This month's issue of Research Ethics Digest includes thought-provoking articles on topics including the challenges the FDA faces, new research on pediatric studies, and consent issues in biobanking.

Articles included:

• The Ethics of Future Trials: Qualitative Analysis of Physicians’ Decision Making
• Pedagogical Support for Responsible Conduct of Research Training
• Translational Research—The Need of a New Bioethics Approach
• Incorporating Ethical Principles into Clinical Research Protocols: A Tool for Protocol Writers and Ethics Committees
• Trial Registration, Reporting, Publication and FDAAA Compliance: A Cross-Sectional Analysis and Ranking of New Drugs Approved by the FDA in 2012
• The Majority of Expedited Investigational New Drug Safety Reports are Uninformative
• A US Food and Drug Administration Perspective on Evaluating Medical Products for Ebola
• Clinical Trial Registration, Reporting, Publication and FDAAA Compliance: A Cross-Sectional Analysis and Ranking of New Drugs Approved by the FDA in 2012
• The Majority of Expedited Investigational New Drug Safety Reports are Uninformative
• A US Food and Drug Administration Perspective on Evaluating Medical Products for Ebola
• Hearing the Voices of Children: Self-Reported Information on Children's Experiences During Research Procedures: A Study Protocol
• Does Promoting Research Advance Planning in a General Elderly Population Enhance Completion of a Research Directive and Proxies' Predictive Ability? A Randomized Controlled Trial
• Developing a New Justification for Assent
• An Open Access Pilot Freely Sharing Cancer Genomic Data from Participants in Texas
• Participant Views on Consent in Cancer Genetics Research: Preparing for the Precision Medicine Era
• Identifying Public Expectations of Genetic Biobanks
• Qualitative Study on Custodianship of Human Biological Material and Data Stored in Biobanks
• Informed Consent in International Normative Texts and Biobanking Policies: Seeking the Boundaries of Broad Consent
• Decision-Making Capacity for Research Participation Among Addicted People: A Cross-Sectional Study
• Exceptions to the Rule of Informed Consent for Research with an Intervention
• Postal Recruitment and Consent Obtainment from Index Cases of Narcolepsy
• Management of Patient-Reported Outcome (PRO) Alerts in Clinical Trials: A Cross Sectional Survey
• The EU Clinical Trials Regulation: Key Priorities, Purposes and Aims and the Implications for Public Health
• What Makes Health Systems Research in Developing Countries Ethical? Application of the Emanuel Framework for Clinical Research to Health Systems Research
• The Potential Exploitation of Research Participants in High Income Countries Who Lack Access to Health Care
• Institutional Animal Care and Use Committee Considerations for the Use of Wildlife in Research and Education
• Balancing the Costs of Wildlife Research with the Benefits of Understanding a Panzootic Disease, White-Nose Syndrome
• Animal Welfare Policy: Implementation in the Context of Wildlife Research—Policy Review and Discussion of Fundamental Issues

PRIM&R’s Research Ethics Digest, an electronic publication, delivers timely and relevant abstracts and full-text articles from a wide array of scholarly journals to the inboxes of PRIM&R members every two months. Articles featured in Research Ethics Digest highlight new research and scholarship related to ethics and regulation that affect—and potentially enhance—daily work.

The Research Ethics Digest Self-Study Program allows PRIM&R members to earn continuing education credits, which can be applied toward their CertifiedIRB Professional (CIP®) credential, CertifiedProfessional in IACUC Administration (CPIA®) credential recertification, or other professional credentials they may hold.