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Main Components of an Informed Consent

BayBiotech.NET
Dear All,

Happy 2010!

I plan to focus on the main components of an informed consent in this blog. Enjoy!

Informed consent (21 CFR 50.20, 21 CFR 50.25(a), and 21 CFR 50.25(b))
is a document prepared for the subjects who may be benefited from a clinical trial and provides the key facts about a clinical trial before deciding whether or not to participate.
In order to help someone decide whether or not to participate, the doctors and nurses involved in the trial explain the details of the study. If the participant's native language is not English, translation assistance can be provided for them.
Main component of an informed consent document are the key details about the study, such as its purpose, duration, required procedures, key contacts as well as risks and potential benefits associated with it. The participant then decides whether or not to sign the consent and participate in the study.
Informed consent is not a contract, and the participant may withdraw from the trial at any time.
Main components of an informed consent forms are:
 Information about the sponsor conducting the research.
 The main objective of the study.
 During the study how the research team will monitor the health and safety of the participants.
 As a participant the requirements for the follow-ups and the duration of the study.
 Possible benefits and risks associated.
 Other treatments those are available for the particular disease or condition.
 How the privacy of the medical records will be protected for the participating patients.
 Compensations if any for the participant’s time.
 The study staff also provides the participants a consent form, an agreement that he /she will sign if he /she decide to join the trial.

Mostly IRBs develop standard formats for informed consents as per FDA regulations and wherever changes are needed from the standard paragraphs or format; the investigators have to satisfy local IRB's concerns by explaining in the submission to the IRB why the changes are necessary.

To find out more about the regulations around Informed Consents follow the link:
http://www.fda.gov/RegulatoryInformation/Guidances/ucm126431.htm

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