|LETTER TO EDITOR
|Year : 2022 | Volume
| Issue : 3 | Page : 56-57
Conducting human research during and after covid-19 pandemic: The need of the hour
Sai Sailesh Kumar Goothy
Department of Physiology, R.D, Gardi Medical College, Ujjain, Madhya Pradesh, India
|Date of Submission||24-Nov-2021|
|Date of Decision||10-Jan-2022|
|Date of Acceptance||14-Feb-2022|
|Date of Web Publication||28-Jul-2022|
Sai Sailesh Kumar Goothy
Department of Physiology, R.D, Gardi Medical College, Ujjain, Madhya Pradesh
Source of Support: None, Conflict of Interest: None
|How to cite this article:|
Kumar Goothy SS. Conducting human research during and after covid-19 pandemic: The need of the hour. MRIMS J Health Sci 2022;10:56-7
The impact of COVID-19 is worldwide in all the fields. Research field is maximum effected by the pandemic. There was a drastic change in the research topics and every scientist in the world started concentrated and worked on COVID-19. It was ultimately led to development of vaccines and comparatively the cases were controlled throughout the world. Post COVID-19, there was a drastic change in the thought process of the participants due to fear of COVID infection. It was my self-experience as a principal investigator for human research. From step one of the research studies, there are challenges. Many teaching hospitals were taking a great role as covid centres as well as vaccination centers. As we people are from these teaching hospitals, some participants are not allowing the research staff to meet them due to fear of COVID infection. This is a common issue experienced by every researcher during this pandemic era. It was a herculean task to explain and convince the participants to join the study. After recruiting, there will be a collection of data and follow-up of patients in clinical trials. The parameters that can be collected at home like blood samples can be collected at patient's home itself. However, if the study involved sophisticated tests such as magnetic resonance imaging (MRI) and computed tomography (CT), there is a lot of reluctance expressed by the participants as well as their family members. Again, this is due to fear of COVID-19 infection. Hence, there is an increased attrition rate. With these many challenges, conducting a research study involving human subjects is not an easy task. Although we ensure to follow the safety protocol, still the participants were afraid of the infection.
This fear which is an emotional aspect has an influence on study results also. As the participants were more stressed and anxious due to COVID-19, these psychological events have a negative impact on the treatment protocols. Hence, there is an additional job for research staff to counsel the participants at regular intervals to reduce their stress and anxiety. This will invariably increase the workload on the research staff. Furthermore, the researcher has to spend more time for the study than before. On the other hand, the research staff who will be approaching the participants also have the fear of the infection. In this situation, there is a strong concern to all investigators about cancellation of trials or delay of trial. Either of these has a large financial impact on the host institutions and funding agencies.
All the study procedures may not be able to conduct on participants like the procedures which require patients to visit the hospital like recording MRI and CT. Hence, the studies have to be reframed for the safety of participants and research staff. The restructuring of the clinical trials decreases the quality of the study. Although the participants can be contacted through video call for follow-up, the physical contact cannot be completely avoided in situations like collection of blood samples. Safety precautions are mandatory when there is direct contact with participants for safety of both participant and research staff.
Screening for COVID-19 should be a mandate for the participants of the study as well as regular screening to the research staff involved in the study should be mandatory. Hence, there is a strong need to educate and increase awareness to both the researchers and the community regarding the COVID-19. This is a mandate for smooth conduction of the research studies which are essential for progression of the medical field and for well-being of the participants. New policies and guidelines should be developed to help the researchers to overcome the challenges in conducting the clinical trials in the COVID-19 era.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
| References|| |
Sathian B, Asim M, Banerjee I, Pizarro AB, Roy B, van Teijlingen ER, et al.
Impact of COVID-19 on clinical trials and clinical research: A systematic review. Nepal J Epidemiol 2020;10:878-87.
Chen Z, Chen L, Chen H. The impact of COVID-19 on the clinical trial. PLoS One 2021;16:e0251410.