CAMPUS ALERT: Due to the weather, all evening classes at CSB and SJU are canceled. The LINK bus will run on its regular schedule until 5 p.m. and then every hour on the hour for the remainder of the evening, weather permitting. Pre-scheduled campus and community events and college/university sponsored events scheduled at off campus locations may continue at the discretion of the divisional VP.

Institutional Review Board

Mission

The mission of the College of Saint Benedict (CSB) and Saint John's University (SJU) Institutional Review Board (IRB) is to protect the dignity and rights of participants in research conducted either on or by members of the CSB and SJU communities.

Why Does the IRB Exist?

The College of Saint Benedict and St. John's University requires that all research activities involving human subjects comply with the Federal Policy for the Protection of Human Subjects (45 CFR 46).  The IRB exists to ensure that:

  • Risks have been minimized and reasonable in relation to anticipated benefits;
  • Informed consent will be obtained from subjects and appropriately documented; and
  • The privacy and safety of subjects will be maintained.

The responsibility for identifying specific risks to human participants rests with the researcher.  If you are a CSB/SJU faculty member, administrator, staff member, or student, you must submit an application to the IRB and receive written approval before you can begin recruiting subjects.

What is Research?

The Federal Register (Volume 56, Number 117, Tuesday, June 18, 1991) defines research as "a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge" (p. 28013). In most cases, federally funded research requires IRB approval.  For more information on federal guidelines see the Human Subjects Regulations Decision Chart.

Does My Study Qualify as Research?

If you believe based on the definition above that your study qualifies as research, you must submit an IRB application.  To determine the type of application you will need to submit, please go to the IRB Application Page.

There may be activities that occur at the institutions that are labeled research but they fall outside of the strict definition of research from the Federal Register.  These activities may not require a submission of an IRB application.  Examples of these activities are:

  • Research that Occurs within the Context of a Class - Classroom activities that are solely instructional do not need to be reviewed as long as the work fits ALL of the following:
    Is a normal part of the student's course work, the only participants are students in the class;
    Is supervised by a faculty member;
    Has as its primary purpose the development of the student's research skills;
    Does not deal with issues of a sensitive nature;
    Is not research that is expected to result in publication or some other form of public dissemination.  Note, scholarship and creativity day is considered public dissemination.
  • Oral History
  • Journalism
  • Research not using human subjects (if animal research is being conducted please review Animal Use and Care Committee Policies
  • Program evaluation

When must I submit an application and why?

The College of St. Benedict and St. John's University requires that all research activities involving human subjects comply with the Federal Policy for the Protection of Human Subjects (45 CFR 46). According to this policy, research activities that intervene in people's lives, observe human behavior, or use data obtained directly or indirectly from living individuals must be reviewed and approved by an Institutional Review Board to ensure that:

  • Risks have been minimized and reasonable in relation to anticipated benefits;
  • Informed consent will be obtained from subjects and appropriately documented; and
  • The privacy and safety of subjects will be maintained.

Please note: The vast majority of research will not fit the exempt category and must be reviewed.  If you are unsure if your project qualifies as research please contact Bob Kachelski, the IRB chair.  If an IRB application is not needed there are still expectations related to ethical conduct of research.

Ethical Conduct of Research

Adhering to the principles of ethical conduct of research is required of all projects involving human subjects:

  1. Evaluation of Ethical Acceptability of Research.  The researcher is responsible for determining the ethical acceptability of the research and must incorporate any safeguards necessary to protect human subjects.
  2. Ethical Practice.  The research establishes and maintains responsibility for ethical conduct of research including protections for human subjects and others involved in the project.  This includes reporting any adverse events immediately to the IRB, informing the IRB of any changes in the study protocol prior to implementation, and maintaining documents (informed consent) for a period of three (3) years after completion of the research.
  3. Freedom from Coercion.  Participants must be free to decide whether or not to participate in the research without this impacting the relationship of the participant with others involved directly or indirectly (including the College/University) with the research.  Participants also have the right to end their research participation at any time.
  4. Debriefing.  Any research that methodologically requires deception must include a statement of debriefing at the conclusion of the research.  The debriefing must include the rationale for the need for deception, full clarification of the study purpose, and removal of any misconceptions.  The researcher is responsible for taking measures to assure that no damaging consequences occur as a result of deception and that appropriate support is provided to research participants.
  5. Freedom from Harm.  The researcher is responsible for protecting participants from harm that may result from the research protocol whenever possible.  This includes any related physical and emotional discomforts and harm that may occur prior to, during, or after the research.  A research procedure that is likely to result in serious or long-term harm will not be approved.  The researcher is responsible for identifying undesired consequences of the research and notifying appropriate authorities, including the IRB chair.  The researcher is responsible for providing recommendations for appropriate aftercare.
  6. Confidentiality.  All research subjects have the right to complete confidentiality of the data and information given to the researchers.  The simplest way to guarantee confidentiality is to collect data without any identifying information.  However, it is sometimes necessary to collect identifying information, such as when data is collected at different times in the study and needs to be matched.  This is best accomplished by using confidential numerical codes, strictly limiting access to the list that matches numerical codes with the subjects' names, and storing this list in a secure location.  Once data has been collected, all such lists and numerical codes can be deleted or shredded.  The privacy and confidentiality of research data provided by the participants must be respected and the procedures for doing so described in the IRB application.