Protecting Human Subjects

Protecting human research subjects: the past defines the future.

The creation of Institutional Review Boards to assure the protection of research subjects came out of terrible research abuses that resulted in the Belmont Report and federal regulations establishing rules for federally funded research and its independent review. The Common Rule became widely accepted as the way to oversee human research that is funded by federal agencies, or used in FDA submis...

Protecting subjects' interests in genetics research.

Biomedical researchers often assume that sponsors, subjects, families, and disease-associated advocacy groups contribute to research solely because of altruism. This view fails to capture the diverse interests of many participants in the emerging research enterprise. In the past two decades, patient groups have become increasingly active in the promotion and facilitation of genetics research. S...

Introduction: the challenge of nanomedicine human subjects research: protecting participants, workers, bystanders, and the environment.

T he growing capacity to build and manipulate materials at the nanoscale is both thrilling and challenging. Engineering at the level of atoms allows much needed problem-solving and innovation, but also raises questions about how to assess the effects and safety of the materials created. The promise and the challenge are especially acute in the domain of nanomedicine. Nanotherapeutics and in viv...

Protecting research subjects--the crisis at Johns Hopkins.

LLEN Roche, a 24-year-old technician at the Johns Hopkins Asthma and Allergy Center and a healthy volunteer in a study of asthma funded by the National Institutes of Health, died on June 2, 2001. Prompted by Roche’s death, the federal Office for Human Research Protections reviewed the system at the Johns Hopkins Medical Institutions for protecting research subjects and found widespread deficien...

Protecting and Promoting Human Health in China