UAB Policy on Scientific/Scholarly Review of Protocols - IRB POL003

Abstract:
This policy details the requirements for reviews of UAB research involving humans.
Effective Date:
2/16/2010
Responsible Party:
Contacts:
None Assigned
Administrative Category:
Applies To:
Faculty, Staff, Students
Material Original Source:

HRPP Document:     POL003
Effective Date:   3/30/07
Revision Date:  2/6/10
Subject:  UAB Policy on Scientific/Scholarly Review of Protocols

POLICY STATEMENT

UAB policy requires that research involving humans undergo review to ensure scientific or scholarly validity by the principal investigator’s department and the IRB. Departmental chairs are responsible for determining that proper scientific and department approvals have been obtained and that the hypothesis and procedures are consistent with generally accepted scientific principles in the discipline. The IRB is responsible for determining that the following requirements are satisfied for each research protocol reviewed. (See PRO138 Procedure for Scientific/Scholarly Review of Protocols.)

Risks to subjects are minimized by using procedures:

  • Which are consistent with sound research design and which do not unnecessarily expose subjects to risks and,
  • Which, whenever appropriate, are already being performed on subjects for diagnostic or treatment purposes.

In addition, the IRB has the discretion to utilize an expert consultant, when needed, to assist in evaluation of the scientific design, proposed anticipated benefits and risks, or the importance of the knowledge to be gained from a study.

Approved on March 10, 2010, by:

Richard B. Marchase, PhD
Vice President for Research and Economic Development

Ferdinand Urthaler, MD
IRB Chair

Sheila Deters Moore, CIP
OIRB Director