RCR Research Skills WorkshopRCR Research Skills Workshop

May 28, 2010May 28, 2010

How to Create a PlanHow to Create a Plan

for RCR Education for your for RCR Education for your

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 (Format, Subject Matter, Faculty Participation, Components (Format, Subject Matter, Faculty Participation, Duration, and Frequency of instruction), as detailed in Duration, and Frequency of instruction), as detailed in NOT-OD-10-019NOT-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.pdfhttp://grants.nih.gov/grants/peer/guidelines_general/Review_Criteria_at_a_glance.pdf

No one discusses ethical norms and principles when No one discusses ethical norms and principles when

things are “normal” and/or going well. things are “normal” and/or going well.

Most professional standards and governmental Most professional standards and governmental

policy related to research have resulted from new policy related to research have resulted from new

technological threats, new barriers between new technological threats, new barriers between new

specialty fields, and professional scandals where specialty fields, and professional scandals where

investigators broke unwritten rules.investigators broke unwritten rules.

Irony of Developing Ethical Standards and PolicyIrony 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

• Research with human subjectsResearch with human subjects

• Research with animalsResearch with animals

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

• Misconduct (“fraud”)Misconduct (“fraud”)

• Computerized databases and privacyComputerized databases and privacy

• Financial conflicts of interestFinancial conflicts of interest

1980s > Concern about the integrity of science1980s > Concern 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

• IOM called for universities to provide “formal IOM called for universities to provide “formal instruction in good research practices” (1989)instruction in good research practices” (1989)

• NIH required schools seeking National Research NIH required schools seeking National Research Service Award training grants to have plans for Service Award training grants to have plans for instruction in the responsible conduct of research” instruction in the responsible conduct of research” for trainees (1989)for trainees (1989)

Professional organizations and research Professional organizations and research agencies promoted education, rather than agencies promoted education, rather than oversight, as the key to scientific integrity.oversight, as the key to scientific integrity.

• NAS called for universities to have “programs that foster NAS called for universities to have “programs that foster

faculty and student awareness of ... the integrity of the faculty and student awareness of ... the integrity of the

research process” (1992)research process” (1992)

• DHHS Commission on Research Integrity urged NIH to DHHS Commission on Research Integrity urged NIH to

certify that institutions had an educational program on certify that institutions had an educational program on

RCR prior to providing federal research funding (1995)RCR prior to providing federal research funding (1995)

• DHHS/OHRP announced new requirements for education DHHS/OHRP announced new requirements for education

of IRB members and human studies researchers, of IRB members and human studies researchers,

focusing on the protection of research participants (1999)focusing on the protection of research participants (1999)

Calls for Education in Research IntegrityCalls for Education in Research Integrity

• DHHS/ORI announced require for “research institutions to DHHS/ORI announced require for “research institutions to

provide training in the responsible conduct of research to all staff provide training in the responsible conduct of research to all staff

engaged in research or research training with PHS funds” (1999)engaged in research or research training with PHS funds” (1999)

• ORI, the Office of Public Health and Science, Office of Human ORI, the Office of Public Health and Science, Office of Human

Research Protections, and Office for Laboratory Animal Welfare Research Protections, and Office for Laboratory Animal Welfare

proposed DHHS Policy on Instruction in the Responsible proposed DHHS Policy on Instruction in the Responsible

Conduct of Research and called for public comment (2000)Conduct of Research and called for public comment (2000)

Calls for Education Programs Calls for Education Programs (cont.)(cont.)

Public comments indicated support for Public comments indicated support for educational efforts, but also concern overeducational efforts, but also concern over• cost and other burdens of implementationcost and other burdens of implementation• scope of staff to receive trainingscope of staff to receive training• prescriptive tone of policyprescriptive tone of policy• short phase-in periodshort phase-in period• possible future additions to core subjectspossible future additions to core subjects• ambiguity regarding what was mandatoryambiguity regarding what was mandatory

Calls for Education Programs Calls for Education Programs (cont.)(cont.)

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

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 2001RCR educational policy in February 2001

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

training grant RCR programs to all researchers. training grant RCR programs to all researchers.

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

government agencies had already begun to articulate government agencies had already begun to articulate

standards and formal policies.standards and formal policies.

Some institutions implemented universal RCR training Some institutions implemented universal RCR training

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

• RCR is an essential part of research trainingRCR is an essential part of research training

• Appropriate instruction should be provided throughout Appropriate instruction should be provided throughout

trainingtraining

• RCR instruction an essential part of grant proposals; new RCR instruction an essential part of grant proposals; new

review criteria:review criteria:

Format, Subject Matter, Faculty Participation, Duration, Format, Subject Matter, Faculty Participation, Duration,

and Frequency of instructionand Frequency of instruction

• Faculty encouraged to contribute to formal and informal Faculty encouraged to contribute to formal and informal

instructioninstruction

• Substantive contact time (8+ hours) expectedSubstantive contact time (8+ hours) expected

• Documented and monitored by programDocumented and monitored by program

NIH Update on RCR Instruction (2009)NIH Update on RCR Instruction (2009)

Recommended topics in RCR (2009)Recommended topics in RCR (2009)

• Conflict of interestConflict of interest• Policies on research with humans and animals and Policies 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 scientists as a member of society, contemporary The scientists 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 provide introductory-level sessions (Lecture and case discussions) designed for

new doctoral students. The sessions are open to post-docs and K-award holders 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.with small registration fee but may be too basic 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 overview of RCR for post-doctoral clinical May provides a comprehensive mid-level overview of RCR for post-doctoral clinical

researchers with assigned readings and final exam. 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 in relation to the CITI IRB course. Satisfactory as one introductory trainees in relation to the CITI IRB course. Satisfactory as one introductory

component; NOT acceptable by itself.component; NOT acceptable by itself.

• Other ad hoc RCR-related events posted through STARBRITE, typically 1 hour, Other ad hoc RCR-related events posted through STARBRITE, typically 1 hour,

various topic; register your attendance with a code number after session various topic; register your attendance with a code number after session https://https://

www.mc.vanderbilt.edu/starbrite/education/schedule.htmlwww.mc.vanderbilt.edu/starbrite/education/schedule.html

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 fieldas an academic researcher in your field

• Human and animal subject protections and related policy are a Human and animal subject protections and related policy are a

subset of the recommended subject areas BUT both the IRB subset of the recommended subject areas BUT both the IRB

and IACUC have separate training requirements that don’t and IACUC have separate training requirements that don’t

“count” toward RCR education. “count” toward RCR education.

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

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

• Over the course of your award demonstrate increasing Over the course of your award demonstrate increasing

leadership in RCR related to your discipline.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

Outline past groundwork, current activities, future training Outline past groundwork, current activities, future training for your self, future sharing with / teaching othersfor your self, future sharing with / teaching others

• 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 Be able to teach and advise on questions relevant to your field and especially to your own researchfield and especially to your own research

• Develop ongoing activities for your colleagues and trainees Develop ongoing activities for your colleagues and trainees

Training in the Responsible Conduct of ResearchTraining in the Responsible Conduct of Research

During the first year of my fellowship training in {program}, I took part in the 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 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 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 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 regarding scientific misconduct and conflicts of interest; 2)ethical considerations of research involving human and animal subjects; 3)data management, record keeping, and intellectual 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 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 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 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 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 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.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 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”, complete the 1 credit-hour, graduate-level course “Research Ethics and Scientific Integrity”, taught by Dr. Elizabeth Heitman (see syllabus in taught by Dr. Elizabeth Heitman (see syllabus in Appendix #?Appendix #?).  This course provides ).  This course provides postdoctoral masters students with a solid foundational knowledge of core areas of RCR and as 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 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 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 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 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 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 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 (journal club session highlighting issues of RCR related to research on (YOUR TOPICYOUR TOPIC), and ), and attend other independent opportunities in RCR education across the campus, as publicized and attend other independent opportunities in RCR education across the campus, as publicized and tracked by the Office of Research Support Services StarBRITE system tracked by the Office of Research Support Services StarBRITE system ((https://https://starbrite.vanderbilt.edu/education/schedule.htmlstarbrite.vanderbilt.edu/education/schedule.html).).