1. WEST VIRGINIA UNIVERSITY Office of Research Integrity and Compliance West Virginia University Office of Research Integrity and Compliance New Faculty Overview Spring 2016

2. WEST VIRGINIA UNIVERSITY Office of Research Integrity and Compliance CONSIDERING RESEARCH? (ORIC) The West Virginia University Office of Research Integrity and Compliance (ORIC) operates as a facilitator, an educator, and a resource center, helping the West Virginia University research community navigate the complex regulatory landscape governing higher education institutions. Our Core Areas include: (IRB)  Human Research Protections (IRB) (IACUC)  Animal Care and Use (IACUC) (COIR)  Conflict of Interest in Research (COIR) (RCR)  Responsible Conduct of Research (RCR) Services Offered by the Office of Research Integrity and Compliance:  IRB and Protocol Development Assistance using the WVU+kc system  IACUC and Protocol Development Assistance  Individual and group training sessions to fulfill federal and institutional requirements in each of the core areas

3. WEST VIRGINIA UNIVERSITY Office of Research Integrity and Compliance HUMAN SUBJECTS RESEARCH The purpose of the Human Subjects Protection at West Virginia University is to provide appropriate protection to all volunteer subjects enrolled in research. This goal is met by providing review and approval by the Institutional Review Board (IRB) of all research involving human subjects before projects are initiated, as well as continuing review and monitoring of approved studies. In this way, the university ensures that research is conducted in accordance with the ethical principles of autonomy, beneficence and justice as set forth in the Belmont Report, and in compliance with internal policies and federal regulations.Belmont Report In June 2008, WVU earned full accreditation from the Association for the Accreditation of Human Research Protection Programs Inc. (AAHRPP), a nonprofit organization that maintains rigorous standards to protect human participants in research. The voluntary accreditation process ensures adherence to rigorous standards of accountability in the conduct of research with human subjects.AAHRPP

4. WEST VIRGINIA UNIVERSITY Office of Research Integrity and Compliance Does your work involve human subjects? YES Requires IRB Review Complete required training for working with human subjects Complete required training for working with human subjects Submit protocol via WVU+kc for IRB Review Submit protocol via WVU+kc for IRB Review AND CITI Training Proceed with project once you receive approval from IRB Do you need to make changes to approved research? Do you need to make changes to approved research? YES Requires IRB Review Submit change of protocol via WVU+kc Submit change of protocol via WVU+kc

5. WEST VIRGINIA UNIVERSITY Office of Research Integrity and Compliance HUMAN RESEARCH PROTECTIONS PROGRAM (HRPP) OVERVIEW Step 1: CITI Training To begin your study review process with the IRB, your first step should be to complete the appropriate ethics training via the CITI Program. To register for training http://www.citiprogram.org and Log in through my institution via SSO.http://www.citiprogram.org All researchers should complete either the Biomedical Research Investigators (if you are in a medical field) or the Social and Behavioral Research Investigators course. These courses can be found under the Human Research section of the course registration screen. Step 2: WVU+kc Training The next step is to complete the KC IRB submission system training by visiting kuali.wvu.edu, click on the WVU+kc Training tab, and go to IRB Protocol Training. You will find a link to a training video on this page. Please watch the video then complete the short test in order to submit your request for access to create protocols.kuali.wvu.edu Step 3: Create Your Protocol Once you’ve completed the ethics and system training steps, you can begin creating your protocol. To do so, you’ll need to login using your WVU MyID and password at kc.wvu.edu.kc.wvu.edu

6. WEST VIRGINIA UNIVERSITY Office of Research Integrity and Compliance HRPP/IRB CONTACT INFORMATION Lilo Ast, M.A. Senior Program Coordinator lilo.ast@mail.wvu.edu | (304) 293-7555 lilo.ast@mail.wvu.edu(304) 293-7555 Responsibilities: Full Board Reviews / Deviations / Adverse Events / UPIRTSOs / Emergency Use Sarah Stutler, MBA, CCRP IRB Coordinator sarah.stutler@mail.wvu.edu | (304) 293-1119 sarah.stutler@mail.wvu.edu(304) 293-1119 Responsibilities: Expedited Reviews / RCR Afton Wagner IRB Administrator Afton.Wagner@mail.wvu.eduAfton.Wagner@mail.wvu.edu | (304) 293-5923(304) 293-5923 Responsibilities: IRB CITI training / Exempt Reviews / NHSR

7. WEST VIRGINIA UNIVERSITY Office of Research Integrity and Compliance ANIMAL CARE & USE The West Virginia University Institutional Animal Care and Use Committee (IACUC) oversees the animal programs, facilities and procedures at WVU, insuring the health and well-being of all animals being used for research, testing, and education. The IACUC serves as a resource to investigators, technicians, students, staff and administrators, providing guidance in fulfilling the obligation to plan and conduct all animal use procedures with the highest scientific, humane, and ethical principles. The IACUC is appointed by the Institutional Official, the Vice President for Research at WVU and includes scientists, veterinarians, non-scientists, and local community representation. The IACUC reviews all proposals for animal use and monitors animal activities to ensure compliance with regulatory requirements and established standards. West Virginia University recognizes and embraces the fundamental interdependence of humans and animals and is committed to humane care and use of all animals. Animal-related activities are an essential part of WVU’s teaching, research and outreach missions and help WVU advance the quality of life for people and animals. Animal activities at WVU are conducted in a manner that is compliant with the humane care and management practices required by standards and regulations promulgated under the Animal Welfare Act, the Public Health Service Policy on Humane Care and Use of Laboratory Animals, the Guide for the Care and Use of Laboratory Animals, and the Guide for the Care and Use of Agricultural Animals in Research and Teaching. WVU has established an IACUC in accordance with all of the above listed standards and regulations.

8. WEST VIRGINIA UNIVERSITY Office of Research Integrity and Compliance Does your work involve vertebrate animals? YES Requires IACUC Review Complete required training for working with animals Complete required training for working with animals Submit protocol via IACUC website Submit protocol via IACUC website AND Training Proceed with project once you receive approval from IACUC Do you need to make changes to approved research? Do you need to make changes to approved research? YES Requires IACUC Review

9. WEST VIRGINIA UNIVERSITY Office of Research Integrity and Compliance ANIMAL CARE AND USE OVERVIEW Step 1: CITI Training  Go to https://www.citiprogram.org/https://www.citiprogram.org/  Click Log in through my institution via SSO, if you already have a username and password OR click ‘Register’ to create an account.  Click the course name(s) you need to complete under “West Virginia University Courses” and complete the course(s).  If the course(s) you need to take is/are not listed, click ‘Add a Course or Update Learner Group’ in the box at the bottom labeled “My Learner Tools for West Virginia University”.  Choose the course(s) that you need to take by adding a checkmark in the box associated with the course(s) Step 2: Occupational Health Questionnaire  Anyone working with animals in any setting is required to complete the Occupational Health Questionnaire, which needs to be updated on an annual basis and records of occupational health clearance are maintained by the Office of Research Integrity and Compliance and WVU Occupational Medicine.  Instructions for completing the Occupational Health Questionnaire Go to https://sole.hsc.wvu.edu/apps/animalsurvey/https://sole.hsc.wvu.edu/apps/animalsurvey/ Complete the survey. If you receive a notice that you are NOT cleared for animal contact, please call WVU Occupational Medicine at(304) 293-3693 OR call Well WVU (Student Health) (304) 293-2311 if you are a student.(304) 293-3693(304) 293-2311

10. WEST VIRGINIA UNIVERSITY Office of Research Integrity and Compliance ANIMAL CARE AND USE OVERVIEW (CONT.) Step 3:  Download the most current version of the main IACUC protocol here.here  Depending on the type of research you may need to use multiple appendices, Appendix A - O.  Submit completed protocol to the IACUC office mhollander@mail.wvu.edu or izfonsecabarbosa@mail.wvu.edu. mhollander@mail.wvu.edu izfonsecabarbosa@mail.wvu.edu  The Protocol will receive a pre-review from the administrative staff which may require some changes from you prior to submission to the IACUC.  After approval of the protocol, any changes to the protocol will require an Amendment, see our instructions here.here  Protocols will need to be renewed every three (3) years if using non-USDA covered species (i.e. rodents, birds) or annually if using USDA covered species (i.e. Dogs, sheep)

11. WEST VIRGINIA UNIVERSITY Office of Research Integrity and Compliance IACUC CONTACT INFORMATION Melinda Hollander, M.S., CPIA Animal Care and Use Officer melinda.hollander@mail.wvu.edu | (304) 293-9368 melinda.hollander@mail.wvu.edu(304) 293-9368 Responsibilities: Animal Studies (IACUC) Izabella Fonseca Barbosa Administrative Assistant izfonsecabarbosa@mail.wvu.edu | (304) 293-1050 izfonsecabarbosa@mail.wvu.edu(304) 293-1050 Responsibilities: IACUC Support

12. WEST VIRGINIA UNIVERSITY Office of Research Integrity and Compliance CONFLICT OF INTEREST IN RESEARCH (COIR) West Virginia University encourages its Faculty, Students and Staff to participate in research activities and to do so with the highest ethical standards. While the potential for Conflicts of Interest to arise is understandable, Investigators must strive to limit introduction of bias into their research. The Office of Research Integrity and Compliance has created guidelines that serve to educate the WVU academic community about Federal and institutional requirements concerning conflict of interest. Financial conflict of interest in research involves situations in which a researcher has a significant financial interest that may compromise, or have the appearance of compromising, professional judgment in the design, conduct, or reporting of research. A significant financial interest could include personal compensation from industry, equity interest or a management role in a company, or royalties generated from intellectual property rights.

13. WEST VIRGINIA UNIVERSITY Office of Research Integrity and Compliance Do you conduct or plan to conduct research at WVU? Complete required CITI Training Complete required CITI Training YES Requires annual DOIR form YES Requires annual DOIR form Submit DOIR form via website if you conduct any research at WVU regardless of funding or funding source Submit DOIR form via website if you conduct any research at WVU regardless of funding or funding source Training Proceed with research once conflict of interest disclosure and training requirements are fulfilled and approved Do have a new financial interest to report? YES Requires DOIR form update and review YES Requires DOIR form update and review Do you receive or plan to apply for PHS funding? Yes No Conflict of Interest requirements must be fulfilled at the time of OSP project or IRB/IACUC protocol SUBMISSION.

14. WEST VIRGINIA UNIVERSITY Office of Research Integrity and Compliance COIR OVERVIEW Step 1: Complete Required CITI Training if you receive or plan to receive PHS funding To access the required COIR training, go to the CITI Website at https://www.citiprogram.org/.https://www.citiprogram.org/  Log into your CITI account.  Choose “Add a course or update your learner groups for West Virginia University”  On Question 2, “Conflict of Interest” Check the box labeled “Conflict of Interest”  Click on “Continue” at the bottom and complete the required modules. Step 2: Complete your Annual Conflict of Interest in Research Form (DOIR) All members of the WVU research Community are required to file a DOIR form annually, and on an ongoing basis within 30 days of discovery or acquisition of a new financial interest. Further, Investigators should review and make any necessary revisions to the annual DOIR form:DOIR  With each new, continuation, or revised grant or contract application submitted to the Office of Sponsored Programs,  With each new protocol involving animal or human subjects, and;  When there is a new or previously unrecognized financial interest not reported on the annual DOIR.

15. WEST VIRGINIA UNIVERSITY Office of Research Integrity and Compliance COIR CONTACT INFORMATION Joy Edwards Conflict of Interest in Research Officer Joy.Edwards@mail.wvu.edu | (304) 293-5475 Joy.Edwards@mail.wvu.edu(304) 293-5475 Responsibilities: Conflict of Interest (COI)

16. WEST VIRGINIA UNIVERSITY Office of Research Integrity and Compliance RESPONSIBLE CONDUCT OF RESEARCH (RCR) A central focus of the Office of Research Integrity and Compliance (ORIC) is to foster the responsible conduct of research and provide support for West Virginia University faculty, staff and students in their research endeavors through training, education and consultation. Required RCR training is dependent on the following sponsor requirements:  NSF - undergraduate students, graduate students, and postdoctoral researchers  NIH - Trainees, Fellows, & Scholars  USDA/NIFA – Principal Investigators, Co-PIs, Program Directors, Co-PDs prior to proposal submission and all others named above, after awarded proposal PI Responsibilities – Identifying all other persons [faculty, students (undergraduates and graduates), postdoctoral researchers and any staff] who will be participating in the project, and – Ensuring their timely RCR training prior to participation or payment from the project. Participant Responsibilities – Each Student or Participating Individual supported by an NSF or NIFA grant must complete the required training within 30 days following addition to the proposal.

17. WEST VIRGINIA UNIVERSITY Office of Research Integrity and Compliance RESPONSIBLE CONDUCT OF RESEARCH (RCR) OVERVIEW Step 1: Identify the funding source  NIH, NSF, USDA/NIFA Does my proposal require RCR Training? What personnel are required to completed RCR training? Step 2: Meet Training Requirement  Core Education Online RCR Course (CITI) Biomedical Sciences 700 Course  Optional Education “The Lab” Interactive Learning Simulation Case Study Videos The Research Clinic

18. WEST VIRGINIA UNIVERSITY Office of Research Integrity and Compliance RCR CONTACT INFORMATION Sarah Stutler, MBA, CCRP IRB Coordinator sarah.stutler@mail.wvu.edu | (304) 293-1119 sarah.stutler@mail.wvu.edu(304) 293-1119 Responsibilities: Expedited Reviews / RCR

19. WEST VIRGINIA UNIVERSITY Office of Research Integrity and Compliance GENERAL ORIC ADMINISTRATION CONTACTS Daniel Vasgird, Ph.D. Director, Office of Research Integrity and Compliance drvasgird@mail.wvu.edu | (304) 293-6094 drvasgird@mail.wvu.edu(304) 293-6094 Deyanira Santiago, MBA, RLATg Assistant Director, Office of Research Integrity and Compliance disantiago@mail.wvu.edu | (304) 293-5791 disantiago@mail.wvu.edu(304) 293-5791 Tracye Tennant Administrative Secretary Tracye.Tennant@mail.wvu.edu | (304) 293-7073 Tracye.Tennant@mail.wvu.edu(304) 293-7073 Responsibilities: Primary Contact, Accounting