RCR Research Skills WorkshopRCR Research Skills Workshop

March 21, 2014March 21, 2014

How to Create a Plan for RCR How to Create a Plan for RCR

Education for your NIH Fellowship or Education for your NIH Fellowship or

Career Development AwardCareer Development Award

Elizabeth Heitman, PhDElizabeth Heitman, PhDVanderbilt University Medical CenterVanderbilt University Medical Center

Center for Clinical and Research EthicsCenter for Clinical and Research Ethics

ObjectivesObjectives

• Review the origins of NIH’s requirement for Review the origins of NIH’s requirement for instruction in the responsible conduct of researchinstruction in the responsible conduct of research

• Examine the November 2009 criteria by which RCR Examine the November 2009 criteria by which RCR education plans will be reviewededucation plans will be reviewed

• Consider how to define your individual needs for Consider how to define your individual needs for RCR education under a Career Development AwardRCR education under a Career Development Award

• Examine formal options for RCR instruction at VUMC Examine formal options for RCR instruction at VUMC and how to describe your own innovative activitiesand how to describe your own innovative activities

NIH Peer Review Criteria at a Glancefor 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. Training in the Responsible Conduct of Research.

For applications submitted for due dates ON OR AFTER January For applications submitted for due dates ON OR AFTER January 25, 2010. Reviewers will evaluate plans for instruction in 25, 2010. Reviewers will evaluate plans for instruction in responsible conduct of research as well as the past record of responsible conduct of research as well as the past record of instruction in responsible conduct of research, where applicable. instruction in responsible conduct of research, where applicable. Reviewers will specifically address the five Instructional Reviewers will specifically address the five Instructional Components (Components (Format, Subject Matter, Faculty Participation, Format, Subject Matter, Faculty Participation, Duration, and Frequency of instructionDuration, and Frequency of instruction), as detailed in ), as detailed in NOT-OD-10-019). The review of this consideration will be guided ). The review of this consideration will be guided by the principles set forth in NOT-OD-10-019. Plans and past by the principles set forth in NOT-OD-10-019. Plans and past record will be rated as ACCEPTABLE or UNACCEPTABLE.record will be rated as ACCEPTABLE or UNACCEPTABLE.

http://grants.nih.gov/grants/peer/guidelines_general/Review_Criteria_at_a_glance.pdf

Most professional standards and governmental policy Most professional standards and governmental policy

related to research have resulted from new technological related to research have resulted from new technological

threats, new barriers between new specialty fields, and threats, new barriers between new specialty fields, and

professional scandals where investigators broke professional scandals where investigators broke

unwritten rules.unwritten rules.

While science educators have always intended to teach While science educators have always intended to teach

good scientific practice, mandatory RCR education good scientific practice, mandatory RCR education

resulted from a series of such challenges.resulted from a series of such challenges.

Why is there a requirement for instruction in RCR? Why is there a requirement for instruction in RCR? The Irony of Developing Ethical Standards and PolicyThe Irony of Developing Ethical Standards and Policy

Threats and Scandal Lead to Ethical Threats and Scandal Lead to Ethical Discourse and Research PolicyDiscourse and Research Policy

• Publicized abuses in research with human subjectsPublicized abuses in research with human subjects

• Publicized abuses in research with animalsPublicized abuses in research with animals

• Genetic research and research with microbesGenetic research and research with microbes

• Misconduct (“fraud”) in federally funded researchMisconduct (“fraud”) in federally funded research

• Computerized databases and concern for privacyComputerized databases and concern for privacy

• Financial conflicts of interestFinancial conflicts of interest

1980s >1980s > Concern about the integrity of scienceConcern about the integrity of science

Congressional hearings on research fraud led Congressional hearings on research fraud led

Congress to seek increased federal control over Congress to seek increased federal control over

research in the late 1980s:research in the late 1980s:

• Creation of regulatory and oversight agenciesCreation of regulatory and oversight agencies

NIH Office of Scientific Integrity (1989)NIH Office of Scientific Integrity (1989)

DHHS Office of Scientific Integrity Review (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 Promotion of education on new policies and ethical standards of practicestandards of practice

1989 - IOM called for “formal instruction in good research practices”1989 - IOM called for “formal instruction in good research practices”

1989 - NIH required NSRA training grants to include “plans for 1989 - NIH required NSRA training grants to include “plans for instruction in the responsible conduct of research”instruction in the responsible conduct of research”

1995 - HHS Commission on Research Commission urged NIH to1995 - HHS Commission on Research Commission urged NIH to certify certify that institutions had an instructional program on responsible that institutions had an instructional program on responsible conduct before providing research fundingconduct before providing research funding

1999 – HHS/ORI issued requirement for institutions to provide RCR 1999 – HHS/ORI issued requirement for institutions to provide RCR instruction to ALL grant-funded students, faculty, staff instruction to ALL grant-funded students, faculty, staff

Since the 1980s, professional societies and Since the 1980s, professional societies and governmental agencies have promoted governmental agencies have promoted educationeducation as the key to scientific integrity.as the key to scientific integrity.

ORI’s Core Instructional Areas in RCR ORI’s Core Instructional Areas in RCR (2000)(2000)

• Data managementData management• Mentor/trainee responsibilitiesMentor/trainee responsibilities• Publication and authorshipPublication and authorship• Peer reviewPeer review• Collaborative scienceCollaborative science• Research with human beingsResearch with human beings• Research involving animalsResearch involving animals• Research misconductResearch misconduct• Conflict of interest and commitmentConflict of interest and commitment

This list was SUPERCEDED in November 2009This list was SUPERCEDED in November 2009

Congressional and professional criticism Congressional and professional criticism prompted ORI to withdraw its universal prompted ORI to withdraw its universal RCR educational policy in February 2001.RCR educational policy in February 2001.

Many institutions had already begun to expand their Many institutions had already begun to expand their

NRSA-required RCR education programs; Some NRSA-required RCR education programs; Some

institutions implemented universal RCR training for institutions implemented universal RCR training for

compliance standards “just in case”.compliance standards “just in case”.

Many professional societies, research organizations, Many professional societies, research organizations,

and government agencies had already begun to and government agencies had already begun to

articulate and publicize standards and formal policies.articulate and publicize standards and formal policies.

Compliance-only orientation toward RCR Compliance-only orientation toward RCR instruction were pervasive after 2001.instruction were pervasive after 2001.

• Training often limited to online programs with no Training often limited to online programs with no

interaction among trainees or trainees and faculty.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 Research showed that RCR education did not affect

behavior in demonstrable waysbehavior in demonstrable ways

• Rates of research misconduct did not fall and sometimes Rates of research misconduct did not fall and sometimes

increased.increased.

• In 2007 the America Competes Act required NSF to In 2007 the America Competes Act required NSF to

require RCR instruction for all funded trainees. require RCR instruction for all funded trainees.

• RCR is an essential part of research trainingRCR is an essential part of research training• Appropriate instruction should be provided throughout trainingAppropriate instruction should be provided throughout training• RCR instruction an essential part of grant proposals; new review RCR instruction an essential part of grant proposals; new review

criteria:criteria:

- - FormatFormat

- Subject Matter- Subject Matter

- Faculty Participation- Faculty Participation

- Duration- Duration

- Frequency of instruction- Frequency of instruction

• Faculty to contribute to formal and informal instructionFaculty to contribute to formal and informal instruction• Substantive contact time (8+ hours) expectedSubstantive contact time (8+ hours) expected• Documented and monitored by programDocumented and monitored by program

NIH updated its requirement on RCR instruction NIH updated its requirement on RCR instruction in 2009, with extensive changes.in 2009, with extensive changes.

NIH’s Recommended topics in RCR (2009)NIH’s Recommended topics in RCR (2009)

• Conflict of interestConflict of interest• PoliciesPolicies** on research with humans and animals and on research with humans and animals and safe laboratory practicessafe laboratory practices• Mentor/trainee responsibilities and relationshipsMentor/trainee responsibilities and relationships• Peer reviewPeer review• Data acquisition, management, sharing and ownershipData acquisition, management, sharing and ownership• Collaborative research, including with industryCollaborative research, including with industry• Responsible authorship and publicationResponsible authorship and publication• Research misconduct and policies for handling itResearch misconduct and policies for handling it• The scientist as a member of society, contemporary The scientist as a member of society, contemporary ethical issues in research, and environmental and ethical issues in research, and environmental and societal impacts of researchsocietal impacts of research

• BRET RCR Orientation (very basic) in August and RCR Workshop (basic) in May BRET RCR Orientation (very basic) in August and RCR Workshop (basic) in May

provide introductory-level sessions (lecture and case discussions) designed for new 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 doctoral students. The May session is open to post-docs and K-award holders but

may be too basic and lab oriented for many.may be too basic and lab oriented for many.

• MSCI course “Research Ethics and Scientific Integrity” (1 credit hour, tuition fee) in 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-May provides a comprehensive mid-level and advanced overview of RCR for post-

doctoral clinical researchers with assigned readings and final exam. doctoral clinical researchers with assigned readings and final exam.

• CITI RCR course: online RCR modules available 24/7 to VUMC faculty, staff, and CITI RCR course: online RCR modules available 24/7 to VUMC faculty, staff, and

trainees through the (trainees through the (www.citi.org) or the VUMC IRB’s “training” webpage. ) or the VUMC IRB’s “training” webpage.

Satisfactory as one introductory component; NOT acceptable by itself.Satisfactory as one introductory component; NOT acceptable by itself.

• Other ad hoc events approved by VICTR for RCR credit; posted through Other ad hoc events approved by VICTR for RCR credit; posted through

STARBRITE, typically 1 hour, various topics; register your attendance with a code STARBRITE, typically 1 hour, various topics; register your attendance with a code

number after session number after session https://www.mc.vanderbilt.edu/starbrite/education/schedule.html

• Other program-oriented events not captured in STARBRITEOther program-oriented events not captured in STARBRITE

RCR instruction at VUMC :RCR instruction at VUMC :

• Plan RCR education that is meaningful to you and your future Plan RCR education that is meaningful to you and your future

as an academic researcher in your field.as an academic researcher in your field.

• Policy on human and animal protections are a subset of the Policy on human and animal protections are a subset of the

recommended subject areas and can be mentioned, BUT the recommended subject areas and can be mentioned, BUT the

training requirements for the IRB and IACUC are separate and training requirements for the IRB and IACUC are separate and

do do notnot “count” toward RCR education requirements. “count” toward RCR education requirements.

• Build a program that is appropriate to YOUR career stage; you Build a program that is appropriate to YOUR career stage; you

will be expected to have done SOMETHING already. will be expected to have done SOMETHING already.

• Over the course of your award you should demonstrate Over the course of your award you should demonstrate

increasing leadership in RCR related to your discipline.increasing leadership in RCR related to your discipline.

Which areas are important to YOUR work?Which areas are important to YOUR work?

Objectives for your (advanced) RCR education planObjectives for your (advanced) RCR education plan

• Know “how to’s” of good research in core areas relevant to Know “how to’s” of good research in core areas relevant to your workyour work

• Know where to find institutional, professional, and federal Know where to find institutional, professional, and federal policies in areas relevant to your workpolicies in areas relevant to your work

• Know how to keep pace with changing standards of practice Know how to keep pace with changing standards of practice and controversies in your fieldand controversies in your field

• Be able to teach and advise on questions relevant to your field Be able to teach and advise on questions relevant to your field and especially to your own researchand 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 The more advanced you are in your career, the more you should comment on how you will teach others about RCRshould comment on how you will teach others about RCR ..

Your plan MUST address the five (5) aspects in Your plan MUST address the five (5) aspects in “Instructional Components” (in any order):“Instructional Components” (in any order):

• Format(s)Format(s)• Substantial face-to-face discussions preferred• Online instruction acceptable but not adequate alone

• Subject Subject mattermatter• NIH’s core areas build on ORI’sNIH’s core areas build on ORI’s• Professional ethics, human protection, animal welfare not enoughProfessional ethics, human protection, animal welfare not enough

• Faculty participationFaculty participation• Mentors and program faculty must be involvedMentors 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 hoursMinimum of 8 contact hours

• Frequency of instructionFrequency of instruction• Not a one-time event, but continuous educationNot a one-time event, but continuous education

http://grants.nih.gov/grants/guide/notice-files/not-od-10-019.html

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.

Your narrative should spell out:Your narrative should spell out:Past instruction : What education/training/mentoring did you receive as

Undergraduate/ Summer research studentMedical student or pre-dissertation grad studentResident 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

Training in the ResponsiTraining in the Responsible Conduct of Research - sample narrative formatble Conduct of Research - sample narrative format Past training:Past training: My introduction to the responsible conduct of research (RCR) came as a {high school/ 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)/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 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 {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, 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 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 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 (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, 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 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 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 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 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 for Research Teams”, and the CITI RCR modules for biomedical investigators (see certificates in Appendix#?).” Appendix#?).”

Current and ongoing activities:Current and ongoing activities: This year I have attended 4 sessions on research integrity and ethical issues 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 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 (see Appendix #). {Name the sessions, their presenters, and the time spent.presenters, and the time spent.

Future activities:Future activities: During the period of my K award, I will complete the 1 credit-hour, graduate-level course 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 “Research Ethics and Scientific Integrity”, taught by Dr. Elizabeth Heitman (see syllabus in Appendix #?Appendix #?).  ).  This course provides foundational knowledge of core areas of RCR and advanced knowledge of responsible 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 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 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 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, 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 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}. 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 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}. session, highlighting issues of RCR related to research on {your topic}.

SAMPLE ONLY

The VICTR Ethics Core provides consultation on The VICTR Ethics Core provides consultation on

RCR instruction plans – just call or write (preferably RCR instruction plans – just call or write (preferably

beforebefore your crunch time). Well before you start your crunch time). Well before you start

planning your application, we can help you build an planning your application, we can help you build an

educational history to use in your application.educational history to use in your application.

Elizabeth Heitman, PhDElizabeth Heitman, PhD

Center for Biomedical Ethics and SocietyCenter for Biomedical Ethics and Society

2525 West End Avenue, Suite 4002525 West End Avenue, Suite 400

(615) 936-2686(615) 936-2686

elizabeth.heitman@vanderbilt.edu