EFFECTIVE PRACTICES IN CREATING A DYNAMIC PROGRAM OF RCR LEARNING FOR POSTDOCTORAL FELLOWS RUTH ELLEN BULGER, PhD PROFESSOR EMERITUS, ANATOMY, PHYSIOLOGY AND GENETICS, USUHS
TEACHING RCR SHOULD BE EASY, SHOULDN T IT? http://www.nationalpostdoc.org/site/rcr_toolkit; Introduction; Getting started; Designing an RCR program for postdocs; Excellent resource; This should be easy, a piece of cake? But is it? It might surprise you what we have and haven t learned from research on RCR and from almost 20 years of teaching predocs (and presumably postdocs) scientific ethics?
WHAT CAN WE LEARN FROM PAST EXPERIENCE? Is there a need for postdoc training in RCR? Who has been trained so far? What are the goals of training? What might be the content of the training? What do postdocs know now? What do they need to know? Who will teach RCR? Why?
WHAT CAN WE LEARN FROM PAST EXPERIENCE? What methods can be used in training? Is teaching Misconduct enough? What about Questionable Research Practices? What about teaching the principles? What about the additional disciplines now in the new misconduct definition? What about special postdoc-related issues? What does the institution need to do to ensure RCR?
NEED FOR POSTDOC TRAINING? WHO HAS BEEN TRAINED? http://www.nationalpostdoc.org/site/rcr_toolkit data; 31% of postdoc had received no training in research ethics with another 1/3 having only on the job training (www.sigmaxi.org/postdoc/all/inst_environment_short.html); Similar issues in Eastwood et al, Ethical issues in biomedical research: Perceptions and practices of postdoctoral research fellows responding to a survey. Sci Eng Ethics 1996; 2:89-114; Kalichman and Plemmons (Acad Med 2007) have found that only 6 of 50 RCR courses being taught due to NIH requirement include all graduate students.
HAS NIH ENSURED THAT NRSA TRAINEES RECEIVE REQUIRED RCR INSTRUCTION? NIH has encouraged universities with NRSA training grants to include all trainees (pre and postdoc) in their teaching of RCR (1992 training grant requirement); Has NIH examined whether training grant faculty provide the RCR instruction required for NRSAfunded pre- and post-doctoral trainees since 1989? Kalichman and Plemmons (2007) reported that 25% of individuals identified by training grant directors as their program s RCR instructor said they did not teach RCR, and 22% of instructors interviewed explicitly said that their course participants were not NIH trainees.
HAS TEACHING RCR BEEN SHOWN TO BE EFFECTIVE? A survey was created and tested in four research intensive universities using topics chosen because of their inclusion in the most RCR texts and their importance in knowing research regulation (Heitman E and Bulger RE (Accountability in Research 2005;12:207-224) and Heitman E. et al., (Acad Med 2007; 82;838-845) Using this survey, Heitman et al. s baseline RCR testing of new graduate found that about one third of 300 new students had prior graduate degrees in the biomedical sciences or health professions; the mean test score of 16 who reported prior RCR instruction was only 67.7%, compared to the total mean of 59.5% of all entering graduate students.
HAS TEACHING RCR BEEN SHOWN TO BE EFFECTIVE? Martinson et al., (2005) found that 28% of early-career NIH-funded respondents reported that they committed FFP and/or QRPs which raises questions about the effectiveness of RCR instruction or the mentoring they received as part of their NIH-funded activities (compared with 38% of mid-career investigators); Anderson MS et al. (Acad Med 2007; 82:853-869) showed that research mentoring has the potential to influence behavior in ways that both increase and decrease problematic behaviors; research ethics training among mid-career investigators was associated with decreased odds of some problematic behavior.
HAS TEACHING RCR BEEN SHOWN TO BE EFFECTIVE? Although promoting ethical behavior is widely discussed as a goal of teaching RCR, improved behavior has not been clearly demonstrated as an outcome; Kalichman and Plemmons (2007) did not find that changing behavior was one of the 50 goals for RCR training listed by RCR instructors; Obviously other goals are important.
ARE GOALS FOR TEACHING RCR CLEAR? In 1996, Mastroianni A and Kahn JP (AIR 1999; 7: 85-100) reviewed course material from NIH training grants at 45 institutions, finding few clearly defined goals for RCR courses and wide variation in content and teaching methods; Kalichman MW and Plemmons DK (Acad Med 2007; 82: 846-852) reported that 67 RCR instructors listed over 50 diverse goals in the five areas. There was no consensus on goals for RCR courses and ratings of importance varied markedly, suggesting course outcomes will vary. Some instructors even confused goals and methods.
GOALS OF RCR TRAINING Think clearly about what your goals are for teaching RCR to postdocs; And when during the postdoctoral experience, teaching particular material is most appropriate for the postdoc.
GOALS FOR TEACHING SCIENTIFIC RESPONSIBILITY Open lines of communication about RCR; Say the institution finds this to be important; Encourage interest in ethical issues; Learn national, state, and institutional policies and guidelines, where existing; Reinforce a sense of moral obligation and personal responsibility;
GOALS FOR TEACHING SCIENTIFIC RESPONSIBILITY Recognize ethical problems relating to research practices; Use ethical principles and moral reasoning skills in decision making for gray areas; and Understand basic standards (if they exist) for issues such as authorship, conflict of interest and commitment, and intellectual property.
PRINCIPLES OF RESPONSIBLE CONDUCT OF RESEARCH What is it about science as a profession that requires it to be done in a responsible manner? Why is objectivity so important and yet so difficult to obtain in research? What do scientists so often suffer from gullibility and self-deception? What is questionable research behavior and how common is it? How common is misconduct? And the elephant in the room, what are the perverse incentives scientists experience in their careers and what can be done about them?
WHAT DO POSTDOCS KNOW NOW? WHAT DO THEY NEED TO KNOW? Can it be demonstrated that postdocs know the basic RCR concepts? If the postdocs lack the basic knowledge, how can they get this information? Which other RCR topics relate directly to or provide a deeper knowledge for the postdocs research experience and when are they best considered?
WHO WILL TEACH RCR? HOW ARE RCR INSTRUCTORS EDUCATED, ENCOURAGED, AND REWARDED? What resources, both educational and human, are institutions providing for RCR instruction for their trainees and investigators? Kalichman and Plemmons (2007) raised questions about RCR instructors knowledge of research ethics, adult education, and the key issues and available resources for RCR instruction, as well as the appropriateness of their disciplinary backgrounds and research experience.
METHODS BY WHICH YOU LIKE TO LEARN Cases; Newspaper articles; Journal club; Student talks; Computer resources; Reading assignments; Lecture; and Combinations.
New estimates suggest that there are 7.5 million girls and women 14 to 24 years old in the US who are infected with human papilloma virus (HVP), a microbe that can lead to cases of cervical cancer in 2.2 percent of women carrying one of the two strains that are most likely to cause cervical cancer. This new finding, published in Journal of the American Medical Association, is likely to encourage the use of a vaccine that has been approved by the Food and Drug Administration for females 9-26 years of age. A company that produces this vaccine, has been said to be talking to members of state legislatures to have them require vaccination of middleschool girls. This is now being considered in 18 states. For example, Texas s governor earlier issued an executive order requiring the vaccine in school girls. Some parents have objected to such mandates for the use of the HPV vaccination because the infection is transmitted only through sexual contact and that can be avoided by choice. Please discuss the ethical issues that this raises. (Information from David Brown, Washington Post, Wed February 28, 2007)
SCIENTISTS BEHAVING BADLY Martinson et al.,. (Nature. 2005; 435:737-738) Martinson, et al., found high rates of selfreported questionable research practices (QRPs) as defined by scientist focus groups and judged likely to be sanctionable by six compliance officers (they included FFP): 33% responding scientists had engaged in at least one of the top ten behaviors in the previous three years, including 28% of early-career scientists, and 38% of mid-career scientists.
COMPARING FFP WITH QRP Steneck (2006) provided evidence that simply based on higher levels of occurrence, QRP should have proportionally greater impacts on research than FFP : Higher levels of occurrence (Martinson et al.); Savings on reduced publications from removing estimated 10 to 20% duplicate publications saving millions each year; Deaths of research subjects due to QRP (faulty literature review and conflicts of interest), not FFP; M. Angell in The Truth About the Drug Companies, (Random House, Inc, NY 2004) argues that bias and unprofessional conduct waste $100s of million in health care expenses and adverse effects.
WHY DOES ORI ONLY INVESTIGATE FFP NOT QRP? The authorization of ORI (42 U.S.C. 289b) requires the Secretary of HHS to establish a definition of misconduct and then the definition more or less limits all of ORI s subsequent duties to this definition; Scientists, institutions and professional associations are powerful lobbying groups? If the impact of QRP on how science is done is greater than that of FFP, is this limitation appropriate? Who represents the public in decisions like this?
SHOULD ORI REQUIRE BROADER RCR EDUCATION ORI s December 2000 proposed Policy on Instruction in the Responsible Conduct of Research called for instruction for everyone with direct and substantive involvement in proposing, performing, reviewing, or reporting research or who receive research training supported by PHS funds ; The anticipated costs of the policy, its timeframe, the number of people to be trained, and the choice of core areas, were strongly criticized; Rep. Billy Tauzin, chair, House Energy and Commerce Committee strongly objected and the policy was suspended. Is such education needed? This policy was quickly withdrawn. Who benefits?
WHAT ABOUT NEWLY INCLUDED DISCIPLINES IN MISCONDUCT LAW? Disciplines such as economics, education, mathematics, and linguistics were brought under the new federal policy on research misconduct in 2000; How are these disciplines meeting the need for RCR education? Have they begun the process? What are the core instructional areas relevant for these fields (general RCR content and special, disciplinespecific content); Are unique educational resources in RCR available or being prepared for these disciplines?
WHAT ABOUT OTHER EDUCATION ON ETHICAL ISSUES BESIDES THE BASIC AREAS, WHICH SPECIFICALLY RELATE TO THE POSTDOC RESEARCH YEARS AND THE TIME WHEN ONE IS APPLYING FOR A POSITION?
STEP 1: ENSURING THAT POSTDOCS KNOW THE BASIC CONCEPTS Which BASIC RCR topics relate to my research? Can I demonstrate that I know the basics concepts? What about a pretest? If not, can I build on an existing RCR course in my institution? Start a new one? How about the www like the CITI courses (Biomedical, Social and Behavioral, Physical Sciences and Engineering, Humanities, IACUC)? www.citiprogram.org/register
STEP 2: RCR WITH A FOCUS ON RESEARCH DURING THE EARLY POSTDOC YEARS Making the laboratory a safe place for everyone (ethics of lab safety); How to keep a useful research notebook? What does your look like? What options are there? How to maintain objectivity (conflicts of interest, biases)? Research expectations, laboratory and time management; Communication, publication and collaboration; and
STEP 3: PREPARING FOR A FACULTY POSITION OR OTHER JOB Getting published without shortcuts; Giving good talks; Writing a good but honest Curriculum vita; Applying for positions; Project management, hiring and working with employees; Learning about opportunities; and Understanding the job market and the University structure.
WHAT DOES THE INSTITUTION NEED TO DO? Why is the institution important to RCR? Is there a list (with emails) of all the postdocs at the institution? Do you have a postdoc handbook? Roles of the Office of Research at the institution; Misconduct and whistle blowing; Conflicts of interest and commitment; Authorship; Data management; Intellectual property; Collaborate research; Financial policies; Sexual harassment.
WHAT DOES THE INSTITUTION NEED TO DO? (CONTINUED) Do your trainees and faculty see your institution as FAIR and JUST? Is there a way to reward learning in RCR? Is there a way to reward teaching of RCR? Is there a money for lunches, etc? Hire an ombudsperson; What else have you done?
ARE EDUCATIONAL INSTITUTIONS ENSURING THAT RESEARCH IS CONDUCTED RESPONSIBLY? Are institutions seeking to create an environment that promotes responsible conduct by individual scientists and that fosters integrity by monitoring and evaluating the institutional environment of research as suggested by the IOM (National Academy Press, 2002)? Is there an elephant in the room? Better to introduce him (or her). Hold Institutional Ethics Rounds at which institutional decisions and policies are examined. Provide money for invited speakers to deal with ethical issues.
CONCLUSIONS Research ethics has become an academic discipline in itself characterized by an increasing number of scientific studies on how best to ensure an environment in which responsible and just policies are followed; Learning from this research on what is useful and what is not can help you from making the mistakes again; I complement all of you for coming to a meeting such as this to learn how you might best create a worthwhile program in research ethics.