Education vital in litigious clinical trial arena

Ongoing training keeps you up to date

Right now in Seattle, a lawsuit is pitting families of five research patients against the Fred Hutchinson Cancer Research Center. At issue is whether leukemia patients participating in a study on T-cell depletion fully understood the risks of the proposed treatment and gave informed consent. The study took place in the 1980s, and defense lawyers say that there are plenty pieces of paper with the patients’ signatures on them indicating they knew what they were getting into. The families counter that the informed consent documents were terribly confusing.

This highlights how much things can change over time. Informed consent isn’t a document, but a process. It’s something that those involved with clinical studies are taught as a matter of course now.

Keeping up with changes — not just in law or regulation, but also in ethics — is vital for clinical trial administrators and those they work with, and there are plenty of opportunities and options for how to make sure you are up to date.

Organizations wanting to take advantage of the knowledge gained by the National Institutes of Health (NIH) in Bethesda, MD, can take courses for free at the NIH Clinical Center, or arrange to take the courses off-site through teleconferencing hookups. More than 1,000 health professionals from as far away as Peru and Puerto Rico took part in the classes last year. There are three core courses:

  • Introduction to the Principles and Practice of Clinical Research — A curriculum on how to effectively conduct clinical research and design a successful clinical trial. Since it was established in 1995, this course has trained more than 3,000 people, a third of them off-site.
  • Principles of Clinical Pharmacology — Training in the scientific basis of clinical pharmacology. The course is designed to meet the needs of researchers who have an interest in the clinical pharmacologic aspects of contemporary drug development and use. Nearly 1,600 people have taken this course in the five years it has been offered.
  • Ethical and Regulatory Aspects of Clinical Research — A seven-week course in its sixth year, this is led by two doctors from the Clinical Center Department of Bioethics.

"This is your tax dollars at work," says Frederick P. Ognibene, MD, FCCM, FACP, director of the office of clinical research training and medical education at the NIH Clinical Center. He adds that in the future, there probably will be additional course offerings, including one on how to do informed consent.

Anyone can sign up to take the courses at the center, he says, but if you want to take it off-site, your organization has to foot the bill and provide the infrastructure to do a live video feed of the lectures. Those who have registered for the courses also can access the lectures they may miss on-line.

"Eventually, we may get to the point where individuals can do this, but right now, we do this only institution to institution," says Ognibene.

As the pre-eminent clinical research organization in the country, Ognibene says that what the NIH offers is of the highest standards, even if some of the material is dry. "It’s hard to make statistics and epidemiology interesting," he admits. "But there are more exciting parts of the courses, too, like the parts dealing with interacting with the media and learning about technology transfer."

Nongovernmental options

Another place to go for a wide range of courses is the Association of Clinical Research Professionals (ACRP). One course scheduled for this year involves the ins and outs of pediatric research and costs $600 for members and $695 for nonmembers. Another course, which is repeated throughout the year in several sites around the country, is a two-day seminar called Fundamentals/1st Steps of Clinical Research. It is designed for clinical research professionals who manage studies at clinical research sites or monitoring studies, as well as product managers, clinical investigators, institutional review board members, clinical pharmacologists, research pharmacists, and others with less than one year’s experience conducting clinical trials.

Course content includes a historical perspective on regulation of clinical research, the principles of good clinical practice, the drug development process, the differences between drug and device research, current regulatory and ethical issues, a description of the informed consent process, and the regulatory requirements for reporting adverse events.

There are similar seminars of one- or two-day’s length on topics as varied as project management and budgeting for clinical trials to successful strategies for medical device trials. Seminars cost between $360 and $845 depending on the length of the seminar and membership status in the ACRP.

There also are audio conferences available for $250 including adjunct materials, and tapes and CDs of previous audio conferences available for $100 to $175, depending on whether users order the accompanying materials. Topics for those audio conferences include: patient recruitment under the Health Insurance Portability and Accountability Act (HIPAA); managing research subjects, FDA inspection process; and patient retention.

Contact hours credit, as well as continuing education credit (CE) for nurses, physicians, and pharmacists, often is available through the courses.

There are several options for self-study. Thomson’s Center for Clinical Research Practice has two books appropriate for administrators and others involved in clinical research. First is the Foundations of Human Subject Protection. An independent study course written specifically for IRB members, staff, clinical researchers, and health care professionals involved in the conduct and management of clinical research, the course covers federal regulations and guidance, informed consent process, the makeup and function of IRBs, and how IRBs carry our their mandate. It offers 15 CME or CE credits and costs between $125 and $225, depending on whether and which kind of continuing education credits are desired.

A second course is the Foundations of Clinical Research. Recently updated to include information on HIPAA, this book covers the basic principles and practices of clinical trials. It comes with an accompanying CD-ROM on regulatory references, course questions, and an answer key and costs between $180 and $295, depending on whether and which type of the 16 available CE credits is desired.

Another option is to do an on-line course. One engaging course is While it is available free to any user, institutions can license the program for $800 per year. Licensees can then receive weekly reports on researchers’ use of the training, or modify the program and install it on their own servers.

Course creator Jeremy Wood, PhD, says he developed the program to be entertaining yet taken seriously. "They can’t cheat their way through this," he says. Indeed, there are gentle nudges if users do try to cheat — like screens that say, "That you tried to lie your way through an ethics curriculum is worrisome. That you abandoned the lie pretty readily suggests that there may be some hope for you."

The course, says Wood, includes the kinds of issues that those involved in research may face, the kind of trouble they can get into, and what has happened in the past. "Take Tuskegee," he notes. "I show people how what led to the abuses is understandable — akin to what researchers do every single day. But education has to be about more than saying something is bad. It has to be about changing people’s behavior."