Section 6: FDA Regulated Research/Drugs & Devices

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)}

6.2 Research Involving Investigational and Marketed Devices

1.0 Purpose

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


2.0 Policy


3.0 Definitions


4.0 Requirements


5.0 IRB Procedures


6.0 Exemptions from IDE Requirements


DOCUMENT HISTORY:

 Written: 1/12/2016 - original author not recorded

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

 Revised: 5/6/2022 (Approved: 5/6/2022) - revision not documented

 Revised: 9/29/2022 - corrected typographic errors in section 4.2  {Approved: Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}

 Revised 1/23/2024 – clarified IRB procedures (section 5.1); added definition of custome device, and included such devices as exempt from IDE requirements (sections 3.1.4 and 6.1.4). {Approved Rusty McCulloh (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}

6.3 Humanitarian Use Device (HUD)

1.0 Purpose

The purpose of this policy and procedure is to describe the Organization’s requirements for the use of a medical device that has a Humanitarian Use Device (HUD) designation.


2.0 Policy

It is the policy of the Organization that all uses of an HUD will be reviewed and approved in accordance with FDA regulations at 21 CFR 50, 56 and 814 Subpart H, as well as HHS regulations at 45 CFR 46.


3.0 Definitions


4.0 IRB Review Procedures


DOCUMENT HISTORY:

 Written: 1/12/2016 (Approved: 1/12/2016) - original author not recorded

 Revised: 2/12/2018 - revision not documented

 Revised: 5/26/2021 - Clarified requirement for IDE and for SR/NSR determination when conducting a clinical investigation with an HUD; clarified materials to be reviewed by the IRB; clarified that use of HUD off-label is allowable without additional review; described specific additional information to be included in the CF if HUD is used outside its approved indication; stylistic and organization changes

6.4 Emergency Use of a Test Article

1.0 Purpose

The purpose of this policy is to describe the requirements for utilization of a test article under emergency circumstances where there is not sufficient time to obtain IRB approval at a convened meeting.


2.0 Policy

It is the policy of the Organization that:


3.0 Definitions


4.0 General Considerations


5.0 IRB Requirements


6.0 FDA Notification


7.0 Procedures for Emergency Use of a Test Article


8.0 Informed Consent


DOCUMENT HISTORY:

 Written: 1/12/2016 (Approved: 1/12/2016) - original author not recorded

 Revised: 2/12/2018 - revision not documented

 Revised: 12/7/2022 - Deleted description of expanded access and referred instead to HRPP Policy 6.5; revised procedures to reflect modified “Emergency Use of a Test Article Report” in RSS (including sequential completion of sections I and II of the report); clarified that IRB notification will be made at a convened meeting. {Approved Chris Kratochvil (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}

 Board notified: 1/16/2023

 Revised 1/22/2024 – revised section 4.1 to specify “test article (unapproved drug, device or biologic)” rather than just drug or biologic; minor stylistic changes. {Approved Russell McCulloh (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}

6.5 Expanded Access to Investigational Drugs and Devices for Treatment Use

1.0 Purpose


2.0 Policy


3.0 Definitions


4.0 General Considerations


5.0 Investigator procedures


6.0. IRB / ORA procedures



DOCUMENT HISTORY:

 Written: 1/18/2021 (Approved: 1/18/2021) - original author not recorded