Faculty Guide to Compliance Requirements

This guide was developed as a tool to provide convenient and concise information regarding the various compliance activities faculty members at Washington University are required to fulfill.  To use this guide, simply find the activity you are engaged in and then the applicable requirements will be listed in the Requirement column, with subsequent information provided on how to complete the requirement, hyperlinks that go directly to the requirement, and the estimate time it will take fulfill the requirement.  The hyperlinks located in the For More Information column will take you to appropriate websites for additional information.  If you have questions regarding a specific requirement, please contact the applicable office.

 

While every effort has been made to develop a comprehensive list, this may not represent the entire list of requirements faculty are required to fulfill. 

 

A PDF version of this Guide is available for downloading: Faculty Guide to Compliance Requirements (PDF)

Core Requirements:

Activity

Requirement

Reason for Requirement

Necessary Steps to Fulfill Requirement

Estimated Time Requirement

To Fulfill  the Requirement

For More Information

All Faculty

Basic EHS Training

 

Required for all faculty hired after

March 10, 2008

Faculty are required to have basic safety training.

· Enter your employee ID number and AIS/HRMS password

· Click Go To Breeze Training then follow the instructions provided

.25 Hours

One-time only

Log-in to Take Training

 

 ADDITIONAL INFORMATION

 

Environmental Health and Safety 935-9264

Code of Conduct

The Code of Conduct underscores the University's commitment to integrity, ethical conduct, and legal compliance in everything we do.

· Enter your employee ID number and AIS/HRMS password

· Click on Code of Conduct on the left side of the screen

· Follow the instructions provided.

· Read Materials

· Certify Commitment

.5 Hour

Annually

Log-in to Complete

ADDITIONAL information

 

University Compliance Office 362-4910

Financial Disclosure Statement (COI)

Washington University policies and Federal Regulations require financial disclosures on a regular basis or as changes occur in financial interests or research/patient care activities.

· Enter your employee ID number and AIS/HRMS password

· Click on Financial Disclosure Statement on the left side of the screen

· Then follow the instructions provided

.25 – 1 Hour

Annually

Log-in to Complete

ADDITIONAL iNFORMATION

 

Research Ethics and Compliance Office

747-2904

All School of Medicine Faculty & Danforth Faculty involved in Research

Effort Reporting Education

All Faculty are required to complete Effort Reporting Education as a commitment to the stewardship of federal funds and the appropriate proposing and reporting of effort

· Enter your employee ID number and AIS/HRMS password

· Click Go To Breeze Training then follow the instructions provided

· Watch Presentation

· Take Quiz

.5 Hour

One-time only

Log-in to Take Training

ADDITIONAL iNFORMATION

 

Research Ethics and Compliance Office

747-5571

All School of Medicine (WUSM) Faculty with an appointment in a clinical division.

Expert Witness Attestation

WUSM has established a Code of Conduct, as well as this Policy for Expert Witness Testimony, for faculty members who serve as expert witnesses.

· Read the Expert Witness Code of Conduct.

· Print and sign the Expert Witness Affirmation

· Mail form to the Office of Risk Management

.25 Hour

One-time only

 

However,  submission of expert witness testimony activity is required annually

 

POLICY AND ATTESTATION FORM

Risk Management 362-6956

Requirements Based on a Specific Activity:

Activity

Requirement

Reason for Requirement

· Necessary Steps to Fulfill Requirement

Estimated Time Requirement

To Fulfill the Requirement

For More Information

Research involving Animals

Animal Studies Education

Animal Welfare regulations and the Public Health Service Policy require institutions to ensure that people caring for or using animals are qualified to do so.

· Click on link provided to the right

· Read Introductory Slides

· Click on link to training modules

.5 – 1.5 hours

One Time Only and Annual depending on modules

Introduction to Training

 

ADDITIONAL iNFORMATION

 

Department of Comparative Medicine

362-3700

ASC Protocol

The ASC is required by federal regulations to review all projects (research, teaching, or other) involving the use of vertebrate animals. This is required if funding is through Washington University, or if the animal is housed at this institution.

· Complete eSirius account request form

· Fax completed and signed form to ASC

· eSirius account will be set up upon receipt and your log-in and password sent to you

1 – 1.5 Hours

 

Account Request Form

aDDITIONAL INFORMATION

 

Animal Studies Committee office

362-3229.

Participating in CME activities sponsored by WUSM

CME Disclosure of Financial Relationships

All speakers, planning committee members, or persons in a position to influence the content of an educational activity, are expected to disclose to the audience any financial interest or other relationship

· Enter your employee ID number and e-mail

· Then follow the instructions provided

.25 - .5 Hour

Log-In to Complete

Additional Information

 

Continuing Medical Education  Office

362-6891

Working with a gamma irradiator

Irradiator Exam and training

An individual needing to use a self-shielded gamma irradiator at Washington University and the Medical Center should contact Radiation Safety for information on the process, security requirements, and alternatives.

· Formal request by individual’s Authorized User or Department

· Successfully pass a background check including fingerprinting & FBI criminal history records check

· Irradiator Exam

· Facility Training

· Operator Training

· IC Program Didactic Security Training

· IC Program Hands-on Security Training

· Annual Refresher Training is also required.

Initially:

2 to 6 months for background check

 

6 to 8 Hours spread over 4 to 6 weeks for exam & training

 

Annually:

1 Hour

Phone (362-3476) or email radsafety@wustl.edu

Radiation Safety 362-3476

Research involving human subjects

HRPO Protocol Submission

Studies which need IRB approval should be submitted to the Human Research Protection Office.

· Download appropriate form from HRPO’s Website

· Complete the form and submit it to the HRPO Office

· Complete Human Subjects Training

.5 – 2 Hours

 

HRPO Forms

ADDITIONAL iNFORMATION

 

Human Research Protection Office

633-7400

Human Subjects Research Training Module (CITI)

School of Medicine researchers will need to complete the Biomedical Investigation track.

- or-

Danforth Campus Researchers will need to complete either:

-Researchers in Social Work, Anthropology, Economics, Education, Political Science, Psychology, Program in Philosophy, Neuroscience & Psychology, Program in Social Thought and Analysis or

-All other Danforth Depts./Schools

· Click on the link provided to the right

· Enter your employee ID number and AIS/HRMS password

· Click on Human Subjects Education on the left side of the screen

· Follow the instructions provided

2 - 4 Hours

One-Time Only

Log-in to Take Training

ADDITIONAL iNFORMATION

 

Human Research Protection Office

633-7400

Working in a laboratory setting

EH&S Annual Lab Safety Training

WU laboratory and clinical faculty, staff, and students working in laboratories are required to have annual training covering OSHA and EPA topics.

· Click on the link provided on the right and choose which option best suites your situation

· If choosing On-Line Training, enter your employee ID number and AIS/HRMS password

· Click Breeze Training on the left side of the screen, then follow the instructions provided

2 Hours

Annually

Information on Training

ADDITIONAL iNFORMATION

 

Environmental Health and Safety 935-9264

Working with lasers

Confirm that Radiation Safety has the machine on its inventory list

To notify Radiation Safety of the presence of the machine, to ensure it is placed on the inspection schedule, and confirm that the PI has safety program implemented.

· Complete inventory form and submit to Radiation Safety

· Annual safety audit

Initially:

0.5 Hour

 

Annually:

1 Hour audit

Submit laser inventory form to Radiation Safety by fax at 362-4776, email attachment to radsafety@wustl.edu, or Campus Mail box 8053.

ADDITIONAL iNFORMATION

 

Radiation Safety

362-3476

Working with strong magnetic fields

Confirm that Radiation Safety has the machine on its inventory list

To notify Radiation Safety of the presence of the machine, ensure it is placed on the inspection schedule, and confirm that the PI has safety program implemented.

· Submit inventory form.

· Annual safety audit

 

Initially:

0.5 Hour

 

Annually:

1 Hour audit

Submit inventory form to Radiation Safety by fax at 362-4776, email attachment to radsafety@wustl.edu, or Campus Mail box 8053.

 

Radiation Safety

362-3476

Provide patient care or clinical lab services

Office of Physician Billing Compliance – Billing Compliance 101

Employees (faculty physicians, fellows, and staff) must participate annually in billing compliance education if they are involved in patient care services, and/or if they are involved directly or indirectly in the professional reimbursement process.

· Click on the link provided on the right,

· Enter your employee ID number and AIS/HRMS password

· Click Breeze Training on the left side of the screen, then follow the instructions provided

1 Hour

Annually

Log-in to Take Training

ADDITIONAL iNFORMATION

 

Office of Physician Billing Compliance

747-7661

EH&S Annual Clinical Safety Training

WU laboratory and clinical faculty, staff, and students working in laboratories are required to have annual documented training covering OSHA and EPA topics.

· Click on the link provided on the right and choose which option best suites your situation

· If choosing On-Line Training, enter your employee ID number and AIS/HRMS password

· Click Breeze Training on the left side of the screen, then follow the instructions provided

2 Hours

Annually

Information on Training

ADDITIONAL iNFORMATION

 

Environmental Health and Safety 935-9264

Risk Management Patient Safety Training

The MedRisk training program provides risk prevent skills training specific to a physician’s specialty or area of interest

· Follow link to the MedRisk welcome page.

· Register by using your Employee ID as your username and establish a password of your choice.

· Choose course and follow directions provided.

2-4.5 Hours

One-Time Only

lOG iN TO tAKE TRAINING

Risk Management

Elaine Cooper

362-4645

Working with positron emitting radioactive materials (PET isotopes)

PET Safety Exam and training to qualify as PET Worker

Ensure training and regulatory compliance for personnel working in positron emission tomography (PET) facilities, cyclotron facilities, or PET radiochemistry laboratories.

· Qualify as Radiation Worker, below.

· For initial training, download the training manual.

· Call or email Radiation Safety to schedule an appointment to take the PET Safety Exam (362-3476 or radsafety@wustl.edu)

· Annual Refresher Training is also required.

2 Hour initially

 

1 Hour

annually

Information on Training

 

Frequently asked questions

 

Radiation Safety

362-3476

Access to Protected Health Information (PHI)

HIPAA Training

HIPAA training is required for everyone who accesses PHI.

 

*Annual refresher training, while not mandated by the University, is mandatory for some departments.  Please contact your Department Administrator for further information.

· The HIPAA Privacy Liaison for your department will e-mail you with a log-in, password, and instructions for the HIPAA training system.

1 -1.5 Hours

One-Time Only*

Log-In to Take Training

ADDITIONAL iNFORMATION

 

Privacy Office

747-4975

Working with radioactive materials

Radiation Safety Exam and training to qualify as Radiation Worker

Ensure training and regulatory compliance for personnel prior to working with radioactive materials

· For initial training, download the training manual.

· Call or email Radiation Safety to schedule an appointment to take the Radiation Safety Exam (362-3476 or radsafety@wustl.edu)

· Annual Refresher Training is also required.

2 Hour initially

 

1 Hour

annually

Information on Training

 

Frequently asked questions

 

Radiation Safety

362-3476

Faculty Principal Investigator needing to use radioactive materials (may include PET) in non-human research

Approval to possess and use radioactive materials as Authorized User, for non-human research.

Ensure training and experience and regulatory compliance for Radiation Safety Committee approval of Authorized Users.

· Qualify as Radiation Worker or PET Worker as appropriate, above

· Document more than 40 hours of training and relevant hands-on experience with radioactive materials (T&E Form).

· Submit an Application.

· Participate in an Authorized User interview.

Initially:

1 Hour for form and application

 

2 to 4 weeks for review and approval

 

Approval lasts 2 to 5 years

Submit a T&E Form and an Application to Radiation Safety by fax at 362-4776, email attachment to radsafety@wustl.edu, or Campus Mail box 8053.

ADDITIONAL iNFORMATION

 

Radiation Safety

362-3476

Research that employs: recombinant DNA, biological toxins, infectious microorganisms, potentially infectious cell lines, animal or human tissues or fluids

IBC Protocol

This form provides OBCS and the Institutional Biological and Chemical Safety Committee a detailed description of regulated or hazardous research elements and their management, providing a basis for risk assessment.

· Download appropriate form from the link to the right

· Complete the form and submit it to the Office of Biological and Chemical Safety, Environmental Health and Safety Office

2 - 4 Hours

 

IBC approval is valid for 5 years.