2. 1 Developed by: U-MIC To start the presentation, click on this button in the lower right corner of your screen. The presentation will begin after the screen changes and you press enter.

3. PRINCIPAL INVESTIGATOR RESPONSIBILITIES per the HRPP Operations Manual and the Common Rule Developed by: U-MIC University of Michigan IRB Collaborative

4. PI responsibilities HRPP Operations Manual Part 6: Roles and Responsibilities of Investigators and Research Staff Principal Investigators (PIs) Other requirements may apply. o past U-MIC presentations: FDA Guidance: Investigator Responsibilities — Protecting the Rights, Safety, and Welfare of Study Subjects Department of Defense Research (Parts One and Two) 3 Developed by: U-MIC

5. PI responsibilities Who is eligible to serve as PI? University faculty and staff (non-temporary) trainees (with sponsorship by mentor) others (with sponsorship by UM faculty or staff) Mentors should appear as faculty advisors in eResearch. 4 Developed by: U-MIC

6. PI responsibilities General responsibilities knowledge of/compliance with Common Rule (45 CFR 46 Subpart A), as well as Institutional policies and procedures ultimate responsibility for proper conduct of study and fulfillment of all associated obligations 5 Developed by: U-MIC

7. PI responsibilities Minimizing risks and protecting subject rights and welfare protocols that comply with ethical principles, regulatory requirements, and Institutional policies procedures that are consistent with sound research design o reasonable expectation that study will answer proposed question o anticipated knowledge is sufficiently important to justify research equitable subject selection procedures already performed for diagnostic and treatment purposes (whenever possible) evaluation of resources at research site(s) protection of privacy and confidentiality additional safeguards for vulnerable subjects 6 Developed by: U-MIC

8. PI responsibilities Compliance with IRB and other review unit requirements Consult with IRB to ensure activities that meet definition of human subjects research undergo review and approval (or are determined to be exempt) before initiated. Cooperate with IRB in terms of initial and continuing review, monitoring, record keeping, and reporting. o Provide information requested IRB in a timely fashion. o Conduct research as specified in IRB-approved protocol.  Any proposed changes must be approved in advance by IRB unless necessary to eliminate apparent immediate risks to subjects. o Comply with IRB determinations, including directives to terminate participation in designated research activities. o Report unanticipated problems involving risks to subjects or others, ORIOs, and adverse events; revise risk information in consent and other study materials as appropriate. o Report potential noncompliance with applicable laws or regulations or IRB requirements, whether by investigators, research staff, or others. 7 Developed by: U-MIC

9. PI responsibilities Obtaining and documenting informed consent Consent is not a single event or document, but an ongoing process. Obtain and document consent of each subject (or subject’s LAR) before research begins, unless IRB has issued waiver or alteration of consent or waiver of documentation. Convey information in language that is understandable to potential subjects. Ensure consent is sought under conditions that minimize possibility of undue influence or coercion. Include all basic elements of consent and additional elements if applicable. 8 Developed by: U-MIC

10. PI responsibilities Conflict of interest disclosures UM policy on conflicts of interest o http://www.provost.umich.edu/programs/COI_COC/ http://www.provost.umich.edu/programs/COI_COC/ As long as conflicts are reported and managed or resolved, they do not distort (and can benefit) the research process. When in doubt, disclose. 9 Developed by: U-MIC

11. PI responsibilities Accountability and administrative requirements Perform or delegate to qualified research staff all tasks that are necessary to carry out study. Provide members of research team with sufficient information and training to facilitate protocol adherence. Cooperate with evaluations, inspections, and audits performed by authorized external reviewers or internal oversight authorities. Inform IRB of disapprovals, suspensions, or terminations of project. Create and securely maintain accurate records. 10 Developed by: U-MIC

12. PI responsibilities Education Program for Education and Evaluation in Responsible Research and Scholarship (PEERRS) “Human Subjects” module Ensure that personnel complete PEERRS certification, as required. The UM IRBs and other HRPP components provide workshops, seminars, and one-on-one training (please see Education link at: http://www.hrpp.umich.edu /). http://www.hrpp.umich.edu / 11 Developed by: U-MIC

13. PI responsibilities 12 Developed by: U-MIC Principal Investigator responsibilities per the HRPP Operations Manual and the Common Rule Operations Manual: http://hrpp.umich.edu/om/Part6.htmlhttp://hrpp.umich.edu/om/Part6.html HHS Common Rule: http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html#subpartahttp://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html#subparta UM Policy on Faculty Advisors: http://irb.umich.edu/policies/facultyadvisors.pdfhttp://irb.umich.edu/policies/facultyadvisors.pdf PEERRS: http://my.research.umich.edu/peerrs/http://my.research.umich.edu/peerrs/

14. THANK YOU. Adam Mrdjenovich IRB-HSBS Brian Seabolt IRBMED 13 Developed by: U-MIC