Impact of the Final Rule on the Rate of Clinical Cardiac Arrest Research in the United States

Hiller, Katherine M.

doi:10.1197/j.aem.2005.04.025

Cited by 17 publications

(3 citation statements)

References 82 publications

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“…Food and Drug Administration, 2004), but few studies have been conducted under these regulations (Hiller, Haukoos, Heard, Tashkin, & Paradis, 2005; Nichol, Huszti, Rokosh, Dumbrell, McGowan, & Becker, 2004). Many investigators have noted difficulty and confusion in implementing the regulations, particularly requirements for community consultation and disclosure (Biros, 2007a; Flynn, 2008; Halperin, Paradis, Mosesso et al, 2007; Kremers, Whisnant, Lowder, & Gregg, 1999; Passamani & Weisfeldt, 2000; Schmidt, 2007).…”

Section: Introductionmentioning

confidence: 99%

Patients' perceptions of research in emergency settings: A study of survivors of sudden cardiac death

Dickert

Kass

2009

Social Science & Medicine

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Conditions such as stroke, sudden cardiac death, and major traumatic injury are major causes of morbidity and mortality, and there is a need for clinical research to improve treatment for these conditions. However, because informed consent is often impossible, research in these situations poses ethical concerns. Despite growing literature on the ethics of emergency research, little is known about the views of relevant patient populations regarding research in emergency settings conducted under an exception from informed consent (EFIC).In this qualitative study, survivors of sudden cardiac death (SCD)-recruited from an outpatient cardiology clinic in late 2005-were asked their views on scenarios representing different types of EFIC research. Patients were generally accepting of such research, more than previous studies would have predicted. Their concerns focused primarily on study risks and benefits and less on waiving consent or randomization.EFIC research is of international importance and ethical controversy. This study represents the first attempt to assess views of SCD survivors on this type of research and one of the first to assess patients' views in-depth. Findings indicate broad acceptance of EFIC research among this population and refocus discussion on what risks are reasonable for non-autonomous subjects. The study also demonstrates potential for valuable input from patients regarding complicated and ethically challenging issues using a method that allows them to develop opinions on unfamiliar issues.

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Section: Introductionmentioning

confidence: 99%

Patients' perceptions of research in emergency settings: A study of survivors of sudden cardiac death

Dickert

Kass

2009

Social Science & Medicine

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“…The American system has, among other things, hampered methodological innovation, blocked potentially controversial research to protect institutional reputations, and subjected social science to controls more suited for biomedical fields (Israel, 2015;Schrag, 2009Schrag, , 2010. Some have even accused it of needlessly hindering research at the cost of human lives, for example by introducing a ban on studying resuscitation, since patients in such cases are unable to provide informed consent (Hiller et al, 2005). Researchers have also accused research ethics systems in general of more fundamental flaws, such as displacing the moral order that existed in research before its introduction, turning researchers from critically assessing ethical situations to ritualistically complying with the rules (Heimer, 2010).…”

Section: Regulating Research Integrity and Research Ethicsmentioning

confidence: 99%

Empowering the Research Community to Investigate Misconduct and Promote Research Integrity and Ethics: New Regulation in Scandinavia

Vie

2022

Sci Eng Ethics

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Researchers sometimes engage in various forms of dishonesty and unethical behavior, which has led to regulatory efforts to ensure that they work according to acceptable standards. Such regulation is a difficult task, as research is a diverse and dynamic endeavor. Researchers can disagree about what counts as good and acceptable standards, and these standards are constantly developing. This paper presents and discusses recent changes in research integrity and ethics regulation in Norway, Denmark, and Sweden. Recognizing that research norms are developed through practice and are therefore unsuited for comprehensive national regulation, the Scandinavian countries focus on empowering the research community to regulate itself instead, except for the most severe cases of misconduct. This empowerment takes the form of giving research institutions tools and investigatory powers while also holding them responsible for ensuring that both the institution and individual researchers are up to date on relevant norms. In this way, the Scandinavian governments seek to avoid some of the challenges found in more legalistic approaches, which risk lagging behind the continuous development of research norms and can be insensitive to the fact that different disciplines have different norms. While the new approach in Scandinavian has several potential benefits, it also involves potential trade-offs and limitations. The new laws can create confusion about what researchers are allowed to do. Another issue is that it only addresses the fundamental drivers of misconduct to a limited extent.

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“…In fact, there was a significant increase in the number of cardiac arrest trials in Europe as compared to the US after 1993 when the US temporarily suspended resuscitation research performed without consent and Europe continued to allow it. 11 This may be changing as the European Union has adopted new guidelines to govern medical research. One of the requirements will be to obtain informed consent from the legal representative before including a subject not capable of providing informed consent for himself or herself in a clinical trial.…”

mentioning

confidence: 99%

A qualitative study of institutional review board members’ experience reviewing research proposals using emergency exception from informed consent

et al. 2007

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Background: Emergency exception to informed consent regulation was introduced to provide a venue to perform research on subjects in emergency situations before obtaining informed consent. For a study to proceed, institutional review boards (IRBs) need to determine if the regulations have been met. Aim: To determine IRB members' experience reviewing research protocols using emergency exception to informed consent. Methods: This qualitative research used semistructured telephone interviews of 10 selected IRB members from around the US in the fall of 2003. IRB members were chosen as little is known about their views of exception to consent, and part of their mandate is the protection of human subjects in research. Interview questions focused on the length of review process, ethical and legal considerations, training provided to IRB members on the regulations, and experience using community consultation and notification. Content analysis was performed on the transcripts of interviews. To ensure validity, data analysis was performed by individuals with varying backgrounds: three emergency physicians, an IRB member and a layperson. Results: Respondents noted that: (1) emergency exception to informed consent studies require lengthy review; (2) community consultation and notification regulations are vague and hard to implement; (3) current regulations, if applied correctly, protect human subjects; (4) legal counsel is an important aspect of reviewing exception to informed-consent protocols; and (5) IRB members have had little or no formal training in these regulations, but are able to access materials needed to review such protocols. Conclusions: This preliminary study suggests that IRB members find emergency exception to informed consent studies take longer to review than other protocols, and that community consultation and community notification are the most difficult aspect of the regulations with which to comply but that they adequately protect human subjects.

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Impact of the Final Rule on the Rate of Clinical Cardiac Arrest Research in the United States

Cited by 17 publications

References 82 publications

Patients' perceptions of research in emergency settings: A study of survivors of sudden cardiac death

Patients' perceptions of research in emergency settings: A study of survivors of sudden cardiac death

Empowering the Research Community to Investigate Misconduct and Promote Research Integrity and Ethics: New Regulation in Scandinavia

A qualitative study of institutional review board members’ experience reviewing research proposals using emergency exception from informed consent

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