Volume 3, Issue 4
In this issue:
- When a Principal Investigator leaves UT
- Training and Outreach Opportunities
- IRB Metrics
- Contact Us
This month’s issue includes updates on regulatory requirements and guidance regarding recruitment methods. Also, the office continues to see a reduction in review turnaround times.
– HRPP Staff
When a Principal Investigator Leaves UT
Often principal investigators (PIs) leave an institution without effectively managing their research studies. PIs are responsible for ensuring the disposition of their studies prior to their departure. Likewise, faculty advisors and department administrators have a responsibility to ensure these duties are carried out before the PI leaves.
Below are the procedures required for studies involving human research participants. Please consider the status of the study as well as the PI’s future plans related to the study.
If all study activities have been completed and no research data/specimens will be transferred to a new institution, submit a Form 7 Study Closure Form in iMedRIS. All consent documents must be deposited with the departing PI’s faculty advisor or department head.
Study Active – PI No Longer Involved in Study:
If the study will remain active at UT and the departing PI will have no further involvement with the study, submit a Form 2 Change Request in iMedRIS to assign a qualified individual as the new PI. Revise any documents (consent documents, recruitment materials, etc.) to list the new PI’s name and contact information. Confirm in the Form 2 that all study records and data have been deposited with the new PI.
Study Active – PI Continues Involvement in Study:
If the study will remain active at UT and the departing PI will continue as part of the research team, submit a Form 2 Change Request in iMedRIS to:
- assign a qualified individual as the new PI, and
- explain the departing PI’s new role, including a description of any continued access to identifiable data or specimens, and
- confirm that all study records and data have been deposited with the new PI or explain any alternate arrangements.
- list the departing PI’s new contact information and institutional affiliation, and
- submit a copy of the departing PI’s IRB approval from his/her new institution, and
- revise any documents, such as consent documents, recruitment materials, etc., to list the new PI’s name and contact information.
Transfer of Research Data/Specimens to a New Institution: Any departing investigators
wanting to transfer research records, data and/or specimens to a new institution must do the following:
- Contact the IRB to determine next steps. The IRB is obligated to ensure protections promised to research participants are maintained.
- Contact Robert Nobles (firstname.lastname@example.org, 865-974-3053) Associate Vice Chancellor of Research, to ensure all university requirements are met.
- Other Issues: Should a departing investigator encounter an issue not covered in the above procedures, please contact the IRB.
Training and Outreach Opportunities
Check out scheduled training sessions posted on ORE’s Training and Workshops website as details become available.
The chart below shows the number of new submissions received by the IRB during April 2017 compared to the number submissions received during the preceding year.
April 2017 – A total of 385 submissions were received compared to 326 during April 2016.
Turnaround Time Averages
The chart below shows the average review time for all submissions on a monthly basis during the past year.
April 2017 – Average review turnaround time for all submissions during March improved by several days – from 12 days in 2016 to 7 days in 2017. March review times demonstrate the continuing trend of reduced turnaround time.
Submissions by College
The chart below show the number of submissions from each college.
Newsletter Archives – View past issues of our newsletter archived on http://irb.utk.edu/.
If you have questions or concerns, please do not hesitate to contact any of our team members.