Holly Fernandez Lynch
Biographic Data
| ID | 6381332 |
|---|---|
| NAME | Holly Fernandez Lynch |
| GIVEN NAMES | Holly Fernandez |
| FAMILY NAME | Lynch |
| SIGNATURE | LYNCH H F |
| AFFILIATIONS | University of Pennsylvania |
| ORCID | 0000-0001-7813-9879 |
| VERIFIED | Yes |
| TOTAL WORKS | 25 |
| TOTAL CITATIONS | 6 |
| AUTHOR COUNT | 24 |
| EDITOR COUNT | 1 |
| FIRST PUBLICATION YEAR | 2012 |
| LATEST PUBLICATION YEAR | 2024 |
| H-INDEX | 1 |
The relational recession in social work
The primary resources available to social workers are themselves, with building and using effective relationships central to the social work task. More than a decade of austerity policies has impacted how social workers practice. The current barriers to relationship-based practice in work with adults are such that we are experiencing a relational recession – that is the inability to practice in a way that prioritises the relationship. The present…
Engaging key stakeholders to overcome barriers to studying the quality of research ethics oversight
The primary purpose of Institutional Review Boards (IRBs) is to protect the rights and welfare of human research participants. Evaluation and measurement of how IRBs satisfy this purpose and other important goals are open questions that demand empirical research. Research on IRBs, and the Human Research Protection Programs (HRPPs) of which they are often a part, is necessary to inform evidence-based practices, policies, and approaches to quality …
Big Mistake
Pushing back on policies favored by dying patients is a challenging endeavor, requiring tact, engagement, openness to bidirectional learning, and willingness to offer alternative solutions. It's easy to make missteps, especially in the age of social media. Holly Fernandez Lynch shares her experience learning with and from the amyotrophic lateral sclerosis (ALS) community, first as a caricature of an ivory tower bioethicist and more recently as a …
Extending the US Food and Drug Administration’s Postmarket Authorities
Under current FDA approaches to drug approval, patients, clinicians, and payers may be left with little confidence about a drug's benefit not only when it first enters the market but also for an extended period thereafter. If policy makers continue to favor earlier market access over evidentiary certainty, flexible approvals must be matched by more expansive use of postmarket safeguards, an approach possible within the FDA's existing legal author…
Allocation of Opportunities to Participate in Clinical Trials during the Covid‐19 Pandemic and Other Public Health Emergencies
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 an urgent medical need with limited therapeutic interventions. We assess the three main approaches to…
We measure what we can measure”
Academic Advocacy
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 entering a complex environment of legal requirements and institutional policies that they may not full…
Compensating for research risk
When payment is offered for controlled human infection model (CHIM) research, ethical concerns may be heightened due to unfamiliarity with this study design as well as perceptions—and misperceptions—regarding risk. Against this backdrop, we commend Grimwade et al 1 for their careful handling of the relevant issues, coupling empirical and conceptual approaches. We agree with foundational elements of the authors’ analysis, including the acceptabili…
The role of community engagement in addressing bystander risks in research
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 importance of community engagement in biomedical research, this umbrella term includes many different goa…
The right to withdraw from controlled human infection studies
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 debates about the ethics of controlled human infection (CHI) studies in which participants are intent…
Minimal or reasonable? Considering the ethical threshold for research risks to nonconsenting bystanders and implications for nonconsenting participants
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 risks imposed outside the research setting. For nonconsenting participants, US research regulations ty…
Prescription Requirements and Patient Autonomy
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, prescription requirements are justified when nonprescription status would risk harm to third parties and when …
Offering Payment in Clinical Research
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 importance they assign to various ethical and practical factors when designing offers of payment and a…
Transparency in Health and Health Care in the United States
Introduction to Part IV
A summary is not available for this content so a preview has been provided. Please use the Get access link above for information on how to access this content.
Patient‐Engaged Research
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 engagement can offer fresh perspectives that shape research in valuable ways, then at least two important …
Patient‐Centered Outcomes Research
IRB Oversight of Patient-Centered Outcomes Research
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 from research-intensive institutions in the United States. Findings address the responsibilities of IRB…
Of Parachutes and Participant Protection
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 and how well they actually achieve what they were designed to do. In other words, it is critical to ex…
Using Social Media as a Research Recruitment Tool
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 navigating the ethical issues such use raises. We begin to fill this gap by first defending a nonexceptionalist methodology for assessin…
Regulating Research with Biospecimens under the Revised Common Rule
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 amid rumors of intractable disagreement among Common Rule agencies, the Final Rule published on the las…
A Proposal to Address NFL Club Doctors’ Conflicts of Interest and to Promote Player Trust
How can we ensure that players in the National Football League receive excellent health care they can trust from providers who are as free from conflicts of interest as realistically possible? NFL players typically receive care from the club's own medical staff. Club doctors are clearly important stakeholders in player health. They diagnose and treat players for a variety of ailments, physical and mental, while making recommendations to the playe…
Confronting Biospecimen Exceptionalism in Proposed Revisions to the Common Rule
On September 8, 2015, the Department of Health and Human Services issued a Notice of Proposed Rule Making to revise the Federal Policy for the Protection of Human Subjects, widely known as the “Common Rule.” The NPRM proposes several changes to the current system, including a dramatic shift in the approach to secondary research using biospecimens and data. Under the current rules, it is relatively easy to use biospecimens and data for secondary r…
A Response to Commentaries
Our article “NFL Player Health Care: Addressing Club Doctors’ Conflicts of Interests and Promoting Player Trust” focused on an inherent structural conflict that faces club doctors in the National Football League. The conflict stems from club doctors’ dual role of providing medical care to players and providing strategic advice to clubs. We recommended assigning these roles to different individuals, with the medical staff members who are responsib…
Ethical Evasion or Happenstance and Hubris
It's tempting to explain the Guatemala STD inoculation study as an attempt to evade the strictures of U.S research ethics. In fact, the researchers appear to have had benign reasons for going abroad. Only after they reached Guatemala did the study fly out of control
Of Parachutes and Participant Protection
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 and how well they actually achieve what they were designed to do. In other words, it is critical to ex…
IRB Oversight of Patient-Centered Outcomes Research
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 from research-intensive institutions in the United States. Findings address the responsibilities of IRB…
Ethical Evasion or Happenstance and Hubris
It's tempting to explain the Guatemala STD inoculation study as an attempt to evade the strictures of U.S research ethics. In fact, the researchers appear to have had benign reasons for going abroad. Only after they reached Guatemala did the study fly out of control
A Proposal to Address NFL Club Doctors’ Conflicts of Interest and to Promote Player Trust
How can we ensure that players in the National Football League receive excellent health care they can trust from providers who are as free from conflicts of interest as realistically possible? NFL players typically receive care from the club's own medical staff. Club doctors are clearly important stakeholders in player health. They diagnose and treat players for a variety of ailments, physical and mental, while making recommendations to the playe…
Confronting Biospecimen Exceptionalism in Proposed Revisions to the Common Rule
On September 8, 2015, the Department of Health and Human Services issued a Notice of Proposed Rule Making to revise the Federal Policy for the Protection of Human Subjects, widely known as the “Common Rule.” The NPRM proposes several changes to the current system, including a dramatic shift in the approach to secondary research using biospecimens and data. Under the current rules, it is relatively easy to use biospecimens and data for secondary r…
A Response to Commentaries
Our article “NFL Player Health Care: Addressing Club Doctors’ Conflicts of Interests and Promoting Player Trust” focused on an inherent structural conflict that faces club doctors in the National Football League. The conflict stems from club doctors’ dual role of providing medical care to players and providing strategic advice to clubs. We recommended assigning these roles to different individuals, with the medical staff members who are responsib…
Using Social Media as a Research Recruitment Tool
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 navigating the ethical issues such use raises. We begin to fill this gap by first defending a nonexceptionalist methodology for assessin…
Regulating Research with Biospecimens under the Revised Common Rule
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 amid rumors of intractable disagreement among Common Rule agencies, the Final Rule published on the las…
Patient‐Engaged Research
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 engagement can offer fresh perspectives that shape research in valuable ways, then at least two important …
Patient‐Centered Outcomes Research
IRB Oversight of Patient-Centered Outcomes Research
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 from research-intensive institutions in the United States. Findings address the responsibilities of IRB…
Of Parachutes and Participant Protection
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 and how well they actually achieve what they were designed to do. In other words, it is critical to ex…
Transparency in Health and Health Care in the United States
Introduction to Part IV
A summary is not available for this content so a preview has been provided. Please use the Get access link above for information on how to access this content.
Academic Advocacy
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 entering a complex environment of legal requirements and institutional policies that they may not full…
Compensating for research risk
When payment is offered for controlled human infection model (CHIM) research, ethical concerns may be heightened due to unfamiliarity with this study design as well as perceptions—and misperceptions—regarding risk. Against this backdrop, we commend Grimwade et al 1 for their careful handling of the relevant issues, coupling empirical and conceptual approaches. We agree with foundational elements of the authors’ analysis, including the acceptabili…
The role of community engagement in addressing bystander risks in research
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 importance of community engagement in biomedical research, this umbrella term includes many different goa…
The right to withdraw from controlled human infection studies
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 debates about the ethics of controlled human infection (CHI) studies in which participants are intent…
Minimal or reasonable? Considering the ethical threshold for research risks to nonconsenting bystanders and implications for nonconsenting participants
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 risks imposed outside the research setting. For nonconsenting participants, US research regulations ty…
Prescription Requirements and Patient Autonomy
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, prescription requirements are justified when nonprescription status would risk harm to third parties and when …
Offering Payment in Clinical Research
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 importance they assign to various ethical and practical factors when designing offers of payment and a…
We measure what we can measure”
Allocation of Opportunities to Participate in Clinical Trials during the Covid‐19 Pandemic and Other Public Health Emergencies
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 an urgent medical need with limited therapeutic interventions. We assess the three main approaches to…
Engaging key stakeholders to overcome barriers to studying the quality of research ethics oversight
The primary purpose of Institutional Review Boards (IRBs) is to protect the rights and welfare of human research participants. Evaluation and measurement of how IRBs satisfy this purpose and other important goals are open questions that demand empirical research. Research on IRBs, and the Human Research Protection Programs (HRPPs) of which they are often a part, is necessary to inform evidence-based practices, policies, and approaches to quality …
Big Mistake
Pushing back on policies favored by dying patients is a challenging endeavor, requiring tact, engagement, openness to bidirectional learning, and willingness to offer alternative solutions. It's easy to make missteps, especially in the age of social media. Holly Fernandez Lynch shares her experience learning with and from the amyotrophic lateral sclerosis (ALS) community, first as a caricature of an ivory tower bioethicist and more recently as a …
Extending the US Food and Drug Administration’s Postmarket Authorities
Under current FDA approaches to drug approval, patients, clinicians, and payers may be left with little confidence about a drug's benefit not only when it first enters the market but also for an extended period thereafter. If policy makers continue to favor earlier market access over evidentiary certainty, flexible approvals must be matched by more expansive use of postmarket safeguards, an approach possible within the FDA's existing legal author…
The relational recession in social work
The primary resources available to social workers are themselves, with building and using effective relationships central to the social work task. More than a decade of austerity policies has impacted how social workers practice. The current barriers to relationship-based practice in work with adults are such that we are experiencing a relational recession – that is the inability to practice in a way that prioritises the relationship. The present…
Political science (21 works) · Psychology (17 works) · Medicine (16 works) · Ethics in Clinical Research (14 works) · Law (14 works) · Public relations (13 works) · Business (10 works) · Research ethics (8 works) · Biomedical Ethics and Regulation (7 works) · Computer Science (7 works)