Commentary Evolution of an Innovative Approach to the Delivery of In-Person Training in the Responsible Conduct of Research Karen L. Schmidt, Ph.D.1, Laurel Yasko, M.P.P.M.1, Michael Green, M.D.2,3, Jane Alexander, B.S.Ed.4, and Christopher Ryan, Ph.D.1 Abstract The responsible conduct of research (RCR) Center is an innovative, workshop-based approach to research ethics education at the University of Pittsburgh. A flexibly scheduled program of workshops combines the benefits of traditional case–based discussion and in-person instruction with greater accessibility and a broader disciplinary reach. Essential features of the program include a rotating schedule of independent workshops with separate registration, expert speakers, and a dedicated program director position. At an institutional level, this novel response to National Institutes of Health-mandated training requirements increases access to a wide range of interactive RCR training programs and promotes interdisciplinary conversations on research ethics that involves investigators, trainees, and the research community at large. Clin Trans Sci 2014; Volume 7: 512–515
Keywords: ethics, methodology, appropriateness Introduction
Going beyond compliance to promote a better understanding of basic principles of research integrity is the ultimate goal for research ethics training.1 Recent changes in requirements for responsible conduct of research (RCR) training by the National Institutes of Health (NIH) have created a demand for in-person interactive research ethics training that may not be easily met in existing educational environments. Although universities have acknowledged the need for appropriate, accessible instruction in RCR, there are barriers to the effective large scale delivery of in-person experiences. Results from a recent survey of institutions receiving CTSA funding demonstrated that across sites there is an alarming lack of coherence in the planning and objectives of RCR training programs, as well as a lack of unique, tailored RCR training materials across universities.2 In designing a university-wide program of instruction in the RCR, we pursued a discussion-based approach that could promote enhanced recognition of the nuances of ethical reasoning through interactive case discussion. We aimed to make face-toface instruction accessible to the research community at large, so that biomedical and psychosocial researchers would integrate RCR into their daily professional lives.3 The RCR Center is a novel institutional level response to the ongoing need for improvement in the development and in-person delivery of RCR training, evolving from existing and previous instructional models to a flexible system of interactive workshops, presented by members of the local research community, and highly accessible to research investigators, trainees, and staff. Foundation for RCR Center Program Development
Before the initiation of the RCR Center program, the University of Pittsburgh had previously developed and implemented a comprehensive online system of core research ethics courses for researchers and trainees.4 Online programs, including the Internet-based Studies in Education and Research, Research Practice Fundamentals, and Collaborative Institutional Training Initiative have been employed to deliver online research integrity education on a wide reaching scale.4 Research personnel complete and maintain training certification through these centralized systems. Although online modules provide required instruction,
they do not provide an engaging format for learning and cannot address the need for in-person interactive training in RCR. The University of Pittsburgh Survival Skills and Ethics program was originally developed to address early career development training needs, and secondarily to address interactive RCR training needs.5 Career development and research ethics discussion based training was provided primarily to health sciences trainees and junior faculty through intensive all day career development and ethics workshops held on Saturdays.5 Lunch was provided for attendees and RCR topics were addressed informally during the lunch hour, following the morning career development program. Building on the university-wide model of online training and the interactive format of the Survival Skills and Ethics Program, we developed the RCR Center training program. An advisory group consisting of local ethicists, instructors, and experts in research ethics was consulted to discuss potential issues in implementing an interactive, large scale RCR program. Through consultation with local ethics faculty and experienced training grant investigators, we identified the scope of training needs of the audience, including timing of workshops, locations, as well as the publicity necessary to generate attendance. A pilot program of core RCR workshop presentations was developed (Table 1), sponsored by CTSI, and presented to postdoctoral trainees in the Department of Psychiatry. The RCR Center Training Program Model
Lessons learned from the pilot program allowed us to finetune the RCR workshops and develop the current program of more than 30 distinct 1 hour workshops that are now available to the University of Pittsburgh clinical research community (Table 1). Individual workshops begin with a clear statement of specific learning objectives. Recruited speakers give a didactic presentation of 25–30 minutes in length that often incorporates audience response facilitated by audience response technology (Turning Technologies, Youngstown, OH, USA). Presenters are asked to focus on ethics concerns and research practices as they are currently implemented at the University of Pittsburgh as well as more widely relevant RCR issues. Case-based discussion or question and answer with the workshop presenter(s) fills the
Univ. of Pittsburgh CTSI, Forbes Tower, Suite 7057, Atwood & Sennott Street, Pittsburgh, PA 15260, USA; 2University of Pittsburgh, School of Medicine, M240 Scaife Hall 3550, Terrace Street, Pittsburgh, PA 15261, USA; 3Children’s Hospital of Pittsburgh 4401 Penn Ave, Pittsburgh, PA 15224, UPMC Health Plan, US Steel Tower, 600 Grant Street, Pittsburgh, PA 15219, USA; 4UPMC Health Plan, Pittsburgh, Pennsylvania, USA. 1
Correspondence: Karen Schmidt ([email protected]) DOI: 10.1111/cts.12169
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WWW.CTSJOURNAL.COM
Schmidt et al. Evolution of an Innovative RCR Program n
Core instructional RCR topics Identifying issues in the responsible conduct of research Implementing ethical conduct of human participant research Strategies for effective teaching and mentoring of students Making the most of a mentoring relationship: mentee responsibilities Performing animal research: the do's and don’ts Responsible use of animals in biomedical research Inviting community participation in your research: educational and research ethics Managing conflict of interest: protecting the integrity of research Developing and optimizing collaborative research interactions Reviewing scientific colleagues: responsibilities of peer review An author's responsibilities: publication and authorship Specialized RCR topics Human participant research: creating an ethical mindfulness Demonstrating respect and enhancing trust: mastering the informed consent process Working toward solutions in IRB protocol design Informing patients about their data from clinical research studies: clinical, ethical, and measurement considerations Understanding research participant perspectives: reducing burden in clinical research Societal responsibility: communicating research to the public Working with community agencies to promote a cooperative research agenda Table 1. RCR workshop topics.
remaining part of each hour long workshop. Workshop attendance is limited to thirty-five participants and discussion is facilitated by RCR Center personnel, maximizing face-to-face interaction of participants and presenters. Administrative features of the workshops that have proven to be popular with attendees include frequent, flexible scheduling and the provision of continuing education credit (CEU or CME). Workshops are offered on different days of the week and at convenient times and places. Attendees register online for individual 1 hour workshops and there are no prerequisites; researchers can attend as many or as few sessions as they like. Incorporating audience response technology has allowed us to collect anonymous evaluations quickly and easily in the final 5 minutes of each program. Attendees are also encouraged to provide additional written feedback (Table 2). RCR Center programs are developed and run by a full time, doctoral level administrator whose effort is dedicated to developing RCR workshops, recruiting expert speakers, maintaining attendance and evaluation data, and monitoring workshop quality. Support for this position is provided by funding from a CTSA award (UL1TR000005). Supporting a full time director for the RCR Center has enabled us to recruit expert speakers from across the health sciences, offering wider perspectives for our audience. Attendance is maintained and letters certifying training are prepared by the Center at researchers’ request. Continuing education credit has also been made available through an arrangement between the Center and the Continuing Education Office. By developing a series of a la carte 1 hour RCR workshops, we have created a scalable model for disseminating in-person RCR training to the research community in a flexible, economical manner. WWW.CTSJOURNAL.COM
RCR workshops: research ethics topics and individualized RCR training programs Year round workshop scheduling allows the RCR center to present multiple workshops on nine core RCR topics, often with presenters from varying disciplines and perspectives. In 2013, for example, workshops on human participant research were offered 16 times by six different speakers. Although providing the basics for research trainees that are seeking to fulfill their requirements, we acknowledge that the scope of RCR training extends beyond the limited list of topics originally proposed by the Department of Health and Human Services (HHS).6 Our training program has evolved, including additional specialized topics, based on comments from workshop attendees and interest from local research ethics experts (Table 1). Researchers may choose to build mini curricula of targeted RCR topics through attendance at a series of four RCR center workshops with research integrity, human participant, or bench science focus. The RCR Center director is available for consultation on the suitability of workshops for individual trainees and workshop attendees are encouraged to build their own training programs, incorporating workshops into their overall RCR training plans. Through the implementation of an institutional RCR Center, wider perspectives on individual departmental or lab based RCR educational programs can also be offered.7 Dedicated RCR training personnel can discuss available options and assist in customizing RCR training plans to include both local and institutional training. RCR workshops: characteristics of attendees and presenters During the pilot program, eight RCR presentations were given to a group of 101 attendees, with a majority having attained a doctoral VOLUME 7 • ISSUE 6
513
Schmidt et al. Evolution of an Innovative RCR Program n
RCR workshop characteristic
Attendee responses
Range of topics
“This RCR program has been really comprehensive.” “You have covered many of the topics that I have needed.”
Meets needs for required training
“This surpassed my expectations.” “I am going to recommend...that this be mandatory for all first semester PhD students.”
Promotes discussion of research ethics
“This prompted a good discussion! These issues come up all the time.”
Research ethics cases
“Using real life research examples was extremely helpful.” “I enjoyed the use of case studies to illustrate the topics being discussed. They were very helpful and useful in driving home the concept.”
Comparison with other RCR training
“reinforced the course material” “I like ‘live’ training better than on-line.” “Nice complement to CITI training. I really liked seeing the standard conflict of interest management plan.”
Table 2. Positive responses to RCR workshop characteristics.
degree (68%), reflecting the specific context of the postdoctoral training program. Between May 2012 and December 2013, 65 additional RCR workshops were presented as additional speakers were recruited (Table 1). Overall in both pilot and regular RCR workshops, 717 individual researchers have attended a total of 1627 hours of in-person training. A majority (57%) attended a single workshop and 98% attended eight or fewer workshops. By gaining access to multiple campus venues, at varying weekday times that fit researchers’ availability, and offering continuing education credit, we have attracted an interdisciplinary group of attendees. A majority of attendees were affiliated with the University of Pittsburgh, School of Medicine or other Health Sciences affiliation (82%), although other nonhealth science disciplines were also represented (18%). The value of RCR Center programs to the institution is enhanced by the diversity of research personnel served by the program. These include graduate students and postdocs who are completing their training, graduate students and postdocs who have funding that mandates a specific type of training program (e.g., who are funded by NIH), advanced students and junior faculty who are preparing an individual research training grant application requiring a specific RCR training plan, faculty mentors responsible for exposing their students and junior colleagues to research ethics issues, and training grant directors who are responsible for developing and implementing a formal RCR training plan for their trainees. Workshop participants included not only junior faculty and postdoctoral fellows, but also graduate students, medical students and undergraduate research students, and research staff and coordinators. Overall, the largest group of attendees were those without a doctoral degree (n = 387; 54%), many of whom were not explicitly seeking NIH mandated training. Presenters of workshops were recruited from professional networks of the RCR Center director and colleagues. Investigators with experience and interest in specific research ethics topics were approached individually by the Center director and invited to prepare a workshop. Presenters were also asked for names of other potential recruits, facilitating campus-wide snowball type recruitment of potential speakers that were interested and enthusiastic about RCR, but who may not have previously had an opportunity to present on the topic. The director is also available for working together with interested presenters in building new workshops, suggesting avenues to increase audience participation and developing and editing case studies for discussion. Workshop 514
VOLUME 7 • ISSUE 6
presenters receive written and quantitative evaluations and are assisted in documenting their service to the RCR Center with an annual letter. A total of 73 workshops were presented between October 2011 and December 2013 by 32 different speakers. There were 23 faculty members from the Schools of Medicine, Dental Medicine, Arts and Sciences, Nursing, Pharmacy, Public Health, and Social Work. Twelve of these were repeat presenters, demonstrating their commitment to the RCR Center programs. Other speakers were staff from the Research Conduct and Compliance Office, the Institutional Review Board, the Health Sciences Library System, and CTSI. RCR workshops: evaluation Pilot workshops (n = 8) were evaluated on an individual basis. Attendees reported increased likelihood of thinking more critically about research ethics, changing their behavior, and meeting future RCR challenges. Overall the pilot workshops were well received (80.6 average rating on a 0 (disagree)–100 (agree) scale, in response to “The time I spent in this training program was valuable.”). Based on these results, we determined that the topics, speakers, and hour-long format provided a feasible delivery method for RCR training. In the first several months of regular Center programs, limited evaluation questions were asked. The most relevant was “To what degree did the lecture contribute to your learning and understanding of the subject matter?” which received an average score of 5 on a 0–6 scale (0 = not at all, 6 = to a great degree). Between July and December 2013, workshops received an average overall rating of 4.83 (n = 26), between “good” and “very good” on a scale of 0 (very poor)–6 (excellent). Conclusions and recommendations for RCR training programs A flexible program of RCR Workshops can be used to meet research ethics training needs where individual faculty may not be able to provide such instruction either because of a lack of time or familiarity with the research ethics literature. In a survey of 3,500 graduate faculty, only 59% of faculty had discussed scientific misconduct policies with their students and only 42% had worked with student to prepare human or animal subject protocols.8 These gaps may be addressed at least in part by trainee access to institution-wide RCR programs. Senior research staff members serve as professional role models for junior.7 The WWW.CTSJOURNAL.COM
Schmidt et al. Evolution of an Innovative RCR Program n
inclusion of these staff members in RCR training programs can be an effective approach to complement and enhance the influence of the informal curriculum of research ethics that dominates the experience of trainees in research environments. Based on our experience, we suggest that institutions with large populations of research trainees could address research ethics training gaps with a formalized, carefully structured program of RCR workshops. Core research ethics topics covered in RCR workshops are an important resource, especially for trainees with less than optimal mentoring.9 We recognize that researchers have diverse backgrounds in research ethics training, and the RCR Center approach allows trainees to choose topics that best fit their needs for instruction by using a customizable program of independently presented workshops. Our recommendations reflect research on stakeholders in our unique university setting. Not every research community will face a similar diversity of needs and experience. Our approach to RCR training addresses the futility of attempting to design instruction relevant to disparate disciplines within the context of a single university-wide ethics core course.10 In a typical research community, discipline-specific RCR instruction can and should be supported within existing departmental or other academic units.7 Face-to-face research ethics training through the RCR Center provides the logical next step for incorporating general ethical principles into discussion of RCR practices. Reinforced with general knowledge gained through online modules and in person training from RCR workshops, researchers are advised and supported in continuing their research ethics training within their disciplinary units and investigative teams. In our program, we include PIs as speakers and we saw that PIs attended training sessions as well.7 Opening the training to all, and ensuring that senior faculty are involved in presenting these workshops are the beginning steps toward promoting attention to RCR at all levels of scientific investigation.1 It is critically important in implementing a program of this type to maintain sensitivity to the needs of the local trainee population, avoid duplication of training effort, and gain credibility for RCR programs. The application of our findings in a smaller university, or in a university populated largely by non-PHS funded researchers could be very different. For institutions without a large community of research trainees or a lack of institutional funding, the primary challenge would be creating critical mass
WWW.CTSJOURNAL.COM
for a community of RCR learners that could be served by an RCR Center. Expanding RCR training across the university is in its early stages at the University of Pittsburgh. There are some challenges in developing appropriate and targeted approaches to RCR training for disciplines outside the traditional biomedical focus of RCR.10 We have begun to address these challenges through incorporation of workshop topics at the boundary of biomedical and social science research (such as our workshop on developing research collaborations with community agencies) and workshop topics of general interest (mentoring/teaching, managing conflict of interest; Table 1). A significant number of trainees from outside the health sciences disciplines are already taking advantage of our generalized RCR workshops. Acknowledgments
Funding for the RCR Training Center is provided by National Institutes of Health through Grant Number UL1TR000005 Financial Support
National Institutes of Health award UL1TR000005 References
1. Geller G, Boyce A, Ford DE, Sugarman J. Beyond “compliance”: the role of institutional culture in promoting research integrity. Acad Med. 2010; 85: 1296–1302. 2. DuBois JM, Schilling DA, Heitman E, Steneck NH, Kon AA. Instruction in the responsible conduct of research: an inventory of programs and materials within CTSAs. Clin Transl Sci 2010; 3: 109–111. 3. Plemmons DK, Kalichman MW. Reported goals of instructors of responsible conduct of research for teaching of skills. J Empir Res Hum Res Ethics 2013; 8: 95–103. 4. Barnes BE, Friedman CP, Rosenberg JL, Russell J, Beedle A, Levine AS. Creating an infrastructure for training in the responsible conduct of research: the University of Pittsburgh’s experience. Acad Med 2006; 81: 119–127. 5. Fischer BA, Zigmond MJ. Promoting responsible conduct in research through “survival skills” workshops: some mentoring is best done in a crowd. Sci Eng Ethics 2001; 7: 563–587. 6. Kalichman MW. Overview: underserved areas of education in the responsible conduct of research: authorship. Sci Eng Ethics 2011; 17: 335–339. 7. Peiffer AM, Hugenschmidt CE, Laurienti PJ. Ethics in 15 min per week. Sci Eng Ethics 2011; 17: 289–297. 8. Titus SL, Ballou JM. Ensuring PhD development of responsible conduct of research behaviors: who’s responsible? Sci Eng Ethics 2014; 20: 221–235. 9. Alfredo K, Hart H. The university and the responsible conduct of research: who is responsible for what? Sci Eng Ethics 2011; 17: 477–457. 10. Bulger RE, Heitman E. Expanding responsible conduct of research instruction across the university. Acad Med 2007; 82: 876–878.
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Keywords: ethics, methodology, appropriateness Introduction
Going beyond compliance to promote a better understanding of basic principles of research integrity is the ultimate goal for research ethics training.1 Recent changes in requirements for responsible conduct of research (RCR) training by the National Institutes of Health (NIH) have created a demand for in-person interactive research ethics training that may not be easily met in existing educational environments. Although universities have acknowledged the need for appropriate, accessible instruction in RCR, there are barriers to the effective large scale delivery of in-person experiences. Results from a recent survey of institutions receiving CTSA funding demonstrated that across sites there is an alarming lack of coherence in the planning and objectives of RCR training programs, as well as a lack of unique, tailored RCR training materials across universities.2 In designing a university-wide program of instruction in the RCR, we pursued a discussion-based approach that could promote enhanced recognition of the nuances of ethical reasoning through interactive case discussion. We aimed to make face-toface instruction accessible to the research community at large, so that biomedical and psychosocial researchers would integrate RCR into their daily professional lives.3 The RCR Center is a novel institutional level response to the ongoing need for improvement in the development and in-person delivery of RCR training, evolving from existing and previous instructional models to a flexible system of interactive workshops, presented by members of the local research community, and highly accessible to research investigators, trainees, and staff. Foundation for RCR Center Program Development
Before the initiation of the RCR Center program, the University of Pittsburgh had previously developed and implemented a comprehensive online system of core research ethics courses for researchers and trainees.4 Online programs, including the Internet-based Studies in Education and Research, Research Practice Fundamentals, and Collaborative Institutional Training Initiative have been employed to deliver online research integrity education on a wide reaching scale.4 Research personnel complete and maintain training certification through these centralized systems. Although online modules provide required instruction,
they do not provide an engaging format for learning and cannot address the need for in-person interactive training in RCR. The University of Pittsburgh Survival Skills and Ethics program was originally developed to address early career development training needs, and secondarily to address interactive RCR training needs.5 Career development and research ethics discussion based training was provided primarily to health sciences trainees and junior faculty through intensive all day career development and ethics workshops held on Saturdays.5 Lunch was provided for attendees and RCR topics were addressed informally during the lunch hour, following the morning career development program. Building on the university-wide model of online training and the interactive format of the Survival Skills and Ethics Program, we developed the RCR Center training program. An advisory group consisting of local ethicists, instructors, and experts in research ethics was consulted to discuss potential issues in implementing an interactive, large scale RCR program. Through consultation with local ethics faculty and experienced training grant investigators, we identified the scope of training needs of the audience, including timing of workshops, locations, as well as the publicity necessary to generate attendance. A pilot program of core RCR workshop presentations was developed (Table 1), sponsored by CTSI, and presented to postdoctoral trainees in the Department of Psychiatry. The RCR Center Training Program Model
Lessons learned from the pilot program allowed us to finetune the RCR workshops and develop the current program of more than 30 distinct 1 hour workshops that are now available to the University of Pittsburgh clinical research community (Table 1). Individual workshops begin with a clear statement of specific learning objectives. Recruited speakers give a didactic presentation of 25–30 minutes in length that often incorporates audience response facilitated by audience response technology (Turning Technologies, Youngstown, OH, USA). Presenters are asked to focus on ethics concerns and research practices as they are currently implemented at the University of Pittsburgh as well as more widely relevant RCR issues. Case-based discussion or question and answer with the workshop presenter(s) fills the
Univ. of Pittsburgh CTSI, Forbes Tower, Suite 7057, Atwood & Sennott Street, Pittsburgh, PA 15260, USA; 2University of Pittsburgh, School of Medicine, M240 Scaife Hall 3550, Terrace Street, Pittsburgh, PA 15261, USA; 3Children’s Hospital of Pittsburgh 4401 Penn Ave, Pittsburgh, PA 15224, UPMC Health Plan, US Steel Tower, 600 Grant Street, Pittsburgh, PA 15219, USA; 4UPMC Health Plan, Pittsburgh, Pennsylvania, USA. 1
Correspondence: Karen Schmidt ([email protected]) DOI: 10.1111/cts.12169
512
VOLUME 7 • ISSUE 6
WWW.CTSJOURNAL.COM
Schmidt et al. Evolution of an Innovative RCR Program n
Core instructional RCR topics Identifying issues in the responsible conduct of research Implementing ethical conduct of human participant research Strategies for effective teaching and mentoring of students Making the most of a mentoring relationship: mentee responsibilities Performing animal research: the do's and don’ts Responsible use of animals in biomedical research Inviting community participation in your research: educational and research ethics Managing conflict of interest: protecting the integrity of research Developing and optimizing collaborative research interactions Reviewing scientific colleagues: responsibilities of peer review An author's responsibilities: publication and authorship Specialized RCR topics Human participant research: creating an ethical mindfulness Demonstrating respect and enhancing trust: mastering the informed consent process Working toward solutions in IRB protocol design Informing patients about their data from clinical research studies: clinical, ethical, and measurement considerations Understanding research participant perspectives: reducing burden in clinical research Societal responsibility: communicating research to the public Working with community agencies to promote a cooperative research agenda Table 1. RCR workshop topics.
remaining part of each hour long workshop. Workshop attendance is limited to thirty-five participants and discussion is facilitated by RCR Center personnel, maximizing face-to-face interaction of participants and presenters. Administrative features of the workshops that have proven to be popular with attendees include frequent, flexible scheduling and the provision of continuing education credit (CEU or CME). Workshops are offered on different days of the week and at convenient times and places. Attendees register online for individual 1 hour workshops and there are no prerequisites; researchers can attend as many or as few sessions as they like. Incorporating audience response technology has allowed us to collect anonymous evaluations quickly and easily in the final 5 minutes of each program. Attendees are also encouraged to provide additional written feedback (Table 2). RCR Center programs are developed and run by a full time, doctoral level administrator whose effort is dedicated to developing RCR workshops, recruiting expert speakers, maintaining attendance and evaluation data, and monitoring workshop quality. Support for this position is provided by funding from a CTSA award (UL1TR000005). Supporting a full time director for the RCR Center has enabled us to recruit expert speakers from across the health sciences, offering wider perspectives for our audience. Attendance is maintained and letters certifying training are prepared by the Center at researchers’ request. Continuing education credit has also been made available through an arrangement between the Center and the Continuing Education Office. By developing a series of a la carte 1 hour RCR workshops, we have created a scalable model for disseminating in-person RCR training to the research community in a flexible, economical manner. WWW.CTSJOURNAL.COM
RCR workshops: research ethics topics and individualized RCR training programs Year round workshop scheduling allows the RCR center to present multiple workshops on nine core RCR topics, often with presenters from varying disciplines and perspectives. In 2013, for example, workshops on human participant research were offered 16 times by six different speakers. Although providing the basics for research trainees that are seeking to fulfill their requirements, we acknowledge that the scope of RCR training extends beyond the limited list of topics originally proposed by the Department of Health and Human Services (HHS).6 Our training program has evolved, including additional specialized topics, based on comments from workshop attendees and interest from local research ethics experts (Table 1). Researchers may choose to build mini curricula of targeted RCR topics through attendance at a series of four RCR center workshops with research integrity, human participant, or bench science focus. The RCR Center director is available for consultation on the suitability of workshops for individual trainees and workshop attendees are encouraged to build their own training programs, incorporating workshops into their overall RCR training plans. Through the implementation of an institutional RCR Center, wider perspectives on individual departmental or lab based RCR educational programs can also be offered.7 Dedicated RCR training personnel can discuss available options and assist in customizing RCR training plans to include both local and institutional training. RCR workshops: characteristics of attendees and presenters During the pilot program, eight RCR presentations were given to a group of 101 attendees, with a majority having attained a doctoral VOLUME 7 • ISSUE 6
513
Schmidt et al. Evolution of an Innovative RCR Program n
RCR workshop characteristic
Attendee responses
Range of topics
“This RCR program has been really comprehensive.” “You have covered many of the topics that I have needed.”
Meets needs for required training
“This surpassed my expectations.” “I am going to recommend...that this be mandatory for all first semester PhD students.”
Promotes discussion of research ethics
“This prompted a good discussion! These issues come up all the time.”
Research ethics cases
“Using real life research examples was extremely helpful.” “I enjoyed the use of case studies to illustrate the topics being discussed. They were very helpful and useful in driving home the concept.”
Comparison with other RCR training
“reinforced the course material” “I like ‘live’ training better than on-line.” “Nice complement to CITI training. I really liked seeing the standard conflict of interest management plan.”
Table 2. Positive responses to RCR workshop characteristics.
degree (68%), reflecting the specific context of the postdoctoral training program. Between May 2012 and December 2013, 65 additional RCR workshops were presented as additional speakers were recruited (Table 1). Overall in both pilot and regular RCR workshops, 717 individual researchers have attended a total of 1627 hours of in-person training. A majority (57%) attended a single workshop and 98% attended eight or fewer workshops. By gaining access to multiple campus venues, at varying weekday times that fit researchers’ availability, and offering continuing education credit, we have attracted an interdisciplinary group of attendees. A majority of attendees were affiliated with the University of Pittsburgh, School of Medicine or other Health Sciences affiliation (82%), although other nonhealth science disciplines were also represented (18%). The value of RCR Center programs to the institution is enhanced by the diversity of research personnel served by the program. These include graduate students and postdocs who are completing their training, graduate students and postdocs who have funding that mandates a specific type of training program (e.g., who are funded by NIH), advanced students and junior faculty who are preparing an individual research training grant application requiring a specific RCR training plan, faculty mentors responsible for exposing their students and junior colleagues to research ethics issues, and training grant directors who are responsible for developing and implementing a formal RCR training plan for their trainees. Workshop participants included not only junior faculty and postdoctoral fellows, but also graduate students, medical students and undergraduate research students, and research staff and coordinators. Overall, the largest group of attendees were those without a doctoral degree (n = 387; 54%), many of whom were not explicitly seeking NIH mandated training. Presenters of workshops were recruited from professional networks of the RCR Center director and colleagues. Investigators with experience and interest in specific research ethics topics were approached individually by the Center director and invited to prepare a workshop. Presenters were also asked for names of other potential recruits, facilitating campus-wide snowball type recruitment of potential speakers that were interested and enthusiastic about RCR, but who may not have previously had an opportunity to present on the topic. The director is also available for working together with interested presenters in building new workshops, suggesting avenues to increase audience participation and developing and editing case studies for discussion. Workshop 514
VOLUME 7 • ISSUE 6
presenters receive written and quantitative evaluations and are assisted in documenting their service to the RCR Center with an annual letter. A total of 73 workshops were presented between October 2011 and December 2013 by 32 different speakers. There were 23 faculty members from the Schools of Medicine, Dental Medicine, Arts and Sciences, Nursing, Pharmacy, Public Health, and Social Work. Twelve of these were repeat presenters, demonstrating their commitment to the RCR Center programs. Other speakers were staff from the Research Conduct and Compliance Office, the Institutional Review Board, the Health Sciences Library System, and CTSI. RCR workshops: evaluation Pilot workshops (n = 8) were evaluated on an individual basis. Attendees reported increased likelihood of thinking more critically about research ethics, changing their behavior, and meeting future RCR challenges. Overall the pilot workshops were well received (80.6 average rating on a 0 (disagree)–100 (agree) scale, in response to “The time I spent in this training program was valuable.”). Based on these results, we determined that the topics, speakers, and hour-long format provided a feasible delivery method for RCR training. In the first several months of regular Center programs, limited evaluation questions were asked. The most relevant was “To what degree did the lecture contribute to your learning and understanding of the subject matter?” which received an average score of 5 on a 0–6 scale (0 = not at all, 6 = to a great degree). Between July and December 2013, workshops received an average overall rating of 4.83 (n = 26), between “good” and “very good” on a scale of 0 (very poor)–6 (excellent). Conclusions and recommendations for RCR training programs A flexible program of RCR Workshops can be used to meet research ethics training needs where individual faculty may not be able to provide such instruction either because of a lack of time or familiarity with the research ethics literature. In a survey of 3,500 graduate faculty, only 59% of faculty had discussed scientific misconduct policies with their students and only 42% had worked with student to prepare human or animal subject protocols.8 These gaps may be addressed at least in part by trainee access to institution-wide RCR programs. Senior research staff members serve as professional role models for junior.7 The WWW.CTSJOURNAL.COM
Schmidt et al. Evolution of an Innovative RCR Program n
inclusion of these staff members in RCR training programs can be an effective approach to complement and enhance the influence of the informal curriculum of research ethics that dominates the experience of trainees in research environments. Based on our experience, we suggest that institutions with large populations of research trainees could address research ethics training gaps with a formalized, carefully structured program of RCR workshops. Core research ethics topics covered in RCR workshops are an important resource, especially for trainees with less than optimal mentoring.9 We recognize that researchers have diverse backgrounds in research ethics training, and the RCR Center approach allows trainees to choose topics that best fit their needs for instruction by using a customizable program of independently presented workshops. Our recommendations reflect research on stakeholders in our unique university setting. Not every research community will face a similar diversity of needs and experience. Our approach to RCR training addresses the futility of attempting to design instruction relevant to disparate disciplines within the context of a single university-wide ethics core course.10 In a typical research community, discipline-specific RCR instruction can and should be supported within existing departmental or other academic units.7 Face-to-face research ethics training through the RCR Center provides the logical next step for incorporating general ethical principles into discussion of RCR practices. Reinforced with general knowledge gained through online modules and in person training from RCR workshops, researchers are advised and supported in continuing their research ethics training within their disciplinary units and investigative teams. In our program, we include PIs as speakers and we saw that PIs attended training sessions as well.7 Opening the training to all, and ensuring that senior faculty are involved in presenting these workshops are the beginning steps toward promoting attention to RCR at all levels of scientific investigation.1 It is critically important in implementing a program of this type to maintain sensitivity to the needs of the local trainee population, avoid duplication of training effort, and gain credibility for RCR programs. The application of our findings in a smaller university, or in a university populated largely by non-PHS funded researchers could be very different. For institutions without a large community of research trainees or a lack of institutional funding, the primary challenge would be creating critical mass
WWW.CTSJOURNAL.COM
for a community of RCR learners that could be served by an RCR Center. Expanding RCR training across the university is in its early stages at the University of Pittsburgh. There are some challenges in developing appropriate and targeted approaches to RCR training for disciplines outside the traditional biomedical focus of RCR.10 We have begun to address these challenges through incorporation of workshop topics at the boundary of biomedical and social science research (such as our workshop on developing research collaborations with community agencies) and workshop topics of general interest (mentoring/teaching, managing conflict of interest; Table 1). A significant number of trainees from outside the health sciences disciplines are already taking advantage of our generalized RCR workshops. Acknowledgments
Funding for the RCR Training Center is provided by National Institutes of Health through Grant Number UL1TR000005 Financial Support
National Institutes of Health award UL1TR000005 References
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