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• W2016388638 abstract "A recent New England Journal of Medicine (NEJM) commentary and an example from across the Atlantic have led to renewed calls for more flexibility in the informed consent process, particularly in comparative effectiveness research. Medical ethicists in the NEJM commentary “Informed Consent, Comparative Effectiveness, and Learning Health Care”1Faden R. Beauchamp T. Kass N. Informed consent, comparative effectiveness, and learning health care.N Engl J Med. 2014; 370: 766-768Crossref PubMed Scopus (140) Google Scholar have reignited the desire for more flexibility. Instead of rigid adherence to the all-or-nothing approach, with either full and prospective informed consent or a regulatory exception to informed consent, the authors propose a middle ground—a “streamlined consent process.” A coauthor of the commentary, Ruth Faden, PhD, acknowledges that the proposed consent process is part of “an envisioned system not yet in this world…probably” requiring a change in informed consent regulations. However, future comparative effectiveness research (CER) studies could use the proposed process within the framework of “a mature learning health care system with ethically robust oversight policies.”1Faden R. Beauchamp T. Kass N. Informed consent, comparative effectiveness, and learning health care.N Engl J Med. 2014; 370: 766-768Crossref PubMed Scopus (140) Google Scholar At the same time the NEJM commentary was published, researchers in the United Kingdom released results from a randomized CER study (the Unfractionated Heparin Versus Bivalirudin In Primary Percutaneous Coronary Intervention [HEAT-PPCI] study)2Shahzad A. Kemp I. Mars C. et al.Unfractionated heparin versus bivalirudin in primary percutaneous coronary intervention (HEAT-PPCI): an open-label, single centre, randomised controlled trial.Lancet. 2014; : 1-10Google Scholar that did use a streamlined consent process. British researchers compared the efficacy of 2 antithrombic drugs in an emergency setting. Because prospective informed consent was not possible, delayed consent was sought afterward. The ethics commentary and British study have drawn the interest of US emergency physicians. They face stiff challenges meeting informed consent regulations in the emergency setting. The challenge arises from the comprehensive rules borne from abuses of the midtwentieth century such as the Nazi war crimes and the Tuskegee syphilis experiment in the United States. As a result, the past several decades witnessed the formulation of strict, robust informed consent regulations in the United States and internationally.321 CFR Part 50 (research subject to Federal Drug Administration's regulations).Google Scholar, 445 CFR Part 46 (for HHS research not subject to FDA regulations).Google Scholar Although strict, some exceptions from informed consent (EFIC) in emergency medical research settings exist.521 CFR § 50.24.Google Scholar Conditions for EFIC are quite clear at the ends of the spectrum. If the patient is awake and coherent and can give fully informed, prospective consent, then there is no emergency setting and no exception. On the other end of spectrum, patients who cannot “give informed consent as a result of their medical condition”621 CFR § 50.24(a)(2)(i).Google Scholar may qualify for the exception. Initially, EFIC seems contrary to the underlying rationale of informed consent—ie, respect for the person. However, understanding the nature of emergency research and its benefit to medical science, federal law uses the concept of community consultation and public disclosure.721 CFR § 50.24(a)(7)(i)-(iii).Google Scholar Clinical researchers proposing a trial in an emergency setting in which informed consent is not possible interact with members of the surrounding community. Sharing information about the study, and asking community members about their views and general attitudes, results in a comprehensive community consultation and public disclosure program. This may substitute the community for the patient as an informed partner in the clinical trial. However, the devil is in the details. Often in emergency medical situations a patient may be awake or coherent, yet the patient’s extreme pain or lack of time allows no possibility of prospective, informed consent. Robert Silbergleit, MD, University of Michigan School of Medicine, Department of Medical Research, calls this the “middle ground.” According to him, some institutional review boards (IRBs) have been reluctant to find EFIC regulations applicable in this middle ground. Enter the NEJM commentary and British study. These provide a framework for an actual example of how to address this middle ground in the United States. Various approaches have emerged at the forefront. These include a reexamination of EFIC requirements to allow expedited pretreatment consent, or alternatively, modification of the British approach for delayed consent. Dr. Silbergleit believes further examination of federal regulations may indicate more flexibility in this middle ground. One of the criteria for considering waiver of or modification to informed consent is the risk to the patient.845 CFR 46.116(d)(1)(the research has to involve “minimal risk to the subject”); 21 CFR § 50.24(a)(3)(iii)(risks must be “reasonable”).Google Scholar According to Dr. Silbergleit, perhaps this area of federal law could give IRBs the flexibility to consider some EFIC research when the risk to the subjects is minimal. Unlike Dr. Faden, he believes that a renewed look at existing federal regulations may provide sufficient flexibility today, including the possibility of streamlined pretreatment consent. In the NEJM commentary’s proposal for streamlined consent under limited circumstances, patients participating in qualifying CER studies would receive some “specific notification” that falls short of full informed consent. According to Dr. Faden, patients could receive information about the treatment but have “a reasonable opportunity to decline.” Dr. Silbergleit proposes a similar idea, with an expedited version of consent in clinical trials in which there is minimal risk to the patient, and the patient can communicate somewhat but not at the level required for full informed consent. Arvind Venkat, MD, Allegheny General Hospital, Allegheny, PA, echoes this approach. Dr. Venkat believes that current practice focuses too much on the formalities of signing the informed consent documents. Patients get weighed down by the sheer volume of documentation and listing of every possible adverse effect. He advocates a return to the fundamental outcome of informed consent requirements: making sure the patient understands the realistic risks and can ask questions about them. In clinical trials in which alternative treatments pose minimal risk to the patient, researchers should have the ability to “quickly educate the patient or family” about the upcoming treatment. Dr. Venkat stressed, however, that the applicability of streamlined consent depends completely on the details of each clinical trial. True clinical equipoise and substantial benefit to medical science are good indicators, but it’s a case-by-case determination. Other researchers point to opportunities for posttreatment consent such as in HEAT-PPCI. Jestin Carlson, MD, Saint Vincent’s Hospital, Erie, PA, outlined how this could work. With more flexibility, informed consent requirements could be tailored to the circumstances and needs of a given CER study and yet still appropriately balance the needs of efficient emergency medical research with the best interests of the patients involved. Dr. Carlson believes delayed consent is one such solution. In the British HEAT-PPCI study, researchers designed an open-label, randomized, controlled trial to compare the efficacy of 2 well-established antithrombic drugs (unfractionated heparin and bivalirudin) in primary percutaneous coronary intervention in more than 1,800 patients.2Shahzad A. Kemp I. Mars C. et al.Unfractionated heparin versus bivalirudin in primary percutaneous coronary intervention (HEAT-PPCI): an open-label, single centre, randomised controlled trial.Lancet. 2014; : 1-10Google Scholar Instead of attempting to prospectively obtain informed consent from a compromised patient or appropriate representative, HEAT-PPCI used delayed consent. No attempt was made to obtain informed consent before angiography. However, subsequently the patient (or the patient’s representative) was asked for formal consent for both the treatment and continued participation in the clinical trial. This approach for delayed consent was ethically approved in advance by appropriate British ethics and health care agencies. It was found justified on several grounds. First, the patients were confronted with a life-threatening situation and informed consent was not feasible (and there was also insufficient time to seek informed consent from the patient’s representative). Second, both unfractionated heparin and bivalirudin had been successfully used and were well established, so there was minimal incremental risk to the patients. Third, the research would be beneficial to future patients and society. The outcome of the clinical trial was designed to determine whether one of the 2 antithrombic drugs was more efficient or cost-effective. Although the clinical trial was conducted in the United Kingdom, Drs. Silbergleit and Venkat believe more flexibility by IRBs could make a similar approach feasible in the United States. Many of the regulatory preconditions for exceptions from or modifications to US informed consent law were likely met in HEAT-primary percutaneous coronary intervention (PPCI). For example, risk to the patient was minimal because of the documented efficacy of both unfractionated heparin and bivalirudin in PPCI. Because the goal of HEAT-PPCI was to determine the better treatment for patients, this meets the federal EFIC precondition that the emergency medical research benefit patients.921 CFR § 50.24(a)(3).Google Scholar However, one aspect of the preapproval for delayed consent would have to be refined for use in the United States. The British investigators received preapproval from appropriate health care and ethics agencies. US investigators would need to convince IRBs to allow this tailored and flexible approach. HEAT-PPCI provides a model for investigators and IRBs in the United States. However, it also gives reluctant IRBs a persuasive rationale for reconsidering policies and procedures. Such reluctance is understandable. Amid proposals for more flexible or tailored informed consent approaches, the fundamental tenet underlying the necessity of informed consent—respect for patients and their right to receive more information or decline participation—is not forgotten. So it becomes relevant to understand just how strongly patients perceive and embrace this right to know. It is true that several studies have indicated that the general public has a lukewarm attitude toward EFIC in emergency settings. Public approval has ranged from 36% to 81%,10Dickert N. Mah V. Baren J. et al.Enrollment in research under exception from informed consent: the patient’s experiences in emergency research (PEER) study.Resuscitation. 2013; 84: 1417-1420Abstract Full Text Full Text PDF Scopus (37) Google Scholar displaying an array of communal feelings about not obtaining informed consent. When asked about their hypothetical participation in emergency treatment without informed consent, potential participants had a similar disparate response, with approval ranging from 45% to 95%.10Dickert N. Mah V. Baren J. et al.Enrollment in research under exception from informed consent: the patient’s experiences in emergency research (PEER) study.Resuscitation. 2013; 84: 1417-1420Abstract Full Text Full Text PDF Scopus (37) Google Scholar However, although the studies focusing on public views of EFIC are informative and indicate some level of general concern about waiving informed consent, there is a more relevant question. How do patients who actually participated in emergency research, without prospective informed consent, feel about it? This question is not meant to minimize the import of such a basic tenet of informed consent. Rather it’s to obtain information for future discussions about allowing more flexibility in delaying or modifying informed consent. Surprisingly, 2 recent studies indicate that most patients who participated in a clinical trial in an emergency setting (with EFIC or delayed consent) had no issue with the participation. For example, in HEAT-PPCI, more than 98% of the patients gave delayed consent. Of 1,829 patients, 17 could not give consent because they had died. Another 13 failed to respond to requests for delayed consent. Only 3 refused retroactive consent, and 1 refused to further participate in the study.2Shahzad A. Kemp I. Mars C. et al.Unfractionated heparin versus bivalirudin in primary percutaneous coronary intervention (HEAT-PPCI): an open-label, single centre, randomised controlled trial.Lancet. 2014; : 1-10Google Scholar A second comprehensive research project has confirmed patients’ willingness to accept exceptions from or modifications to informed consent requirements. The Rapid Anticonvulsant Medication Prior to Arrival Trial (RAMPART) comprises a series of studies comparing the efficacy of intravenous versus intramuscular benzodiazepine anticonvulsants for status epilepticus.10Dickert N. Mah V. Baren J. et al.Enrollment in research under exception from informed consent: the patient’s experiences in emergency research (PEER) study.Resuscitation. 2013; 84: 1417-1420Abstract Full Text Full Text PDF Scopus (37) Google Scholar In this comprehensive RAMPART resuscitation research project, one embedded study, the Patients’ Experiences in Emergency Research study, specifically examined patients’ feelings about EFIC. In that study, 59 participants in RAMPART (or the participants’ surrogates) were successfully interviewed. Most of the interviewees (82%) appreciated participation in RAMPART, and two thirds (67%) found EFIC acceptable in RAMPART.10Dickert N. Mah V. Baren J. et al.Enrollment in research under exception from informed consent: the patient’s experiences in emergency research (PEER) study.Resuscitation. 2013; 84: 1417-1420Abstract Full Text Full Text PDF Scopus (37) Google Scholar The interviewees provided several reasons for their acceptance of EFIC. First, they understood how it potentially furthered medical benefits. Second, they recognized the difficulty of obtaining informed consent in emergencies. Third, some of the interviewees simply felt good about themselves for supporting medical research.10Dickert N. Mah V. Baren J. et al.Enrollment in research under exception from informed consent: the patient’s experiences in emergency research (PEER) study.Resuscitation. 2013; 84: 1417-1420Abstract Full Text Full Text PDF Scopus (37) Google Scholar This acceptance of EFIC did not surprise Dr. Venkat. In his experience, patients who are told the risks of treatment “after the fact” are appreciative and happy to participate. Patient awareness and the right to refuse participation in medical studies are a cornerstone of the foundation that built modern informed consent law. Yet the 2 aforementioned studies do indicate that most patients who participated in emergency medical research, without prospective informed consent, support waiver or modification of it. This information may provide IRBs additional grounds for allowing investigators a more tailored approach for informed consent consistent with the circumstances of their emergency medical research. Emergency medical researchers strive to balance the benefits of emergency CER while not losing focus on the best interests of the patients, including their informed consent. Innovative ideas proposed by clinical researchers and medical ethicists and used in HEAT-PPCI suggest that improvements in this endeavor may be forthcoming." @default.
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• W2016388638 title "Minimum Risk and HEAT-PPCI" @default.
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