Should Zelen pre-randomised consent designs be used in some neonatal trials?
نویسنده
چکیده
My aim is to suggest that there is a case for using a randomised consent design in some neonatal trials. As an example I use the trials of extracorporeal membrane oxygenation (ECMO) in neonates suffering pulmonary hypertension. In some trials the process of obtaining consent has the potential to harm the subject, for example, by disappointing those who end in the control group and by creating additional anxiety at times of acute illness. An example of such were the trials of extracorporeal membrane oxygenation (ECMO) in neonates suffering pulmonary hypertension. Pre-randomised consent could avoid or lessen these harms. However, a number of ethical objections are made to these research designs. They involve denial of information, using people, denial of choice, and "overselling" of allocated treatment. Furthermore, they are the wrong response; better communication might be the answer, for example. I argue that these objections are not completely persuasive. However, they are enough to suggest caution in the use of such designs.
منابع مشابه
A qualitative study exploring the acceptability of the McNulty-Zelen design for randomised controlled trials evaluating educational interventions
BACKGROUND Traditional randomised controlled trials evaluating the effect of educational interventions in general practice may produce biased results as participants know they are being evaluated. We aimed to explore the acceptability of a McNulty-Zelen Cluster Randomised Control Trial (CRT) design which conceals from educational participants that they are in a RCT. Consent is obtained from a t...
متن کاملUsing the Zelen design in randomized controlled trials: debates and controversies.
BACKGROUND The use of the randomized consent design (commonly known as the Zelen design) is a controversial issue in randomized controlled trials. In the Zelen design, participants are randomly allocated prior to seeking consent. Those participants allocated to the intervention group are then approached and offered the intervention, which they can decline or accept. Zelen first proposed the des...
متن کاملThe reform study: a cohort multiple randomised controlled trial
Background Undertaking randomised controlled trials can be challenging. Many trials fail to recruit, there may be issues around consent, patient preferences and treatment comparisons. The patient preference and Zelen designs have attempted to address the issues around recruitment and patient preference. However the cohort multiple randomised controlled trial has been suggested as an alternative...
متن کاملThe ACCESS study a Zelen randomised controlled trial of a treatment package including problem solving therapy compared to treatment as usual in people who present to hospital after self-harm: study protocol for a randomised controlled trial
BACKGROUND People who present to hospital after intentionally harming themselves pose a common and important problem. Previous reviews of interventions have been inconclusive as existing trials have been under powered and done on unrepresentative populations. These reviews have however indicated that problem solving therapy and regular written communications after the self-harm attempt may be a...
متن کاملConsent processes in cluster-randomised trials in residential facilities for older adults: a systematic review of reporting practices and proposed guidelines
OBJECTIVE To assess the quality of reported consent processes of cluster-randomised trials conducted in residential facilities for older people and to explore whether the focus on improving the general conduct and reporting of cluster-randomised trials influenced the quality of conduct and reporting of ethical processes in these trials. DESIGN Systematic review of cluster-randomised trials re...
متن کاملذخیره در منابع من
با ذخیره ی این منبع در منابع من، دسترسی به آن را برای استفاده های بعدی آسان تر کنید
برای دانلود متن کامل این مقاله و بیش از 32 میلیون مقاله دیگر ابتدا ثبت نام کنید
ثبت ناماگر عضو سایت هستید لطفا وارد حساب کاربری خود شوید
ورودعنوان ژورنال:
- Journal of medical ethics
دوره 25 4 شماره
صفحات -
تاریخ انتشار 1999