Frequently Asked Questions

Is my project Human Subjects Research?

If your project meets both the definition of research: a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.

Please see the definition of generalizability in the section labeled Definitions, below, for more on this term.

and includes

human subjects: living individuals about whom an investigator conducting research obtains data through A. intervention or interaction with the individual or B. identifiable private information. 

If your project meets both of these definitions, then it is considered to be human subjects research and therefore requires review by the IRB. This flow chart can be a helpful tool to decide if your project is human subjects research. 

You can review the Step by Step Guide For Researchers for the criteria for the classifications of review, and you're also encouraged to contact the IRB office with questions: IRB@stedwards.edu 

Where do I start?

You can use the Step-By-Step Guide For Researchers which will guide you through creating a proposal and the required supporting materials. The IRB Submission Checklist provides a tool to check for completeness of your proposal before submitting. Please contact the IRB office with questions that come up:  IRB@stedwards.edu

I'm a student conducting research for the first time. What do I need to know?

First, welcome to the St. Edward's University research community! We want you to know that the process of ethics review is an important part of human subjects research in academia, government, and private sectors. In the United States and many other countries, 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 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 with the support of a faculty advisor. The mission of the Institutional Review Board (IRB) is to protect the dignity, the well-being, and the safety of all human participants. Keep these principles in mind while designing your study, and remember that your St. Edward's University research community is here to help you.

Who can I ask for help?

It's a good idea to reach out when you have questions! Here are three individuals who can help you:

1. Your faculty advisor
2. The IRB Administrative Assistant, IRB@stedwards.edu or 512-416-5838
3. The IRB Chair, Dr. Laurie Heffron, lheffron@stedwards.edu

Do I need to submit my proposal via the IRB Portal Site?

Yes. The exception to this is in the case you are submitting an Exemption Request, which should be emailed to IRB@stedwards.edu. Remember that Exempt Review is still a form of IRB oversight. Please see the Step-By-Step Guide For Researchers for more information about each of these processes. 

What course do I need to take on CITI? How do I find the course?

After creating or logging in to your CITI account, at citiprogram.org, click View Courses. On the course page, go to the very bottom of the page where you will see a section labeled Learner Tools. The first option under Learner Tools is Add a course. When you select that option, you will see questions that walk you through the steps to choose a course. In the first question, Human Subjects Research, you will see these options:

Faculty Biomedical Research

Faculty Social Research

Student Biomedical Research

Student Social Research

IRB Members

Community-Engaged Research (CEnR)

Students will select either Student Biomedical Research or Student Social Research, as appropriate, and Faculty will select Faculty Biomedical Research or Faculty Social Research, as appropriate. 

How long does my CITI certification last?

CITI certification is valid for 3 years. 

What do I need to submit with my proposal?

For all proposals, you will need the following: CITI certificates from all investigators, including your faculty advisor if applicable, and anyone who is going to be involved in the research, a consent form, all recruitment materials including the text of any emails that would be sent out, scripts for announcements to be made, flyers, social media posts, and survey materials.  For Expedited and Full Board proposals, you'll also complete and submit an IRB Application Form. Attach the IRB Application Form your Smartsheet proposal, along with the other attachments, when you submit to the IRB. You can refer to this IRB Submission Checklist to check your materials for completeness. 

Which proposals qualify for an exempt review?

A proposal is classified as exempt if it is an activity that qualifies as human subjects research but does not pose greater than minimal risk to participants. There are eight exemption categories in section 46.101(b) of DHSS 45 CFR 46, and you can use these flow charts to review the exemption criteria. Remember that exempt does not mean that your proposal will not be reviewed, but rather it will receive limited oversight. You'll submit a CITI certificate, and submit your materials that include an outline of your survey or interview questions. 

Which proposals qualify for an expedited review?

A project qualifies for expedited review if the project poses minimal risk to participants. Expedited review does not require the convening of a full board and can often, but not always, take less time than a full board review.

Which proposals will require a full board review ?

When a project involves greater than minimal risk to participants, the IRB must discuss the proposal in detail during its monthly meeting, attended by a quorum of members. Projects that involve vulnerable populations, include more than a minimal risk, or that receive federal funding require a full board review.

Do I need IRB review if I am conducting an oral history or marketing study?

These are types of projects that tend to NOT meet the definition of human subjects research. We recommend that you review the definitions of human subjects and research carefully, and also contact the IRB office to discuss your project if you are unsure, IRB@stedwards.edu 

How long do I need to keep records from my study?

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

Does the IRB review proposals during the summer?

Generally, the IRB only processes requests for exempt review during the summer. In specific cases, we may be able to review research proposals that have expedited status. The full IRB committee does not meet during the summer months. 

How do I know if I qualify for an exempt review?

You can review the criteria for exempt review with the Guidance for Researchers (.docx) datasheet linked here, and you can use these flow charts, (chart 2-10) to check the criteria.  If you qualify, a Request for Exemption should be emailed to IRB@stedwards.edu along with the appropriate documentation listed in the instructions section of the form.

How long will it take for my exempt request to be reviewed?

Requests for exempt review take about 10 business days. 

Where can I submit my IRB Proposal materials?

Here's a link to the portal where you'll submit all of your materials:

IRB Online Submission Form

 How long will it take to hear back from the IRB about my project?

Typically about 20 days, however, a full board review may take longer. In general, we recommend that researchers plan for up to six weeks when considering the length of time between their initial application and final IRB approval. After receiving feedback from the IRB, the researcher may need to make adjustments to their proposal and re-submit the 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 office by email: IRB@stedwards.edu

What happens after I submit?

After you submit, there is a waiting period while your proposal is reviewed. If your project is classified as exempt, it will be processed at the administrative level, which takes about 20 days. If your project is classified as expedited, review will also take roughly 20 days for the first round of review notes. If your project is considered expedited, it will be reviewed by two IRB members. A proposal reviewed by the full board will likely take more than 20 days. The dates for our monthly meetings can be found here.  Proposals that are likely to require a full board review should be submitted at least 14 days before a monthly meeting. On the other hand, if your project is not likely to require Full Board review, you will not need to reference our meeting calendar.

How do I know if my project will need a full board review?

There are several automatic triggers for full board review and some that are harder to identify without a closer look. If you are working with pregnant women and fetuses, minors, prisoners, persons with diminished mental capacity, and those who are educationally or otherwise disadvantaged, your project will require full board review. 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 512-416-5838 to reach the IRB Administrator. The IRB Chair will make the ultimate determination about whether or not you will need full board review. 

Since the levels of review have different timelines, you may wish to examine the potential of review needed by your project. For instance, if you submit a proposal that is determined to be in need of full board review, then you may have 4-6 weeks before you are able to start data collection because you missed that month's Full Board deadline (at least 14 days ahead of our meeting, see meeting dates here. In this case, you would need to wait until the next month to receive a review. To avoid delays, contact the IRB office IRB@stedwards.edu if you are unsure whether you need full board review. Keep in mind also that full board reviews take longer than other reviews, sometimes up to 6-8 weeks in the case revisions are required. 

How do I respond to a request for revisions from the IRB?

The request for revisions letter that you receive from the IRB will contain specific information about what should be changed or added to your proposal, to meet human subjects protection requirements. You’ll make changes in your original IRB Application Form document. Please add a summary of all changes at the beginning of the document, and also highlight changes within the document. If you make changes in other documents, such as the consent form or recruiting flyer, you will also resubmit those documents, again with changes highlighted. Include the word revised in the file name of files that are re-submitted. You will submit all documents by email to IRB@stedwards.edu.

How do I make changes to my previously approved project?

If your project was approved by the IRB, but you need to alter or revise it, you can submit your request via email, along with the revision form and any materials that are new or revised. Use this form to submit with your request for revision. It is also available in the Forms and Templates section. 

How can I use Concealment and Deception ethically in my project?

The American Psychological Association (APA) has developed guidelines for research that includes deception. The guidelines are as follows: 

1. Don't use deception unless you have determined that the use of a deceptive technique is justified by the study's significant prospective scientific educational or applied value and that equally effective non-deceptive alternative procedures are not feasible. 

2. Do not deceive participants about significant aspects that would affect their willingness to participate, such as risks, discomfort or unpleasant emotional experiences

3. Any deception that is an integral feature of the design or conduct of the experiment must be explained as early as possible in the process. Ideally this would happen at the conclusion of their participation but no later than the conclusion of the study. 

Keep in mind, also, that deceptive procedures make it impossible to obtain full informed consent. 

What if I'm using data that is publicly available and has been stripped of identifying information. Do I need to submit a proposal to the IRB?

This type of research most likely does not meet the definition of human subject research. However, we recommend that you contact the IRB for a letter stating that the IRB has concluded that the definition of research was not met. This is especially important if there is potential for your work to be published.

How do I find appropriate resources to provide to subjects in case of distress? 

The IRB maintains an abundance of caution for mental health, protection from risk in human subjects, and vulnerable populations. We require that research which might result in any type of emotional or psychological distress include crisis resources both in consent materials and reflected frequently throughout the protocol in any recurrent instances. For a list of crisis resources from the National Alliance on Mental Health, please click here. 

What if I work with another agency for recruitment? 

On the IRB proposal application form, you'll see the question: "Are any other institutions/agencies involved? Describe the involvement of any other institution (school districts, government agencies, business settings etc) in this study. Please attach documentation below (on official letterhead) of approval for your research to be conducted at these sites." If you are partnering with an agency or institution to recruit participants or conduct research, you'll need to request a letter and have it available to upload along with your proposal. 

How is generalizability defined?

Generalizability refers to how reliably the results can be generalized to a setting outside of the controlled laboratory. Generalizability is one of the conditions that must be met for something to be considered human subjects research. An example of a study that is NOT generalizable would be if an investigator conducts interviews for historical purposes. This study is not generalizable because the interviewees would be expressing opinions that could not be generalized outside of that setting. This study would not require IRB review. However, if 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 lead to generalizable knowledge, and would, therefore, require review by the IRB.

How is human subjects research defined?

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). The definition of a human subject, as it pertains to research involving human subjects in the HHS regulations defined in 46.102, Subpart A, is 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.

How is informed consent defined?

In 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.

What is an Institutional Review Board (IRB)?

The Institutional Review Board is 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.

How is minimal risk defined? 

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.

How is personally identifying information defined? 

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.

How is private information defined? 

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).

How is sensitive information defined?

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

What is a Certificate of Confidentiality (CoC)?

Certificate of Confidentiality is 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.

What is the definition of anonymous data and how is it different from de-identified data?

Anonymous data is that which all links to the participant have been removed. Keep in mind that most data collected electronically will have some link through IP address, and is generally not considered to be anonymous. You can read more about this in the FAQ sub-section labeled Research Subjects and Privacy Protection. De-identified data is data in which personal identifiers have been removed so that the identify of the subject can not be readily determined. If a survey includes a demographics section or is being collected through a third party vendor, the researcher cannot guarantee anonymity and should not be included in recruitment or consent materials.

What are the kinds of risk research subjects might face?

The following are descriptions of the potential risks associated with research. (Adapted from University of Portland IRB)

Psychological Risk Includes psychological impact that may occur during the research and/or later as a result of participating. Includes anxiety, stress, fear, confusion, embarrassment, depression, guilt, shock, loss of self-esteem, and altered behavior.

Social/Economic Risk Includes alterations in relationships with others that are to the disadvantage of the subject, including embarrassment, loss of respect of others, labeling with negative consequences, or diminishing the subject's opportunities and powers in relation to others. Economic risks include actual costs to the subjects for procedures, loss of wages or income, and damage to employability.

Legal Risk Includes risk of criminal prosecution or civil lawsuit when research methods reveal that the subject has or will engage in conduct for which the subject or others may be criminally or civilly liable.

Loss of Confidentiality Confidentiality is presumed and must be maintained unless the investigator obtains the express permission of the subject to do otherwise. Loss of confidentiality can lead to any of the other risks described above. 

Physical Risk Includes discomfort, pain, injury, illness, or disease brought about by the methods and procedures of the research.

What groups are vulnerable populations?

Federal guidelines identify pregnant women and neonates, minors and prisoners as vulnerable populations.The IRB also seeks to protect all subjects with vulnerability in any of the following areas: cognitive or communicative, institutional, medical, deferential, economic, social, or legal. 

How can I disable collection of IP addresses in Qualtrics?

There are two steps in this process:

1. Go to the Survey Options section of your survey and scroll down to the survey termination section. In that section, check the box for Anonymize Responses, and click Save at the bottom of the screen.
2. Distribute the survey via the “anonymous link” option. 

Can I offer extra credit to my students who participate in my research study? 

The IRB will require that you offer other opportunities that are equally accessible for students to earn extra credit in the event they choose not to participate. 

If you invite students to participate during a class period you can often avoid the need for the extra credit. You can step out of the room and have a colleague or teaching assistant administer the protocol to avoid coercion and also potentially maintain confidentiality. 

Can someone from the IRB come talk to my class?

Yes! The IRB Administrator or IRB Chair are available to schedule a presentation or Zoom session. To schedule, send an email to IRB@stedwards.edu. We also recommend that you review the information available within this Frequently Asked Questions section and the Step-by-Step Guide For Researchers. 

What is a faculty advisor's role in student research projects? 

All student-led proposals must be sponsored by a faculty member. Please help your student determine the level of risk associated with their project by reviewing the Step By Step Guide For Researchers, on this site. If you are unsure of how the student's study will be classified, feel free to contact the IRB Administrator, irb@stedwards.edu. All proposers, student or otherwise,  submitting a proposal for Expedited or Full Board Review must complete the IRB Application Guide which will be submitted as part of the SEU IRB application. You can also encourage students to use this IRB Submission Checklist, as a tool to check for completeness before submitting. 

If the project involves vulnerable populations, deception, or other risks to participants, you may wish to encourage the student to discuss the project with the IRB Administrator before their application is submitted.

If the student is the Principal Investigator, it is important that they are permitted to carry out the majority of the work for the IRB submission. This is a low-risk opportunity for students to become acquainted with the ethics review process. Keep in mind that as the risk to participants rises, so will the responsibilities of the Principal Investigator.

Also note that you'll need to share a copy of your up-to-date CITI certificate with your student. This document is a required part of the student's application.

I'm a SEU faculty researcher. How do I collaborate with an investigator from another university?

The answer to this depends on where you are in the research proposal process and on which institution is the IRB of record. Please contact the IRB office to discuss your situation, IRB@stedwards.edu. 

Can I approve the student projects that will be conducted under my supervision? I'm concerned it will take too long for the IRB to review them.  

We urge you to support your students to create a strong protocol and application, so that the IRB can efficiently process their applications. The IRB’s purpose is the protection of human subjects in research and must support when inexperienced researchers are conducting greater than minimal risk studies involving human subjects. 

I'm a faculty member who will have student projects that involve research in the classroom. Do I need IRB oversight?

For classroom projects involving human subjects research, please refer to this guide. If you believe a class assignment qualifies for exemption from IRB oversight, you will need to submit a Request for IRB Exemption of Classroom Projects form, along with the other materials requested on the form. Ultimately, it is the decision of the IRB to determine if your project(s) qualify for exemption or require IRB oversight.

How early should my I/my student submit an application prior to data collection?

Review by the IRB typically takes about 20 days, however, a full board review may take longer. In general, we recommend that researchers plan for up to six weeks when considering the length of time between their initial application and final IRB approval. After receiving feedback from the IRB, the researcher may need to make adjustments to their proposal and re-submit the updated application form and documents 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 office by email: IRB@stedwards.edu

I am engaged in Scholarship of Teaching and Learning (SoTL). What do I need to know?

The IRB frequently recommends that SoTL 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.

Here is a Sample Informed Student Consent Form (.docx). This 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 submission portal instead of applying for an exemption. If you have other questions, feel free to contact the IRB Administrator at IRB@stedwards.edu.

Here's a good resource for more discussion on SoTL. 

I'm a researcher from another institution and wish to recruit research participants at SEU. How can I do this? 

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)

With which institutions does the SEU IRB have Reciprocity Agreements?

St. Edward's has agreements of reciprocity for research with the institutions listed here: 

http://stedwards.box.com/s/lx3z8nr1jtrmltygbjvk2klym5bwnua8

What if I have approval from an institution with IRB Reciprocity Agreement?

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)

I'm a researcher from another institution, but I do not already have approval from an IRB. How can I work with the SEU IRB? 

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 will submit the request to the IRB on your behalf using the SEU IRB submission portal. 

What will happen if I conduct my research without prior approval from IRB?

If you conduct human subject research without approval from the IRB, you will be in violation of university policy. There are many other potential implications, including loss of funding, loss of ability to publish, and for students, credit may be withheld. 

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

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.

What protocols are in place at St. Edward's to ensure safe research during the COVID 19 pandemic? 

When the COVID-19 pandemic began, investigators conducting human subjects research were notified that all face-to-face human subjects research must be halted to ensure the safety of study participants and researchers. Currently, face-to-face meetings and interventions have been replaced with alternatives such as phone or video conferencing using tools such as Zoom or online survey software, i.e Qualtrics. The IRB, in partnership with OIT, relies on guidance from the CDC, FDA, and NSF on possible online / virtual alternatives with safety, data security and ease of use in mind.

At this time, however, there may be a case where COVID-19 risk can be mitigated to a minimal level, allowing research to resume if a PI has modified the IRB protocol to add the risk of COVID-19 exposure to the procedures and consent form, included necessary safety measures, and re-consented new or continuing participants. Guidance for minimizing the risk of exposure to COVID-19 in human subjects research can be found at CDC, FDA, and NSF. Studies where the COVID-19 risks cannot be mitigated, or are not modified to address risks associated with COVID-19, cannot resume face-to-face procedures at this time. This guidance is in effect for all SEU students and faculty regardless of geographic location.

These guidances are highly dependent on ongoing updates to federal, state, local, and institutional policies related to physical distancing and allowed activities and based on continuous monitoring of the guidelines. Any changes to study procedures must be approved in advance by the IRB. Please contact IRB@stedwards.edu with questions.

IRB Online Submission Portal