Investigator-Responsibilities by hedongchenchen



  C. Karen Jeans, MSN
  COACH Project Analyst
Investigator Responsibilities:
Fact vs. Fiction


•   Define “investigator responsibilities”
•   Compare and contrast regulatory descriptions of
    investigator responsibilities
    • FDA regulations
       •   21 CFR Parts 50, 56, 312 and 812
    • Common Rule
    • VHA 1200.5
What is an Investigator Required to Do
  as Stated in the Human Research
Who is an Investigator?
Principal Investigator:
FDA Regulations
• 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
                                       21 CFR 50.3(d)
Principal Investigator:
FDA Regulations
• Twenty-eight (28) references within
  21 CFR 50 and 21 CFR 56
     • Recipient of IRB actions
     • Specific requirements described for investigators
       to obtain informed consent
Principal Investigator:
FDA Regulations
• Investigational Drug and Investigational
  Device Regulations
  • 173 references in 21 CFR 312
  • 135 references in 21 CFR 812
General Principal Investigator Responsibilities for
FDA-Regulated Studies
•   Ensure investigation is conducted according to:
       • Signed investigator statement,
       • Investigational plan and applicable regulations,
       • Applicable regulations for protecting the rights,
         safety, and welfare of subjects under the
         investigator's care, and
       • Control of drugs and devices under

                                         21 CFR 312 and 21 CFR 812
Specific Principal Investigator Responsibilities for
FDA-Regulated Studies

•   IRB review
•   Supervision of subjects
•   Case histories
•   Record retention
•   Reports: safety, progress, and final
•   Financial disclosure

                                      21 CFR 312 and 21 CFR 812
Investigator: Common Rule
• No definition of an investigator
• Twenty-three (23) references
  • Investigator defined through description of
    obtaining data from a human subject
    participating in activities considered to be
    human research
  • Informed consent requirements
Investigator: VHA 1200.5
• 91 References to Principal Investigator or
• 10 Investigator Responsibilities
• 10 References: Phrase “investigator must”
VHA 1200.5: Who is an investigator?
• Principal Investigator: An individual who conducts
  a research investigation, i.e. under whose
  immediate direction research is conducted, or, in
  the event of an investigation conducted by a team
  of individuals, is the responsible leader of the
  team. The FDA considers a PI and an investigator
  to be synonymous.
                                     VHA 1200.5, Paragraph 3(t)

• Investigator: An individual under the direction of
  the Principal Investigator who is involved in some
  or all aspects of the research project.
                                    VHA 1200.5, Paragraph 3(n)
VHA 1200.5: Ten Responsibilities of
1. Training
2. Research plan
3. Informed consent and authorization for
   use and disclosure of subject PHI
4. Delegation of interview for obtaining
5. Documentation of informed consent
                                 VHA 1200.5, Paragraph 10
VHA 1200.5: Ten Responsibilities of
6. Report Serious Adverse Events and Unexpected
    Adverse Events
7. Approval of amendments and modifications
8. Obtain initial and continuing IRB review and
    submit modifications
9. Retain records at VA facility if investigator leaves
10. Provide IRB with information concerning request
    for waiver or alteration of the HIPAA
                                         VHA 1200.5, Paragraph 10
VHA 1200.5: Investigator
“Investigator Must” References:
     1. Defines who is a VA investigator
     2. Submit a progress report for IRB continuing review
     3. Make appropriate disclosures to a subject’s surrogate
        during an informed consent process
     4. Have approval from the IRB and R&D Committees for
        conduct of investigational device studies
     5. Demonstrate to IRB compelling reason to include
        incompetent persons or persons with impaired decision-
        making capacities as subjects
Five Key Areas of Investigator
•   Research Plan
•   Informed Consent
•   Adverse Event Reporting
•   Records
•   Drug and Device Accountability
Do the Human Research Regulations
        Include All Areas of
    Investigator Responsibilities?

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