As institutions begin to consider more serious responses to the spread of COVID-19, it is likely that human subjects research will also be impacted. In some cases, researchers may be able to move face-to-face contact with research subjects online (e.g., Zoom/Skype). In other cases, the study procedures will be such that online substitutes are not practical or even possible. This will cause serious hardship for research projects in terms of deadlines for completion, time sensitive research processes, grant funding and possibly patient safety. While minimizing the risks of transmission of COVID-19 by pausing studies will often outweigh the harms to research programs, it is important to also consider possible harms to subjects should a study be suspended for a period of time.

Many biomedical protocols require in-person  visits to the clinic and lab assessments to monitor the effects of experimental drugs, devices and biologics, but social science research may also include situations where subjects are placed at higher risk should their interactions with researchers be suspended. Protocols involving mental health (depression, suicide, etc.) and protocols involving non-invasive treatments for disabled individuals (Parkinson’s, dementia, etc.) may present risks to subjects should the interactions with researchers be suspended. IRBs should work with investigators identify those studies for which suspension of the research could place subjects at risk of harm.

Whenever research procedures are changed, investigators are required to submit an amendment/modification to the IRB for approval of the changes in procedures. Moving face-to-face interactions to online methods (e.g., Facetime, Zoom, Skype etc. for interviews) may quickly inundate the IRB with requests for these changes and the IRB may not be staffed to handle 50, 100modification requests in rapid succession. Conversely, the IRB (and the institution) need documentation of study suspensions that may place subjects at risk or where study procedures must be modified that may bring new risks or benefits to participants.

We recommend IRBs:

  • COMMUNICATE: Communicate with your institutional officials (VP of Research, Provost, etc.) about the possibility of harm to research subjects in some sub-set of your protocols. They need to prepare for how to handle these research subjects should the institution close or restrict access.

 

  • PLAN: Plan a response should the institution close or restrict access to research subjects. In health care institutions, this planning is central to their mission and research subjects at risk will be considered along with the general patient population. However, for colleges and universities, some administration officials may not be aware that there are risks and liabilities to research subjects should certain research studies be suspended. It is vital that they know about these protocols and the potential risks.

 

  • REMAIN PROACTIVE: Communicate to your investigators in advance (if possible) of any site closures so that they can prepare and plan for changes and/or suspension of their research. Consider your diverse audiences:
    1. Researchers conducting studies outside of your institution,
    2. External researchers conducting research at your site
    3. Affiliated internal researchers conducting research at your site
    4. Student researchers versus faculty researchers
    5. Researchers conducting grant funded studies with strict reporting timelines
    6. Sponsors and funders of research that may be involved in decision making about the conduct of the research

 

  • PREPARE: Prepare for submission of amendments to the IRB for review and approval of changes to procedures or requests to continue face-to-face interactions with research subjects. We recommend setting up four categories of amendments.

 

    1. If a study can be continued by transferring face-to-face study procedures into an online venue, ask the investigators to submit an amendment to this effect but tell them that as long as the main study procedures are not affected and the risk/benefits are the same, that they can move to the online venue without prior approval by the IRB. This way, even if you are inundated with a significant number of such amendments, you will not delay the research unnecessarily. As time permits, you can review these amendments and issue approvals.
    2. If a study cannot be transferred to an online venue, ask the PI to assess the risks (if any) to the enrolled subjects of suspending the study. If the risks are significant, the IRB should consult with the institutional officials and legal counsel to determine the best course of action to ensure that risks to research subjects are minimized. This may require continuing the study procedures face-to-face or it may mean finding resources to support the subjects while the study is suspended.

 

NOTE: Some studies are conducted at sites not under the control of the IRB’s home institution (schools, community organizations, etc.). In these cases, it may be necessary for the IRB to work with the investigator and their sites when suspension of a study puts the subjects at increased risk to assist the investigator in working out a safe plan of action for the research subjects.

  1. You may wish to ask investigators to report any suspension of research activities to the IRB (to ensure compliance with institutional directives). A suspension of research generally does not require filing of an amendment, but if you wish to track these suspensions, an amendment is the simplest method to handle these.
  2. There is a fourth category of research: those protocols which already do not involve face-to-face contact with research subjects and/or studies that have completed all direct contact with research subjects and are in data analysis phase. These studies can continue without interruption provided that the investigators have proper access to the institutional resources that they need.

The IRB should initially concentrate its limited resources on those studies that present increased risks to research subjects to help investigators and institutional officials come to a solution that minimizes risks to all concerns, but with a strong emphasis on the risks to the research subjects themselves. Changes in procedures in these cases may require full IRB review and members should be prepared for ad hoc meetings (online, hopefully) to work through these issues.

 

Managing Amendments: We suggest that if you are planning to proactively solicit amendments from your investigators when they are faced with changing their study procedures in response to COVID-19, that you add an “Amendment Type” menu to your amendments. In the Mentor IRB platform this is easily configured on the IRB Setup ⇒ System Settings 2 ⇒ Amendments tab. Mentor IRB users can add options to the menue to capture those protocols which can move online and those that must continue with face-to-face methods and present heightened risks to subjects should the protocols be suspended. If desirable, you can add options for investigators to report that they are suspending research activities and to report that research activities continue as they do not involve face-to-face interactions. These menu options will allow you to quickly determine which kind of amendment is being submitted.

The determination of the conflicting risks to subjects from suspension of a study versus the risk of exposure to COVID-19 (of subjects, researchers and site staff) are not easy judgments to make. They involve questions of legal liability as well as basic risk/benefit analysis. We recommend that the IRB obtain medical consultation for individual protocols where risks of suspension are substantial. The strategy is finding the least harmful path forward, not necessarily the perfect solution.

While the federal regulations are fairly strict in the requirement that researchers not make changes to their studies without prior IRB approval, the IRB needs to address those situations where subjects are most at risk if a study is suspended, then work with investigators who wish to move their research activities to non-face-to-face methods. We recommend that the IRB update its “Standard Operating Procedures” (SOPs, sometimes referred to as “Policies & Procedures”) to include provision for handling responses to emergency changes to research due to public health and/or disaster conditions. The SOPs can document how the IRB should respond should campuses or institutions be closed or other emergency measures that may impact human subjects research. Documenting procedures in your SOPs and acting in conformity to those procedures will guide the IRB in how to respond to emergency situations, provide rationale to investigators for the decisions you make, and help protect the IRB and the institution should the IRB be audited or legal questions arise.

For those with clinical studies, the FDA has released guidance on the conduct of clinical trials of medical products.  That information can be found here.

Curtis Naser, Ph.D., Axiom Mentor

Myra Luna-Lucero, Ed.D., Teachers College, Columbia University