Clinical Research Personnel - page 2

Institutional Review Board (IRB) Members

Clinical trials test research discoveries that scientist's hope will benefit patients in the future. The fact that participants in the trial may not derive any direct benefit from their participation, presents a wide range of ethical questions.

The Institutional Review Board (IRB) is the key to the protection of individuals who volunteer for a clinical trial. The IRB is a committee composed of people who understand the concerns of their local community where the study is being conducted.

Their mission is to review clinical trial applications and monitor ongoing studies in order to determine if the way the trial is being conducted meets ethical standards.

In order to obtain IRB approval, the clinical research protocol should carefully describe the study purpose, trial design and details about how it will be carried out. It will also include the informed consent form that must be signed by the patients who agree to participate. All of these issues are discussed later in this section.

Some IRB reviews are now conducted by for-profit organizations known as independent or commercial IRBs. The responsibilities of these IRBs are identical to those based at academic or medical institutions, and they are governed by the same federal regulations.

"In order to meet FDA requirements the composition of an IRB for the FDA's requirements is set in Federal Law number 21 CFR 56.107.

1.0. The IRB must have at least five members.

1.1. The members must have enough experience, expertise, and diversity to make an informed decision on whether the research is ethical, informed consent is sufficient, and appropriate safeguards have been put in place.

1.2. If the IRB works with studies that include vulnerable populations, the IRB should have members who are familiar with these groups.

2.0. The IRB should include both men and women, as long as they aren't chosen specifically for their gender.

2.1. The members of the IRB must not be all of the same profession.

2.2. The IRB must include at least one scientist and at least one non-scientist.

2.3. The IRB must include at least one person who is not affiliated with the institution or in the immediate family of a person affiliated with the institution. These are commonly called "Community Members." Many advocates fill this role.

2.4. IRB members may not vote on their own projects.

2.5. The IRB may include consultants in their discussions to meet requirements for expertise or diversity, but only actual IRB members may vote."

- Quote taken from the FDA website

In order to vote on a proposal, more than half of the members of the board must be present, one of who must be a non-scientist. There are exceptions for an expedited review, in which only the chair of the committee or a designee reviews research, but these are relatively narrow.

Data Safety and Monitoring Board (DSMB) Members

The Data Safety and Monitoring Board (DSMB) is an independent group of experts (typically three to seven members) who monitor both patient safety (adverse events) and treatment efficacy data during a clinical trial. This is different from an IRB that focuses on ethics and study design issues.

The primary mandate of the DSMB is to protect patient safety. If adverse events of a particularly serious type were more common in the experimental arm compared to the control arm, then the DSMB would have to strongly consider termination of the study. This evaluation has to be made weighing the risk vs. benefit.

In many cases, the patients in the experimental arm could experience serious adverse events (chemotherapy, for example may cause severe diarrhea), but the resulting improvement in survival outweighs these temporary adverse events thus producing greater benefit despite the risks.

		Usually at least one DSMB member is a statistician. Clinicians knowledgeable about the disease or condition being studied should be included, as well as clinicians experienced in handling any suspected major side effects (e.g. cardiology). A few long-term, well-publicized trials may include an ethicist or even a representative from a patient advocacy group. The DSMB will convene at predetermined intervals (three to six months typically) and review unblinded results, i.e. results they will know are either from the experimental or the control arms of the study.

The DSMB has the power to recommend termination of the study based on the evaluation of these results. There are typically three reasons a DSMB might recommend termination of the study: safety concerns, outstanding benefit, and futility.