Narrative Inquiry in Bioethics

The first case of COVID-19 was confirmed in Kenya in March 2020. The announcement made by the Ministry of Health created panic [End Page E20] in the country and many changes in the normal way of living. The Government of Kenya issued a number of directives to curb the spread of the disease. The containment measures affected all sectors of the economy, including health. The Kenya Medical Research Institute was at the epicenter in responding to the pandemic through testing, surveillance and systematic investigation into the novel virus. Scientists at KEMRI responded to the various calls for research proposals on COVID-19.

The KEMRI's Scientific and Ethics Review Unit (SERU) is a unit that houses the Research Ethics Committee (REC). All research proposals must be reviewed and approved by the ethics committee before study implementation. Prior to the announcement of the first case of COVID-19 in Kenya, KEMRI SERU operations were purely paper-based. We had to shift to the online submission system and virtual REC meetings to curb the spread of the killer disease. We had to respond to the increased number of proposals for review and keep the disease at bay. To date, the KEMRI SERU has reviewed and approved more than 50 new proposals related to COVID-19.

The new normal of providing research oversight with strict adherence to the various guidelines of curbing the spread of COVID-19 came with a fair share of challenges. The problems in reviewing and overseeing COVID-19 research ranged from administrative to logistical issues. Members of staff at the research regulation arm had to stay and work from home. We experienced challenges such as intermittent internet access and lack of equipment like computers, scanners, printers, and photocopiers at home. All research proposals on COVID-19 were reviewed on a quick turnaround basis. The challenge to this is to supervise staff who are working from home and ensure that they respond to urgent requests. All requests for ethical reviews were received through e-mail. There was a challenge in putting all documents in a centralized location because staff could access the email at home. Documents management requires a centralized system that can be accessed remotely. An upsurge in the number of expedited review requests strained the limited resources in the unit.

Our work involved issues of autonomy and respect for persons who test positive for COVID-19 and researchers want to use their samples for different research purposes. Human beings enrolled in research should be treated as autonomous agents regardless of the situation at hand. No one should disrespect the rights and welfare of research participants in the name of responding to the pandemic. Researchers must ensure that they seek informed consent from COVID-19 patients to use their collected samples for research purposes. The Research Ethics Committee has also found it difficult to conduct site monitoring visits due to travel restrictions. We have to rely on self-reported protocol deviations, violations, safety, and other notifications received from principal investigators to conduct passive monitoring of the study.

The KEMRI SERU made necessary adjustments to accommodate urgent review of COVID-19 research proposals during this period of the pandemic. One of the special accommodations made is the expedited review of all COVID-19 research—the unit endeavors to respond to the investigators within ten days. We have not increased the number of staff but considered motivating them further. The institute issued Telkom cards with sufficient inter-net bundles to allow the staff to access the Internet from home. The reviewers were also given a token of appreciation during this period. Expanded access requests are being reviewed jointly between REC and the national regulators. Initially, studies were reviewed by the REC and the national regulator sequentially. However, during this period, some studies have been reviewed jointly/concurrently by the national regulator and the IRB to reduce the turnaround time.

The review of an increased number of COVID-19 research proposals has taught us many lessons that we can share with other IRBs. It would be helpful to have separate reviewers for expedited reviews and motivate them...