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The use of patient-reported outcome measures (PROMs) is increasingly common in routine clinical practice. As tools to quantify symptoms and health status, PROMs play an important role in focusing health care on outcomes that matter to patients. The uses of PROM data are myriad, ranging from clinical care to survey-based research and quality improvement. Discerning the boundaries between these use cases can be challenging for institutional review boards (IRBs). In this article, we provide a framework for classifying the three primary PROM use cases (clinical care, human subjects research, and quality improvement) and discuss the level of IRB oversight (if any) necessary for each. One of the most important considerations for IRB staff is whether PROMs are being used primarily for clinical care and thus do not constitute human subjects research. We discuss characteristics of PROMs implemented primarily for clinical care, focusing on: data platform; survey location; questionnaire length; patient interface; and clinician interface. We also discuss IRB oversight of projects involving the secondary use of PROM data that were collected during the course of clinical care, which span human subjects research and quality improvement. This framework provides practical guidance for IRB staff as well as clinicians who use PROMs as communication aids in routine clinical practice., (© 2024 The Authors. Ethics & Human Research published by Wiley Periodicals LLC on behalf of The Hastings Center.)

With the rapid spread of SARS-CoV2 has come a rapid proliferation of clinical research studies, resulting in considerable strain on research ethics committees (RECS), which need to review study proposals. RECs are pressured to move through the review process quickly so that studies can get underway to address the pandemic. These committees are also asked to increase efficiency without relaxing the standards for ethical review. RECs are accustomed to external pressure for approval from investigators; however, in the Covid-19 era, this pressure is coming from not only the sponsors and investigators but also many other stakeholders, including world leaders, the community, the media, and professional organizations. Drawing on the authors' experiences on a central REC reviewing complex multicenter Covid-19 studies, this commentary describes challenges that are inherent to Covid-19 research studies, such as the difficulty of obtaining informed consent from patients ill with the highly infectious virus. The commentary recommends several steps that RECs can take to ensure ethical review of research studies during the Covid-19 pandemic and future infectious disease outbreaks., (© 2021 by The Hastings Center. All rights reserved.)

Many are calling for concrete mechanisms of oversight for health research involving artificial intelligence (AI). In response, institutional review boards (IRBs) are being turned to as a familiar model of governance. Here, we examine the IRB model as a form of ethics oversight for health research that uses AI. We consider the model's origins, analyze the challenges IRBs are facing in the contexts of both industry and academia, and offer concrete recommendations for how these committees might be adapted in order to provide an effective mechanism of oversight for health-related AI research., (© 2021 by The Hastings Center. All rights reserved.)

In response to researcher noncompliance with ethical and regulatory provisions governing research with humans, protocol deviations, and unanticipated problems with research, institutional review boards (IRBs) or institutions sometimes impose restrictions on the use of research data, although specific cases in which this happens are unlikely to be known publicly. We review IRB policies at top research institutions in the United States about restrictions on the use of research data and describe potential reasons for restricting the use of such data in the context of ensuring compliance with human subjects research standards. We also discuss ethical considerations related to restricting the use of research data and argue that IRBs have limited regulatory authority to take such actions. Finally, we offer recommendations regarding decision-making about restricting the use of research data and call for additional guidance in this area., (© 2020 by The Hastings Center. All rights reserved.)

Individual-cluster trials randomize groups of individuals but deliver study interventions directly to individual participants. We examine three arguments that might justify the perception that the bar for a waiver of consent should be lower in such trials than for individually randomized trials. We contend that if these arguments are treated as sufficient to grant a waiver of consent, then a loophole emerges in research oversight. Such loopholes are morally hazardous for study participants, the integrity of science, and public trust in the research enterprise. We conclude by articulating the standards that research ethics committees should use to evaluate requests for waivers of consent in individual-cluster trials., (© 2020 by The Hastings Center. All rights reserved.)

This article describes the process of designing, approving, and conducting an investigator-initiated protocol to use an eye-tracking device in a health care setting. Participants wore the device, which resembles eyeglasses, in a front-facing manner in an intensive care unit for the study of personnel gaze patterns, producing a visual record of workflow. While the data of interest for our study was not specifically the health information protected by the privacy rule of the Health Insurance Portability and Accountability Act (HIPAA), a wide variety of such data was captured by the eye-tracking device, and the prospective consent of all people who might have been incidentally videotaped was not feasible. The protocol therefore required attention to unique ethical considerations-including consent, privacy and confidentiality, HIPAA compliance, institutional liability, and the use of secondary data. The richness of eye-tracker data suggests various beneficial applications in health care occupational research and quality improvement. Therefore, sharing our study's successful design and execution, including proactive researcher-institutional review board communication, can inform and encourage similarly valuable, ethical, and innovative audiovisual research techniques., (© 2020 by The Hastings Center. All rights reserved.)

The implementation of pragmatic clinical trials (PCTs) can be accompanied by unique regulatory challenges. In this paper, we describe the experience and management of regulatory noncompliance during a 25-site acute care PCT. During the trial, the study team conducted a comprehensive audit of all enrollment forms (informed consent and Health Insurance Portability and Accountability Act authorization forms) and related study documentation. A review of 997 participants' enrollment forms identified 138 (13.8%) that required reporting to the institutional review board due to noncompliance. To prevent subsequent noncompliance, the study team developed and introduced a revised participant tracking system, reviewed all enrollment documentation, and retrained sites regarding study procedures. Based on these experiences, we developed a set of recommendations for future PCTs to ensure both operational success and regulatory compliance., (© 2020 by The Hastings Center. All rights reserved.)

The near-routine exclusion of pregnant women from clinical research has resulted in evidence gaps that endanger the health of pregnant women and their future offspring. Although existing literature documents numerous obstacles along the clinical trial pathway that can stymie research involving pregnant women, there is little guidance on how to facilitate such research. This qualitative study aims to fill that void by examining the experiences of individuals involved in conducting, approving, or overseeing research involving pregnant women at one academic institution. The study identifies factors throughout the clinical pathway-from protocol development, to IRB review, and ultimately trial execution-that likely contribute to the successful conduct of research with pregnant women. Attention to those factors, coupled with agreement among stakeholders that research with pregnant women should and can be done ethically and legally, is critical to shifting the narrative from "why we cannot" do such research to "how we can.", (© 2020 by The Hastings Center. All rights reserved.)

In response to increasing concerns regarding inconsistency in the decision-making of institutional review boards (IRBs), we introduce the decision-maker's dilemma, which arises when complex, normative decisions must be made regularly. Those faced with such decisions can either develop a process of algorithmic decision-making, in which consistency is ensured but many morally relevant factors are excluded from the process, or embrace discretionary decision-making, which makes space for morally relevant factors to shape decisions but leads to decisions that are inconsistent. Based on an exploration of similarities between systems of criminal sentencing and of research ethics review, we argue for a discretionary system of decision-making, even though it leads to more inconsistency than does an algorithmic system. We conclude with a discussion of some safeguards that could improve consistency while still making space for discretion to enter IRBs' decision-making processes., (© 2019 by The Hastings Center. All rights reserved.)

Ethics guidelines and commentary suggest that a central function of research ethics committees is to assess the scientific merit of the protocols they review. However, some commentators object to this role, and evidence suggests that the assessment of scientific merit is a significant source of confusion and animosity between ethics committees and clinical investigators. In this essay, we argue that ethics committees should assess the scientific value and validity of research protocols and that new decision-making tools are needed to help them do so in a systematic, transparent, and reliable way. We present a novel ethical framework that can assist in this task., (© 2019 by The Hastings Center. All rights reserved.)