The federal order that directed Columbia to find its heart patients and tell them more about their drug study illustrates the continuing weakness in safeguards of clinical trials and specifically the procedures for obtaining informed consent--the written acknowledgement by a patient that he or she understands the risks of participation in a clinical trial.
Details of ethical approval, procedures for obtaining informed patient consent, tissue acquisition, and histopathological and molecular quality control and validation have already been described (Riddick et al, 2003).
Detailed procedures for obtaining informed patient consent, tissue acquisition, and histopathological and molecular quality control and validation have already been described (Riddick et al, 2003).
These groups meet regularly and have provided important feedback on the conduct of the study including designing appropriate materials for obtaining informed assent, phrasing of some questions, and helped consider ways to improve retention of young people.
A clear oral explanation, a demonstration of the procedures, showing an informative video, and eliciting and answering questions are other means to obtain informed consent.The following guidelines explain the steps for obtaining informed consent.
When secondary participants are not considered human subjects, ethical procedures for obtaining informed consent and protecting confidential information may be neither required nor considered.
A trial nurse responsible for obtaining informed consent was requested to present standard informed consent information on the microbicide study to the 18 women in the non-intervention group, in addition to health information on cervical cancer, and was advised to allow the women to ask questions.
This paper proposes a three stage process for obtaining informed consent from postgraduate physiotherapy students learning pelvic floor examination and treatment skills.
The requirement for obtaining informed consent was waived.
The need for obtaining informed consent was waived by the institutional review board for this retrospective study.
During the scheduled visit, research staff followed the process for obtaining informed consent required by each site's IRB.
