The Process for Institutional Review of Research Involving the Use of Human Studies

The completed application and supporting documents should be emailed to irb@xlqx.net. Only electronic submissions in either .doc or .pdf formats will be accepted. All attached files should be titled with the primary investigator's last name and the name of the file (for example: Wilson IRB Informed Consent). Following submission, the Chair will review your application for category designation and potential review by the committee.

All questions must be answered and requested materials included for the application to be considered by the IRB.  Incomplete applications, or those with little detail and specifics will delay review.  Questions must be answered on the form - do not answer with “see attached.”  Carefully read each question and be certain you have thoroughly provided what is requested.

The application must include the original signature of the principal investigator(s) and, for student research, the original signature of the faculty advisor.  Applications without signatures will be considered incomplete. Signatures indicate understanding of the policies and procedures of the Aquinas College research policies, and the principles of ethical treatment of human participants in research projects as set forth in the Belmont Report.

Application Categories

Exempt from Review: At Aquinas College, the determination of exempt does not need to be provided by the IRB.  Faculty, staff, or faculty advisors to student research can make this determination.  An IRB member should be consulted if you are unsure whether or not your research is exempt from IRB review.

Activities that are exempt include research involving evaluation of normal education practices (such as regular faculty evaluations); research utilizing existing data that is publicly available or cannot be linked to individual subjects (such as census data); or activities undertaken for educational purposes that will not be presented or published. 

Expedited Review:  Applications for research with human subjects who are not in a vulnerable group and with minimal potential risk for participants, receive an expedited review by the IRB on an ongoing basis.  During Fall and Spring semesters, most applications will be reviewed within two weeks of submission.  In the summer and during academic breaks this process will take a longer period of time.

Full Review:  Applications for research with a vulnerable group (under 19, those with mental impairment, etc.) and/or research with potential risk for participants, require full review.  Full review occurs one time per month at the meeting of the IRB. Applications requiring full review are due to the Provost’s Office by 5 p.m. on the first Monday of each month. 

IRB Decisions

For the IRB to render a decision regarding an application, four of the five Board members must be in attendance at the meeting. Approval of an application requires a unanimous decision of the IRB.  An absent IRB member may submit written comments to be considered by those present, but will not have a vote on the application.

However, in the case of applications for protocols that include subjects under the age of 18 or those who may be considered compromised vulnerable subjects, unanimous approval must include all five IRB members Following review of the application, the IRB will arrive at one of the following decisions:

• Approved without Modification: No changes are needed; the application is approved as of the date of the decision.
• Application Pending:   The application is incomplete, needs simple concurrence by the investigator, or minor changes before it can be considered by the IRB.
• Approved with Modifications: The protocol requires modifications.  It is approved as of the date of the decision, however, modifications need to be provided to and approved by the IRB Chair before data collection begins.
• Denied:  The research design or methods do not ensure human subject protection.

The Chair of the IRB will notify the Principal Investigator and the Provost's Office of the IRB decision regarding each application. A letter will be mailed to the investigator(s) at the address provided in the application.  In the case of student research, a copy of this letter will be sent to the faculty advisor.

In the event that modification is required, additional information is required, or the application is denied, the Chair will notify the Principal Investigator in writing of the changes needed, information requested, or reason for denial.

Pursuant to federal regulations, all IRB applications, correspondence, and minutes of all meetings are kept in the Provost's Office and retained for at least three years, and records pertaining to research will be retained for three years following completion of the research.

Approval of a research project is for the duration of 12 months from the date of IRB approval. IRB approval must be renewed at the end of the 12 month period for the research to remain in compliance with the College policy. Renewal is submitted using the Application for Institutional Review of Research Involving Human Subjects.

Researchers Not Affiliated With Aquinas College

This classification includes 1) principal investigators who are not current Aquinas College administrators, faculty, staff, or students and 2) principal investigators who are not identified as principal investigators or other investigators on research projects with current Aquinas College administrators, faculty, staff, or students.

If a researcher is not affiliated with Aquinas College, but wants to use College resources for research purposes or collect data from Aquinas College students, faculty, staff, or administrators, the following information must be submitted before the IRB will conduct a review of a research proposal (IRB approval is required before data collection begins):

A written statement from the College President or the College President’s designee granting the researcher permission to contact members of the campus community (human subjects) for his/her/their proposed human subjects research.

• A letter to the IRB that details:
  • the researcher's institutional affiliation and position,
  • the researcher’s education and training,
  • the purpose of the proposed project, and
  • the reasons for collecting data at Aquinas College.
• A copy of the approved application for Institutional Review of Research Involving Human Subjects from the researcher's home institution.
• A completed research application for review by the Aquinas College IRB