Faculty and Staff

Below are some helpful IRB resources for SEU Faculty and Staff.

If you have any questions or concerns that are not addressed below, please feel free to contact IRB@stedwards.edu.

Submitting Your Own Research

  • Guidance for Researchers (.pdf) - Use this tool to approximate the type of review that your proposal will be assigned (e.g., Exempt; Expedited; Full Board)
  • Request an Exemption (.docx) - If your proposal is eligible for an exemption, please make a formal request to the IRB before beginning data collection.
  • IRB Application Guide (.docx) - Use this document to prepare your answers before starting your non-exempt submission to the SEU IRB Portal.
  • Request for Revision and/or Continuation (.docx) - An already-approved study that requires revision and/or continuation approval will require this form.
  • Request for Revision of Personnel (.docx) - If you only intend to change the personnel associated with your study, then you may use this request form.
  • Unanticipated Problem Form (.pdf) - If you discover an unanticipated problem while carrying out your study that has raised the risk to your participants beyond those that were described in your IRB application, then you must submit an Unanticipated Problem Form to the IRB within 5 business days of this discovery. Examples of risks may include bodily harm, data breach, problems with personnel, or other unanticipated issues that affect the safety and/or well-being of your participants as a direct result of their participation in your study.

How to respond to the IRB's request for revisions

  1. Please use a "track changes" function or otherwise highlight any edits made to your documents.
  2. If you originally submitted your proposal via the SEU IRB Portal, then please upload any revised documents to the same place, adding "_revised" to the end of each updated file name.
  3. Please make use of the "Portal" comments section when responding to the IRB's notes. This helps us to maintain records in a centralized location.
  4. Please notify the IRB Administrative Assistant at IRB@stedwards.edu once you have completed your revisions.

NOTE: It is difficult for the Board to identify changes to documents without your help. Please highlight - or track - your changes to avoid delays in your review. A revised proposal that lacks highlighted - or "tracked" - changes may not be accepted by the IRB, requiring you to make these additions before re-submitting.

Faculty Supervising Student Research

  • All student-led proposals must be sponsored by a faculty member. You may wish to help your student determine the level of risk associated with their project by reviewing the Guidance for Researchers document. If you are unsure of how the student's study will be classified, feel free to ask a member of the IRB. Non-exempt proposals should be uploaded to the SEU IRB Portal and exempt proposals can be submitted by email to IRB@stedwards.edu. Please encourage your student to complete the IRB Application Guide before they begin their SEU IRB Portal application. If the project involves vulnerable populations, deception, or other risks to participants, you can encourage the student to discuss their project with the IRB Administrator before their application is submitted.
  • In general, as the risk to participants rises, so too will the responsibilities of the Principal Investigator. For instance, a debriefing form will likely be required if intentional deception is involved in the study. It is best for the student to anticipate these potential requests from the IRB in an effort to avoid delays during the ethics review process.
  • You will need to share a copy of your up-to-date CITI certificate with your student. This document will be a required part of the student's application.
  • If the student will be the Principal Investigator, it is important that they are permitted to carry out the "heavy lifting" for their IRB submission. This is simply a suggestion. This is a low-risk opportunity for students to become acquainted with the ethics review process.

Classroom Projects

SoTL (Scholarship of Teaching and Learning) Guidance

  • The IRB frequently recommends that SoTL (Scholarship of Teaching and Learning) investigators arrange for another person (a non-Co-Investigator) to distribute and collect all measurement tools while the instructor steps out of the classroom. This policy is intended to help the University to avoid the potentially coercive situation of an instructor directly asking students to participate in their study. With the teacher outside of the classroom, this gives students more freedom to freely give their consent to participate in a SoTL study.
  • Sample Informed Student Consent Form (.docx) - A standard Consent Form may be required when student participants need to be made aware of risks (e.g., mild discomfort; a request for personally identifying information in pre-post tests).
  • In most cases, SoTL research will not exceed "minimal risk" to student participants. For these cases, the investigator will simply submit an exemption request (along with all relevant documents) to IRB@stedwards.edu.
  • Note that an exemption may not be possible if any of the following criteria are true about the study:
  1. The potential risk to participants is expected to exceed that of "minimal risk" [as defined by the DHHS 45 CFR 46 46.102(i)]
  2. If vulnerable populations (such as minors) are involved, or
  3. If there is a possibility that the research results will be disseminated outside of the University.

If any of the scenarios above describe your project, please upload your proposal via the SEU IRB Portal (instead of applying for an exemption). If you have other questions, feel free to contact your school's IRB representative or the IRB Administrator at IRB@stedwards.edu.

Students

Below are some helpful IRB resources for SEU Students.

If you have any questions or concerns that are not addressed below, please feel free to contact IRB@stedwards.edu.

First-time Researchers

Welcome to the St. Edward's University research community!

The process of ethics review is a staple of human-subjects research across the areas of academia, the Government, and the private sector. In many countries, including the United States, human-subjects investigators must obtain approval from an ethics board before they carry out a scientific study. This process is fundamental to a researcher's work, and, as such, it is expected that a successful human-subjects researcher will interact with ethics review boards continually throughout their career. As a student researcher, you have the benefit of familiarizing yourself with this important process ahead of the pack. Just remember, the mission of the IRB (Institutional Review Board) is to protect the dignity, the well-being, and the safety of all human participants. The more you consider this when designing your study, the fewer revision requests you will receive from the ethics board. Remember also that your St. Edward's University research community is here to help you, so seek advice when you have questions.

Who can I ask for help?

You should ask questions of those who are familiar with human-subjects research. Here are three individuals who can help you:

  1. Your faculty advisor
  2. The IRB Administrative Assistant (IRB@stedwards.edu or 512-637-5676)
  3. Your school's IRB representative

Remember to reach out when you have questions!

Overview of the Process

In general, the following events will occur with each non-exempt submission:

  1. The researcher determines whether or not their activity qualifies for exemption.
  2. The researcher completes their Collaborative Institutional Training Initiative (CITI) ethics training (~4.5 to 6 hours the first time).
    • All researchers MUST complete their CITI training before engaging in human subjects research at St. Edward's University.
    • You will also need to request a copy of the up-to-date CITI certification that belongs to your faculty advisor.
  3. The researcher references the IRB Application Guide when organizing all required information.
    • Unfortunately, you cannot "save as you go" on the SEU IRB Portal website. To get around this fact, simply use the IRB Application Guide to help prepare your submission ahead of time. It mirrors the questions that appear on the web submission form, so you will be well prepared to enter your submission in one sitting when the time comes to really submit.
    • NOTE: The SEU IRB Portal may automatically "boot" users off of the application webpage after about an hour for security purposes. This could be problematic if you were composing your answers within the website itself. If it takes you longer than an hour, there's a chance that you may lose a record of your work! Save yourself a potential headache by preparing your answers ahead of time with the IRB Application Guide.
  4. The researcher submits their proposal via the SEU IRB Portal by referencing their answers from the IRB Application Guide.
  5. The IRB reviews the proposal (with an eye for participant protections) and offers feedback.
    • We typically offer revision requests using the SEU IRB Portal "comments" section of your submission. For Exemption requests, we will reply via email instead.
    • Expedited Proposals take roughly a 20 days before IRB revision notes are posted (expect delays around holidays).
    • Full Board proposals may sometimes take three-to-four weeks before IRB feedback is posted. Since Full Board studies pose a greater risk to participants, they are reviewed by all voting members (instead of by a couple of reviewers, as is the case with Expedited reviews). For Full Board proposals, you must submit via the SEU IRB Portal AT LEAST fourteen (14) days in advance of a regularly scheduled meeting (see Full Board Meeting Dates on the IRB Home Page)
  6. The researcher uploads their revised documents and replies in the comments section of their original submission on the SEU IRB Portal
  7. The IRB may approve the project OR request further revisions as needed.
  8. The researcher is given an approval letter, which typically expires after one year.
  9. When data collection has come to an end, the researcher immediately submits a Study Closure Form.
  10. The researcher retains their data for a minimum of 3 years after completion.

At St. Edward's University, we like to maintain a culture of honesty and openness regarding research ethics concerns. If you discover any unanticipated problems during your study -- specifically, problems that may have raised the risk to your participants -- then you are required to submit an Unanticipated Problem Form to the IRB within 5 business days of the event. You can send this document to IRB@stedwards.edu. You may also wish to discuss the issue with your school's IRB Representative or the IRB Chair. If you are a participant or student who has experienced an unpleasant event associated with the St. Edward's research community, please contact the Chair of the IRB directly to report your concerns.

Guidelines, Forms, and Templates

Guidance for Researchers (.pdf) - Use this tool to approximate the type of review that your proposal will be assigned (e.g., Exempt; Expedited; Full Board)
Request an Exemption (.docx) - If your proposal is eligible for an exemption, please make a formal request to the IRB before beginning data collection.
IRB Application Guide (.docx) - Use this document to prepare your answers before starting your non-exempt submission to the SEU IRB Portal.

How to respond to the IRB's request for revisions 

  1. Please use a "track changes" function or otherwise highlight any edits made to your documents.
  2. If you submitted your proposal via the SEU IRB Portal, please upload all revised documents via your unique submission URL, adding "_revised" to the end of each revised file's name. In addition, please make use of the comments section when responding to the IRB's notes. Your unique submission URL will have been assigned to you when you first submitted your proposal.
  3. Please notify the IRB Administrator at IRB@stedwards.edu when you have completed your revisions.

Please note that a re-submitted proposal that does not have highlighted - or "tracked" - changes may not be accepted by the IRB. This is because it is difficult for the Board to identify changes if they are not identified by you, the Principal Investigator. Please highlight - or track - your changes in content to avoid delays in your review.

Collaborators Not Affiliated with St. Edward's

Welcome! Outside researchers who would like to request an ethics review from the St. Edward's Institutional Review Board (IRB) will find guidance below.

If you have questions or concerns that are not addressed below, then please feel free to contact the IRB Administrator at IRB@stedwards.edu or 512-637-5676.

There are three ways in which non-SEU researchers may request a review from the St. Edward's University Institutional Review Board.

Option 1

Request to Recruit for Non-SEU Investigators (.docx) - If you have IRB approval from another institution and you would like to request recruitment of participants at St. Edward's, please send an email to IRB@stedwards.edu and include the following documents with your request:

  • Request to Recruit for Non-SEU Investigators (.docx)
  • Letter of IRB approval from the Investigator’s academic institution (i.e., the IRB of Record).
  • Copies of recruitment materials (flyers, emails, etc).
  • Copies of informed consent and debriefing forms
  • Copies of all measures that will be administered
  • A description of your study methodology
  • Certificate of CITI Research Ethics Training for all individuals who will carry out the research (and Faculty Advisor for student PIs)

Option 2

Request for Approval by Reciprocity (.docx) - If you have IRB approval from another institution that is included among our list Reciprocity Agreements, then the St. Edward's IRB may waive a detailed review (if your proposal meets the requisite qualifications). Note that Approval by Reciprocity for a "Full Board" study is unlikely. If you wish to apply for this time-saving opportunity, then please submit the following documents to IRB@stedwards.edu:

  • Request for Approval by Reciprocity (.docx)
  • Letter of IRB approval from the Investigator’s academic institution (i.e., the IRB of Record).
  • Copies of recruitment materials (flyers, emails, etc).
  • Copies of informed consent and debriefing forms
  • Copies of all measures that will be administered
  • A description of your study methodology
  • Certificate of CITI Research Ethics Training for all individuals who will carry out the research (and Faculty Advisor for student PIs)

Option 3

If you are a non-SEU researcher who does not already have approval from another institution, then you will need to identify a research partner at St. Edward's University before requesting the SEU IRB to act as the "IRB of Record" for your project. The St. Edward's University partner may be a faculty or staff member who elects to participate as a co-investigator or simply as a local "sponsor" to the research. The St. Edward's University partner would ideally submit the request to the IRB on your behalf however, you are permitted to do so yourself as needed. If you elect to submit the proposal yourself, then please send your request to IRB@stedwards.edu along with the following documentation:

  • A letter of support from a St. Edward's research partner (printed on St. Edward's letterhead)
  • One of the following applications:
  • Copies of recruitment materials (flyers, emails, etc).
  • Copies of informed consent and debriefing forms
  • Copies of all measures that will be administered
  • A description of your study methodology
  • Certificate of CITI Research Ethics Training for all individuals who will carry out the research (and Faculty Advisor for student PIs)

FAQs

Frequently Asked Questions

Q: Does my project need IRB review?

A: It might. Please review the Guidance for Researchers (.docx) datasheet to get a basic idea of classifications. Please contact an IRB representative if you are unsure.

Q: What kind of submission should I prepare for the IRB?

A: It depends. First, make sure that you do not qualify for an exemption. You can do this using the Guidance for Researchers (.docx) datasheet. A non-exempt proposal should be submitted through the SEU IRB Portal and a Request for Exemption should be emailed to IRB@stedwards.edu along with the appropriate documentation.

Q: My research will include participants who are minors, prisoners, newborn babies, AIDS patients, or mentally handicapped individuals. Do I need to do anything different with my application?

A: Yes. You will be asked additional questions as you work your way through the smart application on the SEU IRB Portal. You may need an Assent Form as well as other documents. Your study will also require Full Board review, so please submit your request at least 14 days in advance of a Full Board meeting, the dates of which can be found here under the tab labeled "Full Board Meeting Dates".

Q: Who can I contact for help with my application?

A: You may contact IRB Administrator at IRB@stedwards.edu or 512-637-5676 for general questions about your application. Please allow 1-2 business days for a reply during the school year. You may also contact your school's IRB representative; their contact information for may be found here, under the tab "Committee Members."

Q: What happens after I submit?

A: There is a waiting period. If your project is Exempt, then it will be processed at the administrative level, which occurs in about 20 days. An Expedited review will also take roughly 20 days for the first round of review notes, and a Full Board proposal will likely take more than 20 days. If your project is considered Expedited, then it will be reviewed by two of our IRB members. If your project is identified as a Full Board study, then it will be reviewed by all IRB members at our monthly meeting. The dates for our monthly meetings can be found here under "Full Board Meeting Dates". Proposals that are likely to require a Full Board review should be submitted at least 14 days before of one of our posted meetings. Other proposals that are not classified as Full Board will not need to reference our meeting calendar.

Q: How do I know if I will need a Full Board Review?

A: There are several automatic triggers for Full Board Review and some triggers that are harder to identify without a closer look. If you are working with minors, prisoners, newborn babies, AIDS patients, or mentally handicapped individuals, then you will need Full Board review. Also, you may need Full Board review if it is determined that your research topic or risk-level to participants will require close scrutiny. If you are unsure, please contact IRB@stedwards.edu or call 512-637-5676 to reach the IRB Administrative Assistant. The IRB Chair will make the ultimate determination about whether or not you will need Full Board review. Your timeline is the main reason you will want to know the level of review in advance. For instance, if you submit a proposal to the SEU IRB Portal that is then bumped to Full Board Review without your prior knowledge, then you may have unexpectedly lost 4-6 weeks of data collection time simply because you had missed that month's Full Board deadline (at least 14 days ahead of our monthly meeting). In that case, you would need to wait until next month to receive a review. This kind of delay is what you want to avoid. To do so, simply ask if you are unsure whether you need Full Board review. Keep in mind that Full Board reviews take longer than other reviews, sometimes up to 6-8 weeks of back-and-forth revisions. Therefore, this is a pertinent scheduling detail that you will want to know in advance as a researcher.

Q: How long will it take to hear back from the IRB?

A: Typically about 20 days, however, a Full Board review may take longer. In general, we recommend that researchers "Hope for two weeks but plan for six" when considering the length of time between their initial application and final IRB approval. After receiving feedback from the IRB, the researcher will make adjustments to their proposal and re-submit their updated proposal to the IRB. When studies involve higher risk to participants, this back-and-forth process may happen more than once. For this reason, a well-prepared first submission can save you time. If you would like to receive preliminary feedback on your proposal, please contact the IRB member associated with your school or contact the IRB Administrative Assistant.

Q: How do I respond to the IRB's revision requests?

A: If you originally uploaded your proposal to the SEU IRB Portal, then please use the "comments" section of your already-submitted proposal to reply to the IRB. In addition, please highlight or use "track changes" to illustrate changes within your revised proposal. Please also add "_revised" to the end of the updated file names.

Q: What if I encounter a problem during my study that puts my participants at risk?

A: You are required to inform the IRB within 5 days of discovery. If a safety issue, data breach, or other major problem occurs during your study, then you are required to alert the IRB immediately using the Unanticipated Problem Form (.pdf). The researcher is required to submit this form within 5 business days of the unanticipated event.

Q: Do I need IRB review if I am conducting an oral histories or marketing study?

A: Probably not, but it is good to check if you are unsure.

Q: How long do I need to keep records/data from my study?

A: Three years. All records must be retained by the principal investigator for three years after completion of the research.  Records may include such items as research proposals, informed consent documents, progress reports, reports of injuries to subjects, and all related correspondence concerning the use of human subjects.  Unless otherwise stipulated by the IRB, records may be destroyed at the end of three years following the completion of the research project.

Q: How long does my CITI certification last?

A: Three years, and then it must be renewed.

Glossary of Terms

Below is a Glossary of Terms relevant to the ethics review process and the IRB.

Certificate of Confidentiality (CoC) - an agreement issued by the National Institutes of Health (NIH) that guarantees that participants' data cannot be forcibly obtained via a warrant or court order. A CoC is particularly helpful for participant protections when details are obtained regarding illegal activity or otherwise highly sensitive personal information. The NIH will only grant these agreements for health-related studies. Find out more here.

exempt review - an activity that qualifies as human subjects research but does not pose above minimal risk to participants. There are six exemption categories in section 46.101(b) of DHSS 45 CFR 46.

expedited review - a project with minimal risk to participants may be subject to this less rigorous review process. Expedited review does not require the convening of a full board and often requires less time than a Full Board review.

Full Board review -  when a project involves greater than minimal risk to participants, the IRB will discuss the proposal in detail during its monthly meeting. If the project involves vulnerable populations or receives federal funding, it will require Full Board review.

generalizability - the "ecological validity" of a study's results -- or, how reliably the results can be generalized to a setting outside of the controlled laboratory. For example, if an investigator conducts interviews for historical purposes, these results would not qualify as generalizable knowledge (and not require IRB review) because the interviewees would be expressing opinions that could not be generalized outside of that setting. If, however, the researcher were conducting a formal assessment of how the phrasing of a question might influence a person's answer, then a systematic investigation of these results may, in fact, lead to generalizable knowledge, and would, therefore, require review by the IRB.

human subjects research - The Department of Health and Human Services (DHHS) defines research as a "systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge" 46.102(d). Research is considered to involve human subjects when an investigator conducting research obtains (1) data through intervention or interaction with a living individual, or (2) identifiable private information about a living individual. In both cases, the generalizability of the study design will determine whether the activity qualifies as human subjects research (45 CFR 46).

human subjects - as it pertains to research involving human subjects in the HHS regulations defined in 46.102, Subpart A – a living individual about whom an investigator conducting research obtains (1) data through intervention or interaction with the individual, or (2) personally identifiable information (3) private information.

informed consent - Investigators inform participants about (1) the purpose of the research, expected duration and procedures; (2) their right to decline to participate and to withdraw from the research once participation has begun; (3) the foreseeable consequences of declining or withdrawing; (4) reasonably foreseeable factors that may be expected to influence their willingness to participate such as potential risks, discomfort or adverse effects; (5) any prospective research benefits; (6) limits of confidentiality; (7) incentives for participation; and (8) whom to contact for questions about the research and research participants' rights. They provide the opportunity for the prospective participants to ask questions and receive answers. This definition is found in the Ethics Code of the American Psychological Association.

Institutional Review Board (IRB) - an ethics committee that is required by federal law for all institutions that receive federal funding for research. Without exception, the IRB must review all research involving human subjects at its host institution. In carrying out its duties, the IRB upholds the ethical principles of beneficence, respect for human dignity, and justice. Defined in 46.102, Subpart A of 45 CFR part 46.

minimal risk - The research is considered minimal risk if the probability and magnitude of harm or discomfort anticipated are to be no greater than the discomfort encountered in everyday life, or encountered during the performance of routine physical activities, or during physical/psychological examinations.

personally identifying information - includes any of the following pieces of data about participants: First and Last Name (or either if it is particularly rare or unique), Date of Birth, Address or GPS Coordinates, Phone Number, E-mail Address, Social Security Number or other Taxpayer Identification Number, Photographs or Video Recordings

private information - Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information that has been provided for specific purposes by an individual and that the individual can reasonably expect will not be made public (for example, a medical record). Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects. 45 CFR 46.102(f).

sensitive information - Information that, if known by others, could potentially harm the reputation, occupation, or freedom of a participant. Examples of sensitive information include, but are not limited to: substance use, sexual behavior (excluding sexual orientation and/or gender identity), illegal activity, experiences with an employer.

vulnerable population(s) - Federally protected under 45 CFR 46: individuals with mental illness, individuals with disabilities, cognitively impaired individuals, children, prisoners, pregnant women and neonates. The SEU IRB may extend protections to include other groups, such as: immigrants, those with perceived cultural and/or institutional vulnerabilities. See Inclusion of Women and Minorities Policy Implementation Page and Inclusion of Children Policy Implementation Page.

This page can help to guide you through your human-subjects research submission to the St. Edward's University Institutional Review Board (IRB).

A Ten-Step Overview of the Process

In general, the following ten steps will occur with each non-exempt IRB submission: