Setting the stage : the past and present of human subjects research regulations / Amy L. Davis and Elisa A. Hurley
De minimis risk : a suggestion for a new category of research risk / Rosamond Rhodes
Risk level, research oversight, and decrements in participant protections / Ana S. Iltis
Classifying military personnel as a vulnerable population / Efthimios Parasidis
Children as research partners in community pediatrics / Adam Braddock
Back to the future? : examining the Institute of Medicine's recommendations to loosen restrictions on using prisoners as human subjects / Osagie K. Obasogie
Toward human research protection that is evidence based and participant centered / Michael McDonald, Susan Cox, and Anne Townsend
Outsourcing ethical obligations : should the revised common rule address the responsibilities of investigators and sponsors? / Seema K. Shah
Subjects, participants, and partners : what are the implications for research as the role of informed consent evolves? / Alexander Morgan Capron
Democratic deliberation and the ethical review of human subjects research / Govind Persad
IRBs and the problem of "local precedents" / Laura Stark
Biospecimen exceptionalism in the ANPRM / Ellen Wright Clayton
Biobanking, consent, and certificates of confidentiality : does the ANPRM muddy the water? / Brett A. Williams and Leslie E. Wolf
Mandating consent for future research with biospecimens : a call for enhanced community engagement / Carol Weil, Hilary Shutak, Benjamin Fombonne, and Nicole Lockhart
Take another little piece of my heart : regulating the research use of human biospecimens / Gail H. Javitt
Reconsidering privacy protections for human research / Suzanne M. Rivera
In search of sound policy on nonconsensual uses of identifiable health data / Barbara J. Evans
What is this thing called research? / Zachary M. Schrag
What's right about the "medical model" in human subjects research regulation / Heidi Li Feldman
Three challenges for risk-based (research) regulation : heterogeneity among regulated activities, regulator bias, and stakeholder heterogeneity / Michelle N. Meyer
Protecting human research subjects as human research workers / holly Fernandez Lynch
Getting past protectionism : is it time to take off the training wheels? / Greg Koski
Appendix. Regulatory changes in the ANPRM : comparison of existing rules with some of the changes being considered.