Preparation and Submission of HHS-520 Requests

1. Preparation and Submission of HHS-520 Requests for Employees & Supervisors NIH Enterprise Ethics System (NEES) v2.0 National Institutes of Health National Institutes of Health (NIH)9000 Rockville PikeBethesda, Maryland 20892 *Document saved using MS Word 2007

2. 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

3. 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 60days prior to the start of an activity. • If Employees/Filers know a request will require NEAC approval, they should allow 90days (three months) for processing.

4. Introduction The following documents help you learn NEES 2.0: 520 Users Guide (located on NEES website at the bottom) Training PowerPoint (this document)

5. Introduction Topics that will not be covered in today’s class: • Ethics, policies, rules and laws • For more information on the topics listed above, contact your Deputy Ethics Counselor (DEC) or Ethics Coordinator (EC).

6. Section I Overview of NEES 2.0

7. 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.

8. About NEES, v2.0 Submitting Requests 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.

9. Benefits of NEES, v2.0 Employees/Filers • 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

10. Benefits of NEES, v2.0 Supervisors • 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

11. Section III NEES Security Measures

12. 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.

13. Section IV NEES 2.0 Workflow

14. Starting Out: Employee & Filer status • If you do not file a financial disclosure report, you are considered an Employee. Employee 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. • If you do file a financial disclosure report, you are considered a Filer. Filer

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

16. NEES 2.0 IC Workflow Question: After an employee/filer submits a request, where does it go? Employee/Filer Consists of: IC POC IC Reviewer IC Certifier (Delegate) { Supervisor Optional IC Ethics Office Assistant

17. 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)

18. NEAC Workflow Additional Review at NIH-level

19. 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.

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

21. NEAC Review If applicable Second Supervisor Employee/Filer Supervisor IC Ethics Office Optional OFFLINE Assistant NIH Ethics Office NEAC Committee NIH DEC OFFLINE

22. 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.

23. Section V NIH NED Directory

24. 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.

25. Section VI HHS-520 Login Process

26. 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.

27. Accessing NEES Production Login (secured site) • NEES is NIH-login enabled. • Your login ID is the same as your NIH network login.

28. 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

29. 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.

30. 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).

31. My Info tab • Interface • My Info tab* • Employee Information • Ethics Data • Manage Assistants • My Reports tab • Change Role • Log Out

32. Reports List • Reports and their status’ are shown here. • Choosing of the report type is done on this screen as well. • Choose Report Type, 520. • Click on Create Report/Request.

33. Section VI NEES 2.0 Submission Process

34. Getting Started

35. 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

36. 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.

37. Employee Information Employee information is auto-populated into NEES. It cannot be changed in NEES. Choose appropriate Appointment type if not GS.

38. 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. 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. Choose Save and Continue.

39. 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.

40. Supervisor Search Results Choose the name of your immediate supervisor AND click on

41. Supervisor Information Choose to return to beginning of Employee information screen. Choose to return to Supervisor Search screen. Chooseif Supervisor information is correct. Select the Continue button.

42. Outside Activity

43. Outside Activity • Important! • The determination of a request going for a NEAC review in this section, depends on activity chosen.

44. Outside Activity Summary: Indicates the type of activity you are requesting approval for. • Notice the navigation and links are the same.

45. 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.

46. 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.

47. 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.

48. Outside Activity – Self Employment Provide a description and/or documents that relate to any self employment that deal with personal services to: • 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. If yes, add a description in the text box or attach a document. Choose Save and Continue.

49. Outside Employer

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