For the purposes of IRB policy, research misconduct means knowing and willful non-compliance with requirements of the conduct of research involving human subjects. Examples of research misconduct might include any of the following:

1. failing to seek IRB approval before beginning research with human subjects, whether knowingly or inadvertently
2. failing to seek renewal of IRB approval following the lapse of such approval
3. failing to report adverse events with human subjects
4. modifying a research protocol without consulting IRB
5. failing to adequately report risks to human subjects
6. failing to secure and properly document informed consent

The University and the IRB recognize that honest errors are an inevitable part of the research process. To distinguish instances of knowing and willful research misconduct from “honest” errors, simple carelessness, and minor infractions, the IRB will conduct a for-cause audit, according to the following procedures.

For-cause Audit:  Under 45 CFR 46.113 requirements, this review is performed when concerns regarding compliance, protocol adherence, or subject safety are brought to the attention of the IRB or the IRB Monitor. This audit may take place on-site or on the Seattle University campus, at the discretion of the IRB, and may include review of:

1.       Protocol file/regulatory documentation

2.       IRB Documentation

3.       Consent/Assent Forms

4.       Individual Participant Records. A random sample to determine if :

a)       The participants met the inclusion/exclusion criteria for the study.

b)       Study related procedures are performed according to the protocol.

c)       Study related procedures are scheduled and performed per the study time line.

d)       Data is recorded and stored securely as described in the Consent Form.

Documents that may be selected for review include, but are not limited to:

1.       Regulatory submissions and associated IRB correspondence

2.       Changes in the protocol and associated IRB correspondence

3.       Review of any lapses in IRB approvals

4.       Review of eligibility criteria

5.       Review of all informed consents

6.       Review of subject accrual and recruitment practices

7.       Review of data collection tools and procedures

8.       Review of adverse event reporting (including timeliness of reports to the IRB, Sponsor and other regulatory agency.

9.       Review of protocol deviations (including timeliness of reports to the IRB, Sponsor and other regulatory bodies)

10.   Review of continuing review reports

Audit Reports will be conducted by a member of the IRB staff and at least one IRB board member. In the case of a for cause audit, the IRB may request a 100% audit of study participant’s records and/or collected data. The Report will be presented to the entire Board at the next scheduled IRB Meeting. Subsequently, notification of observations of noncompliance will be sent to the PI with a detailed explanation of the basis for the findings.

Actions will not be taken by the IRB against any investigator or project without providing the investigator an opportunity to provide information in writing that might mitigate or refute an adverse finding.