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 ...

This workshop covers the five Ws of obtaining truly informed consent. It includes What should be covered through an examination of the correspondence between the HRP-503 Protocol Template and HRP-502 ...

It can be a rewarding experience to participate in research studies that offer many potential personal, medical, and financial benefits. However, if you are new to or are not entirely familiar with ...

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 ...

Although informed consent for clinical treatment has become a vital part of contemporary medical practice, it means different things in different contexts (Figure 1), is variably practised and rarely ...

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 ...