KATHMANDU, JUNE 13
The National Health Research Council under the Ministry of Health and Population has issued the National Ethical Guidelines for Health Research, 2022 to overcome challenges confronting the health research and to make it more effective.
One of the requirements set by the guideline is related to informed consent process in health research. Informed consent is a process by which prospective participants are approached by the researcher before enrolment. "It is the responsibility of the researcher to inform the prospective participant about the aims and objectives of the research, participant's role and responsibilities, research procedures, potential benefits and risks of such participation, among others," it says.
After communicating information in the best way, a participant can understand the rationale behind the research.
It will be the responsibility of the researcher to allow the prospective participant to be fully involved in the decision-making process. According to the guideline, the researcher must ensure that the prospective participant has fully understood the information being provided. Adequate time should be given to the participant to comprehend the process. The researcher has to clearly emphasise that the participant is being asked for permission to participate in the study voluntarily and thus is very much entitled to withdraw from the study at any point without any prejudice.
"The participant should also be assured that refusal to participate will not affect the way he/she is getting treatment now or in future. Research details should be outlined in the informed consent document in the manner and language the prospective participant can easily understand.
Sufficient time has to be provided to him/her to think and take decision on whether to participate or not to participate," the guideline reads.
Similarly, it is mandatory to document voluntary informed consent before commencement of research involving human participants.
It is also necessary to maintain privacy and confidentiality of the participant's personal information during all stages of the study. As per the guideline, the prospective participant must be provided with detailed information on the research subject to make a fully informed decision. Such detailed information may include potential risks and benefits, nature of involvement, discomfort, compensation for time, travel, and lost wages.
Participants should be medically competent to give a valid, well-informed and voluntary consent.
The guideline requires consent to participate in the research voluntarily without any pressure, coercion, or any undue inducement. Written informed consent must be obtained from participants above the age of 18 years. A child's refusal to participate or continue in the research should be respected. The age of the child needs to be determined by child's birth certificate/school record or competent documentary evidence.
Likewise, participants should be given sufficient information about the proposed research, including information on procedures, purpose, risks/discomforts, anticipated benefits and alternative procedures. The participants should also be provided with a statement that clearly mentions their right to ask question and withdraw from the research at any point without any penalty.
A version of this article appears in the print on June 14, 2022, of The Himalayan Times.
