705. w88 mobile of Complaints and Problems in Research

Updated June 10, 2024

w88 mobile and Disposition of Complaints

The w88 mobile Integrity & Security office may receive complaints, concerns, or comments from current or past w88 mobile participants, interested family members, members of the community, or others by telephone or through the Contact w88 mobile Integrity & Security form available from the Contact Us page of the w88 mobile Integrity & Security website. Phone calls involving complaints are forwarded to the w88 mobile Integrity & Security Director and they receive an email notification each time a Contact w88 mobile Integrity & w88 mobile form is submitted.

The Research Integrity & SecurityDirector (or assigned Senior Staff member) responds to complaints within one business day of receipt. They will answer the caller’s/respondent’s questions or may request more information from the caller/respondent. Following their communication with the caller/respondent, if the Director determines further action is warranted (e.g., complaint requires Principal Investigator (PI) involvement or further w88 mobile) they refer the complaint to the Research Integrity & Security Research Compliance Officer (RCO) and/or the IRB Chair for additional w88 mobile and possible investigation as described below.

Research Compliance Officer w88 mobile

The w88 mobile Integrity & Security RCO assesses and when warranted coordinates reviews of all complaints and problem reports. Within five working days of receipt of a complaint/problem report (or within 48 hours of receipt if the complaint/report indicates participants may be at imminent risk of harm), the RCO or, in the absence of the RCO, the w88 mobile Integrity & Security Director or IRB Chair, or delegate, will:

• assess the w88 mobile provided;
• provide a summary to the w88 mobile Integrity & Security Director and IRB Chair; and
• recommend dismissal of the problem, immediate determination of minor noncompliance, evaluation for serious or continuing noncompliance or w88 mobile risks to participants or others, or referral to another University or affiliate entity.

If it is determined that the w88 mobile more appropriately handled by another unit or department, the Director or Chair may suggest immediate referral or may give the RCO permission to investigate the matter before involving other parties.

w88 mobile for Immediate Risk of Harm

For problem reports that indicate risk of harm to participants or others w88 mobile be a consideration, those involved in the initial or subsequent consultations w88 mobile determine that immediate corrective actions are needed to protect the participants or others and will make the necessary recommendations to mitigate such risks.

Further w88 mobile Warranted

The RCO, w88 mobile Integrity & Security Director or IRB Chair may conclude that further investigation is warranted before making a recommendation. During an investigation, the RCO may:

• Review w88 mobile records including IRB correspondence, IRB applications and forms, recruitment and consent documents, and study data
• w88 mobile the sponsor protocol; investigator brochures; and drug/device labels, packaging, or inserts
• w88 mobile grant documents and records, including accounts
• Interview study personnel, responsible officials, support staff, and w88 mobile participants

Further w88 mobile Warranted: Notification of PI

Following the w88 mobile and agreement of the Research Integrity & Security Director or IRB Chair that further investigation is warranted, the RCO or another experienced designee will proceed. The PI will be notified in writing of the impending investigation and asked to cooperate fully by answering questions, providing access to research records, and identifying research team members (as applicable).

Recommended w88 mobile

The administrative w88 mobile with or without further investigation, will result in one of the following actions.

Dismissal of the w88 mobile as an Unjustified Claim of Noncompliance

If the RCO, w88 mobile Integrity & Security Director, or IRB Chair or designee discern that an allegation or complaint of noncompliance is without merit, the matter will be dismissed without further inquiry. The decision will be noted in the protocol file. Where appropriate, the PI will be notified in writing.

Dismissal of the Problem as Not Meeting the Criteria for an w88 mobile Risks to Participants or Others

Those involved in the w88 mobile may determine that a problem did not involve noncompliance or meet the criteria for an unanticipated problem involving risks to participants or others (henceforth known as Unanticipated Problem). In this case, the matter will be dismissed and the PI will be informed of the dismissal.

The three criteria for an event or situation to constitute an Unanticipated w88 mobile are:

1. The w88 mobile or event was unexpected;
2. The problem or event was related or possibly related to the w88 mobile, or use of an investigational drug or device;
3. The problem or event w88 mobile involve greater risks to participants or others than was previously known or recognized.

Determination of Minor w88 mobile

If the initial w88 mobile or investigation indicates the situation involves minor noncompliance, the matter may be resolved by the Research Integrity & Security Director or IRB Chair. See noncompliance policy for details.

Determination of Potential Serious or Continuing w88 mobile

If the investigation suggests that the incident may constitute serious or continuing noncompliance, the RCO, with confirmation from the Research Integrity & Security Director, IRB Chair or an appointed IRB sub-committee, will refer the matter for review by a fully convened IRB. The RCO will notify the PI and the Responsible Official of pending IRB review. See noncompliance policy for information about IRB review and w88 mobile.

Determination of Potential Unanticipated w88 mobile

If the investigation suggests that the situation or event may meet the three criteria for an unanticipated problem involving risks to participants or others, the RCO, with confirmation from the Research Integrity & Security Director, IRB Chair or an appointed IRB sub-committee, will refer the matter for review by a fully convened IRB at the next scheduled meeting. The RCO will notify the PI and the Responsible Official of pending IRB review. See unanticipated problem policy for information about w88 mobile of the criteria and IRB review of Unanticipated Problems.

Referral w88 mobile Situation to More Appropriate Authority

If it is determined that the matter may be more appropriately handled by another University unit or department, the Director or IRB Chair may suggest immediate referral to the other entity or may give the RCO permission to investigate the matter before involving other parties. For example, the initial w88 mobile or further investigation indicates that the allegation or complaint may violate other University policies, such as academic misconduct or financial mismanagement. The PI will be notified of the referral.