Informed consent process: Foundation of the researcher–participant bond
Amrita Sila b c d e, NilayKanti Dasf g h i j
- aDepartment of Pharmacology, Institute of Post Graduate Medical Education and Research, Kolkata, West Bengal, India
- bMember of Dermatology Clinical Trials Special Interest Group, IADVL Academy of Dermatology, India
- cMember of Institutional Ethics Committee, Institute of Neurosciences, Kolkata, West Bengal, India
- dDepartment of Pharmacology, Institute of Post Graduate Medical Education and Research, Kolkata, West Bengal
- eMember of Institutional Ethics Committee, Institute of Neurosciences, Kolkata, West Bengal
- fCoordinator of Dermatology Clinical Trials Special Interest Group, IADVL Academy of Dermatology, India
- gDepartment of Dermatology, Bankura Sammilani Medical College, Bankura, West Bengal, India
- hMember of Institutional Ethics Committee of Human Research, Medical College, Kolkata, West Bengal, India
- iDepartment of Dermatology, Bankura Sammilani Medical College, Bankura, West Bengal
- j
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Abstract
Consenting to participate in a clinical research study after being properly and correctly informed upholds the basic ethical principle of "autonomy" in human research. The informed consent is a process by which the physician sensitizes the patient about the nature, procedures, risks benefits, treatment schedules, etc of the study in a language that is non-technical and understandable by the study participant. Informed consent document (ICD) has got two parts: the 'Subject Information Sheet' and the 'Informed Consent Form' (ICF); and they have to be approved by the Institutional Ethics Committee (IEC) before administration. Consent should be obtained without any coercion. In case of a situation where a participant is not able to give informed consent (e.g. unconscious, minor or those suffering from severe mental illness or disability) or is illiterate, it has be obtained from a legally acceptable representative (LAR). If the participant or LAR is unable to read/write, then an impartial witness should be present during the entire informed consent process and must append his/her signatures to the consent form. For children < 7 years, verbal consent is essential and for mature minors (age group 7 to 18 years) informed assent should be obtained.
TL;DRThe informed consent is a process by which the physician sensitizes the patient about the nature, procedures, risks benefits, treatment schedules, etc of the study in a language that is non-technical and understandable by the study participant. (Semantic Scholar)