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

Table of Contents

FOIA and Privacy

Grantee and Contractor Conduct

Conflict of Interest

Clinical Research Ethics

FOIA and Privacy

Read the questions and answers below or see the Table of Contents above.

Are my application and grant confidential?

NIH and the institutes follow strict rules to protect confidentiality for unfunded applications.

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. Reviewers may not take materials from peer review and use them without attribution.

If your application is funded, NIH makes the title and abstract public through RePORTER. For advice on preparing your abstract, see Complete the Forms in the Strategy for NIH Funding.

Most other grant and contract materials are confidential, including progress reports, contract proposals, and proceedings of review meetings.

In general, unfunded applications are confidential, and funded applications and grants may be subject to Freedom of Information Act requests. See the next question, Can my grant or application be made public under the Freedom of Information Act?

For more information, go to these resources:

Can my grant or application be made public under the Freedom of Information Act?

Generally, NIH releases only funded applications in response to a Freedom of Information Act (FOIA) request.

Most grant and contract materials are confidential. However, some materials as well as parts of funded applications may be requested through the Freedom of Information Act.

Before releasing grant information to the public, NIH works with investigators to make sure no portion could violate personal privacy or reveal confidential commercial or financial information. Read NIH's Information for Requesters Who Ask for a Grant Application.

An exception to this rule is our Sample Applications and Summary Statements , which we've published with the permission of the PIs.

Can I get more reviewer comments through a Freedom of Information Act request?

No. We do not release comments by reviewers concerning grant applications and contract proposals through the FOIA. Read NIH's Information for Requesters Who Ask for a Grant Application.

Grantee and Contractor Conduct

Read the questions and answers below or see the Table of Contents above.

Do NIH grantees and contractors have ethical requirements?

Yes. Grantees are subject to the Public Policy Requirements and Objectives section of the NIH Grants Policy Statement. Contractors must meet Contractor Qualifications.

For investigators trained with NIH support, see the Responsible Conduct of Research: Training SOP .

For human subjects research, see What does NIH do to preserve ethical standards for clinical research? below.

What constitutes research misconduct?

Federal policy defines research misconduct as "fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results." See the Definition of Research Misconduct from the HHS Office of Research Integrity.

The law also says misconduct must be an intentional or reckless departure from "accepted practices of the relevant research community."

For more information on research misconduct generally, go to NIH's Research Integrity portal. To read about NIAID's processes, see our Bars to Grant Awards—Research Misconduct and Allegations of Research Misconduct SOPs.

What should I do if I suspect misuse of NIAID grant or contract funds?

Grantees should contact NIH's Office of Management Assessment. Contractors should send a report to the HHS Inspector General at Htips@os.dhhs.gov. For more details, read our Reporting Fraud, Waste, and Abuse SOP.

You may contact NIAID, but our staff are required to refer your allegations elsewhere, confidentially, often without responding to you.

What should I do if I suspect research misconduct on an NIAID grant or contract?

If you feel comfortable notifying your institution's business office, start there. Your institution must, by law, have policies and procedures for addressing allegations of research misconduct.

You may also contact HHS's Office of Research Integrity at AskORI@hhs.gov, but that office customarily deals directly with your institution's officials. NIAID staff cannot provide assistance or guidance.

Where do I find a list of PHS misconduct actions?

Go to Handling Misconduct—PHS Administrative Action Bulletin Board of the HHS Office of Research Integrity.

Conflict of Interest

Read the questions and answers below or see the Table of Contents above.

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

No. NIH and the institutes follow standard procedures to prevent contracting officer's representatives, peer reviewers, or Council members who may have a real or apparent conflict of interest with an applicant from participating in a peer review.

Members of peer review committees must leave the room during discussions of 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 Basic Layout of a Peer Review Meeting in Part 5. Assignment and Review in the Strategy for NIH Funding.

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

Yes. Like peer 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 Institute 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.

Does my institution need to report financial conflicts of interest?

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

Read the Financial Conflicts of Interest for Awardees SOP for instructions.

Go to NIH's Financial Conflict of Interest Web site for more information on financial conflicts of interest regulations. NIH may suspend funding if your institution does not comply.

Where can I find information on conflicts of interest policies and procedures?

For conflicts of interest in peer review, read NIAID's Conflict of Interest in Peer Review SOP and go to NIH's Initial Peer Review Conflict of Interest Policy page.

For financial conflicts of interest, visit NIAID's Financial Conflicts of Interest for Awardees SOP and NIH's Financial Conflict of Interest Web site.

Clinical Research Ethics

Read the questions and answers below or see the Table of Contents above.

What does NIH do to preserve ethical standards for clinical research?

NIH has rules about research misconduct, financial conflicts of interest, and human subjects protections. If you violate any of those rules, it can terminate your funding and refer you for legal action.

If you're writing an application or managing an award involving clinical research, you must comply with NIH's policies. Use the resources in our Human Subjects Resources portal and visit NIH's Bioethics Resources on the Web to learn more.

For a description of ethical standards in specific situations, read the Public Policy Requirements and Objectives section in the NIH Grants Policy Statement.

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

Yes, with a certificate of confidentiality. See Can NIH help me protect the confidentiality of my research subjects? in our Human Subjects questions and answers page, our Certificates of Confidentiality SOP, and NIH's Certificates of Confidentiality Kiosk.

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 include privacy rule costs in your Research Plan and budget for grant or cooperative agreement applications, or your technical and business proposal for contracts.

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

Yes. Go to these resources:

Where do I find a list of clinical investigators who are the subject of an FDA action?

Go to FDA's Clinical Investigator - Disqualification Proceedings and FDA Debarment List (Drug Product Applications).

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.

 

Last Updated September 27, 2012

Last Reviewed November 15, 2011