Development and Pilot Testing of a Human Subjects Protection Training Course Unique to Registered Dietitian Nutritionists

The house of delegates of the Academy of Nutrition and Dietetics recently selected research engagement as a mega-issue because research is critical to showing the value of the registered dietitian nutritionist’s (RDN’s) services, but many RDNs do not consider research as part of their role or believe they lack the skills to participate.1 Dietetics Practice Based Research Network (DPBRN) projects have provided evidence to support RDN services in containing costs and improving patient outcomes.2 Engaging a diverse array of members in a culture of research is particularly relevant given the recent House of Delegates mega-issue. After identifying human subjects protection training (defined and described later) as a barrier to research participation, the Academy’s DPBRN developed and pilot-tested a research ethics course specific for RDNs. This article describes the development and pilot-testing of this course as well as next steps for all Academy members to use this resource. In a 2002 survey of RDNs, only 27% of respondents had participated in research.3 The most frequently selected barrier to conducting research was not having research skills (65% of those who had not conducted research), followed by lack of time or staff (41% of those who had not conducted research).3 However, RDNs consistently believe that research is important to the profession and many would like to participate.4 This is not unique to the dietetics profession; previous studies have shown a lack of participation in research by health care providers not associated with academic institutions, such as a practicing RDN. One barrier to participating in research is the requirement for human subjects protection training. To overcome this barrier, the Academy worked with research ethics experts to create a human subjects protection training specific to nutrition and dietetics. Protection of human subjects in research is a key concern of both investigators and research regulators such as the institutional review boards (IRBs). IRBs must ensure that all individuals listed as key personnel on funded National Institutes of Health grants are educated in the protection of human subjects.5 To address this need, most institutions (or their IRBs) require a human subjects protection training course for all researchers who interface with human subjects or their data.6 The majority of these courses are based on the assumed needs of academic researchers and require a baseline level of research knowledge for comprehension.6 Given the traditional target audience of these training programs, nonacademic researchers frequently perceive the content as not relevant or inaccessible. These programs may not fulfill the needs of nontraditional researchers such as clinicians and community partners regarding the type of ethical dilemmas or concerns that arise outside the traditional academic research context.6 For example, clinicians who are also acting as researchers, including RDNs, may serve multiple roles (clinician and researcher) in relation to a single patient/subject. These dual roles usually have different priorities, and the difference may not be obvious to patients, which can affect the ethics of recruiting and obtaining informed consent.7 Community-based participatory research (CBPR) has also encountered the challenge of making training in human subjects protection relevant to nontraditional researchers. To overcome these barriers and ensure that community researchers have the training needed to conduct studies ethically, some institutions have developed alternative human subjects protection trainings to meet the needs of community researchers.6 Examples include the CIRTification (Community Involvement in Research Training) from the University of Illinois at Chicago, the Field Training Guide for Human Subjects Research Ethics from Johns Hopkins University, and Protecting People Who Participate in Research from the University of North Carolina-Chapel Hill.6 Given that a baseline knowledge of research terminology and regulations (such as how research is defined and the differences between research and standard clinical care) is assumed in many of the existing human subjects protection training courses,6 lack of research knowledge and skills adds another level of difficulty to completing the course. Thirty-one percent of RDNs surveyed in 2000 indicated that their preferred route to research knowledge was through training tailored to clinical dietitians,8 showing that RDNs are more interested in research when concepts are specific to them. The need for the learner to perceive applicability to be interested in a topic is not unique to RDNs; the study of adult education emphasizes the importance of the learner’s internal motivation, past experience, and perceived utility/applicability of the lesson.9 To provide external as well as internal motivators, a direct benefit (such as continuing professional education [CPE] credits) may provide an incentive for professionals to find time in their schedules to complete the training. Annual surveys of Academy of Nutrition and Dietetics’ membership show that obtaining CPE credits is very important to most individuals (Academy of Nutrition and Dietetics Research Committee, unpublished data, 2013). In a separate recent survey of the Academy membership, 69% of respondents reported that regulatory requirements such as human subjects protection training were a barrier to their participation in research.10 One of the courses frequently required by academic institutions to fulfill their Human Subjects Protection Training requirement is the Collaborative Institutional Training Initiative (CITI) basic course.11 CITI was developed by the University of Miami and covers the topics listed in the middle column of the Figure. CITI is a self-guided module consisting of reading, supplemental resources, and a quiz. An 80% average on all quizzes must be achieved to pass. This is also the course required by the American Academy of Family Physicians (AAFP) IRB, on which the Academy of Nutrition and Dietetics relies for reviews of research involving human subjects. Figure Standard human subjects protections topics and their coverage in the Research Ethics for the Registered Dietitian Nutritionist course. aCITI (Collaborative Institutional Training Initiative) Basic Courses in the Protection of Human Research Subjects. ...