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AV / Research / Research Compliance / IRB / INVESTIGATORS’ GUIDE / STEP THREE

IRB Review of New Protocol Submissions:

A submitted protocol will be accepted for IRB review only when the IRB Office determines that the application is complete and the information and materials submitted present an adequate description of the proposed research.

The IRB Office determines the level of risk and appropriate type of review:

  • If the research methods pose no more than minimal risk and the protocol fits the requirements of one of the 8 categories of exempt research (45CFR46.104(d)), the research is determined to be EXEMPT.
  • If the research methods pose no more than minimal risk and the protocol does not meet the requirements of any of the 8 categories of exempt research described at 45CFR46.104(d), then the application undergoes EXPEDITED REVIEW.
  • If the protocol describes research methods that pose greater than minimal risk to the participants, the application will be reviewed by the FULL BOARD. Generally, research that involves vulnerable populations (such as research with children, prisoners, the handicapped, the homeless, etc.) will require a full board review.

Types of IRB Reviewfor a detailed description of each review category.

Exempt Determinations

The federal regulations identify of minimal risk research(new categories for 2018) that are exempt from the full application of. At AV, all exempt research must provide adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data. The research methods must also uphold the Belmont principles: respect for persons, beneficence, and justice. Therefore, exempt research methods must include provisions to gain informed consent to the extent commensurate with the level of risk.

Exempt determinations and approval are conducted through the IRB Office, and typical exempt protocols are approved in 1-2 weeks from the time the application is first received. However, applications that require heavy revision may take longer to be approved for exemption.Exempt research activities are not permitted to begin until an IRBNotice of Exemption is issued by the IRB Office.

Expedited Reviews

Any proposed protocol that poses no greater thanminimal riskto study participants and does not meet the requirements of any of the 8 categories of exempt research, may receive expedited review. The DHHS has described

Expedited review is a process by which certain types ofresearch may be reviewed and approved without convening a meeting of the full IRB. Expedited reviews are not necessarily“quicker” or conducted with less rigor, but fewer reviewers are required for approval. Designated IRB members are chosen to complete expedited reviews based on their area of expertise and availability. Student research proposals are reviewed by at least one designated expedited reviewer; faculty research proposals are reviewed by at least two designated expedited reviewers. Expedited projects are reviewed by the IRB according to.

At AV, typical expedited reviews are completed in 2-3 weeks from the time the application is first received. However, applications that require heavy revision may take longer to be approved by an expedited review.Expedited protocolsare not permitted to begin until an IRB Notice of Approvalis issued by the IRB Office.

A single IRB member cannot disapprove a research proposal during an expedited review. If for any reason, a designated reviewer is unable to approve a research proposal, the proposal is then reviewed and voted onby the full IRB during a convened IRB meeting.

Full Board Reviews

Any proposed protocol that poses greater thanminimal riskto study participants and has been determined to require a Full Board Review will be reviewed at thenext 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 requireContinuing Reviewby 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, the overall criteria for IRB approval are:

  1. The risks to subjects are minimized as much as possible:
    • By using procedures that are consistent withsound research designand 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 involvessubjects 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. Informed consentis adequate and in accordance with.
  5. Informed consent will be appropriately documented or appropriately waived in accordance with
  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 thevulnerable subjects(children, prisoners, veterans, the homeless, the handicapped, etc.).