Skip Over Navigation Links

NIH Office of Emergency Care Research and Department of Bioethics Workshop

​Ethical and Regulatory Challenges to Emergency Care Research

Executive Summary

On March 5 and 6, 2014, the NIH Office of Emergency Care Research and the Department of Bioethics in the NIH Clinical Center convened a working group to review ethical and regulatory challenges to emergency care research. After a review of the current regulations by representatives of the Office for Human Research Protections and Food and Drug Administration (FDA), the group focused on four areas.

1. Comparative Effectiveness Research (CER) in Emergency Care
There are several factors that make CER in emergency care especially challenging. These include the lack of an existing physician-patient relationship and an inability to choose the location of care or the provider, given the patient’s urgent need to seek treatment. Adaptive design was suggested as a means of treating patients as effectively as possible while answering a clinical question. In order to improve the consent process in CER, the group suggested that the process should be tailored to the ethical concerns raised by the particular research. Participants also suggested that a valid clinical consent need not describe the method of selecting the treatment arms, and that consent in CER can be brief and focused (as described in Kim and Miller, NEJM 2014:370:8;769-72 [PDF, 389KB] Link to external Web site). Community consultation has an important role to play in helping investigators and review committees consider whether there is any reason to think that specific individuals would be opposed to enrollment in research. The relationship between consent for research and consent for care was discussed, and it was suggested that many CER drug trials that require FDA oversight are of such minimal risk that they should be classified as such. 

2. Consent Process
Rather than simply considering a patient as being able or unable to give consent, this capacity should be seen as spanning a spectrum. However, current regulations treat the capacity for consent as “all or nothing.” In a similar manner, risks lie across a spectrum, and some kinds of risk are qualitatively different from others.  It is important to tailor the consent process to the specifics of each study, and one proposal at the workshop was for a more liberal use of the exception from informed consent (EFIC) mechanism, supplemented with strategies to involve patients as much as possible. In order to improve participation in research trials, the group suggested that the consent process could be altered in cases when full consent is not possible, but acknowledged the need to address potential regulatory considerations surrounding this approach.

3. Community Consultation
Lessons from the NHLBI-sponsored Community Views on Informed Consent in Emergency Situations (VOICES) study were shared, and it was noted that the definition of community is multidimensional. Lessons from the current best practices for community consultation suggest that it should include members of the institutional review board (IRB) so that targeted feedback can reach the IRB. In addition, investigators should consider a two-principal investigator model where one investigator manages the clinical trial and the second oversees the human subjects activities. There is a need to keep public disclosure (the process of informing a community about a trial) and community consultation activities separate. Community consultation can take several months, especially if additional consultation is required by the IRB. While in some cases it results in only minor protocol changes, interactive community consultation provides more informed feedback and demonstrates respect for the community. It was suggested that community consultation be scaled according to the risks of the study, with minimal-risk studies requiring only minimal consultation. In addition, the emphasis in community consultation should change from informing to hearing and responding.

4. Central IRB Review
Central IRB review is critical, since in some pre-hospital trials as many as 58 separate IRBs were involved and the approval process took as long as 18 months. The current FDA regulations already allow for a centralized IRB review, but the likelihood of success depends on local factors. Many IRBs lack the necessary expertise to review EFIC studies, which further emphasizes the need for central IRBs staffed with experts. The group noted that these central IRBs should possess expertise in the ethical, regulatory and consent issues in emergency care research; should include a degree of local content review; and should clearly delineate the responsibilities that are managed by the central IRB and those that may be managed by the local entities involved.

Next Steps
Presenters from the conference have established working groups to produce publications for submission to a peer-reviewed journal.

Staff Contact
Jeremy Brown, M.D.
NIH Office of Emergency Care Research

This page last reviewed on December 30, 2015