If your study needs IRB review, the next step is to identify the level of review required – full committee review, expedited review or exempt certification.
The level of review reflects the level of risk to the subject. The risk level is compared to "minimal risk" as defined by the federal regulations:
Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests (45.CFR.46.102(j)) Common Rule).
Contact the DU IRB at IRBAdmin@du.edu if you are unsure about which level of review is needed.
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Full Committee Review
These studies are reviewed by the IRB committee at a convened meeting. Full committee review is required for:
- Greater than minimal risk studies OR
- Studies that are minimal risk, but do not fit in an expedited review category
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Expedited Review
Expedited review studies typically are reviewed by a small number of IRB reviewers designated by the IRB Chair. Expedited review is appropriate for studies that according to 45 CFR 46.110 and 21 CFR 56.110:
- Involve no greater than minimal risk AND
- Fit into one (or more) of the following seven specific expedited review categories.
Expedited Review Categories
- Category 1: Approved drug or device being used for its approved indication
- Category 2: Blood sampling (limited amounts)
- Category 3: Prospective collection of biological specimens for research purposes by noninvasive means.
- Category 4: Noninvasive, routine clinical procedures, such as MRI or IKG (no sedation, general anesthesia, x-rays or microwaves)
- Category 5: Use of data, documents or specimens collected for non-research or research purposes (e.g., chart reviews)
- Category 6: Collection of data from voice, video, digital, or image recordings
- Category 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, focus group, human factors evaluation or quality assurance methodologies.
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Exempt Certification
DHHS regulations in 45 CFR 46.104 (Common Rule) identify several different categories of minimal risk research as being exempt from federal policy for the protection of human subjects.
Exempt research involves human subjects, and although it is exempt from the federal policy, you must submit the study to the IRB. The IRB will review the application and certify that the study qualifies for the exemption. You will receive an exempt certification letter, not a letter of approval. The IRB will NOT certify research as exempt at DU involving prisoners as subjects.
DU does not allow for the use of reliance agreements (ceding) on our exempt certification.
Exempt research must be minimal risk AND fit into one (or more) of the following categories:
- Category 1: Research, conducted in established educational setting, that involves no changes to the curriculum for the purposes of the research.
- Category 2: Research involving the use of standard educational tests, survey (online or in-person), interviews, or observation of public behavior.
- To qualify, one of the following must be met:
- All data collected will be anonymous
- If subjects can be identified, the research would not reasonably place them at any risk (such as legal, reputation, employability, etc.), or
- If there is risk to identifiable participants, the IRB has conducted "limited IRB review" to ensure privacy and confidentiality are protected.
- Category 3: Research involving "benign behavioral interventions". The data collected must be:
- Anonymous
- If potentially identifiable, the research would not reasonably place participants at risk (i.e., legal, reputation, employability), or
- If there is risk to participants, the IRB has conducted "limited IRB review" to ensure privacy and confidentiality are protected.
- Category 4: Secondary research for which consent is not required and at least one of the following criteria is met:
- The information/biospecimens are publicly available;
- Information, which may include information about biospecimens,
- Researchers will not record any information that would make participants identifiable, and will not contact or re-identify participants;
- Information is identifiable, but regulated by HIPAA; or
- the research is conducted on behalf of a federal department or agency and the study involves the use of federally generated non-research information.
- Category 5: Evaluation research on public benefit and services and research and demonstration project that are conducted or supported by a Federal department or agency.
- Category 6: Taste and food quality evaluation and consumer acceptance studies if wholesome foods without additives are consumed or the food contains ingredients at or below the level and for a use found to be safe by the Food and Drug Administration.
