Implementation of community consultation for waiver of informed consent in emergency research: one Institutional Review Board's experience.

BACKGROUND: This article describes how one Institutional Review Board (IRB) chose to implement the issue of waiver of consent for a research study involving brain trauma victims brought to an emergency department. METHODS: Presentations were conducted in the state of Mississippi among cultural and ethnic groups representative of Mississippi's demographic composition. Individuals from the neurotrauma research team, including neurosurgeons and nurse study coordinators, conducted all of the presentations. One IRB member served as an objective "community liaison" and attended all presentations. This individual administered evaluation forms to attendees that measured their levels of comprehension and acceptance for the use of waiver of consent in the brain trauma study. RESULTS: All of the 137 attendees in 7 community consultation meetings gave their approval for the use of "waiver of consent." Continued community consultations are planned for the duration of the brain trauma study. CONCLUSION: Based on our experience, we conclude that in collaborating with local IRBs, research teams can successfully develop strategies for obtaining "acceptable community consultations" as required by regulatory mandates. We suggest that standardized community consultation guidelines be developed for obtaining waivers of informed consent in emergency research. Such criteria should form the basis for local IRBs to obtain their respective community consultations.     

The Research on Community Consultation: An Annotated Bibliography

Community consultation is a required element of research studies that use a waiver of or exception from informed consent. Its intent is to provide an additional patient safeguard in emergency research circumstances when prospective informed consent is not possible. Investigators have reported that community consultation may be the most difficult aspect in implementing research trials using a wavier of or exception from informed consent. This article presents a brief overview of the sparse literature available on the process of community consultation since the inception of the current emergency research regulations. To determine if the process is meeting its goals, more research will be required.     

Conducting research using the emergency exception from informed consent: the Public Access Defibrillation (PAD) Trial experience

BACKGROUND: The Public Access Defibrillation (PAD) Trial, a prospective, multicenter, randomized clinical trial comparing two prehospital resuscitation strategies, was conducted under the regulations for exception from informed consent (21CFR50.24) in 24 communities in North America. These regulations place additional requirements for human subject protection on investigators and Institutional Review Boards (IRBs), including conducting community consultation (CC) and public disclosure (PD). OBJECTIVE: To describe the IRB approval process at study sites and the number and types of community consultation and public disclosure activities conducted. METHODS: The 24 study sites in the United States and Canada submitted IRB applications, CC and PD plans, and a structured report on IRB process and investigator perceptions to the Clinical Trial Center at the University of Washington. RESULTS: The primary IRBs for all 24 trial sites and a total of 101 IRBs approved the study. The median interval from submission to approval was 108 days (IQR 43-196), and the mean number of revisions was two (range 0-7). Investigators conducted nearly 12,000 activities to achieve CC and PD; activities varied greatly from site to site in both type and quantity. CONCLUSION: The length of time to obtain IRB approval and the extent of community consultation and public disclosure varied greatly among trial sites in meeting the current regulations for conducting emergency research with exception from informed consent. This suggests that more specific guidance may be useful and that determination of effective strategies for community consultation and public disclosure is needed.     

Research without Consent: Community Perspectives from the Community VOICES Study

Objective: To explore community attitudes toward the federal regulations that allow investigators to conduct emergency research without obtaining informed consent from participants. Methods: Focus‐group participants were recruited from residential sites in New York City that were enrolled in the Public Access Defibrillation (PAD) Trial. The PAD Trial, a National Institutes of Health–funded, randomized trial in which laypersons were trained to treat cardiac arrest, was granted an exception from informed consent under these rules. Community residents and those who had been trained as lay responders in the PAD Trial were asked about the ethical issues raised by the conduct of research without consent (RWC), their definition of community, and appropriate methods of community consultation regarding RWC studies. Grounded theory content analyses were conducted on focus‐group data. Results: Seventeen (40%) men and 25 (60%) women from 15 buildings participated in six focus groups: four in English; two in Spanish. Definitions of “community” varied widely among and across groups; no strategy for community consultation was consistently endorsed by the participants. There were significant support and occasional adamant opposition to conducting RWC; participants often recounted specific personal experiences as the basis for both positive and negative opinions. Individuals with negative attitudes toward RWC often voiced strong support for specific RWC scenarios. Conclusions: There is no consensus regarding the definition of “community” or appropriate methods of consultation. Community members' attitudes toward RWC are often shaped by their personal experiences, and their general attitudes often differ from their reactions to specific RWC protocols.     

Development and validation of a questionnaire to self-assess the quality of interprofessional team meetings in primary and community healthcare

ABSTRACT

In the context of a quality assurance policy, a regional network initiated a project to measure the quality of interprofessional consultation meetings. A questionnaire was evaluated on content validity by 48 stakeholders: healthcare professionals, representatives from healthcare organizations, interprofessional consultation meeting coordinators, and representatives from patient organizations. A revision resulted in two subscales (each consisting of 16 items) for assessing process and outcome aspects of interprofessional consultation meetings. After validating the instrument, it was used in a hands-on test by individuals and in a pilot series of team-based self-assessments. Responses were used to analyse reliability and consistency of the subscales and the items, and to reveal first indications of relative weaknesses and strengths in interprofessional consultation meetings. Results point out that the subscales, now part of the Interprofessional Practice and Education Quality Scales (IPEQS), can be useful for self-assessment of the quality of such meetings in primary and community healthcare, but maybe also in other areas of interprofessional collaboration.     

Writing to patients: a randomised controlled trial

It has been suggested that consultants should consider writing directly to patients with a summary of their outpatient consultation. In a controlled trial involving consecutive new referrals to a haematology outpatient clinic, we randomised patients to receive either a personal letter from their consultant summarising their consultation (n = 77) or a brief note thanking them for attending the clinic (n = 73). Patients were assessed for recall of and satisfaction with the consultation by a single independent observer, using standardised methods. At the second visit to outpatients, the patients' median percentage recall of items discussed during the consultation was 67% (IQ range 50-80%) in the intervention group, versus 57% (IQ range 43-76%) in the control group (p = 0.3). Strongly positive views on the personal letter were expressed by patients and referring clinicians. The findings suggest that although personal letters do not substantially improve recall of the clinical encounter, they are feasible, highly valued by patients and acceptable to referring clinicians.     

Consent in resuscitation trials: Benefit or harm for patients and society?

CONTEXT: Research in an emergency setting is challenging because there may not be sufficient opportunity or time to obtain informed consent from the patient or their legally authorized representative. Such research can be conducted without prior consent if specific criteria are met. However consent is sometimes required for continued participation and may bias the results of the study. OBJECTIVE: To review regulations related to waiver of consent in emergency research, and evidence of whether such regulations introduce bias. RESULTS: Emergency research can be conducted without consent, either through community disclosure and consultation followed by patient or family notification and consent for continued participation after the intervention was applied, or under a minimal risk waiver. Review of the clinical record is necessary to determine important outcomes such as survival to discharge. If consent is required for this review but not granted, then these data are missing during analysis. If seriously ill or disadvantaged patients are less likely to assent, then investigators cannot determine reliably whether these vulnerable patients were harmed by the intervention. If missing data are different from complete data, then the analysis is susceptible to bias, and the conclusions could be misleading. Extrapolation from non-consent rates in resuscitation studies to results from the DAVID trial demonstrates that the rate of absence of data and information due to lack of assent can influence whether there is a significant difference between treatment groups (survival of control versus intervention: p=0.04 for complete data; p=0.08 for 10.8% lack of assent; p=0.40 for 19.7% lack of assent). CONCLUSIONS: Exception from consent for emergency research should extend to review of the hospital record as the standard in emergency research. The only potential risk to patients associated with review of the clinical record after the intervention is loss of privacy and confidentiality. Appropriate safeguards can be taken to minimize this risk.     

Testing a rating scale of video-taped consultations to assess performance of trainee nurse practitioners in general practice

BACKGROUND: Nurse practitioners (NPs) in the United Kingdom are taking on some of the consultation work previously done by general practitioners (GPs) without there being any established professional standards that they must achieve before doing so. There is a need to develop and test methods of assessing their consultation performance for reasons of professional accreditation and patient safety. AIMS: 1. To make independent summative assessments of trainee nurse practitioners' (TNPs) consultation performance. 2. To assess the validity and reliability of an existing video-taped assessment tool. METHOD: Four TNPs taking part in the EROS (extended roles of staff) study video recorded seven or eight consecutive consultations with typical patients during one surgery. Each consultation was rated nine times by members of a panel comprising eight independent GP trainers, four NPs and the GPs and TNPs in the EROS practices. A rating scale developed by Cox & Mulholland was used for the purpose. RESULTS: Eight of the 37 items and four consultations had more than 10% missing data, mean = 7.7 items per rater. Factor analysis yielded a single factor solution explaining 32.6% of the variance and indicated that items could be summed to provide a single score. Internal consistency was high, alpha coefficient = 0.92. Individual differences between raters in scoring consultations were taken into account in providing a score for each consultation. Scores obtained were found to cluster at the positive end of the distribution indicating a high level of performance. Greater differences were found between scorers than between consultations. CONCLUSIONS: This instrument is appropriate for scoring NP consultations and this small sample was rated as showing a uniformly high standard of performance. Some items could be deleted since they do not feature in the range of consultations currently performed. If this or a similar tool was to be adopted more widely for summative rating purposes then it should be tested rigorously for validity and reliability, training should be given to raters and criteria provided by which to make judgements.     

社区老年人抑郁筛查量表的初步编制及信度效度检验

目的编制社区老年人抑郁筛查量表。方法经文献复习、小组讨论和专家咨询确定了60个条目组成的条目池,在93名社区老年人和59名老年抑郁症患者中测试,并进行项目分析形成正式量表。然后在200名社区老年人和68名老年抑郁症患者中检验量表的信度和效度。结果量表最终纳入30个条目,所有条目在病例组的发生率明显高于社区组,内部一致性Cronbach’sα系数为0.98,一周后重测信度为0.68(P<0.05),与抑郁自评量表(SDS)标准分的相关系数为0.71(P<0.05),探索性因素分析揭示了量表单维的因素结构。在量表分数取临界值14时,灵敏度为91.20%,特异度为93.00%。结论本次研究编制的社区老年人抑郁筛查量表具有较好的信度和效度。     

应用Delphi法对助产士特定情况下处方权内容的初步探讨

[目的]探讨中国助产士在特定情况下的处方权内容及处方形式。[方法]采用Delphi法对从事助产专业的18名护理专家及18名医疗专家进行第一轮的问卷咨询。[结果]有3名医疗专家不同意授予助产士处方权。其余同意的专家对子宫收缩乏力、子宫收缩过强、产后出血、胎膜早破、正常分娩这五种情况可以给予助产士处方权的赞同度较高,对引产、产时高热、妊娠期高血压疾病和羊水栓塞的赞同度较低,对哌替啶及芬太尼的认同率较低,根据专家意见对特定情况及具体条目进行调整,制成第二轮专家咨询问卷。[结论]参与咨询的专家大多支持授予助产士处方权,专家权威程度高,对特定情况的赞同度协调性较好,结果可信。     

Communicating with Communities about Emergency Research

The challenge of effectively communicating with communities about research is particularly salient for investigators who are conducting emergency research with an exception from informed consent. The authors discuss the ethical basis for the community consultation requirement and describe the nature and extent of the consultative process required to achieve these ethical purposes. The findings of the consensus conference are summarized as follows. 1) The requirements for community consultation and public disclosure for exception from informed consent studies serve important ethical purposes and should be retained. 2) Community consultation allows investigators and institutional review boards to obtain input from the community regarding planned research. The process serves to facilitate understanding, promote trust, ensure justice, and protect research participants. 3) Community consultation is a process that requires active participation by community members; however, it does not require their approval, consent, or consensus. The practical challenges involved in conducting meaningful community consultation are also discussed: defining the community and its appropriate representatives, methods to actively engage the community, the lack of uniformity among institutional review boards in required community consultation activities, and the lack of measures to evaluate the adequacy and appropriateness of community consultation. The recommendations of the consensus conference regarding future research about community consultation are summarized. Priorities include identifying best practices; defining effectiveness and developing measures to evaluate community consultation; evaluating alternative models and potential infrastructures to facilitate, conduct, and/or oversee effective community consultation processes; and developing educational modules for community members to empower their active participation in discussions about emergency research in their communities.     

社区护士健康教育实施情况的调查

目的了解社区护士健康教育实施状况。方法采用问卷调查荆门市115名在职社区护士健康教育的方法和内容,并分析其影响因素。结果社区护士采用的健康教育方法中最多的是就诊时面对面咨询,占60．87％;最少的是宣传机构撰写健康教育材料,占1．74％。健康教育内容最多的是控烟教育,占56．52％;最少的是精神卫生,占17．39％。与健康教育内容有关的是职称。结论社区护士的健康教育能力不容乐观,有待进一步提高：     

复方丹参滴丸治疗冠心病心绞痛随机对照试验的质量评价

目的调查复方丹参滴丸治疗冠心病心绞痛随机对照试验(RCT)的现状,并评价其能否为临床应用提供高质量证据。方法计算机检索1994~2005年l2月国内外公开发表的有关复方丹参滴丸治疗冠心病心绞痛的RCT,采用Jadad评分量表、CONSORT标准和其他自拟评价指标进行质量评价。结果共纳入115篇RCT,其中1篇3分,6篇2分,106篇1分,2篇0分。无RCT执行分配隐藏。按CONSORT标准,仅4篇(3.5%)RCT描述了如何产生随机顺序,其中2篇为半随机,没有RCT报道如何执行随机,有1篇(0.9%)RCT采用安慰剂对照,1篇(0.9%)报道了终点指标,9篇(7.8%)实施单盲,4篇(3.5%)采用双盲,11篇(9.6%)进行了具体统计量计算,2篇(1.7%)提供了随访记录,1篇(0.9%)报道了阴性结果,25篇(21.7%)报道不良事件,均未进行样本含量计算、意向性分析(ITT)和分层分析,属于多中心的仅有1篇(0.9%),均未进行伦理审批和知情同意。描述了中医证型的有27篇(23.5%),所有试验均未采用模拟剂。结论目前复方丹参滴丸治疗冠心病心绞痛临床研究的方法学和报告质量尚低,还不能为临床应用提供可靠的依据。     

基于转型冲击理论构建新护士护理安全培训内容体系

目的 构建基于转型冲击理论的新护士护理安全培训内容体系。方法 课题小组参考相关文献,基于转型冲击理论,拟定培训内容体系初稿并编制专家咨询问卷,运用德尔菲法对16名护理教育、管理及临床专家进行2轮专家咨询。结果 2轮咨询问卷有效回收率均为100%,专家权威系数为0.90,肯德尔和谐系数分别为0.269和0.250（均P<0.01）,2轮咨询后,各指标变异系数为0～0.21。形成的“基于转型冲击理论的新护士护理安全培训内容体系”包含4个一级指标、25个二级指标、83个三级指标,在入职1年内分3个阶段完成,第1阶段（入职后0～3个月）包含32个培训内容,第2阶段（入职后4～9个月）包含42个培训内容,第3阶段（入职后10～12个月）包含9个培训内容。结论 构建的培训体系内容充实、科学可靠、实用可行,可为医院开展新护士护理安全培训提供参考和借鉴。     

Exception from Informed Consent Enrollment in Emergency Medical Research: Attitudes and Awareness

Objectives
To explore attitudes surrounding exception from informed consent enrollment into research studies. In addition, the authors sought to determine the level of awareness of such an ongoing study among potential subjects, as defined by their presence in an emergency department (ED).
Methods
A convenience sample of urban academic ED patients and visitors was surveyed during a visit regarding their attitudes and awareness of an emergency exception from informed consent, blood-substitute trial ongoing in the community.
Results
There was a 13% refusal rate, and 32% of those approached had characteristics that met exclusion criteria. There were 497 surveys analyzed. There was a predominance of women, Caucasians, and persons with at least some college education. Only 39 (8%) of respondents reported awareness of the ongoing blood substitute trial, and only 19 (4%) were able to list a risk or benefit of participation. Education, income, and age were not associated with reported awareness. Male gender, younger age, awareness of the existing exception from informed consent study, and being married were associated with greater acceptability for such enrollment practices.
Conclusions
The overall awareness of an ongoing exception from informed consent trial after community consultation and notification was low. A population with potential for enrollment in such a study did not demonstrate a high degree of acceptance of such practices. There were differences among certain demographic groups in the degree of acceptance. These differences may guide institutional review boards and investigators in community-consultation strategies for future waiver of or exception from informed consent studies.     

Willingness to Accept Expedited COVID-19 Vaccine Research for Children Aged <12 Years After Adult Vaccine Approval

PurposeThe goal of this study was to assess if caregivers’ attitudes toward the regulatory process of approving the vaccine against coronavirus disease 2019 (COVID-19) for children aged <12 years changed after a vaccine was approved for adults.MethodsThis was a larger scale COVIPAS (COVID-19 Parental Attitude Study) survey of caregivers presenting with their children aged ≤12 years for emergency care in 12 hospitals in the United States, Canada, and Israel. The study compared willingness to support abridged research into COVID-19 vaccines for children between the peak of the pandemic (March–May 2020) and after a COVID-19 vaccine became available for adults (December 2020–March 2021).FindingsA total of 1956 surveys were included in the analyses. Overall, 385 (30.9%) caregivers in the pre–vaccine approval period and 250 (35.3%) caregivers in the post–adult vaccine phase supported abridged research into COVID-19 vaccines (P < 0.001). In both phases, mothers were less likely to favor abridged approval. Those with children who were fully vaccinated based on the pediatric schedule in their country favored abridged approval in phase 1 (odds ratio, 1.98; 95% confidence interval, 1.31–3.08) but less so in phase 2. In both phases, age and concerns of parents that they had COVID-19 or their child had COVID-19 were not associated with changes in response between phases.ImplicationsWillingness to expedite vaccine approval increased after the emergency approval of COVID-19 vaccine for adults. Mothers are much less likely to approve expedited approval. No significant changes have been found in the composition of caregivers willing to forego regulatory demands on vaccine approval.