Due to the ongoing severity of COVID-19, the government has announced measures to reduce or avoid non-essential activities that may lead to the spread of the disease, which affects public health. In cases where research involves close and prolonged interaction with participants, it increases the risk for both researchers and participants. The Food and Drug Administration has issued guidelines for conducting clinical trials during the COVID-19 pandemic, which can be applied to other types of research to ensure safety for all parties involved.
The Mahidol University's Central Research Ethics Committee has established guidelines for conducting research during the COVID-19 pandemic, in line with the FDA's announcement, as follows:
1. For research projects that have not yet started:
- Delay recruiting participants until the COVID-19 situation improves, especially for projects that involve close physical interaction.
- If it is necessary to conduct the research urgently and specifically during the COVID-19 situation, a plan must be in place to prevent the spread of the disease, following the Ministry of Public Health's guidelines, and/or adjust the research methodology, such as:
- Maintaining social distancing, wearing masks, and using other protective equipment as appropriate.
- Cleaning and disinfecting all equipment used in the research process with disinfectant before reusing it with other participants.
- Limiting the number of participants and scheduling appointments to prevent more than 5 participants from waiting at the same time.
- Adjusting the research process to reduce close contact, such as:
- Using digital questionnaires instead of paper-based ones.
- Conducting telephone or online interviews instead of face-to-face interviews, but if face-to-face interaction is necessary, maintaining social distancing and wearing masks and other protective equipment throughout the process.
- Replacing focus group discussions with online focus groups or in-depth interviews, if necessary, while maintaining social distancing and wearing masks and other protective equipment.
2. For research projects that have already started:
- Delay recruiting new participants until the COVID-19 situation improves, especially for projects that involve close physical interaction.
- If participants have already been recruited and the research process has begun:
- A plan must be in place to prevent the spread of the disease, following the Ministry of Public Health's guidelines, such as:
- Maintaining social distancing, wearing masks, and using other protective equipment as appropriate.
- Cleaning and disinfecting all equipment used in the research process with disinfectant before reusing it with other participants.
- Limiting the number of participants and scheduling appointments to prevent more than 5 participants from waiting at the same time.
- The research process can continue if it is necessary to maintain the integrity of the research or if stopping the research would have a negative impact on the participants.
- The research process should be adjusted to minimize the risk of infection, such as rescheduling appointments or delaying non-essential procedures until the situation improves, and notifying the Ethics Committee of any changes to the research protocol.
- If it is necessary to add COVID-19 testing for participants during the research, it can be done without deviating from the approved research protocol.
- Changes to the research protocol to reduce or eliminate immediate hazards or to protect the lives and well-being of participants (e.g., reducing COVID-19 exposure) can be made before obtaining approval from the Ethics Committee, but must be reported to the Committee as soon as possible.
