May 8, 2014 | Posted By John Kaplan, PhD

The Graduate Studies Program of AMC has provided education and training in research integrity and the responsible conduct of research (RCR) since the early 1990s. This program has been directed to graduate students in the basic sciences working toward masters and doctoral degrees and to post-doctoral fellows in the basic sciences. The impetus for initiation of such education and training was the mandate issued by the National Institutes of Health that required a description of activities related to instruction in RCR in institutional training grant applications. We will describe the initiation, development, evolution, and current status of our curriculum.

The individual training grant directors were responsible for the initial activities of this endeavor, which were sporadic, inconsistent, and undocumented. Subsequently, in 1994, the Dean of AMC charged the Associate Dean for Graduate Studies, who happened to be me, with the task of developing a formal graduate course to address this mandate.

This task was initially addressed by identifying faculty who would develop and teach this course, create curriculum plans and objectives, and identify materials useful in teaching. This process also included self-education because this area had not been previously taught here. It also involved a good deal of public relations because most students and faculty resisted the implementation of training in RCR as an intrusion upon time that should be most profitably spent in the laboratory.

Solicitations were sent to basic science faculty for volunteers to lead the development effort and teach the course. No one volunteered, so I became course director by default. That is how I became an RCR instructor two decades ago. My background was in science, so an additional instructor, a clinical ethicist, was identified and recruited to participate in this venture. This was a successful pairing. As we taught the course, I learned a great deal about the ethical basis for RCR and became conversant on the subject. The clinical ethicist learned to apply ethical principles in the research context. We retained this model until the next decade when I became adequately versed in bioethics to play both roles and the bioethicist stepped away. Eventually we added two more faculty members to the course, who were trained initially in basic science and became familiar with RCR through both training and experience. We have retained this model, of involving faculty,  to the current time.

The development of the curricula and the selection of educational materials were linked in many senses. The process was meaningfully facilitated by the release by the American Association of Medical Colleges of Teaching the Responsible Conduct of Research through a Case Study Approach, A Handbook for Instructors, prepared by Stanley Korenman and Allan Shipp. This volume provided well-designed cases and appropriate discussion questions to launch our additional offering. It provided a wealth of advice for instructors, nearly all of whom, at that time, were new to the field. It included cases focused on the conduct of research; reporting of research; peer reviews; handling of research data, materials, and proprietary information; mentoring and laboratory supervision; misconduct, conflicts of interest, humans and animal research, and genetic research. We still use many of these cases and have replaced some which became outdated. Although other sources of cases are available, those from this original volume stand out as extremely well developed, allowing students to relate easily to the described scenarios and participants. The ensuing decade saw the development of many other excellent resources for RCR education, an effort facilitated by a grant program for this purpose sponsored by the Office of Research Integrity.

Three considerations guided placement of the class in the curriculum: providing early exposure to students who were just beginning their research careers, allowing time for students to gain some familiarity with working in the laboratory, and fitting the class into the existing schedule for students in six different basic science departments. This original class, which was 12 contact hours and entitled Discussions in Scientific Integrity, was placed in the fall term of the second year to allow students to have gained research experience to relate to the cases. After several years, we added an Introduction to Research Integrity during the fall of the first year to provide earlier exposures and more skills. This component added six more contact hours and addressed current topics in scientific integrity, introduction to ethical thinking, a workshop on case analysis by moral reasoning, and considerations in selecting a research mentor. These two courses are taught as a continuum and provide a research ethics curriculum as opposed to a single course. Ultimately, to achieve even earlier exposure and to emphasize the importance of this material, programming was added to our new student orientation. Additional opportunities, including pursuit of a master’s degree in Bioethics, are available to students wishing more exposure to the field.

These educational opportunities were designed to utilize principles of adult learning and are largely student led and interactive. There are no lectures. Most classes have included 10 to 25 students. These courses are required of all master’s and doctoral students in basic science regardless of their source of support. Before the first two-hour session in the first year, students are assigned to find articles on research ethics and scientific integrity in the current media. Students provide short reports to the rest of the class, and these current topics are utilized to develop ethical principles through both student participation and faculty moderation. During the second two-hour session, students learn moral reasoning and case analysis from a faculty-led workshop through adaptation of the methods described by Bebeau and co-workers. The students apply this knowledge during the remainder of the scientific integrity curriculum. The third two-hour session consists of a case-based discussion of the consideration students might use for the selection of a laboratory and research mentor. At the end of these first-year sessions, students are told that the first session of the second year will consist of their verbal reports of when they have utilized lessons and principles of scientific integrity. These reports include how they selected their mentors, conflict with others in the lab, data ownership (since these students “inherited” projects from other students who have graduated), and cases of others absconding with their reagents or monopolizing their equipment. They also frequently describe their difficulty and often frustration in developing techniques utilized by others. They are candid in describing people who they do not believe have acted honorably, although these generally refer to experiences before they joined our graduate program.

After this first session of the second year, the additional sessions are case-based discussions of specific topics led by students. Each session is led by one student or a pair of students working as a team. Students are responsible for a short PowerPoint type of introduction to the topic and applicable policies. These are compiled on an online course management site (we use Sakai, but any will work) so they can be accessed later. The remainder of the session consists of student-led discussions of cases pertinent to the session topic. The final session is a faculty-led wrap-up of the two-year curriculum, a discussion of how students will use these lessons going forward. Students receive one hour of credit for the first- and second-year course combined. The courses are graded on a pass/fail basis based on participation. Any missed sessions require make-up assignments.

Additional opportunities are available to revisit and expand on these experiences. Some departments have asked me to provide questions for their students’ written preliminary examinations. These have consisted of cases for students to apply their background in ethics case development by moral reasoning. Students wishing greater exposure to this and related topics have entered a dual degree program in which they can pursue a Master’s of Science in Bioethics simultaneously with their Ph.D. studies in their chosen field. This degree includes a comprehensive three-credit hour course, entitled Fundamentals of Research Ethics.

My commentary describes not  only  the development and the evolution of our scientific integrity curriculum, but it also describes a 25-year period in which my primary area of emphasis has evolved from physiology and cell biology to bioethics with a focus on scientific integrity. I hope that these reflections will be useful to others engaged in education on this essential topic.

Please click here to view this blog originally published in the Office of Research Integrity newsletter.

The Alden March Bioethics Institute offers a Master of Science in Bioethics, a Doctorate of Professional Studies in Bioethics, and Graduate Certificates in Clinical Ethics and Clinical Ethics Consultation. For more information on AMBI's online graduate programs, please visit our website.

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BIOETHICS TODAY is the blog of the Alden March Bioethics Institute, presenting topical and timely commentary on issues, trends, and breaking news in the broad arena of bioethics. BIOETHICS TODAY presents interviews, opinion pieces, and ongoing articles on health care policy, end-of-life decision making, emerging issues in genetics and genomics, procreative liberty and reproductive health, ethics in clinical trials, medicine and the media, distributive justice and health care delivery in developing nations, and the intersection of environmental conservation and bioethics.