 Some links will work for NIAID staff only.
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This SOP has internal roles only.
Standard Operating Procedure Table of Contents
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Purpose
To address occurrences of misconduct in government-funded research.
Procedure
The HHS Office of Research Integrity (ORI) handles research misconduct cases for NIH. Also, if misconduct involves a clinical trial, the institutional review board should be notified.
For an overview of the steps described below, see the NIH
Process for Handling Allegations of Research Misconduct flowchart.
Program Officers
- Treat any information you receive about such cases as strictly confidential. If contacted, thank the person for providing information, but do not divulge any other information or express personal opinions. Doing so could jeopardize an investigation.
- Do not contact a principal investigator, scientific review officer or review group.
- Do not get involved in any way, beyond referring the information to your Research Integrity Officer (RIO). If you get involved, ORI may not be able to use you as a subject matter expert.
- If called to testify in a misconduct investigation, inform your supervisor and provide testimony as a government expert.
Activity |
Response |
| Critical findings -- Unintentional but seriously neglectful actions (does not indicate research misconduct because it is unintentional). |
- Do not notify RIO or ORI.
- Seek immediate division intervention, such as required staff retraining in Responsible Conduct in Research or Research Ethics.
- Request documentation of action from PI.
- If needed, recommend that PI replace study staff.
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| Research misconduct -- Intentional misconduct by non-scientific staff but not by PI or co-investigator. |
- Notify your RIO.
- Depending on impact, your RIO will notify ORI.
- If needed, replace staff and train new staff intensely.
- If clinical trial, closely monitor site for six months to a year.
- Request documentation of action from PI.
- The program director of the Grants Management Program may suspend funding if continued funding could result in harm to human subjects, vertebrate animals, the environment, or national security.
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| Research misconduct by PI or co-investigator -- Intentional fabrication, falsification, plagiarism, or other practices that seriously deviate from those commonly accepted by the scientific community. |
- Notify your RIO, who notifies ORI.
- Wait for instructions from ORI.
- When asked, provide information and support for ORI's investigation.
- The program director of the Grants Management Program may suspend funding if continued funding could result in harm to human subjects, vertebrate animals, the environment, or national security.
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Grants Management Specialists
- Treat any information you receive about such cases as strictly confidential. If contacted, thank the person for providing information, but do not divulge any other information or express personal opinions. Doing so could jeopardize an investigation.
- Notify your RIO.
- Do not discuss the matter with anybody else.
- Follow any instructions you receive from ORI, including terminating an award based on findings of scientific misconduct.
- For more information, see the Bars to Grant Awards -- Research Misconduct SOP and GMP's Office of Research Intergrity (ORI) -- Misconduct in Science SOP.
Scientific Review Officers
- Treat any information you receive about such cases as strictly confidential. If contacted, thank the person for providing information, but do not divulge any other information or express personal opinions. Doing so could jeopardize an investigation.
- Notify your branch chief, who will follow up on the allegations and, if necessary, contact the RIO.
- Do not discuss the matter with anybody else.
- Follow any instructions you receive from your branch chief.
SRP Branch Chief
- Receive allegations of misconduct from SRO.
- Without discussing the matter with anybody else, make an initial, confidential investigation of the merit of the allegation. For example, review recent guidance on the matter.
- If the allegation merits further investigation, refer the matter to RIO.
- If RIO suggests, confer with SRP program director, SRO, and RIO on the matter in question.
Division of Extramural Activities Director
- Serve as Research Integrity Officer (RIO) for NIAID.
- Refer allegations of misconduct to the Agency Extramural Research
Integrity Officer (AERIO), who sends pre-inquiry assessment to
ORI for review and recommendations.
- If allegation does not meet criteria
for research misconduct, AERIO and ORI close case and notify complainant
and Agency Research Integrity Liaison Officer.
- If allegation meets criteria for research misconduct, AERIO requests
that institution initiate formal inquiry and provide inquiry report
to ORI.
Definitions
There are two levels of prohibited conduct, based on whether or not an improper activity was intentional, knowing, or reckless.
A. Critical findings -- Unintentional but seriously neglectful
breaches of accepted research policies and procedures. Examples of critical
findings include:
- Identifying data errors after publication but submitting a retraction.
- Using an expired version of informed consent for a volunteer.
- Dispensing study product to a non-study patient.
B. Research misconduct --
Fabrication, falsification, or plagiarism in proposing, performing, reviewing,
or reporting research.
- Fabrication is making up data or results.
- Falsification
is manipulating research resources or processes, or changing or omitting
data or results to render the research record inaccurate.
- Plagiarism
is appropriating another person's ideas, processes, results, or words
without giving credit.
- Research misconduct does not include honest error
or differences of opinion.
Contacts
NIAID's Research Integrity Officer (RIO) -- Dr. Marvin Kalt, kaltmr@niaid.nih.gov, 301-496-7291.
Agency Extramural Research Integrity Officer (AERIO) -- Dr. Sally Rockey, rockeysa@od.nih.gov, 301-496-1096.
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
NIAID Extramural Staff Training on Misconduct
Office of Research Integrity -- Handling Misconduct Regulations Subpart A
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