Please review the following frequently asked questions. The questions are arranged in sections, to help you find the information you need.
Frequently Asked Questions
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.
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.
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.
Where do I start?
You can start by checking the SEU IRB Proposal Types Flowchart to see if your research is Exempt, Expedited, or Full Board Review. Then, 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
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:
- Your faculty advisor
- The IRB Administrator at IRB@stedwards.edu
- The IRB Chair, Dr. Lisa Holleran, firstname.lastname@example.org
How do I submit my proposal?
For an Exemption request, fill out the online IRB Exempt Application. For an Expedited or Full Board Review proposal, fill out the IRB Expedited or Full Board Review Application. Please see the SEU IRB Proposal Types Flowchart or 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?
Please refer to this Powerpoint for step-by-step instructions on how to get CITI certified. 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?
You will need the following: CITI certificates from all investigators, including your faculty advisor(s) 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, all data collection instruments (surveys, list of interview questions, etc.), plus any authorization letters from other universities if you will be recruiting students outside of SEU. Please 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 detailed charts to review the criteria. Remember that Exempt does not mean that your proposal will not be reviewed, but rather it will receive limited oversight. You'll still need to submit a CITI certificate, and any supporting materials to include Consent Form, survey or interview questions.
Which proposals qualify for an Expedited review?
A project qualifies for Expedited review if the project poses minimal-to-greater risk to participants. Expedited review does not require the convening of the IRB and can often, but not always, take less time than a Full Board Review.
When a project has a greater-than-minimal risk to participants, the IRB must discuss the proposal in detail during its monthly meeting attended by a quorum of voting members. Examples of projects that require Full Board Review:
- includes vulnerable populations (minors, pregnant women, incarcerated persons, or persons with diminished decision-making capacity)
- includes sensitive subject matter that leads to greater participant risk
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 will review only Exempt and Expedited proposals through June, depending on faculty/staff availability. There are no reviews conducted in July and August. Additionally, the full IRB Committee does not meet May-August.
How do I know if I qualify for an Exempt Review?
You can review the SEU IRB Proposal Types Flowchart (.pdf) and these federally designated charts (2-10) to check the criteria. If you qualify, an online IRB Exempt Application should be submitted along with the appropriate documentation listed in the file upload section of the form.
How long will it take for my Exempt Application to be reviewed?
Exemption reviews usually take between 7-10 days.
Where can I submit my IRB Proposal materials?
For the Exempt proposals, fill out this online form:
For all other proposals, fill out the IRB Expedited or Full Board Review Application.
How long will it take to hear back from the IRB about my project?
Typically an initial review will be conducted by the IRB Chair and the IRB Administrator within 7-10 days of the submission date. You should receive initial feedback within that time. The entire approval process usually takes between 14-21 days for Expedited proposals, but could take longer depending on the number of revisions required. A project designated Full Board Review can take several weeks to be approved.
In general, researchers should plan for up to six weeks, considering the length of time between their initial application submission and final IRB approval.
After receiving initial feedback from the IRB, the researcher might need to make adjustments to their proposal and submit corrected materials. When studies involve higher risk to participants or when the materials lack sufficient details, this back-and-forth process could happen multiple times. For this reason, a well-prepared first submission can save you time.
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 10 days. If your project is classified as Expedited, it will be reviewed by two IRB members and review will take roughly 14 days for the first round of review notes. A proposal reviewed by the Full Board will likely take more than 21 days. View the dates for the IRB monthly meetings. Proposals that are likely to require a Full Board Review should be submitted at least 14 days before a monthly meeting.
How do I know if my project will need a Full Board Review?
This IRB Proposal Flowchart can give you a good idea of how your proposal will be designated. 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, or persons with diminished decision-making capacity, your project will require Full Board Review. Also, if the IRB determines that your research topic or risk-level to participants will require closer scrutiny. If you are unsure, please contact IRB@stedwards.edu 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 IRB@stedwards.edu if you are unsure whether you need Full Board Review. Keep in mind also that these review 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 official 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 or other documents as required. Please add a summary of all changes at the beginning of the document, and also highlight changes within the document. You will save the revised documents with the word REVISED in the file names, and resubmit all 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 the IRB Modifications or Continuing Review Application online form and attach your supporting materials. 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 subjects 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. View the list of crisis resources from the National Alliance on Mental Health.
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.
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.
Research Subjects and Potential Risks
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:
- 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.
- Distribute the survey via the “anonymous link” option.
Faculty Researchers and Advisors
What is a faculty advisor's role in student research projects?
All student-led proposals must be sponsored by a faculty advisor. Students may need assistance understanding the level of research detail required in the IRB Application, plus the level of risk associated with their project.
Student Principal Investigators are expected to carry out the majority of the work for the IRB submission, as it is a low-risk opportunity to become acquainted with the ethics review process. Faculty advisors should be involved in a supervisory role.
*Faculty advisors must review and approve their student's IRB materials
before IRB review.
- When a student researcher submits the online IRB application, their faculty advisor receives an automated email from Smartsheet that includes the student's application and supporting materials.
- The faculty advisor should read/check all the documents for errors, clarity, and thoroughness.
- Download and use the IRB Submission Rubric for Faculty Advisors to track what is missing or needs extra work in the proposal.
- The faculty advisor can then determine whether to "Approve" or "Decline" the proposal and leave comments for the IRB team.
- Once the IRB receives the faculty advisor's response, the proposal will progress to the next step in the IRB process.
- If the proposal is "Declined", the IRB Administrator notifies the student and coordinates corrections before assigning faculty reviewers.
Please note if there is not enough project detail provided within the submitted materials, IRB approval could be delayed. Students may use the IRB Submission Checklist to prepare.
*Faculty advisors will need to provide a copy of their up-to-date CITI certificate ("Faculty Social Research") to their students for each research proposal. Students are required to submit it during the application process.
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 with minimal revisions. The IRB’s purpose is the protection of human subjects in research and must review 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?
Please submit an Exempt Classroom Research Application. The IRB Chair will determine if your classroom project qualifies for exemption.
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 Chair and IRB Administrator can be available for a presentation or Zoom session. To schedule, contact IRB@stedwards.edu. We also recommend that you review the information within this Frequently Asked Questions section, the IRB Proposal Types Flowchart, and the Step-by-Step Guide For Researchers.
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 IRB@stedwards.edu to discuss your situation.
How early should my I/my student submit an application prior to data collection?
Review by the IRB on average takes about 14 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 and documents. 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.
A Sample Consent Form for Adults 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 complete an IRB Exempt Application and upload all relevant documents through the online form.
Note that an exemption may not be possible if any of the following criteria are true about the study:
- The potential risk to participants is expected to exceed that of "minimal risk" [as defined by the DHHS 45 CFR 46 46.102(i)]
- If vulnerable populations (such as minors) are involved, or
- 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.
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 complete the form below and attach supporting materials:
- IRB SEU Recruitment Application (online form).
- 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.
- Certificate of CITI Research Ethics Training for all individuals who will carry out the research and any faculty advisor CITIs.
With which institutions does the SEU IRB have Reciprocity Agreements?
St. Edward's has Reciprocity Agreements with the institutions listed. However, a researcher is not limited to this list and can submit an IRB Reciprocity Application to conduct studies from any reputable institution.
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 of Reciprocity Agreements, St. Edward's IRB may waive a detailed review if your proposal meets the requisite qualifications. Note that Reciprocity Approval for a "Full Board" study is unlikely. Please submit the following online form and attach supporting materials:
- IRB Reciprocity Application (online)
- 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, if students, the faculty advisor CITIs.
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 if I need permission from SEU first before getting approval from another institution's IRB?
The St. Edward's IRB can issue a "Conditional Approval Letter" in certain circumstances. Please email IRB@stedwards.edu to discuss your specific situation.
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 IRB Unanticipated Problem Form (.docx). The researcher is required to submit this form within 5 business days of the unanticipated event.
Do research protocols need to be changed because of COVID 19?
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.
At this time, COVID-19 risks have been mitigated to a minimal level due to widely available and frequently updated vaccinations, allowing researchers to resume in-person protocols. Zoom conferencing and online survey software (i.e Qualtrics) are still useful alternatives to in-person measures.
All pandemic and public health emergency guidances are highly dependent on ongoing updates to federal, state, local, and institutional policies. Guidance for minimizing the risk of exposure to COVID-19 in human subjects research can be found at CDC, FDA, and NSF.