*Each agency has its own IRB process. Work within your agency for specific agency IRB processes.*
The primary purpose of the Institutional Review Board (IRB) is to protect the welfare of human subjects used in research. If the type of evaluation proposed requires IRB approval, factor appropriate time into the schedule for review, approval, and continuing review. IRB reviews can take considerable time and may have cost implications to both the schedule and the budget.
To ensure appropriate protections are in place and maintained, IRBs serve as an independent and objective ethics committee to ensure the protection of human subjects. An IRB’s job is to approve (or disapprove) human subjects’ research or require modifications prior to approval. IRB review should occur prospectively—that is, before study procedures are implemented. IRBs are also responsible for continual review by monitoring active research projects, reviewing and addressing any unanticipated problems, and reporting serious adverse events to regulators. IRBs have the authority to suspend or terminate research that does not comply with the rules to protect research participants from harm. The table below summarizes the main roles and responsibilities of IRBs. IRBs are registered and regulated by the Department of Health and Human Services (HHS). In general, IRBs are at medical centers and universities; although, some research firms also host their own IRBs.
The selected evaluator will likely have experience with and knowledge about which IRB to use and how to contact the IRB, and the overall process involved to receive approval for the study (if required) before engaging human subjects. The IRB will let the evaluator know whether the study is “exempt” from review or is “non-exempt” and needs to undergo a formal board review.
The decision to include a protocol for IRB review—and the level of review, either expedited or full board— depends on a variety of the following factors, the:
- Level of risk to participants overall and relative to the potential social benefit of the research;
- Vulnerability of the population under study; and
- Steps the evaluator takes to minimize risks and safeguard participants.
Generally, studies that may pose minimal or greater than minimal risk to participants need review by the IRB. Evaluation requirements that constitute exempt research, minimal risk, or greater than minimal risk are decided by an IRB, not the evaluator.
The process could take anywhere from one to several months. The time it takes to prepare an application for IRB review, have it reviewed, respond to comments or requests for revisions, and receive approval depends on both the complexity of the research project and the level of risk it poses to participants.
Four major areas for consideration during the IRB review process include:
- The study’s procedures for informed consent;
- How the evaluator will protect privacy and confidentiality;
- The plan for data security; and
- How the evaluator will handle adverse events and unanticipated problems.
These factors have very real, on-the-ground implications for how the study will unfold. The state agency sponsor for the study will want to be aware of and may be involved in executing these aspects of the study protocol.
Informed Consent: To collect information from and about individuals participating in a research study, the evaluator needs to obtain their legally effective informed consent (or that of a parent or guardian if the participant is a minor under age 18). Obtaining informed consent includes giving prospective study participants sufficient opportunity to consider participation and minimizing undue influence and coercion. Informed consent is a process (not just a form) that begins with explaining the study. The information provided to prospective participants during the consent process must help them understand the implications of participation. It is essential to disclose all relevant information honestly and to give each individual the opportunity to ask questions and receive answers to their questions.