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¶ … Consent of Subjects Included in Biomedical Research
Informed Consent is the basis of the transfer of information to a subject who is a candidate to participate in a clinical trial. The process of obtaining informed consent is a moral and ethical component of clinical trials conducted under Good Clinical Practices (GCPs). A subject is informed of all aspects of a clinical trial that are determined relevant to their decision to participate including risks, trial purpose, and safety documentation so that the subject can make a decision and confirm their willingness to participate. Informed consent precedes enrollment in a clinical trial and is documented by means or a written, signed and dated consent form.
Purpose of Informed Consent
Except in a few narrow instances such as life threatening situations, all research involving any drug including biological products, food additives, medical devices, or color additives must take place with legally effective informed consent of the subject of the clinical trial (21CFR 1998). All informed consent must take be documented by means of an approved, written, signed and dated informed consent form (ICH GCP E6 1996). The informed consent should consist of a template form that clearly identifies any research purpose for a study and include any information the subject needs to know to decide whether or not they will participate in a study. This information has to include any potential risks and benefits related to participating in the study. The subject should be able to completely understand...
After reviewing the information contained in an IRB-approved informed consent document a subject should be able to weigh all risks and/or benefits and decide whether or not to participate in the study.
Requirements for an Informed Consent Document
The informed consent form (ICF) must be approved by the IRB for the site where clinical research is to take place. It is important to understand that the ICF is not a static document but must be revised any time new information is available that is relevant to subjects consent (ICH GCP E6 1996) and any revisions must be reviewed and approved by the IRB. It is critical that none of the ICF documentation can cause a subject o waive any legal rights or release the investigator or sponsor from liability for negligence (21 CFR 1998, ICH GCP E6 1996). The ICF must be written in a language that subjects can understand with medic al and technical terms explained and for patients who do not speak the language of the written ICF, a reviewed and documented translation must be provided (ICH GCP E6 1996). The following elements are required elements for GCP (21CFR 1998):
A. A statement that the study involves research
B. An explanation of the purpose of the research
C. The expected duration of a subject's participation
D. A description of any procedures to be followed during the trial
E. Identification of all parts of the trial that…
References
Protection of Human Subjects, 21 C.F.R. § 50 U.S. FDA (1998)
E6 Good Clinical Practice: Consolidated Guidance for Industry U.S. FDA (1996)
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