This section offers a basic and general explanation of how the principles of responsible research are applied.
What does review by an Institutional Review Board involve?
IRBs examine research protocols, guided by the Common Rule and by the Belmont Report. Qualified experts examine methods, instruments, documents (including consent forms and scripts for recruiting participants) and other technical aspects of the projects. IRBs are required to have non-scientist members and members unaffiliated with the sponsoring institution.
In a typical case, a researcher planning a project fills out forms intended to help the researcher and the IRB identify ethical issues posed by the research, with emphasis on the level of risk carried by the study. The forms are submitted to an IRB representative with copies of the consent documents, a description of the research procedures and other relevant documents. A large percentage of social science projects are approved as “exempt” (meaning the project does not require detailed review even if it did need to be submitted for approval). Others qualify for “expedited review,” which can be accomplished without waiting for the next full IRB meeting. Projects carrying greater than minimal risk require full IRB review. This means discussion by a quorum of IRB members.
IRBs have the obligation and authority to stop research affiliated with their institutions if the research does not merit approval. Researchers have responsibility to submit proposals for human subjects research for review, and to stop an impermissible project even if the subjects give consent. Thus the IRB, the researcher and the research participant (subject) each have veto power.