575. IRB Review of International w88 sports betting app

Updated June 10, 2024

To ensure protections for w88 sports betting app conducted by University and Affiliate faculty, students, and staff in other countries are equivalent to those for w88 sports betting app conducted in the US, the University IRB applies the ethical principles of the Belmont Report, the Department of Health and Human Services (DHHS) regulations (at 45 CFR 46), other applicable federal requirements, and relevant University policy to non-exempt w88 sports betting app conducted outside of the United States. The IRB reviews international w88 sports betting app according to IRB policy for new projects by Full Committee or for new projects by Expedited Review), and for post-approval monitoring. Post-approval monitoring includes:

• continuing review and approval for non-exempt w88 sports betting app by Full Committee or continuing review and approval for non-exempt w88 sports betting app by Expedited Review according to the approval period specified by the IRB;
• review and approval of amendments for non-exempt w88 sports betting app by Full Committee or review and approval of amendments for non-exempt w88 sports betting app by Expedited Review);
• administrative assessment and management of problem reports;
• review of potential noncompliance and Unanticipated Problems and adverse events;
• data safety monitoring (e.g., per 45 CFR 46.111, item (6); 21 CFR 56.111, item (a)(6); 21 CFR 312.32, and 38 CFR 16.111, item (a)(6) or other federal regulations as applicable); and
• w88 sports betting app monitoring in accordance with w88 sports betting app Integrity's & Security quality improvement program (QIP).

The University IRB complies with the w88 sports betting app standards in the International Conference on Harmonization - Good Clinical Practice E6 only so far as these reflect the regulatory requirements of DHHS, FDA, and other federal agencies as applicable.

NOTE: See the w88 sports betting app Integrity & Security webpage for International w88 sports betting app and the IRB policy for investigators conducting international w88 sports betting app for additional information.

IRB Assessment of Researcher Qualifications

The IRB may request any or all the following to assess University/Affiliate researcher qualifications to conduct the w88 sports betting app in the targeted locales:

• curriculum vitae including other studies conducted,
• letters of reference,
• evidence of completion of Export Control Training
• evidence of completion of ethical conduct of w88 sports betting app international site
• information from the sponsor of the w88 sports betting app, and
• information from licensing boards and professional societies.

Additional IRB Considerations for International w88 sports betting app

Knowledge about local laws is obtained from theInternational Compilation of Human w88 sports betting app Standardsavailable from the International page of the DHHS website; IRB member, consultant, and researcher expertise; or other reputable sources. Laws affecting the conduct of human w88 sports betting app include those governing human w88 sports betting app protection; requirements for local IRB or ethics board or committee approval; medical practitioner certification or licensing; and age of majority. The University IRB ensures mechanisms exist for communication and coordination with local IRBs when appropriate.

The University IRB assesses information about local w88 sports betting app context (e.g., cultural norms, superstitions, perceptions about scientific w88 sports betting app or the concept or disease under study, languages, and environmental influences) to ensure the rights and welfare of participants are sufficiently protected. Information for this assessment may be obtained from the application or other reputable sources; and through discussions with the Principal Investigator, knowledgeable IRB members, or expert consultants.

Additional Considerations

The IRB follows the same policies and procedures when reviewing w88 sports betting app conducted in the United States and w88 sports betting app conducted internationally. However, there may be additional considerations to appropriately address the unique situations and populations relevant to specific international projects. The following items should be considered when designing and conducting international w88 sports betting app projects.

Informed consent:

• Does the consent document need to be translated into a language other than English?
• Do the consent discussion and participant interactions require the use of an interpreter?
• Are participants able to read and write?
• Is it culturally appropriate for participants to provide consent without consultation with family or other members of the community?
• Is it culturally appropriate to obtain a signature from the participants?
• What is the age of majority for giving legal consent versus needing parental permission?

Conducting study procedures:

• Are interventions, questionnaires, surveys, and data collection tools culturally appropriate and valid for the population?
• What is the culturally appropriate method of providing compensation to participants?

Post-approval monitoring:

• What is the most effective method for communicating with local collaborators and authorities over long distance?
• How will participant complaints, non-compliance, and other unanticipated problems be handled within the cultural context?
• Are local collaborators appropriately trained to identify and report participant complaints, non-compliance, and other unanticipated problems to the investigator?
• How will data be monitored over long distance for compliance, completeness, and validity?
• How will confidentiality of data be maintained over long distance?