Human being Subjects Protections:
Does my Research Need IRB Review?

Before submitting an IRB application, first decide if IRB review is actually required for your project. Review the "Does my Inquiry Require IRB Review" menstruum chart and the guidance beneath to aid in this determination.

Why this Matters

  • If your activity doesn't fit ane of the definitions of research (below), y'all exercise not need to obtain IRB approving or a determination of exempt status.
  • The specific definition (if any) that applies to your activity determines which regulations and requirements govern your research.

The Regulations
Federal regulations require that enquiry projects involving human subjects exist reviewed by an IRB. The IRB must approve or determine the project to be exempt prior to the first of any research activities. The IRB cannot provide approving or determinations for research that has already been concluded.

IRB review and approving is required for projects that:

  • Meet the definition of research
  • Involve human subjects and
  • Include any interaction or intervention with human subjects or involve access to identifiable private information

What is Research?
Inquiry is defined as a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.

ASystematic Investigation follows a predetermined plan for looking at a detail effect, testing a hypothesis or research question, or developing a new theory that may include:

  • Collection of quantitative or qualitative data
  • Drove of data using surveys, testing or evaluation procedures, interviews, or focus groups
  • Drove of data using experimental designs such equally clinical trials
  • Observation of individual or grouping behavior

Contribute toGeneralizable Noesis means that the purpose or intent of the project is to test or to develop scientific theories or hypotheses, or to depict conclusions that are intended to exist applicable and/or shared across the populations or situations being studied.  This may include one or more of the following:

  • Presentation of the data at meetings, conferences, seminars, poster presentations, etc.
  • The cognition contributes to an already established body of knowledge
  • Other investigators, scholars, and practitioners may benefit from this knowledge
  • Publications including journals, papers, dissertations, and master's theses

If the project does non come across the definition of research (i.due east. is not a systematic investigation or does not contribute to generalizable knowledge), as described above, and then the projection does non require IRB review and an IRB application is not required.

My Project is Considered Inquiry, At present What?
If the project meets the definitions of research (i.due east. is a systematic investigation or does contribute to generalizable knowledge), equally described above, the next set of questions utilise.

Are Human Subjects Involved?
A Human being Subject area is a living private about whom an investigator conducting research obtains (1) data through intervention or interaction with the individual or (2) identifiable private information.

If the project does non meet the definition of inquiry or the project does not include man subjects, as described above, then the project does not require IRB review.

My Project Includes Human Subjects, Now What?If the project does include a man subjects aspect, y'all demand to determine if there is whatsoever interaction or intervention with subjects or if there is whatever admission to identifiable data.

  • Interaction–Whatever advice or interpersonal contact between the investigator(s) and the subjects.  This includes in-person, postal service, telephone, etc.  Online surveys (fifty-fifty if anonymous) involve interaction.
  • Intervention–Physical procedures or manipulations of the subject or his/her surroundings (e.chiliad. taking blood samples, practise studies, use of devices, cerebral tasks, etc.)

Access to Identifiable Private Information
Private Data–Information about behavior that occurs in a context in which the individual can reasonably expect that no observation or recording is taking place (e.g. person'southward home, exam room, public restroom, etc.) OR has been provided for specific purposes with a reasonable expectation that information technology will not be made public (east.thousand. medical records, student records, employee file, etc.)

Identifiable Information–The identity of the individual is or may be readily ascertained by the investigator or others either directly or indirectly through the use of codes or a combination of data points.

If the projection does not include any interaction or intervention with human subjects or include any access to identifiable private information, then the project does not require IRB review. If even one of the above categories are met (intervention, intervention, access to identifiable private information), an IRB awarding is required.

Instance of Studies that Generally Crave IRB Review

  • Pilot studies that involve homo subjects
  • Main's theses
  • Dissertations
  • Use of identifiable data from medical records, student records, employment records, or other private sources, Research studies that collect data near human subjects through interaction or intervention with subjects, such equally surveys (paper, online, telephone, etc.), interviews, focus groups, cognitive testing, etc.
  • Enquiry studies that include subjects to examine devices, products, nutrient, drugs, supplements, etc.

Examples of Studies that By and large Do Not Require IRB Review

  • Data nerveless for internal departmental or administrative purposes, such equally educational activity evaluations, student performance information, etc.
  • Activities designed solely for quality improvement or evaluation of a program, course, etc.
  • Oral histories or biographies (unless data will also be used to contribute to generalizable knowledge)
  • Training activities unless the training action is conducted for inquiry purposes
  • Single case studies