Many “checkpoints” ensure that research meets strict scientific guidelines and follows rules that protect the subject. Several groups who are not part of the research team examine both the scientific plan and procedures to protect the interests of participants before an investigator may begin the research.
Each proposed study, including its provisions for the protection of human subjects and its consent form, must be approved by an Institutional Review Board (IRB). Every organization that conducts research, for example a university or hospital, must have an IRB. The membership of these boards includes scientists, persons who are not scientific experts, and at least one “public” member who is not associated with the organization.
An important IRB responsibility is to review the informed consent materials that an investigator develops for those who take part in the study. This information allows the IRB and more critically you to judge the value, risks, and potential benefits of a research project. If an IRB has concerns about any part of the research proposal, the committee will tell the director of the study. The researcher must attend to these concerns before submitting the research proposal to a funding agency.
A funding agency, such as the National Institute of Mental Health (NIMH), provides the next review of human subject provisions for clinical research proposals. The funding agency also judges the scientific importance of a research proposal, and how the researcher will learn from it. Both the IRB and the funding agency conduct regular reviews to be sure that the researchers are meeting all the rules for the protection of human subjects.
You can be certain that a range of persons, both scientists and others, have reviewed any IRB-approved research that you may be asked to join. Nonetheless, having a general understanding yourself of how scientists conduct clinical research will help you feel more confident when talking about the project with the research director.