Initial Review

All research studies involving human subjects are reviewed in one of three ways: Exempt (from further) Review, Expedited Review, and Full Review. FDA regulated research is always reviewed by Full Review.

Every research application begins with a complete submission to the Office of Research Compliance.

The Office of Research Compliance staff works closely with the principal investigator to prepare the required IRB documents for IRB review.

This includes:

An IRB application called Minimal Risk Studies Involving Human Subjects form

Informed consent forms

Evidence of approval by another IRB or Institution  (Documentation of Permission to use patient data or school students by the appropriate institution’s administration)

Data collection instruments (e.g., questionnaires, interviews, surveys, etc.)

Recruitment materials

Once the application is determined to be complete, it is formally accepted by the Office. This is the starting point for the IRB review process.

Upon receipt of all required paperwork, the Compliance Coordinator logs the IRB submission, scans the materials, enters the application into InfoEd (the electronic data management system), assigns an application number, reviews the application for completeness, notifies the assigned Primary Reviewers, and places the application on the agenda for the next IRB meeting.

If the application does not require Expedited or Full Review, the Compliance Coordinator will indicate in a letter to the Principal Investigator that the study is exempt from further review. All reviewed applications that are unfunded are submitted to the Office. If the study is or becomes funded, a copy of the letter previously sent to the Principal Investigator is forwarded to the Office of Grants and Contracts for inclusion in their files.

If the application requires an Expedited Review, the Compliance Coordinator forwards the application to the IRB Chair or his/her designee. The IRB Chair or his /her designee conducts the Expedited Review.

If the application requires a Full Review, the Compliance Coordinator forwards the application to the IRB Chair for assignment of two Primary Reviewers to evaluate the application, discuss concerns with the Principal Investigator, and serve as advocates during the Full Review. All information or revision requests by the Primary Reviewers are sent to the Principal Investigator through e-mail and copied to the Office including notes of oral communications. All IRB Board Members have access to the application and communications between the Primary Reviewers and the Principal Investigator via InfoEd. When IRB review is completed, the Compliance Coordinator notifies the Principal Investigator in writing of the application’s status.

Continuing Review

The IRB conducts continuing review of all research, funded or unfunded, approved through the Expedited or Full Review procedures in accordance with the policies and procedures outlined in Federal Regulation 45 CFR 46 Protection of Human Subjects, at intervals appropriate to the degree of risk, but not less than once per year for the life of the project. No study continues beyond the one-year approval without IRB review. Applications previously approved by Full Review are reviewed for continuation by Full Review.

It is the Principal Investigator's responsibility to secure continuing approval.  Principal Investigators are reminded at one and two month intervals by the Office to seek continuing review. Requests are placed on the Continuing Review form. Principal Investigators who fail to obtain continuing approval are notified by the Office (by telephone, email, and letter) that their investigation has been terminated and that subjects are no longer allowed to participate in the investigation.

Revision/Amendment

If the Principal Investigator, during the course of conducting the research, needs to revise the application (e.g., makes changes to the informed consent form, conduct of the study, survey instruments used, or number and nature of subjects), the principal investigator must notify the Office and seek approval prior to making any changes. The Compliance Coordinator will notify the original Primary Reviewers and they will determine the need and degree of additional review needed for approval. Note: for investigations initially approved by Full Review, changes that alter the degree of risk to the subjects require Full Review.

The Principal Investigator must submit in writing any intended changes to the study to the Office using the, Request for Modification/Amendment form. The Principal Investigator is reminded that no changes can be implemented until the Chair and/or the Committee approves the changes, and that failure to do so may result in the application’s suspension and/or termination.

Review of IRB Actions

As a part of the Expedited and Full Review procedures, the IRB has the authority to approve, request revision and resubmission, or disapprove the research application.

Approval

The application is approved with or without IRB required changes.

Request Revision and Modification

When an application is not approved during Full Review because problems are identified within the application, the status of the application is considered to be pending approval. When problems fall into either of two categories, i.e.,: 1) the Principal Investigator needs to clarify an aspect of the study, provide additional information, or discuss in greater detail the potential risks and benefits the study presents, or 2) minor changes need to be made to the informed consent document(s) or the research design, approval may be given after the Principal Investigator rewrites the application, informed consent, or submits to the Chair a written response to the IRB's questions and concerns. The Chair may then poll IRB members, ask the Primary Reviewers for their recommendation, approve the changes as submitted, or forward the application to the committee for Full Review.

For applications with a high degree of risk, the IRB may request that the Principal Investigator resubmit the revised application for Full Review.

Disapproval

The IRB can disapprove a proposed application if the risks to the subjects outweigh the benefit or value of the knowledge to be gained.  A research activity may be disapproved only after a Full Review has been conducted.

Suspension or Termination of Research

The IRB has the authority to suspend or terminate research that is not conducted in accordance with the IRB's requirements, other institutional and federal requirements, or has been associated with any serious harm to subjects. Concerns regarding the conduct of research are to be reported to the Chair of the IRB by any individual having such knowledge. Any suspension or termination of research must include a statement of the IRB's action and the Chair must report the IRB’s decision promptly to the Principal Investigator. The Office of Grants and Contracts will be notified of the IRB’s action in the case of a sponsored project.

The Compliance Coordinator will notify the Principal Investigator in writing regarding the IRB’s action for approvals, pending approvals, disapprovals, suspensions, or terminations.

Final Report Form

All Principal Investigators conducting research should submit a final report form to the Office upon completion of their project. The form should be submitted within 30 days of completion or the termination of all research activity for a study.