Regulatory Requirements and Informed Consent
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Regulatory Requirements and Informed Consent
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l l e protection of the rights and wevare of study subjects is a hallmark of clinical research practice in most countn'es. However; it is important to keep in mind what is informed consent and what a signed informed consent form means. In the United States, informed consent requirements apply to all clinical investigations regulated by the FDA as well as clinical investigations that support applicationsfor marketing permits for products regulated by the FDA. It is important to note what is informed consent and what a signed informed consent form means.
Michoel R. Hornroll, PhD, RAC MORIAH Consultants, Yorba Linda. California
Kev Words Informed consent; Regulatory: HlPAA Correspondence Address Michael R. Hamrell, MORlAH C m ~ l t a n t s , Yorba Linda, CA 92886.
I N T R 0 D U [T I0 N One of the most important aspects of compliance associated with good clinical practice (GCP) and clinical studies is the obtaining and documentation of informed consent. The protection of the rights and welfare of study subjects is a hallmark of clinical research practice in most countries. However, it is important to keep in mind what is informed consent and what a signed informed consent form means. The informed consent requirements apply to all clinical investigations regulated by the FDA as well as clinical investigations that support applications for marketing permits for products regulated by FDA. Informed consent must be obtained from each subject participating in a clinical study (1) and must be obtained before beginning any study-specific procedures or tests. In a broader sense, informed consent is an essential part of medicine in a nonresearch environment as well. The same principles also apply to permission for standard medical tests and procedures and for any type of research study, even nonmedical studies, such as psychological and behavioral studies. The regulations state that no investigator may involve a human being as a subject in research covered by these regulations unless the investigator has obtained the legally effective in-
formed consent of the subject or the subject's legally authorized representative. Consent must be documented by use of a written consent form approved by the institutional review board (IRB) and signed by the subject or subject's legal representative. Informed consent must also be personally dated by subject. The International Conference on Harmonization (ICH) GCP Guidance (2) recommends that consentor, the person obtaining consent, should also sign the consent and a copy of the signed and dated form should be given to the subject (3). The US regulations as stated in 21 CFR 950.20 require that the investigator obtain the "legally effective informed consent" of the subject or the subject's legally authorized representative. This consent must be in writing and dated (3) to verify that the subject gave consent before entering the trial or taking any study medication. Every clinical study must conform to the IRB and informed consent regulations
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