Barbara E Bierer
Dados Biográficos
| ID | 1741606 |
|---|---|
| NOME | Barbara E Bierer |
| PRENOMES | Barbara E |
| SOBRENOME | Bierer |
| ASSINATURA | BIERER B E |
| AFILIAÇÕES | Brigham and Women's Hospital |
| ORCID | 0000-0001-6448-8170 |
| VERIFICADO | Sim |
| TOTAL DE OBRAS | 9 |
| TOTAL DE CITAÇÕES | 4 |
| TOTAL COMO AUTOR | 9 |
| TOTAL COMO EDITOR | 0 |
| PRIMEIRO ANO DE PUBLICAÇÃO | 2014 |
| ANO MAIS RECENTE DE PUBLICAÇÃO | 2025 |
| ÍNDICE H | 1 |
An Analysis of Institutional Review Board Policies for Enrollment of Adults with Impaired or Uncertain Decision-Making Capacity
Background: Unwarranted exclusion of people with uncertain or impaired decision-making capacity from participation in research violates principles of justice and fairness and adversely impacts the health and welfare of these populations. Methods: We conducted a cross-sectional study of institutional review board (IRB) policies for investigators and IRB members at 94 top-funded U.S. research institutions to better understand the guidance they prov…
Communicating complex numeric information in clinical research
The ability to understand and use numeric information in healthcare and clinical research is a critical component of informed decision-making for patients and study participants. Health numeracy levels in the general population, however, tend to be quite low and as such, the responsibility falls on communicators to ensure that the information being shared is designed to facilitate recipient comprehension and support their autonomy. Here, we intro…
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 …
Data sharing in the context of community-engaged research partnerships
Over the past 20 years, the National Institutes for Health (NIH) has implemented several policies designed to improve sharing of research data, such as the NIH public access policy for publications, NIH genomic data sharing policy, and National Cancer Institute (NCI) Cancer Moonshot public access and data sharing policy. In January 2023, a new NIH data sharing policy has gone into effect, requiring researchers to submit a Data Management and Shar…
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…
Protecting the Vulnerable and Including the Under-Represented
Since their inception, Institutional Review Boards (IRBs) have been charged with protecting the vulnerable in research. More recently, attention has turned to whether IRBs also have a role to play in ensuring representative study samples and promoting the inclusion of historically under-represented groups. These two aims-protecting the vulnerable and including the under-represented-can pull in different directions, given the potential for overlap…
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…
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…
Research Misconduct Involving Noncompliance in Human Subjects Research Supported by the Public Health Service
Over the past three decades, two separate federal regulatory structures have emerged, each seeking to assure separate aspects of the integrity and ethics of research conducted using federal funding. One set of regulations is described in the Public Health Service Policies on Research Misconduct and relates to research misconduct, defined as consisting of fabrication of data or results, falsification of data and results, or plagiarism, in accordan…
Protecting the Vulnerable and Including the Under-Represented
Since their inception, Institutional Review Boards (IRBs) have been charged with protecting the vulnerable in research. More recently, attention has turned to whether IRBs also have a role to play in ensuring representative study samples and promoting the inclusion of historically under-represented groups. These two aims-protecting the vulnerable and including the under-represented-can pull in different directions, given the potential for overlap…
Data sharing in the context of community-engaged research partnerships
Over the past 20 years, the National Institutes for Health (NIH) has implemented several policies designed to improve sharing of research data, such as the NIH public access policy for publications, NIH genomic data sharing policy, and National Cancer Institute (NCI) Cancer Moonshot public access and data sharing policy. In January 2023, a new NIH data sharing policy has gone into effect, requiring researchers to submit a Data Management and Shar…
Research Misconduct Involving Noncompliance in Human Subjects Research Supported by the Public Health Service
Over the past three decades, two separate federal regulatory structures have emerged, each seeking to assure separate aspects of the integrity and ethics of research conducted using federal funding. One set of regulations is described in the Public Health Service Policies on Research Misconduct and relates to research misconduct, defined as consisting of fabrication of data or results, falsification of data and results, or plagiarism, in accordan…
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…
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…
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…
Protecting the Vulnerable and Including the Under-Represented
Since their inception, Institutional Review Boards (IRBs) have been charged with protecting the vulnerable in research. More recently, attention has turned to whether IRBs also have a role to play in ensuring representative study samples and promoting the inclusion of historically under-represented groups. These two aims-protecting the vulnerable and including the under-represented-can pull in different directions, given the potential for overlap…
Communicating complex numeric information in clinical research
The ability to understand and use numeric information in healthcare and clinical research is a critical component of informed decision-making for patients and study participants. Health numeracy levels in the general population, however, tend to be quite low and as such, the responsibility falls on communicators to ensure that the information being shared is designed to facilitate recipient comprehension and support their autonomy. Here, we intro…
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 …
Data sharing in the context of community-engaged research partnerships
Over the past 20 years, the National Institutes for Health (NIH) has implemented several policies designed to improve sharing of research data, such as the NIH public access policy for publications, NIH genomic data sharing policy, and National Cancer Institute (NCI) Cancer Moonshot public access and data sharing policy. In January 2023, a new NIH data sharing policy has gone into effect, requiring researchers to submit a Data Management and Shar…
An Analysis of Institutional Review Board Policies for Enrollment of Adults with Impaired or Uncertain Decision-Making Capacity
Background: Unwarranted exclusion of people with uncertain or impaired decision-making capacity from participation in research violates principles of justice and fairness and adversely impacts the health and welfare of these populations. Methods: We conducted a cross-sectional study of institutional review board (IRB) policies for investigators and IRB members at 94 top-funded U.S. research institutions to better understand the guidance they prov…
Political science (8 obras) · Ethics in Clinical Research (7 obras) · Psychology (7 obras) · Business (6 obras) · Medicine (6 obras) · Public relations (6 obras) · Computer Science (4 obras) · Law (4 obras) · Engineering (3 obras) · Engineering ethics (3 obras)