Conducting a successful clinical trial depends on well-designed patient recruitment procedures and retaining the research participants until the completion of the study. The participants must receive ...

The Nuremberg Code (1947) and the Declaration of Helsinki (1978) are credited as the origins of informed consent in clinical research. Participants' informed consent is both a legal and ethical ...

Substance Use Among Young Adult Survivors of Childhood Cancer With Cognitive Impairment: An Analysis of the Project Forward Cohort Consent processes are critical for clinical care and research and may ...

The U.S. Food & Drug Administration (FDA) issued final guidance (Final Guidance) regarding informed consent titled “Informed Consent: Guidance for Institutional Review Boards, Clinical Investigators, ...

The FDA issued “Informed Consent Guidance for IRBs, Clinical Investigators, and Sponsors” that supersedes its 1998 guidance and finalizes its 2014 guidance. The guidance outlines the primary ...

Informed consent is the ethical and legal foundation that ensures respect for individual autonomy in clinical research. It requires that potential participants receive clear, comprehensible ...

A federal regulation called the Common Rule previously requested the public posting of participant consent forms to trials listed in the national clinical study database clinicaltrials.gov, among ...

The US Food and Drug Administration (FDA) on Tuesday announced it has finalized guidance to help institutional review boards (IRBs), clinical investigators, and sponsors comply with informed consent ...

While many people indicate “I have read and agree to the terms and conditions”, very few actually take the time to read through everything to truly understand the small print. One journalist estimates ...

I’m a senior physician with both clinical and clinical research experience. Before this year, I had undergone bilateral total hip replacements and a right total shoulder replacement. (As a younger man ...