Table II.

Themes Concerning Involvement of IRBs in Research Integrity

Roles of IRBs Concerning PI Problems

IRBs define RI differently IRBs interact differently with other institutional offices IRBs differ in amounts of responsibility they feel they have for RI problems

Severity of Problems

Mostly minor ◆ Not involving harm to subjects

What Are the Problems?

Poor informed consent Non-submitting to the IRB ◆ Entire protocols ◆ Changes to protocols “Merely paperwork” ◆ Changes in study design “Arms” of study Inclusion/exclusion criteria Number of subjects

How IRBs Learn of Problems

Continuing review PI self-report Audits ◆ Audits for cause ◆ Questions of when to audit ◆ Random audits Complaints by subjects Complaints by staff (“whistleblowers”) Serendipity

Causes of Problems

Generally not mal intent Poor supervision of staff or students by PI Rarely, PI mental health problems

Responses to Problems

Vary in degree of severity and type ◆ Educating PI ◆ Suspending study ◆ Reporting problem to federal agencies

Implications

Most problems are minor, but not negligible and dismissible Questions of whether better monitoring is warranted, and if so, what