566. Exempt w88 slot online and Approval

Updated February 26, 2024

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

Research 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 w88 slot online under the University’s IRB-Flexibility policy may be submitted for Exempt w88 slot online. (For information about the conditions for Exempt w88 slot online under DHHS or Flex-Exempt categories, in accordance with the IRB policy regarding w88 slot online types. Information about FDA exemptions is provided elsewhere.)

The University grants exclusive authority to Research Integrity for w88 slot online and approval of exempt research. This authority allows qualified Research Integrity staff and IRB members to w88 slot online applications for exempt research.

Requirements for Exempt w88 slot online

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

The University’s Research Integrity office requires w88 slot online research 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 w88 slot online 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 slot online involving interaction with participants, participants are told the activity involves w88 slot online and that participation is voluntary, are provided with a description of the w88 slot online procedures, and are given the researcher’s name and contact information.
• The w88 slot online is designed to minimize harms to participants and maximize w88 slot online 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 w88 slot online

Reviewers also assess for compliance with applicable federal, state, and local laws (including HIPAA, FERPA, and PPRA as described below), and state-mandated w88 slot online for reporting abuse and communicable diseases.

Reviewers use the Exempt w88 slot online Worksheet to assess projects submitted for Exempt w88 slot online.

Reviewers are IRB Members. The person deciding should be familiar with laws, regulations, codes, and guidance governing the w88 slot online, organizational policies, and the nature of the w88 slot online 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 slot online.

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 w88 slot online in IRBNet by making a Recommendation, adding the w88 slot online worksheet and notes (if any), and marking the w88 slot online complete. Research Integrity will communicate the exempt w88 slot online results to the Principal Investigator (PI) and research team members promptly, within two to ten business days of receiving a complete submission.

Exempt w88 slot online Results

w88 slot online reviews result in one of five outcomes:

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

w88 slot online determinations are for the life of the project. w88 slot online research is not required to undergo renewal.

Documentation of Exempt w88 slot online and Approval

For projects that meet the requirements for w88 slot online determination, the reviewer will complete the project in IRBNet by:

• Selecting Exempt w88 slot online for w88 slot online Type
• Selecting w88 slot online for w88 slot online Status
• Selecting w88 slot online for Action
• Noting the date, the w88 slot online determination was finalized as the Effective Date
• Leaving the Expiration Date field blank
• Ensuring Minimal Risk is selected for w88 slot online Risk Level
• Noting the applicable w88 slot online category (i.e., one of six DHHS categories, or Flex-w88 slot online) as a w88 slot online Note.

Notifications of w88 slot online Research Determinations

Research 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 w88 slot online. Exempt notification letters specify the exempt category.

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

Information about w88 slot online determinations is available to IRB members and institutional authorities upon request.

Limited Institutional w88 slot online Board w88 slot online

Limited IRB w88 slot online requires that certain exempt research 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 w88 slot online may not disapprove research.

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 research 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 w88 slot online isto ensure privacy/confidentiality protections are in place with exempt research 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 research 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 w88 slot online is not required for studies that qualify for a limited w88 slot online. IRB retains the authority to suspend or terminate approval of research approved with a limited w88 slot online.

Informed Consent Considerations for w88 slot online of Exempt Research

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 slot online. This may include:

• Statement or explanation that the activity involves w88 slot online.
• 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 w88 slot online.
• Name and contact w88 slot online of the researcher.

Situations for Reviewer Discretion to Request Additional Researcher Forms

For w88 slot online research involving children or that will take place outside of the US, the designated reviewer may require the PI to submit the Population: Children or w88 slot online: International researcher forms, respectively.

Is Online Research Eligible for Exempt w88 slot online?

w88 slot online Integrity will assess minimal risk online w88 slot online on a case-by-case basis to determine the appropriate level of w88 slot online, either Exempt or Expedited w88 slot online.

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

Is Research Involving Audio or Video Recordings, or Photography Eligible for Exempt w88 slot online?

w88 slot online Integrity will assess minimal risk w88 slot online involving audio or video recordings, or photographs on a case-by-case basis to determine the appropriate level of w88 slot online, either Exempt or Expedited w88 slot online.

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

How Do HIPAA, FERPA or PPRA Regulations Apply to w88 slot online Research?

• w88 slot online research involving medical records must comply with HIPAA requirements.
• w88 slot online research involving educational records must comply with FERPA requirements.
• If minimal risk, non-federally funded research involving surveys or interviews with children meets the criteria for exempt w88 slot online, the research must comply with PPRA requirements.

NOTE: Researchers are advised to contact Research Integrity before submitting an w88 slot online application for research involving children.

Notifying Research Integrity of Closure of an w88 slot online Research Project

Investigators may notify Research Integrity of a closed w88 slot online project by submitting a closure request via IRBNet.

Research Integrity Closure of w88 slot online Research Projects

w88 slot online studies do not have a set expiration date. However, Research Integrity will conduct an annual campaign of verifying the active status of research projects determined to be w88 slot online more than 12 months prior to the campaign. Research 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) Research Integrity receives no response from the PI after two attempts; or 3) Research 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).