Ethical issues in residency education related to the COVID-19 pandemic: a narrative inquiry study.

BACKGROUND: The COVID-19 pandemic introduced new challenges to provide care and educate junior doctors (resident physicians). We sought to understand the positive and negative experiences of first-year resident physicians and describe potential ethical issues from their stories. METHOD: We used narrative inquiry (NI) methodology and applied a semistructured interview guide with questions pertaining to ethical principles and both positive and negative aspects of the pandemic. Sampling was purposive. Interviews were audio recorded and transcribed. Three members of the research team coded transcripts in duplicate to elicit themes. Discrepancies were resolved through discussion to attain consensus. A composite story with threads was constructed. RESULTS: 11 residents participated across several programmes. Three main themes emerged from the participants' stories: (1) complexities in navigating intersecting healthcare and medical education systems, (2) balancing public health and the public good versus the individual and (3) fair health systems planning/healthcare delivery. Within these themes, participants' journeys through the first wave were elicited through the threads of (1) engage us, (2) because we see the need for the duty to treat and (3) we are all in this together. DISCUSSION: Cases of the ethical issues that took place during the COVID-19 pandemic may serve as a foundation on which ethics teaching and future pandemic planning can take place. Principles of clinical ethics and their limitations, when applied to public health issues, could help in contrasting clinical ethics with public health ethics. CONCLUSION: Efforts to understand how resident physicians can navigate public health emergencies along with the ethical issues that arise could benefit both residency education and healthcare systems.

Ethical Justification for Deferral of Consent in the AcT Trial for Acute Ischemic Stroke.

The AcT trial (Alteplase Compared to Tenecteplase) compares alteplase or tenecteplase for patients with acute ischemic stroke. All eligible patients are enrolled by deferral of consent. Although the use of deferral of consent in the AcT trial meets the requirements of Canadian policy, we sought to provide a more explicit and rigorous approach to the justification of deferral of consent organized around 3 questions. Ultimately, the approach we outline here could become the foundation for a general justification for deferral of consent.

Compassion fatigue in healthcare providers: A systematic review and meta-analysis.

BACKGROUND: Compassion fatigue is recognized as impacting the health and effectiveness of healthcare providers, and consequently, patient care. Compassion fatigue is distinct from "burnout." Reliable measurement tools, such as the Professional Quality of Life scale, have been developed to measure the prevalence, and predict risk of compassion fatigue. This study reviews the prevalence of compassion fatigue among healthcare practitioners, and relationships to demographic variables. METHODS: A systematic review was conducted using key words in MEDLINE, PubMed, and Ovid databases. Data were extracted from a total of 71 articles meeting inclusion criteria, from studies measuring compassion fatigue in healthcare providers using a validated instrument. Quantitative and qualitative data were extracted and compiled by three independent reviewers into an evidence table that included basic study characteristics, study strength and quality determination, measurements of compassion fatigue, and general findings. Meta-analysis, where data allowed, was stratified by Professional Quality of Life version, heterogeneity was quantified, and pooled means were reported with 95% confidence interval. A table of major study characteristics and results was created. ETHICAL CONSIDERATION: This paper contains no primary data obtained directly from research participants. Data obtained from previously published resources have been acknowledged within references. Psychological distress, particularly compassion fatigue, can be insidious, no health profession is immune, and may significantly impact the ability to provide care. RESULTS: A total of 71 studies were included. Compassion fatigue was reported across all practitioner groups studied. Relationships to most demographic variables such as years of experience and specialty were either not statistically significant or unclear. Variability in reporting of Professional Quality of Life results was found. INTERPRETATION: Compassion fatigue exists across diverse practitioner groups. Prevalence is highly variable, and its relationship with demographic, personal, and/or professional variables is inconsistent. Questions are raised about how to mitigate compassion fatigue.

Deferral of Consent in Acute Stroke Trials.

Background and Purpose- The ESCAPE trial (The Endovascular Treatment for Small Core and Anterior Circulation Proximal Occlusion With Emphasis on Minimizing CT to Recanalization Times) was a multicentre, randomized controlled trial of endovascular thrombectomy versus standard care for patients with acute ischemic stroke that allowed patients to be enrolled with deferred consent. We investigated the knowledge and opinions of these patients or their authorized third parties about the consent process. Methods- All patients (or their authorized third parties) enrolled with deferral of consent in ESCAPE were invited to complete a 12-question survey within the first 4 days of enrollment and again at 90 days. Questions investigated knowledge of the ESCAPE trial and opinions on deferral of consent. Results- Of 56 patients enrolled with deferred consent, 33 (59%) completed the initial survey, and of these, 27 (81%) completed the 90-day follow-up. Enrollment with deferred consent was not associated with a significant difference in door-to-randomization times (50.5 versus 57 minutes; P=0.29) but allowed these 56 patients to participate in the trial. Only 52% of respondents understood that patients could be randomized to thrombectomy or standard care, although most understood the other basic principles of the trial. At baseline and at 90 days, respondents disagreed or strongly disagreed with deferred consent in acute stroke trials generally (82% and 78%) and in the ESCAPE trial specifically (93% and 91%). Conclusions- Respondents generally disagreed with the use of deferred consent for enrollment in the ESCAPE trial and in stroke trials more generally.

Sharing longitudinal, non-biological birth cohort data: a cross-sectional analysis of parent consent preferences.

BACKGROUND: Mandates abound to share publicly-funded research data for reuse, while data platforms continue to emerge to facilitate such reuse. Birth cohorts (BC) involve longitudinal designs, significant sample sizes and rich and deep datasets. Data sharing benefits include more analyses, greater research complexity, increased opportunities for collaboration, amplification of public contributions, and reduced respondent burdens. Sharing BC data involves significant challenges including consent, privacy, access policies, communication, and vulnerability of the child. Research on these issues is available for biological data, but these findings may not extend to BC data. We lack consensus on how best to approach these challenges in consent, privacy, communication and autonomy when sharing BC data. We require more stakeholder engagement to understand perspectives and generate consensus. METHODS: Parents participating in longitudinal birth cohorts completed a web-based survey investigating consent preferences for sharing their, and their child's, non-biological research data. Results from a previous qualitative inquiry informed survey development, and cognitive interviewing methods (n = 9) were used to improve the question quality and comprehension. Recruitment was via personalized email, with email and phone reminders during the 14-day window for survey completion. RESULTS: Three hundred and forty-six of 569 parents completed the survey in September 2014 (60.8%). Participants preferred consent processes for data sharing in future independent research that were less-active (i.e. no consent or opt-out). Parents' consent preferences are associated with their communication preferences. Twenty percent (20.2%) of parents generally agreed that their child should provide consent to continue participating in research at age 12, while 25.6% felt decision-making on sharing non-biological research data should begin at age 18. CONCLUSIONS: These finding reflect the parenting population's preference for less project-specific permission when research data is non-biological and de-identified and when governance practices are highly detailed and rigourous. Parents recognize that children should become involved in consent for secondary data use, but there is variability regarding when and how involvement occurs. These findings emphasize governance processes and participant notification rather than project-specific consent for secondary use of de-identified, non-biological data. Ultimately, parents prefer general consent processes for sharing de-identified, non-biological research data with ultimate involvement of the child.

The biobank for the molecular classification of kidney disease: research translation and precision medicine in nephrology.

BACKGROUND: Advances in technology and the ability to interrogate disease pathogenesis using systems biology approaches are exploding. As exemplified by the substantial progress in the personalized diagnosis and treatment of cancer, the application of systems biology to enable precision medicine in other disciplines such as Nephrology is well underway. Infrastructure that permits the integration of clinical data, patient biospecimens and advanced technologies is required for institutions to contribute to, and benefit from research in molecular disease classification and to devise specific and patient-oriented treatments. METHODS AND RESULTS: We describe the establishment of the Biobank for the Molecular Classification of Kidney Disease (BMCKD) at the University of Calgary, Alberta, Canada. The BMCKD consists of a fully equipped wet laboratory, an information technology infrastructure, and a formal operational, ethical and legal framework for banking human biospecimens and storing clinical data. The BMCKD first consolidated a large retrospective cohort of kidney biopsy specimens to create a population-based renal pathology database and tissue inventory of glomerular and other kidney diseases. The BMCKD will continue to prospectively bank all kidney biopsies performed in Southern Alberta. The BMCKD is equipped to perform molecular, clinical and epidemiologic studies in renal pathology. The BMCKD also developed formal biobanking procedures for human specimens such as blood, urine and nucleic acids collected for basic and clinical research studies or for advanced diagnostic technologies in clinical care. The BMCKD is guided by standard operating procedures, an ethics framework and legal agreements with stakeholders that include researchers, data custodians and patients. The design and structure of the BMCKD permits its inclusion in a wide variety of research and clinical activities. CONCLUSION: The BMCKD is a core multidisciplinary facility that will bridge basic and clinical research and integrate precision medicine into renal pathology and nephrology.

A survey of patient perspectives on the research use of health information and biospecimens.

BACKGROUND: Personal health information and biospecimens are valuable research resources essential for the advancement of medicine and protected by national standards and provincial statutes. Research ethics and privacy standards attempt to balance individual interests with societal interests. However these standards may not reflect public opinion or preferences. The purpose of this study was to assess the opinions and preferences of patients with kidney disease about the use of their health information and biospecimens for medical research. METHODS: A 45-item survey was distributed to a convenience sample of patients at an outpatient clinic in a large urban centre. The survey briefly addressed sociodemographic and illness characteristics. Opinions were sought on the research use of health information and biospecimens including consent preferences. RESULTS: Two hundred eleven of 400 distributed surveys were completed (response rate 52.8 %). Respondents were generally supportive of medical research and trusting of researchers. Many respondents supported the use of their information and biospecimens for health research and also preferred consent be sought for use of health information and biospecimens. Some supported the use of their information and biospecimens for research without consent. There were significant differences in the opinions people offered regarding the research use of biospecimens compared to health information. Some respondent perspectives about consent were at odds with current regulatory and legal standards. CONCLUSIONS: Clinical health data and biospecimens are valuable research resources, critical to the advancement of medicine. Use of these data for research requires balancing respect for individual autonomy, privacy and the societal interest in the greater good. Incongruence between some respondent perspectives and the regulatory standards suggest both a need for public education and review of legislation to increase understanding and ensure the public's trust is maintained.

An exploratory, descriptive study of consumer opinions and behaviors regarding health products sales at 4 chiropractic practices in a large, western Canadian urban center.

OBJECTIVE: This study describes the opinions and behaviors of chiropractic patients in a large, western Canadian urban center regarding the sale of health products by doctors of chiropractic. METHODS: A brief, descriptive survey consisting of both fixed-choice and open-ended questions was distributed by clinic reception staff at 4 chiropractic offices in Calgary, Alberta, Canada. Each practice sold a range of health products, including those relating to musculoskeletal care and nutrition, and served between 275 and 320 clients per week. RESULTS: After a 10-week recruitment interval between January and March 2013, a convenience sample of 103 chiropractic patients was obtained. Most patients supported the sale of health products by doctors of chiropractic (n = 101; 98.1%), and most had made health product purchases from a doctor of chiropractic at some point (n = 73; 70.9%). Products relating to muscular care, exercise/rehabilitation products, and pillows were purchased most often (>40%). Consumers were most supportive of doctors of chiropractic selling products they perceived to be directly related to musculoskeletal care. Some participants believed that there should be limits placed on the range of products sold including the products had to be consistent with the practitioner's area of expertise and had to have some demonstrated level of effectiveness. Primary reasons for health product purchase included the doctor's recommendations, convenience, and perception that the product would improve well-being (>50%). CONCLUSIONS: This study found that chiropractic patients were supportive of health product sales by doctors of chiropractic, assuming certain conditions were met. Consumers believed that product sales should be undertaken with integrity and should be consistent with the doctor's area of expertise. Consumer beliefs appeared to impact their purchasing behaviors.

Causes of death among an urban homeless population considered by the medical examiner.

Those who are homeless face illness and death, however, live in places not conducive to provision of end-of-life care. Limited information exists on causes of death among this group of people. To characterize causes of death, data were requested from the Office of the Chief Medical Examiner for Alberta Justice, Canada, for people determined to be homeless in the period 2007-2009. One hundred and thirty-two deaths were reported. Most deaths that could be classified were attributed to drug and alcohol use/abuse and to natural causes. For many, end-of-life circumstances may have been improved through provision of palliative care delivered in a hospice setting.

Chiropractic care and public health: answering difficult questions about safety, care through the lifespan, and community action.

The purpose of this collaborative summary is to document current chiropractic involvement in the public health movement, reflect on social ecological levels of influence as a profession, and summarize the relationship of chiropractic to the current public health topics of: safety, health issues through the lifespan, and effective participation in community health issues. The questions that are addressed include: Is spinal manipulative therapy for neck and low-back pain a public health problem? What is the role of chiropractic care in prevention or reduction of musculoskeletal injuries in children? What ways can doctors of chiropractic stay updated on evidence-based information about vaccines and immunization throughout the lifespan? Can smoking cessation be a prevention strategy for back pain? Does chiropractic have relevance within the VA Health Care System for chronic pain and comorbid disorders? How can chiropractic use cognitive behavioral therapy to address chronic low back pain as a public health problem? What opportunities exist for doctors of chiropractic to more effectively serve the aging population? What is the role of ethics and the contribution of the chiropractic profession to public health? What public health roles can chiropractic interns perform for underserved communities in a collaborative environment? Can the chiropractic profession contribute to community health? What opportunities do doctors of chiropractic have to be involved in health care reform in the areas of prevention and public health? What role do citizen-doctors of chiropractic have in organizing community action on health-related matters? How can our future chiropractic graduates become socially responsible agents of change?

Hairdressers as a source of social support: A qualitative study on client disclosures from Australian hairdressers' perspectives.

Hairdressing is one of the few non-health professional occupations where workers physically interact with clients, who are often comfortable in confiding private information to them. Despite this, relatively little is known about how hairdressers understand and experience this role as informal confidants. This study aimed to address this using an in-depth qualitative approach to capture what hairdressers are hearing from clients, and how hairdressers respond and feel about supporting clients. Participant led interviews with prompt questions were conducted in South Australia in 2019, transcribed and analysed using Thematic Analysis. Results indicate clients disclose information about family, health, identity, mental health and women's health. Important themes generated in relation to the role of hairdressers included: their need to have a client focus; blurring role boundaries; behaving like a therapist and, providing a place of safety and advice, while also maintaining confidentiality. Hairdressers reported feeling undervalued, emotionally drained, and in need of support in their role, but conversely, also reported having good job satisfaction. Further research is needed to examine whether hairdresser-client interactions may promote better mental and physical health outcomes for clients due to psychological buffering arising from the social support provided by hairdressers, as well as the impact on hairdressers and implications for their training.

Meaning and challenges in the practice of multiple therapeutic massage modalities: a combined methods study.

BACKGROUND: Therapeutic massage and bodywork (TMB) practitioners are predominantly trained in programs that are not uniformly standardized, and in variable combinations of therapies. To date no studies have explored this variability in training and how this affects clinical practice. METHODS: Combined methods, consisting of a quantitative, population-based survey and qualitative interviews with practitioners trained in multiple therapies, were used to explore the training and practice of TMB practitioners in Alberta, Canada. RESULTS: Of the 5242 distributed surveys, 791 were returned (15.1%). Practitioners were predominantly female (91.7%), worked in a range of environments, primarily private (44.4%) and home clinics (35.4%), and were not significantly different from other surveyed massage therapist populations. Seventy-seven distinct TMB therapies were identified. Most practitioners were trained in two or more therapies (94.4%), with a median of 8 and range of 40 therapies. Training programs varied widely in number and type of TMB components, training length, or both. Nineteen interviews were conducted. Participants described highly variable training backgrounds, resulting in practitioners learning unique combinations of therapy techniques. All practitioners reported providing individualized patient treatment based on a responsive feedback process throughout practice that they described as being critical to appropriately address the needs of patients. They also felt that research treatment protocols were different from clinical practice because researchers do not usually sufficiently acknowledge the individualized nature of TMB care provision. CONCLUSIONS: The training received, the number of therapies trained in, and the practice descriptors of TMB practitioners are all highly variable. In addition, clinical experience and continuing education may further alter or enhance treatment techniques. Practitioners individualize each patient's treatment through a highly adaptive process. Therefore, treatment provision is likely unique to each practitioner. These results may be of interest to researchers considering similar practice issues in other professions. The use of a combined-methods design effectively captured this complexity of TMB practice. TMB research needs to consider research approaches that can capture or adapt to the individualized nature of practice.

The perspectives and practices of alberta chiropractors regarding the sale of health care products in chiropractic offices.

OBJECTIVE: The purpose of this study is to describe the practices and perspectives of doctors of chiropractic in Alberta, Canada, regarding the sale of health products. This practice is considered in terms of ethical principles and professional practice standards. METHODS: Chiropractic Web sites in Alberta were identified using the publically available Web site of the Alberta College and Association of Chiropractors. A random sample of chiropractors was drawn and mailed a brief 4-page survey and return envelope. There was a follow-up mail out to nonrespondents 3 weeks later. Practitioners provided responses regarding their personal and professional characteristics and their perspectives and practices regarding health product sales. RESULTS: A total of 265 responses were received (response rate, 51.2%). Most practitioners endorsed health product sales by chiropractors (95%), and most were engaged in the practice (89%). Orthotics (77%) and pillows (69%) were sold most often, followed by nutritional supplements (68%), hot/cold packs (68%), and vitamins (52%). Some respondents identified areas of potential ethical concern, including product safety and efficacy, professional influence on consumer product purchase, and potential conflict of interest. Codes of ethics and conduct offer some guidance to practitioners, but their awareness of standards varied. CONCLUSIONS: The chiropractic profession within Alberta condones product sales, and most of its membership engages in the practice. Individual members differ in their perspectives on this practice and in their awareness of the national code of ethics and conduct.

How Semantics Connotations May Influence Concerns About Donation of Biospecimens.

Introduction: Human biological specimen (biospecimen) donation is routinely requested for clinical care and research purposes. Successfully engaging patients and research participants in biospecimen donation depends on what they understand these initiatives entail, including their perceptions of risk. Human biospecimens are stored in facilities routinely referenced as biobanks or biorepositories, both of which labels are known to embody a variety of connotations. The words chosen to describe biospecimen facilities may influence decisions about donation. Objective: To explore differences in likelihood of donation as a function of the words chosen to represent human biospecimen storage facilities and the commensurate concerns each label evokes. Materials and Methods: Two-group experimental design. Participants completed a survey about a fictitious undertaking requesting that they consider biospecimen donation. The term used to describe the facility housing the biospecimens differed; one half of the surveys referenced a biobank, and one half referenced a biorepository. Results: Two thousand five hundred ninety-six surveys were distributed; 586 completed surveys were received (response rate: 22.6%). Sixty-three percent of respondents, regardless of whether the label referenced a biobank or biorespository, reported being extremely likely to donate. There were no significant differences between the 2 groups on the 11 concerns sampled. Factor analyses revealed that concerns could be classified in two groups: use-related concerns and person-related concerns. The label biobank evoked significantly lower perception of importance of the person-related concerns sampled (e.g., personal or other benefit, discomfort or inconvenience). Conclusions: Our results suggest that researchers may consider using the word biobank to describe the facility housing the biospecimen, as this term appears less subject to concern biases. These outcomes confirm that misunderstandings or misattributions of words used to refer to biospecimen facilities could deter participation in clinical care or research. Participation may be enhanced through ensuring clear understanding of what biospecimen donation entails and by directly addressing common semantic misunderstandings and associations.

An audit of health products advertised for sale on chiropractic Web sites in Canada and consideration of these practices in the context of Canadian chiropractic codes of ethics and conduct.

OBJECTIVE: This study describes the extent to which chiropractors with Web sites practicing in Canada advertise health products for sale and considers this practice in the context of chiropractic codes of ethics and conduct. METHODS: Chiropractic Web sites in Canada were identified using a public online business directory (Canada 411). The Web sites were searched, and an inventory of the health products for sale was taken. The influences of type of practice and province of practice on the sale of health product were assessed. Textual comments about health product marketing were summarized. National and provincial codes of ethics were reviewed, and the content on health product advertising was summarized. RESULTS: Two hundred eighty-seven Web sites were reviewed. Just more than half of the Web sites contained information on health products for sale (n = 158, 54%). Orthotics were advertised most often (n = 136 practices, 47%), followed by vitamins/nutritional supplements (n = 53, 18%), pillows and supports (n = 40, 14%), and exercise/rehabilitation products (n = 20, 7%). Chiropractors in solo or group chiropractic practices were less likely to advertise health products than those in multidisciplinary practice (P < .001), whereas chiropractors in BC were less likely to advertise nutritional supplements (P < .01). Provincial codes of ethics and conduct varied in their guidelines regarding health product sales. CONCLUSIONS: Variations in codes of ethics and in the proportions of practitioners advertising health products for sales across the country suggest that opinions may be divided on the acceptability of health product sales. Such practices raise questions and considerations for the chiropractic profession.

Canadian policy on reporting breaches of research integrity: When should Research Ethics Boards be informed?

In Canada, institutions that receive research funding from the three federal granting agencies must establish research ethics boards (REBs) to review the ethical acceptability of research involving humans. Institutions are also expected to promote the responsible conduct of research, fostering researchers' abilities to act with integrity in the conduct of their research. Where a researcher fails to act with integrity in research with humans, institutional policies and procedures of the U15, Canada's most research-intensive universities, vary in the extent to which they involve their REBs in response to such breaches. Some make no mention of the REB, whereas others state that their REB should be provided with information relating to upheld allegations. In this paper, we argue that when allegations of research integrity breaches are corroborated, the institution's REB should be identified as a party required to receive that information. Only then can REBs ensure compliance with research ethics standards, which is essential to maintain the public's trust.

Everything Is Related and It All Leads Up to My Mental Well-Being: A Qualitative Study of the Determinants of Mental Wellness Amongst Urban Indigenous Elders.

Indigenous peoples in Canada often experience a greater burden of poor health and wellness relative to non-Indigenous Canadians due to a legacy of colonisation and racism. However, Indigenous mental wellness outcomes vary by community, and it is essential to understand how a community has been impacted by the determinants to improve mental wellness outcomes. This article shares insight from a research partnership with the Ki-Low-Na Friendship Society, an urban Indigenous community service organisation. The study used a decolonising, qualitative methodology in which urban Indigenous Elders shared their knowledge of mental wellness and experiences of services and supports. Elders described mental wellness holistically, connected to their relationships, land, language and culture. They described several determinants of wellness including identity, poverty, transportation, abuse and trauma. Elders shared experiences of culturally unsafe care and identified colonisation as root causes of poor mental wellness. They shared how some determinants affect urban Indigenous communities uniquely. This included limited transportation to cultural activities outside urban centres, such as medicine picking, the importance of urban organisations (such as Aboriginal Friendship Centres) in developing social support networks, and the role of discrimination, racism and inequitable care as barriers to accessing services in urban centres.

Correction to: Ethical considerations in conducting surgical research in severe complicated intra-abdominal sepsis.

[This corrects the article DOI: 10.1186/s13017-019-0259-9.].

Ethical considerations in conducting surgical research in severe complicated intra-abdominal sepsis.

Background: Severe complicated intra-abdominal sepsis (SCIAS) has high mortality, thought due in part to progressive bio-mediator generation, systemic inflammation, and multiple organ failure. Treatment includes early antibiotics and operative source control. At surgery, open abdomen management with negative-peritoneal-pressure therapy (NPPT) has been hypothesized to mitigate MOF and death, although clinical equipoise for this operative approach exists. The Closed or Open after Laparotomy (COOL) study (https://clinicaltrials.gov/ct2/show/NCT03163095) will prospectively randomize eligible patients intra-operatively to formal abdominal closure or OA with NPTT. We review the ethical basis for conducting research in SCIAS. Main body: Research in critically ill incapacitated patients is important to advance care. Conducting research among SCIAS is complicated due to the severity of illness including delirium, need for emergent interventions, diagnostic criteria confirmed only at laparotomy, and obtundation from anaesthesia. In other circumstances involving critically ill patients, clinical experts have worked closely with ethicists to apply principles that balance the rights of patients whilst simultaneously permitting inclusion in research. In Canada, the Tri-Council Policy Statement-2 (TCPS-2) describes six criteria that permit study enrollment and randomization in such situations: (a) serious threat to the prospective participant requires immediate intervention; (b) either no standard efficacious care exists or the research offers realistic possibility of direct benefit; (c) risks are not greater than that involved in standard care or are clearly justified by prospect for direct benefits; (d) prospective participant is unconscious or lacks capacity to understand the complexities of the research; (e) third-party authorization cannot be secured in sufficient time; and (f) no relevant prior directives are known to exist that preclude participation. TCPS-2 criteria are in principle not dissimilar to other (inter)national criteria. The COOL study will use waiver of consent to initiate enrollment and randomization, followed by surrogate or proxy consent, and finally delayed informed consent in subjects that survive and regain capacity. Conclusions: A delayed consent mechanism is a practical and ethical solution to challenges in research in SCIAS. The ultimate goal of consent is to balance respect for patient participants and to permit participation in new trials with a reasonable opportunity for improved outcome and minimal risk of harm.

Improving the process of research ethics review.

BACKGROUND: Research Ethics Boards, or Institutional Review Boards, protect the safety and welfare of human research participants. These bodies are responsible for providing an independent evaluation of proposed research studies, ultimately ensuring that the research does not proceed unless standards and regulations are met. MAIN BODY: Concurrent with the growing volume of human participant research, the workload and responsibilities of Research Ethics Boards (REBs) have continued to increase. Dissatisfaction with the review process, particularly the time interval from submission to decision, is common within the research community, but there has been little systematic effort to examine REB processes that may contribute to inefficiencies. We offer a model illustrating REB workflow, stakeholders, and accountabilities. CONCLUSION: Better understanding of the components of the research ethics review will allow performance targets to be set, problems identified, and solutions developed, ultimately improving the process.