Introduction
Before submitting a research study to the Institutional Review Board, it is important, to consider the level at which the review is appropriate as this determines the type of application that the organization will have to submit. The Institutional Review Board levels are generally based on the risk levels of the studies. When an application is submitted, the IRB is responsible for making the final decision to verify the level of review that the entity or organization has applied for. Depending on the subjects, demographics and the risks to be involved proposal fall either under the expedited review, full board review or under the exempt review. After the proposal is submitted the Institutional Review Board chair together with investigators and consultants determine the correct review level, make recommendations if necessary and approves the study (Hart & Belotto, 2010). In regards to the above information, the paper will discuss on the similarities, differences and application of the Exempt and Full board levels of review by different organizations.
Exempt review level
As the word, “exempt” suggests the level entails a study review by only one member of the Institutional Review Board. Sometimes the review can be done in consultation with other IRB members for clarification purposes. The level is suitable for organizations that conduct research studies that are considered low risk. Among these research activities include studies conducted in established educational environments that involve the normal educational practices, studies that involve public officials and the non-risk interviews and surveys. Other research studies that lie under this category include studies involving the collection of information on already existing data, consumer acceptance studies, quality evaluation studies and studies evaluating the benefit of service programs. This type of IRB requires approved consent from the participants, but signed forms are not mandatory. Typically, this type of IRB review takes two weeks to be completed after being submitted to the Institutional Review Board departments (Byerly, 2009).
Full Board review
This type of IRB level is necessary for research studies that are not eligible for the exempt review. Unlike the exempt review, this level requires a full board review by all the IRB members. The level entails research involving more than the minimal risk required or research involving the minority protected groups such as the physically challenged persons, children, and prisoners. Organizations and entities that are willing to conduct research at this level need to give the review team enough time to be able to review the research process completely. Among the studies that lie in this category are the projects involving greater risks, studies where misleading and false information is used and research involving the minority groups such as children and prisoners. As well, research studies that plan to use procedures that may cause harm or legal implications on the general public lie under this review (Parvizi, Tarity, Conner, & Smith, 2007). Just like the exempt level, application review takes at least two weeks before it is completed.
Conclusion
Any organization conducting research needs to work with the IRB to ensure that the participants are protected. It is crucial to protect the rights, confidentiality, privacy and privileges of the participants when conducting research studies and the IRB makes sure that this is done. Organizations need to place great importance on the IRB as its purpose is ensuring that appropriate steps are taken in protecting the welfare of the subjects participating in research studies.
References
Byerly, W. G. (2009). Working with the institutional review board. American Journal of Health-System Pharmacy : AJHP : Official Journal of the American Society of Health-System Pharmacists, 66, 176–184.
Hart, R., & Belotto, M. (2010). The institutional review board. Seminars in Nuclear Medicine. doi:10.1053/j.semnuclmed.2010.03.007
Parvizi, J., Tarity, T. D., Conner, K., & Smith, J. B. (2007). Institutional review board approval: why it matters. The Journal of Bone and Joint Surgery. American Volume, 89, 418–426.
