Do I Need IRB Approval?

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An IRB's oversight extends to research in the health and biological sciences as well as the social and behavioral sciences, regardless of how the research is funded (e.g., institutional, private foundation, state, federal, etc.).

Definitions for Research Involving Human Subjects

If an activity meets the definitions per DHHS or FDA regulations below, it is Research Involving Human Subjects per University policy and requires IRB approval. If an activity does not meet either the DHHS or FDA definitions, then it does not require IRB approval; however, other institutional review may apply. See

Scientific Review Committee

Institutional Data Collection

 

Note that publication is not a determining factor for whether an activity meets these definitions.

Definitions per DHHS regulations

Is it Research?

Does it involve Human Subjects?

Research: a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledg.

Human subject: a living individual about whom an investigator (whether professional or student) conducting research:

  • Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; OR
  • Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.

Definitions per FDA regulations

Is it Research? Does it involve Human Subjects?

Research: any experiment that involves a test article and one or more Human Subjects, and that meets any one of the following:

  • Must meet the requirements for prior submission to the US Food and Drug Administration under section 505(i) of the Federal Food, Drug, and Cosmetic Act meaning any use of a drug other than the use of an approved drug in the course of medical practice;
  • Must meet the requirements for prior submission to the US Food and Drug Administration under section 520(g) of the Federal Food, Drug, and Cosmetic Act meaning any activity that evaluates the safety or effectiveness of a device; OR
  • Any activity the results of which are intended to be later submitted to, or held for inspection by, the US Food and Drug Administration as part of an application for a research or marketing permit.

Human Subject: an individual who is or becomes a subject in research, either as a recipient of the test article or as a control. A subject may be either a healthy human or a patient. A human subject includes an individual on whose specimen a medical device is used.

NWHSU IRB approval is required for any research involving human subjects in which our institution is engaged in research. This may include resarch that:

  • is conducted by University faculty, staff, or students
  • is performed on the premises of the University or clinic system
  • is performed with or involve the use of facilities or equipment belonging to the University
  • involves University patients, students, staff or faculty
  • involves clinic patients and/or patient data
  • satisfies a requirement imposed by the University as the condition for the award of a degree or for completion of a course of study in the University, or
  • is certified by an institutional official to satisfy an obligation of a faculty appointment at the University, including clinical or adjunct appointments

In some instances, it may be determined that our institution is not engaged in research, and therefore NWHSU IRB approval is not required. See

Engagement Determination Worksheet

When research involves multiple institutions, a IRB reliance agreement may be approved to establish a single IRB of record. See

External Collaborations

Examples of activities that generally do not meet the Definition for Research Involving Human Subjects and do not require IRB approval

Program Evaluation/Quality Assurance/Improvement Project
An activity is limited to program evaluation, quality assurance, or quality improvement activities designed specifically to evaluate, assure, or improve performance within a department, classroom, or clinic setting.

Note that an evaluation, assurance review, or improvement project designed specifically for a particular setting may yield useful information for similar organizations, but may still not meet one of the definitions for Research and Human Subjects.

Case Report
An activity consists of a case report or series which describes an interesting treatment, presentation, or outcome. A critical component is that nothing was done to the patient(s) with prior “research” intent.

Note that HIPAA or other local laws may apply to this activity. Please consult the entity from which you received or accessed the information contained in the report for further guidance.

Course-Related Activity
The project is limited to one or more course-related activities designed specifically for educational or teaching purposes where data are collected from human subjects as part of routine class exercises or assignments and otherwise do not meet the definition of Research.

Note that some course-related activities, even those conducted by students, may yield information suggesting additional investigation or analysis. If an additional activity meets the definition of Research, then it must be submitted to the IRB for review.

Journalistic or Documentary Activity
The activity is limited to investigations or interviews involving human subjects that focus on specific events (current or historical), views, etc.

Using Public or Non-Identifiable Private Information about Living Individuals

An activity is limited to analyzing data about living individuals, in which:

  • The data have been retrieved by the investigator from public, non-restricted data sets, OR
  • The private data have been provided to the investigator without any accompanying information by which the investigator could identify the individuals.


Note that “de-identified data” according to HIPAA may be identifiable according to the DHHS definition of “Human Subjects” above.

 

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