Resources

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The PubPeer conundrum: Administrative challenges in research misconduct proceedings

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E-Book: Building the Clinical Research Workforce: Challenges, Capacities, and Competencies

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Pediatric drug development issues during public health emergencies

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The Role of Institutional Review Boards in Improving the Inclusion of Sex and Gender as Variables in Clinical Research

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Editorial: Building the Clinical Research Workforce: Challenges, Capacities, and Competencies

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Acupuncture for hot flashes in hormone receptor‐positive breast cancer: A pooled analysis of individual patient data from parallel randomized trials

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The Occasional Human Sacrifice: Medical Experimentation and the Price of Saying No, by Carl Elliott. New York: W.W. Norton & Company, 2024

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Proposed Increases in Government Authority Over Research Misconduct Proceedings

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A Federally Qualified Health Center-led Ethics & Equity Framework & Workflow Checklist: An Invited Commentary in Response to a Relational Public Health Framing of FQHCs During COVID-19

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First, do no harm: a global perspective on diversity and inclusion in clinical trials

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Ethical Considerations in Decentralized Clinical Trials

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Education and training of clinical research professionals and the evolution of the Joint Task Force for Clinical Trial Competency 

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Consideration and Disclosure of Group Risks in Genomics and Other Data-Centric Research: Does the Common Rule Need Revision?

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Deprioritization of Ongoing Clinical Trials

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Defining “recklessness” in research misconduct proceedings

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Acknowledging Complexity and Reimagining IRBs: A Reply to Discussions of the Protection–Inclusion Dilemma

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The Unresolved Challenge of Triage

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Review of diversity, equity, and inclusion by ethics committees: A Delphi consensus statement

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Enhancing diversity of clinical trial populations in multiple sclerosis

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Site staff perspectives on communicating trial results to participants: Cost and feasibility results from the Show RESPECT cluster randomized, factorial, mixed-methods trial

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Terms and conditions apply: an ethical analysis of mobile health user agreements in research

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Communicating complex numeric information in clinical research

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Losartan in hospitalized patients with COVID-19 in North America

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Bringing data monitoring committee charters into the sunlight

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Guest Blog: New Tools to Support Inclusion of People with Disabilities in Clinical Research 

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DEI in Clinical Research: Tools & Resources for Incorporating DEI in IRB/HRPP Processes (AAHRPP poster)

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Returning Individual Research Results from Digital Phenotyping in Psychiatry

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Data sharing in the context of community-engaged research partnerships

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Conducting a three-country clinical trial during the COVID-19 pandemic: experience and future considerations

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How To Limit Uninformative Trials: Results From A Delphi Working Group

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Disclosure of Possible Trial Termination to Participants of Interventional Clinical Trials

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Use Plain Language to Increase Understanding

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Comparison of Availability of Trial Results in ClinicalTrials.gov and PubMed

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Data visualization explorer: A tool for participant representation

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Establishing a Global Regulatory Floor for Children’s Decisions about Participation in Clinical Research

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Ensuring the Scientific Value and Feasibility of Clinical Trials

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Allocation of Opportunities to Participate in Clinical Trials during the Covid-19 Pandemic and Other Public Health Emergencies

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Protecting the Vulnerable and Including the Under-Represented

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Characterization of Informed Consent Forms Posted on ClinicalTrials.gov.

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Ethical Challenges in Clinical Research During the COVID-19 Pandemic

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Acupuncture for hot flashes in hormone receptor-positive breast cancer, a coordinate multinational study

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Supported decision-making can advance clinical research participation for people with disabilities

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Excluding People With Disabilities From Clinical Research: Eligibility Criteria Lack Clarity And Justification

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Hydroxychloroquine/chloroquine for the treatment of hospitalized patients with COVID-19

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Externalist, Process-Based Approach to Supported Decision-Making

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The proportion of randomized controlled trials that inform clinical practice

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Can Observational Analyses of Routinely Collected Data Emulate Randomized Trials?

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Integrate Health Literacy Training into Your IRB’s Onboarding and Professional Development Activities

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Implementing expanded COVID-19 testing in Massachusetts community health centers

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Developing and Implementing a Self-Monitoring Toolkit For a Coordinated Multinational Randomized Acupuncture Trial

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Approach For Reporting Master Protocol Study Designs on ClinicalTrials.gov: Qualitative Analysis

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Strategies to Optimize Inclusion of Women in Multi-National Clinical Trials

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When Is a Change Significant? The Update Problem of Apps in Medical and Behavioral Research

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IRBs and the Protection-Inclusion Dilemma: Finding a Balance

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Dr. Barbara Bierer is Featured in the Exploring Drug Discovery and Development Article “Scientists and Communicators Team Up To Increase Clinical Trial Participation”

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Completeness of clinical evidence citation in trial protocols: A cross-sectional analysis, published in Clinical and Translational Report

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Self-assessed Competencies of Clinical Research Professionals and Recommendations for Further Education and Training

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Advancing the Inclusion of Underrepresented Women in Clinical Research

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Applying Civil Rights Law to Clinical Research Title VI’s Equal Access Mandate

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Reporting of Clinical Trial Results: Aligning Incentives and Requirements to Do the Right Thing in Clinical Therapeutics

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How To Use Plain Language in Clinical Research Communications

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Developing a consensus-driven, plain-language clinical research glossary for study participants and the clinical research community

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Complete, Rapid Reporting of Clinical Trials: A Necessary Component of the Pandemic Response

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Promoting Equity By Design In Cancer Trials

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Incorporating Competencies Related to Project Management into the Joint Taskforce Core Competency Framework for Clinical Research Professionals

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Leveling the Joint Task Force Core Competencies for Clinical Research Professionals

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Integrating Supported Decision-Making into the Clinical Research Process

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Demystifying Schrems II for the cross-border transfer of clinical research data

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Evaluating the frequency of English language requirements in clinical trial eligibility criteria: A systematic analysis using ClinicalTrials.gov

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Emerging ethical issues raised by highly portable MRI research in remote and resource-limited international settings

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Monitoring the Pediatric Clinical Trials Enterprise

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Genomic Epidemiology Data Infrastructure Needs for SARS-CoV-2

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Fair payment and just benefits to enhance diversity in clinical research

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Navigating the ethics of remote research data collection

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Online Research Participant Communication: Balancing Benefits and Risks

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Trial Reporting and the Clinical Trials Enterprise

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Mutual Recognition Of Physician Licensure By States Would Provide For Better Patient Care

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Justice, diversity, and research ethics review

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A Descriptive-Multivariate Analysis of Community Knowledge, Confidence, and Trust in COVID-19 Clinical Trials among Healthcare Workers in Uganda

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Health Info Blocking Rule Creates Opportunities For Research

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An ethics framework for consolidating and prioritizing COVID-19 clinical trials

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Real-World Evidence: Understanding Sources of Variability Through Empirical Analysis

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Lack of harmonization of coronavirus disease ordinal scales

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Promoting equity in understanding: A cross-organisational plain language glossary for clinical research

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On measuring attitudes about payment for research

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Committing to diversity, equity and inclusion: A call to action for clinical trials

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Critics say new NIH policy on scientific data sharing falls short

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How to fix the GDPR’s frustration of global biomedical research

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Emerging work on Diversity & Clinical Trials: A Spotlight on the MRCT

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Biopharmas Must Address The Reality Of Racial Disparities In Health Outcomes Exposed By Covid-19

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The Decision to Enroll in a Clinical Trial Should Be Unencumbered

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Rethinking ethical oversight in the era of the learning health system

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Diagnostic Testing for COVID-19: Considering False Positive and False Negative Results by Deborah A. Zarin, MD, MRCT Center Program Director and Joseph Lau, MD

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Time for NIH to lead on data sharing

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Disruptive and Avoidable: GDPR Challenges to Secondary Use of Data

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Primed to comply: Individual participant data sharing statements on ClinicalTrials.gov

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Economic Vulnerability and Payment for Research Participation

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Promoting Patient Health Literacy in the Clinical Research Space

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Issues in the registration of database studies

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Committing to the Inclusion of Diverse Populations in Clinical Research

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Health Literacy in Clinical Research: Practice and Impact – Proceedings of a Workshop

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Adding Real-World Evidence to a Totality of Evidence Approach for Evaluating Marketed Product Effectiveness

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Understanding the Need for Non-Interventional Studies Using Secondary Data to Generate Real-World Evidence for Regulatory Decision Making, and Demonstrating Their Credibility

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10-Year Update on Study Results Submitted to ClinicalTrials.gov

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The Culture of Trial Results Reporting at Academic Medical Centers

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Determining Real-World Data’s Fitness for Use and The Role of Reliability

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Trial Effort: Deborah Zarin on Clinical Decision Making and Building a Database for Clinical Trial Results

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Lost Evidence From Registered Large Long-Unpublished Randomized Controlled Trials: A Survey

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Harms From Uninformative Clinical Trials

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Relocation of Study Participants for Rare and Ultra-Rare Disease Trials: Ethics and Operations

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Implementing Regulatory Broad Consent Under the Revised Common Rule: Clarifying Key Points and the Need for Evidence

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Protecting Pregnant Women With Substance Use Disorders and Their Neonates Participating in Research

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Post-Submission Update: The Evolving Regulatory Landscape for Clinical Trials in India

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Credit Data Generators For Data Reuse

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Social Media as an Ethical Tool for Retention in Clinical Trials

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Scientific Merit Predicates Ethical Review of Clinical Research

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Guidance Regarding Interaction Between GDPR and EU Clinical Trials Regulation Leaves Several Questions Unanswered

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The Evolving Regulatory Landscape for Clinical Trials in India

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Returning Aggregate Results of Clinical Trials

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Reimagining Health Data Exchange: An Application Programming Interface-Enabled Roadmap for India

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Development of a Plain-Language Library of Educational Resources for Research Participants

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Assessment of a Shortened Informed Consent Form for Pediatric Research: A Pilot Study

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Truth in Advertising: Disclosure of Participant Payment in Research Recruitment Materials

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On Scarcity and the Value of Clinical Trials

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A Framework for Ethical Payment to Research Participant

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What Do Revised U.S. Rules Mean for Human Research

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Institutions as an ethical locus of research prioritization

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Data Authorship as an Incentive to Data Sharing

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Using Social Media as a Research Recruitment Tool: Ethical Issues and Recommendations

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HHS Finalizes Comprehensive Revisions to the Common Rule

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Incorporating Ethical Principles into Clinical Research Protocols

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Responsibilities of Data Monitoring Committees: Consensus Recommendations

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A Global, Neutral Platform for Sharing Trial Data

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When clinical trials compete: prioritizing study recruitment

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A Tool to Help Address Key Ethical Issues in Research

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Indian Ministry Amends Informed Consent Rules

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Compliance with Results Reporting at Clinical Trials.gov

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Global Clinical Trials: Ethics, Harmonization and Commitments to Transparency

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India’s Proposed Amendments to the Drug and Cosmetics Act

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Clinical Trial Research is No Crime

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CT Regulation in India: Science of Social Justice?

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Clinical Trials, a Lost Opportunity for India

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Moving from Compliance to Competency: A Harmonized Core Competency Framework for the Clinical Research Professional

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Preparing For Responsible Sharing of Clinical Trial Data

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EMA Draft Policy on Publication and Access to Clinical Trials Data Provides Broad Researcher Access to Participant-Level Data