1. Research Compliance at Dartmouth
Henrike Frowein, LL.M
Research Compliance Officer
Office of the Vice Provost for Research
Dartmouth College
Office of the Vice Provost for Research

2. Research Compliance at Dartmouth
Vice Provost for Research: Dean Madden
Research Compliance Officer: Henrike Frowein
Office of Sponsored Projects: Jill Mortali
Technology Transfer Office: Nila Bhakuni
Committee for the Protection of Human Subjects: Liz Bankert
Office of Environmental Health & Safety: Maureen O’Leary
Animal Resource Center/IACUC: Roger Sloboda, Jack Hoopes
Council on Sponsored Activities (CSA) Conflict of Interest Committee (COIC) Dartmouth Policies: 1.) Dartmouth policies relevant on research can be found on OSP website: ) Research Misconduct Policy: ) Conflict of Interest Policy:
Dartmouth College
Office of the Vice Provost for Research

3. Research Compliance at Dartmouth
Research Compliance Office
Henrike Frowein, Research Compliance Officer Nicole Hall Hewett, Administrative Coordinator
Responsible for:
Conflict of Interest in Research
Export Controls
Responsible Conduct of Research
Researcher Education
Policy Development
Dartmouth College
Office of the Vice Provost for Research

4. Research Compliance at Dartmouth
Dartmouth as an institution receiving federal research funds has to fulfill the following requirements:
Policies on responsible and ethical conduct of research.
Training for undergraduates, graduate students, and postdoctoral researchers who will be supported by NSF to conduct research.
Committees to review human and animal research. => CPHS, IACUC
Procedures for investigating and reporting research misconduct and conflicts of interest.
Approve and manage all research budgets, ensure that laboratory safety rules are followed, and follow established practices for the responsible use of hazardous substances in research.
Training for researchers who use animals or human subjects in their research and for individuals supported on NIH training grants.
Dartmouth College
Office of the Vice Provost for Research

5. Research Compliance / COI
Conflict of Interest in Research
Dartmouth as a recipient of Federal grants is required to manage Financial Conflicts of Interest in Research, according to Federal regulations and Dartmouth policy
Research Compliance Office and Conflict of Interest Committee conduct reviews and manages identified conflicts of interest
Dartmouth College
Office of the Vice Provost for Research

6. Research Compliance / COI
Bayh-Dole Act, 35 U.S.C. § 200 (1980) led to accelerating commercialization of research.
In response to growing Congressional concern new COI regulations that broadened the disclosure and reporting requirements for PHS funded research were adopted in 2011.
Senator Grassley
“Universities receive NIH dollars with the understanding that they will manage their
researchers’ conflicts of interest… Universities need to take this issue more seriously,
and the NIH should monitor its grants more closely for this problem.”
Dartmouth College
Office of the Vice Provost for Research

7. Research Compliance / COI
Review Process
Summary Significant Financial Interests (SFI)
Related to your:
Dartmouth researchers (PIs or SKP) are required to submit COI disclosures through online disclosure system annually, latest when applying for research funds (Rapport.Dartmouth.edu) or submitting a study to the CPHS
Each individual researcher who has a significant financial interest related to institutional responsibilities (including research) must submit a disclosure through the Rapport COI system. If human subject research is involved the researcher must respond “Yes” to the question about a financial interest in IRB Rapport when submitting a protocol
Process ?
Records should be kept if researchers don’t answer themselves
Please get in touch with questions!
Dartmouth College
Office of the Vice Provost for Research

8. Research Compliance / COI What qualifies as an SFI?
Summary Significant Financial Interests (SFI)
Related to your:
1) Any equity in or remuneration from a publicly held entity related to IR
Equity worth more than $5k
Remuneration received of more than $5k
Equity interest plus any remuneration of more than $5K
2) Any equity interest in or remuneration from a privately held company related to IR (including faculty startups)
Any equity in privately held company
Remuneration received of more than $5K
3) Intellectual Property: if related to IR (except authorship in scholarly works where royalties > $5,000 not received)
4) Travel: if over $5,000 received from/sponsored by same entity over last 12 months, or expected over next 12 months
Dartmouth College
Office of the Vice Provost for Research

9. Research Compliance / COI
Review Process
Summary Significant Financial Interests (SFI)
Related to your:
Dartmouth College
Office of the Vice Provost for Research

10. Research Compliance / COI
Review Process
Summary Significant Financial Interests (SFI)
Related to your:
Disclosures are reviewed by the Research Compliance Officer and the Dartmouth Conflict of Interest Committee (COIC)
Significant Financial Interest (SFI) related to the discloser’s research?
Financial Conflict of Interest (FCOI) present?
= Significant Financial Interest that could directly and significantly affect the design, conduct, or reporting of research
Can it be managed?
May have to be reported to sponsor and made accessible to the public upon request
Dartmouth College
Office of the Vice Provost for Research

11. Research Compliance / COI Management Plan Elements
Public disclosure (when presenting or publishing)
Consent form disclosure (human subject research)
Independent monitor
Modification of the research plan
Change of personnel or personnel responsibilities
Disqualifications of personnel from participation in all or a portion of the research activities (data analysis, consenting patients)
Reduction or elimination of the financial interest (sale of an equity interest)
Severance of relationships that create financial conflicts
Dartmouth College
Office of the Vice Provost for Research

12. Research Compliance / COI
Thank you for attention! Please never hesitate to contact us with any questions!
Dartmouth College
Office of the Vice Provost for Research