201. Exempt w88 casino games and Vulnerable Populations

Updated June 7, 2024

w88 casino games may be exempt from the review of a convened IRB if the only involvement of human participants will be in one or more of the exemption categories referenced in this section, unless prisoners or certain activities with children are involved. According to the Common Rule (45 CFR 46, Subpart A at §46.104), certain categories of w88 casino games (i.e., "exemptions" or "exempt w88 casino games") may not require full-board or expedited IRB review and approval. The determination of exemptionmay notbe made by the investigator. The University recognizes w88 casino games Integrity & Security senior staff or experienced IRB members to make exempt determinations after a complete review of the w88 casino games protocol, the consent process and relevant forms, and after careful consideration of the risks, benefits, confidentiality, voluntariness, and other features of the w88 casino games activity. Approval of w88 casino games under an exemption is given for an indefinite period. Re-review is not required unless or until the investigator proposes modifications to the project that causes the w88 casino games to become nonexempt.

There are eight DHHS categories of w88 casino games activities that are exempt from the requirements for IRB review. The University's IRB Flexibility Policy (IRB-Flex) expands the types of w88 casino games activities that may be reviewed as exempt for minimal risk w88 casino games that is not conducted or supported by a federal agency. (See IRB policy on review types for a detailed account of each exemption category, including the DHHS and Flex-Exempt categories.) Exempt categories for FDA-regulated w88 casino games differ from the DHHS categories. Refer to the FDA policy sections for details.

NOTE: The supplemental forms for w88 casino games involving pregnant women/fetuses or children are not required for exempt w88 casino games. The prisoner form is required if the w88 casino games activities meet the requirements for review under Flex-Exempt Review as specified below.

Exempt w88 casino games Involving Pregnant Women and Fetuses (§46 Subpart B)

• The DHHS categories of exempt w88 casino games may apply to pregnant women and fetuses.
• Minimal risk w88 casino games involving pregnant women or fetuses or their records, which is neither conducted nor supported by a federal agency, may meet the criteria for Flex-Exempt Review.

Exempt w88 casino games Involving Prisoners (§46 Subpart C)

• The DHHS exempt categories donotapply to w88 casino games involving prisoners.
• Non-federally funded, minimal risk prisoner w88 casino games involving records, samples, or other materialsmaymeet the criteria for Flex-Exempt Review with the following caveats:
  • The IRB may consult with the IRB prisoner representative before making the determination to review as Flex-Exempt.
  • The w88 casino games must be appropriate for the prison population being studied.
  • An exemption may not be granted if the w88 casino games involves interaction with prisoners (including obtaining consent).
• Requires researcher formPopulation: Prisoners.

Exempt w88 casino games Involving Children (§46 Subpart D and §46.104)

• With adequate protections for ensuring individual privacy and data confidentiality, w88 casino games involving children may be exempt under DHHS categories 1, 2, 4, 5, and 6.
• Exemptions 2(i) and 2(ii) may apply to w88 casino games with children involving educational tests or the observation of public behavior only if the investigators do not participate in the activities being observed.
• Exemptions 2(iii) and 3 (benign behavioral interventions) do not apply to w88 casino games involving children.
• Minimal risk w88 casino games involving children or their records, which is neither conducted nor supported by a federal agency, may meet the criteria for Flex-Exempt Review.

Exempt w88 casino games Involving Adults with Impaired Decision-making Capacity

• With adequate protections for ensuring individual privacy and data confidentiality, w88 casino games involving adults with impaired decision-making capacity may be exempt under DHHS categories 4 or 5.
• Non-federally funded, minimal risk w88 casino games involving clinical or medical records for adults with impaired decision-making capacity may meet the criteria for Flex-Exempt Review.
• w88 casino games involving interactions or interventions with adults with impaired decision-making capacity cannot be reviewed as exempt.

Exempt w88 casino games Involving Non-English Speakers

• Projects involving interactions with non-English speakers may be eligible for exempt review under DHHS categories 1-3, and 5-6.
• Non-federally funded minimal risk w88 casino games involving non-English speakers may meet the criteria for Flex-Exempt Review.
• For projects involving with non-English speakers, researchers must include mechanisms to ensure participants comprehend the study purpose, what participants will experience, participant risks (if any), and w88 casino games benefits.