IRB Considerations in Review of Protocols

The IRB will pay special attention to the following:

  1. Identification and Assessment of Risks. These may be of a physical, psychological, social or economic nature. In behavioral, social, and some biomedical research, the methods for gathering information may pose the added risk of invasion of privacy and possible violations of confidentiality.

  2. Determination that Risks are Minimized. Precautions, safeguards, and alternatives should be incorporated into the research design where warranted to reduce the probability of harm.

  3. Assessment of Anticipated Benefits. Benefits may be to subjects and to society. The IRB will look for a clear statement of benefits to subject, as well as identification of the knowledge researchers expect to gain.

  4. Determination that Risks are Reasonable in Relation to Anticipated Benefits. Evaluation of the risk/benefit ratio is the major ethical judgment IRBs must make. In reaching this judgment the IRB will take into account the subject population (e.g., children, pregnant women, terminally ill). In research where no direct benefits to the subject are anticipated, the IRB must evaluate whether the risks presented by procedures performed solely to obtain generalizable knowledge are ethically acceptable.

  5. Informed Consent. Because of the centrality of informed consent to research with human subjects, a separate section below lists the basic elements of the consent document and process. The IRB will evaluate the information to be presented to subjects in light of the risks and benefits of the proposed research procedures.

  6. Privacy and Confidentiality. Privacy can be defined in terms of having control over the extent, timing, and circumstances of sharing oneself (physically, behaviorally, or intellectually) with others. For example, in recruiting subjects through a clinic, institution, or doctor, it is important that potential subjects have an opportunity to refuse participation before their identity or means of contacting them is revealed to a researcher. Confidentiality pertains to the treatment of information that an individual has disclosed in a relationship of trust and with the expectation that it will not be divulged to others in ways that are inconsistent with the understanding of the original disclosure without permission.

The IRB will seek to determine whether an invasion of privacy is involved. It will also examine the research design to assure that information linked to individuals is adequately protected from breaches of confidentiality. There are specialized security measures developed for this purpose. These include the use of codes, storage of date under lock and key, and certificates of confidentiality.