UConn Health’s HSPP Reaccreditation from the

Association for Accreditation of Human Research Protection Program (AAHRPP)

 

On March 27-28, 2024, UConn Health Human Subjects Protection Program (HSPP) underwent a Site Visit evaluation as part of the process of reaccreditation by the Association for Accreditation of Human Research Protection Programs (AAHRPP).  After the HSPP responds to the Site Visit report the application will be reviewed by the AAHRPP Council in June 2024.  This process required team work from many stakeholders. The Director of the Human Subjects Protection Program and the Associate Vice President for Research Integrity & Compliance extend their gratitude to the faculty, staff, IRB members and members of the Scientific Review and Conflicts of Interest Committees, Office of Clinical and Translational Research Services, Sponsored Program Services, Research Pharmacy and Research Safety, and many others who committed their time to the Site Visit and who ensure that we have an outstanding human subjects program every day.

 

 

FDA Regulated Research

Overview of Human Subjects Research with Devices

 

The U.S. Food and Drug Administration (FDA) regulates drugs, biologics, and devices used in the diagnosis, mitigation, treatment, or prevention of diseases.

 Investigators who will be conducting clinical investigations in which the purpose of the study is to obtain data about a medical device (e.g., data on its safety and effectiveness), should become familiar with the information provided below to determine whether: (a) the device is exempt from an investigational device application (IDE), (b) the device fulfills the requirements for an abbreviated IDE, or (c) the device needs an IDE issued by the FDA.

Investigators should only think about these determinations when research participants of a clinical investigation will become part of the group in which a medical device will be used or part of the control group, and the device is the object of the investigation/research study.

Unless the sponsor of the device has made the determination that the device is exempt from the requirements of Part 812.2 (c), the study may be conducted under an abbreviated IDE or the investigator must submit an IDE application to FDA. See Table 1 below.

An investigational device exemption (IDE) is a regulatory status granted by the FDA that allows researchers to conduct clinical investigations on medical devices that have not yet received FDA approval. However, not all device studies are required to submit an IDE application to the FDA.  If a device is determined to be a non-significant device (NSR) in concurrence with the IRB, then an IDE is not necessary.

An IRB may determine that a device is a non-significant device because it does not meet the definition for a significant risk device (SR) (see definition of SR below) and does not present a potential for serious risk to the health, safety, or welfare of participants.

The sections below explains when and how an investigator makes a determination that a device could be used in a clinical investigation under an abbreviated IDE or under an Investigational Device Exemption (IDE).

Abbreviated Investigational Device Exemption

The sponsor makes the initial determination of SR or NSR for the device. However, it is important to note the IRB will make the final determination for NSR devices. If the research study is investigator initiated, then the investigator is also acting as the sponsor.

NSR device studies may not require submission to the FDA providing they comply with the abbreviated requirements of the regulations described in the IRB Policy 2011-021.0.pdf – Investigational Device Studies 

The FDA considers an investigation of a non-significant risk device to have an approved IDE (Abbreviated Investigational Device Exemption) when an IRB concurs with the initial non-significant risk determination of the sponsor or investigator and approves the study. See Table 1 below.

 

Investigational Device Exemption (IDE)

If either the investigator or the IRB has made a determination that the device is a significant risk device an IDE application is to be submitted to the FDA.

To obtain an IDE approval by the FDA, the sponsor or manufacturer of the device must properly fill out an IDE application. This application should be submitted proposing a human clinical researcher to study an unapproved significant risk device or a cleared or approved device for use other than its approved indication or intent.

The application should provide information about the investigational device, including its design, manufacturing process, and intended use. A clinical investigational protocol that outlines study objectives, methodology, patient population, and end points should also be included.  In addition, the sponsor must demonstrate in the application that there is reason to believe that the risks to human subjects from the proposed investigation are outweighed by the anticipated benefits to subjects, the importance of the knowledge to be gained, that the investigation is scientifically sound, and that there is reason to believe that the device as proposed for use will be effective.

An IDE application can be considered approved 30 days after it has been reviewed by the FDA, unless otherwise indicated. The FDA may inform the sponsor of approval, approval with conditions, or disapproval prior to 30 calendar days from the date of receipt.

Once FDA approval is granted, and the IRB has approved the study the sponsor and/or investigator may proceed with the clinical investigation. See Table 1 below.

The FDA grants permission so a device that otherwise would be required to comply with a performance standard or to have premarket approval can be shipped lawfully for the purpose of conducting investigations of that device. This FDA permission is evidenced by the assignment of an IDE number.

Additional Points to Consider About Research Studies with Medical Devices

• Studies of SR Devices require review of the convened IRB.
• NSR device studies generally will require full board review but may be approved through the expedited review procedure if the study falls within a designated approvable category and is minimal risk.
• IRB approval must be obtained before any clinical investigation can begin, and for studies with a SR Device, both FDA and IRB approval must be obtained before any subject can be enrolled.

 

Definitions-

 Clinical investigation means any experiment that involves a test article and one or more human subjects and that either is subject to requirements for prior submission to the Food and Drug Administration under section 505(i) or 520(g) of the act, or is not subject to requirements for prior submission to the Food and Drug Administration under these sections of the act, but the results of which are intended to be submitted later to, or held for inspection by, the Food and Drug Administration as part of an application for a research or marketing permit. The term does not include experiments that are subject to the provisions of part 58 of this chapter, regarding nonclinical laboratory studies.

Significant Risk (SR) Device: A device that presents a potential for serious risk to the health, safety, or welfare of a subject and 1) is intended as an implant, or 2) is used in supporting or sustaining human life, or 3) is of substantial importance in diagnosing, curing, mitigating or treating a disease, or otherwise prevents impairment of human health, or 4) otherwise presents a potential for serious risk to the health, safety, or welfare of a subject.          

 

     Table 1

	Categories of Research Studies with Medical Devices
	IDE Exempt	Non-Significant Risk (NSR)	Significant Risk (SR)
Risk	Lowest Level of  Risk	Low Risk	High risk
FDA Approval	Exempt from 21 CFR Part 812	Must comply with an Abbreviated Investigational Device Exemption in 21 CFR Part 812.2 (b)	Must follow ALL IDE Regulations in 21 CFR Part 812-Investigational Device Exemption (IDE) Application
IRB Review Approval	YES	YES	YES

 

Resources for investigators:
ReGARDD – Regulatory Guidance for Academic Research of Drugs and Devices

Device Advice: Comprehensive Regulatory Assistance | FDA

 

UConn Health IRB Forms and Polices Revisions

&

Educational Resources

 

 

The following forms have been updated:

• Instructions for Requesting Reliance Upon Advarra IRB.docx(2/13/2024, updated contacts at Advarra and consent template injury language section)
• Request for UConn Health as a Recruitment Site -Without Engagement(*new form as of 3/20/24)

 

The following policy has been updated:

• 2011-008.2.pdf– Informed Consent – Waivers and Alterations (1/22/2024) (including the FDA final rule that allows IRBs to approve an informed consent procedure that does not include or that alters certain informed consent elements, or to waive the requirement to obtain informed consent, for certain minimal risk clinical investigations).

The following links were added to the IRB website under online resources for investigators:

• Regulatory Guidance for Academic Research of Drug and Devices 
• Is my Device Study Exempt from Investigational Device Exemption (IDE) Regulations?

 

 

Upcoming Changes in at the HSPP/IRB

 

Education & Development Specialist of HSPP:  As of 4/5/2024, Mayra Cagganello has transferred to a new position within UConn Health.  Mayra has worked for the HSPP for almost 13 years and her dedication and support to the HSPP and research community will be missed!

Investigators who need education, guidance on IRB submission and/or training with the IRIS submission system should contact the IRB at irb@uchc.edu

We wish Mayra the best in her new role!

 

 

 Bibliography

 2011-007.0.pdf – Definitions Applied to Policies

2011-021.0.pdf – Investigational Device Studies

Frequently Asked Questions about Medical Devices

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