Frequently Asked QuestionsInstitutional Review Board
Frequently Asked Questions
Whom should I contact if I have questions about the IRB?
Who is on the IRB?
The IRB is made up of volunteer full-time faculty members of Saint Mary’s University and one community member with no formal relationship to Saint Mary’s. Membership is based on federal requirements for IRB membership to ensure diversity and representation.
How often does the IRB meet?
The IRB holds monthly meetings, which video conference between the Twin Cities and Winona campuses. A full list of dates for upcoming meetings can be found on the IRB website.
How do I know if I need IRB approval for my research project?
All faculty, staff, and students at the University who intend to recruit human subjects in subsequent research that falls under HHS regulations must be reviewed and approved by the IRB prior to the start of the research. Please use the Determining Human Subjects Research worksheet for more information.
I am an Instructor and am requiring students to collect information from human participants as part of a class research project for a course requirement. Do I need IRB review?
A Course-Based Research Project refers to any course requirement that involves the collection of information from or about human subjects. This includes collecting private archival data about living persons.
Course-Based Research Projects must be approved by the IRB but may be eligible for classroom exemption. Please see the Notification of a Course-Based Research Project for more information on whether or not an assignment meets the exemption criteria.
If a classroom projects does not meet the criteria for classroom exemption, each student must submit individually to the IRB. Please see the IRB Standard Operating Procedures for more information on Course-Based Research Projects.
Do I need IRB approval for my research prior to submitting a proposal for external funding?
Most funding agencies understand that applications are submitted pending IRB review. Once a researcher has reasonable assurance that their project will receive funding, they must obtain IRB approval before starting their project, as they normally will not actually receiving the funding without the approval on record. However, researchers should check with the individual funding agency to see what their requirements are for IRB review.
What do I need to do before I submit to the IRB?
Everyone submitting an application to the IRB must include a certificate verifying the completion of required training on ethical issues and procedures for research with human participants via The Collaborative Institutional Training Initiative (CITI). There is no cost to Saint Mary’s students, faculty, or staff for taking CITI modules.
Researchers should review their study and the IRB Standard Operating Procedures to determine the anticipated level of review, which may affect which documents need to be included in the application. The required completed documents should then be collected and submitted with the application.
At any time, you may contact the IRB at firstname.lastname@example.org for any questions about the application process and requirements.
If a student, work with your faculty advisor or supervisor to complete the application.
How do I submit an application to the IRB?
Application documents can be accessed through the IRB website. Researchers should download all the necessary documents directly from the website.
All applications are submitted electronically, either in PDF or Microsoft Word format, to email@example.com. Applications then go through a pre-review to ensure the application includes all the required materials and that no clarifications are needed. Once the pre-review is complete, the application is officially forwarded to the IRB.
Please note: applications submitted via Google Drive will not be accepted.
When do I need to obtain IRB approval?
IRB approval must be obtained BEFORE any data collection can begin. If any data collection occurs before IRB approval is obtained, the researcher risks noncompliance, losing access to any data collected prior to approval.
What is exempt research?
Exempt research is research that is “exempt” from the requirements of the Common Rule. To be considered exempt, the study must meet the criteria for exemption. Exempt research is considered low-risk and non-identifying, such as an online or paper anonymous survey.
The IRB must review and confirm that a study meets the exemption criteria before research can begin.
See the Exemption Criteria Worksheet for more details.
What is full-board review?
Full board review is research that is considered to have more than minimal risk. A full IRB review is required for studies that do not meet the requirements for exempt and expedited review, including:
- Studies involving vulnerable populations
- Studies taking place internationally
- Studies where information may be disclosed that could require mandatory legal reporting (e.g., child/elder abuse, drugs, etc.)
- Studies involving deception which raises the risk level for subjects
- Studies that fall under the jurisdiction of the Food and Drug Association
How long will it take to receive feedback from the IRB?
The IRB aims to review protocols in an efficient and timely manner; however, several factors may delay or inhibit the review process, including submission quality, the number of applications submitted at any point in time, or IRB member workload. For exempt and expedited research, the review process will take an average of 2-3 weeks until feedback is sent to the researcher. Projects requiring full review will not be reviewed until the next convened meeting and should take that into consideration.
What do I need to do if I am conducting research at another organization?
Researchers must obtain letters from those organizations allowing them permission to conduct research at that location. Normally, these letters (Research Cooperation Agreements, or RCAs) must be signed by the authorized individual and submitted as part of the IRB application. However, some institutions require IRB approval before granting permission. If this is the case, the researcher must submit the version of the RCA which will be signed by the authorized individual and note that the individual has agreed to sign upon approval. The IRB will then grant “conditional” approval when it meets the approval criteria, contingent upon the RCA being signed, and the project’s approval will be finalized once the signed RCA is submitted. Researchers cannot begin data collection until approval is finalized.
What if my research includes observation in a public-access facility such as a coffee shop?
Research being conducted in public facilities or sites (such as a coffee shop or park) does not require a letter or RCA to grant permission for the research to be conducted.
What does "conditional" approval mean?
Conditional approval means that the project meets the criteria for approval, but certain conditions must still be met in order to obtain finalized approval. This generally applies to projects where the authorized individual of a cooperating institution will not sign an RCA until approval is granted. In this instance, conditional approval is applied until the RCA is signed and submitted to the IRB. Once the IRB accepts the submitted document, approval is finalized. Only after final approval has been granted may a researcher begin the research.
If I want to do research at a school, what is the procedure for consent?
You must obtain the consent/permission from the following individuals:
- The Administrator of the school district where the research is to be performed (RCA).
- The Principal of the school where the research is to be performed (RCA).
- The Teacher(s) (Informed Consent)
- The Parent(s)/legally authorized representative(s) (Parent Permission))
- The child (Assent) written in language understandable to the child
What if I just want to observe children in a classroom setting?
If your research involves the observation of children in a normal educational setting, and you are participating in the activities being observed, you must obtain Permission from the parent(s) or guardian(s) of the child and Assent from the child. If a child does not obtain parental permission to participate, that child may not be included in the research even if the child assented.
Research that is occurring in a normal education setting that involves only normal education practices falls under one of the categories for exemption. In this instance, researchers may send notification letters to the parent(s)/guardian(s) which notify the parent(s)/guardian(s) that a normal classroom assignment or activity will be used as data for research. Parent(s)/guardian(s) can then choose to opt their child out of the data collection, so that the child still participates in the normal classroom activity, but their results will not be used as data.
If I am doing a study using census data or other data sets that have been archived and are publicly available, do I need to submit a proposal for review?
Yes. This kind of research is generally considered exempt; however, there are still regulations concerning archived data.
What if I want to have a focus group for my research?
Using focus groups increases the risk for a breach of confidentiality. If you are using a focus group, each person in the group must sign an informed consent form which clearly states that confidentiality may not be guaranteed once the group disbands.
How long must I store my research data?
Research and data collection materials must be stored for seven (5) years past the completion of the study (according to APA/HIPAA standards). Documents must be stored in a locked and secure location, stripped of any identifiable private information or participant identifiers, then destroyed upon reaching seven years. Signed consent forms should be stored separately.
If I use audio, video, or digital recordings in my research, how long must I maintain the originals?
The original recordings should be destroyed as soon as they are transcribed. If your research requires a longer retention of the recordings, you must state where they will be stored, who will have access to them while stored, and when they will be destroyed in your application.
How long does my IRB approval last?
For research requiring full review, IRB approval is good for twelve months past the date original approval was granted. If you are still conducting research-related interventions or interactions with participants, or if data collection and analysis of identifiable private information is still on-going at the point of expiration, you must submit an application for Continuing Review. If your Continuing Review application is not received, reviewed, and approved prior to the date of expiration, you will receive a notice of study termination.
What do I need to do if I need to modify my data collection methods after I received approval?
Changes made to research design, procedures and methods, research personnel or documentation (including consent forms) in an already approved study are called Amendments. Amendments to an application must be submitted to and approved by the IRB before they can be implemented in the study. The Application for Amendments can be accessed via the IRB website.
What if I have an adverse event or unanticipated problem during my data collection?
Adverse events must be reported immediately, or no later than 48 hours after the event, to the IRB. Failure to do so may result in noncompliance.
What is the difference between anonymity, confidentiality, and privacy in terms of the research participants?
Anonymity of the participant means that the subject’s identity is never collected, nor can the subject’s identity be linked to the research project.
Confidentiality means that the data collected from the participant can only be identified by the researcher or research team. However, researchers must take every precaution to prevent anyone outside the research project from connecting participants with their information.
Privacy refers to controlling the extent, timing, and circumstances surrounding the research subject’s participation. Researchers should consider strategies for protecting the privacy interests of the individual based on the individual’s needs.