Clinical research is the lifeline of modern medicine; without which medicine would be nothing more than a machine gun. Clinical research allows clinicians to study disease and create appropriate treatments for disease. It ensures that the drugs that are introduced to the market cut the threshold for safety and effectiveness. Finally, it also helps scientists develop preventive strategies to curb the spread of diseases. Therefore, it is the bedrock of a population’s health.
Clinical research involves a myriad of things, with human subjects being the most important component. Researchers use the information they have extracted from human subjects and generalize it to the whole population. Such subjects have to provide their personal information, including the demographics and biological specimens. In clinical trials of a new drug, human subjects have to volunteer as “guinea pigs” for the benefit of the entire population. This makes ethical standards a pertinent issue in clinical research.
It is against such a background that certain ethical considerations must be made regarding clinical research. The following are some of the ethical codes that govern clinical research:
Nuremberg Code (1947)
Declaration of Helsinki (2000)
Belmont Report (1979)
U.S. Common Rule (1991)
Why are Ethics Needed in Clinical Research?
As mentioned earlier, clinical research exposes research subjects to certain risks. When subjects offer their personal information for research purposes, they have certain expectations. For example, they expect that their information will only be used for the intended and specified research agenda. They do not expect their information to be exposed or shared with any third party for financial gains or any other reasons. They also expect that their dignity, rights, and privacy will be upheld at all times.
Ethical guidelines in research are intended to protect the rights of participants and society at large. They protect study subjects from indecent exposure or any other inhumane behavior. Some of the codes and declarations that were formulated to govern ethics in clinical research are as follows.
The Nuremberg Code is a set of ethical principles that guides clinical research. The code was created after several unethical cases were filed after the Second World War.
The World Health Organization has also formulated a statement of ethical principles for clinical research. This is contained in the Declaration of Helsinki of 1964.
The Belmont Report lays down ethical principles for clinical research in the US. It was written after details of the infamous Tuskegee’s Syphilis study were revealed in the public domain.
In India, the Indian Council of Medical Research has created the ‘Ethical Guidelines for Biomedical Research on Human Subjects’. This document outlines twelve principles that guide biomedical researchers in the country.
The Importance and Insufficiency of Patient Consent
Having informed consent is a central component of ethics in clinical research. This demonstrates that a researcher has fully explained the research process, risks, benefits, and alternatives to the potential participants, and they, in turn, have agreed to take part in the research. This respects the participants’ right to withdraw their participation from the research. The researcher should also specify whether any incentive was offered to “coerce” the participant to take part in the research; in cash or kind. However, it is clear that having informed consent is only a first step in ethical clinical research.
Basic Principles of Ethical Clinical Research
The 7 main principles to direct ethics in clinical research are as follows.
The research must add value to health or medical knowledge
The research method must have scientific validity
The research subject must be selected fairly
The inherent risk must be commensurate to the potential benefits
The research must be independently reviewed
There must be an informed consent
Respect for research participants must be upheld
Challenges in Upholding Ethical Considerations
Clinical research laboratories must uphold clinical considerations when handling human biospecimens and the associated metadata. Major challenges include managing thousands of patient consents and codes of conduct documents, ensuring ethical utilization of specimens, limiting access and authorizations, and preventing the conflict of interest among others. Laboratories with resource or technological limitations can find it very difficult to get past these ethical hurdles.
A LIMS can get Your Laboratory Past the Hurdles
A Laboratory Information Management System (LIMS) can help clinical research laboratories navigate through ethical hurdles with ease. A laboratory software for clinical research labs, also known as a clinical LIMS, can help automate workflows and ensure that samples and data are effectively managed. A cloud-based laboratory software for clinical research labs also guarantees safe and secure management of data that can be accessed in real-time. A LIMS facilitates authorizations to prevent compromised access to patient information. Passwords, two-factor authentication, and data encryption offer an extra layer of protection to sensitive patient information. Lastly, a LIMS anonymizes sensitive patient data to ensure that subject privacy is maintained at all times.
Significant ethical challenges confront clinical research laboratories even today. With an efficient LIMS system, a laboratory can move past ethical barriers in clinical research, seamlessly manage data overload, and ensure that the public’s trust in clinical research is maintained.