Human Subjects Protections:
Does my Research Need IRB Review?

Earlier submitting an IRB awarding, first determine if IRB review is actually required for your projection. Review the "Does my Research Require IRB Review" flow chart and the guidance below to assist in this decision.

Why this Matters

  • If your activity doesn't fit ane of the definitions of research (below), yous do not need to obtain IRB approval or a decision 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 research projects involving human subjects exist reviewed by an IRB. The IRB must approve or make up one's mind the project to be exempt prior to the start of any inquiry activities. The IRB cannot provide approval or determinations for research that has already been concluded.

IRB review and blessing is required for projects that:

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

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

ASystematic Investigation follows a predetermined program for looking at a particular issue, testing a hypothesis or enquiry question, or developing a new theory that may include:

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

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

  • Presentation of the data at meetings, conferences, seminars, affiche presentations, etc.
  • The knowledge contributes to an already established torso of knowledge
  • Other investigators, scholars, and practitioners may benefit from this noesis
  • Publications including journals, papers, dissertations, and primary'south theses

If the project does non run into the definition of research (i.e. is not a systematic investigation or does not contribute to generalizable knowledge), equally described above, so the project does non require IRB review and an IRB application is non required.

My Project is Considered Inquiry, Now What?
If the project meets the definitions of research (i.e. is a systematic investigation or does contribute to generalizable knowledge), as described to a higher place, the next prepare of questions apply.

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

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

My Project Includes Human being Subjects, Now What?If the project does include a human subjects aspect, you need to determine if there is any interaction or intervention with subjects or if in that location is any access to identifiable information.

  • Interaction–Whatsoever advice or interpersonal contact betwixt the investigator(due south) and the subjects.  This includes in-person, mail, telephone, etc.  Online surveys (even if anonymous) involve interaction.
  • Intervention–Physical procedures or manipulations of the bailiwick or his/her environs (e.g. taking blood samples, practice studies, use of devices, cognitive tasks, etc.)

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

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

If the project does not include any interaction or intervention with human being subjects or include any admission to identifiable private information, then the project does non require IRB review. If fifty-fifty ane of the above categories are met (intervention, intervention, admission to identifiable private information), an IRB application is required.

Example of Studies that Generally Crave IRB Review

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

Examples of Studies that Generally Practise Not Crave IRB Review

  • Information collected for internal departmental or administrative purposes, such every bit instruction evaluations, student operation information, etc.
  • Activities designed solely for quality improvement or evaluation of a programme, form, etc.
  • Oral histories or biographies (unless information will as well be used to contribute to generalizable knowledge)
  • Preparation activities unless the training action is conducted for research purposes
  • Single example studies