Emergency Medical Service Providers' Attitudes andExperiences Regarding Enrolling Patients in Clinical Research Trials

Objective: The purpose of this study was to evaluate Emergency Medical Services (EMS) providers' attitudes andexperiences about enrolling patients in clinical research trials utilizing the federal rules for exception from informed consent. We hypothesized that Emergency Medical Technicians (EMTs) would have varied attitudes about research using an exception from informed consent which could have an impact on the research. Methods andsetting: Since January 2007, the EMS system has been participating in a randomized, multi-center interventional trial in which out-of-hospital providers enroll critically injured trauma patients using exception from informed consent.A voluntary, anonymous, written survey was administered to EMS providers during an in-service. The survey included demographics andLikert-type questions about their experiences with andattitudes towards research in general, andresearch using an exception from informed consent for an out-of-hospital clinical trial. Results: The response rate was 79.3% (844/1067). Most respondents, 93.3%, agreed that “research in EMS care is important.” However, 38.5% also agreed that individual EMTs/paramedics should maintain the personal right of refusal to enroll patients in EMS trials. Fifty-four percent of respondents agreed with the statement that “the right of research subjects to make their own choices is more important than the interests of the general community.” In response to statements about the current study, 11.3% agreed that “the study is unethical because the patient cannot consent” and69.2% responded that they would personally be willing to be enrolled in the study before they were able to give consent if they were seriously injured. Those who had not enrolled a patient into the study (681 respondents) were asked their reasons: 76.8% had not encountered an eligible patient or did not work for an agency that carried the fluid; 4.3% did not have time; 4.1% forgot and1.1% stated that they were opposed to enrolling patients in studies without their consent. Conclusion: The majority of EMS personnel in one community support EMS research andthis specific out-of-hospital clinical trial being conducted under an exception from informed consent. Potential barriers to enrollment were identified. Further study in other systems is warranted to better understand EMS provider perspectives about exception from informed consent research.     

Informed Consent and Ethical Issues in Military Medical Research

Informed consent in military research shares many of the same fundamental principles and regulations that govern civilian biomedical research. In fact, much of modern research ethics is grounded in events that occurred in the context of war or government‐sponsored research. Despite these similarities and common origins, research in the military has additional requirements designed to preserve service members' informed consent rights. The special nature of the superior–subordinate relationship in the military necessitates careful protections to avoid perceptions of coercion or undue influence on a military subject. Additionally, current legal and regulatory requirements for advanced informed consent significantly restrict the flexibility of the military to conduct research using waiver of consent. This has implications on the ability of the nation to develop effective medical treatments for the global war on terrorism. Nevertheless, work is under way to realign defense research policy with the norms of civilian biomedical practice. Future directions include the adoption of waivers for military emergency research, and the cautious introduction of human subject studies on the battlefield. This paper discusses historical background, regulatory differences, and concerns and challenges of some of these regulatory differences for research personnel that apply to informed consent and waiver of said informed consent for emergency research conducted by the U.S. military.     

Patient Opinions and Attitudes toward Medical Student Procedures in the Emergency Department

OBJECTIVES: To determine emergency department (ED) patients' preferences about having medical students perform procedures as part of medical student clinical training. METHODS: A questionnaire was administered to a sequential sample of 150 patients of 196 approached (76.5% participation rate) in a teaching hospital ED. Patients were asked how many procedures a medical student should have performed on other patients before the participant would allow the student to perform the procedure on them. The procedures included venipuncture, starting an IV, suturing the face, suturing the arm, performing a lumbar puncture, starting a central line, inserting a nasogastric tube, intubation, and cardioversion. RESULTS: If they had their preference, only a minority of patients would allow medical students to perform their first procedure on them for any of the procedures (a high of 42% for venipuncture, with a low of 7% for a lumbar puncture). Many patients prefer that medical students never perform a procedure on them (a high of 56% for a central line and a low of 21% for venipuncture). Patient beliefs were independent of age, gender, or insurance status. CONCLUSIONS: Patients are reluctant to be a medical student's first patient when it comes to procedures in the ED. This has implications for medical training and informed consent.     

An Approach to Community Consultation Prior to Initiating an Emergency Research Study Incorporating a Waiver of Informed Consent

OBJECTIVES: In November 1996, the Food and Drug Administration (FDA) and the Department of Health and Human Services (DHHS) enacted rules allowing a narrow exception to the requirement for prospective informed consent when enrolling critically ill patients in clinical research studies of emergency treatments. These rules require that, prior to initiation of the study, the applicable institutional review board (IRB) assess the acceptability of the proposed research study to members of the community in which the research will be conducted. Specifically, the IRB must perform community consultation-a process during which community members learn about the proposed research and communicate their opinions regarding its acceptability to investigators or IRB representatives. The FDA and DHHS rules do not define specific acceptable methods for performing this community consultation. The objective of this study is to demonstrate the feasibility and utility of one proposed method for performing such community consultation. METHODS: Parents of children being seen for minor traumatic injuries in three pediatric EDs were asked to participate in a study regarding informed consent. After consent, an instructor described to the parent a prospective, randomized, placebo-controlled trial of phenytoin for the prophylaxis of posttraumatic seizures in children with severe closed head trauma. All parents were then asked whether they would have consented for their own child's participation, if their child had suffered such head injury. The parents were further asked to explain the reason(s) for their responses. RESULTS: Parents of 227 children (children's mean +/- SD age 8.0 +/- 4.8 years, 57% male) were interviewed. Sixty-six percent of parents (149/227) stated they would give consent for their child's participation. Of the 149 consenting parents, 85% (126/149) cited potential benefit to their child, 72% (107/149) cited potential benefit to other children, and 60% (90/149) cited furthering medical knowledge. Of the 78 nonconsenting parents (34% of total), 54% (42/78) cited fear of adverse effects, 39% (30/78) did not want their child to be a research subject in general, 27% (21/78) believed they needed to discuss participation with family members who were unavailable, and 26% (20/78) stated they were unable to decide unless they were in the actual situation. Parental ethnicity and household income were found to influence the consent decision, while the parent's gender, religion, language, and educational level were not associated with the consent decision. CONCLUSIONS: Community consultation regarding the acceptability of an emergency research protocol can be obtained via interview techniques in the ED. This methodology may allow investigators to obtain data on opinion from a targeted community for IRB consideration during the review of emergency research studies proposing a waiver of informed consent.     

Attitudes of Emergency Department Patients and Visitors Regarding Emergency Exception from Informed Consent in Resuscitation Research, Community Consultation, and Public Notification

OBJECTIVE: To assess public views on emergency exception to informed consent in resuscitation research, public awareness of such studies, and effective methods of community consultation and public notification. METHODS: A face-to-face survey was conducted in two academic Level I trauma center emergency departments (EDs) in Oregon and Minnesota from June through August 2001. RESULTS: Five hundred thirty people completed the survey, with an 82% response rate. The mean age of the respondents was 41 years (range 18-95) with a standard deviation of 14.5; 46% were female and 64% white. Most (88%) believed that research subjects should be informed prior to being enrolled, while 49% believed enrolling patients without prior consent in an emergency situation would be acceptable and 70% (369) would not object to be entered into such a study without providing prospective informed consent. Informing and consulting the community as a substitute for patient consent in emergency research was thought to be reasonable by 45% of the respondents. Most respondents would prefer to be informed about a study using emergency exception from informed consent by radio and television media (42%). Two hundred fifty-eight respondents (49%) stated they would attend a community meeting; the less educated were more likely to attend than those with college degrees (OR = 0.53; 95% CI = 0.33 to 0.85, p = 0.008). However, only 5% knew of ongoing studies in their community using emergency exception from informed consent. CONCLUSIONS: Most respondents disagreed with foregoing prospective informed consent for research participation even in emergency situations; however, many would be willing to participate in studies using emergency exception from informed consent. Most respondents would not attend community meetings, and would prefer to rely upon the media for information. Very few were aware of emergency exception from informed consent studies in their community. This suggests that current methods of community notification may not be effective.     

Systematic Bias Introduced by the Informed Consent Process in a Diagnostic Research Study

Objectives:  To determine population characteristics, outcomes, and reasons for unsuccessful enrollment among potential study subjects approached for written, informed consent in a minimal-risk emergency department (ED) study. The authors hypothesized that the prevalence of venous thromboembolism (VTE) would be lower among study participants and that medical acuity and refusal to provide a blood sample would be the most common reasons for nonparticipation.
Methods:  The authors requested prospective, written, informed consent for a blood sample and follow-up from consecutive ED patients undergoing evaluation for pulmonary embolism (PE) and recorded spontaneously stated reasons for refusal. VTE was diagnosed or excluded using a combination of D-dimer testing and selective computed tomography (CT) angiography of the chest with venography of the lower extremities. The primary outcome was defined by the number of CT scans positive for VTE among ED patients evaluated for PE.
Results:  Over 16 weeks, 260 of 287 (91%, 95% confidence interval [CI] = 87 to 94%) eligible patients were approached and consent was obtained from 183 patients (64%, 95% CI = 58% to 69%). The prevalence of VTE was 6% among participants and 13% among nonparticipants (95% CI [of the difference] = 1% to 15%). The proportions of African Americans, uninsured, and Medicaid patients were significantly higher among nonparticipants. No significant differences were found in the proportions of nonparticipants who disliked or distrusted research or desired financial reimbursement, compared to those not enrolled due to medical acuity or refused a blood sample.
Conclusions:  These data implicate the written, informed consent process as a significant source of bias on estimated disease prevalence.     

Is Consent “Informed” When Patients Receive Care from Medical Trainees?

Objectives: Medical care requires consent and consent requires information. Prior studies have shown that patients are poorly informed about the medical training hierarchy. The authors assessed the impact of “informed” on “consent,” by assessing willingness to be seen by trainees before and after information about trainee’s credentials. Methods: A convenience sample of patients in an urban emergency department (ED) waiting room was surveyed, ascertaining willingness to be seen before and after information about trainees credentials, using Likert scales. McNemar’s test, linear regression, and mixed models were used to assess statistical significance of information in changing preferences and patient characteristics predicting knowledge, willingness, and change in willingness to be seen with more information. Results: The authors approached 397 patients, and 199 (50%) English speakers participated. Initially, 45% of subjects knew the meaning of “medical student,” and 35%“intern” and “resident.” In a controlled multivariate linear regression, educational attainment (p < 0.0001) predicted more knowledge, Hispanic ethnicity predicted less (p = 0.03). Subjects were less willing to be seen by lower‐ranking trainees (p < 0.001). Information about trainees caused a significant increase in unwillingness to be seen by medical students (17% to 28%, p = 0.004) and interns (8% to 13%, p = 0.029). Conclusions: Substantial numbers of ED patients would prefer not to be seen by trainees. When patients are informed about trainees’ credentials, they become less willing to be seen by more junior trainees. Further research should clarify informed consent for care among non–English speakers and should address these issues in other medical settings.     

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.     

Confronting the Ethical Challenges to Informed Consent in Emergency Medicine Research

The Society for Academic Emergency Medicine believes that protection of human subjects is vital in emergency medicine research and that, whenever feasible, informed consent is at the heart of that protection. At the same time, the emergency setting presents unique barriers to informed consent both because of the time frame in which the research is performed and because patients in the emergency department are a vulnerable population. This report reviews the concept of informed consent, empirical data on patients' cognitive abilities during an emergency, the federal rules allowing exemption from consent under certain circumstances, issues surrounding consent forms, and the new Health Insurance Portability and Accountability Act regulations as they relate to research. The authors conclude that, in many circumstances, informed consent is possible if the researcher is diligent and takes time to adequately explain the study to the potential subject. In cases in which it is possible to obtain consent, precautions must be taken to ensure that subjects have decision-making capacity and are offered time to have their questions answered and their needs met. Sometimes resuscitation and other emergency medicine research must be conducted without the ability to obtain consent. In these cases, special protections of subjects under the exception from consent guidelines must be followed. Protection of research subjects is the responsibility of every researcher in emergency medicine.     

Informed Consent for Research: Current Practices in Academic Emergency Medicine

Background:  The emergency department (ED) environment presents unique barriers to the process of obtaining informed consent for research.
Objectives:  The objective was to identify commonalities and differences in informed consent practices for research employed in academic EDs.
Methods:  Between July 1, 2006, and June 30, 2007, an online survey was sent to the research directors of 142 academic emergency medicine (EM) residency training programs identified through the Accreditation Council for Graduate Medical Education (ACGME).
Results:  Seventy-one (50%) responded. The average number of simultaneous clinical ED-based research projects reported was 7.3 (95% confidence interval [CI] = 5.53 to 9.07). Almost half (49.3%) of respondents reported that EM residents are responsible for obtaining consent. Twenty-nine (41.4%) participating institutions do not require documentation of an individual resident's knowledge of the specific research protocol and consent procedure before he or she is allowed to obtain consent from research subjects.
Conclusions:  It is common practice in academic EDs for clinical investigators to rely on on-duty health care personnel to obtain research informed consent from potential research subjects. This practice raises questions regarding the sufficiency of the information received by research subjects, and further study is needed to determine the compliance of this consent process with federal guidelines.     

ICU research: the impact of invasiveness on informed consent

Purpose

Studies into the preferences of patients and relatives regarding informed consent for intensive care unit (ICU) research are ongoing. We investigated the impact of a study’s invasiveness on the choice of who should give consent and on the modalities of informed consent.

Methods

At ICU discharge, randomized pairs of patients and relatives were asked to answer a questionnaire about informed consent for research. One group received a vignette of a noninvasive study; the other, of an invasive study. Each study comprised two scenarios, featuring either a conscious or unconscious patient. Multivariate models assessed independent factors related to their preferences.

Results

A total of 185 patients (40 %) and 125 relatives (68 %) responded. The invasiveness of a study had no impact on which people were chosen to give consent. This increased the desire to get more than one person to give consent and decreased the acceptance of deferred or two-step consent. Up to 31 % of both patients and relatives chose people other than the patient himself to give consent, even when the patient was conscious. A range of 3 to 17 % of the respondents reported that they would accept a waiving of consent. Younger respondents and individuals feeling coerced into study participation wanted to be the decision makers.

Conclusions

Study invasiveness had no impact on patients’ and relatives’ preferences about who should give consent. Many patients and relatives were reluctant to give consent alone. Deferred and two-step consent were less acceptable for the invasive study. Further work should investigate whether sharing the burden of informed consent with a second person facilitates participation in ICU research.     

Enrollment in research under exception from informed consent: The Patients’ Experiences in Emergency Research (PEER) study

Background

Resuscitation research requires an exception from informed consent (EFIC). Despite concerns that patients may find EFIC unacceptable, the views and experiences of patients enrolled in an EFIC study are largely unknown.

Methods

The Patients’ Experience in Emergency Research (PEER) study was nested within the Rapid Anticonvulsant Medication Prior to Arrival Trial (RAMPART) for pre-hospital treatment of status epilepticus. PEER included 61 EFIC enrollees or their surrogates from 5 sites. Interviews used a structured, interactive guide focusing on acceptance of EFIC enrollment in RAMPART and existing regulatory protections. Simple statistics were generated, and textual data were analyzed for common themes.

Results

24 enrolled patients and 37 surrogates were successfully interviewed. 49/60 (82%) were glad they or their family member were included in RAMPART; 54/57 (95%) felt research on emergency seizure treatment is important. 43/59 (73%) found their inclusion under EFIC acceptable; 10 (17%) found it unacceptable, and 6 (10%) were neutral. There were no statistically significant interactions between enrollment attitudes and demographic characteristics, though there were trends toward lower acceptance among interviewees who were non-white, less educated, or had prior research experience. The most common concerns related to lack of consent prior to RAMPART enrollment. Positive responses related to perceived medical benefits, recognition of the impracticality of consent, and wanting doctors to do what needs to be done in emergencies. Many participants had difficulty understanding the trial and EFIC.

Conclusions

Most subjects had positive views of enrollment, and acceptance generally correlated with results of community consultation studies.     

新生儿科知情谈话记录单的设计与应用

目的应用知情谈话记录单,降低医患纠纷的发生率并提供法律依据。方法将患儿住院期间的病情、治疗护理方案、治疗费用、检查结果等真实情况告知患儿父母并在知情谈话记录单上签名。结果患儿父母对医护工作满意度由95．07％上升至99．13％,投诉率由2．61％下降至0．58％。结论知情谈话记录单的应用有利于提高患儿父母的满意度,减少医患纠纷。     

知情同意在护理实践中存在的问题与对策

为减少和避免知情同意在护理实践中的矛盾，笔者分析了知情同意在护理实践过程中出现的问题：知情同意与医疗保护的矛盾；与医患双方医疗知识不平等的矛盾；与正常医疗护理行为不一致的矛盾；告知病人知情权时医与医、医与护不一致。并针对问题提出相应对策：增强法律知识学习；处理好知情权与医疗保护；与患者沟通的过程中用简洁明了、浅显易懂的语言描述问题；尊重病人的自主权；维护病人知情权中的医护一致性。     

Evaluation of informed consent: a pilot study

AIM: This paper is a report of a study to describe and analyse the use of informed consent in clinical research, from the point of view of voluntary adult research participants, in order to develop and test an interview schedule for the evaluation of informed consent. BACKGROUND: Informed consent is one of the central ethical research principles in healthcare research, but empirical research on this topic is still scarce. To evaluate and develop the ethical quality of scientific research, there is a need to explore the meaning and implications of informed consent for research participants. METHOD: The data were collected in 2004 by interviews using an interview schedule created for this study by the first author and discussed in a multidisciplinary group. The response rate was 81%. The sample consisted of 32 patients with a metabolic syndrome who were participants in a project evaluating the effects of betaine on cardiovascular risk factors. FINDINGS: Participants stated that the key elements of informed consent are information, understanding and decision-making, and that competence is an essential factor in the reception and understanding of information and making an independent decision about participation. Our interview schedule was found to be useful in the investigation of informed consent. CONCLUSION: This study strengthened the perception that more extensive research about research participants is needed.     

Confronting the Ethical Conduct of Resuscitation Research: A Consensus Opinion

An objective of the 2005 Academic Emergency Medicine Consensus Conference, “Ethical Conduct of Resuscitation Research,” was to identify if consensus exists regarding application of the Food and Drug Administration (FDA) Final Rule allowing an exception from informed consent in resuscitation research. At the start of the consensus conference, 49 attendees participated in a survey containing three sections: 1) demographic questions characterizing respondents, 2) questions regarding application of the FDA Final Rule, and 3) complexities associated with seeking informed consent in an emergency setting. Consensus analysis was used to determine if a formal consensus was reached, relying on a Bayesian posterior probability of 0.99 to consider survey responses a “consensus.” Respondents demonstrated consensus regarding the need to further refine and standardize application of the FDA Final Rule in resuscitation research. However, participants agreed that current regulations provide adequate and appropriate protection to safeguard patients. Complexities associated with seeking informed consent in emergency departments were prevalent among most institutions represented at the conference. There was general agreement that current efforts to safeguard human subjects are effective, but participants agreed that refinements to and standardization of the FDA Final Rule would facilitate resuscitation research and enhance patient safety.     

Voluntary Informed Consent in Research and Clinical Care: An Update

Informed consent is important: in research, it allows subjects to make an informed and voluntary choice to participate—or refuse to participate—in a project where they will be asked to take risks for the benefit of others. In both research and clinical care, informed consent represents a permission to intervene on a person's private sphere. The elements of informed consent are usually described as disclosure, understanding, decision‐making capacity, and voluntariness. Each poses distinct difficulties, and can be amenable to improvements. However, research on the quality of informed consent and on strategies intended to improve it have only become the object of research relatively recently. In this article, we describe some results of this research, and outline how they can be relevant to informed consent in research and clinical care. Although much of the data suffers from limitations, it does suggest that disclosure has improved, but is still uneven, comprehension is often poor, for both patients and research subjects. Moreover, trust is a motivating factor for research participation, and thus we run risks if we allow false expectations and prove ourselves unworthy of this trust. Although improving consent forms does not have a clear effect on understanding, improving the consent process may help. Finally, better information may decrease anxiety and seems to have at most a small negative effect on research recruitment.     

Continuity of information in general practice. Patient views on confidentiality

OBJECTIVES: To explore patient views on access to a variety of information in the medical record by the on-call general practitioner and by the practice assistant in relation to the perceived importance of this information for the personal doctor. To relate patient views to patient and practice characteristics. DESIGN: Postal questionnaire survey. SETTING: General practice. SUBJECTS: 873 patients from 35 general practices dispersed throughout The Netherlands. RESULTS: 20% of the patients stated that the on-call GP should not have access to their entire medical record and 44% did not support full access for the practice assistant. Patient consent to the on-call GP being allowed to access a variety of information ranged from 62% for life events to 93% for medication; and to the practice assistant from 37% for home details to 82% for medication. Patients distinguished between "medically oriented information" and "lifestyle and psychosocial information". Their views could hardly be explained by patient and practice characteristics. CONCLUSION: Patient consent to access their medical record should not be taken for granted. We need research on the effectiveness of accessible prior knowledge, and on possibilities to segregate information. Patients should be informed more fully about everyday practice.     

Information in the ICU: are we being honest with our patients? The results of a European questionnaire

Background: We were interested in determining the current practices and views of European intensive care doctors regarding communication with patients and informed consent for interventions. Methods: A questionnaire was sent to the 1272 western European doctor members of the European Society of Intensive Care Medicine. All questionnaires were anonymous. Five hundred four completed questionnaires from 16 western European countries were analyzed. Results: Of the respondents, 25 % said they would always give complete information to a patient, although 35 % felt they should. Thirty-two percent would give complete details of an iatrogenic incident, but 70 % felt they should. There were significant differences in these attitudes between doctors from different countries, with doctors from the Netherlands more likely to give complete information, and doctors from Greece, Spain and Italy less likely. Fifty percent of the respondents required written consent for surgery, but for insertion of an arterial catheter oral consent was more widely accepted. The Netherlands and Scandinavia generally accepted oral requests for procedures, while Germany and the United Kingdom preferred written requests. Doctors of all countries were generally happy with their current practice concerning informed consent. Seventy-five percent would accept the right of a patient to refuse treatment, but 19 % would carry out the procedure against the patient's wishes. Conclusions: Doctors are often not completely honest with their patients regarding their diagnosis or prognosis, or in the event of an iatrogenic incident. However, most doctors will respect a patient's right to refuse treatment. Informed consent practices vary substantially and are largely determined by locally accepted policy and accepted by doctors working in those areas. Received: 13 October 1997 Accepted: 26 May 1998