Hich of the Following Types of Studies Require Approval by an Internal Review Board?

Human Subjects Protections:
Does my Research Need IRB Review?

Earlier submitting an IRB application, first make up one's mind if IRB review is actually required for your project. Review the "Does my Research Require IRB Review" menstruation nautical chart and the guidance beneath to assist in this determination.

Why this Matters

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

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

IRB review and approval is required for projects that:

• See the definition of inquiry
• Involve human subjects and
• Include whatsoever interaction or intervention with human subjects or involve access to identifiable private information

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

ASystematic Investigation follows a predetermined programme for looking at a detail issue, testing a hypothesis or inquiry question, or developing a new theory that may include:

• Collection of quantitative or qualitative information
• Drove of information 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 beliefs

Contribute toGeneralizable Cognition means 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 beyond the populations or situations existence 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 body of knowledge
• Other investigators, scholars, and practitioners may benefit from this knowledge
• Publications including journals, papers, dissertations, and chief'due south theses

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

My Project is Considered Enquiry, 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 side by side set of questions use.

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

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

My Project Includes Homo Subjects, At present 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 at that place is whatever access to identifiable data.

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

Access to Identifiable Private Information
Private Information–Information nigh behavior that occurs in a context in which the individual tin reasonably wait that no observation or recording is taking place (eastward.g. person's domicile, exam room, public restroom, etc.) OR has been provided for specific purposes with a reasonable expectation that information technology volition not be made public (e.g. medical records, student records, employee file, etc.)

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

If the project does non include whatever interaction or intervention with homo subjects or include any access to identifiable private information, and so the project does non require IRB review. If even ane of the above categories are met (intervention, intervention, access to identifiable private data), an IRB application is required.

Example of Studies that Generally Require IRB Review

• Pilot studies that involve human being subjects
• Principal'due south theses
• Dissertations
• Use of identifiable information from medical records, student records, employment records, or other private sources, Enquiry studies that collect data nearly human subjects through interaction or intervention with subjects, such every bit surveys (paper, online, telephone, etc.), interviews, focus groups, cerebral testing, etc.
• Research studies that include subjects to examine devices, products, food, drugs, supplements, etc.

Examples of Studies that Generally Do Non Require IRB Review

• Data nerveless for internal departmental or administrative purposes, such as didactics evaluations, student performance data, etc.
• Activities designed solely for quality improvement or evaluation of a program, grade, etc.
• Oral histories or biographies (unless data will besides be used to contribute to generalizable knowledge)
• Preparation activities unless the preparation activity is conducted for research purposes
• Single case studies

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Source: https://web.uri.edu/research-admin/office-of-research-integrity/human-subjects-protections/does-my-research-need-irb-review/