The process of research is as important as its outcome. More than just a legal requirement, informed consent is a crucial ethical responsibility of researchers working with human participants.

Use of anaesthesia in surgery, the smallpox vaccine, birth control pills, heart transplant. These are just a small sample of breakthroughs which changed the world of medicine. Without volunteers participating in clinical trials and research to evaluate the new drug, tool or treatment, none of these innovations would have been brought to practice.

In recruiting the volunteers, it is not enough to just get them to read and sign on the consent document. Obtaining participant's informed consent is both an ethical responsibility of the investigator and an opportunity for would-be participants to raise questions or concerns.  

What is informed consent?

Anushia Panchalingham, Senior Clinical Research Associate at SingHealth's Research Quality Assurance unit, explains, "Informed consent ensures the prospective participants' understanding of the study and their willingness to take part. More importantly, they can discuss any questions or concerns with the investigator. The discussion is always documented for accountability."

For example, the participant can learn more about his or her rights, the purpose of the study, the exact procedures he or she will go through, their potential risks as well as the benefits of participating in the study.

To ensure all aspects of informed consent are covered, investigators are required to comply with International Council on Harmonisation – Good Clinical Practice (ICH-GCP) Guidelines and the Human Biomedical Research Act. In addition, in SingHealth all informed consent forms for research must first be approved by the SingHealth Centralised Institutional Review Board (CIRB). 

 

"We should always keep in mind that the participants are patients under our care who have volunteered to advance medical science, and that we have their best interests at heart.  After all, they are the ones who make medical trials and research possible and successful."
- Anushia Panchalingham, Senior Clinical Research Associate, SingHealth's Research Quality Assurance unit

"The process can be very tedious, adding workload to researchers who are already stretched for time. But documentation protects both the research team and the patients, and prevents the need to take corrective measures later in the trial, which can be even more time consuming," said Anushia.

She added that it is about the integrity of the trial or research: "Proper research conduct is all about adequate documentation and ensuring that the research conduct is in compliance to applicable regulations, policies and guidelines. If there's none, is the research valid? Without adequate evidence, a research outcome has no value."

Compliance to ethical research

According to Anushia, the most common non-compliance review findings are in the area of informed consent.  "The cases we find are largely due to oversight. For example, the investigator might not have used an updated IRB-approved consent form."

"If this happens, the informed consent has to be obtained again. Investigators would also have to notify IRB."

Informed consent is a very crucial aspect of ethical research. Investigators must understand the principles of proper conduct of research to protect the safety and welfare of their patients.

Anushia added, "We should always keep in mind that the participants are patients under our care who have volunteered to advance medical science, and that we have their best interests at heart. After all, they are the ones who make medical trials and research possible and successful."

​For researchers -
Here's a list of things to remember for informed consent:
1.  Informed consent is necessary if your research involves human participants. This is unless waiver has been sought and given by IRB based on the investigator's study design.

2.  Bear in the mind the four principles of medical ethics: autonomy, beneficence, non-maleficence and justice.

3. Communication is key. Explain the study adequately and in layman terms. For non-English speakers, consider providing translations or translators.

4.  Give prospective participants ample time to understand and consider their involvement. They should never feel coerced to take part.

5.  Documentation is very important! 

6.  Be diligent to ensure compliance with current research regulations and guidelines. Non-compliance can result in severe consequences.

7.  Stay updated - Researchers and study teams are encouraged to update themselves with institution's policies, IRB requirements and ICH-GCP* guidelines and MOH regulations. 

*GCP (Good Clinical Practice) is an international quality standard that is provided by the ICH (International Conference on Harmonisation), an international body that defines standards, which governments can transpose into regulations for clinical trials involving human subjects. GCP enforces tight guidelines on ethical aspects of a clinical study.