Who’s the Boss?

1. Who’s the Boss? Faculty Advisor or Principal Investigator Supervision versus Student Investigator or Study Coordinator Responsibilities Gwenn Snow, MS, RD, CIP IRB Program Manager Office of Human Research Protection University of Nevada, Reno

2. Introduction • Navigating the sometimes mysterious and often misunderstood processes for obtaining Institutional Review Board (IRB) approval can be a daunting task, even to the experienced investigator. • To the uninitiated, the mystery about and lack of familiarity with the IRB-approval process may be confusing and sometimes, intimidating. • To make a complex situation more challenging, regulatory requirements for the oversight of human subjects research have increased and the rules have changed. In fact, major changes are expected within the next couple of years.

3. Gather the Available Human Resources: Form a Team! • At a minimum, the team should include: • Faculty advisor or principal investigator • For student research, these are the same person. • Student investigator or study coordinator • IRB Program Manager from the Office of Human Research Protection • Members of the research team whose roles in the research are significant • Other faculty, colleagues and students with relevant expertise, including experience with the IRB

4. Faculty Advisor / PI Responsibilities: The Global View • Faculty advisors / PIs are educators, mentors and role models and are responsible for • Having a working knowledge about regulatory requirements involving the protection of human subjects • Ensuring students and research team members have the knowledge and skills required for their roles in the research • Overseeing all aspects of their students’ and their own research • “Setting the tone” for the conduct of research and their students’ and coordinators’ involvement in the IRB process • Demonstrating the importance of • Conducting research ethically • Protecting human research subjects

5. Student Investigator Responsibilities: The Global View • Students investigators are learners, apprentices and sponges and are responsible for • Pursuing their education, fulfilling degree requirements and managing their own research studies • Working with their advisors in planning, implementing and closing their research studies • Keeping their faculty advisors apprised of all aspects of the research • Enhancing their own understanding about • Ethical considerations for conducting research involving human subjects • Principles and regulations for protecting human subjects

6. Coordinator Responsibilities:The Global View • Coordinators are facilitators, liaisons and the PI’s right-arms and are responsible for • Organizing and managing the day-to-day activities and occurrences for clinical investigations • Establishing and maintaining communication among all parties involved including • PI and co-researchers • Research institution • Sponsor • IRB • Keeping the PI apprised of all aspects of the research • Ensuring the research meets the regulatory requirements and standards for • The ethical conduct of research • The protection of human subjects

7. Advisor and PI Responsibilities: The Basics • Faculty advisors / PIs are responsible for • Mentoring students and junior investigators in scientific professionalism, and oral and written communication • Enhancing students’ and coordinators’ understanding of the scientific method • Ensuring the soundness and scientific validity of the design of their students’and their own research • Encouraging students and coordinators to work with the IRB in developing, preparing and maintaining IRB protocols • Making sure that students and coordinators have the resources necessary to conduct the research

8. Student Investigator / Coordinator Responsibilities: The Basics • Student investigators and clinical coordinators are responsible for • Educating themselves about research methods and design in general, and specific to the research • Familiarizing themselves with and applying the professional standards of their discipline • Developing research that is compliant with regulatory requirements • Working with the IRB in the preparation of IRB protocols • Implementing the research as described in their IRB protocols • Obtaining the resources necessary for the research, including facilities for storing data securely

9. Faculty Advisor / PI Responsibilities: The Specifics • Faculty advisors and PIs must agree to • Meet regularly with student investigators and coordinators, from development through completion of the research • Assist the student investigator and coordinator (as indicated) in thoroughly assessing risks and benefits of the research • Insure student investigators and coordinators have a good understanding of the following: • Study procedures • Informed consent requirements • Anticipated adverse events associated with study participation and steps for reducing these anticipated risks • Adverse event reporting requirements • Data collection and record-keeping methods and procedures • Emphasize the importance of • Equity in subject selection • Voluntariness of participation • Informed consent • Minimization of risks and maximization of benefits to human subjects • Adherence to research protocols • Subject privacy • Data confidentiality

10. Student Investigator / Coordinator Responsibilities: The Specifics • Student investigators / coordinators must agree to • Meet regularly with faculty advisors / PIs, from development through completion of the research study • Inform faculty advisors / PIs about • Implementation and progression of the research • Planned amendments to the research • Co-researcher conduct • Reportable events • IRB review activities and determinations • Sufficiently inform subjects about the research so they may make an informed decision about their participation including their continuation • Maintain accurate and complete research records including • Research data • Consent documents • IRB applications and correspondance • Provide faculty advisors / PIs with access to all research records

11. Responsibilities Shared by All Researchers • All researchers must • Establish reasonable timelines for • Designing and developing the research study • Meeting requirements for human research protection training • Preparing the IRB protocol and supplemental materials • Initiating and completing the IRB review process • Recruiting subjects • Obtaining informed consent from subjects • Collecting and analyzing the data • Responding to IRB requests for information and revisions • Writing reports and manuscripts • Write IRB protocols and supplementary materials to be clear, concise and complete • Provide all requested documents and related appendices • Complete IRB requests for information and protocol renewals before stated deadlines • Abide by all IRB determinations and requests

12. IRB Coordinator and Program Manager Responsibilities • IRB Coordinators / Program Managers agree to • Remain up-to-date with regulatory requirements for human research protection and communicate changes to constituents • Advise faculty, PIs, student investigators, and coordinators about regulatory and compliance matters related to their IRB protocols • Be available to meet with constituents during all stages of the IRB review and approval processes • Answer questions from faculty advisors, PIs, student investigators, and coordinators related to human subjects research • Assist faculty advisors, PIs, student investigators, and coordinators in the preparation and submission of • New IRB protocols • Protocol amendments • Protocol renewals and closures • Reports of problems and adverse events • Suggest tools and methods for keeping accurate and complete research records • Provide faculty advisors, PIs, student investigators and coordinators with copies of IRB-related correspondence required for their records

13. Office of Human Research Protection Responsibilities • The University of Nevada, Reno Office of Human Research Protection (OHRP) is responsible for • Developing and making available policies, procedures and guidance for human subject research • Ensuring policies, procedures and guidance reflect current regulatory requirements • Routinely conducting quality assurance and improvement activities (QA/QI) for • Investigators • IRB members • OHRP personnel • Informing constituents, administrators and regulatory bodies about QA/QI findings