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. 

 

PDF versions of this Guide and a Glossary of Acronyms are available for downloading.

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.

· Click on the link provided to the right

· Enter your WUSTL Key (or your employee ID number and AIS/HRMS password)

· Click on Main Menu

· Click on Breeze Training

· Click on Login to Breeze

· Click on Launch Breeze

· Select Basic EHS Training from the menu

.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 (or your WUSTL Key)

· 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 (or your WUSTL Key)

· Then follow the instructions provided

.25 – 1 Hour

Annually

Log-in to Complete

ADDITIONAL iNFORMATION

 

Research Ethics and Compliance Office

747-2709

Financial Conflicts of Interest (FCOI) Education Module

Washington University Policies and Federal Regulations require education regarding financial conflicts of interest (FCOI)

· Click on the link to the Research Gateway provided to the right

· Log in using your WUSTL Key (or your employee ID number and AIS/HRMS password)

· Within the “Education and Featured Programs” box click on “FCOI education”

· The follow the  instructions provided

15 minutes

Every four years

Research Gateway

ADDITIONAL iNFORMATION

 

Research Ethics and Compliance Office

362-2709

All Faculty who complete a PAR or who are paid from sponsored funds and/or cost sharing accounts

Effort Reporting Principles

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.

· Click on the link provided to the right

· Enter your WUSTL Key (or your employee ID number and AIS/HRMS password)

· Click on Main Menu

· Click on Breeze Training

· Click on Login to Breeze

· Click on Launch Breeze

· Select Effort Reporting Training from the menu

.5 Hour

One-time only

LOG-IN TO TAKE TRAINING

ADDITIONAL iNFORMATION

 

Research Education and Information

747-5574

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

· Click on the link for the DCM Online Training Modules

.5 – 1.5 hours

One Time Only and Annual depending on modules

Training 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.

· Log-in using your WUSTL Key and password

· 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.

· Login to the Research Gateway via link provided to the right

· Within the “Protocol Submission and Management” section click on Human Subjects (myIRB)

· Follow directions provided to complete and submit the application to HRPO

· Complete Human Subjects Training

.5 – 2 Hours

Research Gateway

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 WUSTL Key (or your employee ID number and AIS/HRMS password)

· Click on Main Menu

· Click on Human Subjects Education

· Click on Initial Education

· 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 (or your WUSTL Key)

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

2 Hours

Annually

Information on Training

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 to the right

· Enter your WUSTL Key (or your employee ID number and AIS/HRMS password)

· Click on Main Menu

· Click on Breeze Training

· Click on Login to Breeze

· Click on Launch Breeze

· Select OPBC Billing Compliance 101 from the menu

· 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 (or your WUSTL Key)

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

2 Hours

Annually

Information on Training

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 instructions on completing HIPAA training , or

· Click on the link provided to the right

· Enter your WUSTL Key (or your employee ID number and AIS/HRMS password)

· Click on Main Menu

· Click on Breeze Training

· Click on Login to Breeze

· Click on Launch Breeze

· Select HIPAA 101 from the menu

· Follow the instructions provided

1 -1.5 Hours

One-Time Only*

Log-In to Take Training

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.

Additional information

Institutional Biological & Chemical Safety Committee

362-6816

Working with Select Agents or Toxins

Select Agent Registration and Education

Federal regulations require that anyone working with Select Agents or Toxins be registered with and approved by CDC.

· Contact the Biosafety Officer to initiate the approval process.

· Obtain Security Risk Assessment from FBI/CJIS/CDC (involves fingerprinting and criminal background check).

· Select Agent security and safety training is required before beginning work.

· Select Agent security and safety refresher training is required annually.

1 Hour

Annually

Please contact Biosafety Officer  747-0309 shcook@wustl.edu

Biosafety Officer 747-0309

Shipping potential infectious materials

EH&S DOT/IATA Infectious Shipping Training

Anyone shipping dangerous goods (such as infectious, biological, chemical or radioactive materials) is required to receive Department of Transportation (DOT)/ International Air Transport Association (IATA) training.

· Follow the link on the right for information regarding classroom training opportunities

· Pick the date and location which is most convenient

· Complete and submit the registration form

3 - 4 Hours

Every 2 years

 

Research requires both Category A & B while Clinical only requires Category B training.

Information on Training

Environmental Health and Safety 935-9264

Working with an x-ray machine, electron microscope, or other x-ray producing machine

Confirm that Radiation Safety has the radiation machine on the State Registration

To notify Radiation Safety of the presence of the radiation machine and to ensure it is properly registered with the State, 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.

ADDITIONAL iNFORMATION

 

Radiation Safety

362-3476

Not Required, But Useful:

Activity

Requirement

Reason for Requirement

Necessary Steps to Fulfill Requirement

Estimated Time Requirement

To Fulfill the Requirement

For More Information

New Faculty

New Faculty Orientation

 

 

4 Hours

 

WUSM HR

362-7196

 Danforth Campus HR

935-5990

 

 

 

 

 

 

 

 

This site is maintained by the Research Ethics and Compliance Office, if you have any comments or suggestions regarding the site, please call 314-747-5571 or E-mail: RECO@msnotes.wustl.edu

 

Last Updated 12.3.2012