Informed Consent in Clinical Research

Informed Consent in Clinical Research

1. Definition & conceptual basis

• Informed consent is the process by which a competent individual, after being given and having understood all relevant information about a research study, voluntarily confirms her/his willingness to participate — it is the operative participant-protection mechanism that the Declaration of Helsinki mandates and the Ethics Committee (EC)/IRB reviews. (ICMR 2017 §5.0, p.49)
• ICMR frames informed consent as a continuous process, not a one-time signature event, comprising three main components: (i) providing relevant information to potential participants, (ii) ensuring competence of the individual and that the information is easily comprehended, and (iii) assuring voluntariness of participation. (ICMR 2017 §5.0, p.49)
• The ethical foundation is respect for individual autonomy — informed consent protects the individual's freedom of choice and respects the right of competent individuals to decide freely whether or not to participate, or to withdraw at any time. (ICMR 2017 §2.2, p.5; §5.0, pp.49–50)
• The Belmont Report (1979) articulated respect for persons — that everyone has the right to make her own decisions about research participation, including providing informed consent and being free to discontinue participation at any time — as the principle underpinning consent; persons lacking decision-making capacity may participate only if a surrogate gives permission and the participant does not object. (Browner 5e Ch.7, pp.2–3)
• Historically, US federal regulations requiring informed consent and IRB review (1974) were a direct response to the Tuskegee syphilis study (1932–1972), in which investigators withheld penicillin and deceived participants — violating respect for persons, beneficence, justice and truth-telling. (Browner 5e Ch.7, pp.2–4)
• The international legal anchor is the UN International Covenant on Civil and Political Rights (1966), Article 7: "no one shall be subjected without his free consent to medical or scientific experimentation." Subjects are entitled to know they are being entered into research even where the research is thought "harmless." (Bennett & Brown Ch.4, p.37)
• Consent is required because in research — unlike routine care — the primary intention is to advance generalizable knowledge so patients in general may benefit; the individual participant may or may not benefit directly. This distinguishes research from innovative medical practice (whose sole intent is to benefit the individual patient) and from audit. (Bennett & Brown Ch.4, pp.38–39)