Informed consent is more than just a form; it is a process that actively involves the participant. It is an "ongoing exchange of information between the investigator and [participant]" per the OHRP.
Informed consent is an agreement between the investigators and the research participants. A signed informed consent form notifies potential research participants of their obligations and rights, and ...
Expedited studies are research projects that meet one of the categories under 46.110 and involve minimal risk. Full board studies are those the IRB determines does not fall under exempt or expedited ...
The primary purpose of informed consent is to protect the prospective human subject. Informed consent provides the individual with the pertinent information regarding the research in which s/he is ...
Federal regulations require that researchers obtain legally effective, documented, voluntary informed consent from prospective subjects (or subjects' legally authorized representatives) before ...
Potential research subjects must be accurately informed of what a project involves, and given the opportunity to decide of their own free will whether or not to participate. This process may be brief ...
The Revised Common Rule requires all clinical trials to post an unsigned consent form on a publicly available website. The Revised Common Rule is in effect for studies approved on or after January 21, ...
The IRB determines, for each protocol it reviews, which of the following elements and disclosures must be included in the informed consent process. Investigators can avoid delay in the review process ...
Research that is exempt under 45CFR46.104 is also exempt from Department of Health and Human Services (DHHS) requirements for informed consent as described under §46.116 and for documentation of ...
Obtaining informed consent is more than getting a signature on a form. Informed consent is one of the primary ethical considerations underlying research with human subjects. ALL human subject research ...
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