Ethics & human research最新文献

Leading medical organizations have called for advancement of pregnancy-specific research to reduce harmful evidence gaps. However, meeting this objective poses ethical, legal, and policy dilemmas for investigators, oversight committees, academic institutions, and sponsors. To better understand the extent to which policies may facilitate or hinder the inclusion of pregnant women in research, we conducted two studies: an international study of laws, regulations, and ethical guidelines from a diverse sample of 59 countries and a study of policies from 84 top-funded US research institutions. We found that most policies use risk-based criteria for determining whether pregnant women should be included in research. Among countries with inclusion policies for pregnant women, 76% had risk-based policies (i.e., inclusion is based on risks and benefits to the pregnant woman and/or fetus), 13% had inclusionary policies (i.e., pregnant women should or must be included in research unless there is a valid scientific or ethical reason for exclusion), and 11% had exclusionary policies (i.e., pregnant women should or must be excluded from research unless there is a valid scientific or ethical reason for inclusion). In the US study, 96% of institutions had risk-based policies, 3% had exclusionary policies, and 1% had inclusionary policies. We also found that many policies referred to pregnant women as vulnerable. To promote fair and responsible inclusion of pregnant women in research, academic institutions, sponsors, and oversight agencies should adopt and implement policies with inclusionary language and refrain from referring to pregnant women as vulnerable.

Effective pain management in prehospital settings remains a significant challenge, particularly for patients with acute trauma. This report examines the complexities of conducting prehospital pain studies, focusing on two clinical trials as case studies. The first trial implemented a novel two-step informed consent process, which, despite its innovation, faced logistical challenges and introduced biases favoring the enrollment of less severely injured patients. The second study, conducted under the federal regulatory pathway for Exception from Informed Consent (EFIC), successfully addressed consent challenges but restricted enrollment to severely injured patients to meet EFIC regulatory requirements. Both studies excluded women of childbearing age due to concerns about fetal safety. These limitations underscore the urgent need for regulatory revisions to expand research with alteration of informed consent, enabling the development of new interventions for prehospital pain management.

For many of the decisions made in the clinical care setting, clinicians lack evidence to inform which treatment would result in the best patient outcomes. This problem is particularly common in emergency care, a field in which the condition of the patient and the urgent nature of the treatment often preclude research conducted using prospective informed consent. Large-scale comparative effectiveness clinical trials could address the evidence gaps in clinical medicine and improve patient outcomes but are hindered by the lack of a clear regulatory framework in the United States for low-to-minimal risk trials comparing commonly used treatments. In this paper, we summarize a presentation and discussion that took place at a workshop held by the National Institutes of Health that focused on the issue of informed consent and the appropriate regulatory pathway for comparative effectiveness trials conducted in the emergency care setting. A key insight of this workshop is that generating the comparative effectiveness data needed to improve clinical care will require revising ethical and regulatory oversight practices and related guidance to support the conduct of this socially valuable research.

The ethical challenges of enrolling critically ill patients into emergency care clinical trials without their consent remain, despite a 30-year regulatory framework for conducting research in the emergency setting. In this series introduction, we outline some suggestions to improve studies conducted under the regulatory framework involving an exception from informed consent for emergency care research. These suggestions were made at a recent workshop sponsored by the National of Institutes of Health.

Institutional review boards (IRBs) are charged with conducting risk-benefit analysis for early phase clinical trials that often involve high levels of uncertainty regarding a trial's potential risks and benefits. Our study used a survey of IRB chairs to explore how IRBs conduct risk-benefit analysis, the unique facets of risk-benefit analysis for early phase clinical trials and specifically for early phase neurology trials, and what facilitates high-quality risk-benefit analysis. The survey measured IRB chairs’ perceived difficulty, preparedness, processes, and satisfaction with risk-benefit analysis for early phase trials. The survey was completed by 148 of the 259 eligible IRB chairs for a response rate of 64.6%. Two-thirds of respondents found risk-benefit analysis for early phase clinical trials more challenging than for later phase trials. Ninety-one percent of respondents felt that their IRB did an “excellent” or “very good” job conducting risk-benefit analysis, but more than one-third of respondents did not feel “very prepared” to conduct key aspects of risk-benefit analysis. Over two-thirds of respondents reported that additional resources, like a standardized process for conducting risk-benefit analysis, would be mostly or very valuable. Our results suggest that conducting risk-benefit analysis for early phase clinical trials generally and early phase neurology trials specifically is challenging for IRBs. One-third of respondents reported that they lack preparation for assessing the scientific value of these types of trials and the risks and benefits to research participants, and a majority desire additional support.

Enhanced protection for research participants is often stated as a goal and potential benefit of engaging community partners in research. However, many community-engaged research teams report challenges in completing human research protection (HRP) training. Some human research protection programs (HRPPs) require community researchers to complete the same training that university faculty and staff members are required to do, while others allow alternatives that are more accessible and appropriately suited to community researchers’ background and roles. To learn more about general HRPP requirements for training and alternatives for community researchers, we surveyed 163 research institutions funded by the National Institutes of Health's Clinical and Translational Science Award program. Out of 55 respondents, 34 HRPPs (61.8%) allow community researchers to complete different HRP training from that required for faculty/staff. Reasons for allowing or denying alternative training vary, and some institutions that currently do not allow alternatives report that they are reconsidering their policy. The fact that some institutions do not allow alternatives and are not considering changing their policies, even when requested by the principal investigators of studies, may pose significant barriers to community-engaged research. Effort is needed to increase awareness about alternatives as well as their acceptability in meeting training requirements of federal funding agencies.

Physicians engaged in clinical research have dual roles as members of the research team and as physicians. Although various medical ethics codes and associated ethics opinions state that physicians have substantially similar obligations to research participants as they have to patients, the reality is different. Research physicians follow study protocols that often require practices that depart from the standard of care. The proposed Bill of Rights for Clinical Research Participants incorporates key ethics principles from the physician-patient relationship, some of which already are reflected in provisions of the ethics codes and opinions addressing nontraditional physician relationships. The Bill of Rights is intended to promote greater transparency and accountability in a frequently misunderstood relationship.