11.1 What requires IRB approval?
- See OHRP decision charts here.
- Any systematic investigation that is designed to develop or contribute to generalizable knowledge via interaction (or obtaining identifiable data about) with living individuals.
- Determinations can be obtained by completing an online determination form that is available on our forms page or by contacting our office.
- Exempt research and not human subjects research are different. Exemptions are issued by the IRB and are to be conducted in accord with the Common Rule. It is the IRB's recommendation that any study involving "humans" abide by the Belmont Report.
11.2 Do I need IRB approval if my grant proposal lacks definite plans for involvement of human subjects, but eventually will?
- In consultation with Sponsored Programs we can issue what is known as a 118 determination; this is sometimes known as an approval in principle. More information: https://www.ecfr.gov/cgi-bin/retrieveECFR?gp=&SID=83cd09e1c0f5c6937cd9d7513160fc3f&pitd=20180719&n=pt45.1.46&r=PART&ty=HTML#se45.1.46_1118
11.3 Retroactive IRB approval
- There are no provisions in the federal regulations that allow the IRB to approve research that has already been conducted.
11.4 Does the IRB have a stance on scholarly and journalistic activities?
- Generally, scholarly and journalistic activities do not fall within the scope of the IRB.
- For more details on guidance from OHRP.
11.5 Pilot study, do I need IRB review?
- Usually not. A pilot study is preliminary feasibility study or test that is conducted with a small number of people. They are to help investigators refine procedures and/or processes and are not designed to contribute to or create generalizable knowledge and are not considered human subjects research that requires IRB review. Data collected from a pilot must not be used as research data. If you are planning a pilot study that involves invasive or biomedical procedures or may involve more than minimal risk activities contact the Office of Research Compliance. Regardless of the need for IRB review, any pilot must be conducted according to sound and ethical research practices including those stated in the Belmont Report.
11.6 Do Public Health Surveillance activities require IRB review?
- Generally, public health surveillance activities do not fall within the scope of the IRB.
- For more details on guidance from OHRP.
11.7 Is my study regulated by the FDA and does it invoke 21 CFR 50?
- The FDA defines a human subject as an individual who is or becomes a participant in research, either as a recipient of the test article or as a control. A subject may be either a healthy human or a patient.
- A test article is defined as any drug (including a biological product for human use), medical device for human use, human food additive, color additive, electronic product, or any other article subject to regulation under the act or under sections 351 and 354-360F of the Public Health Services Act.
- A clinical investigation is any experiment that involves a test article and one or more human subjects and that either is subject to requirements for prior submission to the FDA under section 505(i) or 520 (g) of the act, or is not subject to requirements for prior submission to the FDA under these sections of the act, but the results of which are intended to be submitted later to, or held for inspection by, FDA as part of an application for a research or marketing permit. The term does not include experiment that are subject to the provisions of part 58 (21CFR) of this chapter, regarding nonclinical laboratory studies.
- To know more about 21 CFR 50
- KSU IRBs are not able review FDA-regulated and KSU cannot serve as a sponsor at this time.
- Review can be coordinated with Advarra. There is a cost associated with this service. Please contact researchcompliance@kent.edu if you have questions about FDA regulations or to coordinate Advarra review.
11.8 Practicum and Internship Guidance
Practicums and internships are required by many academic programs and offer students an excellent opportunity to gain firsthand experience in their field of study. The majority of practicums and internships do not involve human subjects research. However, practicums and internships that include systematic investigations that are designed to develop or contribute to generalizable knowledge may require IRB review.
Common internship and practicum activities and scenarios are listed below along with guidelines for IRB review. In all circumstances, students are to adhere to the principles of the Belmont report and abide by relevant professional ethics. The faculty person overseeing the practicum or internship is responsible for obtaining an IRB determination/review from the host site or KSU as necessary.
If a project is determined to not be research by another institution and includes obtaining PHI, KSU student data, or will occur on KSU property please contact the Office of Research Compliance. If determined to be QI by another institution and does not include PHI submit via self-determination.
The following is a list of common activities and typical review requirements.
- Activity: An experience that falls within the business activities of the hosting agency and data is collected, but research (as defined in the federal regulations) is not the intent.
- KSU IRB Review: No
- Activity: Student conducts a unique project that involves data collection in order to inform business processes, measures quality initiatives, or similar and the results will not develop or contribute to generalizable knowledge.
- KSU IRB Review: No
- Activity: An experience where no data of any kind is collected.
- KSU IRB Review: No
- Activity: Serving as an engaged* investigator on a KSU IRB-approved project.
- KSU IRB Review: Yes
- Activity: Serving as a research associate on a human-subjects research project approved by a non-KSU IRB. A written determination from the external PI/IRB should be maintained in the faculty files.
- KSU IRB Review: An IRB reliance agreement if required by the external institute. Call the ORC for more information.
- Activity: Independent research project that meets the federal definition of human-subjects research regardless of performance site.
- KSU IRB Review: Yes, if reviewed by a non-KSU IRB please contact the Office of Research Compliance.
11.9 Is my study evaluation, research or both?
- The following is a list of common program evaluation projects followed by similar research activities. Contact researchcompliance@kent.edu or complete the IRB review determination form if you are unsure if your project required IRB review.
- Program Evaluation: Assessment of how well a process, product or program is working in a specific context
- Research: Aims to produce new knowledge to contribute to a broader societal endeavor
- Program Evaluation: Focus on Process, product or program
- Research: Focus on population (human subjects)
- Program Evaluation: Designed to improve a process, product, or program via:
- needs assessment
- process, outcome or impact evaluation
- cost-benefit or cost-effectiveness analyses
- Research: Same as project evaluation, but adds procedures, component(s) or analyses aimed to generalize (e.g., combining data with other projects, randomization, expanded sites, literature review)
- Program Evaluation: Assessment of program or product as it would exist regardless of the evaluation
- Research: May include an experimental or non-standard intervention
- Program Evaluation: If publication results, has no impact on how the project is designed or analyzed
- Research: The desire to disseminate impacts the choice of procedures or analyses, in order to strengthen generalizability
- Program Evaluation: Assessment of program or product as it would exist regardless of the evaluation
- Research: May include an experimental or non-standard intervention
- Program Evaluation: Activity will rarely alter the timing or frequency of standard procedures
- Research: Standard procedures or normal activities may be altered by an experimental intervention
11.10 Class Projects
- Class projects are designed for educational purpose in support of the University’s pedagogical mission. They are not designed to create or contribute to generalizable knowledge and do not meet the definition of human subjects research. They are not subject to the Common Rule. IRB review is not required.
- Class Projects should be registered via the Class Projects self determination form.
- Class projects are intended as a learning exercise. The results are not considered generalizable but may be shared during classroom activities or other KSU sponsored events or programs. De-identified information may be presented during these activities.
- The course instructor is responsible for the responsible conduct of the projects. This includes training students and requiring the use of the Class Project Consent form or a similar information sheet.
- Class projects must be minimal risk, may not enroll populations that may need additional protections, and in most cases may not be conducted with support of external research funds. If you plan to use external research funds to conduct a class project, please contact researchcompliance@kent.edu.
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