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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

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department administration and compliance office the optimal partnership

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
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 partner1
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
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
Identification of Compliance Area(s)
  • Human Subjects
  • Animals
  • Bio-safety
    • DNA
    • Hazard Materials
    • Infectious Diseases
  • Conflict of Interest
identification of compliance area s1
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
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
Department Responsibilities
  • Know Sponsor Guidelines
  • Proposal Submission vs. JIT
  • Establish Timelines
  • PI or DRA
  • Coordination with Compliance Office
sponsor guidelines
Sponsor Guidelines
  • Requirements may Differ
  • Know Sponsor-specific Requirements
    • Proposal Stage
    • Award Stage
  • Federal vs. Non-Federal
    • Approved
    • Pending
requirements at proposal stage
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
Timelines
  • Set Realistic Deadlines for:
    • Principal Investigator
    • Proposal Development
    • Compliance Office
    • Sponsored Projects Office
    • Funding Agency
timelines1
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
Working with Investigators
  • University-specific procedures
  • Clearly defined and explained
    • Website
    • Brochures/Written Materials
    • Seminars
  • Multiple Protocols – Who identifies the right one
working with investigators1
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
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
thank you
Thank You!
  • Candyce Lindsay

Candyce.Lindsay@asu.edu

480-965-8016

  • Vicki Krell
  • Vicki.Krell@asu.edu
  • 480-965-2171