# Presentation: 549871

## Preparation and Submission of HHS-520 Requests

- NIH Enterprise Ethics System (NEES) v2.0

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

*Monique Montague Davis, Facilitator*

*for Employees & Supervisors*

*CAB/DECA/CIT/NIH*

- *Document saved using MS Word 2007

## Overview

- Section I.     Introduction to NEES 2.0
- Section II.	    Overview of NEES 2.0
- Section III.   NEES Security Measures
- Section IV.   IC and NEAC Workflow
- Section V.    HHS-520 Login Procedures
- Section VI.   NEES 2.0 Submissions
- Section VII.  Lead-Time Requests
- Section 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 _**60**__ _days prior to the start of an activity.
- If Employees/Filers know a request will require NEAC approval, they should allow _**90**_** **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 I
Overview of NEES 2.0

**Section I**
- Overview 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.

- 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, v2.0

**Submitting 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 III
NEES Security Measures

**Section III**
- NEES 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 IV
		NEES 2.0 Workflow

**Section IV**
- 		NEES 2.0 Workflow

## Starting Out: Employee & Filer status

- 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.

## Assistant 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?

## NEES 2.0 IC Workflow

- Supervisor

- Employee/Filer

- Assistant

- Optional

- 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 Workflow
Additional Review at NIH-level

- 	**NEAC Workflow**
***Additional 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?

If the employee is designated as holding a Senior (Top 5) position
If the compensation > $10,000
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)
If the method of compensation for the requested activity is in the form of stock, stock options or other equity interest 
If the request is to engage in prohibited employment; 520 must include Request for Waiver of Outside Activity Prohibition (requires DAEO approval)
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
If needed, reviewers in the IC Ethic Offices can manually change a non-NEAC request to a NEAC HHS-520. See slide 22. 

- If the employee is designated as holding a **Senior (Top 5) position**
- If the compensation _**>**_** $10,000**
- 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)
- If the method of compensation for the requested activity is in the form of **stock**, **stock options** **or other equity interest**
- If the request is to **engage in prohibited employment**; 520 must include Request for Waiver of Outside Activity Prohibition (requires DAEO approval)
- 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**
- 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.

## NEAC Review

- IC Ethics Office

- Employee/Filer

- Supervisor

- Assistant

- Second Supervisor

- NIH Ethics Office

- If applicable

- NEAC Committee

- NIH DEC

- Optional

**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 V
NIH NED Directory

**Section V**
- NIH 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 VI
HHS-520 Login Process 

**Section VI**
- HHS-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**
- 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

- Choose Report Type, **520**.
- 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 VI
NEES 2.0 Submission Process

**Section VI**
- NEES 2.0 Submission Process

## 
Getting Started

- 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 Type

**Initial 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 Information

- Employee 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 Search

- Enter 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

## 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.

- Choose **Save and Continue**.

## 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:

- Choose **Save and Continue**.

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

## 
Outside Employer

- 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.

- Choose **Save and Continue**.

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

## 
Location

- 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

## Time

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

## Time

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

- 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

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

- 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

## 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

- Takes you to the beginning of the Compensation section.

- 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

- Takes you to the beginning of the Compensation section.

- 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

- Takes you to the beginning of the Compensation section.

- 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, 2006**
**Georgetown Hospital; health care (R.N.), $20,000, 2005**
**Georgetown Hospital; health care (lab technician), $5,000, 2004**
**Georgetown 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.

## Compensation- Prior Compensation

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

- Takes you to the beginning of the Compensation section.

## Compensation- Prior Compensation

- 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

## 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

## 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:**
- Waiver to the Prohibition
- Acknowledgement & Consent
- Ready to Send screen
**Exception:**
- If the request of the Outside Activity is <60 days, the following screen will appear
- BEFORE 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 A**cknowledgement 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.

- Choose                      at the bottom of the screen.

**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.

- Choose                               at the bottom of the screen.

## 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 VII
Lead-Time Requests

**Section VII**
**Lead-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.

## Approval of Lead-Time Request

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

## Approval of Lead-Time Request

- The IC DEC receives a confirmation screen.

## Approval of Lead-Time Request

- 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 VIII**
**Supervisor 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:
- _[helpdesk@mail.nih.gov](mailto:nihhelpdesk@mail.nih.gov)_
- Website addresses:
- NIH Helpdesk: _http://ithelpdesk.nih.gov_
- NIH Ethics website: _http://ethics.od.nih.gov/_

## Thank you for attending!