The Institutional Review Board is a committee at Notre Dame of Maryland University established to perform ethical review of research involving human subjects.
How to Apply
- Complete and sign the initial application for research.
- Submit one original application with signatures and one copy of the signed, original application to the Chair of the IRB, Mark Fenster.
- Submit an electronic copy of your application to email@example.com. (Both hard and electronic copies are required for consideration.)
Upon submission, your application will be assigned a unique IRB number. Please refer to this number on all correspondence with the Board.
The Office for Human Research Protections of the Department of Health and Human Services provides detailed information on the IRB process.
Please also review Notre Dame’s IRB policy and procedures (PDF).
Frequently Asked Questions
Why does Notre Dame have an Institutional Review Board?
Federal (and University) regulations require that the use of human subjects in research be reviewed and approved by the IRB.
Who needs to apply for research approval from 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.
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.
What kinds of IRB review are there?
There are three (3) levels or types of review:
The type of review your proposal will need depends on the level of risk to the human subjects in the research:
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.
Research involving no more than minimal risk to human subjects may be considered for expedited review.
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.
Does IRB approval ever need to be renewed?
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 60 days prior to the expiration date of your initial approval.
What if I want to modify my research project after it has been approved?
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.
How long does the IRB approval process take?
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.
Where can I find more information on the IRB process?
Recommended Reading & Resources
- UMCIRB Handbook
- Basic Protection for Human Subjects
- Belmont Report
- Compliance Oversight from OHRP (PDF)
- Declaration of Helsinki
- Differences in DHHS and FDA Regulations
- ECU Research Related Policies
- FDA Information Sheets
- Good Clinical Practice
- Guidance Expedited Review
- Human Subjects Decision Chart
- Informed Consent Checklist
- IRB Procedures
- National Bioethics Advisory Commission
- Nuremberg Code
- OPRR Compliance Activities: Common Findings
- OHRP Continuing Review
- OHRP IRB Guidebook
- OHRP Website
- UMCIRB Website
Categories for Review
- 21 CFR 50
- 21 CFR 56
- 21 CFR 312
- 21 CFR 314
- 21 CFR 812
- 21 CFR 814
- 21 CFR 10
- 21 CFR 54
- 21 CFR 310
- 21 CFR 320
- 45 CFR 46
Inclusion of Children
Inclusion of Women & Minorities
- IRB 101 from OHRP—Checked out from office
- OHRP Video Tape—Checked out from office
- Criteria for Waiver of Documentation of Informed Consent
- Criteria for Waiver of Some or All of the Elements of Informed Consent
- Informed Consent Document 8 Essential and 6 Additional Elements
What are the responsibilities of investigators and staff of the IRB?
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.