Clinical research is the basic element of medical and healthcare research. It is intended to generate knowledge to enhance our understanding of human diseases and identify novel ways to prevent and cure them for improving human health.
Clinical research aids the development of new treatments, cures, and preventive measures that help control the spread of diseases. Clinical research also helps ascertain if the new treatments are safe for the patients. Clinical researchers need to follow ethical protocols and thoroughly test new drugs and treatments before launching them on the market.
Human subjects are the principal component of clinical research. They donate their specimens and share their personal information, such as demographics and clinical history, with the researchers. Ethics in clinical research are necessary to assure the safety of the participants. The objective of the ethical guidelines is to prevent inhumane behavior with the participants during research experiments.
Codes of Ethics in Clinical Research
Following are a few formal documents and ethical frameworks designed in the 20th century to govern clinical research:
- The Belmont Report (1979) was developed by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. This report was aimed at safeguarding the rights of human participants involved in biomedical and behavioral research. The document underlines ethical principles for clinical research in the U.S.
- The World Medical Association (WMA) formulated the ethical principles for clinical research that are present in the Declaration of Helsinki of 1964. It was revised several times to address new ethical concerns.
- The Nuremberg Code (1947) provides an international standard for ethics in clinical research. The code was created after the Second World War when Nazi scientists conducted several abusive and exploitative clinical trials.
- The Indian Council of Medical Research (ICMR) has created a document titled “Ethical Guidelines for Biomedical Research on Human Subjects”, which outlines twelve principles that guide biomedical researchers in the country.
- The U.S. Common Rule (1991) defines basic protections for human participants in clinical trials.
The Need of Ethics in Clinical Research
Research subjects are exposed to certain risks in clinical research that can be detrimental to their health and privacy. For instance, there might be a risk of exposing their personal information to a third party without their consent. Furthermore, a drug or vaccine under trial may put their life at risk. It is essential to protect them against such risks. Ethics in clinical research protect the dignity, rights, and privacy of subjects. Ethical guidelines also allow subjects to withdraw their participation at any time, and it is not mandatory to specify a reason for withdrawal.
Ethics in Clinical Research: Here are the 7 Basic Principles
- The research should provide a scientific understanding of health and should be valuable enough for people to accept risks for the good of society.
- The research should have a clear scientific objective. Invalid research is unethical and can pose a risk to human subjects.
- Subject selection should be fair and not based on factors unrelated to the purpose of the study.
- Risks and inconvenience to research subjects should be minimized to maximize the potential benefits.
- An independent review of the research study is necessary to ensure it is ethically acceptable.
- Informed consent is essential to inform participants of the purpose, methods, risks, and benefits of the research and make a voluntary decision regarding their participation.
- Individuals should be respected throughout their participation and even after their participation ends.
Why Informed Consent is Important
It is individuals’ right to decide if they want to be a part of the clinical research process. Informed consent ensures that the subject has not forcefully participated in the research. Informed consent includes the purpose, methods, risks, and benefits of the research. Informed consent acts as the hallmark of ethical clinical research. A well-documented informed consent is paramount for ethical clinical research, especially in developing countries, such as India, with a fair number of uneducated and economically backward participants. Although informed consent makes clinical research ethical, it is not sufficient.
How a Laboratory Software for Clinical Research Labs Can Help Overcome Ethical Barriers
Clinical research laboratories struggle to manage the consent of participants and codes of conduct documents, ensure ethical utilization of specimens, limit access and authorizations, and prevent the conflict of interest, among others. A laboratory software for clinical research labs, also known as a clinical Laboratory Information Management System (LIMS), can help follow ethical guidelines with ease. A LIMS can securely manage samples and informed consent. A LIMS ensures the safe and secure management of data that could be accessed in real-time. A LIMS safeguards patient information throughout the various phases of research by anonymizing sensitive patient data. A LIMS protects sensitive patient information through passwords, two-factor authentication, data encryption, and role-based access data access rights to staff.
Conclusion
Clinical research aids in developing new drugs and treatments for the betterment of mankind. The people who participate in clinical research play a key role in the process. However, clinical research tends to pose risks to the participants. Ethical clinical research can protect the personally identifiable information (PII) of participants and thus maintain data privacy. However, research laboratories face significant ethical challenges. A laboratory software for clinical research labs helps move past ethical barriers in clinical research, seamlessly manage data overload, and maintain public trust in clinical research.