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Institutional Review Board

The Institutional Review Board is a committee at Notre Dame of Maryland University established to perform ethical review of research involving human subjects.


 

Frequently Asked Questions

 

Why does Notre Dame have an Institutional Review Board? Back to Top

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? Back to Top

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, or
  • 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, or
  • 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 (see http://www.hhs.gov/ohrp/policy/engage08.html)

 

What kinds of IRB review are there? Back to Top

There are three (3) levels or types of review: full, expedited, and 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.
 

Does IRB approval ever need to be renewed? Back to Top

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? Back to Top

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 do I apply? Back to Top

The required initial application for research must be completed and signed. Please submit one original application with signatures and one copy of the signed, original application to the Chair of the IRB, Kwadwo Amankwa. Also submit an electronic copy to irbndm@ndm.edu. Both hard and electronic copies are required for an application to be considered. Upon submission, your application will be assigned a unique IRB number. Please refer to this number on all correspondence with the Board.

 

How long does the IRB approval process take? Back to Top

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? Back to Top

The Office for Human Research Protections of the Department of Health and Human Services has detailed information on their website. This document covers the responsibilities of investigators and staff. More information about helpful sites on various topics related to the Institutional Review Board. Also be sure to review Notre Dame’s policy and procedures.