Research Fraud: For Whistleblowers (Complete Guide)

What is Considered Research Misconduct?

Research fraud is when results are intentionally tampered with to deceive or influence research outcomes.

It includes abuses such as fabricating data, plagiarism, manipulating results, or falsifying information in the recording or reporting of scientific results.

This is a violation of the False Claims Act when government funds are used by the research institution or company.

Scientific whistleblowers should be aware that researchers honestly attempting to determine results based on cause and effect are not guilty of misconduct if they are proven wrong.

Abuse can also occur within the administrative side of research programs and studies.

 

Research Misconduct includes:

• Fabrication of results
• Falsification of records
• Plagiarism of documentation
• Serious deviation from commonly accepted methods

 

These are all violations and should be reported and stopped.

Some actions are not considered research violations, however.

 

Research Misconduct does NOT include:

• Honest errors within research studies
• Honest differences of opinion in results
• Conflicting interpretations of data
• Judgements and Conclusions on outcomes

 

Misconduct occurs when proven results are dishonestly altered as part of an agenda to defraud the Government to continue funding for a study.

This type of misconduct occurs directly within the study, but it is usually accompanied by other types of fraud.

 

 

 

Scientific Research & Administrative Fraud Overview

There are other forms of research misconduct occurring outside the laboratory setting.

These violations happen on the Administrative side of institutional research. The administration of Government grant funds is an important aspect of research fraud.

The distribution of grant money is the most common area where whistleblowers and investigators identify and report fraud.

Fake science created to deceive in return for government money erodes trust in the honest researchers and is theft from taxpayers.

 

8 Common Research Fraud Schemes:

• Allocation of time for a specific grant spread across multiple grants.
• Improper reporting of time spent on grant research. Lack or no knowledge of time used for grant activities.
• Expensing non-chargeable activities. For example: Charging for grant-writing.
• “Spend-Downs”. Close to expiration funds are spent unnecessarily to avoid loss.
• Non-research salaries charged against grants. Summer, Spring and Winter break salaries would not have been paid unless charged to grants.
• Over-inflated administration costs of federal grants
• Failure to properly pay, account for and measure efforts of researchers.
• Submission of false documentation to obtain Federal Grant Funds

 

Unfortunately, these schemes do exist in the research community.

Often, it is only with the help and courage of whistleblowers are these abuses revealed.

 

Code of Silence

A code of silence refers to informal group prohibition on members to withhold important information or report misconduct in an effort to protect the medical research community.

Scientists and administrators will threaten “loss of job and reputation” or “never working in the field again” (blackballing) when allegations surface.

These ARE violations of the FCA whistleblower protection laws.

 

Individuals will be protected and institutions are required to reinstate whistleblowers to their former position. They are also responsible for any loss of opportunity costs among other potential damages.

 

 

Qui tam whistleblowers are eligible to share in these settlements. Bounties from recovered money is offered to encourage people who have knowledge of wrongdoing to come forward.

Federal and State Governments are willing to compensate whistleblower because it is almost impossible for them to discover fraud without an insider's knowledge of misconduct.

The whistleblower rewards are 15%-30% of the recovered funds depending on intervention by the Government on the plaintiff's behalf.

Once reported to the Federal Government and Attorney General the whistleblower is protected and their information is sealed under court order.

The Government does its due diligence, investigates and decides whether or not to pursue the case.

If the Federal Government decides to not pursue the case, individuals can take action on their own with the help of a qui tam attorney.

Whistleblowing on Research Misconduct

Whistleblowers are normally associated with government contract abuse and Healthcare fraud.

Scientific research whistleblowers are often an underappreciated resource in the fight against fraud.

Scientific Research is a lesser known area where the False Claims Act and whistleblower protections are utilized.

Biomedical and behavioral research, research training, research-related grants or cooperative agreements, under government programs must have policies to protect those who make allegations of wrongdoing in good faith.

Institutions utilizing Federal grants need to follow the rules set forth by the NIH Grants Policy Statement.

Research companies and institutions are experiencing an increased level of litigation from the Government and private whistleblowers using the FCA to fight dishonesty in science.

The Office of Research Integrity, under the US Department of Health and Human Services, recommends institutions involved in Government funded research have guidelines.

These guidelines should be consistent with the Whistleblower Bill of Rights.

Whistleblowers should understand these key principles and how these are used in a research setting before making a claim.

7 Keys to the Whistleblower Bill of Rights

 

Individuals who are aware of research misconduct should consider reporting it or seeking legal counsel.

 

Before reporting you should understand the 7 key principles of the Whistleblowers Bill of Rights.

"Whistleblower laws protect and incentivize people to do the right thing."

What to Know About the Whistleblower Bill of Rights

1. Whistleblowers are free to disclose any information that supports the reasonable belief of misconduct as defined by Public Health Service Policy.
2. Companies & Institutions have a duty to not permit or take part in retaliation against good faith whistleblowers.
3. Research facilities have a duty to provide fair and unbiased procedures. These should be used for examining and resolving disputes, allegations and complaints.
4. Institutions have a duty to avoid conflict of interests. This includes procedures that are not corrupted by issues arising from personal or institutional sources of bias.
5. Whistleblower concerns should be drawn out, evaluated completely and objectively addressed. This is the duty of research institutions.
6. Responsible resolutions should not be compromised, and institutions have a responsibility to address alleged misconduct as quickly and efficiently as possible.
7. When proceedings conclude it is the responsibility of companies and institutions to credit and restore individuals. This should be done publicly and privately for those whose allegations are proven or dismissed.

These principles are designed to protect Whistleblowers from retaliation and intimidation.

 

Coming forward about what you reasonably believe is research misconduct should not affect your career or future opportunities.

Institutions have a duty to follow the Whistleblower’s Bill of Rights and can be held liable when in violation of the law.

 

What to do if you Suspect Research Misconduct

 

Whistleblowers who honestly believe misconduct or fraud exists within an institution’s research programs should report it.

One way the report misconduct is anonymously through the U-Report system. ^[7]

You can also report fraud directly to the institution that is conducting the research. Each institution utilizing Federal Grant money is required the follow the rules regarding whistleblower protection.

Researchers or Administrators can also contact a False Claims Act attorney for qui-tam lawsuit information and to learn their rights and protections under the law.

Qui Tam attorneys are an excellent source for guidance and protection. Initial consultations are free.

 

If you are contemplating reporting personal knowledge of fabrication of data or misconduct, first ask yourself the following questions:

• Was there fabrication or falsification of data, research procedures or data analysis?
• Did anyone destroy data for fraudulent purposes?
• Where any documents or data plagiarized?
• Did the institution or its employee(s) commit abuse of confidentiality?
• Were other fraudulent actions in the proposing, performing, reviewing, or reporting results of research or other scholarly activity present?

 

These would all lead directly to a violation of research and the FCA.

Once allegations are made institutions address the problem quickly as part of the guidelines they are required to follow.

The Office of Research Integrity exist to help these Universities and Institutions protect themselves.

Access to research information, data and administrative documents are more difficult to obtain after research misconduct is reported. Defendants are trying to mitigate their risk and exposure.

 

Retaining qui tam attorney representation before allegations are made is recommended for two important reasons.

1. To Protect YOUR as a Whistleblower Institutions are liable for whistleblower retaliation actions and attorneys will help you identify violations.
   
2. Financial Rewards Your whistleblower lawyer will work to ensure you receive the full financial rewards you may be entitled for reporting the misconduct.