Protocol (Involving Human Subjects)

For a research activity involving human subjects to be conducted at an institution, a submission must be made to its institutional review board (IRB) for review and approval. The documents reviewed include the local application, the investigator's brochure (for experimental drug or device research), applicable consent documents, any recruitment tools (such as advertisements) proposed for use, and a detailed research protocol.

General scientific protocols include the background, aims, and actual procedures to be employed to answer the scientific hypothesis in question. However, when humans are proposed as subjects to be enrolled in the research, specific federally mandated criteria must be met for a study to be granted approval. To meet most of these criteria, a protocol involving human subjects must additionally contain information about foreseeable risks and (therapeutic) benefits to the subject, inclusion and exclusion criteria, provisions for protecting privacy of subjects and confidentiality of the subject's data, plans for safety monitoring, and additional protections for subjects who may be considered vulnerable to coercion or undue influence.

The protocol's description of foreseeable risk and benefit is critical in the assessment of whether or not a study may be approved by an IRB. The IRB is federally mandated to ensure that a protocol's risks are reasonable in relation to anticipated benefits. The review of inclusion and exclusion criteria helps an IRB meet its ethical and legal obligation to ensure that the selection of subjects is fair, given the purpose of the research.

The protocol details concerning purpose, research procedures, risks, benefit, and so on must be accurately presented in the research consent form that is used to enroll subjects into the study. The consent form, unlike the protocol, must be written in lay terminology to ensure readability by subjects; it also includes details concerning the subjects' rights as a participant, including the right to refuse participation and the right to withdraw from the research without affecting the subject's status at the institution.