Clinical research is one of the most heavily regulated fields in the world – and for good reason. Slips of ethics and oversight, whether in establishing informed consent, setting up proper trial recruitment or even simple communication failures, can have serious and – in some cases – deadly consequences, especially in drug trials involving humans. Even if the worst-case scenario doesn’t come to pass, lapses like plagiarism and faulty data taint important research, as well as potentially wasting millions of dollars and damaging the reputations of companies and research institutions.
Although the dangers are clear, the heavy workloads and intense strains on researchers – competition over public funding or research contracts means there is always pressure to produce positive results – creates a system ripe for compliance breaches. But what happens to the researchers responsible for such failures? Major offenders might be destined for ignominious unemployment, but what about good researchers who have made a seemingly isolated mistake?
In the US, a group of experts in psychology, research ethics and medical remediation education decided to establish a course designed to rehabilitate wayward researchers and help them regain suspended research privileges. The three-day course, which was developed with funding from the National Institutes of Health (NIH), was initially called the Restoring Professionalism and Integrity in Research (RePAIR) programme and launched in 2013.
Now with a simplified name – the Professionalism and Integrity Program, or P.I. Program for short – the course is still administered several times a year through the Clinical Research Training Center at Washington University in St. Louis. We met the course’s director, Washington University Professor of Medicine Dr James DuBois, to discuss the course, the root causes of compliance breaches and overcoming the initial defensiveness of attendees.
Chris Lo: Could you give me some background on how the course came to be, and the gap you intended to fill?
James DuBois: For years, physicians who breached professional standards – for example, by improperly prescribing opioids or having outbursts of anger – had access to remediation programmes to enable them to retain or regain the privilege of practicing medicine. But nothing of that nature existed for researchers. Moreover, a growing body of evidence indicates that standard research ethics education does not have a positive impact on behaviour. We wanted to design a programme that would support positive behaviour change.
CL: The course was subject to some criticism before it launched – what was the basis for that criticism?
JD: The most common criticism we encountered was that researchers who are ‘cheats’ do not deserve a second chance, especially when funding for research is increasingly scarce. What we have found is that the researchers we trained are generally talented researchers whom institutions wish to retain. As a general rule, we’re not attracting those individuals who commit the worst offences, such as making up all data in multiple studies. Such individuals typically have their employment terminated.
CL: Are many of the course’s attendees clinical and pharmaceutical researchers? Do you think the complexity and heavy regulation of the pharma sector and clinical trials means researchers in these areas are more likely to slip up?
JD: Almost half of our participants do clinical research with humans, and about one third are running drug or device trials. I do believe that the complexity and time burden of regulatory compliance makes it easier for well-intentioned but overextended researchers to get into trouble. The risks increase when their coordinators or support staff are inadequately trained or their projects are understaffed. In some ways, I think investigator-initiated trials may pose more of a risk, because pharmaceutical companies often provide a lot of training and infrastructure. They also conduct audits and use standard operating procedures fairly extensively.
CL: How did you go about putting together a curriculum that satisfies the needs of attendees from diverse backgrounds and with different issues to cover, in only three days?
JD: We focus on root causes, and many of the root causes cut across different domains of research. For example, being overextended affects social scientists and engineering researchers as much as clinical investigators. Our paper in Nature tried to illustrate a number of root causes that can lead to problems. We also assist each participant in writing a professional development plan, and these are tailored to their individual needs. Following the course, we coach them through their plans during phone calls.
CL: Would you say the programme is well-established among researchers and research companies at this point?
JD: I think we are much better known in academic institutions than in industry. It’s actually much easier to identify the names and contact information of compliance officers and chief research officers in academia than in industry, so we have had some difficulty reaching that audience.
CL: Would you like to forge closer ties with industry in the future?
JD: I would love to forge closer ties with industry research programmes. Our website, www.integrityprogram.org, provides contact information. We are happy to exchange emails or set up phone calls to tell institutions or companies more about our services, or to discuss potential referrals. In general, if a company chooses to continue the employment of a researcher who has struggled with compliance or research integrity, they need to insist on behaviour change. We have had great success assisting researchers as they develop new habits and patterns of thinking about compliance.
CL: Under what circumstances do researchers tend to sign on to complete the course?
JD: To my knowledge, only one participant referred himself to the programme. In general, institutions require participants to attend as part of a negotiated action plan following a noncompliance or research integrity event. Participants are often displeased that they need to attend the workshop, but by the end of day three, I think every participant thus far has thanked us for developing the workshop. I think most people find it very helpful to identify strategies for positive change, and they find it helpful to recognise that other good researchers have struggled with similar issues.
CL: Do you think the three-day group workshop component of the programme is an important way for attendees to share their experiences and release any initial defensiveness?
JD: I cannot imagine that a large classroom or an online format could achieve what our small group format achieves. People build trust with each other, share opening, engaging in troubleshooting, and arrive at new insights and solutions. Defensiveness is sometimes high in the first few hours, but passes quickly. I observed the same thing when I attended a workshop for physicians held at Vanderbilt University – an excellent programme for ‘distressed physicians’.
CL: What are the most common infractions or ethical lapses that bring researchers on to the course?
JD: The most common infractions are failing to provide adequate oversight of projects or project staff, informed consent violations and plagiarism. But people have also been referred for a wide variety of reasons, including problems with animal care, conflicts of interest, and inappropriate subject recruitment.
CL: Why do you think issues like oversight and consent are such common sources of problems for researchers?
JD: Researchers are often very, very busy – running multiple studies while playing other roles such as instructor, physician or administrator. So they are not dedicating adequate time to overseeing their projects, or the way that informed consent is obtained and documented. Of course, we make time for things that we prioritise. So another common problem is not prioritising compliance, not treating it as an essential aspect of conducting a study.
CL: As an academic, what have you learned personally from your time administering this course?
JD: I have actually hired people to assist me in checking the work of research assistants – I know I get overextended, and I know oversight is essential. I’m also a lot quicker to call colleagues or administrators to ask questions when I’m feeling uncertain. One piece of advice I would offer to all investigators is be particularly cautious when moving into a new area of research. Seek mentoring and support from knowledgeable coordinators or staff members.