Institutional Review Board
If you are facing a serious diagnosis such as cancer, your days are full of processing this life challenge. If you are considering applying to be part of a clinical trial, you may have questions about what is involved. Naturally, you will be concerned about how these studies are reviewed for your safety and scientific integrity. To save you some wear and tear, here are some facts about Institutional Review Boards, the groups that review research proposals like clinical trials.
An Institutional Review Board (IRB) is a committee made up of at least five members at a university or other clinical research study site. Their job is to review research projects that human participants, such as clinical trials, to be sure the project meets ethical and scientific requirements. This is also necessary especially when federal funding is often involved. Two requirements that research needs to meet for IRB review are that the project must considered real research and the project must involve human subjects (which can include the use of bio-specimens and private information about the subjects.) An Institutional Review Board then has the obligation to either require changes and modifications to the project, approve it, or disapprove it.
An Institutional Review Board looks for certain information about a clinical trial to study an experimental drug or device for the potential treatment of a disease. These are some of the crucial issues that they look into:
- Clear procedures and protocols (study plans) for the research
- An adequate research site or institution
- Proof that all human beings involved in the research have given their informed consent to participate voluntarily in the program
- Clear statements of the benefits and risks of the research proposal
- Information about the criteria used to select human volunteers and details about the population of the volunteers, including what is used to determine who can be included or excluded in the project
It is a big responsibility to be part of an Institutional Review Board, and there are certain requirements mandated by the Food and Drug Administration for the makeup of an IRB which include:
- One scientist
- One nonscientist
- One member who is not affiliated with the university or institution
- Equal representation of cultural backgrounds, race, and gender
- At least five members with different backgrounds
- Competency in evaluating ethical and scientific aspects of trial
The IRB reviews the research thoroughly before the project can receive federal funds, but they can also review projects that have other funding sources. They look into how the study will get volunteers as well as all the materials that will be used by the volunteers including any surveys, tests, and questionnaires. The IRB also reviews all benefits and risks of the research. Benefits include how the volunteers are affected as well as broader benefits to society. Risks cover physical risks to volunteers as well as psychological, social, or economic factors. All these things are part of what an IRB considers when looking to be sure the volunteers are adequately protected.
It is reassuring to know that any clinical trial or study undergoes this scrutiny. It can help you when considering whether to participate in a clinical trial for an experimental drug or treatment. An Institutional Review Board is a vital part of ensuring that research is done ethically and that all volunteers involved are protected.