Volume 195 - Issue 1
The implications of mandatory notification for clinician-researchers involved in observational research in health services
Authors: Rick A M Iedema and Donella A Piper
Med J Aust 2011; 195 (1): 54. || doi: 10.5694/j.1326-5377.2011.tb03197.x
Published online: 4 July 2011
Published online: 4 July 2011
To the Editor: The Health Practitioner Regulation National Law Act 2009 (Part 8, Sections 140 and 141) enshrines mandatory notification in the new national registration framework. As registered health practitioners, clinician-researchers are bound by the notification requirements. This raises the question of whether mandatory notification has implications for observational research in health services that is conducted by clinician-researchers. In particular, how likely is it that these requirements will lead to reclassification of one’s observations from “research data” to “notification evidence”?
Three initial considerations are important here. First, the Act was designed to make health care safer for patients. Its intent is to limit incidents by ensuring clinicians are more open about and address inappropriate care. Second, serious incidents are rarely isolated, instantaneous and therefore easily observable disasters. When something goes seriously wrong, problems tend to be inherent in how teams practise, communicate and support one another over time. Third, observers may encounter instances of substandard care, but these become notifiable only when the threshold of unsafety is surpassed. This threshold is pegged to relatively high levels of severity, frequency and risk.1 In all, observational research can help clinicians to identify existing risks, but it is unlikely to become a source of notification.
Human research ethics committees may also feel obliged to acknowledge and consider the possibility of incident notifications arising from observational research. However, it would not be wise to regard the risk of such notification as detracting from a study’s potential for obtaining ethics approval. The situation calls for specification of:
how the observers will deal with incidents if and when observed
the observers’ understanding of the definition and threshold of notification
how the definition of notification is likely to bear on the study
how the design of the study affects the likelihood of notification (eg, does the researcher seek to identify care irregularities or track these irregularities over time?)
a projection of the relevant service’s vulnerabilities to notification, and plans for addressing and resolving existing vulnerabilities.
In addition, mandatory notification does not mean that observational research will be more difficult to “sell” to ethics committees and frontline clinicians. The aim is generally to stimulate learning and raise awareness of problems. Our experience is that if the research is designed with frontline clinicians, and they contribute to its implementation, analysis and publication,2 it attracts considerable interest and support.3 Frontline staff know that the best way to understand the complexities inherent in their everyday work is through observation. Such research takes seriously their specific and unique circumstances, enabling them to actively participate as analysts and improvers of their own practice. Observation encourages reflection, and this means they become aware of and can proactively resolve their own vulnerabilities. Ultimately, the priority for clinician-researchers involved in observational research in health services, as for patients, is to reduce risks and prevent incidents.
References
- Health Care Complaints Commission, New South Wales Government. Mandatory reporting — what practitioners need to know. Sydney: HCCC, 2010. http://www.hccc.nsw.gov.au/Information/Information-For-Health-Providers/Mandatory-reporting---What-Practitioners-need-to-know-/default.aspx (accessed Apr 2011).
- Iedema R, Merrick ET, Rajbhandari D, et al. Viewing the taken-for-granted from under a different aspect: a video-based method in pursuit of patient safety. Int J Mult Res Approaches 2009; 3: 290-301. 0_CBBBBFDA
- Iedema R. Creating safety by strengthening clinicians’ capacity for reflexivity. BMJ Qual Saf 2011; 20 Suppl 1: i83-i86. 0_CBBJAFIB