1.8 Investigational Activities Requiring IRB Review and Approval

1.0 Purpose

The purpose of this policy is to describe the investigational activities that require IRB approval.


2.0 Policy

It is the policy of the Organization that:


3.0 Definitions


4.0 HRPP Classifications of Human Subject Research


5.0 Activities Which Are Not Human Subject Research

Note: Publishing or presenting the results of a quality improvement project does not necessarily mean the activity is research. Descriptions of non-research activities (e.g., an account of the quality improvement project) are often an expected outcome of the project. On the other hand, re-analysis of the data derived from the quality improvement project in order to prove or disprove a hypothesis is research. Depending on whether or not subject identifiers are maintained, it may qualify as exempt research.


6.0. Other Activities Deemed Not Research

Other activities specifically defined in 45 CFR 46.102(l) are deemed “not research.” These activities include:


7.0 Determination of When an Activity Constitutes Human Subject Research


8.0 Type of Review


DOCUMENT HISTORY:

 Written: 5/6/2016 (Approved: 5/6/2016) - original author not recorded

 Revised: 9/27/2017 - revision not documented

 Revised: 3/3/2018 - revision not documented

 Revised: 2/18/2019 - revision not documented

 Revised: 10/4/2022 - Removed references to “after effective date of revised regulations”; deleted redundant descriptions of activities deemed not research per 46.102(l); simplified section 7.0 to remove specific IRB and ORA procedures {Approved Chris Kratochvil (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}

 Board Notified: 11/16/2022

 Revised: 2/8/2023 – revised section 7.0 to describe use of website NHSR Decision Tool. {Approved Rusty McCulloh (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}

 Board Notified: 2/15/2023

 Revised: 5/9/2023 – clarified characteristics of Student Projects (section 5.6); added description and defined parameters of Pilot Testing (section 5.7).{Approved Rusty McCulloh (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}


Revision #17
Created 21 October 2019 21:44:59 by Autumn M Eberly
Updated 24 October 2024 12:53:18 by Robert A Lewis