Defending Research Misconduct Cases (Part I – The Overview)

By: Sara Kropf

We’ve written about Office of Inspector General investigations several times (see here and here and here). But there’s a small component of OIG investigations that relate to scientific research misconduct. This is the first of multiple posts about research misconduct investigations.

This series will explain how this particular investigative process works and offer some guidance about how to defend against those investigations.

The targets of research misconduct investigations are scientists and other researchers working at universities and other research institutions. Those scientists and researchers apply for federal funds for their work. If they win grants, then they use federal funds and report back to the government about the research.

This close nexus between private actors (the researchers) and billions of dollars of federal funds means that someone has to keep an eye out for fraud. This type of fraud has the gentler name of “research misconduct,” but the repercussions are still severe.

We’re talking about employment consequences, expulsion from federally-funded research for years, public shaming and, possibly, criminal charges.

When the government uncovers research misconduct, it does not hesitate to make that misconduct public. For example, every quarter, the Office of Research Integrity (ORI) publishes a newsletter on its website. A prominent part of the newsletter is called “Research Misconduct Case Studies.” In that section, ORI describes in some detail its findings of misconduct against a federally-funded researcher. The researcher’s name is prominently featured in the article, along with the likely career-ending punishment imposed.

If you aren’t a researcher, you may be wondering: What is the ORI? How did it get so powerful?

You may also be wondering: Why is this a topic for a white-collar criminal defense blog?

Let’s start with the second question first.

Over Four Years in Prison for Research Misconduct

In 2014, Dr. Dong Pyou Han was indicted for making false statements (18 U.S.C. § 1001) in federal grant applications for funding. Dr. Han was a researcher at the University of Iowa at the time and was developing an HIV vaccine.

Those false statements included falsifying data to support the grant application to the National Institutes of Health (NIH), as well as false statements about the research conducted under the grant in various required progress reports to NIH.

What’s stunning is that he was sentenced in July 2015 to 57 months in prison and ordered to repay $7.2 million in the grant monies received.

The Perfect Storm

Criminal prosecutions of scientists are rare, but Dr. Han’s case shows that it’s possible. That makes sense. Researchers apply for funds from federal agencies. In those applications, they make statements about results from preliminary research (to justify the award of a grant to advance the study). If a researcher is given federal funds, she has to make regular progress reports to the agency showing how the research is proceeding.

If those statements are knowingly untrue, then they are false statements under 18 U.S.C. § 1001. Given the size of some grants—in the millions or even tens of millions—there’s little question why the federal government may care about those false statements.

On a personal level, scientists at research centers and universities are under immense pressure to bring in funding dollars and justify their continued employment and research.

The combination of this pressure and government oversight creates a perfect storm to increase the likelihood that a researcher will (1) fabricate or falsify findings, and (2) get caught.

What Is ORI?

The Office of Research Integrity (ORI) is within the Department of Health and Human Services. It directs research integrity activities for the Public Health Service (PHS). What is PHS? Well, PHS is an umbrella agency that includes NIH, the Centers for Disease Control and Prevention, the Office of Public Health and Science and several others.

Here’s why PHS matters: PHS provides over $30 billion (with a “b”) annually for what it calls “intramural” and “extramural” funding. Relevant here is extramural funding, which is provided to medical schools, universities and research institutes that are not part of the federal government.

Given that there are billions of research dollars at stake, it’s no wonder that the government has developed an oversight function to protect those dollars from fraud.

PHS has promulgated its Policies on Research Misconduct at 42 CFR Part 93. We’ll get to know Part 93 well over the course of these posts.

PHS oversees that funding in several ways, as it describes on its website:

• developing policies, procedures and regulations related to the detection, investigation, and prevention of research misconduct and the responsible conduct of research;
• reviewing and monitoring research misconduct investigations conducted by applicant and awardee institutions, intramural research programs, and the Office of Inspector General in the Department of Health and Human Services (HHS);
• recommending research misconduct findings and administrative actions to the Assistant Secretary for Health for decision, subject to appeal;
• assisting the Office of the General Counsel (OGC) to present cases before the HHS Departmental Appeals Board;
• providing technical assistance to institutions that respond to allegations of research misconduct;
• implementing activities and programs to teach the responsible conduct of research, promote research integrity, prevent research misconduct, and improve the handling of allegations of research misconduct;
• conducting policy analyses, evaluations and research to build the knowledge base in research misconduct, research integrity, and prevention and to improve HHS research integrity policies and procedures;
• administering programs for: maintaining institutional assurances, responding to allegations of retaliation against whistleblowers, approving intramural and extramural policies and procedures, and responding to Freedom of Information Act and Privacy Act requests.

An Overview of the Investigative Process

There is good news and bad news about a research misconduct investigation.

First the good news. The process is generally well established and covered by written policies. That’s already an improvement over most OIG investigations. OIGs generally do not make their investigative manuals public and the process can be mysterious.

Also, there are multiple stages to defend a researcher’s work, and researchers can hire counsel to assist in their defense in those various stages.

Now for the bad news. Because the investigation has so many steps, it’s a long, stressful process for the subject. That means months or even years under the microscope (pun intended). Like our cl ients under criminal investigation, you’ll find that this feeling of intense scrutiny can be wrenching and affect your day-to-day life in unimagined ways.

Most universities and research institutes have a written policy that sets forth the basic process. Here are the steps of that process in a sample university setting:

1. Complaint. The complaint comes to the attention of the university’s designated Research Integrity Officer (RIO), perhaps through an anonymous complaint.
2. Assessment. The RIO undertakes a quick “assessment” of the allegations. The assessment determines if the allegation is sufficiently credible, whether it falls within the jurisdiction of Part 93 and whether the allegation is of “research misconduct” under Part 93.
3. Inquiry. If the RIO determines that the complaint passes the assessment stage, then next is the “inquiry.” In the inquiry stage, the RIO will appoint an Inquiry Committee that will conduct an initial review of the evidence. After giving the respondent a chance to comment, the Committee issues a report to the Deciding Official indicating whether an investigation is warranted.
4. Investigation. The appointed Investigation Committee will gather and analyze the evidence more thoroughly and draft a report summarizing its findings. ORI must be informed of an investigation.
5. Deciding Officer decision. The Deciding Officer will review the report to decide whether the institution accepts the report’s findings and proposed institutional actions, and determine what actions the institution will take.
6. Appeal. There may be an appeal within the institution, if its procedures allow it.
7. Final institutional decision. Once there is a final decision, the RIO will inform the complainant and respondent as well as decide whether anyone else must be informed, such as law enforcement, licensing boards, professional societies, journals in which the research was published and so forth.
8. ORI decision. ORI will review the findings and decide whether debarment or other punishment is warranted.
9. Appeal of ORI decision to Administrative Law Judge (ALJ) of HHS. Although appeals are technically allowed, a hearing on such an appeal is extremely rare and decisions are generally affirmed.
10. Federal district court proceeding. Challenging an ALJ’s decision in federal court is technically allowed but extremely rare.

Next time, we’ll focus on what “research misconduct” means and how to defend against allegations of misconduct.