Office of Sponsored Research

STEP THREE: Gaining Approval

IRB Review, Revisions, and Gaining Approval

See Types of IRB Review for a detailed description of each review category.

Full Board Reviews

Any proposed protocol that poses greater than minimal risk to study participants and has been determined to require a Full Board Review will be reviewed at the next scheduled IRB meeting. A quorum of the IRB membership roster must be present at this meeting in order to conduct an official review. The voting members present during this review have the authority to approve, require modifications to secure approval, or disapprove the application. Immediately after the review, the IRB will notify investigators in writing of its decision to approve or disapprove the proposed research activity, or of modifications required to secure IRB approval of the research activity. If the IRB decides to disapprove a research activity, it shall include in its written notification a statement of the reasons for its decision and give the investigator an opportunity to respond in person or in writing.

In cases where the proposed research activity involves vulnerable subjects or a specific area of research that is outside the areas of expertise of the IRB members, a subject area expert may be invited to participate as a consultant in the Full Board Review process.

Research activities that are approved by a Full Board Review will require Continuing Review by a fully convened IRB at intervals appropriate to the degree of risk, but not less than once per year. When the Notice of Approval is issued to the investigator(s), the approval period and expiration date of approval will be noted.

 

 

Approval Criteria

Based on the Federal Regulations found at 45 CFR §46.111, the overall criteria for IRB approval are:

  1. The risks to subjects are minimized as much as possible:
    • By using procedures that are consistent with sound research design and that do not unnecessarily expose subjects to risk, and
    • Whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes.
  2. The risks to subjects are reasonable in relation to anticipated benefits.
  3. The selection of subjects is equitable.
    • The IRB should be particularly cognizant of the special problems of research that involves subjects who are vulnerable to coercion or undue influence, such as children, prisoners, individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons.
    • Students or advisees who are research subjects in studies conducted by faculty members are vulnerable to coercion, and steps must be taken by the researcher to mitigate this risk.
  4. The informed consent is adequate and in accordance with §46.116.
  5. Informed consent will be appropriately documented or appropriately waived in accordance with §46.117
  6. Where appropriate, the research plan makes provisions for the safety of the subjects during the data collection process.
  7. Where appropriate, there are adequate provisions to protect the privacy of subjects and maintain the confidentiality of data.
  8. Appropriate safeguards are included within the study to protect the rights and welfare of the vulnerable subjects (children, prisoners, veterans, the homeless, the handicapped, etc.).