Preparation and Submission of HHS-520 Requests

Preparation and Submission of HHS-520 Requests

NIH Enterprise Ethics System (NEES) v2.0

National Institutes of Health (NIH)9000 Rockville PikeBethesda, Maryland 20892

for Employees & Supervisors

National Institutes of Health

*Document saved using MS Word 2007

Overview

Section I. Introduction to NEES 2.0Section II. Overview of NEES 2.0Section III. NEES Security MeasuresSection IV. IC and NEAC WorkflowSection V. HHS-520 Login Procedures Section VI. NEES 2.0 Submissions Section VII. Lead-Time RequestsSection VIII. Supervisor Responsibilities

Introduction

The system has been set-up to enforce policies and regulations that have always been in place but could not be easily enforced in the manual system. Policies:

Employees/Filers cannot submit a request that is incomplete. Employees/Filers cannot renew a request if the end date has

passed. Employees/Filers need to submit a renewal 6060 days prior to the

start of an activity. If Employees/Filers know a request will require NEAC approval,

they should allow 9090 days (three months) for processing.

Introduction

The following documents help you learn NEES 2.0:

Training PowerPoint (this document) 520 Users Guide (located on NEES website at the bottom)

Introduction

Ethics, policies, rules and laws

For more information on the topics listed above, contact your Deputy Ethics Counselor (DEC) or Ethics Coordinator (EC).

Topics that will not be covered in today’s class:

Section IOverview of NEES 2.0

About NEES, v2.0 Request for Approval of Outside Activity (HHS – 520)

Any outside activity involving “professional” work requires advance approval. Professional work generally means that some level of advanced

education or training is necessary to engage in the activity, such as licensure, certification or degree.

Some activities, though professional, do not require advance approval. If you are not sure, check with your ethics staff for guidance.

Activities may be a one-time event (or short duration) or be expected to continue for multiple years.

Regardless of the expected length, approval in NEES is granted for one year at a time.

Starting in February 2008… there will be a requirement to submit requests in NEES to pursue

an outside activity. effective April 15, 2008, paper submissions of the HHS-520 will no

longer be allowed after the grace period. a grace period will be in effect allowing employees and staff to

gradually move to the new system. no previous data will be brought into NEES 2.0. Information has

not been validated.

About NEES, v2.0Submitting Requests

Benefits of NEES, v2.0

Simplification of submitting requests The online HHS-520 is the same as the paper version.

Ease of yearly renewals

Will be able to track all requests easily

Acceleration of the approval process for ethics activity requests

Employees/Filers

Benefits of NEES, v2.0

Review process creates an audit trail of changes and clarifications

COI reports provide comprehensive profile snapshots of employee data referring to recent 278’s, 520’s (approved and approved with conditions), travel, NIDB PI projects/publications, ProTrack clinical trial data.

Acceleration of the review process for ethics activity requests

NEES, v. 2.0 standardizes the whole process

Supervisors

Section IIINEES Security Measures

Security

Information used during this training session will not:

be recorded and saved into any database or server.

will not be used for any other purpose than training.

be factual information to complete and submit an actual HHS-520 form.

Section IVNEES 2.0 Workflow

Employee

If you do not file a financial disclosure report, you are considered an Employee.

Filer

If you do file a financial disclosure report, you are considered a Filer.

Objective:

Whether a person is an employee or filer, the primary responsibilities are to insert information and submit a request relating to an outside activity.

Starting Out: Employee & Filer status

Employee Filer

Assistant

An assistant can fill out a HHS-520 if given permission by employee or filer.

Only employees/filers can designate an assistant.

The assistant can fill out form BUT cannot submit it.

An assistant can be a contractor.

Question: Can a person be given permission to fill out the HHS-520 form on behalf of an Employee or Filer?

Assistant Status

Question: After an employee/filer submits a request, where does it go?

Supervisor

Employee/Filer

Assistant

Optional

NEES 2.0 IC Workflow

IC Ethics Office{

Consists of:

IC POC

IC Reviewer

IC Certifier (Delegate)

Employee Responsibilities

You are responsible for keeping track of your HHS 520.

You can always see where the request is in the system. You do not have to call anyone to find out.

You need to renew an approved request (60 - 90 days prior to end of your currently approved request)

NEAC WorkflowAdditional Review at NIH-level

NEAC Review

What is NEAC? NEAC stands for NIH Ethics Advisory Committee.

The NEAC is an advisory group (non-voting) who makes recommendations to the NIH Deputy Ethics Counselor (DEC) who co-chairs the meeting.

The purpose of NEAC is to review and make recommendations on proposed outside activities of NIH employees.

The NEAC is co-chaired by the NIH DEC and the Deputy Director for Intramural Research.

When does an employee/filer obtain a NEAC review?

1. If the employee is designated as holding a Senior (Top 5) position2. If the compensation > $10,0003. If the compensation will generate a stream of income reasonably anticipated to

exceed $10,000 within 5 years (includes past compensation the employee has already received)

4. If the method of compensation for the requested activity is in the form of stock, stock options or other equity interest

5. If the request is to engage in prohibited employment; 520 must include Request for Waiver of Outside Activity Prohibition (requires DAEO approval)

6. If the request involves expert testimony in Federal Court (requires DAEO approval) and starting in February 2008 with a rule change, any request that involves expert witness testimony

7. If needed, reviewers in the IC Ethic Offices can manually change a non-NEAC request to a NEAC HHS-520. See slide 22.

NEAC Review

Automatic flags in NEES 2.0 that prompt for a NEAC review.

IC Ethics Office

Employee/Filer

Supervisor

Assistant

Second Supervisor

NIH Ethics Office

If applica

ble

NEAC Committee NIH DEC

NEAC ReviewOptional OFFLINE

OFFLINE

NEAC Review

If a NEAC review is applicable:

One or more reasons on the previous slide will automatically “flag” the system for a NEAC review.

Ethics reviewers can submit requests for a NEAC review. They can manually flag items that they think may need a NEAC request.

The IC Ethics officials submit requests to NIH Ethics officials, which in turn make a determination if a NEAC review is needed or not.

Section VNIH NED Directory

NIH Enterprise Directory (NED)Before logging into NEES for the very FIRST time, please go to the NIH Enterprise Directory (NED) and enter in your NIH Postal Address if one is not entered.

It is very important that this field is complete for the HHS-520. Any changes made to NED will reflect in the NEES system the next day or so.

If you have updated your information in NED and there is no Postal Address information listed in NEES 2.0, you can still complete and send the request to the workflow for a final determination of the activity.

If you do not update the Postal Address field in NED, you run the risk of having the request sent back to you by an IC reviewer to complete.

Section VIHHS-520 Login Process

Accessing NEES

Production URL: https://nees.nih.gov (secured site)

Use the production URL when you file your requests.

In the classroom, Internet Explorer (IE) will be used. Other browsers that can be used: IE 6.0 and IE 7.0 for Windows Firefox 2.x for Windows Firefox 2.x for Mac Safari 2.x for Mac

Be aware of pop-up blocker problems and windows opening in back of other windows.

Accessing NEES

Production Login (secured site)

NEES is NIH-login enabled.

Your login ID is the same as your NIH network login.

NEES 2.0

Type https://NEESLAB.NIH.GOV in to access the training website.

This URL is used for training only.

NIH USERNAME

Training Password: TrainMe

NEES 2.0

1. Select the role that is specific to your duties and choose

2. In this example, choose Filer or Employee, whichever is listed.

You will only see the roles that you are responsible for doing.

My Reports tab

After logging in, the starting point in NEES 2.0 is the Reports List.

Interface

•My Reports tab

•Reports List

•My Info tab

•Change Role

•Log out

The system keeps all reports and requests for a period of six year. However, only active reports and requests will appear on this screen. Expired requests are found on the Ethics data screen (under the My Info. tab).

My Info tab

Interface

•My Info tab*

•Employee Information

•Ethics Data

•Manage Assistants

•My Reports tab

•Change Role

•Log Out

Reports List

1. Choose Report Type, 520.

2. Click on Create Report/Request.

•Reports and their status’ are shown here.

•Choosing of the report type is done on this screen as well.

Section VINEES 2.0 Submission Process

Getting Started

Employee Information

•My Reports tab

•Reports List

•Report Data*

•Attachments

•Comments

•View/Print

•Navigation bar

•Common Questions

•Save and Continue button

*indicates current information shown in My Reports tab

Request TypeInitial Request – This is a new Outside Activity.

Renewal – An on-going Outside Activity continued beyond the one-year approved period.

Choose the appropriate Request Type.

If renewal, insert Start and End dates according to the length of when the activity was first pursued.

Employee InformationEmployee information is auto-populated into NEES. It cannot be changed in NEES.

Choose appropriate Appointment type if not GS.

Getting Started – Employee Info.Can Office Contact information on the screen be modified in NEES?No. Since information is auto-populated, it cannot be directly edited in NEES. However, it can be updated in NED by clicking on the appropriate link. Please see slide 24 for more information on NED. Changes to NED will not immediately be seen in NEES.

Choose Save and Continue.

If your office contact information is not in NEES, please choose the Update NED link before progressing in NEES (unless you updated the information before logging into NEES)

Clicking the Update NED link takes you to the update screen for the NED Directory.

Supervisor SearchEnter in the name of your immediate supervisor. Search by:

•Last name, first name.

Type in your supervisor’s name.

Select the Search button.

Supervisor Search Results

Choose the name of your immediate supervisor AND click on

Supervisor Information

Choose to return to beginning of Employee information screen.

Choose to return to Supervisor Search screen.

Choose if Supervisor information is correct.

Select the Continue button.

Outside Activity

Outside Activity

Important!The determination of a request going for a NEAC

review in this section, depends on activity chosen.

Outside Activity

Summary: Indicates the type of activity you are requesting approval for.

•Notice the navigation and links are the same.

Outside Activity

Select the appropriate outside activity.

Select the Attach Document button to attach letter of invitation, contract, offer letter, etc.

Attaching a document is mandatory. If you do not have any attachments, an error message will occur. If invitation was via email, copy the email message into a text document and attach.

Outside Activity - Attachment•Attachment can be uploaded to NEES 2.0.

Choose Browse.

Select document from your computer, choose Open.

Upon returning to Attachment screen, select the Save button.

Choosing Cancel will return you to the Outside Activity screen.

Outside Activity

After attaching document to request, the attachment’s type, name and description (if applicable) appear.

You can:

•Edit,

•Delete or,

•View the document.

If necessary, insert additional information about the outside activity.


Outside Activity – Self Employment

•Multiple clients,

•Patients,

•Customers or,

•Others

as a self-employed individual or independent contractor.

If the outside activity is not a self-employed activity, select No.

Choose Yes or No.

Provide a description and/or documents that relate to any self employment that deal with personal services to:


If yes, add a description in the text box or attach a document.

Outside Employer

Outside Employer

Summary: This section applies to the company or organization contact information.

Outside Employer

Insert location and contact information about Outside Employer or Other Entity.


The name of your request will be whatever you type for the Outside entity name. So, be specific.

Location

Location

Summary: This section provides more details in regards to where work is being performed.

Location

•Indicate where the activity or service will be performed. The Outside entity address refers to the address you inserted in the Outside Employer section.

Input location information of were services will be performed.

Choose .

Takes you to the Outside Employee section.

Location - Travel•Next, indicate if travel (local or no-local) is involved with the outside activity.

•If costs and reimbursements amounts are not known, estimate them.

Choose .

Takes you to the beginning of the Location section.

Insert the correct travel information.

Time

Time

Summary: Information should be inputted in regards to time of activity.

Time


Choose .

Input information that is provided in your script.

Your activity “From” date listed should be at least 60-90 days before start of the activity.

•If you request an activity and it is less than the 60 day timeframe, a Lead-Time Threshold for the activity time span will need to be approved by your DEC before HHS-520 can be submitted to the workflow.

•You will see the Lead Time Threshold screen in the Send Report section of the HHS 520.

Time


Choose .

Input information that is provided in your script.

If your activity occurs during the day on Monday - Friday, but you have an Alternate Work Schedule (AWS) or work another shift, indicate this to show the activity will not affect your work schedule.

This will allow the Ethics Office a clearer explanation of the activity.

Compensation

Compensation

Summary: This section deals with compensation that will be paid to you by outside activity. Please be specific as possible.

Compensation

Takes you to the Time section.

If the following are chosen, a NEAC review will be required:

•Stock

•Stock Option or,

•Royalties.

Input compensation information. If you do not know the exact amount of payment, estimate to the nearest whole dollar.

Compensation

Takes you to the beginning of the Compensation section.

Is a third party organization paying you for services? For example, you are giving a presentation at ABC’s seminar, however they are

not paying you to speak. The University of Maryland is paying you.

Compensation – Funding Source


Is any funding coming from an HHS grant, contract, cooperative agreement or any other HHS source funding?

Are the services related to any services funded by HHS, regardless of the specific source of compensation?

Compensation


Does the client, employer, or other person on whose behalf the services are performed receiving, or intending to seek, an HHS grant, contract, cooperative agreement, or other funding relationship?

Compensation- Prior Compensation


Choose Yes or No.

If yes, add the additional information.

Example:Georgetown Hospital; health care (R.N.), $22,000, 2007 Georgetown Hospital; health care (R.N.), $20,000, 2006Georgetown Hospital; health care (R.N.), $20,000, 2005Georgetown Hospital; health care (lab technician), $5,000, 2004Georgetown Hospital; health care (lab technician), $8,000, 2003

This year - Insert all your information in regards to compensation from same source.

Next year – Previous information entered the year before would stay in the system. However, you must indicate amount received last calendar year, and also for current calendar year up through date of activity request.


•If adding past compensation amounts for the same source in this section, be specific.



•After adding past compensation, it will appear on the Record of Prior Compensation from Same Source screen.

•There are Edit and Delete features for the records.

Takes you to the Compensation – Grantee, Contractor, or Other Status section.

Official Duties

Official Duties

•Provides a summary of the duties performed in your current NIH position. This information can be typed or attached to the request.

Official Duties

Important! There are three major questions in this section that

need to be answered.Please answer each question carefully. Do not type

the same answer for all three questions.

Official Duties - Relationship

•How do your official duties relate to the Outside Activity you want to pursue?

•Describe how they are alike or if they differ.

Takes you to the Nature of Official Duties screen.

Question 1 of 3

Official Duties - Relationships

•In performing your official duties, explain how your actions or the matters upon which you may be called upon to work could affect the interests of the person for whom or the organization for which the proposed activity will be performed. If the exercise of your official duties would not have such an effect, explain why.

Takes you to the Relationship of Official Duties to Outside Activity screen.

Question 2 of 3

Official Duties - Relationships

•Describe any official duty assignments or other interactions you have had that involve the person for whom or the organization for which the proposed activity will be performed and indicate when such assignments or interactions occurred. If none, explain.

Takes you to the Effect of Official Duties on Outside Employer screen.

Question 3 of 3

Send Report

Send Report

Summary: Allows you to double check information inputted in the HHS-520 request.

Send Report

After the Double Checking screen, the following pages appear:

1. Waiver to the Prohibition2. Acknowledgement & Consent 3. Ready to Send screen

Exception:If the request of the Outside Activity is <60 days, the following screen will appearBEFORE the Ready to Send Screen:

Lead-Time Request

Waiver of the Prohibition

Can the outside entity be considered a SAO?

A biotechnology or pharmaceutical company; a medical device manufacturer; or a corporation, partnership, or other enterprise or entity significantly involved, directly or through subsidiaries, in the research, development, or manufacture of biotechnological, biostatistical, pharmaceutical, or medical devices, equipment, preparations, treatments, or products.

If you don’t believe a waiver is necessary, don’t check the box.

Takes you to the Double Checking screen.

Send Report

•Acknowledge that information inserted in the request is true, complete and correct to the best of your knowledge.

Check that Acknowledgement and Consent box.

Choose at the bottom of the screen.

Takes you to the Waiver of the Prohibition screen.

Send Report

If the request has been “flagged” for a NEAC review, and the start date is more than 60 days but less than 90 days from today’s date, a warning will appear indicating that it requires a NEAC approval and may require more time for approval.

NEAC review needed

Send Report

•If enough lead time has been given for the request, no red message will appear.

•Once the acknowledgement is complete, the report can be submitted. The report is saved in your Report List. If a report needs to wait to be submitted, it can be retrieved from the Report Listings.


NEAC review NOT needed

Send Report

•If the report is requiring additional information, an Incomplete page appears.

Use the Navigation bar buttons to return to the appropriate section to respond to the specific error messages.

Incomplete Information on Request

Send Report – Request Submitted

•After choosing to submit report, a screen appears to indicate that the request has been submitted for review.


Send Report Important!

Assistant’s cannot submit requests. When they are done with your request, they should notify you.

If the request has been sent to your supervisor and no action has been taken in five (5) days, the employee will receive an email notice that the request is still awaiting action. It is the employee’s responsibility to take action to move the request along. The

system will not take any action. They should contact the supervisor off-line.

If the assigned supervisor cannot perform the review, the employee may re-route the request to another supervisor. (This is the only time a user is able to make a change to a request while in another’s control.)

If the review at a second level supervisor and a review cannot be performed, the employee/filer should contact the IC Ethics Office.

Section VIILead-Time Requests

Lead-Time Requests

What if I cannot meet the 60 day lead-time approval? Submission later than 60 days prior to the proposed start date of the activity

will require approval from your Deputy Ethics Counselor. You will not be able to submit the request for review until the DEC has approved a lead-time exception.

If your request requires review by the NIH Ethics Advisory Committee (NEAC), it may take longer than 60 days to gain approval. You may not start work until you receive notification of approval.

If the start date is less than 60 days from today's date, you will be given the option to request an exception; you must include a reason for the exception.

You will not be able to submit the request until your DEC has approved the lead-time exception and you have been notified by e-mail.

Lead-Time Requests

•If starting date is entered into NEES and it is less than 60 days to activity, a Lead-Time Threshold screen will appear under the Send Report tab before you submit the request.

•There are two options:

•Change the start date (recommended) or,

•Request a lead-time exemption with explanation.

Takes you to the beginning of the Send Report section.

Lead-Time Requests

•Once the request has been submitted, a message shows indicating that the Lead Time request has been submitted.

•Remember, you cannot start the outside activity until final determination has taken place. This does not include the Lead-Time Threshold Request approval.

•Status’ of Lead-Time Requests can by checked by the employee/filer in the Time tab section of their HHS 520 request.

Let’s continue to look at the process…

Approval of Lead-Time Request

Your IC DEC will receive email notification of a lead-time request. The DEC will either approve or deny the activity request on the Exception List.


Your IC DEC will go forth to approve or deny the request.


The IC DEC receives a confirmation screen.


Upon IC DEC approval, the Time tab will show Approval type for the employee/filer for the timeframe only.

Once approved, the employee/filer must submit the activity request to the workflow by choosing Send Report navigation tab. Go through the Send Report screens to dispatch the request on the Ready to Send screen.

Once you dispatch the request, your HHS 520 has been submitted to the workflow with the Supervisor being the first point of contact.

Section VIIISupervisor Responsibilities

Responsibilities of Supervisor

•The Supervisor makes a recommendation regarding whether an activity should be approved.

•Can request additional information from employee/filer

•Submits HHS-520 requests for assignment to the IC Ethics Office

Supervisor

Supervisor

This is the initial screen after login for the Supervisor.

Choose the Review button for the request you want to review.

Review tab

• Active Requests

• Change Role

• Log Out

Supervisor Review

The Supervisor reviews the

information using the

navigation tabs.

The supervisor must check

The Agreement to Consent

Box under the

Recommendations tab.

Supervisor Review

The supervisor must provide a statement about the employee/filer.

Is there a relationship between the employee’s official duties and the outside activity?

Supervisor Review

The Supervisor can:

•Recommend Approval

•Recommend Disapproval

•Request Additional Information

Supervisor Review

References

NIH Help Desk: Phone:301-496-4357(6-HELP) (local) 866-319-4357 (toll free) 301-496-8294 (TTY or Relay Users Only)

Email: [email protected]

Website addresses: NIH Helpdesk: http://ithelpdesk.nih.gov NIH Ethics website: http://ethics.od.nih.gov/

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Preparation and Submission of HHS-520 Requests

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