Program emphasizes seeking facts, consensus

IRB withholds judgment until review is finished

The Baylor College of Medicine in Houston has a prescribed inquiry process for complaints generated by human subject research at the institution, says Kathleen Motil, PhD, MD, associate professor of pediatrics and chair of two of the college’s IRBs.

"We purposely do not call it an investigation," Motil says. "The AAMC [Association of American Medical Colleges in Washington, DC] has some very clearly defined guidelines for university investigations, and that’s not exactly what we’re about."

Motil outlines the steps an inquiry would take, once a person calls with a complaint:

  • A staff member records the facts as the person describes them over the phone, then asks the person to submit their comments in writing. "The litany that they gave you on the phone may be more or less relevant to what actually gets written on paper," Motil says.
  • A review by senior staff, such as director of assurance and compliance or an IRB chair, is held to determine what to do next. If safety or medical health is an issue, the person can be referred for medical care. After weighing the merits of the complaint, the IRB chair and assurance staff will convene a subcommittee of the IRB and designate an audit team. That team notifies the principal investigator and research staff that an audit will be conducted.
  • An audit of all documentation surrounding the study in question is conducted. Staff review the consent forms, adverse event reports, amendment reports, and investigators’ brochures or grants.

    "We look for ongoing documentation of individual subjects throughout the course of that particular study," Motil says. "So for example, if [the investigator] has been allowed to enroll 25 patients and has 32, we will take note of all of that."

  • Staff and administrators are interviewed as well as the investigator to determine operating procedures. "If we perceive that there is a problem, we will suspend any further enrollment if we have to," she says. "But what we try to do is follow the judicial system if you will — you’re innocent until you’re proven guilty."
  • The results of the inquiry are presented to the IRB subcommittee, which can send it back to the audit team for more questions. Once the subcommittee is satisfied, a letter is sent to the investigator for a response, which the subcommittee again reviews. Before the matter moves any further along through the process, the investigator is invited to meet with the IRB subcommittee to be sure there is no miscommunication of the facts.
  • The subcommittee sends its findings to the fully convened IRB, which does its own deliberations. "If the full IRB still has questions, then it goes all the way back to the audit team to resolve or if the subcommittee can resolve it in subsequent meetings, then that happens, too. We don’t want third-hand gossip; we want it straight from the source," Motil explains.

Consensus reached

When the full IRB has had all of its questions answered, its members deliberate and come to a decision about the complaint.

Motil notes that the Institute of Medicine has recommended that IRBs reach their decisions by consensus, rather than simply a majority of members.

"That’s how we operate all the time. We operate in terms of consensus agreement," she says.

The investigator is notified, as are any other departments or agencies that need to become involved. For example, if staffing on a study is an issue, then the departmental chair might be notified, she says.

The IRB reports to the executive vice president and dean of medicine, as well as the vice president and dean of research. Legal counsel receives a report, and may in fact be involved earlier in the inquiry process if there are serious issues of non-compliance, Motil says.

"If we have angst about some things, we will very clearly involve them as early as the subcommittee reviews," she says.

The U.S. Department of Health and Human Services’ Office for Human Research Protections (OHRP) is notified if the IRB finds any serious issues of noncompliance.

Motil says the IRB waits until all of the questions have been resolved before involving OHRP. "We are not going to report hearsay to OHRP. Once all the deliberations have been completed and the IRB has been presented the facts, and the vote has been taken, that’s when we do our report."

Finally, the person who made the complaint also is notified of the IRB’s decision, again at the end of the process, when all of the questions have been resolved. Motil says that process can take years. In the meantime, she says her office often hears from subjects checking on the progress of their complaints.

"We do hear from subjects again, but we don’t make any definitive statements until the facts are settled," she says.