Training needs can be met with a variety of tools

Content, not format, critical to effectiveness

Human subjects training is typically a part of human subjects protections programs. Such training has taken the form of in-house seminars given at regular intervals and web-based activities. Regardless of the form, the objectives are simple: Give those involved in human subject research ethics and regulatory information that will promote beneficence and compliance with regulations.

Since 1989, three reports issued by the Institute of Medicine (IOM) and the National Academy of Sciences have recommended that research institutions develop educational programs to promote the responsible conduct of research. A 2002 IOM report, "Integrity in Scientific Research: Creating an Environment that Promotes Responsible Conduct," specifically recommended that "institutions should implement effective educational programs, guided by basic principles of adult learning, to develop the abilities that give rise to the responsible conduct of research."

Here are some training programs that are available to the researchers and IRB members.

The National Institutes of Health offers a free, web-based training course for researchers. Housed at http://cme.cancer.gov/c01/, the course, "Human Participant Protections Education for Research Teams," covers six areas: History, The Basics, Informed Consent, IRB Review, Ongoing Protections, and International research. Among the learning objectives:

  • Describe at least five historical events that have influenced current ethical guidelines, including the Tuskegee Syphilis Study and the Jewish Chronic Disease Hospital study.
  • Define informed consent and describe the elements that should be included in an informed consent document.
  • Describe conditions that may affect a person’s capacity to consent and the responsibilities of the researcher in seeking consent from research participants;
  • Define institutional review board, describe its membership requirements, and identify at least four responsibilities of an IRB.
  • List the criteria each study must meet in order to be approved by an IRB.

IRB members can receive similar training on the Office of Human Subject Research web site — http://206.102.88.10/nihtraining/ohsrsite/. Though the training is designed for NIH IRB members, the test can be accessed by nonmembers. In addition to information specific to the NIH, the course is designed to instruct members on their responsibilities, including:

  • Determining whether a study is scientifically sound and the steps that can be taken should they determine the study is not scientifically sound.
  • Determining the level of risk — including physical, emotional, social, and economic — to subjects using four recommended approaches: 1) common-sense estimation; 2) experience of investigators or board members with similar procedures or interventions; 3) statistical information regarding procedure or intervention; and 4) the situation of the proposed research subjects (for example, are potential subjects ill, healthy, young, institutionalized, etc.).
  • Subject selection or who is being enrolled (men/women; ill/healthy, are vulnerable populations involved, etc.).
  • Informed consent, including the elements that should be contained in a consent document and the informed consent process.

The course takes an hour to complete, and participants do not have to finish in one sitting. Upon completion, a certificate will be generated.

Facts, figures, and threats are not as effective as some might imagine when it comes to educating researchers about human subject protections, says communications expert Jeremy Wood, PhD. "The important thing is to teach people concepts and get them to care," says Wood, a communications consultant and founder of IRBtool.com, a start-up company providing medical/health web design services. "The goal of education should be to change behavior," he posits.

Wood created IRBeducator (www.irbeducator.com), an interactive, Internet-based training tool. IRBeducator takes a concept, as opposed to facts, approach.

On his web site, he wrote, "IRBeducator does not focus on teaching researchers the complex details of the Common Rule, as much as it tries to communicate basic principles, motivate researchers to focus on protecting human subjects, and provide tools for efficiently learning the relevant details when needed."

The material is presented in four sections that feature a narrative/case study format. At the end of each case study are question and answer choices such as, "I know the answer" or "Give me a hint." Selecting any of the answer choices will bring you to the explanation of the principles being discussed.

The quiz that follows is not multiple choice; it’s essay format. Wood says his testing methodology is based on the law school model whereby students take principles and apply them to various situations. "If you want to protect human subjects you have to do more than present information from the past," he says. "You need to teach researchers the important concepts that will impact their research."

Essay answers, which can be compared to answers provided for comparison with each question, are sent to Wood and company for evaluation. Notification of successful completion can be sent to the participant or institution heads.

"It’s the old, You-can-lead-a-horse-to-water’ situation. Requiring people to complete IRB training won’t bring about the kind of behavior change we want unless the training engages the user’s mind and gut," says Wood. "You need to intrigue them, make them laugh, and get them to see that it’s in their best interest to respect human subjects."

Good, old-fashioned pen and paper

If you’re looking for something more portable, the Center for Clinical Research Practice offers two textbook courses.

Foundations of Human Subject Protection is designed for IRB members and clinical staff. The topics covered in the 100-page textbook include ethical guidelines and federal regulations; study design, including balancing ethics and science in research design; the informed consent process; and IRB responsibilities and considerations, including review of genetic research and protocols involving vulnerable populations such as children. A bonus CD, "Regulatory References — Institutional Review Board," contains a 391-page reference manual on topics such as "ICH Guidelines for Good Clinical Practice" and "Guidance for IRBs," including a frequently asked questions section. The cost is $175 for up to 15 CE nursing credits; $225 for up to 15 CME credits.

For researchers, there is Foundations of Clinical Research. The textbook covers these topics: phases of clinical research, regulation of research, protecting human subjects, and clinical trials management. Additionally, there is a workbook that allows participants to apply learned principles to a case study scenario. The final test is multiple choice. Cost: $250 for CE nursing credits; $295 for CME credits.

You can order either by going to www.ccrp.com and clicking on the Education & Training icon.