Responsible Conduct of Research
All individuals involved in research are required to complete the CITI Responsible Conduct of Research course before performing research activities. This requirement also applies to faculty mentors listed in the IRB application who are responsible for the conduct of research for their students. Re-certification is required every 4 years.
- Responsible Conduct of Research (CITI)
Trainees who receive National Science Foundation (NSF), National Institute of Health (NIH) or other support from a training grant may be required to complete additional, in person, discussion-based RCR training. The University of Pittsburgh Clinical & Translational Science Institute (CTSI) holds RCR Center workshops which may meet these requirements. If you have any questions about this additional requirement, contact Karen Schmidt at firstname.lastname@example.org.
Conflict of Interest
The University of Pittsburgh COI Policy (11-01-03) requires that all investigators who are externally funded (regardless of funding source) must complete the CITI COI course. For successful new applications for research funding that are submitted after February 1, 2017, regardless of sponsor, release of funding will be contingent upon all investigators on the project having completed COI training within 4 years of when the award is executed and before initiating research. This supersedes the previous requirement that training be completed prior to submission of a research funding application. Re-certification is required every 4 years.
- Conflict of Interest (CITI)
NOTE: Many investigators who are not supported by agencies of the Public Health Service (PHS) have completed an ISER module to fulfill their COI training requirement. Those investigators are now required to complete the CITI COI Course by February 1, 2018, or prior to commencing work on a PHS-funded research project (whichever comes first).
Investigator includes any individual, regardless of title or position, who is (or may be perceived to be) independently responsible for or significantly influences, the design, conduct or reporting of the research.
The Principal Investigator (PI) is responsible for identifying the individuals who meet this definition (see guidance below). When funding is awarded, the PI must provide the Office of Research with a list of those who meet this definition and the date of completion of the CITI COI course. It is the responsibility of the PI to maintain a copy of the course completion certificates on file for all investigators and to update the list as personnel changes occur.
Individuals who conduct research without any external funding do not need to complete the COI training module unless they have disclosed outside financial interests on their University faculty Researcher COI disclosure form or have been directed by their department chair or dean to complete COI training.
Guidance to address who is an investigator:
This is a guidance tool and may not capture all scenarios /description of an investigator. It is better to complete the training if there is any uncertainty.
The Principal Investigator, any Co-Investigator and any others who are independently responsible for or who have or may acquire the authority from the PI to significantly influence the direction of the research, data acquisition, method and analysis of the research are considered Investigators.
Any Co-Investigator and any others who may be a co-author on manuscripts or presentation of the research findings are considered Investigators (this also includes students who meet this definition).
Senior/Key Personnel who are identified on a grant or funding application or report as contributors to the research are considered Investigators whether or not they receive salary support.
Collaborators and consultants at the University of Pittsburgh who are independently responsible for or significantly influence any portion of the research, data acquisition, or method and analysis of the research are considered Investigators.
Sub-recipients, collaborators and consultants outside of the University of Pittsburgh who are performing PHS funded research on behalf of Pitt who are independently responsible for or significantly influence any portion of the research, data acquisition, or method and analysis of the research are considered Investigators and must complete COI training. The University of Pittsburgh will accept COI training from outside Institutions that have PHS-compliant policies. If the outside institution does not have a PHS-compliant COI policy, the Investigator must complete Pitt’s CITI COI training module.
Postdoctoral students and Clinical fellows may be considered Investigators depending on their ability to independently and significantly influence the research. This should be determined by the PI on a case by case basis.
If an investigator leaves the University before the research is published and he/she is included as an author, the COI training must have been complete at the time the work was done that contributes to the paper. Retraining after departure from the Institution is not required.
The following are not usually considered Investigators:
Consultants who provide a “fee for service” only and do not conduct the research are not considered Investigators.
Administrators or individuals who perform routine or supportive tasks related to the research are not considered an Investigator.
More information is available on the Pitt COI office website.