About the IRB

Doane University uses an Institutional Review Board (IRB) process to review research projects involving human participants conducted by faculty and students to ensure the protection of those participants.

According to federal regulations, the IRB must have a minimum of 5 voting members, including at least one member whose primary concerns are outside the area of science, and one member who is not affiliated with the college and has no immediate family member affiliated with the college. IRB members will be appointed by the Vice President of Academic Affairs to 3-year terms. Appointments to the IRB will be guided by the criteria provided by the Code of Federal Regulations, part 46. The criteria are designed to ensure appropriate levels of expertise, diversity, and familiarity with community attitudes among the IRB members. The IRB chair will be chosen by the board members for a 1 year term. Members of the IRB who have a research project under consideration will be required to recuse themselves from voting on the acceptability of that project.

Researchers conducting work involving human subjects that is not exempt from review will be subject to the following process:

• Submit a proposal: The primary investigator (i.e., lead researcher on a project) would submit a proposal form to the Chair of the IRB. This form, available in electronic form from the IBR chair, requires the investigator to describe the nature of the project and address specific ethical issues. In the event that the research project is federally supported, the required form will follow the specific guidelines of the “Common Rule,” 45 CFR 46. 

• Proposal is reviewed initially by the IRB Chair (or a member designated by the Chair), and when appropriate, by the full IRB

  1. If the Chair (or designate) determines that the proposed project presents no greater than “minimal risk” to the research participants (i.e., risk no greater than what they would expect to encounter in normal daily life), the proposal qualifies for expedited review and therefore need not be reviewed by the full IRB. The Chair (or designate) can still request that modifications to the project be made before approval is granted.

  2.  If the Chair (or designate) determines that the proposed project presents more than “minimal risk” to the participants, the proposal will be reviewed by the full IRB. The IRB may request that modifications to the project be made before approval is granted.

• The decision of the Chair (or designate) or the full IRB can take one of several forms:

  1. Reject the project.

  2. Approve the project, pending revisions.

  3. Approve the project, with no revisions necessary.

  4. Request more information from the investigator(s) prior to decision.

**Note: Approval of a project is effective for one year maximum. In cases of projects involving more than minimal risk, the IRB may request more frequent review, depending on the nature of the project. If a project is not completed within a year, a proposal for continuing review must be submitted by the primary investigator.

• Submission of termination notice (for federally supported projects)

Upon completion of data collection, the primary investigator will submit a termination notice to the IRB, indicating that the project has been concluded.