Independent ethics committee

An IRB is an independent committee of physicians, statisticians, community advocates, and others, who ensure that a clinical trial is ethical and that the rights of study participants are protected. All institutions that conduct or support biomedical research involving humans must, by federal regulation, have an IRB that initially approves and periodically reviews the research. At least five people comprise an IRB, and at least one member must come from a nonscientific discipline such as the law or the clergy. 

The confidentiality of records that could identify subjects should be protected to assure their privacy The trials must be accepted by an Independent Ethics Committee (lECj/lnstitutional Review Board (IRB) before commencing the study... 

Dated, documented approvai / favourabie opinion of Institutional Review Board / Independent Ethics Committee... 

Under US regulations, each institution conducting research with human subjects must have its own IRB. These perform the same functions as the Independent Ethics Committees in Europe, and should contain at least five members, one of which should be independent of the institution. There should be available a mixture of scientific and non-scientific expertise capable of assessing research proposals from legal, ethical and scientific perspectives. The IRB must grant written authorisation to the investigator before a study can commence. They are also responsible for on-going reviews of research, and must report to the FDA ... 

Unlike human trials. Institutional Review Boards/Independent Ethics Committees are not involved, while informed consent is only required from the owner of the trial animals. In addition to the standard items associated with human trials, aspects such as management and housing of animals, diet and disposal of trial animals and their produce should be included in the trial protocol. Studies may be blinded from the investigators in order to avoid bias in the reporting of animal observations. 

Independent Review Board/Independent Ethics Committee (IRB/IEC)... 

Modern review boards or independent ethics committees (lECs) are required to act on behalf of the community in deciding whether the proposed research is justified on ethical grounds. They also act on behalf of members of the community in ensuring that there are sufficient safeguards to protect those individuals who directly participate in the research, and, for both the study subjects and those not directly participating, that confidentiality of participant s medical information will be maintained. 

Dated documentation of independent ethics committee (lEC) approval for ... 

Independent ethics committees and the institutional authorities often modify the core ICR Local conditions, customs, interpretation of words and regulations may require some changes to the ICR It may be acceptable to describe Alzheimer s disease as memory loss however, removal of the section informing the study subject that other individuals besides the investigator will review his or her medical records is not acceptable since it is fundamental to ICH GCR... 

The protocol should be approved by an independent ethics committee/institutional review board prior to study start... 

Once the animal studies are completed human studies can commence, moving through phase I (up to 50 naive patients to establish a sufficient immune response) phase (several hundred patients in several locations) to phase III in which expanded studies on as many as thousands of patients. The trials require to be randomized and closely controlled by being blinded to avoid bias in interpretation. The patients all have to provide informed consent and strict adherence to good clinical practices in accordance with ethical principles is required to ensure risk-benefit considerations justify the risks associated with all trials of this type. The safety of the patients is an overall requirement and trials must be supervised by the appropriate independent ethics committee or the local Institutional Review Board. 

An IRB or an independent ethics committee (IEC) is an administrative body that has been formally designated to review and monitor biomedical... 

The ethics committee at each center approved the protocol. The consent form or modification based on local independent ethics committee recommendations was completed by all enrolled subjects and signed by the operating physician. 

Institutional Review Board/ Independent Ethics Committee and Informed Consent Protecting Subjects Throughout the Clinical Research Process... 

The goal of the IRB (known also as the Independent Ethics Committee, or IEC) is the protection of the rights, safety, and welfare of human subjects involved in clinical research investigations. The review board is, therefore, primarily responsible for the evaluation of the proposed research. All evaluations should have the following objectives (a) to determine that the research is properly designed (b) to determine that the benefit of the intended therapy will outweigh the potential risk and (c) to determine that the patient will be provided with adequate information to enable him or her to make an informed decision regarding participation in the clinical trial. 

The key to the ethics of such studies is informed consent from patients, efficient scientific design and review by an independent research ethics committee. The key interpretative factors in the analysis of trial results are calculations of confidence intervals and statistical significance.The potential clinical significance needs to be considered within the confines of controlled clinical crials.This is best expressed by stating not only the percentage differences, but also the absolute difference or its reciprocal, the number of patients who have to be treated to obtain one desired outcome.The outcome might include both efficacy and safety... 

Guarino, R.A. Institutional review board/independent ethics committee and informed consent. Protecting subjects throughout the clinical research process. In New Drug Approval Process, 3rd Ed. Marcel Dekker, Inc. New York, 2000 100, 271. 

All CTs (phase IV ones included) need ethical approval by independent central or regional ethics committees, as specified by a Decree of the Minister of Health in 1987, to be issued in an amended form in 1999. Phase I-III trials also need authorization by the competent medicine regulatory authority (the NIP or the Executive Office of the National Chief Medical Officer). The documentation needed for authorization does not differ from that in the EU. In short, it consists of the following (if not specified, it may be in English German may also be accepted) ... 

Specific responsibilities for investigators, sponsors, and the IRB/Independent Ethics Committee (lEC) detailed in the GCP provisions include the following. 

The responsibilities and obligations include knowledge of the elements of informed consent, the role and responsibilities of Institutional Review Boards/Independent Ethics Committees (IRB/ IEC) and the importance of Clinical Study Quality Assurance. 

In the case of studies in incompetent adults, again most Ethical Committees will accept a legal guardian or custodian in lieu of the patient himself or herself, provided that there is sufficient evidence that the custodian has a bona fide and independent interest in the patient s welfare. Again, forms of concurrence can be employed when possible. The ordering of a patient s participation in a clinical trial by a Court Order would usually be a form of duress and could thus violate the concept of autonomy described above. 

Ethics committee review and approval All studies must be independently reviewed by ethics committees/IRBs, to assess the risk for study subjects, before clinical studies begin. Review must continue throughout the study Informed consent All study subjects must be given the opportunity to personally assess the risk of study participation by being provided with certain information. Their assent to participate must be documented Monitoring A primary means of quality control of clinical studies involves frequent and thorough monitoring by sponsor/CRO personnel... 

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