Candice Yekel, M.S., Director, Conflict of Interest Official Sharon Shriver, Ph.D., Assistant Director – Educational Programs Debra Thurley, J.D., Assistant Director, COI Program Clinton Schmidt, J.D., COI Program Coordinator RESEARCH ETHICS AND CONFLICT OF INTEREST

Sharon Shriver, Ph.D Training Graduate Students in the Responsible Conduct of Research and Scholarship : The SARI Program

Penn State’s program for the education of graduate students in ethical research and scholarship Inspired by the America COMPETES Act (2007): NSF-funded institutions must “…provide appropriate training and oversight in the responsible and ethical conduct of research” Act enforced January 2010

Rationale RCR training is required by many granting agencies, including NIH (training grants) and NSF. Ethical issues in research and scholarship have become more complex, due to advances in technology, multidisciplinary collaborations, and globalization. Council of Graduate Schools: “…the time has come for a proactive and comprehensive strategy to educate scholars and those they train about the norms and the ethical standards that are central to ensure the quality and integrity of research.” (

SARI Program format Part 1: Online RCR training offered by CITI (Collaborative Institutional Training Initiative) RCR courses in biomedical sciences, physical sciences, engineering, social and behavioral sciences, humanities IRB courses in human subjects research (for biomedical or social scientists) Part 2: Five hours of discipline-specific discussion Offered through PSU colleges and graduate programs

Part 1 SARI requirement (CITI online training) can be met through any CITI course Examples of SARI plans (for Part 2): An existing semester-long RCR course fulfills SARI requirement The college will offer two 2-hour evening RCR discussions; students fulfill remaining hour with on-campus seminar (e.g. ORP workshop, Rock Ethics Institute event) The college will offer 5-hour discussion one Saturday

SARI Program Timeline

*one program will include 09/10 data with their 10/11 report, due to administrative changes

Student participation in SARI training AY 2009/2010: PSU is among the first institutions to undertake training on this scale The SARI program is serving as a model for other institutions. We have consulted with Florida State, Washington State, University of Chicago, Vanderbilt University, Clemson University, University of Kentucky, and Georgia Tech.

Resources Office for Research Protections RCR workshops, Brownbag series, Survival Skills and Ethics workshops, human and animal subjects training, workshop video archives SARI Resource Portal SARI program documents, forms, FAQ, newsletter Classroom resources for RCR education Online resources, articles, links Train-the-trainer workshops for SARI leaders

Debra Thurley, J.D. Clinton Schmidt, J.D. FINANCIAL CONFLICTS OF INTEREST

GOALS 1.Understand what is a financial COI (and a SFBI) –Other key terms: disclosure and management 2.Become familiar with the COI Process & COI Program at Penn State 3.Clear up some misconceptions surrounding COI – it’s not a BAD thing! 4.Proposed changes to federal COI regulations & impact at Penn State

CONFLICT OF INTEREST PROGRAM AT PENN STATE Candice Yekel, Conflict of Interest Official, Director of the ORP Debra Thurley, Assistant Director Clinton Schmidt, COI Program Coordinator (Individual COI) Susan Seman, COI Assistant Individual Conflict of Interest Committee (for UP and all campuses except COM) Institutional Conflict of Interest Committee (all of Penn State)

CONFLICT OF INTEREST PROGRAM AT PENN STATE (COM) Dr. Donald Martin, CIRC Chair, Associate Dean for Administration Dr. Roger Anderson, COI Monitor, Professor & Chief, Public Health Sciences Dr. Neal Thomas, COI Coordinator, Associate Professor Dr. Sheila Vrana, Associate Dean for Research Susan Smith, Administrative Coordinator Conflict of Interest Review Committee (COM only)

WHAT IS A FINANCIAL CONFLICT OF INTEREST?????

COI DEFINITION (RA20) “situations in which financial considerations may compromise, or have the appearance of compromising, an employee’s professional judgment in designing, conducting, evaluating, or reporting on University Research... ”

THREE NECESSARY PIECES financial considerations – financial or business interests but not non-financial interest may compromise, or have the appearance of compromising – addresses “two P’s”: –potential and perceptions University Research – Penn State research or scholarly activities (training, education, outreach, etc.)

FIRST NECESSARY PIECE financial considerations = “significant financial or business interest” (“SFBI”) Compensation or other payments for services (e.g. consulting fees, honoraria, travel funds, gifts, etc.) – greater than $10,000/yr OR related to h.p. research Equity interests (e.g. stocks, stock options or other ownership interests) – greater than 5% interest OR $10,000 value OR related to h.p. research Intellectual property rights (e.g. patents, copyrights, and royalties rights) Holding a management position or playing an advisory or consultative role (whether compensated or not) with a company or on the board of a company

FIRST NECESSARY PIECE (con’t) SFBI’s can be held by individual researcher (PI, co-PI, etc.) OR researcher’s spouse or dependent child(ren) If h.p. are involved, there are NO DE MINIMIS AMOUNTS!!! Any amount of compensation or equity interest = SFBI Individuals are responsible for identifying if they have an SFBI –COM requires annual disclosures from all researchers –UP and all others require “transaction based” disclosures and annual updates SFBI ≠ COI

SECOND NECESSARY PIECE “may compromise, or have the appearance of compromising” SFBI does not have to actually compromise the research SFBI has the potential to compromise or creates the perception that it could compromise the research COI Committees and COI staff make this determination! COI ≠ BIAS or MISCONDUCT

THIRD NECESSARY PIECE “... University Research” SFBI is related (directly or indirectly) to the Individual’s Penn State research or other scholarly activities E.g. sponsor (or competitor of sponsor), sub- contractor, consultant, an entity that has a business interest in the field of individual’s PSU research

WHAT IS A FINANCIAL CONFLICT OF INTEREST?????

PENN STATE’S COI POLICIES RA20 – Individual Conflict of Interest –Financial conflicts of interest affecting individual investigators and their Penn State research –Individual = all researchers (PI, co-PI, PSU or non- PSU research personnel), and can be faculty, students, or staff –All research – funded or unfunded –Modeled after NIH’s COI regulations & NSF’s grant policy Only difference – de minimis amounts for h.p. research RA21 – Institutional Financial Conflict of Interest –Financial conflicts of interest affecting Penn State and Penn State research (*and other activities)

THE PENN STATE COI PROCESS 1.Disclosure 2.Review – Administrative and Committee 3.COI Determination 4.Management of COI (minimize, reduce or eliminate) 5.Annual Review and Compliance –See RAG20

Step 1: Disclosure Process starts with individual researchers –Do you (researcher) have a “significant financial or business interest” that is related to your Penn State research? (remember the 1 st and 3 rd “necessary pieces” of COI definition) Compensation, equity, ownership, management position? Sponsor, competitor of sponsor, etc.? –If yes, DISCLOSE – tell us about it IRB application (Q.14), PIAF/AIAFPIAF/AIAF SFBI Disclosure Form on COINSCOINS

Steps 2 & 3: Review and Determination Is there a COI? (SFBI ≠ COI) –Administrative review by COI Staff before going to COI Committee review –COI Committee review –Basic question the COI Staff/Committee has to answer: Is there a potential that the SFBI could compromise or appear to compromise the Individual’s related Penn State Research? If yes, then COI.

COI COMMITTEE COI Committee meets 1x/month Comprised of faculty from various disciplines (including at least one h.p. researcher) and administrators from various units (IPO, OSP, Procurement, COI Staff, etc.) Researchers are invited to meet with Committee to discuss disclosure and answer questions from Committee – not required but helps to make process more efficient Committee gathers information needed to decide: –Is there a COI? –If yes, then what will be the MANAGEMENT PLAN?

Step 4: COI MANAGEMENT PLAN COI Management Plan – measures put into place to reduce, eliminate or minimize the potential and/or perception that the SFBI will or could adversely affect the research or will or could adversely affect the protection of human participants. –Researcher has input into the terms of the management plan implemented –Management Plan is communicated to IRB if human participants are involved –Management Plan made broad enough to cover future related research

WHAT DOES A COI MANAGEMENT PLAN LOOK LIKE? COI Management Plan can include: Disclosure to participants in the consent form Disclosure to other researchers, in publications/presentations, etc. No contact with h.p. by conflicted investigator Monitoring (of research and/or students) Modification of research plan Removal of conflicted investigator from the research (COI not manageable) Dissolution of the SFBI (COI not manageable)

Step 5: Annual Review and Compliance COI Staff monitors and ensures COI Management Plan is being followed –monitoring reports submitted to ORP Required Annual Updates to Disclosure –Changes in relationship with the company –Changes in relationship to Penn State research

HIGHLIGHTS SFBI ≠ COI COI ≠ BIAS ≠ MISCONDUCT –Competing interests are everywhere and not inherently bad –Disclosure and Proper Management is the KEY Disclose, disclose, disclose – individual responsibility Manage, manage, manage – institutional responsibility

CHANGES PROPOSED BY NIH AND THE LIKELY IMPACT ON PENN STATE POLICY

Relatedness of Research Who determines? Proposed Rule: Institution to be responsible for determining relatedness of financial interests. This means that Annual Reports will be required of all researchers University-wide, in order for institution to make the determination. Current Rule: Researchers are responsible for determining whether their financial interests are related to their University research. Reports are now transaction- based – researchers only disclose as needed.

Lower de minimis amounts Proposed rule: $5,000 threshold for combined value of compensation from, and equity in, a publicly-traded company Current rule: $10,000 threshold for compensation or equity value; 5% equity stake. Proposed rule: $5,000 of compensation, or ANY equity in a non-publicly traded, or “start- up” company Current rule: same as for publicly-traded companies

Publicly Accessible Website Investigator’s name, role on the project, nature of the financial interest Approximate value of the interest –Less than $20,000 –Less than $50,000 –Less than $100,000 –Less than $250,000 –Greater than $250,000 Information to be available for five years after last update

Other Impacts on Penn State Training to be required for all researchers every two years Cost of implementation to be borne by F&A recovery Final rule to be promulgated by late 2010? May be implemented in a staggered fashion

HELPFUL RESOURCES: RAG20: NIH Reg : FAQ’s : *Tutorial: COI Staff at the ORP Clinton Schmidt, Susan Seman, Debra Thurley,