Research Personnel | Office of Research Compliance | Kent State University

Research Personnel

  • Who is considered an investigator?
    • The HHS regulations at 45 CFR part 46 use the term “investigator” to refer to an individual performing various tasks related to the conduct of human subjects research activities, such as obtaining informed consent from subjects, interacting with subjects, and communicating with the IRB. Investigators can include physicians, scientists, nurses, administrative staff, teachers, and students, among others. Some research studies are conducted by more than one investigator, and usually one investigator is designated the “principal investigator” with overall responsibilities for the study. In every human subjects research study, investigators have certain responsibilities regarding the ethical treatment of human subjects.
    • For the purposes of the HHS regulations, OHRP interprets an “investigator” to be any individual who is involved in conducting human subjects research studies. Such involvement would include:
      • obtaining information about living individuals by intervening or interacting with them for research purposes
      • obtaining identifiable private information about living individuals for research purposes;
      • obtaining the voluntary informed consent of individuals to be subjects in research; and
      • studying, interpreting, or analyzing identifiable private information or data for research purposes
  • 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 and knowledgeable about research procedures and the ethical conduct of research.
  • 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.
  • 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.
  • 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 (including the video overview) 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.
  • 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.
  • I have data that needs to be transferred from my former institute. What do I do? 
    • Please reach out to the Office of Research Compliance for guidance. In general, you will need to seek IRB approval 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.
  • 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 there are one of two things 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 a 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.