The National Health Research Council, which is part of the Ministry of Health and Population, has released the National Ethical Guidelines for Health Research, 2022, to address the issues that health research faces and improve its effectiveness. One of the standards’ requirements is that the informed consent process in health research is followed.
Before enrolment, prospective participants are addressed by the researcher for informed consent. “It is the researcher’s job to tell the prospective participant about the research’s aims and objectives, the participant’s role and duties, research processes, and potential benefits and hazards of such participation,” the statement states. A participant can grasp the rationale for the research after receiving information most effectively. It will be the researcher’s job to ensure that the potential participant is fully involved in the decision-making process.
The researcher must ensure that the prospective participant has properly comprehended the material being delivered, according to the criteria. The participant should be given enough time to understand the process. The researcher must make it clear that the participant is being asked for permission to engage in the study willingly and that he or she has the right to withdraw from it at any time.
“The participant should also be assured that declining to participate will have no impact on how he or she is treated now or in the future. Details about the study should be described in the informed consent letter in a way that the potential participant can understand. He or she must be given sufficient time to ponder and make a decision about whether or not to participate.”
Similarly, before the start of any research involving human participants, voluntarily informed consent must be documented. During all stages of the study, it is also vital to safeguard the privacy and confidentiality of the participant’s personal information. To make an informed decision, the potential participant must be given thorough information on the research subject, according to the criteria. Potential hazards and advantages, nature of involvement, discomfort, reimbursement for time, travel, and lost pay are all examples of extensive information. To grant valid, well-informed, and voluntary consent, participants must be medically competent.
The rule stipulates that participants in the study must give their agreement voluntarily, without any influence, intimidation, or undue incentive. Participants over the age of 18 must sign a written informed consent form. The refusal of a youngster to participate or continue in the study should be honored. The child’s age must be determined using the child’s birth certificate, school record, or other reliable documentary evidence.
Participants should also be given enough information about the proposed research, such as methods, objectives, perils and afflictions, expected benefits, and alternative techniques. Additionally, participants should be given a statement that clearly states that they have the right to ask questions and withdraw from the study at any time without penalty.