Institutional Review Board (IRB) & Human Research Subjects

Research Development Resources
- Project Development
- Institutional Review Board (IRB) & Human Research Subjects
- Award Management
- Policies

The mission of Pratt Institute’s Human Research Subjects Committee / Institutional Review Board (IRB) is to ensure quality research involving human subjects conducted under the auspices of the University. The IRB is guided by ethical principles outlined in the Belmont Report (1979) and legal mandates outlined in the Code of Federal Regulations Title 45, Part 46 (2009).

All projects conducted at Pratt involving human subjects that meet the definition of research must be reviewed by the IRB. Before submitting an IRB application, use the IRB Decision Tree to see if your project requires IRB approval.

IRB Decision Tree [PDF]

The main purpose of the IRB is to ensure the protection of human subjects through the review, approval, modification, or disapproval of research applications submitted by faculty, staff, or students. The IRB is responsible for communication, record keeping, reporting, monitoring, education of the campus community about ethical issues, and the overseeing of all research activity involving human subjects.

Required Materials

Download and complete the Human Subjects Research Application [PDF]. Once complete, submit it through the IRB Protocol Submission Form for consideration. Applications submitted through other methods will not be accepted. Students are required to have a faculty member serve as an advisor for any student project.

Human Subjects Research Application [PDF]

For the most efficient review, please download the latest Human Subjects Research Application each time you start a new IRB protocol request. Since procedures and application requirements are periodically updated, using the most current forms helps ensure your submission has everything it needs from the start. Depending on your research, you may also need to include additional documents such as sample surveys, consent forms, or recruitment materials. Check the instructions on the Human Subjects Research Application to see what applies to your project.

All researchers must complete CITI certification. Proof of certification should be submitted with the Human Subjects Research Application. The application is a fillable PDF; download and open the form in Adobe Acrobat, which is free for full-time Pratt students, faculty, and staff.

Submit all application materials as PDFs via the IRB Protocol Submission Form.

IRB Protocol Submission Form

Collaborative Institutional Training Initiative (CITI) Requirement

Researchers are required to take the Collaborative Institutional Training Initiative (CITI)’s online Responsible Conduct of Research training through Pratt Institute’s subscription. Once you complete your training and receive a certificate of completion, please upload the PDF of the certificate with your Human Subjects Research Application, or email it to irb@pratt.edu.

Pratt-specific guide on how to register for your CITI account and begin training [PDF]
How to set up your CITI account [external link]
How to download your certificate of completion [external link]

The CITI portal and required training are subject to change to align with institutional and federal guidelines, as well as research best practices. Current guidelines and practices will be updated on this webpage.

How to Submit Your Project for IRB Review

Prior to filling an application, use the IRB Decision Tree [PDF] to see if your project meets the definition of human subjects research, and therefore requires an IRB protocol request. Read this document carefully. If there is any doubt as to whether or not your activities could qualify as human subject research, please contact us at irb@pratt.edu. Students who are still unsure after using the IRB Decision Tree should first check with their advisor or professor before contacting our office.
- Possible situations to consider:
  - Educational activities: While individual theses and research papers might need IRB approval, class projects distributed by instructors that are primarily educational activities do not require IRB approval. However, instructors are responsible for ensuring that the project is conducted ethically. For example, if students collect data from other students, the instructor should ensure that the students cannot be identified.
  - Research component: If a class project has both an educational component and a research component (leading to publication, distribution, and/or upload to the Pratt Library and ProQuest), IRB review is required. This includes projects where the instructor plans to use the data collected by students for their own research.
  - Systematic investigation: If the project is a systematic investigation that aims to contribute to generalizable knowledge, IRB review is required. This includes projects that contact human subjects or use archival data that could be connected to humans.
If your project meets the definition of research involving human subjects based on the IRB Decision Tree, complete the Human Subjects Research Application [PDF]. Do not include documents like your thesis statement; simply answer the questions as directly and succinctly as you can. Additional documents that are not required for IRB review and do not impact the result of the protocol request may not be reviewed.
Adapt the Consent Form for Adults [Google Doc], Consent Form for Minors [Google Doc], and/or the Oral Consent Guidance [Google Doc], as is applicable to your project. These can be uploaded to the submission form, alongside your Human Subjects Research Application. If your project relies on supplementary materials such as recruitment protocols or survey questions, these should be included with your application. All attachments should be attached as PDFs only; Google Doc links, Word Docs, or Pages documents cannot be accessed reliably and will therefore cause delay in review.
Everyone listed on your application, including co-researchers, community collaborators, and faculty advisors, must be CITI-certified. If you are not yet certified with CITI’s online Responsible Conduct of Research Training, set up your account and begin your training [PDF]. For clarification on who on your team needs IRB and CITI approval, please reference the FAQs. Applicants must provide PDFs of CITI Certifications for themselves, their collaborators, and their faculty advisors, where applicable. Forwarded emails from CITI will not be accepted.
Submit your project for review through the IRB Protocol Submission Form. Email submissions will not be accepted. Be advised that the minimum review time for applications is 30 days. This does not guarantee approval at 30 days—simply that the proposal will be reviewed within 30 days of submission. If revisions are required or additional processes must be completed, the turn-around time can be longer. It is recommended that all applicants submit their IRB applications at least six weeks prior to the intended start of research.

Note: While you will be able to submit an IRB Human Subjects Research Application before completing CITI training, you may not publish your research until the Office of Research and Strategic Partnerships receives a certificate of your completion. A graduate thesis qualifies as a publication and if it involves human subjects research, IRB and CITI certification are required, prior to thesis submission. Pratt administration is unable to access your CITI certification unless you provide a PDF certificate of your training. Please do not forward your CITI completion email to our office; we will only accept PDFs.

If you have already submitted an IRB application or have been approved by Pratt’s IRB, please attach your certificate of completion as a PDF to the email chain wherein you received your approval. Otherwise send the PDF to irb@pratt.edu. If you have completed your CITI certification before submitting an IRB request, please attach your certificate of completion PDF with the rest of your application.

If you are a faculty advisor providing CITI certification, please clearly indicate the name(s) of your students whose applications will need to be updated.

If you have any additional questions, please contact irb@pratt.edu.

Resources for Students, Instructors, and Advisors

If a student needs IRB approval to complete course or graduation milestones, these tips and resources might help to make the process as efficient as possible.

CITI training leads to fewer revisions and prompt approval. Completing CITI training, including the optional Foundations course, will allow for earlier IRB Protocol submissions and help to make the process shorter.
Thesis drafts are not required for IRB approval. For human research to be approved, applicants do not need to supply complete theses, literature reviews, or writing plans. Applicants only need research plans, sample materials, and adapted consent forms to apply. Additional documents that are not required for IRB review and do not impact the result of the protocol request approval may not be reviewed.
Revisions are common and may delay approval. Most revisions concern incomplete applications and a lack of understanding of concepts covered in CITI training. In accordance with Pratt’s federal compliance responsibilities and researchers’ ethical responsibilities, it is important that protocol requests are complete and informed.
Additional processes may be necessary. If your research is higher risk, involving physical activity, wearable devices, or tactile materials, you may be institutionally required to provide new liability or consent forms. If your research involves collaborators external to Pratt Institute, you may be required to sign a data transfer agreement. These forms must be generated by the Institute before research begins, and can delay approval. While our office is prepared to help you navigate these processes and discuss amendments to your research, these requirements are binding and, in the case of certain research scenarios, cannot be avoided. For more information, please see the FAQs at the bottom of this webpage.
Students must attach their faculty advisor’s CITI certification to their IRB Protocol Request. Due to the high amount of requests our office receives and the amount of CITI certifications we manage, we request faculty advisors give each student a PDF of their CITI certification so that it can be submitted with that student’s IRB protocol request. If CITI certification is not yet completed upon application, we ask that students or faculty be responsible for sharing the certification with irb@pratt.edu as soon as possible, with the names of students whose IRB Protocol Requests the certification should be attached to.
IRB processes might delay your students’ timelines. Our office regularly adapts to comply with federal and institutional guidelines. That said, some newer processes might necessitate curricular adaptations as well. If you are a professor or mentor concerned about how the IRB approval process might require changes in your syllabi or programming, please reach out to irb@pratt.edu.
Students should seek support from their advisor and/or professor before engaging in the IRB process. While our office is happy to discuss revisions and research projects, our ultimate goal is to facilitate compliance with federal and institutional guidelines. We encourage our faculty partners to familiarize themselves with IRB guidelines and processes so that syllabi, course requirements, and student success are aligned with ethical research standards.
Research involving human subjects may not begin until it is IRB approved. Research is not IRB-approved until an applicant receives a formal and dated approval letter from our office. Research begins upon the recruitment of or interaction with human subjects. Instructors, advisors, or professors cannot provide IRB approval for research involving human subjects.

The Office for Human Research Protection (OHRP) has a published resource guide [PDF] that can help educators and researchers navigate the IRB process.Educators in our office are happy to discuss approaches to curricular planning around IRB approval. Please contact irb@pratt.edu if you would like to discuss how your course might be updated to better accommodate IRB approval timelines.

Educators in our office are happy to discuss approaches to curricular planning around IRB approval. Please contact irb@pratt.edu if you would like to discuss how your course(s) might be updated to better accommodate IRB approval timelines.

Frequently Asked Questions

Exempt and Expedited are official categories of research defined by the U.S. government. Despite the names, both require submission to the IRB for review and approval.

“Exempt” research may qualify for exemption from certain regulations, but it still must be reviewed by the IRB.
“Expedited” research is not faster. Expedited review applies to projects that involve the collection of biological samples or physical engagement, and still goes through the standard IRB process.

Most research at Pratt falls under the Exempt category, which typically involves studies on human behavior.

A third category, Full Board Review, is required for research that involves greater or more complex risks to participants. Pratt does not offer Full Board reviews, which is usually reserved for advanced or high-risk studies.

Examples include publication in a scholarly journal, presentation at a professional conference, sharing results with a newspaper reporter, or a presentation to an outside client for a capstone course. Thesis or capstone projects conducted to meet the requirement of a graduate degree are usually considered generalizable, meaning they require IRB approval.

Oral presentation to classmates and the course instructor(s) in a research methods course or internal presentation to Pratt administrators for utilization and review purposes are NOT considered publication.

There are a set number of courses that should automatically populate in your Pratt CITI account upon registration:

Human Subjects Research – Foundation (Optional, but highly recommended)
- Defining Research with Human Subjects
- Privacy and Confidentiality
- History and Ethics of Human Subjects Research
- Informed Consent
Human Subjects Research – Special Topics Studio
- Privacy and Confidentiality
- Introduction to Community-Engaged Research
- History and Ethics of Human Subjects Research

The CITI portal and required training are subject to change to align with institutional and federal guidelines as well as research best practices. Current guidelines and practices will be regularly updated on this webpage.

CITI certification is required by law to obtain IRB approval. It covers regulatory compliance with relevant guidelines like the Common Rule, ensuring researchers are aware of and compliant with the legal and ethical guidelines for conducting research.

As researchers we have an obligation in human subjects research to respect participants, minimize harm, and ensure fair treatment. Key principles of ethical research include obtaining informed consent, protecting confidentiality, and avoiding deception. These principles are rooted in the idea of beneficence (doing good), non-maleficence (avoiding harm), respect for persons (autonomy), and justice (fairness).

No. Full Board Reviews are only reserved for research of human subjects that present more than minimal risk, i.e., risk greater than what one might encounter in daily life or routine exams.

Pratt cannot offer Full Board Reviews. While this might sometimes involve children, interaction with minors can still be categorized as Exempt research if it does not present more than minimal risk, thereby only requiring an Exempt approval.

Please review our definitions of Exempt and Expedited research in this FAQ for more info, and also note that we provide sample consent forms for minors.

A “vulnerable participant” is any individual whose ability to consent to participate in research might be compromised. Federal regulations have identified particular “vulnerable populations” and “categories” which you can review on the National Institute of Health (NIH)’s website. UVA has also compiled robust resources on the topic.

In the context of behavioral and exempt research, you may still acquire approval to conduct research with vulnerable participants, provided you justify their participation and make clear how you will obtain informed consent. CITI training, especially the recommended Foundations course, gives thorough definitions of informed consent, as well as historical context as to why it is ethically imperative.

No. IRB approval is reserved for interaction or intervention, not for observation. Taking images of public places like town halls or city streets, even if there are people in the images, does not qualify as interaction. If you wish to observe or take images of events or places that are not public, however, you must obtain consent from the individuals or from their parental guardians if they are minors. You should follow Pratt’s Marketing Photo/Video Consent Policy and Guidelines and use Pratt’s Photography/Videography Consent and Release Form to obtain consent.

Our IRB Decision Tree is designed to help you decide if your research needs IRB approval. It includes federally written language about interacting with experts, as opposed to interacting with private citizens:

“If data are exclusively being collected from community leaders, elected officials, industry experts, or medical professionals, and they are speaking from their own professional experience and expertise, IRB review is not required. However, they are not allowed to share information or speak on behalf of patients, clients, or constituents unless you have IRB approval.”

This means if you are only interacting with public officials, doctors, or other community leaders about already generalized knowledge, public information, or their general expertise, you do not need consent forms or IRB approval to engage in that research. As soon as this interaction strays to information that is not generalized or public, which deals with other human beings who are private citizens, it requires IRB approval. Examples of interactions with experts that require IRB approval include: a doctor speaking on experience with a specific patient, or a public servant invoking one of their private constituents.

To avoid this happening during your research, we recommend beginning verbal interactions with these subjects with the following language:

“I do not have IRB approval from my institution to conduct this research, meaning our interaction cannot involve or invoke private citizens beyond your generalizable or public work as an expert or community leader. I ask that you thereby focus on generalizable and public information only, and that you do not invoke any other private citizens at any point in our interaction.”

The threshold to adding someone as a co-investigator and/or additional persons needing IRB approval is if these individuals have access to data before it is anonymized. Anyone that has access to data before it is disentangled from non-confidential identifiers to human subjects must obtain IRB approval before engaging with that research.

If your research will be shared with another institution, you must also provide an IP or data transfer agreement.

Privacy relates to methods of gathering information and having control over the extent, timing, and circumstances of sharing oneself with others. Confidentiality refers to the protection of information disclosed to you and the treatment of consent.

With respect to informed consent, researchers should be mindful of these definitions when adapting consent forms and in what they guarantee participants. These topics are covered in the optional Foundations course in CITI training.

IRB only applies to human research participants in the U.S. If 1) your research includes participants both inside and outside of the U.S. and/or 2) research with U.S. participants will be conducted outside of the U.S., research projects must be approved by the local equivalent of an IRB before you submit an IRB Protocol Request at Pratt. If your research only includes non-U.S. participants, we are unable to offer approval, and encourage you to seek the local equivalent.

Where there is no equivalent board or group, investigators are expected to consult with local experts and/or community leaders and secure their support of the research. We require that there be a good faith effort made to secure local compliance and to document those efforts as part of the application.

Federal guidelines define physical activity broadly—anything beyond a participant’s everyday movements (e.g., sitting, standing) counts. If your research involves physical activity, health monitors, wearable devices, or tactile materials with any physical risk (even minor), participants may need to sign a liability form in addition to the standard consent form. These liability forms must be created and/or approved before IRB approval is granted.

When you submit your IRB Protocol Request, you’ll answer questions to determine whether your research involves these elements. If so, you’ll indicate whether the research takes place on or off campus:

Off campus: Supplement Pratt’s IRB with a liability form from the external facility.
On campus: Pratt’s IRB and Legal Counsel will generate the liability form.

In both cases, signed forms must be submitted to our office before research begins.

Exception: New liability forms aren’t needed if participants have already consented to the activity elsewhere—for example, Pratt students engaging in coursework-aligned research they consented to upon enrollment, or participants in an existing external course who’ve already signed a waiver. In these cases, the standard Informed Consent Form (for adults or minors) is sufficient.

If our office determines your protocol request is incomplete, needs more supplementary materials, or clarifying information, we will let you know via email, where we will also provide clear instructions on how to proceed.

Our office can take up to 2 weeks to respond to revisions provided via email. If you receive a notice that revisions are needed, we recommend you reply promptly and thoroughly.

Per the guidelines on this webpage, our office guarantees a preliminary review of IRB Protocol Requests within 30 days of submission. Applicants should not expect or request shorter review times.

Please also note Pratt’s Administrative Holiday Schedule and consider how closures (e.g., the two-week closure for Winter Break and New Year’s observations) might delay our office’s response to email inquiries.

Institutional Review Board (IRB) & Human Research Subjects

Required Materials

Collaborative Institutional Training Initiative (CITI) Requirement

How to Submit Your Project for IRB Review

Resources for Students, Instructors, and Advisors

Frequently Asked Questions

What are the Exempt and Expedited research categories, and how do I know which one my project falls under?

What counts as publishing research?

Can I publish findings from research that did not have IRB approval?

How can I troubleshoot enrolling in CITI training?

What are the required CITI courses/modules?

Why do I have to be CITI-certified?

How long is CITI certification valid?

Which of my collaborators need to be CITI-certified?

Does interacting with children automatically require a Full Board Review?

Who are “vulnerable participants,” and how can this distinction impact the categorization or approval of my research?

Do I need IRB approval to take images or observe public places or events?

Who qualifies as “community leaders, elected officials, industry experts, or medical professionals,” and why don’t I need IRB approval to speak to them?

Which of my collaborators need to obtain IRB approval?

What is Pratt’s IP policy?

Who can I share my research with?

How long can data be stored?

What is the difference between privacy and confidentiality?

Can research be conducted outside of the U.S.?

Can I conduct research that involves physical activity, wearable devices, and/or tactile materials?

What happens if revisions are needed?

Why do I get an auto-response from the IRB email?

Will research be approved during holidays?