Open AccessInformed consent process: Foundation of the researcher–participant bond
Author(s) -
Abheek Sil,
Nilay Kanti Das
Publication year - 2017
Publication title -
indian journal of dermatology/indian journal of dermatology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.395
H-Index - 36
eISSN - 1998-3611
pISSN - 0019-5154
DOI - 10.4103/ijd.ijd_272_17
Subject(s) - informed consent , witness , autonomy , medicine , coercion (linguistics) , foundation (evidence) , voluntariness , family medicine , psychology , law , alternative medicine , political science , pathology , linguistics , philosophy
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.