Human Subjects Review Process

Introduction

The purpose of this document is to assist researchers planning to conduct projects involving human subjects.  Please read all of the information carefully.

 Policy Statement

The United States Department of Health and Human Services (DHHS) and Ouachita Baptist University have established standards and guidelines to protect individuals who may be at risk as a consequence of participation in a research activity.  Standards for the committee’s reviews are based on the Code of Federal Regulations, 45 CFR 46, and researchers will want to refer to this code in planning their research.  All applications must reference specific sections of the Code that apply to the project.

To What Does This Policy Apply?

All projects undertaken by faculty, staff, or students in the School of Natural Sciences at Ouachita Baptist University involving human participants in any way, regardless of the source of funds, must be reviewed and approved by the School of Natural Sciences Research Committee.  This includes activities in which a faculty member is supervising student research activities. All ongoing research projects must be reviewed annually.

 How Is A Project Submitted For Review?

Projects are submitted by completing the form “Application for Approval of Investigations Involving the Use of Human Subjects.”  Other information is requested on the application, including the survey or questionnaire (if appropriate), and the consent form.  Applications are available in the School of Natural Sciences Office.

The Research Committee meets at least once each month during the academic year, if there are projects in progress.  Applications must be received in the School of Natural Sciences Office at least one week prior to an upcoming Research Committee meeting in order to be presented at the next meeting.

 

What Kinds Of Projects Must Be Reviewed By The Research Committee?

A project meeting any of the specific guidelines spelled out in the Code of Federal Regulations, 45 CFR 46.  Some examples are that the research

  1. Places subjects at more than minimal risk (physical, emotional, psychological, or social risk).  Minimal risk is defined as those risks experienced in everyday life.
  1. Involves minors or other vulnerable populations (pregnant women and fetuses, mentally disabled individuals and other special populations).
  1. Investigates behaviors and/or experiences related to sensitive topics.
  1. Involves the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior that identifies human subjects’ and/or their responses.

 What Action Does The Research Committee Take?

The Research Committee will take one of the following actions in regard to applications reviewed:

 1.      Approve:  The Research Committee will approve the project as submitted.

 2.      Approve with minor revision:  If only minor modification is needed the Research Committee will approve the application with the stipulation that described changes are made before the project begins.  Additional review is not required.

 3.      Defer for revisions:  The Research Committee will defer a project contingent upon modification.  The project may not proceed until final approval from the Research Committee is received.

 4.      Disapprove:  When the Research Committee disapproves a project, considerable revision is needed.  The investigator may revise and resubmit the proposal.  The project may not proceed until final approval from the Research Committee is received.

 

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