Dealing with complaints: Listen, investigate, and report findings
April 1, 2003 8 minutes read
Dealing with complaints: Listen, investigate, and report findings
Research programs need systems for accepting, addressing concerns
It’s a call an IRB office dreads getting — a patient with a complaint about a study or a researcher, or an anonymous caller alleging problems with a clinical trial.
While informed consent documents must list contacts to call if a person has questions or concerns about research, that’s only the first step, says Marjorie Speers, PhD, executive director of the Association for the Accreditation of Human Research Protection Programs (AAHRPP), a Washington, DC-based accrediting body.
"I think of it in three parts: having a mechanism for concerns to be voiced, investigating [those concerns], and then reporting back on what the findings were and what actions were taken," Speers says.
She says that in the past few years, research institutions have begun to take more proactive steps to ensure that anyone with complaints or concerns can be heard — everything from 24-hour hotlines and web sites to standing committees of research participants set up to advise IRBs. "I think the changes are tied to a number of things," Speers says. "The suspensions of research programs are one thing. Another is just the need to recruit individuals into research, trying to increase subject enrollment, and competing for research studies."
Most institutions she sees that have made the effort to institute a process for dealing with complaints do a good job, she says.
"It’s as if institutions fall into two categories. They either have some type of mechanism in place to hear concerns, or they don’t," Speers says. "If they do have something in place, then it’s usually pretty good."
But one area that she says often needs strengthening is providing a systematic, objective process for investigating every complaint. That process need not necessarily be carried out within the IRB.
"The IRB is very busy doing what it is mandated to do under the regulations, which is to review and approve research," she says. "Also, some of the concerns might actually be raised about the IRB, and so you want individuals who are not sitting on the IRB dealing with concerns that are expressed about them."
She says the complaints that are most appropriately handled by an IRB are those coming directly from subjects.
At Baylor College of Medicine in Houston, the Office of Assurance and Compliance handles complaints and questions about human research from staff, subjects, and anyone else involved in clinical trials, says Kathleen Motil, PhD, MD, associate professor of pediatrics and chair of two of the college’s six IRBs.
"The ethicist within an institution may call us, or the nurse coordinator may call us," she says. "In some instances, we may have physician clinicians outside the specific research project who may also raise questions about the nature of the project."
Motil says the office often is seen as a sort of ombudsman, taking all kinds of calls, including those not directly related to the research at hand. As a result, those receiving the calls have to be very knowledgeable about the departments around them and who does what.
According to Speers, a wide variety of questions or concerns can be raised about research, particularly by subjects. "It can be [asking] why were they chosen to be in this study," she says. "Maybe they don’t like something about the investigator or the research staff. They want to know what’s going to happen to their data. They haven’t been paid. There’s a whole range of concerns that subjects will raise.
"Very often the people who receive those complaints can just deal with them. If it’s a payment issue, for example, you just contact the investigator and find a way to have the subject compensated," Speers adds.
At Baylor, once someone calls, that person then is asked to submit written comments, a step that Motil says often helps clarify the issues involved.
"That doesn’t mean to say that we ignore oral complaints, but I think the insistence that somebody commit to writing about their complaint is very important," Motil says. "And quite often people are not shy about putting their complaints in writing." She says she doesn’t remember a complaint that was halted because a person didn’t want to submit it in writing.
"I think that says something about the people who handle the calls," Motil says. "I think people feel comfortable enough with the voice on the other end and that someone’s listening that they really do put their thoughts on paper."
Speers notes that regardless of the form in which the complaint is received, the person making it needs to be able to remain anonymous if he or she chooses. She cites the hypothetical example of a staff person who has a problem with an investigator, but is concerned about losing his job. "There needs to be a message from the institution that we want to hear about your concerns and your questions, and if you want to raise them anonymously, we will listen to you," Speers points out. "We think providing that protection is important."
When OHRP gets involved
At Baylor, a complaint triggers a systematic inquiry process that, depending upon the complexity of the case, can take several years to complete, Motil says. Once the inquiry is complete, the IRB determines whether to involve the U.S. Department of Health and Human Services’ (HHS) Office for Human Research Protections (OHRP). Under HHS regulations, all "serious or continuing noncompliance" must be reported to OHRP.
While this type of report from an institution can prompt an oversight investigation by OHRP, the trigger for an investigation is more commonly a complaint from a subject or a whistle-blower alleging noncompliance with human subjects protections, says Michael Carome, MD, OHRP associate director for regulatory affairs in Rockville, MD.
An OHRP compliance oversight evaluation can take one to two years, Carome says, and the agency has a full range of tools at its disposal to deal with noncompliance, including possibly restricting or withdrawing an institution’s assurance of compliance.
After reaching a peak of 182 open compliance oversight investigations in August 2000, OHRP currently has about 40 open investigations, he says.
Motil says Baylor hasn’t seen any increase in complaints in the wake of the highly publicized problems at research programs nationwide. "I think we always have a steady amount," she explains.
She says that in evaluating a complaint, it’s important to keep the perspective of the person making the complaint in mind.
"If people think that something has gone wrong, whether it’s true or not, it is true in the reality that they see," Motil says. "Sometimes, you have to educate people about the research enterprise, about how the system works. And in those cases, they may say, Oh, I didn’t know that; I guess this isn’t such a big deal after all.’ But in many instances, that isn’t the case."
However an investigation or inquiry of a complaint turns out, that final contact with the person who lodged it is important, Speers says.
"We find in the more successful programs, where investigators and IRB members are satisfied with the program, that part of that open communication is getting back in touch with the individual," she says. "So that they know the issue was addressed. Changes might have occurred or they might not have, but there is that feedback loop."
A culture of communication
In order to be accredited by AAHRPP, research programs must demonstrate that they have policies in place to allow subjects to raise concerns about research and investigators to raise concerns about the research process, including IRB review.
The goal, Speers says, is "a corporate culture where they’re open to communication, where investigators and other research staff, if they have a question or concern, have a mechanism to express it and to have it addressed."
Along those lines, many institutions have instituted toll-free telephone numbers, not only for research subjects to use, but also for employees to use if they want to raise issues anonymously. At larger institutions, Speers says, the lines are staffed around the clock. Web sites geared toward participants also are becoming more common. Some compliance offices also maintain logs of complaints in an effort to track patterns or problems.
"If there’s a particular study and a lot of people are calling in about that study, then the IRB may need to get involved and contact the investigator, or even potentially reevaluate the study if things have changed in some way," she says.
Speers notes that one institution regularly surveys its employees regarding IRB issues — asking whether they are satisfied with the IRB process, with educational training, and with the resources available to support research.
Both Speers and Motil say institutions are moving toward more proactive steps in dealing with complaints — not just reacting to problems, but trying to head them off down the road.
Many institutions have taken steps to more fully involve research subjects in the research process, Speers says. Some have community advisory groups that are asked to comment on the design of studies. "A couple of places have subject or participant advisory groups," she says. "If they’re working in particular communities or doing certain types of research, they’ll actually have a standing committee of participants who advise them about research studies."
Speers says that public input can improve the research, by providing insight that can help increase enrollment or keep people in the study longer.
Motil says the key to preempting complaints is "education, education, education," not just in medical proficiency but in communicating with subjects. "It’s the way in which you present yourself and the activity you’re about to engage in," she says. "How you relate to people. It’s about listening skills. Those are the kinds of things that I think minimize the complaints that will be registered.
"Yes, there will be things that go awry that you in your worst nightmare don’t want to see happen. That’s the human factor in just about everything we do. But the ability to listen, the ability to communicate, to present yourself in a straightforward manner without an attitude problem — those go a long way," Motil adds.
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