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ACADEMICS

Institutional Review Board (IRB)

About the IRB

Southeastern University’s Institutional Review Board (IRB) oversees all formal research studies associated with the SEU community and reserves the right to approve, reject, monitor and request modifications to them. The IRB’s primary objective is to protect human subjects in research by ensuring their rights and promoting the ethical and responsible treatment of them.

Questions?

Please reach out to the IRB team at irb@seu.edu and we will assist you with any questions. You can also find answers to several frequently asked questions about the IRB review process below.

1. Start Here

Do I Need IRB Review?
Before conducting a research study at Southeastern University, you may need to first have your plans reviewed by SEU’s Institutional Review Board, particularly if your research involves human participants. Click the link below to determine whether or not you will need the IRB to review your research plans.

What’s Next?
Prior to your research project being reviewed by the SEU IRB, you must complete a training module through CITI Program, even if you will not be directly involved in working with human participants. Learn more and register below.

2. Guidance for Faculty

Faculty members at SEU may conduct course activities that are research-related. This section is to provide guidance regarding whether or not these activities require IRB review.

If a course research project uses methods designed to develop or contribute to generalizable knowledge, involves human participants and any of the following apply, IRB review is required:

  • A student plans to share the results with an audience beyond the classroom (e.g., presentations at local, regional, and national conferences; publications; blogs and websites). Presenting results at an event on campus does not necessarily require IRB review unless one or more of the conditions described in the following bullet points apply.
  • The research involves deception.
  • The project involves greater-than-minimal risk to participants. This means that the likelihood and magnitude of physical or psychological harm is greater than what would normally be encountered in their daily lives.
  • The project involves collecting sensitive information that is recorded in such a way that the responses can be linked to the respondents (whether through demographic data or collected identifiers). Sensitive information may include information about family violence, drug use, sexual preferences or other similar topics.
  • The project collects data from people who are unable to provide informed consent due to their limited mental capacity, age or incarceration.

The determining factor in defining IRB jurisdiction is the federal definition of research, which is “a systematic investigation (i.e., the gathering and analysis of information) designed to develop or contribute to generalizable knowledge.” The following sections illustrate when IRB review may or may not be required for activities combining teaching and research. Faculty members should consult with the IRB team if they are unsure whether their classroom activities require IRB review.

Demonstrations
Classroom projects designed to teach students about research, conduct statistical analysis or illustrate scientific principles — and whose results are not for dissemination beyond the instructor and other students in the class — are not considered to be human subjects research because they are not intended to develop or contribute to generalizable knowledge. The following paragraph provides additional guidance regarding circumstances where classroom projects do not require review by the IRB.

Data are collected from students in a course for the purpose of demonstrating principles of science and/or behavior firsthand or to provide data for learning statistical analysis. The demonstrations are public only within the context of the class, the students are permitted to choose not to participate and are provided alternate means of earning participation credit, and the risks are known to be minimal. The data are not shared outside the course or collected for publication in scholarly journals. There are no restrictions about how long the demonstration lasts (one or more class periods), where the data are initially collected (during or outside class time) or how “well-known” the principle being demonstrated is. The primary components of these types of class activities are that the risk of harm to students is minimal and gathering and dissemination of the data is confined within the class setting. If the activities in a class conducted by faculty are as described in this section, IRB review is not required.

Students Learning About Research or How to Do Research in a Class
This category differs from the first regarding demonstrations in that students may be asked to be participants in research projects as a credit-earning class activity, but the research is not confined to just one class. An example is joining a participant pool of students enrolled in introductory social science classes or students conducting human participant research as a component of a research methods class.

If students are enrolled in a course where, as a component of the course, they are offered the opportunity to participate in research as subjects, this should be clearly stated in the course syllabus. SEU faculty members who are teaching courses where credit is offered for participating in research should seek a single, global informed consent for participation from the students (or students’ parents or legal guardians if they are under 19 years of age) for all participation opportunities throughout the semester. Researchers should then obtain assent from the subject pool participants for each project in which an opportunity to participate is offered.

In other cases students may be enrolled in classes designed to develop research capacity and skill. Students in these classes may individually or jointly conduct several research projects in one semester. Faculty instructing these classes should request IRB approval for all projects to be conducted in the class at the beginning of the semester. The faculty member must stipulate that none of the projects will be disseminated beyond the classroom or SEU campus setting, involve greater-than-minimal risk, collect sensitive information that is recorded in such a way that the respondent can be linked with their responses or collect data from people unable to provide informed consent.

When students are asked to serve as researchers with non-class participants serving as subjects, then the interests of these non-class members take precedence. If the project would readily fit under the exemption categories of the IRB, then the professor may seek “blanket” IRB approval in advance, based on a generic description of topics and/or methods that the professor will subsequently allow students to pursue. Otherwise, the project should be submitted under standard IRB procedures.

Students Doing Research Under Faculty Guidance
Students doing individual or group research under faculty guidance (e.g., senior project, independent study, honors projects, etc.) are not conducting classroom projects and may or may not require IRB review. Consultation with the IRB is recommended.

If the original project is primarily for instructional purposes but researchers wish to disseminate the results publicly at a later time, the researchers or course instructor may file for IRB review of the archival data analysis at that time. Similarly, if the investigator finds that demonstration or instructional research conducted and/or approved under the principle of minimal risk of harm to participants poses a greater-than-minimal risk of harm, the research must stop. Full IRB review and approval is required before the research may continue.

3. CITI Training

All researchers involved in a study at Southeastern University, even if they will not be directly involved in working with human participants, must have submitted a report to the SEU IRB demonstrating that they have successfully completed the appropriate module of the Collaborative Institutional Training Initiative (CITI) Program. Click below to register for your training. (Click here for detailed instructions on getting started.)

What is CITI?
Used worldwide by more than 2,200 academic institutions, government agencies and other organizations each year, CITI Program is a leading provider of Web-based educational courses in research ethics, compliance, responsible conduct of research and more. Learn More

Next Steps
Once you complete your CITI training, it’s time to request for the IRB team to review your research plans. Click below to access the forms, policies and templates needed to begin this process.

Get More Info
If you have additional questions about CITI training, how to register or how to log in to the CITI website, please contact the SEU IRB at irb@seu.edu

Resources

Forms

Request the SEU IRB to review a project involving human participants. Download the form here.

Request a faculty sponsor for a student research project. Download form here.

Report a problem or adverse event regarding your approved research. Download the form here.

Make changes to a previously approved research project. Download the form here.

Request extended time for your research project. Download the form here.

Templates & Examples

If you need assistance with creating consent forms for your research participants, the guide and templates below will help ensure that you include all the necessary information.

Create a consent form that does not require a participant’s signature and/or can be used online. Download the template here.

Provide an adult with information about your research, and request his or her consent to participate. Download the template here.

Create a form requesting parents’ permission for their children to participate in your research project. Download the template here.



Provide a child with information about your research, and request his or her assent to participate. Download the template here.

Resources

Policies

Find out about the makeup of the IRB team and how members are chosen. View the policy here.

Learn about the requirements to qualify for an expedited IRB review. View the policy here.




Learn what types of research may be exempt from IRB review. View the policy here.

Need Something Else?

Not finding the correct form, policy or template? Reach out to us at irb@seu.edu for help.

FAQs

The questions and answers provided here are intended to assist students and other first-time applicants with requesting SEU’s Institutional Review Board (IRB) to review a research project. Click each question below to view its answer in a drop-down menu. If your question is not listed here, contact us at irb@seu.edu for assistance.

The Southeastern University Institutional Review Board (SEU IRB) was established to safeguard human subjects in research by protecting their rights and promoting the ethical and responsible treatment of research subjects. SEU IRB policy requires that all research involving human subjects conducted under the auspices of SEU must be reviewed and approved by the IRB before the data-gathering phase may commence. The SEU IRB upholds and applies the ethical principles of The Belmont Report and operates in compliance with federal law outlined in the Code of Federal Regulations Title 45 Part 46 (45 CFR 46) in compliance with state laws and college policies.

Completion of the appropriate training course via the Collaborative Institutional Training Initiative (CITI) Program is a prerequisite for IRB review. You are encouraged to complete your training immediately. The entire application process will be much easier if you complete the training course before working on the request for review.

The IRB reviews proposals that constitute research, as defined by the U.S. Department of Health and Human Services Code of Federal Regulations and The Belmont Report. Research, according to The Belmont Report, “designates an activity designed to test an hypothesis, permit conclusions to be drawn and thereby to develop or contribute to generalizable knowledge (expressed, for example, in theories, principles and statements of relationships). Research is usually described in a formal protocol that sets forth an objective and a set of procedures designed to reach that objective.” In the Code of Federal Regulations (45 CFR 46.102), research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.

Human subjects, sometimes referred to as participants, are living individuals about whom an investigator or investigators (whether professional or student) in the course of research obtain (1) data through intervention or interaction with the individual or (2) identifiable private information.

Click here to view a decision tree that will help you determine whether or not your project requires an IRB review.



Application submission deadlines are as follows:

  • Full board review: 15th of every month
  • Expedited or exempt review: 1st OR 15th of every month

Click here to access the application for requesting an IRB review.

Southeastern University is committed to the ethical conduct of research and has adopted the ethical standards of The Belmont Report. The principles and applications found in The Belmont Report excerpted below provide context for understanding the need for review. The report articulates ethical principles to be applied in the human subjects research setting and explains in a general way how the principles apply.

Guiding Principles and Applications from The Belmont Report

Principle: Respect for Persons. Incorporates at least two ethical convictions: first, that individuals should be treated as autonomous agents and, second, that persons with diminished autonomy are entitled to protection. The principle of respect for persons thus divides into two separate moral requirements: the requirement to acknowledge autonomy and the requirement to protect those with diminished autonomy.

Application: Informed Consent. Respect for persons requires that subjects, to the degree that they are capable, be given the opportunity to choose what shall or shall not happen to them. This opportunity is provided when adequate standards for informed consent are satisfied.

Principle: Beneficence. Persons are treated in an ethical manner not only by respecting their decisions and protecting them from harm but also by making efforts to secure their well-being. Such treatment falls under the principle of beneficence. The term “beneficence” is often understood to cover acts of kindness or charity that go beyond strict obligation. In this document, beneficence is understood in a stronger sense, as an obligation. Two general rules have been formulated as complementary expressions of beneficent actions in this sense: (1) do not harm and (2) maximize possible benefits and minimize possible harms.

Application: Assessment of Risks and Benefits. The assessment of risks and benefits requires a careful arrayal of relevant data, including, in some cases, alternative ways of obtaining the benefits sought in the research. Thus, the assessment presents both an opportunity and a responsibility to gather systematic and comprehensive information about proposed research. For the investigator, it is a means to examine whether the proposed research is properly designed. For a review committee, it is a method for determining whether the risks that will be presented to subjects are justified. For prospective subjects, the assessment will assist the determination whether or not to participate. Furthermore, this benefit must outweigh the risks.

Principle: Justice Requires That People Be Treated Fairly. Researchers should not take from research participants without giving back.

Application: Selection of Subjects. Just as the principle of respect for persons finds expression in the requirements for consent and the principle of beneficence in risk/benefit assessment, the principle of justice gives rise to moral requirements that there be fair procedures and outcomes in the selection of research subjects.

Based on the principles and applications of The Belmont Report and 45 CFR 46, a wide array of factors is considered by the SEU IRB during a review of proposed research. You will be asked to provide documentation regarding informed consent and the selection of subjects. One of the most important factors, related to the principle of beneficence, is the design or protocol of the research project. A key factor in the approval/disapproval decision by the SEU IRB is based on weighing the benefits of the research (as defined above) against the risks to participants. All research projects pose some risk of harm to participants, so the weight assigned to risk in any review is never zero. However, if the design of the research project is flawed, then hypotheses cannot be tested, research questions cannot be answered and no contribution to generalizable knowledge is possible. The benefit side of the benefit-to-reward ratio is given a weight of zero. In this circumstance, even though the risk to subjects is minimal, the proposed research will not be approved.

It is important that research proposals submitted for review clearly articulate the potential benefits of the research and provide sufficient information regarding the design of the research so that the capacity of the research to provide the benefit is established as well as that risks to subjects are clearly identified and addressed.

Different rules apply to research with the general population versus research that may involve vulnerable populations, including children, pregnant women, prisoners and the cognitively impaired. Contact the SEU IRB at irb@seu.edu if your research involves a vulnerable population.