Human Research Protections Program
The mission of the IRB is to protect the rights, privacy, and welfare of human participants in research conducted by Princeton University faculty, staff, and students.
Frequently Asked Questions
What does "IRB" stand for?
The IRB stands for Institutional Review Board.
What does the IRB oversee?
The IRB oversees human subjects research. Both components (“human subjects” and “research”) have to be met for the IRB to oversee it.
What are the definitions of "human subjects" and "research"?
“Research” is defined as a systematic investigation designed to develop or contribute to generalizable (widely applicable) knowledge.
"Human subject" is defined as a living individual about whom an investigator (whether professional or student) conducting research obtains data through intervention or interaction with the individual, or obtains identifiable private information (no intervention or interaction required).
Note that if your proposed research activity involves a drug, device, or biologic, other regulations and definitions may apply. Please contact the IRB for further clarification.
Can a student conduct human subjects research?
Yes, the regulations directly address that students can be investigators in human subjects research. However, all student-led research must have a faculty member identified as the principal investigator on their research application. The individual designated as PI must be eligible to serve as a PI at Princeton. Please see the PI eligibility criteria here
Can my activities done as part of an internship, summer work, junior project, or senior thesis constitute human subjects research?
Yes, any of these activities may constitute human subjects research.
Is it possible to conduct human subjects research without any interaction with individuals?
Yes, if you will obtain private identifiable information about individuals for research purposes. Definitions of these key terms follow:
- “Obtains” means obtaining, using, studying, analyzing, collecting, gathering, or viewing.
- “Private” means that the data are about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place OR the individuals have provided the data for specific purposes in which the individuals can reasonably expect that it will not be made public, e.g, tax record, medical record, or educational record.
- “Identifiable” means that the investigator can readily ascertain or associate the information with the individuals’ identities. Examples of identifiers include names, social security numbers, medical record numbers, OR any other code that permits the data to be linked to individually identifiable living individuals.
Is it possible to conduct human subjects research without the recording of private identifiable information?
Yes, even if you are not recording private identifiable information, if you are obtaining it for research purposes, the activity is human subjects research.
If I’m interacting with individuals and obtaining data from them, but the data is not private and identifiable, does this mean I’m not doing human subjects research?
If you’re obtaining data through intervention or interaction with an individual for research purposes, the activity is human subjects research, though the data is not private and identifiable.
If I’m interacting with individuals and obtaining data from them, and the data is private and identifiable, does this mean I’m doing human subjects research?
Not necessarily. The activity may not be human subjects research because the knowledge from your systematic investigation may not be designed to be generalizable (widely applicable).
Example: If you are interacting with individuals to improve Princeton University, the activity may not be designed to develop or contribute to generalizable (widely applicable) knowledge.
Example: If you are interacting with individuals to learn about the history of Princeton University the activity may not be not designed to develop or contribute to widely applicable knowledge.
The IRB Review Process
Where are the IRB forms?
The forms are on the Forms Page of our website.
What are the components of a new study submission?
A new study submission consists of the following:
- Initial review application: either the exempt application or the expedited/full board application. The individual designated as PI must be eligible to serve as a PI at Princeton. Please see the PI eligibility criteria here.
- Signatures: the form must be signed by the PI and the student investigator (if applicable). Signature information can be found here
- If applicable: the consent form using the template on our Forms page.
- If applicable: the survey, questionnaire, and interview guide.
- Verification of human subjects training. This is a one-time training requirement. The training can be from any source if the training directly addresses human subjects research. For example, training in conflicts of interest, biosafety, animal research, or responsible conduct of research work will not be recognized. Please see pages 5-6 of Princeton University IRB SOP 202 for details.
How can I minimize delays in the IRB review process?
- Submit only one version of each document. For example, submit the IRB application, not the IRB application and a copy of the IRB application
- Submit via one method (e-mail or delivery)
- The principal investigator and the student (if applicable) must sign the application.
- Provide verification of human subjects training for the PI and all research personnel.
- Submit the study measurements (survey, questionnaire, and interview guide).
- Use the current IRB templates (application and consent).
- Use simple, direct language in the consent form that is targeted to your audience.
- If the IRB asks for revisions, reference your IRB project number. Include a tracked change response and a clean copy. Only submit the items we ask for. In other words, if we ask for revisions to the application, do not resubmit the consent form.
How do I submit my study?
You can either email your submission to the IRB ( firstname.lastname@example.org ) or deliver the submission to the IRB Office at 87 Prospect Avenue, room 310.
I submitted my study to the IRB. Can I start my study now?
No. You must not do human subjects research until you receive the IRB approval letter.
I received a letter from the IRB that states that my study was conditionally approved. Can I start my study now?
No. You must not do human subjects research until you receive the IRB approval letter.
When will the IRB implement an electronic submission system?
The tentative date for implementation of our new electronic submission system is summer 2017.
When will my item be reviewed?
Submissions are reviewed within 5 business days of submission. The most common decisions are approve; approve pending revisions; or assignment to a convened Board (which occurs monthly, except for the summer). Please see the "Institutional Review Board" section of our site for the meeting schedule. Note that only 1% of submissions require review by the convened Board. Even so, we encourage you to submit your item as soon as possible.
Do I have to use the informed consent template?
We encourage you to use the informed consent form template. Since it's a template, you can modify it according to your study's needs. However, substantial variations may result in a delay of the review process.
Why isn't there an assent template?
The assent form should be an explanation of the proposed research procedures in a language that is appropriate to the child's age, experience, maturity, and condition. The explanation should include a discussion of any discomforts and inconveniences, in non-technical terms, the child may experience if she or he agrees to participate. Due to these variables, the investigator is in a better position to draft the assent form.
What are my obligations as an investigator?
Princeton University SOP 207: Obligations of the Principal Investigator for Human Subjects Research lists the investigator's obligations.
What if I'm unsure whether my activity is human subject research?
E-mail a synopsis of the proposed activity (2-3 paragraphs) to the IRB. Please include the following in the synopsis:
- Study funding
- Study procedures
- Any draft study measurements (survey, questionnaire, and interview guide).
What if I'm collaborating with a researcher from another institution or organization?
Your role in the human subjects research may engage Princeton University in the research. E-mail a synopsis of the proposed activity (2-3 paragraphs) to the IRB. Please include the following in the synopsis:
- Study funding
- Study procedures
- Any draft study measurements (survey, questionnaire, and interview guide). We will determine whether your role in the research requires Princeton IRB review.
My study was given exempt status. What does this mean?
Exempt studies are still human subjects research and must be submitted to the IRB for an exempt determination. Once the IRB determines that the study has exempt status, the investigator must follow the IRB-approved protocol. The investigator is also required to submit modifications to an exempt study before implementing the modification. Note that exempt studies do not require an annual renewal. However, when the study is complete, the PI must submit a closure request to the IRB. See further clarification about study closure elsewhere on this page.
What if I want to modify my approved study?
All modifications must be approved by the IRB before implementation of the modification. If you want to change the protocol (conduct of the study) or any other aspect of the study (e.g., research personnel, consent form edits, recruitment changes, number of subjects, etc), please submit a modification request form signed by the PI. Please include any new documents and any previously approved documents that are affected by the modification, e.g., initial review application that serves as the protocol; consent form; recruitment materials; survey, questionnaire, interview guide. Submit clean and tracked change versions to allow the IRB to identify the change. After the IRB approves it, you can implement the change.
The expiration date of my study is approaching. Do I need to submit a continuing review?
Continuing review and re-approval of a research project at least annually is required so long as the project continues to involve human subjects. OHRP considers a research project to continue to involve human subjects as long as the investigators conducting the research continue to obtain:
- Data about the subjects of the research through intervention or interaction with them; or
- Identifiable private information about the subjects of the research.
With respect to obtaining identifiable private information , OHRP considers this to include obtaining identifiable biological specimens originating from living individuals. Furthermore, OHRP considers obtaining identifiable private information to include :
- Collecting or receiving identifiable private information (including identifiable biological specimens) from any source (i.e., not already in the possession of the investigator);
- Collecting identifiable private information by observing or recording private behavior without interacting or intervening with the human subjects; and
- Using, studying, or analyzing identifiable private information (including identifiable biological specimens), even if the information was already in the possession of the investigator before the research begins. This includes using, studying, or analyzing any of the following:
- Identifiable private information obtained by interacting or intervening with the human subjects;
- Identifiable private information stored in documents, records, photographs, images, video recordings, or audio recordings provided to the investigators from any source;
- Identifiable private information stored in documents, records, photographs, images, video recordings, or audio recordings already in the possession of the investigator before the research begins;
- Identifiable private information obtained about an individual by interviewing other people (e.g., an individual’s healthcare provider or teacher);
- Identifiable biological specimens provided to the investigators from any source; or
- Identifiable biological specimens already in the possession of the investigator before the research begins.
A research project no longer involves human subjects once the investigators have finished obtaining data through interaction or intervention with subjects or obtaining identifiable private information about the subjects, which includes the using, studying, or analyzing identifiable private information. Once all such activities described in the IRB-approved protocol are finished, the research project no longer needs to undergo continuing review. For example, when the only remaining activity of a research project involves the analysis of aggregate data sets without individual subject identifiers, no further continuing review is necessary. At that point the IRB can formally close the IRB file for that project and advise the investigator of that action. Similarly, simply maintaining individually identifiable private information without using, studying, or analyzing such information is not human subjects research and thus does not require continuing review.
IRB approval for my study expired. What does this mean?
Once IRB approval expires, you must stop all research activities. This includes recruitment, advertisement, screening, enrollment, consent, interventions, interactions, and collection or analysis of private identifiable information.
I need to speak with someone about my IRB application. Is someone available and do I need an appointment?
You're welcome to call the IRB (609-258-0865) or stop by the IRB office at 87 Prospect Avenue, room 310. An IRB representative is almost always in the office. An appointment is not required.