Informed Consent - Help or Hindrance

The Inter-role Confidentiality Conflict in Recruitment for Clinical Research

“…Whilst one can imagine how easily this might occur, and how readily it might contribute to clinical improvement, it plainly constitutes a source of systematic bias which ought to be controlled in any well-designed research. We concur with the view that maximizing good is inherently impossible in a randomized clinical trial genuinely using the null hypothesis, as the investigator here is genuinely unsure which treatment is better (Marsh, 1990). Thus whilst it could conceivably be true, as has been suggested, that adults in cancer trials generally have better outcomes than those outside trials (Van Dongen & Van de Velde, 1996), this requires explanation and justi®cation.…”

“…227±231;Taylor, Margolese, & Soskolne, 1984). This is not surprising and supports the conceptual difference between the two, which is inherent in the fact that whilst maximization of individual patient bene®t is an important objective in clinical practice, it is inherently impossible in clinical trials (Marsh, 1990) which must be founded on the null hypothesis (Freedman, 1987), as we discuss later. The null hypothesis disbars any intention to bene®t the patient speci®cally by entering her in a trial: 4 a genuine null hypothesis means that it cannot be known whether a patient will bene®t from the treatment to which she is allocated (frequently, by randomization).…”