Privacy, Conduct, Conflict of Interest, and Clinical Research Ethics

Questions and Answers Table of Contents

FOIA and Privacy

Is my application confidential?

Most grant and contract materials are confidential, including grants, grant applications, progress reports, contract proposals, and proceedings of review meetings. Two exceptions are a grant application's title and abstract, which NIH makes public.

Reviewers may not take materials from peer review and use them without attribution. On the other hand, abstracts are not confidential. For information, see Project Summary/Abstract and Project Narrative in the NIH Grant Cycle: Application to Renewal.

Can my grant be made public under a Freedom of Information Act request?

Yes. Generally, NIH will release funded applications in response to a FOIA request. NIH will notify an applicant or grantee before releasing information. The investigator will have a chance to identify potentially patentable or commercially valuable information that should not be disclosed. Information that could violate personal privacy is also removed from the application.

An exception to this rule is our Annotated R01 Research Plan and Summary Statement, which we've published with the permission of the PI.

Can I get more reviewer comments through a FOIA request?

No. Comments by reviewers of grant or contract applications are not accessible through the Freedom of Information Act.

Grantee and Contractor Conduct

Do NIH grantees and contractors have ethical requirements?

Yes. Grantees are subject to the regulations in the NIH Grants Policy Statement on Ethical and Safe Conduct in Science and Organizational Operations. Contractors must meet Contractor Qualifications.

Investigators involved in human subjects research must obtain education in protecting research participants. See the Human Subjects Certifications: Training SOP. For additional information, see What is NIH doing to improve ethical standards for clinical research?

What constitutes research misconduct?

Federal policy defines research misconduct as "fabrication, falsification, plagiarism, or other practices that seriously deviate from those that are commonly accepted within the scientific community for proposing, conducting, or reporting research. It does not include honest error or honest differences in interpretations or judgments of data."

If I encounter research misconduct, should I notify my program officer?

No. Don't notify your program officer. Check with your institution since it should have policies and procedures for dealing with research misconduct as well as an official to contact. If your institution can't point you in the right direction, check with the NIH Office of Research Integrity. For more information, see the Research Misconduct Cases SOP.

Do institutions need to report financial conflicts of interest?

Yes. Institutions must report any financial conflicts of interest before spending funds under a new award. If a conflict arises during an award, report it in writing within 60 days.

• For grants, institutions must report the conflict to Mary Kirker, program director of NIAID's Grants Management Program.
• For contracts, institutions must report the conflict to Chuck Grewe, director of NIAID's Office of Acquisitions.

Read the Financial Conflicts of Interest for Awardees SOP for institution, offeror, and grantee responsibilities. Go to OER's Conflict of Interest Web site for FAQs and other resources.

Conflict of Interest

Can reviewers review applications for which they have a conflict of interest?

No. Members of peer review committees must leave the room during discussions of grant applications or contract proposals in which they or close associates have an interest that could bias their evaluations. For more information, see the Conflict of Interest in Peer Review SOP and the Basic Layout of Peer Review in the NIH Grant Cycle.

Do Council members leave the room for discussions of applications with which they have a conflict of interest?

Yes. Like reviewers, Council members must leave the room when they have a conflict of interest with an application that's up for discussion. See Council Conflict of Interest Statement.

Am I free to ask a program officer to co-author a paper with me?

You can ask, but be aware that program officers are bound by conflict of interest guidelines and must get approval before co-authoring papers with non-NIH employees. According to NIH policy, staff members who have close associations with awardees, have influence over funding decisions, or show a pattern of multiple publications with the same contractors or grantees have an apparent conflict of interest that can affect their ability to perform their jobs.

See the Conflict of Interest in Peer Review SOP for information on how co-authorship can affect a program officer.

Where can I find information on conflicts of interest?

Go to Conflict of Interest for financial and peer reviewer conflict of interest information. Also see the Conflict of Interest in Peer Review SOP.

Clinical Research Ethics

What is NIH doing to improve ethical standards for clinical research?

NIH announced sweeping ethics reform as part of HHS' Supplemental Standards of Ethical Conduct and Financial Disclosure Requirements.

Can NIAID help me protect the privacy of my human subjects?

Yes. See Can NIH help me protect the confidentiality of my research subjects? in our Human Subjects questions and answers page. Also, read What is coded private information? in our Private Information or Biological Specimens in Human Subjects Research questions and answers page.

Can NIAID help pay for costs related to the privacy rule?

Yes. You can discuss privacy rule issues in your Research Plan and budget (for grants or cooperative agreements) or technical and business proposal (for contracts).

Do NIH grantees and contractors have ethical requirements for human subjects?

Yes. See the Clinical Terms of Award SOP and Restricted Awards for Contracts Involving Human Subjects SOP.

What if my question wasn't answered here, or I'd like to suggest a question?

Email deaweb@niaid.nih.gov with the title of this page or its URL and your question or comment. We answer questions by email and post them here. Thanks for helping us clarify and expand our knowledge base.