Informed Consent for Clinical Research: Getting it Right From the Start

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.

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.