Question

61 2.2 Waived Consent in a Breast Cancer Trial In the case below, British researchers persuaded an ethics committee that a particular trial should not involve informed consent because the information to be comveyed in that process would be hurtful to the subjects. However, a subject learned later that she had been involved in the trial without her knowledge or consent. This disclo sure opens the question of whether informed consent should ever be waived and, if so, whether justifications for the waiver in this instance were convincing. The case also raises the question of how to respond to a subject whose trust in physicians has been ruptured perhaps irreparably. "In 1980, aclinical trial wasinitiated by the Cancer Research Campaign Clinical Trals Centre. This was a multi-centre collaborative study looking at the use of adjuvant systemic therapy in early breast cancer. Patients would be randomized to receive con- ventional surgical treatment-which in 1980 did not include adjuvant ther apy-or t surgery and tamoxifen. The clinicians entering the trial at King's College Hospital initially argued that informed consent should be waived to avoid causing unnecessary distress to the patient by making her aware of her exact prognosis and the uncertainty of the best treatment. The ethical committee refused to waive consent so the trial was started with each patient giving fully informed consent and receiving an explanatory leaflet "However, 2 months into the trial, at the behest of the nurse counselor, the trial organizers again approached the ethical committee as they felt that the additional burden on patients-who had just learnt that they had cancer, and needed a mastec tomy-of having to consider whether to enter a trial, was causing undue stress and anxiety. Thus the need for consent was waived, but it was agreed that all patients would receive a full explanation of the rationale behind their treatment. "Eighteen months later another trial was started at King's, to investigate a method of improving psychological adjustment of women to mastectomy by the intervention of a professional counselor. Informed consent was not required for this trial. Because funding for only one part-time counselor was available, it was arranged so that at fortnightly intervals patients who presented to the clinic had a 50-50 chance of meeting the nurse counselor. Additionaly any patients identified by the clinician as having psychological problems were referred for counseling. This randomization of a rare resource-in this case counseling time-is commonly used to maintain the principle of justice. "In 1982, Mrs. E.T. was referred to King's College Hospital with carcinoma of the breast. She was entered into both the above trials, receiving what with hindsight was the optimum treatment of the time-mastectomy and tamoxifen. Mrs. E.T. however, subsequently found out that her treatment, rather than being indi to her, had been randomized as part of a clinical trial, and she had

Answer 1

1. Reducing the stress of Breast cancer patient is not an acceptable reason for waiving of patient consent. For any research studies, the subjects have to get adequate knowledge about the research process and the treatment procedure in the protocols. According to IRB, Informed consent can be waived in case of, the research studies that do not harm the subject at any circumstances and does not alter any changes in the subject during the research protocols. So withholding the knowledge of treatment from the patient should not affect the rights and well being of the patient.