Key Personnel - Definition, Responsibilities, and Training
Key personnel are those who have authority or responsibility for the design or management of a project, as well as those involved in recruitment, data collection and management activities, including those responsible for maintaining participant privacy or data confidentiality. Key personnel must have training on file in the IRB Office.
Individuals who typically do not require training are staff involved only in the analysis or management of de-identified datasets, individuals providing video services, or individuals in the community who distribute written materials or make announcements about the study according to written script(s) provided by the research team. Any person who actually explains the study for recruitment purposes or attempts to answer questions about the research must receive training before doing so.
Investigator Responsibilities
All members of the UNI community are responsible for promoting good ethics in research. Principal investigators are responsible for overseeing and maintaining ethical procedures in all projects under their purview.
Researchers contemplating research involving human participants are required to submit an application to the IRB for review and approval before initiating each project. This requirement encompasses a variety of research activities that can range from the simple use of surveys or interview procedures to more complex activities such as treatment interventions. All research must be conducted in accordance with the following documents.
The Belmont Report - This report is a summary of the basic ethical principles identified by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.
Federalwide Assurance - FWA00002159 - This agreement between UNI and the Office for Human Research Protections (OHRP) of the Department of Health and Human Services assures that investigators conducting human participant research at UNI will follow the ethical principles outlined in the Belmont report.
The Code of Federal Regulations for the Protection of Human Subjects, Title 45 CFR Part 46 - These are federal regulations that describe general standards for the composition, operation, and responsibility of an Institutional Review Board. Compliance with these regulations is intended to protect the rights and welfare of human participants involved in research projects. In some cases, other federal regulations will apply as well.
UNI IRB Policies and Procedures – This outlines all of the requirements for human participants research at UNI. It encompasses and is largely, although not exclusively, based on the three documents above.
Faculty Advisor Responsibilities
Faculty advisors are jointly responsible with student investigators for the conduct of student research projects. This responsibility includes assisting students in becoming familiar with ethical principles and IRB rules and processes. Advisors are expected to assist students in the design of their protocols, carefully review their applications for IRB review to ensure they are complete and appropriate, and help students resolve any questions or concerns that arise during the review. Subsequently, they are responsible for ensuring that the student complies with ethical principles and IRB requirements throughout the study. This includes monitoring to ensure that the student submits modification requests to the IRB prior to initiating changes as well as the timely submission of renewal and/or closure forms. Advisors are encouraged to instruct their students to submit a closure form for each completed study before they leave campus.
Training and Qualifications
Researchers and the members of their team must be qualified to carry out the procedures outlined in their research design or obtain the oversight and/or participation of others who do have the qualifications. If questions arise, the IRB may request that the researchers document that they or their key personnel have the appropriate qualifications. This is typically only an issue when special procedures are being undertaken that require particular expertise, such as certain therapeutic procedures. All key personnel, however, should be trained in human subjects protections and research procedures that they are responsible for (e.g., how to invite participation in a study without introducing undue influence). In addition, the IRB requires that all researchers document they have formal training in human subjects protections before submitting an application for IRB review. See IRB Training for details on some of the training options available.