Campus IRB Review Process

Campus Institutional Review Board 483 McReynolds University of Missouri Columbia, MO 65211 573 882-9585 phone 573 884-0663 fax umcresearchcirb@missouri.edu

The Department of Health and Human Services (DHHS) recognizes that not all research proposals pose greater than minimal risk and warrant review by a convened Full Board Committee. Accordingly, the DHHS regulations permit the Campus IRB to review lower-risked research proposals posing at levels other than by the full board. The Initial Review Process authorizes the Campus IRB to categorize the proposed activities at the "Exempt", "Expedited" and "Full board" levels in an effort to appropriately assess the risks in relation to the benefits of participation. The initial review process is a one-time determination of the proposal risk assessment at that time, however, subsequent review proposals may result in a different review category allocation depending on the proposed risks to subject participants and interpretative IRB guidelines.

What are the Levels of Review?

1. Exempt is the level of review for human subject research activities that pose little, if any, risk to human subjects. The IRB must make the determination of whether or not a project is Exempt, not the investigator. All research categorized as "Exempt" must meet the same ethical standards as any other application submitted to the IRB. Exempt research may not be required to meet the as extensive document submission requirements as expedited or full board proposals. Exempt projects may be reviewed and approved by the IRB administratively. Exempt applications require the investigator to describe the Informed Consent Process and Instruments to be distributed, but may not require submission of the actual document. The investigator is expected to respect research subjects by providing an Informed Consent process in conformity with the "Belmont Report."
    
   • Belmont Report
   • Campus IRB Review Process Policy (PDF, 224K)
2. Expedited is the level of review for human subject activities involving no more than minimal risk or minor changes in previously approved research. LINK: 45 CFR 46.110. The expedited review process can only be conducted by the Campus IRB Chair or other voting Campus IRB members previously designated by the Chair.
    
   • Campus IRB Review Process Policy (PDF, 224K)
3. Full Board review is required for human subject research activities that pose greater than minimal risk and must be reviewed by a convened board. All activities must be docketed on the agenda in accordance with Campus IRB policies and procedures. LINK: Please see our "Deadlines for Submitting Full Board Applications" link.
    
   • Campus IRB Review Process Policy (PDF, 224K)

Assessment of Scientific Merit

The investigator shall assure the proposed activities have scientific merit. All research proposals reviewed by the Campus Institutional Review Board (Campus IRB) shall undergo a rigorous review to assess the scientific quality, importance of the research to increase knowledge, and the appropriateness of the study methodology to answer a precisely articulated scientific question. The Campus IRB Scientific Members will provide the membership with their review of the scientific merit and feasibility of the proposal.

• Assessment of Scientific Merit (PDF, 64K)

Assessing the Level of Risk

All human research proposals will be reviewed to assess the level of risk in relation to the benefit afforded to the subject from participation in the proposed activities. The Campus IRB will make an assessment as to whether the research poses greater than minimal risk, and if the proposed methods adequately minimize the risk to subject participants. The level of risk is assessed on a case-by-case basis and shall accurately reflect the foreseeable risks as a result of participation.

• Assessing the Level of Risk (PDF, 112K)

Processes

The Campus IRB regularly reviews and approves applications and continuing review status reports of previously approved projects. All continuing reviews must be conducted at least once per year, and may be required as frequently needed as the degree of risk to the subject participants mandates.

The investigator should submit an application to the Campus IRB for initial review and approval of the proposed activities.

• Campus IRB Review Process Policy (PDF, 224K)
• Login to eIRB (Opens in a new window) [Campus IRB Application]

Amendment

Federal regulations require the Campus IRB to develop processes for ensuring prompt reporting to the IRB of changes in previously approved research activities. Investigators may not initiate modifications to human research activities without the prospective review and approval from the Campus IRB except where necessary to eliminate apparent immediate hazards to the human subjects. In such a case, the research team should contact the IRB immediately for directives.

• Amendment Processes Policy (PDF, 64K)
• Login to eIRB (Opens in a new window) [Amendment Application]

Continuing Review Policy

The Campus IRB assures that all human subject research conducted under its jurisdiction is afforded the opportunity for renewal in the form of a continuation review process. The required Continuing Review Status Report must be submitted 45 days prior to the project expiration date to avoid the risk of delays in the review process or expiration of IRB approval. Reports received after the required 45 date deadlines are not guaranteed to be reviewed prior to the expiration date. Investigators should comply with the 45 day submission deadline to avoid interruptions in the IRB approval term. Reports received after the expiration date will not be reviewed and IRB approval will automatically expire. If the investigator intends to continue to conduct research, they must contact the IRB immediately for directives regarding the "Application Submission Process" and what activities must cease.

When considering whether or not to renew a study, the CIRB will review the CRR report, all supportive documents, and the investigator's responses to determine that:

1. The risks to subjects continue to be minimized and reasonable in relation to the anticipated benefits;
2. The selection of subjects continues to be reasonable in relation to anticipated benefits;
3. Informed consent continues to be appropriately obtained and documented;
4. There are appropriate provisions for safety monitoring of the data, if necessary;
5. There are protections in place ensuring the privacy of the research subjects and confidentiality of the data.
6. Appropriate safeguards have been made for vulnerable populations.

• Continuing Review Process Policy (PDF, 80K)
• Login to eIRB (Opens in a new window) [Continuing Review Report]

Deviation

Unforeseen circumstances may arise that require a researcher to deviate from the IRB approved methodology, in the best interest of the safety of a human subject research participant. The researcher shall grant top priority to assuring the subject's safety and welfare and then immediately contact to the Campus IRB for compliance directives. The research team must complete

• Deviation Policy (PDF, 48K)
• Login to eIRB (Opens in a new window) [Deviation Report]

Unanticipated Problems or Adverse Events Causing Harm to Participants or Others

The Campus Institutional Review Board (Campus IRB) has established policies and procedures for ensuring prompt reporting to the IRB and appropriate institutional officials regarding unanticipated problems or adverse events causing harm to participants or others in accordance with State, Federal and local law.

The investigator shall ensure prompt reporting to the IRB, appropriate institutional officials, sponsor, coordinating center and the appropriate regulatory agency heads of unanticipated problems or adverse events causing harm to participants or others.

• Unanticipated Problems or Adverse Events Causing Harm to Participants or Others Policy (PDF, 112K)
• Login to eIRB (Opens in a new window) [Unanticipated Problems or Adverse Events Causing Harm to Participants or Others]

Non-Compliance

The Campus Institutional Review Board (Campus IRB) is required to provide a mechanism to immediately investigate reports of noncompliance to further protect study participants, and shall have the authority to take action to assure research activities are conducted in accordance with the regulations that govern human subject research.

The Campus IRB considers noncompliance as potentially one of the highest risks exposed to subjects. Reports or notice of noncompliance shall receive priority consideration and review by the Campus IRB with the goal of assuring human subjects are protected.

Investigators shall ensure all human subject research activities comply with Campus IRB policies.

• Compliance Breach Policy (PDF, 96K)
• Login to eIRB (Opens in a new window) [Compliance Breach]

Suspensions and Terminations

The convened IRB or IRB designee may order a suspension or termination of approved research when in the judgment of the convened IRB or IRB designee, it is in the best interest to protect the rights or welfare of participants.

Conflicts of Interest

Identification and management of a conflict of interest is an important step in the IRB. The Campus IRB requires the investigator to comply with institutional "disclosure methods" that may potentially affect human subjects to facilitate preserving the integrity of the IRB processes.

The investigator must disclose a conflict of interest in the following situations, but not limited to:

1. Disclosure to the government (if applicable)
1. Inform the appropriate regulatory authority
2. Disclosure to the Institution (Mandatory)
1. Mandatory for those receiving federal funds
2. Must contact the Conflict of Interest Committee in the Office of Research (573) 882-9500.
3. Disclosure to the Campus IRB (Mandatory)
1. This is a routine portion of the proposal submission process
2. Disclosure "after" Campus IRB approval requires notice to the Conflict of Interest Committee.
3. The Campus IRB may restrict IRB activities pending a disposition from the Conflicts of Interest Committee
4. The Campus IRB will coordinate its review efforts with that of the Conflicts of Interest Committee.
4. Disclosure to the Subject
1. Subjects should be aware of any conflicts so that they can make an informed decision of whether to participate in the research.
2. The Campus IRB engages in proactive education of key personnel and research teams
3. The Campus IRB promotes a culture of compliance that promotes self-identification and resolution before there are problems.
4. If a conflict of interest arises after a project has been approved, the researcher should contact the IRB for directives.

• Office of Research Conflict of Interest Disclosure Form (Word, 64K)
• Conflict of Interest Policy (PDF, 96K)