In-office research can trip up even the most ethical doctors
By Paula S. Katz
Brian J. McMahon, MACP, took pride in adhering to the highest ethical standards during a sponsored practice-based research study on a hepatitis vaccine. So when the sponsor’s drug monitor offered to conduct the data analysis and prepare the paper for publication—with Dr. McMahon listed as author and the sponsor’s name not listed as an author or in the acknowledgement section—he politely declined and wrote the paper himself.
When sponsors control the data or has one of their employees write the paper for publication, “They can interpret it in a way that’s not necessarily wrong, but tends to favor the results that they want to see, and that’s a conflict of interest,” said Dr. McMahon, scientific and medical director of the liver disease program at the Alaska Native Medical Center in Anchorage.
“Physicians have to distinguish between when sponsors are merely facilitating work and making it easier for the doctor and when they are crossing the line.”
—Michael J. Werner
Dr. McMahon’s instincts were sound, said Michael J. Werner, president of a medical research consulting firm, who has led workshops at College meetings to help educate community-based internists about participating in medical research. “Physicians have to distinguish between when sponsors are merely facilitating work and making it easier for the doctor and when they are crossing the line,” he said.
The distinction is important as the number of community physicians participating in office-based research grows. To help those who may be doing it for the first time, the College has introduced a support program, as well as its own primary care practice-based research network (PBRN)—ACPNet.
Physicians who participate in research often are motivated by having access to cutting-edge treatments, even if they’re in experimental stages. But they also should be aware of ethical concerns, such as conflict of interest, informed consent, how patients are going to be treated and what’s going to happen to the results, issues that can trip up even the best-intentioned internist.
Still, those issues shouldn’t be deal breakers, Mr. Werner said. “Physicians have to know what they’re doing or they can get caught up in something that can quickly be out of their control,” he said. “It doesn’t mean they shouldn’t do research.”
ACP steps up
A recent Web-based ACP member survey found that nearly 60% of respondents had been asked to participate in community-based research in the past two years. Nearly 58% did. Yet more than one-third of respondents said they felt unprepared to evaluate the ethical soundness of research proposals. Although 79% said they had been trained in informed consent, only about 51% received training in research misconduct.
In response, the College’s Center for Ethics and Professionalism, funded by a grant from the Association of American Medical Colleges (AAMC) and the DHHS Office of Research Integrity under their Responsible Conduct of Research Program for Academic Societies, developed a workshop on evaluating the validity and ethics of a research proposal.
“We hope this program raises awareness in professional societies and spurs long-lasting action,” said Tony Mazzaschi, senior associate vice president for biomedical and health sciences research at the AAMC in Washington, D.C. “To the extent that ACP’s efforts encourage community-based physicians to actively and ethically engage in research, it’s a win-win.”
ACP’s program covers key concerns in research, including how to understand the principles of human subjects’ protections and the role of the institutional review board (IRB); how to recognize and avoid recruitment issues such as coercion and undue influence; and how to better understand potential conflicts of interest, said Lois Snyder, JD, director of the ACP Center for Ethics and Professionalism. In addition, the center has developed a patient brochure on volunteering for research for physician-investigators available online.
“We want physicians to feel prepared to deal with research ethics issues and alert to concerns that are raised by taking on the dual role of clinical and investigator,” she said.
Watching for pitfalls
As more physicians with less experience in research take that road, expect a learning curve, warned Mr. Werner, president of the Werner Group, a bioethics, public policy and medical research consulting firm based in Washington, D.C.
If a practice is researching a drug that may get FDA approval, there are all types of standards as well as adverse event reporting requirements, noted Karen J. Maschke, associate for ethics and science policy at the Hastings Center, a bioethics research institute. Even if a practice works with an IRB to look at risks, benefits, consent process, confidentiality issues, etc., the buck stops with the physician, she said.
“The person with contact with the research subject is ultimately responsible,” she said. That’s why it is also important to train staff about privacy, confidentiality, and HIPAA rules.
Then there’s the issue of money. Most research is reimbursed per patient to account for physician and staff time as well as any needed special facilities or equipment, such as a secure locked area to store drugs and records. “Physicians are busy enough that they need some kind of incentive to participate in research, so I don’t have a problem with them being compensated for their time,” Mr. Werner said.
The ethics get trickier, he said, if there’s a bonus for recruiting a certain number of patients. While some say absolutely, “No,” to the bonus, there are no hard and fast rules. “The law doesn’t say $1,000 to recruit 100 patients is okay, but $5,000 is not okay,” he said. “You just have to decide how comfortable you are with it and how comfortable you think your patients will be.”
But specialty societies such as ACP go further. Finder’s fees for referring patients to a study and bonuses are not ethical, according to ACP’s Ethics Manual, which is available online at http://www.acponline.org/ethics. Payments should be commensurate with the time, effort and actual expense on the research project, according to Lois Snyder, director of the College’s Center for Ethics and Professionalism.
To simplify ethical decisions, some physicians are choosy about the projects they agree to take on. Dr. McMahon, for example, said he decided not to do any studies involving drugs that are not well tested, because it may put his patients at risk.
Some physicians never feel comfortable doing office-based research.
“There are pitfalls in what you tell patients and how you think about it, what’s reasonable to do and how to be sure you’re not sucked into some industry boondoggle,” said Richard L. Neubauer, FACP, chief of service, internal medicine at Alaska Native Medical Center in Anchorage, who spent 27 years in private practice and never participated in a research study. “It [can be] incredibly difficult to do.”
Working with a PBRN, where organizations like ACP vet the projects then coordinate them among a group of practices devoted principally to patient care is appealing to many concerned about dealing with ethical issues. According to the Agency for Healthcare Research and Quality (AHRQ), there were more than 110 primary care PBRNs in the U.S. in 2004. ACP’s original PBRN began in 1997 as QNet and became ACPNet in 2001 (www.acponline.org/acpnet).
ACPNet staff handle all the design and methodology of various projects, data management and analysis, as well as writing the papers for peer reviewed journals. They also send reports and feedback to participating physicians on quality indicators to manage the disease being studied. All the quality improvement interventions are web-based as it is a convenient medium for dissemination of and access to information for physicians, an interactive format, and easy updating when new information becomes available. Current ACPNet projects include diabetes, alcohol use disorder and geriatric conditions such as falls, urinary incontinence. More are expected in near future, according to Amir Qaseem, MD, PhD, ACPNET Director. College ethics staff work with ACPNet and an IRB on human subjects and privacy reviews.
Physicians who participate not only have access to cutting-edge practice tools based on the latest evidence-based medicine, it also helps them prepare their practice for the performance measurement arena. In addition, the physicians have an ability to earn practice-based CME and MOC through research projects. Currently, more than 800 College members nationwide participate.
Just knowing ACP is involved is reassuring, said Fred C. Campbell, Jr., FACP, an internist with Community Medicine Associates in San Antonio, Texas, who has worked with ACPNet and just signed on for the diabetes project. “I’m suspicious of a drug study sponsored by a pharmaceutical company,” he said. “It’s much easier to work with ACP. ... I know there’s unlikely to be a problem with objectivity.”
To be involved with ACPNet, contact Amir Qaseem, MD, PhD, at email@example.com. To have ACP come to your town to do a workshop for your chapter about the ethics of conducting research in a community-based office, contact Lois Snyder, JD, director, the College’s Center for Ethics and Professionalism at firstname.lastname@example.org, 215-351-2835 or visit the ACP Center for Ethics and Professionalism. Also, ethics staff members are available to research and respond to member inquiries about research ethics, integrity and possible misconduct.
The Alaska Heart Institute in Anchorage has figured out a unique way to defuse the ethical headaches that surround taking money for conducting office-based research. Its solution: Set up a foundation that examines and handles all the financial issues of every physician-approved proposal. That leaves physicians to do what they do best—think about the science—and even give back to the community.
“We wanted to do research, but we wanted it to be squeaky clean,” said Steven J. Compton, FACP, director of clinical electrophysiology at the Institute. “We wanted to eliminate any possible financial conflict of interest, essentially by volunteering our physicians’ time.”
The group established the Alaska Cardiovascular Research Foundation in 2000 as a completely separate research and education entity with its own board. It is staffed by one non-researcher from the cardiology group and two community members.
The group’s physicians first evaluate research proposals to make sure they are clinically relevant and answer important questions. A red flag, for example, might be a post-marketing trial, or a study of something that has already been figured out, Dr. Compton said. “That just stinks a little bit,” he said. “We think that some of the post-marketing ‘research’ amounts to inappropriate physician kickbacks.”
Proposals that get the nod go to the foundation, which evaluates whether the payments will cover the costs of doing the project and how much time the institute’s two full-time research nurses, who are trained in trial work and NIH requirements, will have to put into the protocol. Once a project is accepted, a private Institutional Review Board reviews the trial, which helps keep the group on top of regulatory requirements. “It’s a lot like having an accountant do your taxes,” Dr. Compton said. “If you don’t do it all the time, how do you keep track of all the changes?”
The foundation’s set-up addresses a lot of physician concerns about participating in office-based research. “It’s an interesting idea,” said Michael J. Werner, president of the Werner Group, a bioethics, public policy and medical research consulting firm based in Washington, D.C. “It encourages physicians to participate in research while insulating them from potential legal and ethical pitfalls.”
Since the foundation was established, the 25-physician practice has performed 30 studies in seven years, and has about seven going on at any one time. Dr. Compton explained that the volume is partially due to the field continually coming up with new technological intervention trials that move faster than, say, a new drug potentially seeking FDA approval. Plus, as the primary cardiology group in the state, its stable referral base and long-term relationship with patients is ideal for short- and long-term clinical trials.
Because the physician typically chooses what pacemaker, catheter or defibrillator the patient will use, it’s particularly important to avoid any appearance of conflict of interest in terms of payment for the study, he noted.
And in those instances in which the payments for the studies outweigh the costs, the foundation has an answer: invest in the community. In fact, a year and a half ago the foundation gave a $100,000 grant to the University of Alaska, Anchorage, to fund a fellowship grant to cover undergraduate research in life sciences. The grant, administered by a university board, covers room, board, housing and tuition for a semester.
Making an effort to give back to the community removes any stigma that might be attached to the financial aspects of conducting office-based research. Dr. Compton advised those physicians to ask themselves a critical question before beginning a study: Would you be comfortable telling your patient where the money goes?
For the surprisingly few patients who actually ask that, Dr. Compton is completely comfortable with his answer. “I don’t mind telling them what’s going on. Actually, I’m proud of it.”
Those who talked to ACP Observer about office-based research offered the following advice for avoiding ethical dilemmas:
- Evaluate the primary aim. What research question will be answered? Is it marketing or research?
- If it is a drug trial, does it involve a drug in the same class that offers minimal benefit or a “me too drug”?
- If it is a placebo/control drug trial, does the patient have to stop medication for a particular disease, and will patients be at risk of increased discomfort or even medical jeopardy if is randomized to the placebo arm?
- Evaluate the study design, including informed consent and risk/benefit assessment.
- Think about conflict of interest.
- Know your federal and state regulatory requirements.
- Think about using a study coordinator such as a nurse or physician assistant.
- Think about what’s going to happen with the data. Who’s going to analyze it? Can you see data from other sites? Who’s going to write the article? Can you review it?
- Consider the dual role as physician-researcher and carefully explain to your patients that the research is not part of continuing care.
- Understand recruitment issues: patients are volunteers and are counting on you to enroll them in a study appropriately.
- Get educated, whether through ACP, outside conferences, online or in-house training. Just reading about doing research, experts say, is not enough.
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