Do I need IRB Review?

What requires IRB approval?

  • 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.  
  •  See OHRP decision charts here

Do I need IRB approval if my grant proposal lacks definite plans for involvement of human subjects, but eventually will? 

Retroactive IRB approval

  • There are no provisions in the federal regulations that allow the IRB to approve research that has already been conducted.

Does the IRB have a stance on scholarly and journalistic activities?

Do Public Health Surveillance activities require IRB review?

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   
  • A comparison of the HHS and FDA regulations is available here
  • KSU IRBs will not review FDA-regulated studies at this time. 

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 student is to obtain or access medical or educational records for projects that are not under the oversight of the KSU IRB, the faculty person overseeing the project is responsible for ensuring that the proper approvals are in place

Activity

KSU Review 

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.

No

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.  

No

An experience where no data of any kind is collected.

No

Serving as an engaged* investigator on a KSU IRB-approved project.

Yes

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

An IRB reliance agreement if required by the external institute.

Yes, if required by the external institute. Call the ORC for more information.

Independent research project that meets the federal definition of human-subjects research regardless of performance site.

Yes, if reviewed by a non-KSU IRB please contact the Office of Research Compliance.

Is my study evaluation, research or both? 

 

Program Evaluation

Research

Assessment of how well a process, product or program is working in a specific context

Aims to produce new knowledge to contribute to a broader societal endeavor

Focus on Process, product or program

Focus on population (human subjects)

Designed to improve a process, product, or program via:

  • needs assessment
  • process, outcome or impact evaluation
  • cost-benefit or cost-effectiveness analyses

Same as at left, but adds procedures, component(s) or analyses aimed to generalize (e.g., combining data with other projects, randomization, expanded sites, literature review)

Assessment of program or product as it would exist regardless of the evaluation

May include an experimental or non-standard intervention

If publication results, has no impact on how the project is designed or analyzed

The desire to disseminate impacts the choice of procedures or analyses, in order to strengthen generalizability

Activity will rarely alter the timing or frequency of standard procedures

Standard procedures or normal activities may be altered by an experimental intervention

Does international research need IRB review?

  • Yes. Human-subjects research conducted in other countries must comply with both U.S. and international standards, including local custom. This includes GDP compliance if collecting information from subjects in the European Union.