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Lock icon: This link will not work for public visitors.Some links will work for NIAID staff only.

This SOP has internal roles only.

Standard Operating Procedure Table of Contents

Purpose

To ensure that extramural employees have NIAID approval to 1) author papers and other documents and 2) give public presentations when those activities are part of their official duties.

Procedure

NIH policy requires institutes to approve publications and public presentations involving real or apparent conflicts of interest.

Extramural federal employees can have an apparent conflict of interest under the following circumstances:

  • They have close associations with awardees.
  • They have influence over funding decisions.
  • They show a pattern of publications with the same contractor or grantee.

To ensure Institute compliance with NIH policy, extramural federal employees must have their supervisor and other Institute officials review and approve their request to publish and give public presentations when those activities are part of their official duties.

An activity that is not an official duty may be an outside activity, which requires approval from the Lock icon: This link will not work for public visitors.NIAID Ethics Office (not an employee's supervisor).

Extramural contractors should consult the terms of their contract for guidance on publication clearance.

Other considerations

Influential scientific information that NIH issues to the public must go through peer review. A scientific journal's peer review fulfills this requirement. See the NIH Information Quality Intranet for decision trees and an exemptions list to determine whether a publication or presentation requires peer review.

For scientific manuscripts, you will need to comply with NIH's public access policy. Read the Public Access of Publications SOP.

NIAID Extramural Staff

To get approval for co-authoring a scientific paper with an outside investigator, do the following:

  • Fill out the correct form.
  • Attach a copy of the manuscript and a bibliography of your publications for the past three years with the clearance form.
  • Get the signature of your branch chief, program director (if applicable), and division director. Then submit two copies to the DEA director for review and approval.

To obtain approval for other writing or editing activities, do the following:

  • Letter to the editor. Send a copy to your division director, who will determine whether it contains any sensitive material. If it does, your division director must send two copies to the DEA director for clearance.
  • Manuscript review, editing a textbook, or service on a journal's editorial board. Get approval from your supervisor.
    • Consider the possibility of a conflict of interest if a co-author is a current or likely grantee or a collaborator within your purview.
    • If an author plans to submit an application to NIH, do not review his or her manuscript within one year of the application. Ask your supervisor whether you should let more time pass between your manuscript review and the application.
  • Article to a scientific journal. Submit the Lock icon: This link will not work for public visitors.NIAID Co-authorship Clearance Short Form.
  • Press releases and other media contacts. Get approval from your supervisor and then NIAID's News and Public Information Branch. Contact Laurie Doepel, ldoepel@niaid.nih.gov, 301-496-5717.
  • Materials for Congress. Get approval from your supervisor and then NIAID's Legislative Affairs and Correspondence Management Branch. Contact Jill Harper, jharper@niaid.nih.gov, 301-594-3961.

For a public presentation, do the following:

  • Speech at a professional organization's event. Get approval from your supervisor, who should review your remarks.
  • Expert witness. Seek advice from the HHS Office of General Counsel; call 202-619-0153. If you receive permission to present, get approval from your supervisor.
  • Responses to media inquiries. Consult with NIAID's News and Public Information Branch, If approved, get approval from your supervisor. Contact Laurie Doepel, ldoepel@niaid.nih.gov, 301-496-5717.
  • Responses to congressional inquiries. Consult with the Office of General Counsel. If approved, get approval from your supervisor.

Questions and Answers

Q. If my publication involves work I did before coming to NIAID, do I need to request clearance?

A. No. You do not need clearance if your publication involves work you did before you started working at NIAID.

Q. If I'm writing an article with other NIH staff that does not involve outside investigators, do I need to request clearance?

A. Yes. The basic principle is that your supervisor and management should be aware and approve of your publishing with others. A good rule of thumb is, when in doubt, fill out the form. Also keep in mind that other organizations have their own processes. For example, the Division of Intramural Research has a separate review process for all intramural publications.

Q. If a professional organization asks me to review a book in my area of scientific expertise, I know I need clearance for an outside activity, but do I also need publication clearance? What if the review gets published in an organization's magazine, e.g., ASM News?

A. You do not need publication clearance in either case.

Q. If I am publishing research I did from a previous job, do I have to submit a form?

A. No, not unless you have fiscal oversight of a grant or contract from that institution. If you would rather be covered by the form, you have the option to submit it.

Contacts

Lock icon: This link will not work for public visitors.Contact for NIAID Staff

Lock icon: This link will not work for public visitors.Contact for NIAID Staff

If you have knowledge to share or want more information on this topic, email deaweb@niaid.nih.gov with the title of this page or its URL and your question or comment. Thanks for helping us clarify and expand our knowledge base.

Links

Lock icon: This link will not work for public visitors.NIH Policy Manual 1184, Scientific and Professional Information Presented by NIH Employees: Review, Approval, and Distribution

Lock icon: This link will not work for public visitors.NIH Official Duty Policy

Lock icon: This link will not work for public visitors.NIH Conflicts Assessment Sheet

Lock icon: This link will not work for public visitors.NIH Official Duty Table

Lock icon: This link will not work for public visitors.Conflict of Interest Procedures for Extramural NIH Employees in the Conduct of Their Official Duties

Lock icon: This link will not work for public visitors.Extramural Official Duties and Conflicts of Interest Case Studies

NIH Ethics Program

OMB Information Quality Bulletin for Peer Review

Lock icon: This link will not work for public visitors.NIH Information Quality Intranet

Cooperative Agreements (U) SOP

NIH Public-Private Partnerships Conflicts of Interest

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