Research Personnel (Section 7)

7.2 Research personnel management for level I studies 

• Personnel changes to level I studies and for new level I, other than change in PI or external personnel, no longer need to be reported to the IRB. The PI continues to be responsible for personnel and ensuring that all personnel are properly trained; this includes the requirement to complete CITI training. There are no changes being made to personnel management processes for level II/III studies. 

7.3 What is required of the principal investigator?

• The requirements are detailed in the application’s Assurance Page, but in general the principal investigator has overall responsibility for the study and the ongoing conduct of the approved research. This includes completing an IRB application and obtaining IRB review/approval, including continuing review and amendments if necessary, and ensuring the research is conducted as described in the protocol. Finally, the principal investigator must ensure all personnel working on the project are adequately trained and knowledgeable about research procedures and the ethical conduct of research.

7.3 Minors: Are there any special requirements for minors working in my lab?

• Please review the KSU University Policy 5-19 Regarding Minors (http://www.kent.edu/policyreg/university-policy-regarding-campus-activities-  involving-minors) and complete any action that may be required of that policy. The minor must complete applicable training programs including CITI, lab specific training, and applicable training offered through Compliance and Risk Management. Additionally, the minor’s parent/guardian must complete a waiver that is available through Compliance and Risk Management.

7.4 Volunteers: Are there any special requirement for volunteers working in my lab?

• Please review the KSU Administrative Policy 6-04.4 Regarding Volunteers (http://www.kent.edu/policyreg/administrative-policy-regarding-volunteers), complete appendix B and indicate they are volunteers (this will add the personnel to the project  or change the status of the personnel), and complete the Volunteer Agreement form. The Volunteer Agreement form must be signed by your Chair or Dean and maintained in the investigator/department file for at least two years beyond the completion of the volunteer’s duties. The minor must complete applicable training programs including  CITI, lab specific training, and applicable training offered through Compliance and Risk Management.

7.5 I am new faculty at KSU or I am new to human subjects research, what are tips on getting started?

• We recommend starting by reviewing our IRB Help page  and completing CITI training. In most cases, if you completed CITI at another institute we will accept your certificate through its expiration date. You must change your affiliation to Kent State no later than your next required refresher.

7.6 I have an open project at my former institute. What do I need to do?

• In most cases you will need to seek approval of a new application or inter institutional authorization agreement from the KSU IRB if you want your former institute to remain as the IRB of record. Additionally, you should contact your former institute for guidance on their policies.

7.7 I have data that needs to be transferred from my former institute. What do I do? 

• In general, you will need to seek IRB approval prior to transfer and data should be managed as described in the in the protocol for which the data was collected under. Also, you should contact your former institute’s IRB (and funder if applicable) to ensure you are compliant with their rules.
• Coming soon - data security and use standards!

7.8 Leaving Kent State University?

• If your study is funded, contact Sponsored Programs. 
• PI leaving KSU: if an open project is to continue and the PI is leaving one of two actions typically happen. First, if KSU will continue to be the main contributor (including primary recipient of funds) a change in PI must be submitted. The person leaving KSU will need to be added as external personnel (using appendix B) and if they continue to be engaged in the research, an IAA must be completed. Second, if KSU will cease being the main contributor, the study must be closed and the PI needs to consult their new institute’s IRB. 
• Co-Investigators leaving: if an exiting Co-I continues to be engaged they will need to obtain their own  IRB approval or seek an IAA (IAA’s are mandatory for federally funded projects). Co-Is can be removed via the annual review form. If your study is not subject to annual review you do not need to notify the IRB. If they are no longer engaged, access should be revoked as described in the IRB application. If only using de-identified data, complete a de-identified data use agreement.
• If a student is to leave the institute and continue to be engaged in the research they will need to be added as external personnel (using appendix B). If they are unaffiliated after leaving KSU, they may be considered volunteers.
• Questions regarding data ownership, management, and use must be directed to your Department Chair or College Dean.

7.9 Do transcriptionists and translators need to be added to my protocol?

• Typically not. Transcriptionists and translators are not considered engaged so long as all of the following apply: their services do not merit professional recognition or publication rights, their services are typical of those performed for non-research purposes, and they are not administering a study intervention or being evaluated under a protocol. University Counsel requires the use of a confidentiality or non-disclosure agreement.