# Presentation: 706198

## INVESTIGATOR RESPONSIBILITIES

- C. Karen Jeans, MSN
- COACH Project Analyst

## 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

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

- 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 team.
- 							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 investigation.
- 						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 Investigator
- 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 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

## 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

## 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 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 Responsibility

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

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