Clinical research helps determine the efficacy and risks of new medical products, drugs, and treatments on human beings. The most important aspect of research ethics is to respect the moral rights of research subjects to decide on research participation. Research participants are subjected to one or more health-related interventions such as drugs or surgical procedures to evaluate their effects on human health. However, it is essential that the subjects voluntarily participate in these trials. Furthermore, regulatory bodies such as the Institutional Review Boards (IRB) or Independent Ethics Committee (IEC) should ensure that the research is being conducted ethically without jeopardizing the rights, safety, and well-being of human subjects.

What is Informed Consent?

Informed consent is a written, signed, and dated form required when the research involves human beings, including patients, children, and healthy volunteers, and uses human genetic material, biological samples, or personal data. Ethical and valid consents indicate the voluntary participation of the subjects in clinical research. Informed consent should be written in an easy, understandable language and should be non-influential, unbiased, and coercion-free.

Informed consent for clinical research usually includes more information than the consent forms meant for standard treatments. It provides ongoing information to help subjects make an educated decision to participate in clinical trials.

Informed consent must provide all necessary information for the participant to make an informed decision. It should include the following details:

• Research statement, purpose, and duration
• A statement that the subject’s participation is voluntary and not compulsory
• Procedures that will be a part of the trial
• Potential benefits, risks, and discomfort of the research
• Measures to ensure the safety and privacy of the Protected Health Information (PHI) of the subject
• Information in case of procedural failure
• The subject’s rights, for example, the subject can withdraw his/her consent for participation anytime
• Contact information of the person who can solve the subject’s queries
• Alternative procedures for treatments, if any

Importance of Informed Consent in Clinical Research

Clinical research facilities should receive signed informed consent from all participants involved in the research study. However, informed consent is more than just asking for participants’ permission. It also involves communicating with the researchers, doctors, and physicians to ensure that the participants understand all procedures involved in the study. Participants need to know that the research studies intend to test the safety and effectiveness of new medicines and treatments for the health and welfare of the public. They should understand that they are not patients but subjects when they become a part of the study. By communicating about the risks and benefits of the participation, subjects can make an informed decision regarding their participation without compromising their cultural, psychological, and social beliefs. Informed consent builds the trustworthiness of subjects for all stakeholders involved in the research. It also reduces the risk of possible legal actions and regulatory penalties.

How to Obtain Informed Consent?

There are two common ways to document informed consent; paper format and electronic format. Paper consent is collected by a research professional from the participant in person, whereas electronic consent (eConsent) is obtained electronically, scanned, and maintained digitally. Obtaining informed consent has always been difficult due to its sensitivity and complexity. Regulatory bodies governing clinical research have provided a few guidelines to obtain informed consent from research subjects. Some of them are mentioned below.

• 1. Competent subjects should personally decide and provide their consent for research participation.
• 2. Incompetent subjects need the consent of their legally acceptable representative (LAR), preferably guardians.
• 3. The potential subject should be aware of LAR’s consent, and any objection by the subject should not remain unnoticed.
• 4. The subject should be informed about the trial using simple language and small consecutive pieces of information.
• 5. An impartial witness should be a part of the informed consent discussion in case the subject or LAR could not read the written information.
• 6. If the subject wants his/her primary physician to be informed about the participation, the stakeholder should obey the subject’s decision.
• 7. Documents such as an informed consent document (ICD) that comprises a patient information sheet (PIS) and an informed consent form (ICF) should be provided before participation.
• 8. Researchers should conduct an interactive session with the subject to avoid any last-minute confusion.
• 9. Based on the understanding of the study, the subject signs the eICF confirming his/her voluntary participation in the study.

Exceptions to Informed Consent

There are a few exceptions to the ethics or general rule of obtaining informed consent. These are emergency research and therapeutic privilege. However, the subject still has the right to refuse to participate in the research study.

• Emergency Research

  It is a situation where human subjects need emergency medical care, are not in a condition to provide their consent, and also do not have any LAR to represent them.

• Therapeutic Privilege

  It is a situation where information disclosure is excused considering that disclosing the information would cause potential harm to the physical, mental, or social well-being of the participant.

Role of a Laboratory Software for Clinical Research Labs in Managing Informed Consent

Failure to obtain informed consent is a crucial issue in clinical research. A laboratory software for clinical research labs, also known as Laboratory Information Management System (LIMS), can help clinical research labs seamlessly manage subject data, demographic and clinical history of subjects, and informed consent to meet ethical and legal requirements. Moreover, it can help associate consent forms with the correct subject records and obtain consent electronically from participants.

Conclusion

Human subjects play a key role in clinical research. The unavailability of research subjects will prevent researchers from testing new drugs and treatments and may halt the advancement of biomedical research and the development of personalized medicine. Therefore, researchers should provide complete care to the participants and respect their decisions. Informed consent assures the integrity of researchers and motivates the voluntary participation of candidates. Digitization can minimize the risk of errors and help manage consent forms easily. A laboratory software for clinical research labs is an important tool to streamline clinical research, securely manage subject data, consent, and documents, and effectively drive clinical research.

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.