566. Exempt Review and Approval

Updated February 26, 2024

All human w88 bet in which University or affiliate faculty or staff are engaged must be approved or acknowledged by the University w88 bet Integrity or IRB. The University allows certain categories of w88 bet to be exempted from Department of Health and Human Services (DHHS) requirements for IRB review and approval (i.e., the Common Rule).

w88 bet activities in which the only involvement of human participants is in one of the DHHS categories exempted at 45 CFR 46.104 or that meet the criteria for Exempt Review under the University’s IRB-Flexibility policy may be submitted for Exempt Review. (For information about the conditions for Exempt Review under DHHS or Flex-Exempt categories, in accordance with the IRB policy regarding review types. Information about FDA exemptions is provided elsewhere.)

The University grants exclusive authority to w88 bet Integrity for review and approval of exempt w88 bet. This authority allows qualified w88 bet Integrity staff and IRB members to review applications for exempt w88 bet.

Requirements for Exempt Review

In no case will a w88 bet project be reviewed by an individual with a real or perceived conflict of interest relevant to that project.

The University’s w88 bet Integrity office requires exempt w88 bet to be consistent with the ethical principles described in the Belmont Report (in accordance with the IRB policy for a summary of the Report) as exemplified by the following:

• Risk to participants is no greater than minimal.
• Participant selection is equitable.
• Recruitment and consent procedures are designed to be free from coercion and undue influence.
• For w88 bet involving interaction with participants, participants are told the activity involves w88 bet and that participation is voluntary, are provided with a description of the w88 bet procedures, and are given the researcher’s name and contact information.
• The w88 bet is designed to minimize harms to participants and maximize w88 bet benefits.
• Individual privacy is protected.
• Provisions are adequate to maintain the confidentiality of the data. There are adequate provisions to maintain the privacy interests of participants

Reviewers also assess for compliance with applicable federal, state, and local laws (including HIPAA, FERPA, and PPRA as described below), and state-mandated requirements for reporting abuse and communicable diseases.

Reviewers use the Exempt Review Worksheet to assess projects submitted for Exempt Review.

Reviewers are IRB Members. The person deciding should be familiar with laws, regulations, codes, and guidance governing the w88 bet, organizational policies, and the nature of the w88 bet to make sound judgments. An exemption determination may not be made solely by the researcher, or someone with a conflict of interest in the w88 bet.

Reviewers may seek clarification from the investigator or request additional information, changes, or researcher forms before making an exempt determination. Reviewers will apply the DHHS/FDA regulations regarding exempt categories and/or University’s Flexibility Policy to determine exempt status. The assigned reviewer completes the review in IRBNet by making a Recommendation, adding the review worksheet and notes (if any), and marking the review complete. w88 bet Integrity will communicate the exempt review results to the Principal Investigator (PI) and w88 bet team members promptly, within two to ten business days of receiving a complete submission.

Exempt Review Results

Exempt reviews result in one of five outcomes:

1. Project does not constitute human subject w88 bet.
2. Project meets requirements for exempt determination.
3. Information is needed before exempt determination may be granted.
4. Project requires Expedited Review.
5. Project requires Full Committee Review.

Exempt determinations are for the life of the project. Exempt w88 bet is not required to undergo renewal.

Documentation of Exempt Review and Approval

For projects that meet the requirements for exempt determination, the reviewer will complete the project in IRBNet by:

• SelectingExempt ReviewforReview Type
• SelectingExemptforProject Status
• SelectingExemptforAction
• Noting the date, the exempt determination was finalized as theEffective Date
• Leaving the Expiration Date field blank
• EnsuringMinimal Riskis selected forProject Risk Level
• Noting the applicable exempt category (i.e., one of six DHHS categories, or Flex-Exempt) as aProject Note.

Notifications of Exempt w88 bet Determinations

w88 bet Integrity staff will generate and publish an exempt determination letter in IRB. The PI and contact person (if applicable) will be notified that the letter is available for review. Exempt notification letters specify the exempt category.

For projects that do not meet the requirements for exempt determination, w88 bet Integrity staff will notify the investigators either the project was acknowledged and may proceed as “not human subjects w88 bet” or the project requires Expedited or Full Committee Review.

Information about exempt determinations is available to IRB members and institutional authorities upon request.

Limited Institutional Review Board Review

Limited IRB review requires that certain exempt w88 bet be reviewed by an IRB chair or IRB member designee for privacy and confidentiality under requirements in 45 CFR §46.111(a)(7) or §46.111(a)(8). IRB members conducting limited IRB review may not disapprove w88 bet.

The regulations at §46.111(a)(7) state, “When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data,” and §46.111(a)(8) states “… (iii) If there is a change made for w88 bet purposes in the way the identifiable private information or identifiable biospecimens are stored or maintained, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data. “The purposeof limited IRB review isto ensure privacy/confidentiality protections are in place with exempt w88 bet that involves the collection or use of sensitive, identifiable data (exemptions 2, 3 and 8) and, for exemption 7, that “broad consent” was obtained and (if appropriate) documented according to an approved protocol. This process is only applicable to certain new provisions in the exempt categories 2, 3, 7, and 8.

The Exempt application must contain sufficient information to determine whether the proposed w88 bet fulfills the relevant criteria for approval required under limited IRB view. Documentation should provide adequate protections for privacy interests of participants and the confidentiality of identifiable data. Continuing review is not required for studies that qualify for a limited review. IRB retains the authority to suspend or terminate approval of w88 bet approved with a limited review.

Informed Consent Considerations for Review of Exempt w88 bet

If the researcher will be interacting with participants, there is an agreement to participate that discloses adequate information for participants to make a voluntary decision regarding whether to participate in the w88 bet. This may include:

• Statement or explanation that the activity involves w88 bet.
• Description of the procedures.
• Statement of risks and benefits.
• Statement that participation is voluntary.
• Statement that there are adequate provisions to maintain the privacy interests of participants.
• Name and contact information of the researcher.

Situations for Reviewer Discretion to Request Additional Researcher Forms

For exempt w88 bet involving children or that will take place outside of the US, the designated reviewermayrequire the PI to submit thePopulation: Children or w88 bet: Internationalresearcher forms, respectively.

Is Online w88 bet Eligible for Exempt Review?

w88 bet Integrity will assessminimal risk online w88 beton a case-by-case basis to determine the appropriate level of review, either Exempt or Expedited Review.

• With adequate protections for ensuring individual privacy and data confidentiality, online w88 bet may be exempt under DHHS category 2 or 3.

Is w88 bet Involving Audio or Video Recordings, or Photography Eligible for Exempt Review?

w88 bet Integrity will assessminimal risk w88 betinvolving audio or video recordings, or photographs on a case-by-case basis to determine the appropriate level of review, either Exempt or Expedited Review.

• With adequate protections for ensuring individual privacy and data confidentiality, w88 bet involving recordings or photography may be exempt under DHHS category 2 or 3.

How Do HIPAA, FERPA or PPRA Regulations Apply to Exempt w88 bet?

• Exempt w88 bet involving medical records must comply with HIPAA requirements.
• Exempt w88 bet involving educational records must comply with FERPA requirements.
• Ifminimal risk, non-federally funded w88 bet involving surveys or interviews with children meets the criteria for exempt review, the w88 bet must comply with PPRA requirements.

NOTE: Researchers are advised to contact w88 bet Integrity before submitting an exempt application for w88 bet involving children.

Notifying w88 bet Integrity of Closure of an Exempt w88 bet Project

Investigators may notify w88 bet Integrity of a closed exempt project by submitting a closure request via IRBNet.

w88 bet Integrity Closure of Exempt w88 bet Projects

Exempt studies do not have a set expiration date. However, w88 bet Integrity will conduct an annual campaign of verifying the active status of w88 bet projects determined to be exempt more than 12 months prior to the campaign. w88 bet Integrity will contact Principal Investigators to ask if their protocol is still active. Protocols will be closed if 1) the PI confirms the protocol can be closed; or 2) w88 bet Integrity receives no response from the PI after two attempts; or 3) w88 bet Integrity determines that the PI is no longer eligible to serve in that capacity (e.g., as a result of having left the institution or retired).