Protocols review boards

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. 

When conducting a clinical trial, the well-being of the study subjects is primary. Subjects must be treated fairly and with respect. The two primary methods of ensuring fair treatment of study subjects are review of the study protocol by an Institutional Review Board (IRB) or Ethics Committee and... 

Most consent forms that have been developed have at some time been reviewed by standing ethical review boards, usually associated with a university. The format of the consent form described above has been reviewed over time by more than one ethical review board and would be acceptable in most States for the purpose of acquiring the consent of potential volunteers in a worker exposure or re-entry study. If performing worker exposure studies in California, the researcher is advised to contact the State regulatory agencies and submit the draft consent form and study protocol to the State-appointed ethical review board for review and approval prior to initiation of the field phase of the study. Of course, if the researcher has any doubt about the acceptability of the proposed consent form, he/she should contact the appropriate state agencies where they plan to perform the study. 

Weapons, Lieutenant General Taylor reported Furthermore, the review mechanisms applied to Edgewood have been tightened over the last two years so that protocols are reviewed by the Army Investigational Dmg Review Board and Human Subjects Research Review Board and relevant Department of Defense and Food and Dmg Administration regulations are followed. ... 

Today, an ethical review is an essential part of the biomedical research process. lECs provide ethical guidance on research protocols and ensure the protection of research participants. In the United States, similar bodies called institutional review boards (IRBs) have a similar role to that undertaken by lECs in the rest of the world. 

The government had required that the sponsors should have their own in-house study review board to review the ethical aspects of clinical trial protocols. Such a requirement was based on the former Japanese GCP, which stipulates that the company should organise an internal formal body or mechanism that reviews and authorises its planned studies before submitting to either study centres or the MHW for clinical trial plan notification. 

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

Institutional Review Boards. In university clinics and other hospitals engaged in research, ethics committees (also called Institutional Review Boards, IRBs) have been formed over the last three decades to monitor clinical research activities from scientific, legal, ethical and social viewpoints. All protocols relating to clinical trials must be submitted to these committees, which are generally made up of one or several doctors, a lawyer, a representative of the nursing staff and also community representatives such as priests. This composition forces clinical researchers to set out their intentions in such a way as to be clear enough for a lay person to understand and to assess whether the inconvenience and risks involved for the patient are in a reasonable relationship to the possible benefit of the planned trial. 

Drug (IND) must be filed with the FDA (Figure 5-1). The IND includes (1) information on the composition and source of the drug, (2) chemical and manufacturing information, (3) all data from animal studies, (4) proposed clinical plans and protocols, (5) the names and credentials of physicians who will conduct the clinical trials, and (6) a compilation of the key data relevant to study the drug in man made available to investigators and their institutional review boards. 

Fitzgerald, D. W., A. Wasunna, and J. W. Pape. 2003. Ten Questions Institutional Review Boards Should Ask When Reviewing International Clinical Research Protocols. IRB 25 14—18. 

G.F. Whalen, Lipid coated microbubble (LCM)-facilitated ultrasonic treatment of liver tumors, Clinical Protocol No. 99-235 filed with Office of Clinical Research, Institutional Review Board (IRB), Univ. of Connecticut Health Ctr. (IRB Approval by full Board for first phase granted 5-13-99) in conjunction with Critical Technologies Funding Competition (G.F. Whalen and J.S. D Arrigo, Co-P.I. s), 1999 (limited distribution reports). 

A participant database was created under an Independent Review Board (IRB)-approved protocol (Western IRB, Olympia, Washington) (Table 11.1, activity 1). The ata collection process began in October 2003 and continued through April 2005 at... 

The review of the protocol ensures that there are adequate selection criteria and procedures to protect vulnerable study populations. In addition, information within the protocol, the informed consent, and the Investigator s Brochure are reviewed to assess safety information that may affect subjects. Institutional review boards are empowered with the authority to approve or disapprove research activities that are covered by regulations, as well as to require modifications to secure approval. Informed consents will be reviewed to assure that all the information provided is in accordance with 21 CFR 50.25 the IRB may also require that additional information be provided to study subjects in a separate format, such as a patient information sheet. If this requirement is waived, a written statement may be given to the subject. If a very short window of opportunity exists to dispense a research treatment to avoid a devastating or fatal outcome, a waiver for this requirement may be requested. It is important to note, however, that the sponsor must clearly describe or define the situations that would require testing without administering a written informed consent. Also, provisions that will be made to obtain the consent from family members must be in place. This issue will be discussed in more detail in the section on informed consent. In summary, the following criteria are used by IRBs to approve research ... 

Institutional review board records that do not adequately track or log research documents that have been submitted by the clinical investigator, including protocols, amendments, consent forms, Investigator Brochures, IND safety reports, advertisements, patient information sheets, and correspondence between the investigator and the IRB. 

Institutional Review Board letter of approval for protocol, informed consent, advertisements (newspapers, flyers, television) to be used to recruit study subjects and any other written information to be provided to subjects. 

Problems noted during inspections of the Institutional Review Board (also known as the Ethics Committee in Europe the group that reviews and approves the research to be done in that facility, the clinical protocol, investigator s brochure, and so on), again by an experienced FDA investigator, include ... 

All European countries require, in common with the United States, and in conformity with the Declaration of Helsinki, that ethics committees (the European version of institutional review boards in the United States) review protocols from phase I-IV and the general conduct of trials outside the formal protocol document. However, there is wide variation in Europe as to how this procedure is enacted. In countries such as France, Spain and Germany, there is a national system of ethics committees that duplicate similar work at a local level. In the United Kingdom, there are a wide variety of ethics committees, such as commercial committees, those set up by the Royal College of Physicians, and those run by local area health authorities or hospital trusts. 

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. 

Investigational drug information (e.g.. Institutional Review Board activities, central depository of study protocols, providing patients and practitioners with information about investigational drugs, managing medication studies). 

The ethics conunitee of clinical research is the institutional entity at the local institution that is responsible for protecting the rights of human. It plays a similar role to the institutional review board in other countries. The main functions of this entity are to examinate the methodological, ethical, and regulatory issues of each protocol proposed for development in the hospital. 

The protocol and attachments/appendices should be scientifically and ethically appraised by one or, if required by local laws and regulations, more review bodies (e.g. institutional review board, peer review committee, ethics... 

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