According to 45 CFR 46, a human subject is "a living individual about whom an investigator (whether professional or student) conducting research:
Are you conducting human subject research? Will your study contribute to generalizable (scholarly) knowledge? Have you developed research questions?
If so, reflect on the meaning of a systematic investigation, which is an activity involving a prospective plan that incorporates data collection, either quantitative or qualitative (or a combination of both), and data analysis to answer a research question. If your study includes both human subjects and systematic investigation, you will likely need to submit it to TC IRB. For further support in determining whether your study includes human subjects, please refer to the U.S. Department of Health and Human Services' Human Subject Regulations Decision Charts.
Does your research include any (or all) of the following? If so, it will likely qualify as a systematic investigation.
Dissertation projects involving human subjects conducted to meet the requirement of a graduate degree are typically considered generalizable (as they will be made public) and require IRB review and approval. All dissertation research for graduation should be submitted after a successful proposal hearing defense. Please review our Doctoral Dissertation Research and the IRB blog for more guidance.
Classroom exercises or projects solely to fulfill course requirements or to train students in the use of particular methods or devices (under the guidance of a faculty member) are not generalizable (not research) and likely do not need IRB review. If students will practice research methodologies on human subjects, they should be instructed in the ethical conduct of such activities and be advised to obtain informed consent from their practice participants. Faculty members can direct students to review the Training & Certification resources. Masters students conducting research for their integrative project or masters' thesis should consult our Master’s Students and the IRB guidance to determine whether to submit their project to TC IRB.
If an instructor determines that there is a possibility that a student's proposed research project may result in a formal presentation or publication, the instructor should recommend that the student submit the project for IRB review before beginning the study. If you are unsure if your research should be reviewed by the IRB you can contact IRB@tc.edu or call 212-678-4105.
A student or instructor may wish to access and analyze previously collected data with the intent of contributing to generalizable knowledge. In this case, the primary investigator should submit an IRB protocol for review and explain how the study was originally collected for educational purposes. For example:
Now that you have a better understanding of human subject research, generalizable knowledge, and systematic investigation, you will want to familiarize yourself with IRB regulations and review categories before beginning any IRB protocol. To begin, visit our Training & Certification page and review the information on how to get human subject research trained and certified. CITI certification is required before an IRB protocol can be approved.
IRB reviewers will determine, based on your actual submission, if your protocol is exempt, expedited, or full review. However, if you need additional support determining your IRB review category, please download the following documents:
For further information on preparing your research study, please see the information below.
All Key Personnel involved with human research subjects must have a current and complete Human Subjects Protection Certification and should be familiar with federal regulations and TC IRB policies. Key personnel is defined as the Principal Investigator (PI), research collaborators, research coordinators, research assistants, external researchers, research staff, administrators, and other investigators who are directly involved in conducting research with study participants or who are directly involved with handling private information related to study participants during a research project. For more information, please see our Training & Certification page.
Please see our Review Categories page for a complete description of each category.
Exempt Research: Constitutes no more than minimal risk AND only involves human subjects in one or more of the following categories:
Note: Federal regulations indicate that certain research is exempt from review. However, under Teachers College's Policy for the Protection of Human Subjects, a research protocol proposing the use of human subjects must be submitted to the IRB to determine if it qualifies for exempt status. Exemptions do not apply to research conducted with pregnant women, prisoners, or vulnerable populations.
If you need additional support determining if your protocol is exempt, please review the following guide: Is my protocol exempt from IRB review?
Expedited Research: Constitutes no more than minimal risk AND only involves human subjects in one or more of the following categories:
If you need additional support determining if your protocol is expedited, please review the following: Does my human subjects research fall under the expedited review category?
Full Board: Studies that involve more than minimal risk require review at a fully convened IRB meeting. Studies that involve deception require full board review. The full board meets monthly. Meeting dates for the full board are posted in the Meetings and Deadlines page. Research submitted as a full review requires approval from a majority of IRB members.
Standard Review of Research: All IRB members have an opportunity to review or comment on any project approved by expedited or exempt review. If the Chairperson decides that a project should not be approved by expedited or exempt review, the project will be reviewed at the next convened full board meeting using the standard practices for new and continuation applications.
An IRB protocol may include materials for different audiences, including IRB reviewers, participants, and in some cases, parents or caregivers who will consent on behalf of the child participant. Researchers must distinguish between writing for a general audience, versus an academic or scientific audience. Discipline-specific language or jargon might not be appropriate for use with participants. Please visit our Writing for an IRB Review page for more information on writing for the correct audience.
The Primary Investigator (PI) is the primary individual responsible for the preparation, conduct, execution, and administration of a research grant, cooperative agreement, training or public service project, contract, or other research projects in compliance with applicable laws and regulations and institutional policy governing the conduct of research.
As the PI of record for a protocol, you are required to:
Failure to adhere to your responsibilities as a study PI can result in action by the IRB up to and including suspension of your approval and cessation of your research.
A Co-Investigator (Co-PI) is key personnel who has responsibilities similar to that of a PI on research projects. While the PI has ultimate responsibility for the conduct of a research project, the Co-PI is also obligated to ensure the project is conducted in compliance with applicable laws and regulations and institutional policy governing the conduct of sponsored research.
Each PI and Co-PI must confirm (a) that they will comply with all regulatory compliance directives; (b) that all information submitted within the proposal is true, complete, and accurate to the best of their knowledge; (c) that any false, fictitious, or fraudulent statements or claims may subject the investigator(s) to criminal, civil, or administrative penalties; (d) and that the investigator(s) agree to accept responsibility for the conduct of the project and to provide all required reports as applicable if a project is awarded as a result of the proposal.
The PI and Co-PI confirm that they understand their responsibility to abide by the IRB's and sponsor's policies, procedures and directives for the proper administration of research with human subjects.
If you are a student, you must secure a faculty sponsor to support you in your research efforts. Faculty sponsors hold an important role in guiding students who are planning or are in the process of submitting IRB applications for review. Faculty sponsors should provide recommendations about research design aimed at reducing the risk to human subjects while also serving as a point of contact for human subject concerns and questions. A faculty sponsor is required for all students conducting human subjects research.
After you save your protocol in TC's Mentor IRB, your faculty sponsor will automatically receive an email notice requesting they accept their faculty sponsorship role in Mentor. The faculty sponsor must approve the application prior to IRB submission on Mentor. TC IRB will not review a student's IRB protocol until the faculty sponsor has approved their role on the protocol.