Capture the details: Key compliance facts and questions

The first step in finding any research noncompliance is to identify it, and the most efficient method for this is to make it easier for research staff, investigators, and study participants to report their concerns.

"We have more and more self-reports of noncompliance each year simply because people see that we work with them to correct noncompliance issues rather than imposing sanctions that would be inhibitive to their research," says George Gasparis, executive director of the Columbia human research protection program at Columbia University in New York, NY.

Of course, any serious noncompliance must be reported to regulatory authorities, including the FDA and/or Office of Human Research Protection (OHRP), he adds.

The compliance office uses a form for research staff to complete when they have a noncompliance concern. It's called the Columbia University IRB's "Reporting of Allegation of Research Noncompliance or Protocol Deviations Requiring Compliance Oversight."

It's a simple, one-page check-box form that asks for information that includes the following:

• Date of notice, IRB protocol number, IRB of record, principal investigator, study title, protocol level of review, name of individual providing this notice;

• Nature of the event:

- Failure to obtain IRB approval prior to conducting human subjects research;

- Recruitment of study subjects during a period of lapsed IRB approval;

- Performance of study-related procedures or data analysis during a period of lapsed IRB approval;

- Enrollment of subjects in a study without obtaining legal effective informed consent;

- Failure to report/late reporting of serious or recurring problems involving risks to human subjects;

- Protocol deviations requiring COT investigation;

- Dosing errors;

• Please provide a description with sufficient details of the event.

There also are check-boxes for listing actions taken by the board and compliance office. And the form lists the names and e-mails of the compliance oversight team.

The compliance oversight program also has a form that can be used by compliance staff to focus their questions when someone calls with a study concern or complaint. It's called the Columbia University IRB's "Reporting Form for Research Concerns or Complaints."

The form has two pages and provides check-boxes and sections for information.

"We capture the information on the form and begin looking into the situation to see if there really is noncompliance that needs to be investigated," says Jessica Randall, MA, CIP, an audit specialist at the Columbia University IRB.

"We begin to track the situation, using the form," she adds.

"The form has specific questions the person taking the call can ask," she explains. "Someone might not think to tell us what the research protocol number is, or they might not remember the doctor's name."

Here are some items included in the form:

• Name or initials;

• May we reveal that you are the source of this concern or complaint to the study's principal investigator and other study staff?

• Are you making this report for someone else?

• Contact information is required for follow-up: phone, alternate phone, e-mail address, other contact info;

• Please tell us about the study for which you have a concern or complaint: study name or description, name of principal investigator;

• Please tell us about the research concern or complaint you are reporting;

• Please tell us how you would like to see your concern or complaint resolved;

• Have you discussed this concern or complaint with the principal investigator or other study staff? If yes, please let us know who you contacted;

• Are you or were you a participant in the study?

• When (approximately) did you start participating in the study?

• Are you still participating in the study?

There also is a section for the person who handled the call to write down the date the call was received, date it was entered to tracking log, resolution date, who it was referred to, and detailed study information.