Holly Fernandez Lynch's research while affiliated with University of Pennsylvania and other places

Publications (108)

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Background: Institutional review board (IRB) expertise is necessarily limited by maintaining a manageable board size. IRBs are therefore permitted by regulation to rely on outside experts for review. However, little is known about whether, when, why, and how IRBs use outside experts. Methods: We conducted a national survey of U.S. IRBs to charac...
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Background: Meaningfully evaluating the quality of institutional review boards (IRBs) and human research protection programs (HRPPs) is a long-recognized challenge. To be accredited by the Association for the Accreditation of Human Research Protection Programs (AAHRPP), organizations must demonstrate that they measure and improve HRPP "quality, ef...
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The US Food and Drug Administration's decisions about drug approval-though guided by science, as well as relevant statutes, regulations, and guidance documents-reflect normative judgments about how the agency should exercise its discretion. This is particularly true in the context of the "accelerated approval" pathway, where the agency must balance...
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Institutional review boards (IRBs) are permitted by regulation to seek assistance from outside experts when reviewing research applications that are beyond the scope of expertise represented in their membership. There is insufficient understanding, however, of when, why, and how IRBs consult with outside experts, as this practice has not been the p...
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Law and racism are intertwined, with legal tools bearing the potential to serve as instruments of oppression or equity. This Special Issue explores this dual nature of health law, with attention to policing in the context of mental health, schools, and substance use disorders; industry and the environment in the context of food advertising, tobacco...
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Covid-19 raised many novel ethical issues including regarding the allocation of opportunities to participate in clinical trials during a public health emergency. In this article, we explore how hospitals that have a scarcity of trial opportunities, either overall or in a specific trial, can equitably allocate those opportunities in the context of a...
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Reform requires clarity about whether, when, and how meaningful postapproval trials are possible.
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After witnessing extraordinary scientific and regulatory efforts to speed development of and access to new COVID-19 interventions, patients facing other serious diseases have begun to ask "where's our Operation Warp Speed?" and "why isn't Emergency Use Authorization an option for our health crises?" Although this pandemic bears a number of unique f...
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There has been a persistent lack of clarity regarding how to define and measure the quality of Institutional Review Boards (IRBs). To address this challenge, we interviewed 43 individuals designated as IRB Stakeholders, including leaders in research ethics oversight, policymakers, investigators, research sponsors, and patient advocates, about their...
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Full-text available
In justifying the accelerated approval of aducanumab (Aduhelm; Biogen), US Food and Drug Administration (FDA) officials emphasized that many patients with Alzheimer disease and their families “made it clear that they are willing to accept the trade-off of some uncertainty about clinical benefit in exchange for earlier access to a potentially effect...
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Institutional review boards (IRBs) have been criticized for inconsistency and lack of transparency in decision‐making, problems that undermine both trust in their ability to protect human research participants and respect for their decisions among researchers. The absence of robust documentation of their decisions and the inability or unwillingness...
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Background/objective: Along with the greater research enterprise, Institutional Review Boards (IRBs) had to quickly adapt to the COVID-19 pandemic. IRBs had to review and oversee COVID-related research, while navigating strict public health measures and a workforce largely relegated to working from home. Our objectives were to measure adjustments...
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Employees are often considered a vulnerable research population due to concerns about consent and confidentiality, but there is insufficient guidance regarding their ethical inclusion in research. In the context of Covid-19, frontline health care workers comprise a particularly relevant research population in light of their risks of viral exposure...
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To prepare for potential human infection challenge studies (HICS) involving SARS-CoV-2, we convened a multidisciplinary working group to address ethical questions regarding whether and how much SARS-CoV-2 HICS participants should be paid. Because the goals of paying HICS participants, as well as the relevant ethical concerns, are the same as those...
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Given the dearth of established safe and effective interventions to respond to COVID-19, there is an urgent ethical imperative to conduct meaningful clinical research. The good news is that interventions to be tested are not in short supply. Unfortunately, the human and material resources needed to conduct these trials are finite. It is essential t...
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The COVID-19 pandemic has highlighted the challenges of evidence-based health policymaking, as critical precautionary decisions, such as school closures, had to be made urgently on the basis of little evidence. As primary and secondary schools once again close in the face of surging infections, there is an opportunity to rigorously study their reop...
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In most U.S. jurisdictions, clinicians providing informal “curbside” consults are protected from medical malpractice liability due to the absence of a doctor-patient relationship. A recent Minnesota Supreme Court case, Warren v. Dinter , offers the opportunity to reassess whether the majority rule is truly serving the best interests of patients.
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When new drugs are approved by the Food and Drug Administration, the default assumption is that they will be available by prescription only, safe for use exclusively under clinical supervision. The paternalism underlying this default must be interrogated in order to ensure appropriate respect for patient autonomy. Upon closer inspection, prescripti...
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There is limited guidance on how to assess the ethical acceptability of research risks that extend beyond research participants to third parties (or “research bystanders”). Community or stakeholder engagement has been proposed as one way to address potential harms to community members, including bystanders. Despite widespread agreement on the impor...
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Allocating access to unapproved COVID-19 drugs available via Pre-Approval Access pathways or Emergency Use Authorization raises unique challenges at the intersection of clinical care and research. In conditions of scarcity, prioritization approaches should minimize harm, maximize benefit, and promote fairness. To promote continued data collection,...
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Background Research ethics review committees (RERCs) and Human Research Protection Programs (HRPPs) are responsible for protecting the rights and welfare of research participants while avoiding unnecessary inhibition of valuable research. Evaluating RERC/HRPP quality is vital to determining whether they are achieving these goals effectively and eff...
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Evaluating the quality and effectiveness of the institutional review boards (IRBs) responsible for overseeing research involving human participants is critically important but perpetually challenging. Seemingly common-sense measures, such as the number of proposals approved with and without major modifications and the number of unexpected adverse e...
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Full-text available
Clinical research is critical to combatting COVID-19, but regulatory requirements for human subjects protection may sometimes pose a challenge in pandemic circumstances. Although regulators have offered some helpful guidance for research during the pandemic, we identify further compliance challenges regarding institutional review board (IRB) review...
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A variety of trials are in development and underway to examine potential interventions for the treatment and prophylaxis of novel coronavirus disease 2019 (COVID-19). How should we think about offering payment to participants in these trials? Payment for research participation is ethically contentious even under ideal circumstances, and pandemics a...
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Full-text available
Development of an effective vaccine is the clearest path to controlling the coronavirus disease 2019 (COVID-19) pandemic. To accelerate vaccine development, some researchers are pursuing, and thousands of people have expressed interest in participating in, controlled human infection studies (CHIs) with severe acute respiratory syndrome–coronavirus...
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When research poses risks to non‐participant bystanders, it is not always practicable to obtain their consent. One approach to assessing how much research risk may be imposed on nonconsenting bystanders is to examine analogous circumstances, including risk thresholds deemed acceptable for nonconsenting research participants and for nonconsensual ri...
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The right to withdraw from research without penalty is well established around the world. However, it has been challenged in some corners of bioethics based on concerns about various harms—to participants, to scientific integrity, and to research bystanders—that may stem from withdrawal. These concerns have become particularly salient in emerging d...
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Offering payment is an important means of facilitating research participation. Yet, offers of payment raise ethical challenges that may be heightened when prospective participants suffer from or are at risk for opioid use disorder (OUD). We surveyed principal investigators (PIs) conducting research in this population to characterize the relative im...
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Full-text available
In the face of rising rates of antibacterial resistance, many responses are being pursued in parallel, including 'non-traditional' antibacterial agents (agents that are not small-molecule drugs and/or do not act by directly targeting bacterial components necessary for bacterial growth). In this Perspective, we argue that the distinction between tra...
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Medical school faculty and their colleagues in schools of nursing, public health, social work, and elsewhere often research issues of critical importance to health and science policy. When academics engage with government policymakers to advocate for change based on their research, however, they may find themselves engaged in "lobbying," thereby en...
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Faced with the prospect of death or debilitating disease, patients and their families may be willing to try almost any treatment. A number of systems exist to help prevent this understandable desperation from resulting in serious harm, including standards of medical professionalism, requirements for product approval by the US Food and Drug Administ...
Chapter
Transparency in Health and Health Care in the United States - edited by Holly Fernandez Lynch June 2019
Chapter
Transparency in Health and Health Care in the United States - edited by Holly Fernandez Lynch June 2019
Article
The revised Common Rule includes a new option for the conduct of secondary research with identifiable data and biospecimens: regulatory broad consent. Motivated by concerns regarding autonomy and trust in the research enterprise, regulators had initially proposed broad consent in a manner that would have rendered it the exclusive approach to second...
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In Reply Pediatric phase 1 cancer trials are widely viewed as offering a therapeutic opportunity for children who meet eligibility criteria, which typically include exhaustion of other treatment options.¹,2 This perspective likely grounds the way such trials are reviewed by local ethics committees, as well as what children and their guardians are t...
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Recognising that offers of payment to research participants can serve various purposes—reimbursement, compensation and incentive—helps uncover differences between participants, which can justify differential payment of participants within the same study. Participants with different study-related expenses will need different amounts of reimbursement...
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Newly revised regulations for human research affecting translational oncology will become effective in January 2019. A substantial component of the debate leading to this revision was how to regulate biospecimen research; specifically, whether all biospecimens should be considered inherently “identifiable,” thereby necessitating informed consent fo...
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Importance Offers of payment for research participation are ubiquitous but may lead prospective participants to deceive about eligibility, jeopardizing study integrity and participant protection. To date, neither the rate of payment-induced deception nor the influence of payment amount has been systematically studied in a nationally representative...
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Attrition is a serious problem in many clinical trials. The practice of offering completion bonuses—financial incentives offered to participants on the condition that they remain in a trial until they reach a prespecified study endpoint—is one means of addressing attrition. Despite their practical appeal, however, completion bonuses remain ethicall...
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There are several reasons to believe that Institutional Review Boards (IRBs) and Human Research Protection Programs (HRPPs) contribute to ethical research and the protection of research participants, but there are also important reasons to interrogate this belief. Determining whether IRBs and HRPPs “work” requires empirical evaluation of whether an...
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Advances in pediatric cancer treatment represent one of modern medicine’s greatest achievements. This progress would not be possible without testing new therapies in children. However, pediatric research must satisfy stricter ethical and regulatory standards than research with adults, in light of children’s inability to provide consent. We contend...
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To the Editor: I agree with the call of Fernandez Lynch and colleagues (June 21 issue)¹ for a collaborative approach to informed consent while maintaining the central roles of the treating doctor and the patient. Rendering informed consent a nondelegable responsibility in the United States could have far-reaching implications if it were to establis...
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Social media communication among clinical trial participants has the potential to pose risks to their safety and to trial integrity. The Social Media ADEPT framework may help mitigate that potential by encouraging investigators and patient partners to work together to Assess social media risks, Design studies to minimize those risks, Educate partic...
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A key aim of patient-centered outcomes research (PCOR) is to generate data that are important to patients by deliberately and extensively involving them in all aspects of research, from design to dissemination. However, certain elements of PCOR raise challenging and potentially novel ethical and regulatory issues for institutional review boards and...
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To ensure that the information resulting from research is relevant to patients, the Patient‐Centered Outcomes Research Institute eschews the “traditional health research” paradigm, in which investigators drive all aspects of research, in favor of one in which patients assume the role of research partner. If we accept the premise that patient engage...
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On May 30, 2018, President Trump signed into law the federal Right to Try Act of 2017,1 providing patients with life-threatening conditions a pathway to access investigational drugs without authorization from the Food and Drug Administration (FDA). Ethicists, physicians, and patient groups have raised concerns about this type of legislation at the...
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In the century since Justice Benjamin N. Cardozo famously declared that "[e]very human being of adult years and sound mind has a right to determine what shall be done with his own body,"1 informed consent has become a central feature of American medical practice. In an increasingly team-based and technology-driven system, however, who is - or ought...
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Patient-centered outcomes research (PCOR) is becoming increasingly common. However, there is little evidence regarding what novel ethical challenges, if any, are posed by PCOR with relevance to institutional review board (IRB) oversight and human subjects protections. This article reports the results of a national survey of all IRB chairpersons fro...
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Shortfalls in clinical trial recruitment and retention constitute a major obstacle to scientific advancement.¹ One means of increasing patient participation rates is to reduce associated financial burdens. In several states, efforts are under way to achieve this goal for patients in cancer clinical trials through legislation explicitly allowing rei...
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The practice of paying research participants has received significant attention in the bioethics literature, but the focus has been almost exclusively on consideration of factors relevant to determining acceptable payment amounts. Surprisingly little attention has been paid to what happens once the payment amount is set. What are the ethical parame...
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This qualitative study examined how NFL players and their family members characterized the impact of an NFL career on the mental and emotional health of NFL players. We interviewed 25 NFL players (23 former and 2 current) and 27 family members (24 wives and 3 others) to elicit players’ experiences during and following their time in the NFL. While p...
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When data from all aspects of our lives can be relevant to our health - from our habits at the grocery store and our Google searches to our FitBit data and our medical records - can we really differentiate between big data and health big data? Will health big data be used for good, such as to improve drug safety, or ill, as in insurance discriminat...
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Institutional Review Boards (IRBs) have substantial power and authority over research with human subjects, and in turn, their decisions have substantial implications for those subjects, investigators, and the public at large. However, there is little transparency about IRB processes and decisions. This article provides the first comprehensive taxon...
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The authors propose a framework for evaluating the appropriateness of payments to research participants. They distinguish three acceptable rationales for payment: out-of-pocket expenses, time and burdens of participation, and incentive to participate.
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A bill passed by the Senate would sharply curtail the FDA’s oversight of access to investigational drugs. Although its impact would probably be limited, the motivation behind it threatens to weaken the FDA’s ability to pursue its public health mission.
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Public access to clinical trial consent forms, beyond those individuals involved in reviewing, conducting, or participating in a trial, has been notoriously poor, resulting in missed opportunities for empirical analysis and improvement, among other benefits. However, recent changes to the Common Rule and policies governing ClinicalTrials.gov promis...
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When the Obama administration included contraception in the essential benefits package to be covered by employer-sponsored health insurance plans under the Affordable Care Act, it sought to preserve access for women while addressing the concerns of employers with religious objections. Although the accommodations and exemptions were not enough for s...
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Since 2011, the research community had waited with bated breath as regulators contemplated for the first time bringing secondary research with nonidentifiable biospecimens under the Common Rule and dramatically tightening the criteria for waiving consent to biospecimen research. After considerable pushback from both researchers and patients and ami...
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Investigators and institutions have begun to prepare for new federal protections of study participants set to take effect in 2018.
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Ensuring that clinical trials, once launched, successfully complete and generate useful knowledge is an important and indeed ethically imperative goal, given the risks and burdens borne by research participants. Since there are insufficient willing research participants to power all the trials that are currently undertaken,1 addressing underenrolme...
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*Gelinas, *Pierce (co-lead authors)The use of social media as a recruitment tool for research with humans is increasing, and likely to continue to grow. Despite this, to date there has been no specific regulatory guidance and there has been little in the bioethics literature to guide investigators and institutional review boards (IRBs) faced with n...
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It is not uncommon for multiple clinical trials at the same institution to recruit concurrently from the same patient population. When the relevant pool of patients is limited, as it often is, trials essentially compete for participants. There is evidence that such a competition is a predictor of low study accrual, with increased competition tied t...
Book
While the law can create conflict between religion and health, it can also facilitate religious accommodation and protection of conscience. Finding this balance is critical to addressing the most pressing questions at the intersection of law, religion, and health in the United States: should physicians be required to disclose their religious belief...