Institutional Review Board

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 unaffiliated with the institute. The full committee will meet 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.

If you plan to conduct research that includes the use of Human Research Subjects, your 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. Templates of forms required for your submission to the IRB are available on the SKERI Wiki page, which is accessible only by SKERI personnel.

When a staff member of Smith-Kettlewell is part of a research team of a study outside of Smith-Kettlewell, the IRB needs to have a record of this collaboration. When such a study is approved by another OHRP-approved institute review board, this approval needs to be submitted to the SKERI IRB.

Whenever a research study involves human subject participation, the research personnel must be trained in the guidelines of appropriate conduct of research, Human Subjects Training 

Please feel free to contact the IRB with any questions you might have at

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.