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Panel 1: General RCR Panel

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Responsible Conduct of Research (RCR) Instruction Delphi Panel Results

Method

Panel 1 convened RCR experts to address the following questions:
1. What should be the overarching educational objectives of RCR instruction?
2. Are the 9 core areas of RCR instruction complete, or should new core areas be addressed within RCR instruction?

The panel used a version of the Delphi method to achieve consensus. Panelists were asked to complete three successive online questionnaires. All responses were anonymous.

Round 1 consisted of an open-response format. Participants were directed to a website which asked them to list, in corresponding text boxes, at least five educational objectives for RCR education. Participants were also asked whether RCR instruction should address any new core areas in addition to the 9 core areas identified by ORI. After each participant had completed round 1, their responses were carefully condensed, re-worded and organized into topics and subtopics to enhance clarity and prevent redundancy.

Round 2 involved presenting participants the lists of topics they had generated and asking them to evaluate the importance of teaching each topic in an RCR course. Participants were asked to rate the importance of teaching each topic or subtopic on a four-point scale (1 = Unimportant, 2 = Less important, 3 = Important, 4 = Very important). Participants were also asked to make additional comments about each item concerning wording or clarity. Topics receiving a vote of “Important” or “Very Important” from at least two-thirds of participants were deemed to meet consensus criteria and were presented to participants in the next round, after they were revised according to the participants comments. Topics not meeting consensus are nevertheless displayed in the tables below, with their corresponding consensus values and mean scores.

Round 3 added to Round 2 by re-asking participants the importance of teaching each item, and also asked participants to rate the importance of assessing each item within an RCR course. Assessment rankings followed the same four-point scale used in the previous round. For each question (one on teaching, one on assessing), each topic receiving a vote of “Important” or “Very Important” from at least two-thirds of participants was deemed to meet consensus criteria, and is labeled with an asterisk in the table below. The consensus value and the mean score for each topic and subtopic are also shown.


Results: Panel 1

Overarching Educational Objectives for RCR Instruction

Topics (Subtopics indented)Percentage of participants rating item as “important” or “very important” (Mean score)
TeachingAssessing
1. Understand the importance of RCR94* (3.59)81* (2.94)
a. Know the history of research, including historical examples of research misconduct and unethical conduct82* (3.29)56  (2.50)
b. Understand the social context of research94* (3.29)56  (2.78)
c. Consider consequences of unethical conduct in research for self, institution, science, and society100* (3.83)89* (3.22)
2. Identify sources of RCR regulations and policies83* (3.22)50  (2.67)
a. Federal regulations83* (3.22)61  (2.78)
b. State laws 47  (2.65)N/A=
c. Institutional policies78* (3.17)61  (2.83)
3. Examine limitations of RCR regulations and policies and variations in standards across fields, institutions, and labs83* (3.17)61  (2.67)
a. Understand that regulations permit discretion and creative problem solving89* (3.28)61  (2.72)
b. Understand that regulations require discretion and creative problem solving61  (2.94)N/A=
c. Understand that regulations do not cover all ethical responsibilities94* (3.50)78* (3.11)
4. Understand key distinctions within the field of RCR89* (3.22)72* (2.83)
a. Distinctions within ethics, such as ethically obligatory, prohibited, and praiseworthy actions47  (2.65)N/A=
b. Distinction between ethical and regulatory duties83* (3.33)56  (2.67)
c. Distinction between research misconduct and questionable research practices83* (3.33)67* (3.06)
5. Foster research integrity or professional character94* (3.65)44  (2.61)
a. Motivate morally good action83* (3.22)39  (2.56)
b. Inculcate professional values such as pursuit of truth, honesty, intellectual humility100* (3.39)50  (2.72)
6. Foster ethical sensitivity or the ability to identify ethical issues in the conduct of research94* (3.50)83* (3.06)
a. Identify common ethical issues such as those addressed within the core areas of RCR83* (3.06)72* (2.89)
b. Identify threats to RCR, including pressures in the research institution and personal bias100* (3.67)61  (2.83)
c. Distinguish between ethical responsibilities in research versus other professional activities such as education or clinical care50  (2.50)N/A=
7. Develop ethical problem-solving skills89* (3.44)78* (3.11)
a. Knowledge of relevant ethical frameworks, theories or principles67* (2.72)33  (2.39)
b. Ability to identify key elements of an ethical situation, including stakeholders, relevant ethical and legal norms, relevant facts, and options89* (3.39)67* (2.89)
c. Ability to critically reason using ethical principles or values83* (3.39)78* (2.94)
d. Ability to identify ethical resources, such as mentors, peers, institutional officers, educational resources, and consultation services83* (3.28)56  (2.72)
8. Examine ways of preventing ethical problems in research89* (3.22)61  (2.67)
9. Provide an open forum for discussion of individual RCR concerns and challenges83* (3.33)50  (2.33)

Legend:
* - Item achieved a “consensus” by receiving a rating of important or very important from two-thirds of participants
= - Not applicable because these items were eliminated after round 2 and their importance of being assessed was not measured

Additional Core Areas

Core AreaPercentage of participants rating item as “important” or “very important” (Mean score)
TeachingAssessing
1. The financial and operational responsibilities of Principal Investigators50  (2.56)N/A=
2. Social responsibilities of researchers89* (3.28)47  (2.65)
3. Historical background in responsible conduct of research61  (2.72)N/A=
4. Current issues in responsible conduct of research89* (3.28)50  (2.61)
5. Lab safety and environmental health56  (2.72)N/A=
6. Philosophy of science, including roles of bias and world views in science39  (2.50)N/A=

Legend:
* - Item achieved a “consensus” by receiving a rating of important or very important from two-thirds of participants
= - Not applicable because these items were eliminated after round 2 and their importance of being assessed was not measured


Recruitment and Panelist Biosketches

Recruitment:

Recruitment began with (1) a literature search to identify authors actively researching and publishing in RCR, (2) a review of ORI Annual Reports from 2000 through 2005 to identify those who received ORI contracts and grants, and (3) review of recent research administrative and RCR conference programs to identify those who had presented on relevant topics. Lastly, certain subgroups such as current research students, research administrators and journal editors, were identified for specific panels. From the resulting list of possible participants, the Project Director, in consultation with ORI, selected those who were both qualified to serve on a particular panel and represented diverse backgrounds. For the General Panel, experts with overarching knowledge of RCR were recruited, along with some other important subgroups. Recruitment letters were sent to these individuals, asking them to volunteer without compensation for a total of 1.5 hours (30 minutes for each round) over approximately nine months. Those who declined participation, but represented a subgroup of interest, were asked to provide a recommendation for another possible participant. The resulting consenting participants who completed at least two of the three rounds are listed below.

Panelists:

Alison Antes, B.S. is a Research Assistant at the University of Oklahoma Center for Applied Social Research, seeking a M.S. in Industrial and Organizational Psychology. She received her B.S. in Psychology from Indiana State University in 2005. She is the coordinator of an ORI/NIH sponsored project investigating the effectiveness of current approaches to RCR education. At the ORI Research Conference in December 2006, two of her co-authored papers were accepted for presentation: Ethical Decision-Making in Research: Exploring the Influence of Personality and The Development of Ethical Decision-Making: Early Environmental Predictors of Research Integrity.

Ken Bensch, B.S. is a student in the M.D./Ph.D. program at the Saint Louis University School of Medicine. He received is B.S. in Biological Sciences and French from Marshall University in West Virginia in 1998, and also has studied in France and England. He has worked in basic sciences research for four years prior to starting the M.D./Ph.D. program and currently conducts graduate research in the biochemistry department at the Saint Louis University School of Medicine.

Tom Champney, Ph.D. is Deputy Chair in the Department of Anatomical Sciences and Adjunct Professor in the Department of Bioethics at St. George’s University in Grenada, West Indies. He received his Ph.D. in 1984 from the University of Texas Health Science Center at San Antonio in Biomedical Research. A dedicated histology teacher, Dr. Champney also currently teaches the course “Scientific Ethics: Responsible Conduct of Research” at St. George’s University. He has also served as a proposal reviewer for the Office of Research Integrity since 2005.

C. Kristina Gunsalus, J.D. serves as Special Counsel in the Office of University Counsel and Adjunct Professor in the Colleges of Law and Medicine at the University of Illinois at Urbana-Champaign. She received her J.D. from the University if Illinois College of Law. She is a member of the faculty with the Medical Humanities/Social Sciences program and teaches communication, conflict resolution skills and ethics. During her career, she has served on several committees, including the Committee on Research Integrity of the Association of American Medical Colleges (AAMC), the Government-University-Industry Research Roundtable Ad Hoc Group on Conflict of Interest, and the United States Commission on Research Integrity.

Elizabeth Heitman, Ph.D. is Associate Professor of Medical Ethics in the Center for Biomedical Ethics and Society at Vanderbilt University School of Medicine. She holds secondary appointments in the Department of Religious Studies and the Center for Medicine, Health and Society in the College of Arts and Science, where she teaches Responsible Conduct of Research. She received her Ph.D. in Religious Studies in 1988 as the first graduate of the inter-institutional program in clinical ethics offered by Rice University and the University of Texas Medical School at Houston. Her primary research addresses the evaluation of education in the responsible conduct of research, and the cultural awareness and professional socialization of students and researchers. She is principal investigator for a NSF-sponsored study of international science graduate students’ experience of US standards of practice in ethical research.

Michael Kalichman, Ph.D. currently holds several titles including: President of the Responsible Conduct of Research Consortium, Co-Director of the San Diego Center for Ethics in Science and Technology, and Director of the Research Ethics Program, each at the University of California at San Diego School of Medicine and Office of Graduate Studies and Research. Dr. Kalichman received his Ph.D. in Pharmacology from the University of Toronto in 1980. In the past 15 years, Dr. Kalichman has dedicated himself to RCR, believing that working scientists should set the agendas of RCR training. He has worked with numerous institutions to assess the effectiveness of teaching RCR, and in 2004 worked as the PI for a project funded by ORI titled Research on Research Integrity Conference Grant.

John E. Kaplan, Ph.D. is a Professor in the Center for Cardiovascular Sciences at Albany Medical College and Professor of Biomedical Sciences at the State University of New York School of Public Health. Dr. Kaplan received his Ph.D. from Albany Medical College in 1976. Since 1995 he has taught Introduction to Scientific Integrity and Discussions in Scientific Integrity. He is also the course director for Research Ethics: Discussions, an online graduate course, and Responsible Conduct of Research at the School of Public Health. He serves as a grant reviewer for the Office of Research Integrity’s RCR Education Resource Development Program and the RCR Program for Academic Societies of the Association of American Medical Colleges.

Gerald Koocher, Ph.D. is Professor of Psychology and Dean of the School for Health Studies at Simmons College in Boston as well as the 2006 President of the American Psychological Association. Dr. Koocher received his Ph.D. from the University of Missouri in Columbia in 1972 in Clinical and Developmental Psychology. He serves as Senior Associate in Psychology at Children’s Hospital in Boston as well as a member of the Data Safety Monitoring Board in Autism Research within the National Institute of Mental Health. Among his major research interests are ethical and public policy issues in delivery of mental health services, including malpractice in the mental health professions, ethical misconduct in research, academic integrity, quackery in mental health, and functioning of Institutional Review Boards (IRBs).

Greg Koski, M.D. Ph.D. is currently Associate Professor of Anesthesia in the Cardiac Anesthesia Group, Department of Anesthesia and Critical Care, and Senior Scientist of the Institute for Health Policy at the Massachusetts General Hospital. He received his Ph.D. in 1977 and his M.D. in 1978 from Harvard Medical School. Dr. Koski was the first director of the United States Office for Human Research Protections (OHRP) from 2000 to 2002. In addition to his appointments at Harvard Medical School, Dr. Koski serves as President-Elect of the Academy of Pharmaceutical Physicians and Investigators, where he is also vice-president for Ethics and Professional Conduct, and chairs the Ethics Advisory Board of the National Heart, Lung and Blood Institute's Framingham Heart Study.

Charles Lidz, Ph.D. is Research Professor in Psychiatry and Director of the University of Massachusetts Medical School Center for Mental Health Services Research. Dr. Lidz received his Ph.D. in 1974 from Harvard University in Sociology. His research interests include ethical issues in medicine, coercion in mental health care and violence involving people with mental illness. His recent publications focus on relationships between professionals in pharmaceutical clinical trials and their financial sponsors, and clinicians and patients in terms of informed consent. He also studies patients’ willingness to participate in research and other human subjects topics. He is extensively published in mental health research and research ethics.

Kenneth D. Pimple, Ph.D. is Director of Teaching Research Ethics Programs and Assistant Scholar at the Poynter Center for the Study of Ethics and American Institutions at Indiana University-Bloomington. He also serves as Director of "Scientists and Subjects: A Web-based Seminar on the Ethics of Research with Human Subjects" and "Teaching Research Ethics: A Workshop at Indiana University." Dr. Pimple received his Ph.D. from Indiana University-Bloomington in Folklore in 1991. In 2002, he completed his NIH grant project, "Web-based Ethics Course in Research with Human Subjects." His research and expertise is diverse and includes animal research, human cloning, teaching research ethics, research misconduct, treatment of human subjects, and data management.

David Resnik, Ph.D., J.D. is a bioethicist at National Institute of Environmental Health Science, National Institutes of Health. He received his Ph.D. from the University of North Carolina, Chapel Hill in Philosophy in 1990 and his J.D. from Concord University School of Law in 2003.  Dr. Resnick has received grants from the National Institutes of Health and the National Science Foundation for projects relating to Responsible Conduct of Research in Scientific Record-Keeping and Data Management. He also serves on several NIEHS/NIH committees including: the Institutional Review Board for Human Subjects Research as Vice-Chair, the Research Ethics Committee, the Trans-NIH Bioethics Committee, and the NIH Committee on the Conduct of Science. He has also been associate editor of Accountability in Research since 2001.

John Ruffolo, Ph.D. is Associate Vice President for Research at South Dakota State University and Professor in the Department of Biology and Microbiology. Dr. Ruffolo received his Ph.D. in Zoology from the University of Iowa in 1972. In his current position, he Heads the Office of Research & Sponsored Programs providing mostly pre-award services to the University community and serves as the Research Integrity Officer responsible for compliance in the areas of research integrity and conflict of interest. As a research administrator, Dr. Ruffolo’s areas of experience include developing and monitoring research policies and assuring compliance with federal regulations with a strong interest in information processing and electronic research administration.

Adil Shamoo, Ph.D. is the founder and Editor-in-Chief of the journal Accountability in Research. He is currently professor and former chairman of the Department of Biochemistry and Molecular Biology, professor of Epidemiology and Preventive Medicine, and a member of the graduate faculty of Applied Professional Ethics, affiliated with the Center for Biomedical Ethics, at the University of Maryland in Baltimore. Dr. Shamoo received his Ph.D. in 1970 in Biophysics from the City University of New York, and is a certified IRB professional (CIP). Since 1994, Dr. Shamoo has been teaching a graduate course on Responsible Conduct of Research. In 2003, he co-authored a textbook with Dr. David Resnik entitled Responsible Conduct of Research, and has numerous other publications within the field of RCR.

Joan E. Sieber, Ph.D. is Professor Emerita of Psychology at California State University, Senior Research Associate at Simmons College, and a Fellow of the American Psychological Association. During the last 25 years, Dr. Sieber has specialized in empirical research on questions of scientific ethics, culturally sensitive methods of research and intervention, data sharing methodology, and whistle-blowing or alternatives to it. She serves as a site visitor to IRBs seeking accreditation, sat on the Accreditation Council of the Association for the Accreditation of Human Research Protection Programs (AAHRPP), and serves on various editorial boards and review panels.  She is Editor-in-Chief of a new international peer-reviewed nonprofit educational journal, the Journal of Empirical Research on Human Research Ethics (JERHRE).

Regina Smith, Ph.D. is Associate Vice President for Research in the Office of the Vice President for Research (OVPR) at the University of Georgia. Dr. Smith received her Ph.D. in 1985 from the University of Alabama in Educational Research. In her current position, she oversees the Offices for Sponsored Programs and Human Subjects Compliance. She also serves as Institutional Integrity Officer with respect to misconduct in science and scholarly activities and the OVPR contact for conflict of interest issues. Dr. Smith has published articles on the topics of Research Administration, Conflicts of Interest, and Compliance Issues and Grants Administration. Since 2002, she has been a reviewer of Responsible Conduct of Research proposals for DHHS/ORI.

Nicholas H. Steneck, Ph.D. is Professor Emeritus of History in the College of Literature, Science, and the Arts at the University of Michigan and a consultant at the Office of Research Integrity. He joined the University of Michigan faculty after graduate studies in history and the history of science at the University of Wisconsin. He chaired the University of Michigan’s pioneering Task Force on Integrity in Scholarship in 1984 and went on to chair the Public Health Service Advisory Committee on Research Integrity from 1991 to 1993. He has published articles on the history of research misconduct policy, the use of animals in research, classified research and academic freedom, and the role of values in university research. Most recently, he authored the ORI Introduction to the Responsible Conduct of Research (2004).

Dan Vasgird, Ph.D. is Director of Office for Research Compliance at the University of Nebraska in Lincoln. He received his Ph.D. from Syracuse University in Social Psychology. He served as the Director of the Office for the Responsible Conduct of research at Columbia University from 2002-2005 and has received and ORI grant for The Development of RCR Internet-based E-seminars on Collaborative Science and Careers. Additionally, he has also conducted numerous seminars and workshops in areas of human research protection, research compliance, research ethics, research integrity and bioethics education including: “Teaching Research Ethics” at Indiana University Poynter Center, and “Ethical Issues in International Health Research” at Harvard University School of Public Health.

Acknowledgements:
This project was funded by a RCR Resource Development contract from the Office of Research Integrity. James DuBois served as the project director and Jeff Dueker as the research assistant. Kathleen Wyrwich served as a methodology consultant. Courtney Andrews served as a technology consultant and created the online questionnaires. This report was submitted to the Office of Research Integrity by the project director on July 12, 2007.