Institutional Review Board
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 Saint 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, among other things:
- Risks have been minimized and are reasonable in relation to anticipated benefits;
- Informed consent will be obtained from subjects and appropriately documented; and
- The privacy of information obtained from 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 (2018, Title 45, Subtitle A, Subchapter A, Part 46) defines research as: " a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge". Therefore, data collection that is not designed to develop or contribute to generalizable knowledge would not be defined as research. Examples include data collection only for assessment, program evaluation, quality assurance, quality improvement, fiscal or program audits, or similar uses.
In addition, for the purposes of this part of the Federal Register, certain specific activities “are deemed not to be research:
(1) Scholarly and journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal research, and historical scholarship), including the collection and use of information, that focus directly on the specific individuals about whom the information is collected.
(2) Public health surveillance activities, including the collection and testing of information or biospecimens, conducted, supported, requested, ordered, required, or authorized by a public health authority. Such activities are limited to those necessary to allow a public health authority to identify, monitor, assess, or investigate potential public health signals, onsets of disease outbreaks, or conditions of public health importance (including trends, signals, risk factors, patterns in diseases, or increases in injuries from using consumer products). Such activities include those associated with providing timely situational awareness and priority setting during the course of an event or crisis that threatens public health (including natural or man-made disasters).
(3) Collection and analysis of information, biospecimens, or records by or for a criminal justice agency for activities authorized by law or court order solely for criminal justice or criminal investigative purposes.
(4) Authorized operational activities (as determined by each agency) in support of intelligence, homeland security, defense, or other national security missions.”
Do I Need IRB Approval for My Research?
If you believe that your study would be defined as research, based on the definition above, and you are obtaining data from human subjects, you must submit an IRB application. To determine the type of application you will need to submit, please go to the IRB Application Page.
Some categories of research are exempt from formal IRB review, but researchers must fill out an Exempt Form (Form 2) and submit it so that the exemption can be verified and documented. The research project cannot begin until the researcher obtains an official exemption from the IRB.
Research that is not exempt must undergo formal IRB review, and researchers must fill out and submit Form 1 for Expedited or Full Reviews. The research project cannot begin until the researcher obtains an official approval from the IRB.
If your research uses animals rather than human subjects, please review Animal Use and Care Committee Policies.
Ethical Conduct of Research
For all projects involving human subjects conducted either on or by members of the CSB and SJU communities, there are expectations related to ethical conduct of research, even if an IRB application is not needed:
- 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.
- Ethical Practice. The researcher 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.
- 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.
- Any research that methodologically requires deception must include a statement of debriefing at the conclusion of the research. The debriefing must include the reason for the 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.
- 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.
- 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.