1. RCR Research Skills Workshop March 21, 2014 How to Create a Plan for RCR Education for your NIH Fellowship or 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. 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. While science educators have always intended to teach good scientific practice, mandatory RCR education resulted from a series of such challenges. Why is there a requirement for instruction in RCR? The Irony of Developing Ethical Standards and Policy

5. Threats and Scandal Lead to Ethical Discourse and Research Policy Publicized abuses in research with human subjects Publicized abuses in research with human subjects Publicized abuses in research with animals Publicized abuses in research with animals Genetic research and research with microbes Genetic research and research with microbes Misconduct (“fraud”) in federally funded research Misconduct (“fraud”) in federally funded research Computerized databases and concern for privacy Computerized databases and concern for privacy Financial conflicts of interest Financial conflicts of interest 1980s > Concern about the integrity of science 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. 1989 - IOM called for “formal instruction in good research practices” 1989 - NIH required NSRA training grants to include “plans for instruction in the responsible conduct of research” 1995 - HHS Commission on Research Commission urged NIH tocertify that institutions had an instructional program on responsible conduct before providing research funding 1999 – HHS/ORI issued requirement for institutions to provide RCR instruction to ALL grant-funded students, faculty, staff Since the 1980s, professional societies and governmental agencies have promoted education as the key to scientific integrity.

8. 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 This list was SUPERCEDED in November 2009

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

10. Compliance-only orientation toward RCR instruction were pervasive after 2001. Training often limited to online programs with no interaction among trainees or trainees and faculty. Training often limited to online programs with no interaction among trainees or trainees and faculty. Often referred to as “ethics compliance testing” Often referred to as “ethics compliance testing” Research showed that RCR education did not affect behavior in demonstrable ways Research showed that RCR education did not affect behavior in demonstrable ways Rates of research misconduct did not fall and sometimes increased. Rates of research misconduct did not fall and sometimes increased. In 2007 the America Competes Act required NSF to require RCR instruction for all funded trainees. In 2007 the America Competes Act required NSF to require RCR instruction for all funded trainees.

11. 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 - Frequency of instruction - Frequency of instruction Faculty to contribute to formal and informal instruction Faculty 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 updated its requirement on RCR instruction in 2009, with extensive changes.

12. NIH’s 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 scientist as a member of society, contemporary ethical issues in research, and environmental and societal impacts of research The scientist as a member of society, contemporary ethical issues in research, and environmental and societal impacts of research

13. 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 May session is open to post-docs and K-award holders but may be too basic and lab oriented 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 May session is open to post-docs and K-award holders but may be too basic and lab oriented for many. MSCI course “Research Ethics and Scientific Integrity” (1 credit hour, tuition fee) in May provides a comprehensive mid-level and advanced 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 and advanced 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 through the (www.citi.org) or the VUMC IRB’s “training” webpage. Satisfactory as one introductory component; NOT acceptable by itself. CITI RCR course: online RCR modules available 24/7 to VUMC faculty, staff, and trainees through the (www.citi.org) or the VUMC IRB’s “training” webpage. Satisfactory as one introductory component; NOT acceptable by itself.www.citi.org Other ad hoc events approved by VICTR for RCR credit; posted through STARBRITE, typically 1 hour, various topics; register your attendance with a code number after session https://www.mc.vanderbilt.edu/starbrite/education/schedule.html Other ad hoc events approved by VICTR for RCR credit; posted through STARBRITE, typically 1 hour, various topics; 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 Other program-oriented events not captured in STARBRITE Other program-oriented events not captured in STARBRITE RCR instruction at VUMC :

14. 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. Policy on human and animal protections are a subset of the recommended subject areas and can be mentioned, BUT the training requirements for the IRB and IACUC are separate and do not “count” toward RCR education requirements. Policy on human and animal protections are a subset of the recommended subject areas and can be mentioned, BUT the training requirements for the IRB and IACUC are separate and do not “count” toward RCR education requirements. 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 you should demonstrate increasing leadership in RCR related to your discipline. Over the course of your award you should demonstrate increasing leadership in RCR related to your discipline. Which areas are important to YOUR work?

15. Objectives for your (advanced) RCR education plan 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 The more advanced you are in your career, the more you should comment on how you will teach others about RCR.

16. Your plan MUST address the five (5) aspects in “Instructional Components” (in any order): Your plan MUST address the five (5) aspects in “Instructional Components” (in any order): Format(s)Format(s) Substantial face-to-face discussions preferred Online instruction acceptable but not adequate alone Subject matterSubject matter NIH’s core areas build on ORI’s NIH’s core areas build on ORI’s Professional ethics, human protection, animal welfare not enough Professional ethics, human protection, animal welfare not enough Faculty participationFaculty participation Mentors and program faculty must be involved Mentors and program faculty must be involved Outsourced courses acceptable only as one component Outsourced courses acceptable only as one component DurationDuration Minimum of 8 contact hours Minimum of 8 contact hours Frequency of instructionFrequency of instruction Not a one-time event, but continuous education Not a one-time event, but continuous education http://grants.nih.gov/grants/guide/notice-files/not-od-10-019.html

17. Personalize your plan as much as possible, tailoring it to your program, area of research, and specific interests. Do Do not use someone else’s “successful” plan without making it reflect your field, your work, your mentors, and your goals. Do Do not use a University or Department template without revisions that make it reflect your field, your work, your mentors, and your goals. Do not include anything you do not personally know to be available to you. NIH’s 2009 Update was specifically aimed at changing “what we have always done” to promote education that is more meaningful for trainee and their mentors.

18. Your narrative should spell out: Past instruction : What education/training/mentoring did you receive as Undergraduate/ Summer research student Medical student or pre-dissertation grad student Resident in research rotations/ Prior postdoctoral fellowship Current and ongoing activities: What are you doing in your current program? What does your program offer/require? What are you doing on your own? Future training for yourself: What do you recognize yourself to need? Formal RCR instruction in an appropriate form at VUMC RCR-related sessions at national meetings Future participation in others’ mentoring and education YOU as presenter of your growing knowledge to others

19. Training in the Responsi ble Conduct of Research - sample narrative format Past training: My introduction to the responsible conduct of research (RCR) came as a {high school/ undergraduate/medical /graduate student in [subject] at {School}, when I was formally taught {topic(s)/ Past training: My introduction to the responsible conduct of research (RCR) came as a {high school/ undergraduate/medical /graduate student in [subject] at {School}, when I was formally taught {topic(s)/ standards/ good practices in {field} by faculty in {class/department}. In the first year of my {graduate/fellowship} training in {program} at Vanderbilt, I took part in the day-long (RCR) workshop provided by the office of Biomedical Research Education and Training. This program is taught by Drs. Roger Chalkley, Senior Executive Dean, James Patton, Director of the Interdisciplinary Graduate Program Director, and Elizabeth Heitman, head of RCR education for the Vanderbilt Institute for Clinical and Translational Research (VICTR). It introduces trainees to 1) VUMC’s and NIH’s policies on research misconduct and conflicts of interest; 2) ethical aspects and policies on research with human and animal subjects; 3) data management, record keeping, and intellectual property; 4)responsible authorship and review of scientific publications and grants, and 5) research with dual-use potential. Prior to beginning work with my mentor, Dr. {name}. I also completed the Collaborative Institutional Training Initiative (CITI) modules on the protection of human subjects required by VUMC for clinical researchers, the online NIH course “Human Participant Protections: Education for Research Teams”, and the CITI RCR modules for biomedical investigators (see certificates in Appendix#?).” Current and ongoing activities: This year I have attended 4 sessions on research integrity and ethical issues in {topics} approved for RCR credit by VICTR and tracked its StarBRITE system (https://starbrite.vanderbilt.edu/education/schedule.html (see Appendix #). {Name the sessions, their presenters, and the time spent. https://starbrite.vanderbilt.edu/education/schedule.html Future activities: During the period of my K award, 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 foundational knowledge of core areas of RCR and advanced knowledge of responsible practices in data management and collaboration. {In the following year, I will take part in MSCI’s two-hour seminar on advanced topics in responsible publication, and the CRC’s seminar on conflict of interest, and collaboration with industry. As a fellow I will also take part in the Newman Society’s (Translational Bridge program’s) seminar series on professional development and RCR, including topics of mentoring, peer review, and misconduct.} Over the period of my {F/K} award I will attend other independent events in RCR education approved by VICTR, and as relevant sessions at the annual meeting of {your professional society}. Additionally, 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}. SAMPLE ONLY

20. The VICTR Ethics Core provides consultation on RCR instruction plans – just call or write (preferably before your crunch time). Well before you start planning your application, we can help you build an educational history to use in your application. Elizabeth Heitman, PhD Center for Biomedical Ethics and Society 2525 West End Avenue, Suite 400 (615) 936-2686 elizabeth.heitman@vanderbilt.edu