Clinical research consent forms for certain FDA-regulated clinical trials are now required to contain a specific statement advising participants that clinical trial information will be entered into ...

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 ...

Federal regulations require that researchers obtain legally effective, documented, voluntary informed consent from prospective subjects (or subjects' legally authorized representatives) before ...

Although exempt research is exempt from some of the federal regulations, in most cases of interaction with participants, a consent process is indicated. It’s important to understand that even though ...

Exempt research does not require the informed consent to be documented (it is at the discretion of the researcher), but the Bowdoin IRB does expect that informed consent be provided to the ...

When applicable, one or more of the following elements of information shall also be provided to each participant: Disclosure or non-disclosure of particular studies presented in the planned project.

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 ...

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 ...

Background: Consent forms have become too long and often do little to help people understand the risk elements of their participation in research, instead focusing on risk reduction for research ...

NOTE: The University IRB abides by information regarding the current position of the VHA Office of Research & Development’s (per email from Karen Jeans dated 01/03/14) related to use of Craigslist as ...

Starting today, March 7, 2012, clinical research consent forms for certain FDA-regulated clinical trials must contain a specific statement advising participants that clinical trial information will be ...

Informed consent provides the individual with the pertinent information regarding the research in which s/he is being asked to participate, and the opportunity to make an informed decision regarding ...