700-38-Appeal of IRB Decisions

Title:	Appeal of IRB Decisions
Owner:	IRB
Last Update/Revised:	05/01/2024

Policy: The USU IRB has the authority to:

make a determination that a proposed project is not human subjects research,
make a determination that a proposed study is exempt,
conditionally approve any activity that requires approval from a collaborating institution,
approve research activity (either via expedited for full board review),
specify modifications required to secure IRB approval of research activity,
table a proposal,
disapprove any research activity overseen and/or conducted by investigators affiliated with USU,
request investigation of alleged research misconduct/non-compliance
suspend or terminate approval of research that is not conducted in accordance with IRB policies, is not in compliance with applicable Federal Regulations, or that is associated with unexpected serious harm to participants (see 700-34: Administrative Hold, Suspension and Termination of Research).

Research approved by the IRB may be subject to further review by officials of the USU, as appropriate. Such officials may override the IRB’s decision to approve research; however, they may not approve the research if the IRB has not approved it or overrule other decisions made by the IRB.

Investigators may appeal:

revisions required by the IRB;
IRB determinations of non-compliance, serious non-compliance, continuing noncompliance, research misconduct, or an unanticipated problem involving risks to participants or others;
IRB disapproval of research; and
termination of an approved protocol by the IRB.

If the appeal is denied, the IRB decision is final. Documentation of appeal, including all correspondence relating to the appeal, is retained with the research protocol in the IRB Google Drive.

Purpose: The purpose of this policy is to detail the steps an investigator must take in order to appeal an IRB decision.

Procedures:

Procedures for Appealing Revisions Required by the IRB
1. If an investigator disagrees with a revision requested by the IRB, the investigator (or chair, if the investigator is a doctoral student) may submit a written appeal to the IRB Chair. The investigator must include information supporting any arguments made in the appeal.
2. For research reviewed using the expedited review procedure, the appeal is reviewed by the expedited reviewer who requested the revisions. The expedited reviewer may either (a) make a decision on the appeal or (b) refer the appeal to the convened board. If the investigator disputes the decision of the expedited reviewer, the appeal is referred to the convened board for resolution.
3. For research reviewed by the convened IRB, the appeal is reviewed by the convened IRB. The investigator (and chair, if the investigator is a doctoral student) may be invited to a convened meeting to provide clarification or additional information to the IRB. The investigator may also request to be in attendance at a convened meeting to provide clarification or additional information to the IRB. However, the investigator may not be present for the vote on the appeal.
4. The expedited reviewer or convened IRB may accept the appeal, request different revisions, or deny the appeal. The investigator is notified of the decision via email.
  1. If the appeal is accepted, the investigator is not required to submit the requested revisions.
  2. If different revisions are requested, the investigator (or chair, if the investigator is a doctoral student) must submit those revisions.
  3. If the appeal is denied, the IRB decision is final, and the revisions must be made prior to approval.
Procedures for Appealing Determinations of Noncompliance, Serious Non-Compliance, Continuing Non-Compliance, Research Misconduct, or an Unanticipated Problem Involving Risks to Participants or Others.
1. If an investigator disagrees with an IRB determination, the investigator (or chair, if the investigator is a doctoral student) may submit the appeal and any information supporting the appeal to the IRB Chair within 15 days of being notified of the determination.
2. For IRB determinations made through administrative review (review conducted by the IRB Chair or designee), the appeal is reviewed by the individual who made the determination. The administrative reviewer makes a decision on the appeal. If the investigator disputes the decision of the administrative reviewer, the appeal is then referred to the convened board for resolution.
3. For IRB determinations made by the convened IRB, the appeal is reviewed by the convened IRB. The investigator (and chair, if the investigator is a doctoral student) may be invited to a convened meeting to provide clarification or additional information to the convened IRB. The investigator (and chair, if the investigator is a doctoral student) may also request to attend a convened meeting to provide clarification or additional information to the IRB. However, the investigator (nor the chair, if the investigator is a doctoral student)may not be present for the vote on the appeal.
4. The administrative reviewer or convened IRB may accept the appeal or deny the appeal. The investigator is notified of the decision via email.
  1. If the appeal is accepted, a new determination is made using the information provided by the investigator.
  2. If the appeal is denied, the IRB decision is final, and the original determination stands.
Procedures for Appealing the IRB Decision to Disapprove or Terminate a Study
1. If an investigator disagrees with the IRB decision to disapprove or terminate a study, the investigator (or chair, if the investigator is a doctoral student) may submit a written appeal of the decision to the IRB Chair within 15 days of being notified of the decision. The appeal should address the specific concerns of the IRB and the IRB basis for disapproval.
2. The appeal is reviewed by the convened IRB. The investigator (and chair, if the investigator is a doctoral student) may be invited to the convened meeting to provide clarification or additional information to the IRB. The investigator (and chair, if the investigator is a doctoral student) may also request to be in attendance at a convened meeting to provide clarification or additional information to the IRB. However, the investigator (nor chair, if the investigator is a doctoral student) may not be present for the vote on the appeal.
3. The convened IRB votes to accept or deny the appeal. The investigator (and chair, if the investigator is a doctoral student) is notified of the decision in writing via email.
  1. If the appeal to the decision to disapprove a study is accepted, the investigator is invited to submit a new IRB Review Form to the IRB for review and approval, according to the conditions set forth by the IRB in accepting the appeal.
  2. If the appeal to the decision to terminate a study is accepted, the investigator may resume research activities after any conditions set forth by the IRB are met. In some cases, the IRB may require the investigator to submit a new IRB Review Form for review and approval prior to resuming research activities.
  3. If the appeal is denied, the IRB decision is final, and the study may not be approved or resumed.

Scope: This policy applies to investigators who wish to appeal an IRB decision.

Documents and Forms:

None