Before an investigator can receive federal funds to conduct a research project, the protocol (research procedures) is reviewed by the IRB. The researcher provides the IRB with all the necessary materials to conduct their review including a full description of the proposed project, materials the subjects will use (surveys, questionnaires, tests, etc.), a description of the manner in which subjects will be recruited and provide consent to participate in the project (including a consent form), and how the subjects' confidentiality will be maintained.
The IRB examines all these materials to determine if the research participants are adequately protected. The IRB’s consideration is based primarily on weighing the risks and benefits of the research. Risks may be physical, psychological, social, or economic. Benefits include both those to the individual research participant and to society as a whole. The IRB also considers the population being studied — Does it require additional protections? Would this population assess the risks and benefits differently?