Tips for handling study complaints

Investigate, validate, correct

Research institutions should make their complaint process as accessible as possible to researchers, participants, and others, an expert says.

"We have a suggestion box where participants and staff can submit anonymously, and we have a link to the complaint form under a participant tab on our website," says Jan Zolkower, MSHL, CIP, CCRP, regulatory compliance manager at Vanderbilt University Human Research Protection Program (VUHRPP).

Complaints can be submitted online anonymously or with the person's contact information for follow-up.

Research participants and others also can call Zolkower directly if they have a question or concern.

VUHRPP has a written procedure for how investigators and IRBs should handle complaints. Among the key responsibilities listed on the procedure are:

  • Investigators must notify HRPP of any participant or other individual's research-related complaints, and they can report the complaints at continuing review unless there is a risk to participants or others.
  • Investigators must report complaints that pose a risk to subjects or result in a potential change in the risk/benefit ratio of an unanticipated problem as soon as possible and no later than 10 working days after the investigator learns of the complaint.
  • Investigators must cooperate with HRPP, make documents accessible, and respond to written requests within the designated time frame.
  • HRPP will notify the assigned IRB chair or designee of the initial complaint.
  • The IRB chair or designee may request revisions or additions to the planned investigation or directed audit activities.
  • An IRB regulatory compliance analyst will collect as much information as possible when receiving a verbal complaint and complete the IRB Complaint Information Form.
  • All written complaints are forwarded to the HRPP director and the research subject advocate for investigation.
  • When a complaint is substantiated, the HRPP director will forward the complaint to the HRPP Process Improvement Team for further investigation.
  • Complaints that involve sensitivity issues may be forwarded to the IRB Optimization Committee for discussion and recommendations.
  • The investigation's results are reported to the HRPP director, and if the complaint is study-related, it's reported to the IRB.
  • The regulatory compliance analyst forwards all determinations and/or recommendations to the HRPP director.
  • The HRPP director may notify the IRB medical director when warranted.
  • The regulatory compliance analyst will update the IR database, and records of the complaint and investigation will be kept in a separate file in the IRB office.
  • The HRPP suggestion box is checked frequently and responses are given to known complainants.
  • When Zolkower receives an oral complaint, she takes these steps:
  • First, the complaint is investigated: It's important to investigate the complaint with an open mind, she notes.

Sometimes what sounds like a clear-cut violation could turn out to be a misunderstanding.

For example, there was one case where a parent called to complain that his or her child had been enrolled in a research study through the school system when the parent had clearly returned the informed consent, saying he or she did not want the child to participate, Zolkower recalls.

"We made an appointment with the investigator, and I reviewed all documents for all children in this study," she says.

She saw the name of the caller's child, but there were no study data included, and the document said the parent had declined participation.

"In the spread sheet, all remaining data fields were completely blank while all the other data fields for other kids were completely filled in," Zolkower says. "The caller was convinced that their child had been interviewed, but the child could have talked with other children in the class who were in the study and knew what they had been told when they were removed from the classroom."

When speaking with people who are making a complaint, it's important to be careful and validate their experience, she notes.

"You are talking to someone who's very upset and passionate about what has happened," she says. "So be careful and validate, but do a thorough investigation so you can back up whatever answer you're giving."

In the case of the child and consent, Zolkower explained to the parent that the investigator's file contained no documentation to support that an interview had taken place; there were no case report forms or study forms with the child's name on it, and there was no study ID number for the child.

"The parent still was convinced that this had occurred," Zolkower says. "I said, 'If anything else comes up in the future that leads you to believe a study interview has taken place, then here's my contact information.'"

• Secondly, follow-up action occurs: When an investigation shows that a complaint is valid and involves study staff conduct, Zolkower will investigate, notifying the IRB director, associate directors, and chair of any findings. The IRB chair will review the complaint and findings and then determine if it should be discussed at an IRB meeting.

"They make a determination of what course of action needs to be taken and what kind of corrective action plan needs to be implemented," Zolkower says. "I am there to provide details during the IRB meeting, if requested; they usually come up with a plan, and it usually begins with education to the principal investigator and study staff."