision Date:

November 18, 2002

SUBJECT:  Duties of HRAC Manager or His/Her Designee

1.   Review materials for completeness before review by the HRAC

a.       Full protocol

b.       Informed consent form

c.       Any relevant merit reviews or grant applications 

d.       Investigator’s brochure

e.       Advertisements or subject information

f.        Subject surveys or questionnaires

2.   Verify receipt of current consent form and/or protocols for study revisions and  adverse event reports

3.   Contact researcher for additional materials when appropriate

4.   Coordinate the location and attendance at meetings to assure   quorum

5.   Assist the Chair in assigning reviewers to protocols

6.   Prepare and distribute member packets prior to the meetings

7.   Provide background and summary information on policies, rules, and regulations pertaining to issues relevant to protocol review  

8.   Assist the Chair in taking notes at the HRAC meeting  

9.   Prepare correspondence for signature by the Chair