If the team member is a student or trainee the PI must check with the student’s/trainee’s affiliated academic office to ensure that the research activities are within the student’s/trainee’s competencies and/or the parameters for supervision PERSONNEL WITH DIRECT CONTACT: Research employees who perform procedures, interviews, telephone to research subjects, clinical interventions with patients, etc. during the conduct of a research project. PERSONNEL WITH INDIRECT CONTACT: Research employees who do not interact directly with research subjects, but only manage study data, only have access to medical records, or handle human specimens, for research purposes. Engaged/Engagement in research: An individual is in human subject research “engaged” whenever they intervene or interact with living individuals for research purposes, or they obtain, release, or access individually-identifiable private information (or individually-identifiable specimens) for research purposes. [38 CFR 16.102(f)] Human Subject research activities: The research involves observation, manipulation, or sampling of human subjects or their biological samples or identifiable data for research purposes. A human research subject is defined as a living individual about whom an investigator (whether professional or student) conducting research obtains either: (a) Data through intervention or interaction with the individual; interaction includes communication or interpersonal contract between the researchers and the subject; or (b) Identifiable private information (38 CFR 16.102 (f)). For FDA-regulated research, a human research subject is involved as a recipient of a test article or as a control, or as an individual on whom or on whose specimen an investigational device is used or as a control. Animal research activities: The animal research involves physical contact with living or dead animals or their unfixed tissues or urine or feces regardless of the funding source of that research. Lab/Bench research activities: The research involves laboratory procedures or analysis conducted in laboratories at the VAMHCS or in VAMHCS leased space regardless of the funding source of the research.
If the team member is a student or trainee the PI must check with the student’s/trainee’s affiliated academic office to ensure that the research activities are within the student’s/trainee’s competencies and/or the parameters for supervision PERSONNEL WITH DIRECT CONTACT: Research employees who perform procedures, interviews, telephone to research subjects, clinical interventions with patients, etc. during the conduct of a research project. PERSONNEL WITH INDIRECT CONTACT: Research employees who do not interact directly with research subjects, but only manage study data, only have access to medical records, or handle human specimens, for research purposes. Engaged/Engagement in research: An individual is “engaged” in human subject research whenever they intervene or interact with living individuals for research purposes, or they obtain, release, or access individually-identifiable private information (or individually-identifiable specimens) for research purposes. [38 CFR 16.102(f)] Human Subject research activities: The research involves observation, manipulation, or sampling of human subjects or their biological samples or identifiable data for research purposes. A human research subject is defined as a living individual about whom an investigator (whether professional or student) conducting research obtains either: (a) Data through intervention or interaction with the individual; interaction includes communication or interpersonal contract between the researchers and the subject; or (b) Identifiable private information (38 CFR 16.102 (f)). For FDA-regulated research, a human research subject is involved as a recipient of a test article or as a control, or as an individual on whom or on whose specimen an investigational device is used or as a control. Animal research activities: The animal research involves physical contact with living or dead animals or their unfixed tissues or urine or feces regardless of the funding source of that research. Lab/Bench research activities: The research involves laboratory procedures or analysis conducted in laboratories at the VAMHCS or in VAMHCS leased space regardless of the funding source of the research.
Scope_of_Practice_Instructions.docx