ABSTRACT

Montgomery (2003), while recognising the dangers of relying on overseas decisions, suggests that English courts may follow the Canadian case, Halushka v University of Saskatchewan (1965), which held that for consent to medical research to be valid there must be a ‘full and frank’ disclosure of the facts. It is also possible that the consent requirements for therapeutic research (ie, research that may also provide some clinical benefit to the patient) may only require the Bolam standard of information disclosure while non-therapeutic research would require the higher standard of disclosure (but see Gold v Haringey HA (1988), 2.4 above). However, since the Bolam test is based on the opinion of a reasonable body of medical opinion, the requirements for information disclosure in medical research will most likely be greater than for medical treatment. This follows because current professional and ethical guidelines (such as the Declaration of Helsinki 1964 (as amended 2000) and GMC guidance) demand it.