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Institutional Review Board

COVID-19 and Human Research Studies at RFUMS


The University and Dr. Kaplan's office have agreed that investigators can begin the process of resuming in-person human subjects research. This document outlines approval for resuming onsite and offsite, in-person, human subjects research. Please note that investigators will require two different types of approval to resume in person data collection:

  1. Explicit approval from Dr. Kaplan for returning to their research laboratory must be obtained in writing/email after submission of the PI’s plan (outlined in RFU Research Resumption Guidelines).
  2. IRB approval for conducting in-person visits for human subjects research at RFUMS (outlined in Resumption of On Campus Visits for Human Subjects Research).

In an effort to minimize the risk of contracting or spreading COVID-19 in human participant research interactions, RFUMS has placed temporary restrictions on human subject research, effective Tuesday, March 31, and continuing until further notice.  We will continue to reevaluate this as the situation evolves.  

During the COVID-19 pandemic, RFUMS has reduced on-campus populations, including researchers, and continues to work with investigators to enable as much remote work as possible.  Our research support offices (IRB Administration, IACUC Administration, Office of Sponsored Research, Business/Purchasing) remain available from remote locations. 

Information about COVID-19-related restrictions related to human subject research presented here is intended to help investigators and research teams best manage their ongoing human subject research activities and maintain participant safety during this time: 

  1. Which studies must be paused? 
    • Studies involving face-to-face interaction with participants that involve no direct drug or device therapeutic benefit
      • Study procedures involving in-person contact with participants for research purposes beyond those provided during routine clinical care interactions must be paused, effective immediately.
      • Research interactions with participants in studies that previously involved in-person interactions may continue to use telephone contact, remote monitoring, or remote data collection once necessary protocol amendments are made with the IRB.
      • These restrictions are in place for in-person contact that occurs on- or off-campus.
  2. Which studies may continue with existing research participants?  
    • Studies that do not involve face-to-face interactions with participants
      • Studies conducted electronically or via telephone or involving secondary data analysis may continue.
      • All study activities must be done remotely (e.g., by phone, Skype or other means). 
      • For health and safety, these changes should be instituted immediately; please submit an amendment to the IRB to indicate the temporary modifications that may be needed.  If the study is sponsored, be sure to communicate with the study sponsor and submit required modifications as directed.
  3. Can new research participants be enrolled in continuing studies?
    • Yes, but only in studies that do not involve face-to-face interactions with participants
      • Studies conducted entirely electronically or via telephone may continue to enroll new participants.
      • Please submit an amendment to the IRB to indicate the temporary modifications that are needed.  If sponsored, communicate with the study sponsor and submit required modifications as directed as soon as possible.
  4. Other Questions:
    • My study may be impacted by the pause, which could lead to delays in completing my study by the end of the project period. What should I do?
      • Most federal sponsors allow for a one-time no cost extension for 12 months at the end of the project. Other sponsors are also considering the impact of COVID-19 on project timelines.
    • Must the IRB approve amendments to my IRB study protocol before implementing changes?
      • Yes, please submit an amendment as soon as possible and we will try to complete reviews as quickly as possible.
    • Do we need pre-approval from the IRB for communicating with study participants to explain the pause or change in activities?
      • No, it is not necessary to submit a modification for this.
    • If I am pausing study procedures on a project reviewed by an external IRB of Record, must I notify that IRB?
      • Yes, as soon as feasible, since they may require review/approval prior to resumption of study procedures. 

Please email with any other questions you may have and we will attempt to reply quickly.   Thank you for helping us get through this difficult time period.

The Institutional Review Board, or IRB, is a committee that is required by federal law to protect the rights and welfare of human subjects participating in research activities. The committee meets this mandate by reviewing proposed and ongoing research activities, ensuring they meet specific criteria for approval.

The IRB’s function, make-up, and authority are governed by federal law, but meeting the regulations is done on an institution-specific level. The IRB ensures that valid studies meet the ethical mandates of the Belmont Report, and the legal mandates of federal law.

Federal Regulations

The federal law, commonly referred to as 45 CFR 46, formally, the Code of Federal Regulations at Title 45-Public Welfare, Department of Health and Human Services, Part 46-Protection of Human Subjects, is specific to research conducted or supported by a federal department or agency. However, many institutions, including RFUMS, voluntarily apply some or all subparts of 45 CFR 46 (also referred to as the “Common Rule”) to all research conducted by their investigators, regardless of status or source of funding.