News, Resources, and Events Tagged "Human Subjects Research"
Responding to the Call to Meaningfully Assess Institutional Review Board Effectiveness
Independent review and oversight have long been recognized as requirements for ethical research involving human participants, leading institutional review boards (IRBs) to become deeply entrenched in the research enterprise. Against…
Institutional Review Board Use of Outside Experts: What Do We Know?
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…
“We measure what we can measure”: Struggles in defining and evaluating institutional review board quality
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…
Effect of Targeted Behavioral Science Messages on COVID-19 Vaccination Registration Among Employees of a Large Health System: A Randomized Trial
During the 3-day study period, an individual email nudge caused more than twice as many HCWs to register for a COVID-19 vaccination compared with HCWs in the control condition, with…
Promoting Ethical Payment in Human Infection Challenge Studies
Full Author List: Holly Fernandez Lynch (Former Executive Director), Thomas Darton, Jae Levy, Frank McCormick, Ubaka Ogbogu, Ruth Payne, Alvin Roth, Akilah Jefferson Shah, Thomas Smiley, and Emily A. Largent …
The Lost Decade: Clinical Trials Data Access After Seife v HHS
Realization of the full value of data from clinical trials requires that the data be accessible to the broader research community, not just to the investigators who conducted and the…
Waivers and Alterations of Research Informed Consent During the COVID-19 Pandemic
A foundational requirement of ethical research is that persons provide informed consent. Yet, there are exceptions that promote valuable research without unduly compromising participants' interests. Applicable regulations for federally funded…
Right to Try: A ‘well-intentioned’ but ‘misguided’ law
[...] “On its face, it seems as though Right to Try would streamline the process and make it easier for patients, but actually, the FDA approves almost all the requests…
Overcoming obstacles to experiments in legal practice
The importance of evidence-based policy rooted in experimental methods is increasingly recognized, from the Oregon Medicaid experiment to the efforts to address global poverty that were awarded a 2019 Nobel Prize.…
The ‘Nudgability’ Model for More Ethical Clinical Research
The concept of “nudging,” has been thoroughly discussed and debated in the context of health care, and particularly in the public health domain. The use of nudging in…
Economic vulnerability and payment for research participation
Abstract: There has been significant analysis of the ethical and regulatory issues involved with paying research participants, but less attention has been focused specifically on paying economically vulnerable individuals and…
Continuing Education: Ethics of Research with Human Subjects, University of Pennsylvania Medical Ethics & Health Policy
From the course description: Program Overview The goal of this activity is to provide learners with basic knowledge and skills on how to make ethical evaluations on research protocols, including…
Biomarkers in Cancer Drug Approvals: New Opportunities and Challenges: A Health Policy and Bioethics Consortium
The FDA recently approved Keytruda and Vitrakvi, two cancer drugs targeting biomarkers without reference to the site of the disease. Defining cancer in terms of biomarkers alone may require us…
Health Law Workshop: Alex John London: Is There a Moral Dilemma at the Heart of Research with Humans?
Presentation Topic: “Is There a Moral Dilemma at the Heart of Research with Humans?” This paper is not available for download. About the Presenter Alex John London is…
Pay-to-Participate Trials and Vulnerabilities in Research Ethics Oversight
From the article: 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…
Health Law Workshop: Holly Fernandez Lynch: Thinking about Bystanders to Research
Presentation Topic: "Thinking about Bystanders to Research" This paper is not available for download. About the Presenter Holly Fernandez Lynch is John Russell Dickson, MD Presidential Assistant Professor of Medical…
Book Launch: Transparency in Health and Health Care in the United States
Description In June 2019, Cambridge University Press published Transparency in Health and Health Care in the United States. This volume, edited by Holly Fernandez Lynch, I. Glenn Cohen, Carmel Shachar, and…
Filthy Lucre or Fitting Offer? Understanding Worries About Payments to Research Participants
From the article: Offers of payment made in exchange for research participation are common. And yet they are often regarded as, at best, a “necessary evil.” This is…
Relocation of study participants for rare and ultra-rare disease trials: Ethics and operations
From the abstract: Clinical trials for investigational new products to treat rare and ultra-rare diseases typically involve a limited number of research sites recruiting from a small pool of patients…
You No Longer Own Your Face
From the article: “It’s just not what [the IRB] was designed to do,” says Michelle Meyer, a bioethicist who chairs the IRB Leadership Committee at Geisinger,…
Our Aversion to A/B Testing on Humans Is Dangerous
From the article: Meyer and her team found that in nearly every situation they tested, the decision to conduct an A/B test was deemed least appropriate by a considerable…
Paying Clinical Trial Participants: Legal Risks and Mitigation Strategies
From the article: Offering remuneration to participants in cancer trials can promote recruitment and retention. Concerns about the impact of remuneration on consent have received substantial attention, but legal risks…
Objecting to experiments that compare two unobjectionable policies or treatments
From the abstract: Randomized experiments have enormous potential to improve human welfare in many domains, including healthcare, education, finance, and public policy. However, such “A/B tests” are…
People Have A Hard-To-Explain Bias Against Experimental Testing of Policies And Interventions, Prefe
From the article: To anyone who believes in evidence-based decision making, medicine and policy, randomised tests make sense. But as a team led by Michelle N. Meyer at the Center…
Scientific Merit Predicates Ethical Review of Clinical Research
From the article: In the United States, federal regulations codified by the Department of Health and Human Services in the “Common Rule”1 address the conduct and oversight of…
You Don’t Want to Be a Human Guinea Pig? That’s Unfortunate
From the article: In other words, people who thought that A was fine, and also that B was fine, thought that it was unethical to test A and B to…
Why Do Experiments Make People Uneasy?
From the article: People were outraged in 2014 when Facebook revealed that it had run “psychological experiments” on its users. Yet Facebook changes the way it operates on a…
People Really Hate the Idea of Experimenting on People
From the article: There are various other parts to the paper designed to test whether people were upset about lack of informed consent, didn’t understand the reason for…
Recruitment and Trial-Finding Apps—Time for Rules of the Road
From the abstract: The problem of insufficient recruitment to clinical oncology trials is well-known. Some stakeholders view mobile apps as a solution with the potential to make recruitment more efficient,…
When is it ethical to pay clinical trial participants different amounts?
From the post: "This collaboration grew out of our shared experience as scholars studying research ethics and (for some of us) as institutional review board members. We witnessed debates over…
Differential payment to research participants in the same study: an ethical analysis
From the abstract: 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…
Preclinical Alzheimer Disease and the Dawn of the Pre-Caregiver
From the paper: A couple recently came to our memory center for a research visit. The husband is a participant in a clinical trial evaluating the efficacy of a drug…
Patients as Research Partners: How to Value their Perceptions, Contribution and Labor?
From the abstract: Citizen Science refers to the consultation, participation, engagement or involvement of the general public in research. Rationales for this interaction include increased public access and involvement of…
Association Between Financial Incentives and Participant Deception About Study Eligibility
From the article: "Question: Is payment associated with participant deception about research eligibility and, if so, is higher payment associated with more deception? Findings: In this randomized survey experiment of…
Of Parachutes and Participant Protection:: Moving Beyond Quality to Advance Effective Research Ethics Oversight
From the abstract: 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,…
The Ethics of Heritable Genome Editing: New Considerations in a Controversial Area
From the article: Editing the genome of human gametes or embryos is a disruptive unactualized technology and continues to be the subject of a wide range of concerns. The chief…
Simulation and Deliberation to Prepare for Clinical Trials in Infectious Disease Emergencies: Digital Health @ Harvard Series
Description Infectious disease emergencies are opportunities to test the efficacy of newly developed interventions (e.g. drugs, vaccines and treatment regimens), yet they raise many intertwined challenges of politics, logistics,…
On Repugnance, Distribution, and the Global Kidney Exchange: Comment
From the article: Krawiec opens the article by quoting Alvin Roth’s framing of repugnance as a “distaste for certain kinds of transactions [that] can be a real…
Consortium Seeks to Evaluate, Enhance HRPP Effectiveness
From the article: What are the outcomes of an effective HRPP? Can they be empirically evaluated—and, if so, can that data help drive best practices? Those are just…
Protecting Clinical Trial Participants and Study Integrity in the Age of Social Media
From the article: 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…
Ethical Investment in Global Public Health Security: A Health Policy and Bioethics Consortium
Description Health emergencies around the world in recent years have included SARS, MERS, Ebola, and influenza. These epidemics have caused substantial mortality, destabilized governments, and served as significant risks to…
Patient‐Engaged Research: Choosing the “Right” Patients to Avoid Pitfalls
From the article: 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…
Early career researchers’ perspectives and roles in patient-oriented research
Complete author list: Geneviève Rouleau, Jean-Christophe Bélisle-Pipon, Stanislav Birko, Philippe Karazivan, Nicolas Fernandez, Karine Bilodeau, Yi-Sheng Chao, Alexandra de Pokomandy, Véronique Foley, Bruno Gagnon,…
Oversight of Patient-Centered Outcomes Research: Recommendations From a Delphi Panel
From the abstract: 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…
Listening to NFL Players On Mental Health: New report highlights key findings from interviews with players and family members
When it comes to their careers, current and former NFL players express satisfaction – and frustrations – about their lives both on and off the field. “Life on an…
Viewpoint: Promoting Patient Interests in Implementing the Federal Right to Try Act
Former Executive Director and Academic Fellow Alumna Holly Fernandez Lynch has co-authored an opinion piece on the federal Right to Try Act of 2017. From the article: On May 30, 2018, President Trump…
A Fear of Lawsuits Really Does Seem to Result in Extra Medical Tests
From the article: Mr. Gruber and Michael D. Frakes, a Duke economist and lawyer, looked at the health care system for active-duty members of the military. Under longstanding law, such…
Defensive Medicine: Evidence from Military Immunity
From the abstract: We estimate the extent of defensive medicine by physicians, embracing the no-liability counterfactual made possible by the structure of liability rules in the Military Heath System. Active-duty…
When clinical trials compete: prioritising study recruitment
From the abstract: 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…
Putting Patients at the Center of Research: Opportunities and Challenges for Ethical and Regulatory Oversight
Description Efforts to place the patient at the center of medical research, spurred by the Affordable Care Act’s founding of the Patient Centered Outcomes Research Institute, have begun…
IRB Oversight of Patient-Centered Outcomes Research: A National Survey of IRB Chairpersons
From the abstract: 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…
Criticism of ‘right to try’ law for experimental drugs after it passes in US
From the article: The US government has controversially announced that it will allow unapproved, experimental drugs to be given to terminally ill patients. The ‘right to try’ law…
Parenting of the future: Many embryos, each with DNA profile
From the article: Once the genetic profile is done, could it come back to haunt a child if, say, a life insurer or nursing home demanded to see it to…
House passes right-to-try on second try
From the Article: The House of Representatives passed on party lines Wednesday evening a bill designed to let very sick patients request access to experimental medicines without government oversight. The…
National Institutes of Health IRB Internship Program Fall 2018, University of Bergen
General Description: Members of Institutional Review Boards (IRBs), IRB administrators, research ethics committees, tribal governance bodies, and others who are currently employed in positions related to research participant protections are…
Payments to Study Participants: Experts Discuss Potential Framework
Members of the Petrie-Flom Center's collaboration with the Regulatory Foundations, Ethics, and Law Program of Harvard Catalyst | The Harvard Clinical and Translational Science Center at Harvard Medical School today…
A Framework for Ethical Payment to Research Participants
Members of the Petrie-Flom Center's collaboration with the Regulatory Foundations, Ethics, and Law Program of Harvard Catalyst | The Harvard Clinical and Translational Science Center at Harvard Medical School today…
Patient-Centered Outcomes Research: Stakeholder Perspectives and Ethical and Regulatory Oversight Issues
Abstract: The Patient-Centered Outcomes Research Institute (PCORI), the leading research institute in the United States for patient-centered outcomes research (PCOR), funded our multiyear mixed-methods project, the Patient Centered Outcomes Research…
Sixth Annual Health Law Year in P/Review
Couldn't join us? Check out the conversation on Twitter: @PetrieFlom #healthlawpreview2018 and some of our speakers' slide presentations below! Description The Sixth Annual Health Law Year in P/Review…
Big Data, Health Law, and Bioethics
This edited volume stems from the Petrie-Flom Center’s 2016 annual conference, which brought together leading experts to identify the various ways in which law and ethics intersect with the…
Book Launch: Specimen Science: Ethics and Policy Implications
In September 2017, MIT Press will publish Specimen Science: Ethics and Policy Implications, co-edited by Holly Fernandez Lynch (outgoing Petrie-Flom Executive Director), Barbara Bierer, I. Glenn Cohen (Faculty Director), and Suzanne…
Research with Biospecimens: Balancing Individual Interests and Social Goods
This panel at the annual meeting of the American Society for Bioethics and Humanities examined issues addressed at Petrie-Flom's 2015 conference "Specimen Science: Ethics and Policy Implications," and the edited…
Who’s Actually Using ‘Right-To-Try’ Laws?: A Texas Oncologist Explains his Experience
'The record with state-level right-to-try laws also suggests lackluster interest from industry. "It's telling that although 37 states have adopted these laws, when asked to provide examples of success stories,…
Panel: Weighing the Risks of Randomized Controlled Trials and Alternatives
On June 21, 2017, Executive Director Holly Fernandez Lynch participated in a panel discussion on "Weighing the Risks of Randomized Controlled Trials and Alternatives," which was part of the conference "The Need…
Specimen Science: Ethics and Policy Implications
Order through MIT Press and receive 30% off using discount code MSPECIMEN30: Order now! This edited volume stems from a conference in 2015 that brought together leading experts to address key ethical…
Roster exemptions for players with concussions could draw vote from NFL owners
From the article: A short-term injured reserve for players diagnosed with a concussion was among 76 recommendations included in a Harvard Law School report — based on research funded by the…
Why Successful Post-Season Runs Make People Lose Their Minds About Concussions
From the article: Were either or both Crosby and Harden suffering the effects of a head injury, yet seeing game action? Appearances can be deceiving. In addition to medical personnel…
How does the NFL stack up with health care?
Sports Illustrated legal analyst Michael McCann joins OTL to discuss the NFL's health care for its players. Watch video here!
Babies from skin cells? New fertility technology raises ethical questions
From the article: Women producing sperm. Or, for that matter, men producing eggs. Those could, in theory, be some of the results of a new reproductive technology that's looming…
Revised ‘Common Rule’ Shapes Protections For Research Participants
From the article: Research with human participants funded by most federal agencies is governed by a set of rules and procedures designed to protect study participants while enabling the advancement…
2017 Petrie-Flom Center Annual Conference: Transparency in Health and Health Care: Legal and Ethical Possibilities and Limits
Couldn't attend in person? You can still check out the conversation on Twitter: @PetrieFlom #transparencyinhealth! And check out many of the speakers' slide presentations below! Description Transparency is a…
Should We Study Human Embryos Beyond 14 Days?
From the article: [...] Some critics view calls to re-evaluate the 14-day rule as a pernicious moving of the goalposts. How meaningful can they be, the line of reasoning goes, if…
The new Oprah movie about Henrietta Lacks reopens a big scientific debate
From the article: [...] Holly Fernandez Lynch, executive director of the Petrie-Flom Center for Health Law Policy, Biotechnology and Bioethics at Harvard Law School, emphasized that the benefits to society in…
Science Needs Your Cells: New York Times Op-Ed by Executive Director Holly Fernandez Lynch
Biospecimens are essential to medical progress, but just medical waste to patients. Let's promote the science. From the op-ed: Many aspects of Ms. Lacks’s story reflect genuine…
Institutions as an Ethical Locus of Research Prioritisation
Introduction 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.…
In Pausing Human Research On Zika, Medical Ethicists Acknowledge A Dark Past
From the article: That’s why ethics review of human subject research matters. This NIH panel is an especially good model in both its composition — expertise in law,…
Returning Results to Research Participants: A Health Policy and Bioethics Consortium
Clinical investigators, public health advocates, and IRBs have been struggling to develop appropriate policies on how to return results to patients involved in research studies. These results may come in…
Common Rule Revisions: Impact of Public Comment, and What’s Next?
From the blog post: On January 19, the day the final revisions to the Federal Policy for the Protection of Human Subjects were published in the Federal Register, our essay &ldquo…
A New Day For Oversight Of Human Subjects Research
Editor’s note: This post is part of a series stemming from the Fifth Annual Health Law Year in P/Review event held at Harvard Law School on Monday,…
What Experts in Law and Medicine Have to Say About the Cost of Drugs
From the article; Pharmaceutical drug costs impinge heavily on consumers’ consciousness, often on a monthly basis, and have become such a stress on the public that they came up…
Fifth Annual Health Law Year in P/Review
Couldn't make it to the event? Check out some of the speakers' slides as well as the Health Affairs blog symposium! Description The Fifth Annual Health Law Year in…
When clinical trials compete: prioritising study recruitment
Abstract 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…
Public Engagement, Notice-and-Comment Rulemaking, and the Common Rule
Abstract: At the federal level in the United States, development of regulations is governed by the Administrative Procedure Act (APA), the statute by which Congress authorized various federal agencies to…
New rules ease consent requirements for scientists using patient specimens
From the article: Allowing researchers to study such biospecimens without written consent “is the most substantive change from the proposed regulation,” said Dr. Michael Carome, director of Public…
Mid-Atlantic Health Law Works-in-Progress Retreat, Seton Hall Law School
Seton Hall Law School’s Center for Health & Pharmaceutical Law & Policy is pleased to announce the inaugural Mid-Atlantic Health Law Works-in-Progress Retreat, which will be held on…
Academic Fellow Alumna Michelle N. Meyer Named in Forbes List of 10 Favorite: Healthcare Commentaries of 2016!
In a year characterized by the extremes of rhetoric, healthcare entrepreneurs have been blessed with a number of thoughtful commentaries representing the opposite extreme. The selections cited below are measured,…
Paying Research Participants: Ethical and Regulatory Parameters
Couldn't make it to the event? Check out some of the speakers' slide presentations below! Description This symposium brought together a variety of experts to discuss key ethical and…
Clinical Trial Data Sharing and Reproducibility: A Health Policy and Bioethics Consortium
In January, the International Committee of Medical Journal Editors proposed requiring that investigators make de-identified trial data available six months after publication as a precondition of consideration. Many data scientists…
Review of Human Subjects Research Regulation: Perspectives on the Future: edited by I. Glenn Cohen (Faculty Director) and Holly Fernandez Lynch (Executive Director)
From the review: Overall, the editors present an intriguing look at the concerns currently facing human subjects research regulation and provide a number of suggestions for how to go about…
EVENT POSTPONED: HLS Library Book Talk: Charles Fried on Medical Experimentation: Personal Integrity and Social Policy - New Edition
Wednesday, November 9, 2016 at noon Harvard Law School Room WCC 2036 Milstein East B/C 1585 Massachusetts Ave., Cambridge Lunch will be provided. More About Medical Experimentation: Personal Integrity and Social Policy: New…
Cluster Randomized Trials: Ethics, Regulations, Statistics & Design: Harvard Catalyst Regulatory Symposium
Description Please join Harvard Catalyst for a free half-day symposium on the topic of Cluster Randomized Trials: Ethics, Regulations, Statistics & Design. We will provide a general overview of Cluster…
Faculty Director I. Glenn Cohen Joins National Academy of Sciences Committee: Cohen and HMS Center for Bioethics Director Robert Truog to Advise on Issues in Organ Donor Intervention Research
I. Glenn Cohen, Faculty Director of Harvard Law School’s Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics and Robert Truog, Director of the Harvard Medical School Center…
Petrie-Flom seeks RA for project on human subjects research, Petrie-Flom Center, Harvard Law School
The Petrie-Flom Center for Health Law and Policy, Biotechnology, and Bioethics seeks a part-time research assistant for a project with Harvard Catalyst (Harvard Clinical and Translational Science Center)…