Human Subjects Protections:
Does my Research Demand IRB Review?

Before submitting an IRB application, first determine if IRB review is actually required for your projection. Review the "Does my Research Crave IRB Review" flow chart and the guidance beneath to assist in this determination.

Why this Matters

  • If your activeness doesn't fit one of the definitions of research (below), you do non need to obtain IRB approval or a determination of exempt status.
  • The specific definition (if any) that applies to your action determines which regulations and requirements govern your research.

The Regulations
Federal regulations crave that research projects involving human subjects be reviewed by an IRB. The IRB must corroborate or determine the project to be exempt prior to the start of any inquiry activities. The IRB cannot provide approval or determinations for enquiry that has already been concluded.

IRB review and approval is required for projects that:

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

What is Research?
Research 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 particular issue, testing a hypothesis or research question, or developing a new theory that may include:

  • Drove 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 as clinical trials
  • Observation of individual or group behavior

Contribute toGeneralizable Knowledge ways that the purpose or intent of the project is to test or to develop scientific theories or hypotheses, or to draw conclusions that are intended to be applicable and/or shared across the populations or situations being studied.  This may include 1 or more of the following:

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

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

My Project is Considered Research, Now What?
If the projection meets the definitions of enquiry (i.due east. is a systematic investigation or does contribute to generalizable knowledge), equally described in a higher place, the next set of questions apply.

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

If the project does not run across the definition of research or the projection does not include human subjects, as described above, and so the project does non require IRB review.

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

  • Interaction–Any communication or interpersonal contact between the investigator(s) and the subjects.  This includes in-person, mail, phone, etc.  Online surveys (fifty-fifty if anonymous) involve interaction.
  • Intervention–Physical procedures or manipulations of the subject or his/her environs (e.g. taking blood samples, exercise studies, use of devices, cerebral tasks, etc.)

Access to Identifiable Individual Information
Private Information–Information almost behavior that occurs in a context in which the private can reasonably wait 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 it will not be made public (e.grand. medical records, student records, employee file, etc.)

Identifiable Information–The identity of the private is or may exist readily ascertained by the investigator or others either directly or indirectly through the employ 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 projection does not require IRB review. If fifty-fifty 1 of the above categories are met (intervention, intervention, access to identifiable private data), an IRB application is required.

Case of Studies that Generally Crave IRB Review

  • Airplane pilot studies that involve homo subjects
  • Chief's theses
  • Dissertations
  • Employ of identifiable information from medical records, student records, employment records, or other private sources, Research studies that collect data about homo subjects through interaction or intervention with subjects, such as surveys (paper, online, phone, etc.), interviews, focus groups, cognitive testing, etc.
  • Research studies that include subjects to examine devices, products, food, drugs, supplements, etc.

Examples of Studies that Mostly Exercise Non Require IRB Review

  • Information collected for internal departmental or authoritative purposes, such as pedagogy evaluations, pupil performance data, etc.
  • Activities designed solely for quality improvement or evaluation of a plan, grade, etc.
  • Oral histories or biographies (unless information volition as well be used to contribute to generalizable knowledge)
  • Training activities unless the training activity is conducted for inquiry purposes
  • Single case studies