Education in the
Responsible Conduct of Research

Presented at the Annual Meeting of the
Association of Chairs of Departments of Physiology

Michael D. Mann, Nebraska Medical Center
Michael Kalichman, University of California, San Diego
Francis L. Macrina, Virginia Commonwealth University
 

Summary
    Here we present a synopsis of teaching responsible conduct of research (RCR) to trainees in biomedical sciences, summarize the origins of the still evolving definition of RCR and provide an introduction to the goals, content, and strategies for teaching RCR. These should be particularly useful for those contemplating changes in existing RCR courses or the creation of new ones.

Scientific Misconduct and RCR
    Scientific misconduct has contributed significantly to the increased attention to the Responsible Conduct of Research (RCR). In the 1980s and 1990s, defining scientific misconduct accompanied governmental and institutional activities on RCR policies and education. Both lengthy and concise definitions of scientific misconduct have appeared, have been modified, and continue to evolve. But common denominators remain throughout and are summarized as follows. Scientific misconduct is fabrication, falsification, or plagiarism in proposing, performing, reviewing or reporting research. Fabrication is making up data and recording or reporting them. Falsification is manipulating research materials, equipment, or processes, or changing or omitting data so as to misrepresent the research. Plagiarism is the appropriation of another person’s ideas, processes, results, or words without proper attribution. Most definitions affirm that honest error or differences of opinion do not constitute scientific misconduct.

    In 1985, Congress enacted legislation requiring that any institution applying for or holding a grant from an agency of the Public Health Service (PHS) have a defined process for reviewing misconduct allegations and for reporting to the Secretary of Health and Human Services any investigations of “scientific fraud” that appeared to be “substantial.” The late 1980s saw the creation of an oversight and regulatory infrastructure that ultimately led to the inception of the Office of Research Integrity (ORI), a component of the Department of Health and Human Services (DHHS). Definitions of scientific misconduct were promulgated by agencies such as the DHHS and the National Science Foundation, as well as scientific societies and individual research institutions. A history of these events may be found on the ORI web site (http://ori.dhhs.gov/html/about/historical.asp).

    It was in response to well-publicized cases of scientific misconduct that legislative bodies and funding agencies began to mandate some kind of training in (RCR). However, as is often the case, no definition of RCR was offered. Thus, it has been largely defined by the educational requirements of federal funding agencies like the National Institutes of Health (NIH). Such requirements first appeared almost 15 years ago when the NIH mandated education in RCR for pre- and postdoctoral students whose support came from NIH training grants. By default, content areas suggested by federal agencies largely have included protections for human and animal subjects of research, data management, publication practices, peer review, collaborations, mentoring, research misconduct, and conflicts of interest1.
Other topics sometimes included in RCR instruction, but not part of the mandated list, are the appropriate use of research grant funds, environmental health and safety, sexual harassment, and discrimination. These topics are often omitted from such instruction because they do not involve misconduct specific to science, and separate agencies regulate, monitor, and prescribe training in such areas (e.g., environmental health and safety would be covered by regulations of the US Nuclear Regulatory Commission and US Department of Labor Occupational Safety and Health Administration).

    The authors do not agree with the equation of the responsible conduct of research with the absence of scientific misconduct. Clearly, the absence of scientific misconduct is necessary, but not sufficient. Responsible science also requires adherence to “best practices” of research design, data collection and analysis, and students must learn how best to record, store, and share their data. Inclusion of these topics goes well beyond the instruction required by the NIH and other agencies.

Why teach RCR?
    The origins of formal RCR education can be traced to congressional hearings that date back to the early 1980s. These hearings were prompted by an increased awareness of misconduct allegations in scientific research. Throughout the 1970s and 1980s, high-profile cases of alleged scientific misconduct came under public scrutiny and formal investigation. Awareness of and sensitivity to scientific misconduct grew dramatically during this time as reporters and writers made it a public issue. However, it also follows from the realization that part of research training should include exposure to the proper practice of science. For this reason, viable RCR instruction programs have been in place at some institutions for nearly 20 years. To many scientists and observers of science, such training seems to be a good idea, but it isn’t readily apparent why we favor teaching RCR or what goals we should have for RCR instruction.

    One reason to teach RCR is simply that it is required. Although this is not true for everyone, we are obligated under current federal regulations to provide instruction for trainees funded by NIH training grants (NIH 1992) and to key personnel for studies of human subjects (NIH 2000). In addition, for a short time, a PHS policy called for instruction of everyone funded by the PHS for research or training (PHS 2000). Complying with federal regulations is certainly an appropriate end in itself. However, a case can be made that we should not teach RCR solely because we must do so, but rather because we should do so.

    The teaching of RCR is an ethical responsibility for any concerned scientist. First and foremost, we have an obligation to our trainees. The next generation of scientists must be clear about their responsibilities as researchers. Such responsibilities are too diverse and often too complex to be relegated to chance and informal socialization. Second, we have an obligation to the discipline of science. The accumulation of new knowledge depends on the trustworthiness of what is reported. If scientists value their profession, then it follows that they should have an explicit commitment to promoting the integrity of research. Third, we have an obligation to the public, which grants us the privilege of performing research studies. Our funding, space, and opportunities are, for the most part, made possible because society sees value in research. In effect, we have a contractual obligation to deliver a research product that has value and, by extension, integrity.

    It is worth noting that our ethical obligations to promote RCR education are paralleled by clear practical implications. The productivity of our research groups will be enhanced if our trainees understand and nurture their responsibilities as scientists. Scientists will be better able to build on the work of their peers if the standards of scientific conduct are sufficiently clear to have decreased the risk that flawed work will be reported. Finally, the public will be less likely to call for a withdrawal of the privilege to conduct research, and more likely to increase support for research, if it has an assurance that we take that privilege seriously.

What are the goals for teaching RCR?
    The design of an effective program of instruction will depend first on defining our intended goals. This is not as simple as it might at first seem. Based on an ongoing study (Kalichman, Paik, Smith, and Roth, in progress), it has become apparent that even the most experienced teachers of RCR have very different goals.

    This study included three phases, two of which are now complete: (1) an informal survey of nationally recognized leaders in RCR education, and (2) focus group discussions with RCR instructors and others interested in RCR education. The third phase, now underway, is based on interviews with faculty identified by program directors of NIH training grants funded in 2000. Although data collection and analyses are not complete, it is clear that the goals of RCR instruction are multiple and varied. The range of goals most frequently identified can be categorized as seen in Table 1.
 

    Clearly, it is not yet possible to definitively state what combination of these goals is essential for any RCR course. However, it is fair to say that meeting some combination of these goals would improve the research environment and is, thereby, worthy of our consideration.

What should be taught about RCR?
    The first and subsequent publications of RCR instructional requirements provided a suggested list of curriculum topics. The most comprehensive description of RCR instructional core areas appeared in the ORI policy announced in 2000 and suspended in 2001. This may be accessed at: http://ori.dhhs.gov/html/programs/finalpolicy.asp. The core topic descriptions are given below. These are, for the most part, taken verbatim from the ORI web site; in some cases slight modifications have been made. Moreover, the order has been changed to coincide with the list of topics given above. Following the description of each core area, one or more URLs are provided that will take the reader to web sites that will provide more information on the topic.

• Human subjects: issues important in conducting research involving human subjects. This topic includes subtopics such as the definition of human subjects research, ethical principles for conducting human subjects research, informed consent, confidentiality and privacy of data and patient records, risks and benefits, preparation of a research protocol, institutional review boards, adherence to study protocol, proper conduct of the study, and special protections for targeted populations, e.g., children, minorities, and the elderly. (http://ohrp.osophs.dhhs.gov/)

• Research involving animals: issues important to conducting research involving animals. This topic includes subtopics such as the definition of research involving animals, ethical principles for conducting research on animals, federal regulations governing animal research, institutional animal care and use committees, and treatment of animals. (http://grants.nih.
  gov/grants/olaw/references/phspol.htm; http://grants.nih.gov/grants/olaw/
  tutorial/index.htm; http://grants.nih.gov/grants/olaw/references/hrea1985.htm)

• Data acquisition, management, sharing, and ownership: accepted practices for acquiring and maintaining research data; proper methods for record keeping and electronic data collection and storage in scientific research. Along with defining what constitutes data, this topic includes data storage in notebooks or electronic files; data privacy and confidentiality; data selection, retention, sharing, ownership, and analysis; and data as legal documents and intellectual property, including copyright laws.
  (http://rgp.ufl.edu/otl/goodrecords.html,
  http://www.fccc.edu/ethics/RecordKeeping.html, http://www.nap.edu/
  catalog/10613.html)

• Publication practices and responsible authorship: the purpose and importance of scientific publication, and the responsibilities of the authors. This topic includes subtopics such as collaborative work and assigning appropriate credit, acknowledgments, appropriate citations, repetitive publications, fragmentary publication, sufficient description of methods, corrections and retractions, conventions for deciding upon authors, author responsibilities, and the pressure to publish. (http://www.sfn.org/guidelines/, http://www.acponline.org/journals/resource/unifreqr.htm, http://pubs.acs.
  org:80/instruct/ethic.html)

• Peer review: the purpose of peer review in determining merit for research funding and publications. This topic includes subtopics such as, the definition of peer review, impartiality, how peer review works, editorial boards and ad hoc reviewers, responsibilities of the reviewers, privileged information and confidentiality. (http://ori.hhs.gov/html/programs/rcrcontents.asp)

• Mentor/trainee relationships:
  the responsibilities of mentors and trainees in predoctoral and postdoctoral research programs. This topic includes the role of a mentor, responsibilities of a mentor, conflicts between mentor and trainee, collaboration and competition, selection of a mentor, and abusing the mentor/trainee relationship. (http://www1.od.nih.gov/oir/sourcebook/ethic-conduct/mentor-guide.htm, http://www.nap.edu/readingroom/books/mentor/, http://darkwing.uoregon.edu/~gradsch/guidelines.html)

• Collaborative science: research collaborations and issues that may arise from such collaborations. This topic includes subtopics such as setting ground rules early in the collaboration, avoiding authorship disputes, and the sharing of materials and information with internal and external collaborating scientists. (http://ethics.ucsd.edu/courses/integrity/assignments/collaboration.html#intro)

• Research misconduct: the meaning of research misconduct and the regulations, policies, and guidelines that govern research misconduct in PHS-funded institutions. This topic includes subtopics such as fabrication, falsification, and plagiarism; error vs. intentional misconduct; institutional misconduct policies; identifying misconduct; procedures for reporting misconduct; protection of whistleblowers; and outcomes of investigations, including institutional and federal actions. (http://ori.dhhs.gov/)

• Conflict of interest and commitment:
  the definition of conflicts of interest and how to handle conflicts of interest: types of conflicts encountered by researchers and institutions. This topic includes subtopics such as conflicts associated with collaborators, those associated with publication, financial conflicts, obligations to other constituencies, and other types of conflicts. (http://grants.nih.gov/grants/
  guide/notice-files/not95-179.html, http://grants.nih.gov/grants/policy/nihgps/part_ii_2.htm#conflictint, http://www.research.sunysb.edu/research/policies/nsfcoi.txt)

How should RCR be taught?
    Once the decision has been made to start instruction in RCR, it is appropriate to ask what sort of instruction to offer. There are a number of possibilities—each has advantages and disadvantages.
    Courses. Courses provide repeated meetings with possibility for assignments and discussion of homework exercises. There is often ample time for extended discussion because the courses typically meet one to three hours per week and are mixtures of lectures and discussions. Advantages of courses include the possibility for trainees to develop rapport and confidence, homework assignments can continue between course meetings, and principles common to many ethical situations (e.g., basic principles of decision-making) can be emphasized and re-emphasized. There are many who think that lectures are not the optimum method of instruction for RCR; courses can degenerate into simple lecture series without opportunity for discussion or contemplation of issues. This should not be a problem if instruction is at least partly case-based. Busy schedules make commitment to repeated meetings difficult.
For examples see: Scientific Integrity Course, Virginia Commonwealth University (http://www.vcu.edu/courses/rcr); Scientific Ethics Course, University of California, San Diego (http://ethics.ucsd.edu/courses/ethics).
    Workshops. Workshops are typically one-day events of variable duration that can be reviews of relevant resources, regulations or guidelines, invited guest lecturers or case-based discussions. Their advantages are that they can be advertised as special events, they provide an opportunity for intense focus on single topics or a survey of several topics. However, because only a single meeting is held there is no opportunity for follow-up or discussion of assignments.
For examples see: Survival Skills and Ethics, University of Pittsburgh (http://www.edc.gsph.pitt.edu/survival); Clinical Research Workshops, University of California, San Diego, (http://ethics.ucsd.edu/workshops/CRW).
    Discussion series. Discussion series are repeated meetings, typically of one to three hours in duration and that provide a forum for discussion that can be extended. Extensive faculty involvement is an advantage. Such series provide an opportunity to define community standards with respect to RCR. This format may be more appropriate for senior trainees; new students may be intimidated by close contact with faculty. It is important to keep group size small to facilitate discussion. For examples see: Biomedical Ethics Seminar Series, University of California, San Diego (http://ethics.ucsd.edu/seminars).
    Ethics seminars. Another way to provide instruction in RCR is through periodic ethics seminars that may be mixed into ongoing departmental, lab or other similar seminar series. One advantage of this approach is that no additional time is required for instruction. Discussions can take place within a specific research group, thereby emphasizing topics in ethics as having as much importance as other topics of research. One problem with this approach is that issues common to various topics (e.g., Federal guidelines) may receive less emphasis in the context of specific discussions.
    Internet-based Training. Busy schedules can be accommodated by offering internet-based training because this can be accessed by students from nearly anywhere, whenever they wish to do so. Repeated meetings, homework assignments, extended discussions and links to relevant resources are all easily accomplished through email, chat rooms, etc. During such discussions, everyone can have a voice; in fact, it is difficult for one student to hide and not participate. This method allows faculty to remain in the background–—lecturing is nearly impossible. Because students write their comments, they are apt to think them through more carefully than they would in the heat of a classroom discussion. One disadvantage is that trainees may choose to prepare less than for face-to-face encounters. Unless faculty members act as moderators, discussion can become long and unfocused. For examples see: Research Ethics, University of Nebraska Medical Center (http://www.unmc.edu/ethics); Scientific Integrity, University of California, San Diego (http://ethics.ucsd.edu/courses/integrity).
    Ethics in the Core Curriculum. The most efficient way of offering instruction in RCR is to make ethics an inseparable part of professional training–—ethics is inserted as just another aspect of that training. Good mentors make it part of lab meetings and individual or group discussions. It can be inserted into other courses such as writing courses as topics for writing assignments. This requires conscious commitment to RCR on the part of mentors. For examples see: Scientific Writing Course, University of Nebraska (http://perweb.unmc.edu:8080/~writing/), Ethics and Survival Skills, University of Pittsburgh, (http://www.edc.gsph.pitt.edu/survival).
    Conferences. Opportunities for trainees to attend national conferences on RCR are increasing in frequency. They offer training by experienced instructors, presenting up-to-date materials. Attendance by individuals from many institutions lends an ecumenical flavor. The primary disadvantage is that not everyone has the resources to or will attend. For examples see: Survival Skills and Ethics, University of Pittsburgh, (http://www.edc.gsph.pitt.edu/survival), Teaching Research Ethics, Indiana University,
(http://www.indiana.edu/~poynter/tre.html), RCR101, Public Responsibility in Medicine and Research (PRIM&R), (http://www.primr.org/conferences.html).

    Different techniques are available for use in these different approaches. Lectures can be used in most approaches, but most instructors agree that discussion or case studies are more appropriate. Online or email discussions are always possible and especially appropriate for internet-based instruction. Role-playing is used less often, but can be a useful way to help trainees examine their responses to ethical dilemmas. Many movies (e.g., “Fat Man, Little Boy,” “Miss Evers’ Boys,” “Do Scientists Cheat?”) and plays (e.g., Robert G. Martin’s “Stampede of Zebras”) have been used successfully in RCR instruction to present ideas and stimulate discussion. Assignments for both reading and writing can be used to expose trainees to new ideas and allow them to express their own. The authors of this paper have successfully used surveys to help trainees examine their own opinions and compare theirs with those of others (see http://www.courses.vcu.edu/rcr/Main%20pages/micr510.htm).

Conclusion
    The creation of courses in RCR education largely has occurred in response to Federal mandates. This teaching field is still new and curriculum content has been primarily driven by the suggestions made the NIH, the ORI, and some other Federal agencies. Multiple approaches to teaching RCR have been developed and tried with success. Delivery strategy does not fit any prescriptive method, and the needs of individual institutions should be carefully considered when deciding on course design and content. With nascent policies at Federal, institutional, and other levels, curriculum content should be evaluated regularly and adjusted as needed. Fostering lifelong learning is an important goal for RCR instruction delivery to both trainees and scientists.

References

1. Barnbaum, DR and Byron, M. Research Ethics: Text and Readings. Upper Saddle River, NJ: Prentice-Hall, Inc., 2001.
2. Bulger, R, Heitman, E, and Reiser, SJ. The Ethical Dimensions of the Biological Sciences. Second Edition. New York: Cambridge University Press, 2002.
3. Elliott, D and Stern, J. Research Ethics—A Reader. Hanover, NH: University Press of New England, 1997.
4. Historical Background of HHS Office of Research Integrity (26 April 2002). http://ori.dhhs.gov/html/about/aboutori.asp. [1 March 2004]
5. Kalichman, MW. Online Resource for Instruction in Responsible Conduct of Research. http://rcrec.org . [1 March 2004]
6. Korenman, SG and Shipp, AC. Teaching Responsible Conduct of Research Through a Case Study Approach: A Handbook for Instructors. Washington, DC: AAMC, 1994.
7. Macrina FL. Scientific Integrity: An Introductory Text with Cases (second edition). Washington, DC: American Society for Microbiology Press, 2000.
8. NIH. Requirement for Instruction in the Responsible Conduct of Research in National Research Service Award Institutional Training Grants. NIH Guide (27 November 1992) http://grants.nih.gov/grants/guide/notice-files/not92-236.html.
[1 March 2004]
9. NIH. Required Education in the Protection of Human Research Participants. NIH Guide (25 August 2000) http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. [1 March 2004]
10. Penslar, RL. ed. Research Ethics: Cases and Materials. Bloomington, IN: Indiana. University Press, 1995.
11. PHS. PHS Policy on Instruction in the Responsible Conduct of Research (RCR)- Suspended (1 December 2000) http://ori.dhhs.gov/html/programs/finalpolicy.asp. [1 March 2004]
12. Shamoo, AE and Resnick, DB. Responsible Conduct of Research. New York: Oxford University Press, 2003.
13. Stern, J and Elliott, D. The Ethics of Scientific Research—A Guidebook for Course Development. Hanover, NH: University Press of New England, 1997.

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