# Presentation: 513344

## Research Compliance AND Education

- Peggy Beat, R.N. J.D.
- Research Compliance Officer
- Louis Stokes Cleveland DVAMC

## Research Education Topics

- Human Subject Protection
- Animal Subject Protection
- Safety
- Environment of Care
- Ionizing Radiation
- Current Issues & Hot Topics

## Targeted Audience

- Investigators
- Physicians
- Nurses
- Laboratory Technicians & Assistants
- All Study Staff

## Why Educate and Why the Compliance Officer?	

- Compliance and education go hand in hand
- Educated researchers allows for them to be in compliance with regulations
- Makes the RCO’s job easier

## In the Beginning.........

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## Without Compensation (WOC) Appointee

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## VA Paid Employee

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## Human Subject Protection Education

- VA mandated since 2003 stand down
- Previously we worked through the affiliate university
- All individuals participating in human subjects research must complete annual VA education & submit a certificate to our IRB

## Human Subject Protection Education (cont)

- IRB logs it into the Research Education database and files the certificate in a binder
- Annual education based on calendar year
- IRB does not review a study unless all study personnel have completed their human subject protection education.
- CR and Modification Forms capture new personnel and training requirements.

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## Animal Subject Education

- One time
- Videos
- CBT
- On the job training
- Annual Review Forms and Modification Forms capture new personnel and training requirements.

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## Safety Training

- Training required annually of all employees (VA and WOC) include:
- Environment of Care (EOC) Safety Training: Police and Security, Fire Safety, General Safety, Hazard Communication, Disaster Procedures, Infection Control, Bio-chemical Warfare, and ADP Security (computer security).
- Medical Research Service Safety Training: Chemical Hygiene Plan, the Right-to-Know Law, the Hazard Communication Program, and safety policies and procedures that affect research employees.
- No employee may come into contact with any hazardous material until all initial safety training is complete.

## Specific Hazard Training

**Animal**
**Cyanide Safety** –Annual training requirement for the safe handling of cyanide-based chemicals and emergency procedures in the event of cyanide poisoning.
** ****Formaldehyde Training** – OSHA regulation 29 CFR 1910.1048 requires annual training in the hazards of formaldehyde for all its users.
**Radiation Safety Training** – *Any* employee who works with or around radioactive material or radiation-generating equipment must complete orientation and annual review radiation safety training, which is provided by the Radiation Safety Officer.

## Laboratory and Animal Research Facility Security 

- Entrances into secured laboratory space and the Animal Research Facility are secured by the same standard key system plus an electronic proximity key-card/video system.
- This key-card/video system records entries and egresses from research, access doors used, times/dates, and also provides a video record.
-  		Keys are not issued to an employee until 	all safety training is satisfied and 	personnel paperwork has been completed!

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## Current Issues & Hot Topics

## Monthly Research Forums	

- Research Updates
- Clinical Research – Just the Basics
- Research Updates for the FES Center
- Understanding the non-VA Grant Process
- What Can the Research and Education Foundation Do For You?

## Monthly Research Forums (cont.)

- Ask the IRB
- How to Build a Better Clinical Trial Budget & Billing Procedures for Research
- Ionizing Radiation
- Legal Issues in Research Study Agreements
- The Ins and Outs of the VA Merit Review System

## Monthly Research Forums (cont.)

- Orientation to the LSCDVAMC & Preparing Your Lab for an IACUC or  AAALAC Inspection
- DNA Analysis

## Upcoming Research Forums

- HIPAA and Clinical Research Refresher
- Grant Writing 101
- Informed Consent - The Process
- Conflict of Interest -- Where Are We Now?
- Research Misconduct
- How to Break into Research at the VA
- Continue with separate educational sessions

## Clinical Research Orientation 2006

## Clinical Research Orientation	

- Quarterly
- 2 - 1⁄2 day sessions
- CME accredited
- Targeting Physicians, Research Nurses, Research Assistants, OT/PT, Biomedical Engineers, Social Workers, etc.
- Sponsored by our Medical Research and Education Foundation

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## The Education Never EndsBecause...

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