Independent Review Board Committee

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

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... 

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. 

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. 

The guidelines further require that research on human subjects be conducted by qualified individuals and that most clinical research be reviewed by an independent committee, which is generally an institutional review board. 

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. 

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. 

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. 

There are three principal ways for a chemical to be added to the Proposition 65 list. A chemical can be listed if either of two independent committees of scientists and health professionals finds that the chemical has been clearly shown to cause cancer or birth defects or other reproductive harm. These two committees are the Carcinogen Identification Committee (CIC) and the Developmental and Reproductive Toxicant (DART) Identification Committee, and both are part of OEHHA s Science Advisory Board. The committee members are appointed by the Governor and are designated as the State s Qualified Experts for evaluating chemicals under Proposition 65. When determining whether a chemical should be placed on the list, the committees base their decisions on the most current scientific information available. OEH-HA staff scientists compile all relevant scientific evidence on various chemicals for the committees to review. The committees also consider comments from the public before making their decisions. 

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. 

Before a trial is initiated, the FDA requires the protocol to be approved by an institutional review board (IRB) or independent ethics committee. The IRB must address the investigator s qualifications to conduct the proposed trial. It does so by reviewing a current curriculum vitae and other relevant documentation. Pharmacists seeking approval by an IRB must demonstrate experience in the conduct of clinical trials similar to the one for which approval is being sought. The investigator provides information to the IRB, but does not participate in the committee s deliberations. 

An independent body (a review board or a committee, institutional, regional or national), constituted of medical professionals and non-medical members, whose responsibility is to verify that the safety, integrity and human rights of the subjects participating in a particular trial are protected and to consider the general ethics of the trial, thereby providing public reassurance. Ethics committees should be constituted and operated so that their tasks can be executed free from bias and from any influence of those who are conducting the trial. 

The code will be broken and data will be analyzed when the 12-mo follow-up has been completed for all patients. At that time, DHA therapy will be offered to all patients who desire to receive it. Clinical and laboratory studies will be monitored by an independent data and safety monitoring committee. This committee will also perform an interim analysis when 30 patients have completed assessment and has permission to terminate the study if there are significant favorable findings or unanticipated adverse outcomes. A determination of statistical power indicates that this sample size is sufficient to detect a major effect (0.862 standard deviations). With a more modest effect of 25%, however, the statistical power diminishes to 60%. The study has been approved by the Institutional Review Board at the Johns Hopkins Medical Institutions and is supported by a research grant from the Office of Orphan Products Development at the Food and Drug Administration. Fifty-two patients are enrolled in the study at this time. The code has not yet been broken. No adverse effects attributable to the medication have been observed. 

Good Clinical Practice (GCP) regulations in the United States and the ICH guidelines, which meet safety, ethical and efficacy requirements, are comprehensively covered in the clinical research development chapters. Investigator, sponsor, and monitor obligations are detailed and applied practically. Institutional Review Boards (IRBs), Independent Ethics Committees (IECs), and Informed Consent (IC) will be discussed fully along with the... 

A special committee, the Joint Test Group (JTG), was specified in the master plan to provide independent review and approval of program activities. Membership of the JTG includes experienced personnel from Reactor Operations, Reactor Engineering, Maintenance, Reactor Quality Engineering, and the commercial nuclear industry. The DOE participates in JTG activities as a non-voting member. This board participation provides a key basis for a safe and effective startup program. 

The NTP is located administratively at the NIEHS/NIH and receives advice on its activities from three external groups The NTP Executive Committee, the NTP Board of Scientific Counselors, and the Scientific Advisory Committee on Alternative Toxicological Methods. The NTP also uses special emphasis panels for independent scientific peer review and advice on targeted issues. 

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