+ Departmental Research Administrator Training Series FS 206 Compliance Topics: Institutional Committees, Ethics and Professionalism Judith Grant James MacMillan Rachel Graves Martie Trevino

+ Overview of Today’s Course Overview of Research Compliance Electronic Routing Form IRB IACUC Other lab safety committees – IBC, RSC, CSC COI Case Study

+ Overview of Research Compliance

+ Compliance Compliance is the cost of doing business with the government: It’s the LAW Suspension of federal funds is worse and can harm research and the university’s credibility Front page news

+ RCR – Responsible Conduct of Research Conflicts of Interest (and Commitment) Research Compliance Biosafety Authorship Mentorship Human Subjects (IRB) Intellectual Property Export Controls Animal Use (IACUC) Laser Radiation Chemical Safety

+ The Office of Research Integrity and Compliance (est ) Report to Sr. Assoc. VP for Research Administration Responsibilities: Oversight and support for the responsible conduct of University research by facilitating comprehensive regulatory guidance Provide educational activities and training programs Develop and implement written policies, procedures and standards of conduct that support adherence to institutional policies and applicable laws and regulations.

+ Compliance Committees IRB – Institutional Review Board IACUC – Institutional Animal Care and Use Committee IBC – Institutional Biosafety Committee RSC – Radiation Safety Committee CSC – Chemical Safety Committee

+ Other Compliance Areas RCR - Responsible Conduct of Research Misconduct in Science COI – Conflicts of Interest Export Controls Intellectual Property

+ Compliance Committees May request changes or add’l information Annual renewal process Must notify appropriate committee of adverse events, changes to protocol, etc. Faculty and staff Federal/state regulations Often linked to grant proposal JIT approval process Protocol submitted Committee review Approval of protocol Research commences

+ IRB

+ IACUC

+ IBC, RSC, CSC

+ COI

+ What is Conflict of Interest? a situation in which financial or other personal considerations may compromise or have the appearance of compromising an employee's professional judgment in administration, management, teaching, research or any other professional activities.

+ Examples of Possible COIs or those Requiring Management Plans (not inclusive) Failure of the faculty member/researcher to fulfill university responsibilities (e.g., holding classes, advising students, conducting research…), due to involvement in external activities. Sponsored projects or technology licensing arrangements in which any of the involved investigators (or members of their immediate families) have employment or consulting arrangements and significant financial interests in the sponsor, or with subcontractors, vendors, or collaborators. Using university resources to conduct research that is sponsored by an entity in which the faculty member/researcher or his/her family member has a significant financial interest. Serving as a consultant or on the board of directors or major advisory committee of an external for-profit entity which sponsors the faculty member's/researcher's research or provides gift funds for the researcher or his/her department. Hiring university students in consulting activities or a company in which the faculty member/researcher has financial interests. If the student's thesis/dissertation research is supervised by the faculty member, the conflict of interest situation may not be manageable.

+ Guiding Principles The fact is that there will be conflicts. The term Conflict of Interest “implies” wrongdoing. Not all conflicts are necessarily impermissible and MOST are manageable. When human subjects are involved, there will be a higher level of scrutiny Complete and timely disclosure is essential Case by case analysis and management is crucial

Possible Conflict of Interest Situation – Funded Research UTSA ABC Company UTSA Resources/Lab Facilities Student Research Projects Research Data Publications & Possible Commercialization Grades/Graduation Undisclosed Consultant Agreement $75,000 fees & 25,000 shares Faculty/Researcher

+ Components of Conflict of Interest Management Disclosure Review Management Monitoring Reporting

+ How does UTSA Deal With COI? 1. Institutional Conflict of Interest which is driven by Texas Statute (Chapter 572, Government Code)Chapter 572, Government Code  This Statute has different thresholds for reporting and does not define areas pertinent to research (i.e. human subjects, intellectual property, etc.) 2. Conflict of Interest in Research & Intellectual Property  Follows federal regulations (CFR Title 42, Vol1 Part 50 Subpart F & CFR Title 45, Volume 1 Part 94 Section 94.4) First, a distinction was made between the following:

+ Policy UTSA policy applies (and at times exceeds) the federal regulations and includes both funded and non-funded research.

Who should disclose? The Principal Investigator AND any other person responsible for the design, conduct, or reporting of research or proposed research AND includes their Spouse/Domestic Partner, Dependent Children and Others in the Household

Who does that include? Research RAs & Graduate RAs Sub- Contractors Sub- Recipients PIs Co-PIs Other Collaborators Doctoral & Post Doctoral Students Lab Personnel I ncludes their Spouse/Domestic Partner, Dependent Children and Others in the household

+ Significant Financial Interest Anything of monetary value, including but not limited to, salary or other payments for services (e.g., consulting fees or honoraria); equity interests (e.g., stocks, stock options or other ownership interests); and intellectual property rights (e.g., patents, copyrights and royalties from such rights).

+ Investigator Responsibilities Submit financial disclosure statements listing all Significant Financial Interests: That would reasonably appear to be affected by the research In entities whose financial interests would reasonably appear to be affected by the research Comply with all institutional requirements

+ Procedure Created and implemented a procedure for collecting Disclosure Forms Annually (currently by fiscal year) for all researchers, and others specified by Chair/Dean, whether research is funded or not funded Updated PRIOR to submitting a funding proposal or entering into a technology licensing arrangement, or any other contract that binds the University. Within 30 days of hire/appointment for all new faculty researchers or new staff on research projects.

+ ClickCommerce is Coming! An electronic system has been purchased from ClickCommerce and is currently undergoing implementation It will be tied into the mandatory acknowledgements which ALL employees are currently required to complete on an annual basis It will combine the process for reporting ICOI and COIs in Research/IP Scheduled to “Go-Live” on February 1, 2010

+ Homework Assignment CITI RCR Course for Science Administrators See handout for log in instructions

+ URLs for Resources  ORIC Website   Environmental Health Safety & Risk Management Website   DRA Training Wiki