# Presentation: 676641

## Case Study #1

*Presented by*
*Joan P. Porter, DPA, MPH, CIP *
*and*
*Karen M. Smith, PhD*

## Disclaimer

*Case Studies: These cases are hypothetical and drawn from a number of compliance problems noted in both the VA system and the wider research community.  Any resemblance to an actual case is purely coincidental.*

## Allegations

- PI who was also Mary’s physician enrolled subject in two research studies without consent.
- PI enrolled Mary in two research studies for which she was not eligible.
- Enrollment contributed to Mary’s death.
- PI committed “misconduct.”
- Complainant has contacted numerous oversight offices.

- 1

- ?	**Whom would you notify about this allegation at this point, if anyone?**
- ? 	**How seriously should you take the research misconduct allegations?**
- ? **How seriously should you take the noncompliance allegations?**
- ? 	**What would you do next?**

**2**

- ?	**Have all of the appropriate individuals/offices been notified?**
- ? 	**Has the initial response to these allegations been handled properly?**
- ? **Should the investigation of misconduct be combined with the investigation of noncompliance with human subject protection requirements, or conducted separately?**

**3**

**You have ensured that all relevant facility officials and regulatory agencies/offices have been informed.**
- ? 	**What kind of information do you **
**	****need next?**
- ?	**Where do you find it?**
- ?	**How do you know when you have all**
**	****the relevant information?**

**4**

## What We Know

- Dr. Q says that Mary was not enrolled in study VA-123, a natural history study.  He gave her drug VA-123 as the standard of care.
- Dr. Q recalls that Mary was also enrolled in VA-xyz, involving an investigational drug being studied to see if it would ameliorate the side effects of drug 123 Mary was receiving as the standard of care.
- There is incomplete documentation for study VA-123 and no study documentation for Mary’s enrollment in study VA-xyz.

- 5

- ?	**What actions, if any, are warranted at this point in your inquiry?**
- ? 	**What should you do next?**

**6**

## What We Know

- Medical record shows drug 123 was given to Mary and at the same time as drug xyz.
- Drug 123 was stopped when Mary was hospitalized with pneumonia and for a time thereafter.  Drug xyz was stopped also.
- When drug 123 treatment resumed, drug xyz was also resumed.

- 7

- ?	**What do you do next?**

**8**

## What We Know

- Mary appears to have been enrolled in VA-xyz.
- Mary appears to have suffered an adverse event while participating in VA-xyz.

- 9

- ?	**What do you do next?**

**10**

- ?	**Is resumption of treatment with drug xyz, when Mary is not enrolled in study VA-xyz, an acceptable practice?  Why or why not?**
- ? 	**Are there any other places you might go to obtain further information about Mary’s involvement in research?**

**11**

**Assume this is all the information you can obtain.**
- ? 	**What do you conclude about the**
**	****research misconduct allegation?**
- ?	**What is your rationale for that **
**	****conclusion?**

**12**

- ?	**What else, if anything, should you do at this point regarding the research misconduct allegation?**

**13**

**You still have concerns about Mary’s research involvement.**
- ? 	**What area of noncompliance, or **
**	****possible noncompliance, have you**
**	****identified?**
- ?	**What is the appropriate official or**
**	****body at your institution to deal with**
**	****these findings?**
- ?	**What corrective actions, if any, **
**	****would you recommend to that **
**	****official or body?**

**14**

## What We Know

- The subject participated in two research protocols, VA-123 and VA-xyz.
- The subject participated only in the screening phase of VA-123.  She was not eligible for participation in the natural history portion of the study.  Drug 123 was given to her as standard of care.
- The subject was enrolled in VA-xyz, but her participation was not documented in her medical record or in Dr. Q’s study files.
- The subject was withdrawn from VA-xyz, but was later treated with drug xyz, an approved drug for another use, off label.

- 15

## What We Know

- Files for these studies were not properly maintained by Dr. Q.
- A serious adverse event was not reported to the IRB nor documented in the study files.
- The subject was not enrolled in any research studies for at least 8 months before her death.
- The VA Form 10-1086 was not used for either VA-123 or VA-xyz.  This is in accordance with your local policy, but ORO informs you that it is not compliant with VA policy.

- 16

- ?	**Are there any additional actions or**
**	****remediation that you would**
**	****recommend to the IRB, the R&D**
**	****Committee, the ACOS/R&D, the**
**	****Medical Center Director, or anyone**
**	****else?**
- ? 	**Should you provide additional **
**	****information to the complainant?  If**
**	****so, what information?  When?  How?**

**17**