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

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.

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

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

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

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.

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

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

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

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

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

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

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

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

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

Questions?

Thank You! Candyce Lindsay Vicki Krell