1. RCR Research Skills Workshop May 28, 2010 How to Create a Plan for RCR Education for your Career Development Award Elizabeth Heitman, PhD Vanderbilt University Medical Center Center for Clinical and Research Ethics

2. Objectives Review the origins of NIH’s requirement for instruction in the responsible conduct of research Review the origins of NIH’s requirement for instruction in the responsible conduct of research Examine the November 2009 criteria by which RCR education plans will be reviewed Examine the November 2009 criteria by which RCR education plans will be reviewed Consider how to define your individual needs for RCR education under a Career Development Award Consider how to define your individual needs for RCR education under a Career Development Award Examine formal options for RCR instruction at VUMC and how to describe your own innovative activities Examine formal options for RCR instruction at VUMC and how to describe your own innovative activities

3. NIH Peer Review Criteria at a Glance for Parent Announcements: Fellowship (F30, F31, F32, F33), Career Development (K01, K02, K07, K08, K23, K24, K25, K99), and Training Grants (T32) Training in the Responsible Conduct of Research. For applications submitted for due dates ON OR AFTER January 25, 2010. Reviewers will evaluate plans for instruction in responsible conduct of research as well as the past record of instruction in responsible conduct of research, where applicable. Reviewers will specifically address the five Instructional Components (Format, Subject Matter, Faculty Participation, Duration, and Frequency of instruction), as detailed in NOT-OD- 10-019). The review of this consideration will be guided by the principles set forth in NOT-OD-10-019. Plans and past record will be rated as ACCEPTABLE or UNACCEPTABLE. NOT-OD- 10-019NOT-OD- 10-019 http://grants.nih.gov/grants/peer/guidelines_general/Review_Criteria_at_a_glance.pdf http://grants.nih.gov/grants/peer/guidelines_general/Review_Criteria_at_a_glance.pdf http://grants.nih.gov/grants/peer/guidelines_general/Review_Criteria_at_a_glance.pdf

4. No one discusses ethical norms and principles when things are “normal” and/or going well. Most professional standards and governmental policy related to research have resulted from new technological threats, new barriers between new specialty fields, and professional scandals where investigators broke unwritten rules. Irony of Developing Ethical Standards and Policy

5. Threats and Scandal Lead to Ethical Discourse and Research Policy Research with human subjects Research with human subjects Research with animals Research with animals Genetic research and research with microbes Genetic research and research with microbes Misconduct (“fraud”) Misconduct (“fraud”) Computerized databases and privacy Computerized databases and privacy Financial conflicts of interest Financial conflicts of interest 1980s > Concern about the integrity of science

6. Congressional hearings on research fraud led Congress to seek increased federal control over research in the late 1980s: Creation of regulatory and oversight agenciesCreation of regulatory and oversight agencies NIH Office of Scientific Integrity (1989) DHHS Office of Scientific Integrity Review (1989) Merged as Office of Research Integrity (1992) Merged as Office of Research Integrity (1992) Formalization of standards (with professional societies)Formalization of standards (with professional societies) Promotion of education on new policies and ethical standards of practice Promotion of education on new policies and ethical standards of practice

7. IOM called for universities to provide “formal instruction in good research practices” (1989) IOM called for universities to provide “formal instruction in good research practices” (1989) NIH required schools seeking National Research Service Award training grants to have plans for instruction in the responsible conduct of research” for trainees (1989) NIH required schools seeking National Research Service Award training grants to have plans for instruction in the responsible conduct of research” for trainees (1989) Professional organizations and research agencies promoted education, rather than oversight, as the key to scientific integrity.

8. NAS called for universities to have “programs that foster faculty and student awareness of... the integrity of the research process” (1992) NAS called for universities to have “programs that foster faculty and student awareness of... the integrity of the research process” (1992) DHHS Commission on Research Integrity urged NIH to certify that institutions had an educational program on RCR prior to providing federal research funding (1995) DHHS Commission on Research Integrity urged NIH to certify that institutions had an educational program on RCR prior to providing federal research funding (1995) DHHS/OHRP announced new requirements for education of IRB members and human studies researchers, focusing on the protection of research participants (1999) DHHS/OHRP announced new requirements for education of IRB members and human studies researchers, focusing on the protection of research participants (1999) Calls for Education in Research Integrity

9. DHHS/ORI announced require for “research institutions to provide training in the responsible conduct of research to all staff engaged in research or research training with PHS funds” (1999) DHHS/ORI announced require for “research institutions to provide training in the responsible conduct of research to all staff engaged in research or research training with PHS funds” (1999) ORI, the Office of Public Health and Science, Office of Human Research Protections, and Office for Laboratory Animal Welfare proposed DHHS Policy on Instruction in the Responsible Conduct of Research and called for public comment (2000) ORI, the Office of Public Health and Science, Office of Human Research Protections, and Office for Laboratory Animal Welfare proposed DHHS Policy on Instruction in the Responsible Conduct of Research and called for public comment (2000) Calls for Education Programs (cont.)

10. Public comments indicated support for educational efforts, but also concern over cost and other burdens of implementation cost and other burdens of implementation scope of staff to receive training scope of staff to receive training prescriptive tone of policy prescriptive tone of policy short phase-in period short phase-in period possible future additions to core subjects possible future additions to core subjects ambiguity regarding what was mandatory ambiguity regarding what was mandatory Calls for Education Programs (cont.)

11. ORI’s Core Instructional Areas in RCR (2000) Data management Data management Mentor/trainee responsibilities Mentor/trainee responsibilities Publication and authorship Publication and authorship Peer review Peer review Collaborative science Collaborative science Research with human beings Research with human beings Research involving animals Research involving animals Research misconduct Research misconduct Conflict of interest and commitment Conflict of interest and commitment

12. Congressional and professional criticism prompted ORI to withdraw its universal RCR educational policy in February 2001 Many institutions had already begun to expand their training grant RCR programs to all researchers. Many professional societies, research organizations, and government agencies had already begun to articulate standards and formal policies. Some institutions implemented universal RCR training for compliance standards “just in case”.

13. RCR is an essential part of research training RCR is an essential part of research training Appropriate instruction should be provided throughout training Appropriate instruction should be provided throughout training RCR instruction an essential part of grant proposals; new review criteria: RCR instruction an essential part of grant proposals; new review criteria: Format, Subject Matter, Faculty Participation, Duration, and Frequency of instruction Faculty encouraged to contribute to formal and informal instruction Faculty encouraged to contribute to formal and informal instruction Substantive contact time (8+ hours) expected Substantive contact time (8+ hours) expected Documented and monitored by program Documented and monitored by program NIH Update on RCR Instruction (2009)

14. Recommended topics in RCR (2009) Conflict of interest Conflict of interest Policies on research with humans and animals and safe laboratory practices Policies on research with humans and animals and safe laboratory practices Mentor/trainee responsibilities and relationships Mentor/trainee responsibilities and relationships Peer review Peer review Data acquisition, management, sharing and ownership Data acquisition, management, sharing and ownership Collaborative research, including with industry Collaborative research, including with industry Responsible authorship and publication Responsible authorship and publication Research misconduct and policies for handling it Research misconduct and policies for handling it The scientists as a member of society, contemporary ethical issues in research, and environmental and societal impacts of research The scientists as a member of society, contemporary ethical issues in research, and environmental and societal impacts of research

15. BRET RCR Orientation (very basic) in August and RCR Workshop (basic) in May provide introductory-level sessions (Lecture and case discussions) designed for new doctoral students. The sessions are open to post-docs and K-award holders with small registration fee but may be too basic for many. BRET RCR Orientation (very basic) in August and RCR Workshop (basic) in May provide introductory-level sessions (Lecture and case discussions) designed for new doctoral students. The sessions are open to post-docs and K-award holders with small registration fee but may be too basic for many. MSCI course “Research Ethics and Scientific Integrity” (1 credit hour, tuition fee) in May provides a comprehensive mid-level overview of RCR for post-doctoral clinical researchers with assigned readings and final exam. MSCI course “Research Ethics and Scientific Integrity” (1 credit hour, tuition fee) in May provides a comprehensive mid-level overview of RCR for post-doctoral clinical researchers with assigned readings and final exam. CITI RCR course, online RCR modules available 24/7 to VUMC faculty, staff, and trainees in relation to the CITI IRB course. Satisfactory as one introductory component; NOT acceptable by itself. CITI RCR course, online RCR modules available 24/7 to VUMC faculty, staff, and trainees in relation to the CITI IRB course. Satisfactory as one introductory component; NOT acceptable by itself. Other ad hoc RCR-related events posted through STARBRITE, typically 1 hour, various topic; register your attendance with a code number after session https://www.mc.vanderbilt.edu/starbrite/education/schedule.html Other ad hoc RCR-related events posted through STARBRITE, typically 1 hour, various topic; register your attendance with a code number after session https://www.mc.vanderbilt.edu/starbrite/education/schedule.html https://www.mc.vanderbilt.edu/starbrite/education/schedule.html RCR instruction at VUMC :

16. Plan RCR education that is meaningful to you and your future as an academic researcher in your field Plan RCR education that is meaningful to you and your future as an academic researcher in your field Human and animal subject protections and related policy are a subset of the recommended subject areas BUT both the IRB and IACUC have separate training requirements that don’t “count” toward RCR education. Human and animal subject protections and related policy are a subset of the recommended subject areas BUT both the IRB and IACUC have separate training requirements that don’t “count” toward RCR education. Build a program that is appropriate to YOUR career stage; You will be expected to have done SOMETHING already. Build a program that is appropriate to YOUR career stage; You will be expected to have done SOMETHING already. Over the course of your award demonstrate increasing leadership in RCR related to your discipline. Over the course of your award demonstrate increasing leadership in RCR related to your discipline. Which areas are important to YOUR work?

17. Objectives for your (advanced) RCR education plan Outline past groundwork, current activities, future training for your self, future sharing with / teaching others Know “how to’s” of good research in core areas relevant to your work Know “how to’s” of good research in core areas relevant to your work Know where to find institutional, professional, and federal policies in areas relevant to your work Know where to find institutional, professional, and federal policies in areas relevant to your work Know how to keep pace with changing standards of practice and controversies in your field Know how to keep pace with changing standards of practice and controversies in your field Be able to teach and advise on questions relevant to your field and especially to your own research Be able to teach and advise on questions relevant to your field and especially to your own research Develop ongoing activities for your colleagues and trainees Develop ongoing activities for your colleagues and trainees

18. Training in the Responsible Conduct of Research During the first year of my fellowship training in {program}, I took part in the Responsible Conduct of Research (RCR) orientation and subsequent day-long workshop provided by the office of Biomedical Research Education and Training at Vanderbilt. These two day-long sessions were designed to introduce trainees to 1) institutional and NIH policies regarding scientific misconduct and conflicts of interest; 2)ethical considerations of research involving human and animal subjects; 3)data management, record keeping, and intellectual property; 4)responsible authorship and review of scientific publications and grants. During my fellowship I also completed the Collaborative IRB Training Initiative (CITI) training modules on the protection of human subjects required by VUMC for clinical researchers, as well as the online NIH course “Human Participant Protections: Education for Research Teams.” Continuing education in research ethics is required by the Vanderbilt IRB in order to conduct studies with human participants, and I will take part in this training on an annual basis. Next year, as part of my Master of Science in Clinical Investigation program, I will complete the 1 credit-hour, graduate-level course “Research Ethics and Scientific Integrity”, taught by Dr. Elizabeth Heitman (see syllabus in Appendix #?). This course provides postdoctoral masters students with a solid foundational knowledge of core areas of RCR and as well as advanced knowledge of responsible practices in data management and collaboration. In the following year, I will take part in the MSCI program’s two-hour seminar on advanced topics in responsible authorship and publication, the CRC’s two-part seminar “How to Maintain Responsible Conduct in Research”, and the Newman Society’s lecture series on professional development (including topics of mentoring, peer review, and misconduct). Over the period of my K award I will prepare and present an annual departmental/divisional case conference or journal club session highlighting issues of RCR related to research on (YOUR TOPIC), and attend other independent opportunities in RCR education across the campus, as publicized and tracked by the Office of Research Support Services StarBRITE system (https://starbrite.vanderbilt.edu/education/schedule.html ). https://starbrite.vanderbilt.edu/education/schedule.html