1) "Non-Human Research" Determinations
Only the Rutgers IRB can determine if your study is Non-Human Research. If your study is determined to be "Non-Human Research (NHR)", it does not require IRB review and on-going monitoring
A Few Examples of NHR Research:
Submit your study in eIRB to received an official NHR determination. If you need to amend your NHR Study in the future, as compared to what was initially reviewed by the IRB, you may need to review the changes with the IRB to see if your changes did not affect its NHR status.
2) QA/QI Projects
Quality Assurance (QA) and Quality Improvement (QI) consist of activities that are undertaken to measure the effectiveness of standard accepted processes, programs, or services, the results of which are intended to be shared only with individuals associated with the process, program or service being evaluated. QA/QI projects cannot expose individuals to any additional risks.
3) Classroom-Based Research Projects
Federal regulations require that research protocols involving human subjects be reviewed by an Institutional Review Board (IRB) for the protection of human subjects in research. These regulations also allow certain types of studies to be exempted from IRB Review. Rutgers University abides by an approved “Federalwide Assurance” (FWA00003913) that assures the federal Office for Human Research Protections (OHRP) that the rights and welfare of human research subjects recruited to participate in research activities conducted under the auspices of the university are adequately protected. In the case of a student course-related research project assignment, it may be difficult at times to distinguish between research which would require IRB or exemption review and research which is designed simply to provide an experience in research methodology.
IRB has established the following guidelines for determining when institutional review and approval is necessary for projects that are part of an academic course:
Student projects that are solely classroom directed exercises do not require IRB review if they meet all of the following criteria:
- the primary purpose is a learning experience in the methods and procedures of research; AND
- there is uniformity in the research methods conducted by all students (i.e., all students will use the same instruments or methods (surveys, questionnaires, interview guides), to collect the data and/or consent procedures); AND
- Involve no more than minimal risk; AND
- the project does not include sensitive topics or vulnerable populations, such as children or prisoners; AND
- the data must be recorded anonymously by the students (i.e., with no names, social security numbers, or any other codes that can be linked to a list of names, or the recorded data will not identify the subjects through their behavior); AND
- where and whenever possible, the research takes place in a public setting with public access, such as: a classroom, department, dormitory, or other campus setting, a shopping center, park, or street; AND
- the data will not be used beyond the classroom environment (i.e., the data is only used for instructional purposes, which can include a course paper or oral class presentation only. The data cannot be published or presented at a conference, colloquium, department colloquium or poster presentation and cannot be used in further research by the student, other class members and/or the instructor).
In order to determine if the activities fall under the above policy, Instructors must submit a completed Class-Based Research Assignment Request Form and submit it through eIRB. When in eIRB, please do the following: Under Section 1.0 “Submission Type”, please select, “Request for Determination of Non-Human Subject Research” and answer the rest of the questions as they apply to your class-based research assignment. Then upload the information you’ve completed on the form with any other project-related materials. If the IRB Office determines that all criteria have been meet, then these projects shall be deemed “classroom exercises” and are not subject to full review by the IRB. Written notice of this determination will be sent. **Please note that this determination must be made by the IRB Office prior to students engaging in any human subjects research-related activities. The IRB cannot provide retroactive determinations.**
If the instructor is not certain that all of the eight criteria above have been met, they should contact his/her local campus Institutional Review Board.
For Instructors who would like their students to have the flexibility to design, develop and conduct their individual research initiatives, please note that individual projects are not suited to the item 1 above.
Instead, the IRB requires that these individual-based research projects be formally submitted for IRB review and approval prior to the commencement of any research-related activities. This means that the course instructor can submit a request for exemption review and include a protocol outlining the research activities per the course syllabus. As an example, students projects might involve various types of interview procedures otherwise qualifying under exemption category 2 of the federal regulations.
The IRB will review the information and may grant the instructor a provisional IRB approval that requires follow-up. The provisional approval would be pending that subsequent amendment(s) submission is sent by the instructor to the IRB for review of each individual-based student projects to determine if the criteria to qualify under one or more of the six federally allowed exempt categories has been met.
The amendment submitted by the instructor would include each individual student’s CITI training certificate along with a descriptive narrative about their individual projects (typically a detailed one-five page description of their proposed project and methods including their individual consent process). For the purposes of this guideline, an exemption request form should be completed by the course instructor, and all of the student projects qualifying as exempt shall be aggregated as “one classroom project.” Exemption requests are considered and reviewed by a subcommittee of the IRB.
Requests for granting this type of exemption must be received at the office of the IRB not later than September 12 for the fall term and February 12 for the spring term. In the case of a two-semester course, the request of exemption should be submitted at least a month before the students will begin their projects.
**Please note that requests for exemptions must be made by the IRB prior to students engaging in any human subjects research-related activities. The IRB cannot provide retroactive approvals.**
All non-exempt student research projects must be submitted for expedited or full-board IRB review. A faculty member may choose to have their students design and conduct individual projects that do not qualify under an exemption category.
All requests for review of non-exempt projects that are to be completed during any semester must be submitted to the ArtSci IRB in accordance to our published deadlines. In the case of a two-semester course, the students should submit their requests for review at least a month before they wish to start their data collection.
It shall be the responsibility of faculty members to familiarize themselves with the Rutgers regulations for approval of these projects, to review and, if necessary, to assist students in the modification of each project before it is submitted to the IRB office. The IRB is aware that, if approval of student projects is not obtained according to the above schedule, it may not be possible for the projects to be completed in timely manner, and will provide consultation to the extent that its resources allow.
4) Pilot Studies
A Pilot Study is a small-scale experiment or set of observations undertaken to decide how and whether to launch a full-scale project. A pilot would not contribute to generalizable knowledge and therefore is not considered research and does not require IRB review. Data collected from a pilot study cannot be used as research data.