Based on my experiences, I would like to share experiences that I have ever seen regarding to ethical principles and good practices in vaccine development for clinical trials that play an important to guide health care decision-making, especially in the context of controlling policy of the COVID-19 pandemic.
• The principle investigator will ensure that the study is conducted in accordance with relevant regulations and with Good Clinical Practice and the principles of the Declaration of Helsinki.
• The protocol, informed consent form, participant information sheet and any proposed advertising material (if applicable) will be submitted to applicable local/national ethics committees and regulatory agencies for written approval.
• The confidentiality measures in place for study participants. Participants will be assigned an ID number with only initials possibly included on certain documents. All data will be stored securely and accessible only to authorized personnel. The study will adhere to the Data Protection Act 2018, ensuring that personal data is not kept identifiable for longer than necessary.
• The informed consent form (ICF), this is a document used in clinical trials to provide potential study participants with comprehensive information about the study and to ensure they fully understand the nature of the trial, including potential risks and benefits and voluntarily consent to participate without enforcment. Additionally, the ICF outlines participants’ rights, such as the right to withdraw from the study at any time without penalty.
• Study participants will not receive payment for their participation. However, they may be reimbursed for costs incurred during their involvement in the study according to local guidelines and ethics committee policies.
• Additionally, the principle investigator is responsible for reporting an Annual Progress Report to all relevant ethics committees and regulatory agencies on the anniversary of the study’s approval or as defined by local requirements.
• To implement safety monitoring protocols to promptly detect and address any adverse events or safety concerns that may arise during the trial for example implementing real-time monitoring feature to early detection of adverse events.
• To ensure that clinical trial is designed to be accessible to individuals from diverse backgrounds, including different demographic groups and geographical regions, the results are applicable to broader populations. Including those historically underrepresented in clinical research that this can help to promote equitable access including appropriate sample sizes, randomization, and control groups, this can help to minimize bias and confounding factors and ensure the validity and reliability of the findings.
• Study participant’s personal information in clinical trials, including medical history, test results, and demographic data must be handled with strict confidentiality to protect their privacy rights. IRBs/IECs (Institutional Review Boards/Independent Ethics Committees), regulatory authorities, and CROs (Contract Research Organizations) is conducting safely in ensuring the ethical conduct, regulatory compliance and quality management of clinical trials conducted to expedite the development of potential treatments and vaccines while upholding ethical standards and data integrity according to the study protocol.
• To maintain transparency throughout the vaccine development process before initiating clinical trials, vaccine developers should publicly disclose detailed study protocols outlining the research objectives, study design, participant eligibility criteria, intervention details, outcome measures, and statistical analysis plan. This helps build trust among stakeholders and ensures accountability in decision-making.
• Involve communities affected by the COVID-19 pandemic in the vaccine development process through meaningful engagement, consultation, and collaboration for example vaccine developers should establish partnerships with community-based organizations, non-governmental organizations (NGOs), and advocacy groups to facilitate community engagement and enhance the reach of clinical trials + demonstrate cultural sensitivity and respect for community norms, beliefs, and practices when conducting clinical trials (some local people they have their own beliefs to avois being vaccinated).
• To implement post-marketing surveillance systems to monitor vaccine safety and effectiveness after regulatory approval. This allows for the detection of rare adverse events and the ongoing assessment of vaccine performance in real-world settings.
• To collab with international level and data sharing to accelerate vaccine development and to facilitate regulatory approval. This involves sharing research findings, resources, and expertise across borders to address the global health crisis.
Reference: Mahidol-Oxford Tropical Medicine Research Unit (MORU). Chloroquine/ hydroxychloroquine prevention of coronavirus disease (COVID-19) in the healthcare setting; a randomised, placebo-controlled prophylaxis
study (COPCOV). Available from: https://www.tropmedres.ac/covid-19/copcov