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Foundation for Risk Review

When the IRB reviewer looks at the risk in a study, he or she tries to determine what the best and worst case scenarios will be based on the information provided in the protocol. This assessment is based on the experience of the primary reviewer, secondary reviewer, and the entire Board (if the protocol requires full board review) and the ethical concepts that are the foundation for the IRB process. Two documents (among others), the Belmont Report and Code of Federal Regulations 45 part 46, canonize these concepts.  The federal regulations provide a rule structure while the Belmont Report provides an analytical frame work for decision-making, creating a balance between social code and individual judgment. 

Belmont Report

At the core of the Belmont Report are three concepts that govern the ethical deliberations of the IRB:

  1. Respect for Persons: Respect for persons incorporates at least two ethical convictions: first, that individuals should be treated as autonomous agents, and second, that persons with diminished autonomy are entitled to protection.
  2. Beneficence: Persons are treated in an ethical manner not only by respecting their decisions and protecting them from harm, but also by making efforts to secure their well-being.
  3. Justice: Who ought to receive the benefits of research and bear its burdens? This is a question of justice, in the sense of "fairness in distribution" or "what is deserved."

At least one (if not more) of these concepts drives the more practical requirements of the IRB, such as providing informed consent (respect for persons and beneficence), making an assessment of risks and benefits (justice, respect for persons, and beneficence), and selection of subjects (justice).

Federal Regulation’s guidance on risk

According to the federal regulations CFR 45, when the Board reviews a protocol, they are required to determine if the study is minimal risk; if the study is not minimal risk, the Board analyzes if the study minimizes the risks according to good scientific practice. The Board will also weigh the benefits versus the risks. In addition, the Board will evaluate the study’s recruitment and consent procedure. The Board will review the data collection and storage procedures to make sure that confidentiality is protected and the data are properly stored.  All of these elements combined can give the Board a summary of the level of risk in a study, from which they can make recommendations and ultimately make a decision regarding approval. The federal regulations also describe how the Board is supposed to be constructed and how the meetings should be run, as well as the administrative functions of the IRB-SBS.

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