Desirable future clinical trial 4. Informed consent to subject.

Informed consent, confidentiality, and subject rights in clinical trials.

The informed consent process is designed to inform the subject of the risks, rights, and benefits of participation in a clinical research trial. Informed consent, while not always necessary, is a critical component of ethical research involving human subjects. This article includes an overview of two sets of regulations regarding informed consent found in the Code of Federal Regulations (CFR) T...

Informed consent and research subject understanding of clinical trials.

CONTEXT Current evidence suggests many clinical trial participants have incomplete understanding of research objectives and methods. OBJECTIVE Determine consent standards compliance, satisfaction with facility and study staff, and research subject understanding of clinical trials. DESIGN Retrospective review of responses gathered when subjects were interviewed at the inception of clinical t...

Adherence to Informed Consent Standards in Shiraz Hospitals: Matrons Perspective

Background Informed consent is an important part of the patients’ rights and hospitals are assigned to obtain informed consent before any diagnostic or therapeutic procedures. Obtaining an informed consent enables patients to accept or reject their care or treatments and prevent future contentions among patients and medical staff.   Methods This survey was carried out during 2011-2. We assessed...

Measuring informed consent capacity in an Alzheimer's disease clinical trial

INTRODUCTION Accurately and efficiently determining a participant's capacity to consent to research is critically important to protect the rights of patients with Alzheimer's disease (AD). METHODS Understanding of the informed consent document was assessed in 613 community-dwelling patients with mild-to-moderate AD enrolled in a randomized, placebo-controlled trial. Associations were examined...

Informed consent for clinical treatment.