6.1 Research Involving Investigational and Marketed Drugs

1.0 Purpose

The purpose of this policy and procedure is to describe the Organization’s requirements for research involving investigational and marketed drugs.


2.0 Policy


3.0 Definitions


4.0 Procedures


5.0 Studies Requiring an IND


6.0 Exemptions from IND Requirements


7.0 Expanded Access to Investigational Drugs


8.0 Emergency Waiver of IND


9.0 Emergency Use of Investigational Drugs

Emergency use of an investigational drug will be administered to subjects in accordance with HRPP policy 6.4 (Emergency Use of a Test Article).


10.0 Waiver of Informed Consent for Planned Emergency Research

Waiver of informed consent for planned emergency research will be reviewed and approved by the full IRB in accordance with HRPP policy 5.6 (Exception from Informed Consent Requirements for Emergency Research).


DOCUMENT HISTORY:

 Written: 1/25/2016 (Approved: 1/25/2016) - original author not recorded

 Revised: 3/2/2018 - revision not documented

 Revised 1/24/2024 - add reference to FDA 30-day rule (section 5.1.1); added IND exemption 4 (section 6.4). {Approved Rusty McCulloh (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}


Revision #7
Created 24 October 2019 21:40:52 by Autumn M Eberly
Updated 24 March 2025 15:02:11 by Robert A Lewis