ABSTRACT
Chapter 8 returns to the case of Rambha Gajre and asks whether, and if so, under what conditions the offer of payment invalidates consent to participation in a clinical trial. Cases like Rambha’s pose the strongest challenge to ICCJ’s position that the voluntariness of consent is neither a ‘psychological’ concept indicative of the inner states of a person’s mind nor a ‘circumstantial’ concept indicative of a person’s set of options. To address the question of whether offering payment invalidates consent, the chapter starts from the presumption that it does not because consent to financial transactions is normally voluntary. The chapter then tests whether this presumption can be defeated in the context of paid trial participation. It discusses three potential defeaters, namely aversion, lack of acceptable alternatives, and risk. It argues that paying participants invalidates consent only in certain cases of increased risks when investigators illegitimately withhold an option of safer trials or penalise withdrawal. In supporting these claims, the chapter shows how ICCJ neatly aligns with them and therefore best protects people like Rambha.
