Institutional Review Board

Any project that involves research and human subjects must be reviewed by the IRB. Research is defined as a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Continuous quality improvement (CQI) projects designed exclusively for use within our own practices, and which are not intended to be published, would not be defined as research. Human subjects are defined as living individuals about whom an investigator (whether professional or student) conducting research obtains 1) data through intervention or interaction with the individuals, or 2) identifiable private information. Any project that proposes to utilize medical record data must be reviewed by the IRB. In many of these projects, investigators remove identifiable patient information and are deemed to be “exempt” studies, but they still must be reviewed by the IRB.

IRB Application Process:

• After approval by the Research Committee, an IRB application must be completed online, using the Axiom/Mentor system. All resident and student projects must have a faculty or staff member serve as a co-investigator. If you have not yet created a Mentor system profile, please contact either of the IRB administrators.
• IRB applications must be submitted two weeks prior to an IRB meeting, generally held the third Monday of every month. The IRB administrator conducts a pre-review of the applications to ensure that it is complete and signed, and may request revisions before passing it on to the IRB members for review.
• All investigators and key project staff must participate in human subjects protection education prior to IRB review of their research proposals. This is commonly accomplished through the completion of the following web-based course: Protecting Human Research Participants. It takes approximately 45 minutes to complete.
• All investigators and key project staff must participate in good clinical practice education prior to IRB review of their research proposals. This is commonly accomplished through the completion of this web-based course.
• All investigators must also have both an FCOI certificate, and an FCOI annual disclosure form on file with the IRB. PIs can obtain a FCOI certificate through the completion of the following web-based course: NIH FCOI training. The annual disclosure form can be found in the “Important Forms” folder in Mentor.

In order to approve human subjects research, the IRB must determine that all of the following requirements are satisfied:

• Risks to subjects are minimized: (i) By using procedures which are consistent with sound research design and which do not unnecessarily expose subjects to risk, and (ii) whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes.
• Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result.
• Selection of subjects is equitable.
• Informed consent will be sought from each prospective subject or the subject’s legally authorized representative, and will be appropriately documented (see requirements for informed consent detailed in the IRB application form).
• When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects.
• When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.
• When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons, additional safeguards have been included in the study to protect the rights and welfare of these subjects.

• The IRB can approve or disapprove applications, or it can provide a conditional approval which details changes that must be made in order to receive a full approval. With a conditional approval, changes must be presented in writing and approved by the IRB.
• Investigators receive an e-mail explaining the IRB’s decision regarding their applications. It is the responsibility of the investigator(s) to submit a continuing review application of an approved project, which takes place no later than one year after the approval date. All protocols approved by the Institute’s IRB are required to submit an annual continuing review report. Mentor will automatically notify PIs of an impending report due date. In order to submit a continuing review, log in to the Mentor system, go to the view protocol page and scroll down to the set of tabs at the bottom. The Annual Report (aka Continuing Review) tab is the first tab visible. Click on the Context Menu and select “Edit” and complete the resulting form. Please upload all required documents to the Mentor system. You will receive all further communication and information about approval status via Mentor.

The Institute can choose to stop a research project that the IRB has approved, but it cannot allow a study to move forward that the IRB has disapproved.