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Human Subjects

Policies & Guidance

Expedited Research

To qualify for expedited review procedures under 45 CFR 46.110 and 21 CFR 56.110, all research activities must:

  1. present no more than minimal privacy, psychologica,l and/or physical risk to human subjects

    and

  2. only involve procedures listed in one or more of the seven categories listed below.

    The activities listed should not be deemed to be of minimal risk simply because they are included on this list. Inclusion on this list merely means that the activity is eligible for review through the expedited review procedure when the specific circumstances of the proposed research involve no more than minimal risk to human subjects.

    The following guidelines also apply to expedited research:

    • The categories in this list apply regardless of the age of the subjects, except as noted.
    • The expedited review procedure may not be used where identification of the subjects and/or their responses would reasonably place them at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, insurability, or reputation, or be stigmatizing, unless reasonable and appropriate protections will be implemented so that risks related to invasion of privacy and breach of confidentiality are no greater than minimal.
    • The expedited categories outlined below do not apply to classified research involving human subjects.
    • The standard requirements for informed consent and authorization (or their waiver, alteration, or exception) apply regardless of the type of review.
    • Studies involving randomized use of drugs, biologics, or devices do not meet the definition of minimal risk and thus do not qualify for expedited review.
  1. Clinical studies of drugs and medical devices when one of the following conditions is met:
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  2. Collection of blood samples by finger stick, heel stick, ear stick or venipuncture, as follows:
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  3. Prospective collection of biological specimens for research purposes by noninvasive means.
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  4. Collection of data through noninvasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice, excluding procedures involving X-rays or microwaves. Where medical devices are employed, they must be cleared / approved for marketing.
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  5. Research involving materials (data, documents, records or specimens) that have been collected or will be collected solely for non-research purposes (such as medical treatment or diagnosis).
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  6. Collection of data from voice, video, digital, or image recordings made for research purposes.
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  7. Research on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior) or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies.
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