Informed consent process: Foundation of the researcher–participant bond

• Main Authors: Amrita Sil, Nilay Kanti Das
• Format: Article
• Language: English
• Published: Wolters Kluwer Medknow Publications 2017-01-01
• Series: Indian Journal of Dermatology
• Subjects: Informed consent form; informed consent document assent; LAR; vulnerable population
• Online Access: http://www.e-ijd.org/article.asp?issn=0019-5154;year=2017;volume=62;issue=4;spage=380;epage=386;aulast=Sil

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.