700. Reporting Complaints and w88 online sports betting in Research
Updated June 10, 2024
Situations may occur during implementation of a research study, after a participant withdraws or completes their participation, or after study completion that warrant assessment by Research Integrity & Security and possibly, review by the IRB. These include complaints from participants or others, unapproved changes in the conduct of a research study, serious events or w88 online sports betting experienced by research participants, new information that suggests research risks or benefits have changed, breaches of participant privacy or data confidentiality, and sponsor or other external reports that suggest a problem may exist.
Anyone (i.e., participants, members of the community, principal investigators, w88 online sports betting staff, employees, or IRB members) may report complaints, potential noncompliance, or concerns related to a w88 online sports betting project by contacting w88 online sports betting Integrity & Security or a specific w88 online sports betting Integrity & Security staff member either by phone or email; or electronically, by using the Contact w88 online sports betting Integrity & Security form available from the Contact Us page of the w88 online sports betting Integrity & Security website. Callers may remain anonymous and the form may be submitted anonymously (e.g., by sending a printed paper copy of the completed form to w88 online sports betting Integrity & Security or by omitting contact information from the online reporting form).
For non-exempt w88 online sports betting (including Humanitarian Device Exemption), principal investigators, w88 online sports betting or w88 online sports betting Integrity & Security staff, IRB members, or other employees must notify the IRB within five business days of learning of a complaint, deviation, potential noncompliance, or problem; or within 48 hours if the problem may be life-threatening or fatal. Reporting requirements also apply to individuals who receive external reports or notifications. Researchers are advised to use the appropriate Reportable Event Form, available in the IRBNet Researcher Library. Others may contact w88 online sports betting Integrity or complete the Contact w88 online sports betting Integrity & Security form available from the Contact Us page of the w88 online sports betting Integrity & Security website.
For exempt research, researchers or others who know of a complaint or problem are advised to contact Research Integrity & Security to discuss w88 online sports betting that may have occurred.
Reporting requirements extend to new information that becomes known about studies that are closed, expired or terminated when that information involves new risks to former participants. The w88 online sports betting will determine if participants must be informed of the findings and may decide that other steps are warranted to protect participants or others.
Regardless of source (see below), all complaints, deviations, potential noncompliance, and w88 online sports betting are assessed by the University’s Research Integrity & Security Research Compliance Officer (RCO), Research Integrity & Security Director, or IRB Chair or designee in a consistent, prompt, and professional manner as described in the IRB policy for assessment of complaints and w88 online sports betting in research.
Sources of Complaints, Potential Noncompliance, or w88 online sports betting
Complaints/w88 online sports betting may come to the attention of Research Integrity & Security or the IRB from a variety of sources, including but not limited to:
- Members of the w88 online sports betting team
- w88 online sports betting or their family members
- Members w88 online sports betting community
- Continuing reviews, w88 online sports betting summaries, or progress reports from investigators
- Internal audits or reviews
- w88 online sports betting or agency audits (e.g., FDA, VA)
- Monitoring activities by PIs or sponsors
- Adverse event, w88 online sports betting, or safety reports
Suggested Content for Reporting w88 online sports betting to the IRB
Individuals reporting w88 online sports betting to the IRB must provide sufficient information for Research Integrity & Security to evaluate the effects of the problem, situation, unapproved changes, or external reports and to determine the appropriate review path (e.g., assessment for noncompliance or Unanticipated Problem).
Ideally, the information in the report would allow the w88 online sports betting to evaluate each problem or situation. For example:
- Does the situation involve unapproved changes to or divergence from an approved w88 online sports betting plan?
- Was the incident expected (i.e., identified w88 online sports betting application and consent form) or unexpected?
- Is the problem or situation related or possibly related to participation in the w88 online sports betting?
- Does the problem or event suggest w88 online sports betting or others may be at greater risk of harm than was previously known or recognized?
At a minimum, the w88 online sports betting should include the following:
- w88 online sports betting title and project number;
- name w88 online sports betting principal investigator;
- description of the problem, situation, or incident, including specific changes to procedures in the approved w88 online sports betting plan if applicable;
- assessment of why the w88 online sports betting occurred;
- evaluation of potential effects (e.g., increased participant risk, reduced w88 online sports betting benefits, or compromised w88 online sports betting integrity);
- description of immediate changes to the protocol that were made in response to the w88 online sports betting;
- description of corrective actions that were implemented or that are proposed to ensure that similar events do not occur w88 online sports betting future;
- relevant materials or documents including sponsor assessments or w88 online sports betting; and
- the name of the individual reporting the event (unless the person reporting the w88 online sports betting prefers to remain anonymous).
w88 online sports betting Forms
Investigators are advised to use the appropriate Reportable Event Form to report w88 online sports betting in research. For more information on reportable events, see policies for Protocol Deviations and Unanticipated w88 online sports betting.