The IRB at the Biomedical Research Alliance of New York (BRANY) in Lake Success, NY, noticed a problematic trend of researchers amending their studies in the continuing review reports.

The IRB has a reportable event form, but these changes were not always being submitted that way, says Raffaella Hart, MS, CIP, vice president for IRB and IBC services at BRANY.

Sometimes a week or more would pass before the IRB knew that there was an issue that needed action, she adds.

“We had a channel for reporting noncompliance, but people didn’t use that channel because they didn’t think it was noncompliance,” Hart says. “They’d say, ‘We have a deviation,’ but not use the right channel.”

For example, a study team would use the wrong version of an informed consent form and think this was only a minor deviation. When IRB staff investigated it, they’d discover the new information was very important for people to receive in a timely fashion, she explains.

“We sent our auditors — the quality assurance team — to evaluate and help investigators learn how the consenting process should be,” Hart says.

Once the IRB addressed noncompliance in a systematic way, the IRB’s overall data processing time improved. For instance, data show an average processing time in 2013 of 62 days, versus 22 days in 2014, after the change.1

The following is how the IRB achieved its positive results:

  • Educate the IRB team. They gave team members examples of how researchers were not using the correct forms to disclose changes, which resulted in noncompliance, Hart says.

“We educated the team to recognize reports that arrived in a way that we didn’t expect, but which might show noncompliance that needs to be acted on,” she explains. “For example, when a minor deviation report comes in and it doesn’t look so minor based on the description, then consult with a staff person.”

One example was of a case where a researcher sent in a minor development report, saying the study files were lost. “Our team said that didn’t seem so minor,” Hart says.

  • Educate researchers. “We educate researchers about the best way to accomplish prompt reporting,” Hart says. “Sometimes, they didn’t realize that a particular incident needs to come to us on a reportable event form.”

The IRB’s website provides detailed information and education with links to forms and instructions. For example, the Minor Protocol Deviation Log can be downloaded to list deviations and this information:

  • date of deviation,
  • patient ID,
  • associated visit,
  • deviation type,
  • description of deviation,
  • action taken, and
  • if applicable, sponsor notification date.

The form states that it is used to “record minor protocol deviations, which are defined as any temporary alternative/modification to the IRB-approved protocol that do not affect subject safety, rights, welfare, or data integrity. This may include administrative and minor departures from the IRB-approved protocol that do not affect the scientific soundness of the research plan.”

The IRB created guidance on reportable events, explaining what needs to be reported, how, and when. The five-page guidance outlines examples of unanticipated problems involving risks to participants and others.

For instance, it says that examples may include onsite and offsite adverse event reports, injuries, side effects, breaches of confidentiality, deaths, or other problems that occur any time during or after the research study, provided they meet the following three criteria:

  • involve harm to one or more subjects or others, or placed one or more subjects or others at increased risk of harm,
  • unexpected, and
  • related to the research procedures.

Other unanticipated problems could involve a change to the protocol taken without prior IRB review or incarceration of a participant or a protocol violation that places a participant at increased risk, the guidance states.

“Our website publishes a little graphic that has the types of submissions that need prompt reporting, timelines, and the form to use — to make it easier for people,” Hart says. “We updated the instructions on all of our forms to say that if you are trying to submit a deviation report, then you are on the wrong form.”

The education receives positive feedback. “The feedback we got was that sometimes people didn’t realize certain types of events fit into the noncompliance category, and they didn’t realize they were doing it wrong,” Hart says.

  • Make workflow improvements. “We built in workflow so if certain things are flagged, certain people will get alerts about them,” Hart says.

For instance, there are electronic alerts that are sent to a designated person in situations such as when someone indicates there is an unanticipated problem and submits a form, she explains.

“We find that is helpful because there is a lot of stuff going at one time in a study,” Hart says.

  • Use dedicated IRB staff. The IRB has someone who is trained to handle noncompliance and unanticipated problems, but also has other duties.

“It works out because there’s not a steady flow of these things,” Hart says. “They ebb and flow, and sometimes people are doing a good job with no problems and then sometimes there is a rash of problems.”

The IRB also runs a report of noncompliance and unanticipated problem events on a bi-weekly basis.

The process appears to be working well, and the IRB staff and researchers are comfortable with it, Hart says.

“Our dedicated reviewer made suggestions about modifying the electronic reporting form so questions would elicit information that was more helpful to them, and we’re in the process of implementing that,” she says. “We meet monthly to check and make sure the process is going smoothly and to see whether staff have any suggestions for improving it.”

REFERENCE

  1. Modi I, Hart R, Rodriguez M. Managing noncompliance: systematic approach that improves human subject research protections. Abstract presented at the 2016 Advancing Ethical Research Conference, held Nov. 12-15, 2016, in Boston. Poster: 35