Ethical review boards

Review of the consent form by ethical review boards... 

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. 

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. 

While there is no FDA involvement in such investigations, ethical considerations and institutional regulations would generally dictate that informed consent and the approval of the local institutional review board be obtained. However, due to the negligible risks involved these are likely to be a formality and will not involve extensive review or scrutiny. 

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... 

Although IRB members can and should come from a variety of backgrounds, all board members should know the basic elements of clinical research and should stay focused on their role in the ethical review process. Any board member who does not have a research background should take the time to learn the basics of the industry. Books, such as this one, can introduce the language, regulations, and ethical issues in the conduct of research with humans. 

Board members should understand the need to avoid conflicts of interest. Any board member with a conflicting interest in a study should not participate in the deliberations or voting on that study. The IRB may ask that member to leave the room during deliberations and voting to avoid a political environment that is not conducive to objective ethical review. However, it is the IRB s decision whether an individual should remain in the room. 

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

Army Medical Research and Development Command Contract Review Board and the Surgeon General s Human Use Committee and Clinical Investigation Committee, to insure uniform application of ethical standards for human research studies conducted within or sponsored by the Army Medical Department and other Army Agencies. 

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. 

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. 

Expert Panel Report to the National Institutes of Health (NIH) (1998) Research involving individuals with questionable capacity to consent ethical issues and practical considerations for institutional review boards (IRBs). Presented In Bethesda, MD, February 1998. 

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. 

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. 

Despite the extensive experience with biomedical ethics, the infrastructure of institutional review boards (IRBs), and the equivalent for protection of human subjects (Schulte et al. 1997 but see Soskolne 1997), it is essential to address questions of ethics that may be particular to the design of biomonitoring studies. In this section, the committee considers some practical and research issues in biomonitoring ethics but makes no pretense that the list is exhaustive. Ethical issues can stop specific studies, and the field in general, dead in their tracks. Therefore, it is incumbent on investigators, policy-makers, and others to consider these issues carefully. 

Sieber, J. E. (1992). Planning Ethically Responsible Research A Guide for Students and Internal Review Boards, Vol. 31. Newbury Park, CA Sage. 

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