1. Department Administration and Compliance Office: The Optimal Partnership! Candyce Lindsay, CRA Assistant Director Office of Research Integrity and Assurance Arizona State University Vicki Krell, CRA Research Advancement Supervisor College of Liberal Arts and Sciences, Dean’s Office Arizona State University

2. Why Partner The Compliance office within a research institution serves a critical function to assure ethical research practices are implemented, and that governing laws are followed, thus not jeopardizing the research or the institution.

3. Why Partner • Compliance office is designed as the one stop shop for departmental administrators and researchers to collaborate on the varied areas of research compliance • DRA’s do not have to know the in’s and outs of the compliance areas, but need to know the resources available to them

4. When the Two Meet • Compliance office provides guidance to dept. administration during: • Proposal stage • RFP/Contract/MTA • Setting up sponsored award • Non-funded research activity • Compliance Resources are available at the University/Institution in all areas

5. Identification of Compliance Area(s) • Human Subjects • Animals • Bio-safety • DNA • Hazard Materials • Infectious Diseases • Conflict of Interest

6. Identification of Compliance Area(s) • Export Control • I-129 Certifications • Responsible Conduct of Research (RCR) • Misconduct in Research • Other Institutional issues • ASU Native American Studies requirement, etc.

7. Compliance Office Responsibilities • OLAW Regulations compliance • OHRP-Federal Wide Assurance Compliance, USDA, HIPAA etc • NSF and 42 CFR PART 50 Compliance • ITAR/EAR compliance • And several other regulations/policies based on the area of compliance

8. Department Responsibilities • Know Sponsor Guidelines • Proposal Submission vs. JIT • Establish Timelines • PI or DRA • Coordination with Compliance Office

9. Sponsor Guidelines • Requirements may Differ • Know Sponsor-specific Requirements • Proposal Stage • Award Stage • Federal vs. Non-Federal • Approved • Pending

10. Requirements at Proposal Stage • Approved Protocol Prior to Submission • ASU requests American Indian involvement compliance prior to award • Just in Time (JIT) • Includes most Compliance areas

11. Timelines • Set Realistic Deadlines for: • Principal Investigator • Proposal Development • Compliance Office • Sponsored Projects Office • Funding Agency

12. Timelines • Protocol Application • Consider time it takes to get through the process • Consider whether new or renewal application • Learn your institution’s protocol committee(s) meeting schedules so you can help researchers plan ahead

13. Working with Investigators • University-specific procedures • Clearly defined and explained • Website • Brochures/Written Materials • Seminars • Multiple Protocols – Who identifies the right one

14. Working with Investigators • Know the Application Process • New • Renewal • PI Eligibility on Protocol • Tenured/Tenure Track • Adjunct • Emeritus • Graduate Students • Postdocs • Clearly Delineated Responsibilities

15. Working with Compliance Office • Partnership – Nurture and Maintain that Relationship! • Work as a team to ensure PI is in compliance, and that you have what you need • Take advantage of training, brown-bags, seminars, networking opportunities • Stay Current - bookmark your compliance office website…new info is always posted

16. Questions?

17. Thank You! • Candyce Lindsay Candyce.Lindsay@asu.edu 480-965-8016 • Vicki Krell • Vicki.Krell@asu.edu • 480-965-2171