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Articles by Barbara E. Bierer
Managing Multi-Institutional Jurisdiction in Cases of Research Misconduct | Journal of Law, Medicine & Ethics | Cambridge Core
Published online by Cambridge University Press: 28 April 2025 Show author details Keywords Research MisconductJurisdictionMulti-InstitutionCross-InstitutionCollaborationCooperation Type Symposium Information Journal of Law, Medicine & Ethics , First View , pp.
Defamation Claims Arising from Research Misconduct Cases: Best Practices for Institutions | Journal of Law, Medicine & Ethics | Cambridge Core
Published online by Cambridge University Press: 21 April 2025 Barbara Bierer [Opens in a new window] and Show author details Keywords research misconductwhistleblowerdefamationlitigationlawsuit Type Symposium Information Journal of Law, Medicine & Ethics , First View , pp.
A global call to action for disability inclusion in health research - Nature Medicine
Despite bringing great strengths and facing substantial health inequities, disabled people remain underserved by health research; addressing this requires multi-level actions spanning all areas of research.
Towards A National Action Plan To Improve Representation In Clinical Trials
The United States has some of the poorest health outcomes among high-income countries around the world, outcomes that are particularly striking for racial and ethnic minority groups and rural populations. Blacks, Latinos, Native Americans, and certain Asian groups die at two to three times the rate of White Americans as a result of the most prevalent disease conditions, including cardiovascular disease, stroke, diabetes, HIV/AIDS, cancers, and chronic kidney disease.
Declaration of Helsinki-Revisions for the 21st Century
Initially developed in the aftermath of World War II atrocities, the Declaration of Helsinki celebrates its 60th anniversary this year.1 The declaration represents the foundational ethical document addressing the design, conduct, and reporting of medical research, a document referred to internationally.
World Medical Association Declaration of Helsinki
Adopted by the 18th WMA General Assembly, Helsinki, Finland, June 1964 29th WMA General Assembly, Tokyo, Japan, October 1975 35th WMA General Assembly, Venice, Italy, October 1983 41st WMA General Assembly, Hong Kong, September 1989 48th WMA General Assembly, Somerset West, Republic of South Africa, October 1996 52nd WMA General Assembly, Edinburgh, Scotland, October 2000 53rd WMA General Assembly, Washington, DC, USA, October 2002 (Note of Clarification added) 55th WMA General Assembly,...
The Promise and Perils of Diversity Action Plans for Clinical Trials
The Promise and Perils of Diversity Action Plans for Clinical Trials Enacted on December 29, 2022, the Food and Drug Omnibus Reform Act of 2022 (FDORA)1 included novel provisions for advancing clinical trial diversity. Specifically, FDORA granted the US Food and Drug Administration (FDA) the statutory authority to require drug and device sponsors to submit diversity action plans (DAPs) that must specify enrollment goals by race, ethnicity, sex, and age.
The PubPeer conundrum: Administrative challenges in research misconduct proceedings
ABSTRACT The founders of PubPeer envisioned their website as an online form of a “journal club” that would facilitate post-publication peer review. Recently, PubPeer comments have led to a significant number of research misconduct proceedings – a development that could not have been anticipated when the current federal research misconduct regulations were developed two decades ago.
Proposed Increases in Government Authority over Research Misconduct Proceedings
Public scrutiny of academic research continues to intensify, as evidenced by recent resignations of prominent university leaders, retractions of articles by leading scientists, and a proliferation of media coverage concerning research misconduct, which is most often defined as falsification or fabrication of research data, or plagiarism. Science bloggers have emerged as powerful contributors of allegations, with critical blog posts frequently triggering formal research misconduct proceedings.
First, do no harm: a global perspective on diversity and inclusion in clinical trials
COMMENT 08 May 2024 New requirements for clinical trial sponsors to submit diversity action plans to the US Food and Drug Administration (FDA) are an important step to embed planning for diverse representation in clinical trial research. These must not, however, be implemented in ways that are detrimental to other countries’ health and research interests.
Deprioritization of Ongoing Clinical Trials
REFERENCES 1, “Three Big Studies Dim Hopes that Hydroxychloroquine Can Treat or Prevent COVID-19,” Science Magazine, June 9, 2020, https://www.sciencemag.org/news/2020/06/three-big-studies-dim-hopes-hydroxychloroquine-can-treat-or-prevent-covid-19. 2“ Q&A: Hydroxychloroquine and COVID-19,” World Health Organization, June 19, 2020, https://www.who.int/news-room/q-a-detail/q-a-hydroxychloroquine-and-covid-19.
Frontiers | A novel cross-institutional college internship program to train future diverse leaders in clinical research with data-driven approaches to assess impact
Introduction The field of clinical research has identified an immense need to develop a more diverse and inclusive workforce (Locklear et al.; NSF, 2022). While Black, African American, Latino/a, Hispanic, Indigenous, and Native individuals comprise more than 30% of the US population, they comprise less than 19% of bachelor’s degrees and 15% of PhDs in biological sciences, thereby designating them as Historically Underrepresented (HU) groups (Statistics, 1994; NSF, 2022).
The Unresolved Challenge of Triage
The Unresolved Challenge of Triage Triage Procedures for Critical Care Resource Allocation During Scarcity Jackson S. Ennis, BA; Kirsten A. Riggan, MA, MS; Nicholas V. Nguyen, BA; Daniel B. Kramer, MD, MPH; Alexander K. Smith, MD, MS, MPH; Daniel P. Sulmasy, MD, PhD; Jon C. Tilburt, MD; Susan M. Wolf, JD; Erin S. DeMartino, MD In natural disasters, pandemics, war, and conflict, health care practitioners must often allocate limited critical care resources among many patients in need of treatment.
Defining “recklessness” in research misconduct proceedings
ABSTRACT To find research misconduct in research that has been supported by federal funds, an institution must determine that the misconduct was committed intentionally, knowingly, or recklessly. “Intentional” and “knowing” are straightforward standards. Yet “reckless” often mystifies institutions, which struggle to assess whether a respondent’s conduct should be deemed “reckless,” or merely negligent.
Enhancing diversity of clinical trial populations in multiple sclerosis
Abstract Background: Demographic characteristics, social determinants of health (SDoH), health inequities, and health disparities substantially influence the general and disease-specific health outcomes of people with multiple sclerosis (MS). Participants in clinical trials do not represent all people with MS treated in practice. Objective: To provide recommendations for enhancing diversity and inclusion in clinical trials in MS.
Disclosure of Possible Trial Termination to Participants of Interventional Clinical Trials
Disclosure of Possible Trial Termination to Participants of Interventional Clinical Trials Trial termination (the decision to end a trial earlier than planned) has been reported in 17.9% of cardiovascular trials and 16.0% of surgical trials.1,2 Although some trials are terminated for scientific reasons due to safety, efficacy, or futility, many trials are terminated due to inadequate participant enrollment or other nonscientific reasons.
The Global Forum on Research Ethics and Integrity
Curry, D. R. ., Crawley, F. P. ., & Bierer, B. E. . (2022). The Global Forum on Research Ethics and Integrity : A Replicable Model of Open, Global Collaboration Among Researchers, Scientists, Ethicists, and Academics as Individuals and Global Citizens. Acta Bioethica, 28(1). Retrieved from https://actabioethica.uchile.cl/index.php/AB/article/view/67317
Advancing the inclusion of underrepresented women in clinical research
Women, and specifically women of color, are underrepresented in clinical trials, limiting biological understanding and contributing to health inequities and social injustice. Analyses of barriers to inclusion suggest practical interventions that together create a roadmap of specific and actionable steps to increase diverse representation in research and sustainable change.
Evaluating the frequency of English language requirements in clinical trial eligibility criteria: A systematic analysis using ClinicalTrials.gov
Loading metrics Open Access Peer-reviewed Research Article Akila V. Muthukumar, Walker Morrell, Barbara E. Bierer Akila V. Muthukumar, Walker Morrell, Barbara E. Bierer Published: September 14, 2021 https://doi.org/10.1371/journal.pmed.1003758 Figures Abstract Background A number of prior studies have demonstrated that research participants with limited English proficiency in the United States are routinely excluded from clinical trial participation.
Navigating the ethics of remote research data collection
1. Marra, C, Chen, JL, Coravos, A, et al. Quantifying the use of connected digital products in clinical research. NPJ Digit Med 2020; 3: 50. Google Scholar | Crossref | Medline 2. U.S. Food and Drug Administration. Digital health policies and public health solutions for COVID-19, https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/digital-health-policies-and-public-health-solutions-covid-19 (2020, accessed 28 April 2021). Google Scholar 3. U.S. Food and Drug Administration .
Mutual Recognition Of Physician Licensure By States Would Provide For Better Patient Care
The COVID-19 pandemic illuminated the importance of telemedicine and has propelled its adoption as a response to physician shortages and social isolation. A recent study found a more then 20-fold increase in telehealth visits after the pandemic began. While driven by necessity, this rapid adoption has brought clear advantages: Care became more accessible, more convenient, and safer, with greater patient ease of use and satisfaction.
Mutual Recognition Of Physician Licensure By States Would Provide For Better Patient Care
The COVID-19 pandemic illuminated the importance of telemedicine and has propelled its adoption as a response to physician shortages and social isolation. A recent study found a more then 20-fold increase in telehealth visits after the pandemic began. While driven by necessity, this rapid adoption has brought clear advantages: Care became more accessible, more convenient, and safer, with greater patient ease of use and satisfaction.
Justice, diversity, and research ethics review
The disproportionate impact of COVID-19 on certain populations, such as Black, Latinx, and Indigenous populations in the United States, has focused attention on inequalities in health and on the need to increase enrollment of racial and ethnic minorities and other underrepresented groups in biomedical research (1).
An ethics framework for consolidating and prioritizing COVID-19 clinical trials
1. Bauchner, H, Fontanarosa, PB. Randomized clinical trials and COVID-19: managing expectations. JAMA 2020; 323(22): 2262–2263. Google Scholar | Crossref | Medline 2. Rubin, EJ, Harrington, DP, Hogan, JW, et al. The urgency of care during the COVID-19 pandemic—learning as we go. N Engl J Med 2020; 382(25): 2461–2462. Google Scholar | Crossref | Medline 3. U.S. Department of Health and Human Services .
When clinical trials compete: prioritising study recruitment
When clinical trials compete: prioritising study recruitment Free Luke Gelinas1, Holly Fernandez Lynch2, Barbara E Bierer3, I Glenn Cohen1 1Petrie-Flom Center at Harvard Law School and Harvard Catalyst, Cambridge, Massachusetts, USA 2Petrie-Flom Center at Harvard Law School, Harvard Catalyst, and Center for Bioethics, Harvard Medical School, Cambridge, Massachusetts, USA 3Brigham and Women's Hospital, Harvard Medical School, and Harvard Catalyst, Boston, Massachusetts, USA Correspondence to...
Raising standards for global data-sharing-Response
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How to fix the GDPR's frustration of global biomedical research
Summary Since the advent of the European Union (EU) General Data Protection Regulation (GDPR) in 2018, the biomedical research community has struggled to share data with colleagues and consortia outside the EU, as the GDPR limits international transfers of personal data.
How to fix the GDPR's frustration of global biomedical research
Policy ForumData Sharing Jasper Bovenberg1, David Peloquin2, Barbara Bierer3, Mark Barnes2,4, Bartha Maria Knoppers5 1Legal Pathways Life Sciences Law, Haarlem, Netherlands. 2Ropes & Gray LLP, Boston, MA, USA. 3Multi-Regional Clinical Trials Center of Harvard University and Brigham and Women's Hospital, Cambridge, MA, USA. 4Yale Law School, New Haven, CT, USA. 5Centre of Genomics and Policy, Faculty of Medicine, McGill University, Montreal, Quebec, Canada.
Aggregating data from COVID-19 trials
In their Policy Forum “A strategic approach to COVID-19 vaccine R&D” (29 May, p. 948 ), L. Corey et al. discuss the importance of coordinating randomized clinical trial (RCT) protocols to facilitate the evaluation of coronavirus disease 2019 (COVID-19) vaccines, and they highlight the ACTIV (Accelerating COVID-19 Therapeutic Interventions and Vaccines) public-private partnership as one example of productive collaboration.
Economic vulnerability and payment for research participation
1. Gelinas, L, Largent, EA, Cohen, IG, et al. A framework for ethical payment to research participants. N Engl J Med 2018; 378(8): 766–771. Google Scholar | Crossref | Medline 2. Dickert, N, Grady, C. What’s the price of a research subject? Approaches to payment for research participation. N Engl J Med 1999; 341(3): 198–203. Google Scholar | Crossref | Medline | ISI 3. Grady, C. Payment of clinical research subjects. J Clin Invest 2005; 115: 1681–1687. Google Scholar | Crossref | Medline | ISI 4.
Time for NIH to lead on data sharing
The U.S. National Institutes of Health (NIH), the largest global funder of biomedical research, is in the midst of digesting public comments toward finalizing a data sharing policy. Although the draft policy is generally supportive of data sharing (1), it needs strengthening if we are to collectively achieve a long-standing vision of open science built on the principles of findable, accessible, interoperable, and reusable (FAIR) (2) data sharing.
Disruptive and avoidable: GDPR challenges to secondary research uses of data
Abstract The advent of the European Union’s General Data Protection Regulation (GDPR) has posed several significant difficulties for the secondary research uses of data and associated biospecimens and has led to widespread unease within the international biobanking and databanking community.
When Clinical Trials Compete: Prioritizing Study Recruitment
PMCID: PMC5519451 NIHMSID: NIHMS845255 Luke Gelinas, Holly Fernandez Lynch, Barbara E. Bierer, and I. Glenn Cohen Luke Gelinas Petrie-Flom Center at Harvard Law School and Harvard Catalyst, Cambridge, USA Holly Fernandez Lynch Petrie-Flom Center at Harvard Law School, Harvard Catalyst, and Center for Bioethics, Harvard Medical School, Cambridge, USA Barbara E. Bierer Brigham and Women’s Hospital, Harvard Medical School, and Harvard Catalyst, Boston, USA I.
Credit data generators for data reuse
Microscopy images of normal and cancerous human tissue — when reused by others, the impact of the collected data is multiplied.Credit: A. Ahmed, J. Pendjiky and M. Millar (CC BY) Much effort has gone towards crafting mandates and standards for researchers to share their data1–3. Considerably less time has been spent measuring just how valuable data sharing is, or recognizing the scientific contributions of the people responsible for those data sets.
INSIGHT: Will Consent Be Disfavored as Basis for Processing Personal Data in Clinical Research Under EU Data Protection Law?
The European General Data Protection Regulation (“GDPR”), which took effect on May 25, 2018, requires that all processing of personal data subject to the GDPR must have a legal basis under the GDPR’s Article 6. To process special categories of personal data, which includes health and genetic data, data controllers must demonstrate an additional basis under Article 9.
When clinical trials compete: prioritising study recruitment
We must still address a fundamental set of questions involving whether prioritisation can be fair to relevant stakeholders. When evaluating this question, we will assume that, if institutions were to adopt a policy of prioritisation, they would be constrained by ethically defensible criteria—principles that are not obviously unfair and on which reasonable people might agree—when deciding which trials should be prioritised ahead of others (see Section ‘Prioritising studies’).
Specimen Science
Holly Fernandez Lynch is Executive Director at the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School and a member of the faculty at Harvard Medical School’s Center for Bioethics. Barbara E. Bierer is Professor of Medicine at Harvard Medical School and Brigham and Women’s Hospital and Faculty Codirector of the Multi-Regional Clinical Trials Center. I.
Revised ‘Common Rule’ Shapes Protections For Research Participants
Revised ‘Common Rule’ Shapes Protections For Research Participants Barbara E. Bierer1,*, Mark Barnes1 and Holly Fernandez Lynch1 1Barbara E. Bierer (bbierer{at}bwh.harvard.edu) is faculty co-director of the Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard (MRCT Center); director of the Regulatory Foundations, Ethics and Law Program, Harvard Catalyst; and a professor of Medicine at Brigham and Women’s Hospital and Harvard Medical School, in Boston, Massachusetts.
Forensic bitemark identification: weak foundations, exaggerated claims
Several forensic sciences, especially of the pattern-matching kind, are increasingly seen to lack the scientific foundation needed to justify continuing admission as trial evidence. Indeed, several have been abolished in the recent past. A likely next candidate for elimination is bitemark identification. A number of DNA exonerations have occurred in recent years for individuals convicted based on erroneous bitemark identifications. Intense scientific and legal scrutiny has resulted.
Forensic bitemark identification: weak foundations, exaggerated claims
Forensic evidence used in criminal cases has never experienced greater legal and scientific scrutiny than it does today. Some types of forensic science expert testimony, particularly some of the pattern-matching subfields, have in recent years come to be recognized as standing on foundations so weak and making claims so exaggerated that the justification for admitting them as evidence in court has been called into serious doubt.
A Global, Neutral Platform for Sharing Trial Data
Sharing clinical trial data is critical in order to inform clinical and regulatory decision making and honor trial participants who put themselves at risk to advance science.
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