The informed consent process in randomised controlled trials: a nurse-led process.

IntroductionClinical trials involve direct observation of people to answer questions about how illness can be safely prevented, diagnosed or treated. Randomised controlled trials (RCTs) are the only type of clinical trial that can show cause and effect relationships between variables. Patients in RCTs are randomly allocated to either the intervention being investigated or the current standard treatment. The random allocation means any difference between the two groups at the end of the RCT is likely to be caused by the investigational intervention (Jadad & Enkin, 2007).Researchers must ensure patients give well informed voluntary consent to participate in RCTs (Beardsley, Jefford & Milshkin, 2007), and increasingly this important and challenging role has become part of clinical research nurses' responsibilities (Cantini & Ells, 2007; Tomlin, deSalis, Toerien, & Donovan, 2012). Clinical research nurses usually manage RCTs with doctor or researcher supervision (Pick, Liu, Drew, & McCaul, 2010). Gaining informed consent in RCTs involves good communication as participants must understand the purpose, risks and benefits of the research and that taking part is voluntary (National Ethics Advisory Committee, 2012). Information sheets and consent forms are the main tools used to explain the research and to record the participant's signature, indicating consent to take part in the trial. Increasing trial complexity and regulation mean information sheets are lengthening and becoming more complicated (Antoniou et al., 2011). Therefore, informed consent should be seen as an ongoing process and not simply the act of signing a consent form (Allmark & Mason, 2006).Clinical research nurses need a comprehensive understanding of their nursing specialty, and of the research process along with legislative and ethical requirements. The clinical research nurse may write RCT protocols, proposals and submissions to ethics committees, manage budgets, and recruit patients to take part in a trial (Poston & Buescher, 2010). Their nursing role includes ethical trial management and patient protection through patient advocacy (Davis, Hull, Grady, Wilfond, & Henderson, 2002). The clinical research nurse role, in the informed consent process, has been described in international literature as being facilitative or collaborative in nature but further indepth exploration has been recommended (Cantini & Ells, 2007). The study reported in this paper aimed to explore the experience of New Zealand clinical research nurses with respect to the informed consent process in RCTs.Literature ReviewBell (2009) reports there is minimal nursing literature and workforce data related to New Zealand research nurses, and little recognition of their expertise or responsibilities. The Nursing Council of New Zealand (2007) competencies for safety to practice situate responsibility for ensuring informed consent in RCTs with the clinical research nurse. The competencies include establishing that, in order to protect their rights clients have adequate explanation of the effects, consequences and alternatives of proposed treatment options. The competencies also require nurses to discuss ethical issues and make appropriate professional judgements about clients' decisionmaking abilities.As a consequence of researchers ignoring participants' human rights New Zealand guidelines on informed consent have been developed. An investigation into a failure to inform women with cervical cancer that they were in a clinical trial and withholding of treatment without their knowledge, known as The Unfortunate Experiment (Coney, 1988), highlighted this issue. This negation of the women's rights led to the creation of new protections for research participants including The Office of the Health and Disability Commissioner, the Code of Health Consumers Rights (1996) and independent ethics committees to review all research on human participants (Health and Disability Commissioner, 2012). …