Ethical PPE: Overseeing Research in the Time of COVID-19

As many in a weary nation look toward science for insights, answers, and a path out of this modern plague, science itself runs the risk of exposure and illness. Since the end of World War II, the Nuremberg Code (1947), the Declaration of Geneva (1948), the Helsinki Declaration (1964), the Belmont Report (1978) and its codification in the Common Rule in the U.S. Code of Federal Regulations represent serious efforts to protect participants in human subjects research from risks associated with their participation.

In research settings, whether university-, hospital-, or industry-based, it is the Institutional Review Board (IRB) or Human Subjects Committee that is charged with overseeing an institution's human protections program and compliance with regulations. This includes assuring that key research personnel have successfully completed training programs on protecting human subjects from research risks, reviewing research protocols in accordance with federal regulations and criteria, providing feedback and approvals to researchers before implementing protocols, overseeing the proper execution of the research, responding to requests for amendments prior to their implementation, and investigating unanticipated problems and adverse events that may occur despite the best of intentions.

Research is difficult, both theoretically and practically. While the practice of ethical research is grounded in legal regulations, the ethics themselves are rooted in normative values and a more universal moral imperative. Translating this code into practical operations can be a tricky affair. Some very challenging protocols require what verges on Solomonic wisdom to render a decision. Thankfully, most protocols are not that challenging. And many, historically, have carried no more than minimal risk, often defined as the risk associated with day-to-day life.

Yet as COVID-19 captures headlines and the media report daily new case counts and deaths with the fervor of sports fans following their playoff-bound team or investors following the stock market, the risks associated with daily life have changed radically. COVID-19 is not only an important subject of study, but it has affected the context within which research is conducted, and the risk environment within which IRBs must deliberate.

It is within this broader context that I received NIB's survey on COVID-19 and its impact on IRBs. The survey provided an opportunity to reflect and sort out some of the challenges I experienced as an IRB Chairperson, and the efforts we undertook to address them. This personal story shares some of those challenges and what we've learned thus far as well as some emerging dilemmas as the pandemic continues.

The first challenge is a logistical challenge associated with review and oversight of COVID-19 research. This is less a matter of "COVID-19 Research," per se, but accommodations to previously approved protocols that involved face-to-face interviews. These were protocols that were approved before we were even aware of COVID-19 and prior to widespread mitigation efforts, at the state level or nationally. I reached out to all Principal Investigators (PIs) of active protocols requiring amendments if they were still actively engaged in recruitment and/or interviewing. I created a streamlined application process that outlined the required changes (to informed consent, recruitment materials, and the addition of screening questions to online interview protocols), and requested current information on the status of recruitment, interviews completed, and interviews still to be conducted. This resulted in a spike of amendments to be processed, but the streamlined procedures facilitated administration.

The next challenge involved ethical, regulatory, or institutional policy challenges or concerns. Online interviewing carries additional risks and responsibilities. Both the researcher as well as the participant must be able to identify spaces to conduct the interview in which they are unlikely to be observed, overheard or interrupted. Except for those living alone or those with privileged amounts of space, this can pose a challenge. Nevertheless, for much behavioral research, where a breach of confidentiality may be the greatest risk attached to participation, the need to maintain privacy is critically important. In addition to modifying the informed consent documents to stipulate that privacy, the interview protocols must add screening questions regarding the physical setup within which the e...