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Ethical framework for research in prison
Published in Joanne Brooke, Dementia in Prison, 2020
The assessment of risk involves both concepts of beneficence and non-maleficence, and because of the historical context of prison research, there is a strong emphasis on minimising the risk to prisoners with a focus on the benefits. This is reflected in the Belmont Report (1979), which stated ‘the risk and benefits must be balanced and shown to be in a favourable ration’. However, the Council of Europe (2005) identified that ‘non-beneficial’ research may include prisoners, but only if the research can only be conducted with prisoners, the outcome will benefit prisoners and the risk to prisoners who do participate is no more than minimal. Therefore, within the research protocol there needs to be a clear analysis of the potential risks and benefits. The risk analysis needs to identify a risk management plan to deal with any potential risk or harm to a participant. This plan also needs to include the mechanisms for safeguarding, and if the need arises, identify who the relevant information should be shared with to prevent potential self-harm by the participant. Furthermore, a management plan and safeguarding mechanisms for the potential harms to others or the risk of breaching prison security need to be developed with the same considerations.
Privacy and Security Challenges of Improved Patient Engagement
Published in Jan Oldenburg, Dave Chase, Kate T. Christensen, Brad Tritle, Engage!, 2020
As with the use of other technologies, providers deploying patient portals will need to conduct a risk assessment and formulate a risk management plan that implements appropriate and reasonable safeguards. This may include encryption of the information in transit and at rest, authentication of the patient, and logging and review of system activity. Healthcare providers should consider that certain security measures, such as robust password requirements, may act as an obstacle to patient engagement and should consider whether risks can be addressed through a combination of less obtrusive controls.
Risk and Patient Safety for the Legal Nurse Consultant
Published in Julie Dickinson, Anne Meyer, Karen J. Huff, Deborah A. Wipf, Elizabeth K. Zorn, Kathy G. Ferrell, Lisa Mancuso, Marjorie Berg Pugatch, Joanne Walker, Karen Wilkinson, Legal Nurse Consulting Principles and Practices, 2019
Bruce Edens, Andree Neddermeyer
The Centers for Medicare & Medicaid Services (CMS) provides the funding for the health care of a significant proportion of US citizens and has been instrumental in establishing and codifying federal healthcare policy and practice. Specifically, the CMS has opined on the definitions of several healthcare risk terms including:Risk: a measure of the extent to which an entity is threatened by a potential circumstance or event, and typically a function of: (i) the adverse impacts that would arise if the circumstance or event occurs; and (ii) the likelihood of occurrence (CMS, 2012a).Risk Management: the program and supporting processes to manage information security risk to organizational operations (including mission, functions, image, reputation), organizational assets, individuals, other organizations, and the Nation, and includes: (i) establishing the context for risk-related activities; (ii) assessing risk; (iii) responding to risk once determined; and (iv) monitoring risk over time (CMS, 2012a). The Risk Management Plan for a healthcare delivery organization must take into account there are amplified risks related to professional liability and regulatory compliance as well as additional risks occasioned by the nature of the enterprise that are above and beyond risks in a typical business organization. Some of these unique healthcare delivery associated risks are summarized in Table 22.2.
Catalysts towards cancer risk management action: A longitudinal study of reproductive-aged women with BRCA1/2 mutations
Published in Journal of Psychosocial Oncology, 2018
Allison Werner-Lin, Anne L. Ersig, Rebecca Mueller, Jennifer L. Young, Lindsey M. Hoskins, Ria Desai, Mark H. Greene
Creating a risk management plan in collaboration with providers is a critical step for women at increased risk of breast and ovarian cancer to increase confidence, reduce ambiguities, and lower cancer morbidity and mortality. Yet, a narrow, standardized approach to management focused solely on medical outcomes obfuscates the component steps of each behavior; many women pursue multiple, overlapping steps, attended to over time, and some never complete intended actions. Further, a standardized approach fails to incorporate the varied pragmatic, relational, and social ways in which women choose whether to complete these actions, particularly during the reproductive years when risk management and family formation remain in tension (Young et al., 2017; Evans, Hamilton, & Tercyak, 2016; Willis et al., 2017; Hesse-Biber & An, 2016). For example, intent to complete RRBM assumed the presence of a life partner, resolution around family formation and breast-feeding, and time available to recover from surgery. No participant considered the time required to seek out information about the types of surgery, common surgical complications, the need to find providers willing to perform desired techniques, ongoing communication with insurance companies, or competing family pressures.
Regulatory experience of handling Risk Management Plans (RMPs) for medicinal products in the EU
Published in Expert Opinion on Drug Safety, 2021
Dianne Butler, Katarina Vucic, Sabine Straus, Amelia Cupelli, Benjamin Micallef, Anthony Serracino-Inglott, John-Joseph Borg
A risk management plan is a tool to protect public health. It describes what is known and unknown about the safety of the medicinal product, further characterize the risk after authorization and define appropriate measure to minimize the risks associated with the medicinal product. The RMP is a requirement for the authorization of many different types of medicinal products. The developers of a medicinal product must comply with the different requirements of the authority granting the marketing authorization. Typically, the risks to be mitigated are similar across locations. The impact of these risks may, however, differ due to differences within healthcare systems and delivery issues.
Nurse evaluation of the redesigned fertility pen injector: a questionnaire-based observational survey
Published in Expert Opinion on Drug Delivery, 2018
Participants also had access to the unbranded updated IFU for the redesigned pen injector, which describes the injection process in seven distinct steps, with an appendix (Appendix A) containing instructions for completing an incomplete dose (Table 1). This study evaluated perceptions of steps 3–6, Appendix A and the constituent sub-steps, all of which were identified in the risk-management plan for their potential for use errors. The risk-management plan was implemented to identify hazards associated with use, estimate and evaluate risks, and develop, implement, and monitor risk-control measures [28].