Regulatory requirements informed consent

Informed Consent. This must be obtained from study participants in writing before any study-related activities are performed. Regulations clearly describe the required elements of the consent document and the consent process to be followed. A good informed consent process can help ensure that potential subjects understand the nature of the studies they will enter, the type of treatments they will undergo, alternative therapies currently available, and any particular hazards they might experience. They must be informed that they can withdraw from the study at any time without penalty. Subjects are to be asked for their consent to release information from their medical records and told that the medical information may be inspected by sponsor company and regulatory agency representatives. They are to be informed that the results of the trials may be used publicly, but anonymously. 

The investigator should prepare an informed consent form for every study to be performed at the institute and should obtain an approval by the IRB that covers the institute. GCP listed a dozen points to be covered by the informed consent (1C) form (see Table 23.6). The new GCP allows a reasonable amoimt of pa)unent to the patient, such as transport cost. Patients should allow clinical trial monitors, auditors, IRB members and inspectors from the regulatory authority to verify the source documents. This new requirement of obligatory written 1C is regarded as a... 

Setting up clinical studies is a lengthy process, as there are many documents to prepare [e.g. protocols and case report forms (CRFs)], study facilities to be assessed (e.g. study sites, CROs, clinical laboratories, phase I units), regulatory review to be considered and negotiations and agreements with study sites (e.g. contracts, finances, confidentiality, indemnity, insurance) to be undertaken. In addition, as will be dealt with in subsequent sections, ethical aspects of the study must be considered (e.g. ethics committee and IRB review and informed consent requirements), and study medications/devices must be organized. 

In the United States it was as a direct result of the revelation of the Tuskegee Syphilis Study that the next U.S. medical ethics initiative emerged. The National Research Act of 1974 was passed (Public Law 93348), which required regulatory protection for human subjects and created the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. In 1979 this commission produced the Belmont Report, named after the Smithsonian Institution s Conference Center, where the discussions were first held in 1976. The report established three ethical principles to allow problems to be solved in the area of ethics in clinical research (1) respect for persons, (2) beneficence, and (3) justice. In general terms, these categories were equivalent to informed consent, risk-benefit assessment, and an appropriate choice of subjects for the research. 

The ICF consists of two documents - the information sheet and the actual consent form. They must be considered as a pair of documents, not separate entities. Normally, a core ICF should be present in the appendices. The core ICF may need modifications to comply with local regulations. It is the responsibility of the sponsor/ institution, or in an independent study the investigator, to prepare an ICF that meets the requirements of ICH CCP or any additional requirements of the local regulatory authority, and is only used after it has been approved by the relevant I EC. 

The NHS Trust and the Sponsor shall ensure that only those of its officers and employees directly concerned with the carrying out of this Agreement have access to the Confidential Information and each Party undertakes to treat as strictly confidential and not to disclose to any third party any Confidential Information save where disclosure is required by a regulatory authority or by law and not to make use of any Confidential Information other than in accordance with this Agreement without the prior written consent of the other Party. 

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