Procedure:
This procedure provides guidance in accordance with regulations to review and approve human subjects research in an exempt category.
I.
Lead Researcher (LR) Responsibilities
A.
The IRB Application is completed in its entirety and electronically submitted to the Human
Research Protections (HRP) staff for processing. One original IRB Application with
B.
signatures (Lead Researcher, Department Chair, and Faculty Sponsor, if applicable) is submitted. The IRB application and instructions on what to submit are located on the IRB website: http://www.research.uci.edu/ora/forms/ .
The IRB website also includes information on who to contact with questions about
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whether research involving human participants is exempt from regulation.
The Investigator replies to all requests for revisions and/or clarifications requested by the
HRP staff reviewer or IRB reviewer, when applicable.
Any proposed changes to an exempt study must be submitted to the HRP staff for review and approval prior to implementation. If the proposed changes affect the level of review, the IRB Chair will review the proposed changes.
The Investigator is responsible for assuring that the exempt research is carried out in an ethical manner that includes appropriate participant protections (e.g., confidentiality).
Reviewer Responsibilities
A.
Exempt studies are accepted on a rolling basis and are administratively reviewed weekly by HRP staff. The final confirmation of exemption is made by an experienced HRP staff member (Reviewer). Experienced HRP staff members are at an IRB Senior Analyst level
or higher. If needed, the IRB Chair or designated IRB Committee member is available to
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assist the Reviewer in determining if the study meets exemption criteria. If the Reviewer has a conflict of interest, another experienced Reviewer will conduct the review.
The Reviewer reviews the “Application for IRB Review” and validates or declines the researcher’s claim for review under the exempt category.
The Reviewer reviews the proposed research, consents, and applicable documents to determine if the research meets the ethical standards of the Belmont Report. The
Reviewer documents the exempt determination on the “Reviewer’s Checklist.”
When the research involves interaction with subjects, a determination is made by the
Reviewer whether some type of consent process is appropriate. The Reviewer documents the consent process on the “Reviewer’s Checklist”. The Reviewer utilizes the checklist to ensure that the consent document provided to subjects contains such information as:
1.
a statement that the activity involves research;
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a description of the procedures;
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a statement that participation is voluntary;
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a statement that there are adequate provisions to protect the privacy and confidentiality of the subjects; and
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the name and contact information for the researcher.
If the Reviewer disagrees with the proposed level of risk, the appropriate level of review is determined (i.e., Expedited or full Committee), in consultation with the IRB Chair.
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III.
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If the Reviewer approves the request, the Reviewer signs the “Reviewer’s Checklist” and a letter of Exempt Registration is generated.
When revisions are requested prior to initial registration, the modified documents are rereviewed and, if acceptable, exempt registration is granted.
If proposed changes to an exempt study are submitted for review and approval, the
Reviewer will review and approve. If the proposed changes affect the level of review, the
Reviewer will seek the consultation of the IRB Chair to determine the appropriate level of review (i.e., Expedited or full Committee).
Experienced HRP Staff (Analyst level or higher who are CIP or CCRP or as designated by the IRB Chair) are delegated the authority to register IRB applications and approve modifications related to research activities deemed exempt from the federal regulations regarding the protection of human subjects under 45 CFR 46.101 (b) except under the following conditions:
1.
45 CFR 46.101(b)(1): Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as: a. Research on regular and special education instructional strategies; or b. Research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
2.
45 CFR 46.101(b)(2): Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior and children are the proposed population.
3.
The research involves accessing personal or Protected Health Information (PHI) under the Health Insurance Portability and Accountability Act (45 CFR 106, 164).
The Human Research Protections (HRP) Team Responsibilities
A.
The HRP team assures that the submission is complete. Documentation submitted for
IRB review includes:
1.
IRB Application
2.
Protocol Narrative
3.
Investigator’s Assurance document
4.
Disclosure of Investigators’ Financial Interest form
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Proposed Data Collection instruments, or citations, if standardized, if applicable
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Proposed Consent document, if applicable
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Assent form, if applicable
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Recruitment advertisements, if applicable
The Analyst or Administrator communicates (via e-mail) the Reviewer’s findings to the LR and Administrative Contact (AC), when applicable and provides assistance with IRB submission requirements.
The HRP team will review the IRB Application for Exempt Registration to determine if the
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research qualifies for exemption in accordance with IRB policy 12. Only experienced
Analysts or Administrators may serve as Reviewers. An experienced Analyst or
Administrator means an HRP staff member who is CIP or CCRP, has received training relative to both exempt and expedited review categories, and possesses the expertise needed to review the proposed research. If the HRP staff are not CIP or CCRP, they must be designated by the IRB Chair as competent to fulfill this role.
The HRP team will also review the proposed research to determine if it meets the ethical standards of the Belmont Report.
If the research meets the exemption criteria, the Reviewer completes and signs the
“Reviewer’s Checklist.”
The Analyst or Administrator prepares the letter of Exempt Registration.
The HPS database entries are completed.
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H.
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Registered documents are processed.
The Protocol File is collated and filed.
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