Research Oversight at tulane University Brian J Research Oversight at tulane University Brian J. Weimer, JD Tulane University Research Compliance Officer I first want to say Welcome to Tulane! I am proud to be associated with Tulane and particularly the incredible research conducted by our faculty, and I hope you feel the same way or will come to feel the same way. I speak for my colleagues to say that we are all proud to facilitation the research enterprise at Tulane. September 28, 2015

Outline of Presentation Role of the Research Compliance Officer (RCO) Brief overview of the compliance oversight committees and the activities these committees regulate Please stop me at anytime if you have questions Please do interrupt me.

Role of Research Compliance Officer Resource to Tulane community regarding compliance with regulations and university policies that relate to the conduct of research – please contact me with your questions! Policy development related to research – for the research oversight committees and departments, as well as guidance for faculty and staff Role on the compliance oversight committees and departments: Revision or creation of policies in response to regulatory or accrediting body standards Investigate issues regarding noncompliance with regulations and/or policies - for research studies as well as committee operations Auditing – for cause and not-for-cause I am a lawyer. In another life I worked in litigation, and now have the please to work in the Office of Research under the Vice President for Research, Laura Levy, PhD to help facilitate the research enterprise at Tulane. Gail Louis, Associate Vice President for Research, also works with me addressing research compliance needs. Please stop me at any time if you have questions including my colleagues, particularly to correct me. Or if you think of questions afterwards, please contact me. My contact information is included in the handout. Questions – I can loop in the appropriate folks from the compliance oversight committees or departments. We know that non-compliance occurs; main issue is for the investigator to report the issue to the appropriate oversight committee and proactively work with the committee to address the issue. This is what regulatory agency such as FDA, Office of Laboratory Animal Welfare, and DEA, as well as monitoring visits by the study sponsor will be looking for if they are conducting a site visit or audit. Since I work with these committees and departments, as well as general counsel, we can effectively work to address issues with the ultimate goal to move the project forward.

Role of the Research Compliance Officer (cont.) Assist investigators in preparing for site visits by regulatory bodies (FDA, DEA, etc.) Contact the applicable research oversight committee or me if you get notice of such a site visit. Respond to Freedom of Information Act (“FOIA”) and public records requests related to research Contact me before responding to any such request. Export Controls: review and resolution of issues Controlled substances (new initiative by Office of Research in collaboration with Environmental Health and Safety and TUPD): assistance with obtaining controlled substances licenses, record keeping, disposal, and auditing. See RCO website for more info. FOIA Requests – TU is a private university, our records are not considered public records and subject to FOIA unless they have been submitted to the government. There are a number of redactions we can make in the interest of privacy, security (ex: animals, select agents and toxins), and proprietary concerns (competitive disadvantage if released). Security concern examples: research involving select agents and toxins. Export Controls: regulations that govern what and be brought out of the country (depends on the item and where you are going); what can be brought back into the country, and deemed exports – access to controlled technology by foreign nationals working or attending school at Tulane – in some instances, a license is required.

Role of the Research Compliance Officer (cont.) Responsible Conduct of Research (“RCR”) Training (announced on RCO website at http://tulane.edu/asvpr/responsible- conduct-in-research-training.cfm via SPA, TNRPC, and each schools' list-serve): Annual RCR Seminar Series: Wednesdays, Oct. 7th through Nov. 25th; 3:30 to 4:30, Stanley Thomas Hall room 316. As requested Online training via CITI Program: https://www.citiprogram.org/ Serves as the University’s Deputy Research Integrity Officer to process allegations of Research Misconduct in accordance with Tulane policies and federal regulations You have as part of your handouts the RCR Seminar Series schedule, also available on my website. We’ll start the RCR seminar series next week with a discussion of Peer Review. Can also attend in room 504 of JBJ building downtown. Designed to be user-friendly; can register for the class so that it will appear on a student’s official transcript. Or just attend the seminars that interest you. Each sessions is designed to be independent, so you may attend all or just one. We keep a record of the attendance and issue attendance certificates for all who attend each seminar. Tulane individuals stationed abroad may participate via laptop. All seminars are video recorded and placed on the Research Compliance Office’s YouTube Channel on the RCO website.

Research Misconduct Policies listed in the faculty handbook and on Tulane Research Compliance website: http://tulane.edu/asvpr/research- compliance.cfm Research Misconduct is defined as fabrication of data, falsification of data, and/or plagiarism in proposing, performing, or reviewing research, or in reporting research results. Fabrication: making up data or results and recording or reporting them Falsification: manipulating research materials, equipment, or processes, or changing or omitting data or results such that the research is not accurately represented in the research record. Plagiarism: appropriating another person’s ideas, processes, results, or words without giving appropriate credit. Proper record keeping, particularly lab notebooks, are key to defeating an allegation of Research misconduct. This could be an hour long presentation or even a day-long seminar, but I can’t pass up on opportunity to speak to the issue to the ramifications of being subject to a research misconduct allegation.

Research Misconduct (continued) If you discover research misconduct, you are obligated to report it – contact the RCO for guidance. You have the right to remain anonymous. If you are accused of research misconduct, you are entitled to due process rights – contact the RCO for guidance. We are obligated to protect the confidentiality of the process. Research misconduct will be covered at the RCR seminar on Nov. 4th at 3:30. Data management and record keeping will be covered at the RCR seminar on Oct. 28th at 3:30. My advice is to not cut corners in your research, and to have adequate oversight of the faculty, postdocs, and graduate students working in your lab. Check lab notebooks for accuracy and completeness. The easiest way to refute an allegation is to produce the original data and the underlying documentation to back up that original data.

Research Oversight Committees at Tulane Institutional Review Board (IRB) – must approve all human subjects research: http://tulane.edu/asvpr/irb/index.cfm Institutional Animal Care and Use Committee (IACUC) – must approve all activities involving vertebrate animals: http://tulane.edu/asvpr/iacuc/index.cfm Institutional Biosafety Committee (IBC) – must approve all activities involving rDNA, and/or select agents and toxins (SAT), including SATs that require review for Dual Use Research of Concern (DURC): http://tulane.edu/asvpr/biosafety/committee/index.cfm If anyone here from the compliance oversight committees or departments has questions or wished to jump-in or correct me, please don’t hesitate to do so, since we are talking about your units. Very brief overview, with links to the policies. Representatives from most of these committees are here today. If Laura hasn’t already introduced the committees present, introduce them. IRB – Ashanti Canada and Monique Teixeira IACUC – Director and Chair, Sheila Garrison and Attending Veterinarian Dr. Georgina Dobek IBC – Chair Dr. Lucy Freytag and Biosafety Officer Angei Birnbaum

Research Oversight Committees (cont.) Conflicts of Interest (COI) Committee – reviews and manages potential financial conflicts of interest of researchers based on COI disclosure forms submitted by researchers: http://tulane.edu/counsel/conflict-of- interest-policies.cfm International Review Group (IRG) – reviews all activities with an international component: http://tulane.edu/asvpr/ora/upload/IPPQ.pdf Radiation Safety – activities involving radiation: http://tulane.edu/oehs/radiation/radiationsafety.cfm Financial COIs’ – university policies in the faculty handbook. IRB is not permitted under COI policies to issue an approval all COI matters related to that project have been adequately addressed. IRG – Wade Wootan, Director of Global Affairs and Compliance Approval must be obtained before beginning the activity.

Conclusions Human subjects research involved = apply to IRB. Use of vertebrate animals = apply to IACUC Use of rDNA and/or select agents and toxins = apply to IBC International component = complete and summit IPPQ Use of radiation = contact Radiation Safety FOIA or public records requests = contact RCO Research Misconduct guidance = contact RCO Responsible Conduct of Research Training = contact RCO We look forward to working with you! Many times, approvals from several committees are needed. The contact information for the committees is available from all the committees is included as part of your handouts, and more information about what each committee reviews. Due to time limitations, we couldn’t go through all of that. This presentation is also posted to the RCO website.

Questions? Research Compliance and Deputy Research Integrity Officer, Brian Weimer: 504.988.1147 (office) 504.261.6579 (mobile); bweimer1@tulane.edu; Suite 2425 of Tidewater Bldg. (1440 Canal Street); http://tulane.edu/asvpr/research- compliance.cfm Office Hours: 8:00 AM to 5:00 PM, M-F Assistant: Kay Leger

IRB Tulane’s Human Research Protection Office (HRPO): 504.988.2665; irbmain@tulane.edu; http://tulane.edu/asvpr/irb/index.cfm; 1440 Canal Street, Suite 1705 Tulane Human Research Protection Program SOPs: http://tulane.edu/asvpr/irb/policies.cfm Apply to all activities that meet the definition of human subjects research Roxanne Johnson, Director: rjohnson@tulane.edu; 504.988.2665 Roberta McDuffie, Biomedical IRB Chair: rmcduffi@tulane.edu; 504.988.0299 Fred Buttell, Social/Behavioral IRB Chair: buttell@tulane.edu; 504.865.3486; The IRB approval letter will contain an expiration date for IRB approval of the research. Be sure to submit your continuing review application well in advance of the expiration date.

IRB - Definition of Human Subjects Research (45 CFR 46 & Tulane HRPP SOP 1.4) Any systematic investigation (including research development, testing, and evaluation) On a living individual about whom the investigation is being conducted Where the investigator obtains Data through intervention or interaction with the individual; or Individually identifiable private information That is designed to develop or contribute to generalizable knowledge. When in doubt, complete and submit the IRB’s “Human Subjects Research Determination Form” Don’t Start the Research until IRB approval has been maintained. Changes to the research require submittal of an approval of an amendment prior to the research Be aware of IRB approval expiration dates so that continuing review may be submitted in advance of expiration date with appropriate time for review.

IACUC IACUC SOPs: http://tulane.edu/asvpr/iacuc/index.cfm Apply to all activities involving vertebrate animals Sheila Garrison, IACUC Director and Chair; 504.988.6868; sgarriso@tulane.edu Georgina Dobek, DVM, Director of Department of Comparative Medicine; 504.988.5214; gdobek@tulane.edu Operate Tulane Vivariums Animal Procurement Animal husbandry Regularly scheduled monthly training programs and by request: https://tulanedcm.wufoo.com/forms/p1x3lavs1kl9pfw/ DCM upcoming trainings: Thursday, October 29, 2015 Wet Lab from 1pm-3pm on the Downtown Campus  Friday, November 20, 2015 Wet Lab from 10am-Noon on the Uptown Campus  Thursday, December 10, 2015 Wet Lab from 1pm-3pm on the Downtown Campus 

Institutional Biosafety Committee (IBC) The IBC reviews all activities involving rDNA, infectious agents (including select agents and toxins), and Dual Use Research of Concern (DURC). IBC Policies: http://tulane.edu/asvpr/biosafety/committee/policies.cfm Lucy C. Freytag, PhD; IBC Chair; lfreyta@tulane.edu; (504) 988-6772 Angie Birnbaum; Biosafety Officer; (504) 988-0300; birnbaum@tulane.edu

Conflicts of Interest (COI) COI Committee reviews potential financial conflicts of interest of researchers based on the COI disclosure forms submitted by researchers at least annually. Where a potential conflict exists, the COI Committee institutes a conflicts management plan when possible. http://tulane.edu/counsel/conflict-of-interest- policies.cfm Genean Mathieu, Administrative Compliance Specialist; 504.247.1286; gmathieu@tulane.edu

International Review Group (IRG) The IRG meets bi-weekly and reviews the following activities: Sponsored international research Unsponsored international research Academic activities with an international component, including: TU faculty, staff, and students going abroad Foreign nationals coming to Tulane as students, faculty, or staff. IRG members are a swath of administrators and faculty to facilitate international activities.

The IRG facilitates the following activities: International travel & personal baggage Project staffing Hiring foreign employees Deployment of University staff abroad Use of vehicles, equipment & assets abroad Establishing Tulane offices overseas Licensing requirements for foreign nationals who will have access to controlled technology Opening in-country bank accounts Formal collaboration, services or cooperation with foreign governments International shipment of goods Export controls Research Independent Contractor Agreements Purchased Services Agreements

Before undertaking international activity: Complete and submit an International Preliminary Project Questionnaire (“IPPQ”): http://tulane.edu/asvpr/ora/upload/IPPQ.pdf Completion of the form allows the IRG to facilitate the international activity, such as ensuring compliance with export control regulations. IRG Chair: Wade Wootan, JD; Global Affairs & Regulatory Compliance; wwootan@tulane.edu; 504.988.0598 Bring Copy of the IPPQ

Radiation Safety Committee Any activity involving the use of radiation must obtain a license from the Radiation Safety Committee prior to the start of the activity. License application: http://tulane.edu/oehs/radiation- material-licenses.cfm Radiation Safety Policies are online at http://tulane.edu/oehs/radiation/radiationsafety.cfm Natalie Lonsberry, Radiation Safety Officer, 504.988.2867; nlonsber@tulane.edu STATE REGULATIONS DRIVE RADIATION SAFETY