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How to take advantage of a simpler review process and begin your study earlier.

The average time from submission to approval for a newly submitted IRB application varies widely from institution to institution. It can also depend greatly on the type and complexity of the research being considered as well as the level of human subject involvement. There are three levels of review under the IRB guidelines: exempt research, expedited review, and full review. Average wait times can range from 2-3 weeks for an exempt study, 3-4 weeks for an expedited review, and 5+ weeks for a full review. Knowing whether your research qualifies for IRB exemption or the expedited review procedure can help new studies get going much sooner than they would otherwise be able to.

What qualifies as “exempt” research?

Though the name implies that research in this category does not need to go through any IRB review, the IRB committee must assess “exempt” research. In general, these studies involve the least possible risk to the participants and generally consist of studies evaluating already-existing data so long as patient identifiers are removed and anonymity of the subjects is protected. Under article 45 CFR 46.101(b) Categories of Exempt Human Subjects Research, there are 6 federally established categories of research that may qualify for IRB exemption.[1] A few examples are listed below:

  1. Research within established educational settings (i.e., schools, universities, and training facilities) involving instructional techniques, efficacy, curriculum changes, classroom management, etc.
  2. Research involving aptitude tests, public surveys, interviews, or observation of public behavior
  3. Research involving the collection of existing data such as medical records or pathological specimens
  4. Research involving public service programs
  5. Taste and food evaluation studies intending to test consumer acceptance of foods that meet FDA requirements for safety.

It is important to note that the Department of Health and Human Services has added a footnote to their policy regarding exempt research indicating that all research involving prisoners and some research involving children will not be considered “exempt” and must go through either the expedited or full review procedure.

What is the expedited IRB review process?

An expedited review is a procedure through which either the IRB chairperson or several experienced members may review eligible research without waiting for a formal meeting of the IRB. These committee members have all of the authorities of the full committee except disapproval of the application. A formal rejection of an IRB application may only be decided by a full committee meeting. Research eligible for expedited IRB review must meet at least one of two criteria:

  1. It must involve minimal risk to human participants. We will discuss what exactly qualifies as “minimal risk” in more detail in the next section
  2. It must involve minor changes in a previously approved study, during the period covered by the original approval.

How do I know if my study qualifies?

The following research categories may qualify for an expedited review (adapted from the Office of Human Research Protection, Article 45 CFR 46.110 Categories of Research That May Be Reviewed through an Expedited Review Procedure)[2]

    1. Clinical studies of drugs
      1. If they do not require a new drug application
    2. Studies of medical devices
      1. If they do not require an investigational device exemption, or
      2. The device has already been cleared for marketing and is being used in accordance with its approved labeling
    3. Collection and examination of blood samples
      1. If obtained through less invasive finger stick or venipuncture from healthy, non-pregnant adults weighing at least 110 pounds. In addition, there are limitations to the frequency with which blood may be drawn.
      2. Other adults and children with consideration to age, weight, and overall health of the subjects with blood draw frequency limitations.
    4. Noninvasive collection of biological specimens for research purposes
      1. This category includes specimens drawn in a non-invasive/non-disfiguring manner such as nail clippings, hair, sweat, saliva, mucosal cells, and sputum
      2. Other specimens taken during routine medical procedures such as teeth extracted by a dentist for medically necessary purposes and amniotic fluid sampled at the time of membrane rupture by a physician.
    5. Noninvasive collection of data drawn through means commonly used in clinical practice such as:
      1. Measurement of weight or sensory acuity
      2. Magnetic resonance imaging, electrocardiography, echocardiography, ultrasound, etc.
      3. Muscular strength testing
      4. Moderate, age/health-appropriate exercise, flexibility testing

Note: If data collection involves a medical device (i.e., test muscular strength) it must be previously approved for marketing. In addition, if the study intention is to investigate the safety and efficacy of the device it is typically not eligible for expedited review and will be deferred to a full committee review.

    1. Collection of voice, digital, video, or image recordings
    2. Research regarding individual characteristics or behavior such as:
      1. Perception
      2. Cognition
      3. Motivation
      4. Identity
      5. Language
      6. Social behavior
    3. Continuing review of previously approved research that meets at least one of the following:
      1. The study is no longer accepting new research subjects
      2. The currently enrolled subjects have completed all research-related tasks
      3. The research remains active only for long term follow up
      4. The remaining research activities consist only of data analysis
      5. The study does not fall into any of the above categories, but the IRB has documented that it involves no more than minimal risk to subjects

What types of research studies DO NOT qualify for expedited review?

The expedited review process may not be used in situations where identification of the subjects or their responses would place them at risk of criminal or civil liability. In addition, studies in which the subjects’ responses may be damaging to them financially or in terms of their employability or reputation. Furthermore, any classified research involving human participants is not eligible for the expedited review process.

Where can I find more information about IRB review categories and regulations?

A helpful visual decision chart may be found at: http://www.hhs.gov/ohrp/policy/checklists/decisioncharts.html

The applicability requirements are listed in more detail at: http://www.hhs.gov/ohrp/policy/expedited98.html

References:

    1. Federal Article 45 CFR 46.101(b) Categories of Exempt Human Subjects Research, http://www.research.uci.edu/compliance/human-research-protections/docs/categories-of-exempt-human-subjects-research.pdf
    2. U.S. Department of Health and Human Services, Office for Human Research Protections Expedited Review Categories, http://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html#46.102