Institutional Review Board

Federal (and University) regulations require that the use of human subjects in research be reviewed and approved by the IRB.

Employees, students and faculty (agents) at Notre Dame must apply for IRB approval when they conduct research that involves human subjects. This includes research that is part of course work.

Any researcher who is not sure whether IRB review and approval are needed should contact the Chair of the IRB to consult.

Applicability

The approval process is applicable to all research involving human subjects, and all other activities which even in part involve such research if one or more of the following apply:

• The research is sponsored by this institution;
• The research is conducted by or under the direction of any employee or agent of this institution in connection with his or her institutional responsibilities;
• The research is conducted by or under the direction of any employee or agent of this institution using any property or facility of this institution; or
• The research involves the use of this institution’s non-public information to identify or contact human research subjects or prospective subjects.

Affiliated Researchers (e.g., associate faculty members, who thus hold partial University appointment) are not required to submit the research to the NDMU IRB simply because they have a partial University appointment.

Independent researchers or researchers employed by another institution who have a partial University appointment (“Affiliated Researchers”) submit their proposed research to the NDMU IRB for review only when NDMU is “engaged” in the research, as described under Applicability above.

Learn More about Engagement of Institutions

There are three (3) levels or types of review:

• Full
• Expedited
• Exempt

The type of review your proposal will need depends on the level of risk to the human subjects in the research:

Exempt

Research with very minimal risk to human subjects (as determined by regulatory guidelines-see our Policy and Procedures guidelines and the Office for Human Research Protections website for more information on risk determination) may be exempted.

Expedited

Research involving no more than minimal risk to human subjects may be considered for expedited review.

Full

Research with greater than minimal risk to human subjects requires full review.

The main difference between these levels of review is that in the case of the “exempt” and “expedited” categories, there is no need for a majority vote from the full IRB committee. Thus, an expedited or exempt review can be conducted by an individual reviewer (or a few reviewers), rather than going to the full board. This may, but does not necessarily, mean that the review decision will take less time.

It is important to note that the decision whether a proposal will receive “exempt”, “expedited”, or “full” review is determined by the IRB, NOT the applicant.

This means that:

• Even if you believe that your research is eligible for exemption, you still have to submit a proposal, i.e., ALL research involving human subjects must go through IRB review;
• As an applicant you cannot request an “expedited” review. It is the decision of the IRB to establish whether your proposal is eligible for expedited review.

IRB approval for a research project is generally valid for 12 months. In order to continue your research project beyond this time period, you will need to request renewal of approval.

The submission date for renewal is 30 days prior to the expiration date of your initial approval.

Use this form to renew or close an approved study: www.bit.ly/CRorClosure

Once the project is submitted to the IRB for approval, you may not make changes to the research project until the IRB has completed the approval process for your original submission. Once your research is approved, you may submit modifications, but any modifications must be approved by the IRB prior to implementation.

Use this form to submit modifications: https://www.surveymonkey.com/r/5PF8TYZ

The IRB meets every third week of the month during the academic year (September-June). The deadline for application submission is the 1st Thursday of the month.

Under normal circumstances, the IRB reviews all completed proposals received by the deadline for that month and will notify applicants of decisions by the end of the month, or soon thereafter.

Recommended Reading & Resources

• Basic Protection for Human Subjects
• Belmont Report
• Compliance Oversight from OHRP (PDF)
• Good Clinical Practice
• Guidance Expedited Review
• Human Subjects Decision Chart
• Informed Consent Checklist
• IRB Procedures
• National Bioethics Advisory Commission
• OHRP Continuing Review
• OHRP IRB Guidebook
• OHRP Website

Categories for Review

• 21 CFR 312
• 21 CFR 314
• 21 CFR 812
• 21 CFR 814
• 21 CFR 54

Inclusion of Children

• NIH Policy on Inclusion of Children

Inclusion of Women & Minorities

• NIH Policy on Inclusion of Women and Minorities

Principal investigators and research staff have specific responsibilities. They are required to:

• Protect the rights and welfare of human subjects who participate in research.
• Understand the ethical standards and regulatory requirements governing research activities with human subjects.
• Personally conduct or supervise the research.
• Ensure that all staff, collaborators, and colleagues assisting in the conduct of the study are informed about the study, the regulations governing research, and the institutional policies.
• Ensure that all research activities have IRB approval and other approvals required by the institution before human subjects are involved.
• Implement the research activity as it was approved by the IRB.
• Obtain the informed consent of subjects before the subject is involved in the research and document consent as approved by the IRB.
• Maintain written records of IRB reviews and decisions and obtain and keep documented evidence of informed consent of the subjects or their legally authorized representatives.
• Obtain IRB approval for any proposed change to the research protocol prior to its implementation.
• Comply with the IRB requirements for timely reporting of unanticipated problems involving risks to subjects or others including adverse events, safety reports received from the sponsor, or data safety and monitoring summary reports.
• Obtain continuation approval from the IRB on the schedule prescribed by the IRB.
• Make provisions for the secured retention of complete research records and all research materials.
• Ensure the confidentiality and security of all information obtained from and about human subjects.
• Verify that IRB approval has been obtained from all participating institutions in collaborative activities with other institutions.