Levels of Review
Full Committee Research
Proposed human subject research which does not fall into either the exempt or expedited review categories must be submitted for full committee review. Please see the Committee Calendar for submission deadlines and meeting dates for all IRB Committees.
Although the category is called 'exempt', UNLESS SELF-DETERMINED (see below), this type of research does require IRB review and registration. To qualify, research must fall into one of the federally-defined exempt categories. These categories present the lowest amount of risk to potential subjects. At UCI, certain exempt categories are not allowed. Specifically, exempt 4iii and exempt category 7 are not allowed.
Exempt category 4iii is not allowed.
- Why? Exempt 4iii allows for use of identifiable health information when that use is regulated under the HIPAA Privacy Rule. UCI is a hybrid entity and research is designated under the non-covered component, meaning it is not subject to the HIPAA Privacy Rule.
- What does that mean? Once PHI is released to a UCI Researcher via an IRB approved HIPAA research authorization or waiver, the information is no longer protected (regulated) by the HIPAA Privacy Rule. Since the information is no longer regulated under HIPAA Privacy Rule, then Exempt 4iii would not apply at UCI since we can’t meet the requirements of the Common Rule’s exemption. Expedited category 5 would be the appropriate research category for the release of PHI to a UCI Researcher, and for the continued protection of HIPAA under the research context
Exempt category 7 is not allowed.
- Why? The interpretation for this category is that it is for the research storage and maintenance institution-wide of samples and / or data. There does not appear to be current infrastructure in place at UCI to ensure that participants are not (re)approached should they decline an initial broad consent and to track which specimens or data a participant has allowed (and has not allowed) for research use.
- Some examples of Exempt research are:
- anonymous or identifiable surveys or interviews
- passive observation of public behavior with or without the collection of identifiers
- retrospective and prospective medical chart reviews (allowable under specific criteria for UCI Healthcare Workforce)
- analyses of specimens that are publically available or if not publically available, where the identities of the subjecs cannot be readily ascertained
Self Determination of Exemption:
In an effort to facilitate research, Investigators may self determine research that qualifies as exempt, with some exceptions. Self-determination is done by completing the Exempt Self-Determination Form in Kuali Research Protocols (KRP).
If your research meets one or more of the exceptions to self-determination, an IRB application along with consent documents, and recruitment materials, as applicable, must be completed and submitted in KRP.
To qualify for an expedited review, research must fall into nine (9) federally-defined expedited categories. These categories involve collection of samples and data in a manner that is not anonymous and that involves no more than minimal risk to subjects. Some examples of expedited research are:
- studies involving collection of hair, saliva or dental plaque samples,
- studies of blood samples from healthy volunteers,
- analyses of voice recordings
- studies of existing pathological specimens with patient identifiers.
Expedited review as defined by federal regulations allows the IRB chairperson or one or more experienced reviewers designated by the chairperson from among members of the IRB to evaluate and approve specific types of research. Reviewers conducting an expedited review may exercise all of the authority of the IRB except that they may not disapprove a study. When a subcommittee cannot approve the research under expedited review, the study is referred to the full Committee for review.
Applicability of Expedited Review
- Research activities that (1) present no more than minimal risk to human subjects, and (2) involve only procedures listed in one or more of the following categories, may be reviewed by the IRB through the expedited review procedure authorized by 45 CFR 46.110 and 21 CFR 56.110. 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 categories in this list apply regardless of the age of 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, 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 review procedure may not be used for classified research involving human subjects.
- IRBs are reminded that the standard requirements for informed consent (or its waiver, alteration, or exception) apply regardless of the type of review utilized by the IRB (i.e., expedited or full committee review).
- Categories one (1) through seven (7) pertain to both initial and continuing IRB review.
- Category thirteen (13) is UCI's expanded category of minimal risk research procedures which allows for a 2 mm skin punch biopsy for children and adults (limitations are included) and applies to research that is not federally funded and not subject to FDA regulations.
- UCI: 2018 Exempt Review Categories
- UCI: Expedited Review Categories
- OHRP: 45 CFR 46.110
- FDA: 21 CFR 56.110