Advances in scientific research help improve, lengthen and save the lives of many around the world. However, research-driven studies can present risks to subjects, the research enterprise, and our communities. In order to maintain the quality of the research laboratory, protections are needed to preserve participants’ dignity and prevent potential harms. Our reports review the existing ethical and legal guidelines, and consider the opportunities and challenges that face participant-based research.
Returning Individual Research Results to Participants: Guidance for a New Research Paradigm
When is it appropriate to return individual research results to participants? The immense interest in this question has been fostered by the growing movement toward greater transparency and participant engagement in the research enterprise. Yet, the risks of returning individual research …
Responsible Research: A Systems Approach to Protecting Research Participants
When 18-year-old Jesse Gelsinger died in a gene transfer study at the University of Pennsylvania, the national spotlight focused on the procedures used to ensure research participants’ safety and their capacity to safeguard the well-being of those who volunteer for research …
Ethical Conduct of Clinical Research Involving Children
In recent decades, advances in biomedical research have helped save or lengthen the lives of children around the world. With improved therapies, child and adolescent mortality rates have decreased significantly in the last half century. Despite these advances, pediatricians and others argue …
Beyond the HIPAA Privacy Rule: Enhancing Privacy, Improving Health Through Research
In the realm of health care, privacy protections are needed to preserve patients’ dignity and prevent possible harms. Ten years ago, to address these concerns as well as set guidelines for ethical health research, Congress called for a set of federal standards now known as the HIPAA Privacy …
Ethical Considerations for Research Involving Prisoners
In the past 30 years, the population of prisoners in the United States has expanded almost 5-fold, correctional facilities are increasingly overcrowded, and more of the country’s disadvantaged populations— minorities, women, people with mental illness, and people with communicable …
Proposed Revisions to the Common Rule for the Protection of Human Subjects in the Behavioral and Social Sciences examines how to update human subjects protections regulations so that they effectively respond to current research contexts and methods. With a specific focus on social and …
On July 26, 2011, the U.S. Department of Health and Human Services issued an advance notice of proposed rulemaking (ANPRM) with the purpose of soliciting comments on how current regulations for protecting research participants could be modernized and revised. The rationale for revising the …