INVESTIGATOR RESPONSIBILITIES

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INVESTIGATOR RESPONSIBILITIES

• C. Karen Jeans, MSN
• COACH Project Analyst

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Investigator Responsibilities Fact vs. Fiction

• Objectives
• 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

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What is an Investigator Required to Do as Stated
in the Human Research Regulations?
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• Who is an Investigator?

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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
  team.
• 21 CFR 50.3(d)

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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

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Principal Investigator FDA Regulations

• Investigational Drug and Investigational Device
  Regulations
• 173 references in 21 CFR 312
• 135 references in 21 CFR 812

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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 investigation.
• 21 CFR 312 and 21 CFR 812

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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

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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

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Investigator VHA 1200.5

• 91 References to Principal Investigator or
  Investigator
• 10 Investigator Responsibilities
• 10 References Phrase investigator must

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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)

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VHA 1200.5 Ten Responsibilities of Investigators

• Training
• Research plan
• Informed consent and authorization for use and
  disclosure of subject PHI
• Delegation of interview for obtaining consent
• Documentation of informed consent
• 
  VHA 1200.5, Paragraph
  10

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VHA 1200.5 Ten Responsibilities of Investigators

• 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
  Authorization
• 
  
  VHA 1200.5, Paragraph 10

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VHA 1200.5 Investigator Responsibilities

• 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 subjects
  surrogate during an informed consent process
• 4. Have approval from the IRB and RD
  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

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Five Key Areas of Investigator Responsibility

• Research Plan
• Informed Consent
• Adverse Event Reporting
• Records
• Drug and Device Accountability

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Do the Human Research Regulations Include All
Areas of Investigator Responsibilities?