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Researchers and key study personnel

Robert Hood

09/02/2008 08:01 pm

Help for researchers: Researchers and Key Study Personnel

Information about Research Personnel Sample Answers and Examples
General Information The Department is responsible for ensuring that all personnel conducting or supporting research involving humans demonstrate and maintain sufficient knowledge of the ethical principles and federal, state, and local requirements for protecting research participants. In order for the IRB to assess personnel involved in research, the IRB needs to know who these individuals are, and their qualifications.
  • All individuals associated with a study who interact or intervene for research purposes with study participants or who have access to individually-identifiable data, including data analysis, must be listed on a study.
  • This includes, but is not limited to:
    • The Principal Investigator
    • Co-Principal Investigators
    • Sub-Principle Investigators
    • Research Nurses
    • Statisticians
    • Study coordinators
    • If the researcher is a student, the faculty advisor or masters or dissertation committee chair
  • All individuals associated with a study must complete, and maintain certification in the required CITI research ethics course required by the Department.
  • All individuals associated with a study must provide a current curriculum vitae or resume.
  • No changes in personnel may be made without IRB approval.
  • Example: Consider a research project investigating birth outcomes involving midwives, where the midwives are asked by the investigator to hand out a survey to their clients. By handing out a survey, the midwives are interacting for research purposes, and must be listed on the protocol and complete CITI training and provide a resume.
  • Example: Consider an HIV research project investigating enhanced HIV surveillance. A number of individuals are engaged in review and coding of identifiable HIV client data (even though they never talk or otherwise interact with clients). All the study staff working with identifiable data must be listed on the protocol and complete CITI training and provide a resume.
  • Example: Consider a research evaluation of a novel tobacco program in a state health department. As part of the evaluation of the program, a survey company is hired to call thousands of people in Florida. By calling people and asking if they want to participate in research and then asking them questions, the phone bank individuals at the survey company are interacting for research purposes and must be listed on the protocol and complete CITI training and provide a resume.
Required Determinations by the IRB Regulations require the IRB to know who is engaged in the conduct and support of research.
Accreditation Element Standard I-4: The Organization ensures that all personnel reviewing, conducting, or supporting human research demonstrate and maintain sufficient knowledge of the ethical principles and federal, state, and local requirements for protecting research participants.
Regulations FDA 21 CFR Part 56 Subpart A 56.102(h) - An Investigator is an individual who actually conducts a clinical investigation (i.e., under whose immediate direction the test article is administered or dispensed to or used involving, a subject) or, in the event of an investigation conducted by a team of individuals, is the responsible leader of that team.
Guidance OHRP Guidebook – Principal Investigator: The scientist or scholar with primary responsibility for the design and conduct of a research project.
DOH Policies
References Online IRB Application overview (links to forms to create user accounts and CITI course information)

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