July 28, 2022
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.
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:
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.
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.
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.
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.
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.
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.
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.