Human Subjects Protections:
Does my Research Demand IRB Review?

Before submitting an IRB application, start determine if IRB review is actually required for your project. Review the "Does my Research Require IRB Review" menstruation nautical chart and the guidance below to assist in this determination.

Why this Matters

  • If your activity doesn't fit one of the definitions of enquiry (below), yous exercise not demand to obtain IRB approval or a determination of exempt status.
  • The specific definition (if any) that applies to your activity determines which regulations and requirements govern your enquiry.

The Regulations
Federal regulations require that inquiry projects involving human subjects exist reviewed past an IRB. The IRB must corroborate or make up one's mind the project to exist exempt prior to the beginning of any inquiry activities. The IRB cannot provide approval or determinations for inquiry that has already been concluded.

IRB review and approval is required for projects that:

  • Encounter the definition of research
  • Involve man subjects and
  • Include any interaction or intervention with human subjects or involve admission to identifiable private data

What is Research?
Research is divers every bit a systematic investigation, including research evolution, testing, and evaluation, designed to develop or contribute to generalizable noesis.

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:

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

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

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

If the project does not meet the definition of inquiry (i.due east. is not a systematic investigation or does not contribute to generalizable noesis), equally described above, so the project does not require IRB review and an IRB application is non required.

My Project is Considered Research, Now What?
If the project meets the definitions of research (i.e. is a systematic investigation or does contribute to generalizable knowledge), equally described above, the next set of questions use.

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

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

My Projection Includes Homo Subjects, Now What?If the project does include a human subjects attribute, you need to determine if there is whatever interaction or intervention with subjects or if there is any access to identifiable information.

  • Interaction–Any communication or interpersonal contact between the investigator(south) and the subjects.  This includes in-person, mail service, phone, etc.  Online surveys (fifty-fifty if bearding) involve interaction.
  • Intervention–Concrete procedures or manipulations of the subject or his/her environment (e.g. taking claret samples, exercise studies, apply of devices, cerebral tasks, etc.)

Access to Identifiable Private Information
Private Data–Data about behavior that occurs in a context in which the individual can reasonably await that no ascertainment or recording is taking place (e.thou. 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 (east.g. medical records, student records, employee file, etc.)

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

If the project does non include any interaction or intervention with human subjects or include any access to identifiable private information, and 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.

Example of Studies that Generally Require IRB Review

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

Examples of Studies that Generally Practice Non Crave IRB Review

  • Information collected for internal departmental or administrative purposes, such as teaching evaluations, pupil performance data, etc.
  • Activities designed solely for quality improvement or evaluation of a plan, course, etc.
  • Oral histories or biographies (unless information will also be used to contribute to generalizable knowledge)
  • Training activities unless the grooming activeness is conducted for enquiry purposes
  • Single instance studies