The Smith-Kettlewell Institutional Review Board (IRB) is a committee, operating under Federal regulations, State laws, and institutional policy, that reviews research involving human participants to ensure their ethical and equitable treatment. Its primary role is the protection of human subjects in research studies. The responsibility for the appropriate use of human subjects is shared by institutional officials, the IRB, and scientific investigators.
The membership of the IRB Committee must have at least five members with varying backgrounds, including at least one scientist, one non-scientist, and one community member who is not otherwise affiliated with the institute. The full committee meets generally twice a year unless more meetings are deemed necessary. Quorum is achieved if 51% or more of the membership is present. Some studies qualify for Expedited Review and can be reviewed by a senior member of the IRB without requiring the full committee to convene.
When a scientist plans to conduct research that includes the use of Human Research Subjects, the study must be reviewed and approved by the IRB prior to initiating any research. The IRB has the authority to approve, require changes in, or disapprove research involving human subjects.
Please feel free to contact the IRB with any questions you might have at IRB@ski.org.
Per the Office for Human Research Protections (OHRP), a division of the U.S. Department of Health and Human Services (HHS), Regulation (45CFR part 46) states that an institute may conduct research with human subjects only if the institution has OHRP-approved assurance and has certified that the research was reviewed and approved by the IRB, and will be subjected to continuing review.
The Smith-Kettlewell Eye Research Institute has provided assurance to the Department of Health and Human Services (DHHS) in the form of federal-wide assurance (FWA) that it will comply with requirements set forth in 45 CFR 46.