IRB Submission Requirements for Decentralized Clinical Trials

Question:

As decentralized clinical trials (DCTs) become more common, what are the IRB’s requirements for submitting research locations?
-Director, Regulatory Affairs, CRO

Answer:

If the protocol is designed as a decentralized clinical trial or a hybrid decentralized clinical trial, some or all research activities may occur at locations that are not traditional clinical trials sites. For example, a local healthcare provider clinic, a mobile unit or the participant’s house may serve as the location for some research activities.  

The FDA draft guidance, Decentralized Clinical Trials for Drugs, Biological Products, and Devices -Guidance for Industry, Investigators and Other Stakeholders – (May 2023), references the FDA Information Sheet Guidance for Sponsors, Clinical Investigators, and IRBs Frequently Asked Questions – Statement of Investigator  (Form FDA 1572) (2010). That guidance notes the definition of sub investigators to be individuals who make a direct and significant contribution to the study data. Locations of sub investigators activities would be expected to be submitted.

Moreover, WCG IRB applies the Common Rule for this consideration to all research regardless of funding and requires a location to be submitted to the IRB if the location is “engaged in research”.  Determining if a location is engaged in research can be complex and is specific to the individual study.

Utilizing OHRP’s Guidance “Engagement of Institutions in Human Subjects Research” (Engagement of Institutions in Human Subjects Research (2008) | HHS.gov) WCG IRB considers locations with personnel conducting the following activities to be considered engaged in research.  However, please be aware that there are several exceptions to this list and these exceptions are listed in the next paragraph.

• intervention for research purposes with any human subjects of the research by performing invasive or noninvasive procedures
• intervention for research purposes with any human subject of the research by manipulating the environment
• interaction for research purposes with any human subject of the research
• obtaining informed consent of human subjects for the research
• obtaining, for research purposes, identifiable private information or identifiable biological samples

EXCEPTIONS:  When looking at the engagement of a location, there are exceptions to the above, including consideration of activities that may be included in routine monitoring of an individual’s healthcare.  Noted exceptions in which a location would not be considered engaged in research include:

• personnel perform only commercial or other services that are normally performed for non-research purposes, they do not merit professional recognition or publication privileges and they do not administer the study intervention being evaluated
• personnel provide clinical trial-related medical services that are dictated by the protocol and would typically be performed as part of routine clinical monitoring and/or follow-up of subjects.  Examples of these activities include medical history, physical examination, assessment of adverse events, blood test, chest X-ray, or CT scan.  Where the:
  • the personnel at the location do not administer the study interventions being tested or evaluated under the protocol;
  • the clinical trial-related medical services are typically provided by the location for clinical purposes; and
  • the personnel do not enroll subjects or obtain the informed consent of any subject for participation in the research.
• personnel administer study interventions on a one-time or short-term basis in the subject’s best interest, they do not obtain consent, another institution maintains oversight, and the IRB is informed
• personnel just inform potential subjects about the research and permission to contact them, and do not obtain consent
• the institution only allows use of their facility by personnel from another institution
• personnel only release information to another institution
• personnel who author a paper, journal article or presentation describing a human subjects research study.

There are several additional exceptions which are related to the use of identifiable information and coded information.  Please refer to the above referenced OHRP guidance for the specific requirements of those exceptions.

If the location is not engaged in research, WCG IRB does not require the location to be submitted as a research site.

If telehealth visits will be conducted or other digital health technologies will be used, the address of the healthcare clinic or office used by the research staff when conducting the research activities should be submitted as the research location. The address of the participant’s home does not need to be submitted to the IRB.

If mobile units will be used, the address of the affiliated engaged research location can be submitted as the research location. The location where the mobile unit is temporarily located would not be a research location.

Refer to the FDA draft guidance for Decentralized Clinical Trials for Drugs, Biological Products, and Devices -Guidance for Industry, Investigators and Other Stakeholders – (May 2023) and the FDA Information Sheet Guidance for Sponsors, Clinical Investigators, and IRBs Frequently Asked Questions – Statement of Investigator (Form FDA 1572) (2010) for more information.