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Currently submitted to: JMIR Public Health and Surveillance

Date Submitted: Mar 25, 2020
Open Peer Review Period: Mar 25, 2020 - Apr 8, 2020
(currently open for review)

Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.

Conducting Clinical Research in the COVID-19 Pandemic: Investigator and Participant Perspective

  • Prasad R Padala; 
  • Ashlyn M Jendro; 
  • Kalpana P Padala; 

ABSTRACT

As the medical landscape changes daily with the coronavirus disease (COVID-19) pandemic, clinical researchers are caught off-guard and are forced to make decisions on research visits in their on-going clinical trials. Although there is some guidance from local and national organizations, the Principal Investigator (PI) is ultimately responsible for determining the risk-benefit ratio of conducting, rescheduling, or cancelling each research visit. The PI should take into consideration the ethical principles of research, local/national guidance, the community risk of the pandemic in their locale, staffing strain, and the risk involved to each participant to ultimately decide the course of action. While balancing the rights and protection of the human subject, we seldom examine patient’s views and opinions about their scheduled research visit(s). This article discusses ethical principles of beneficence and autonomy in helping the decision process. We discuss ways to weigh-in local and national guidance, staffing strain, and institutional support into the decision process and outline potential changes needed for regulatory bodies depending on the decision. Further, discussion about the need to weigh in the individual risk-benefit ratio for each participant and present a decision tree to navigate this complex process. Finally, we examine participant and caregiver perspectives on their fears, sense of preparedness and factors that they weigh before deciding whether to keep or postpone the research appointments. This entry also provides the Principal Investigator ways to support the research participants in both scenarios including provision of psychological support.


 Citation

Please cite as:

Padala PR, Jendro AM, Padala KP

Conducting Clinical Research in the COVID-19 Pandemic: Investigator and Participant Perspective

JMIR Preprints. 25/03/2020:18887

DOI: 10.2196/preprints.18887

URL: https://preprints.jmir.org/preprint/18887

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