Research Integrity

This Course will focus on research integrity by examining research misconduct. The definition of research misconduct will be presented from the Code of Federal Regulations. This definition influences the work that the US Food and Drug Administration (FDA), The Office of Research Integrity (ORI), and the Office for Human Research Protections (OHRP) perform on behalf of research integrity. We will discuss types of research misconduct and motives to commit research misconduct. We will discuss a range of sanctions for research misconduct, along with the reporting requirements for institutions when an investigation for misconduct is occurs. Objectives :

  • Examine the three primary types of research misconduct
  • Review definitions of research integrity from FDA, ORI, and OHRP.
  • Identify sanctions and ramifications for research misconduct
  • Examine the reporting requirements for a breach of research integrity

Research Integrity

Introduction

This Course will focus on research integrity by examining research misconduct. The definition of research misconduct will be presented from the Code of Federal Regulations. This definition influences the work that the US Food and Drug Administration (FDA), The Office of Research Integrity (ORI), and the Office for Human Research Protections (OHRP) perform on behalf of research integrity. We will discuss types of research misconduct and motives to commit research misconduct. We will discuss a range of sanctions for research misconduct, along with the reporting requirements for institutions when an investigation for misconduct is occurs.

Code of Federal Regulations Definition of Misconduct

The Code of Federal Regulations 42 CFR Part 93 presents the Public Health Service Policies on Research Misconduct. The definition in Part 93 is used by the FDA , ORI, and OHRP. Research misconduct is defined in 42 CFR, subsection 93.103 as the “fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results.” This section further goes on to define fabrication as “making up data or results and recording or reporting them.” Falsification is defined as “manipulating research materials, equipment, or processes, or changing or omitting data or results such that the research is not accurately represented in the research record.” Plagiarism is defined as “the appropriation of another person’s ideas, processes, results, or words without giving appropriate credit.” It is specifically stated that “[r]esearch misconduct does not include honest error or differences of opinion.” (ref 46) According to 42 CFR, subsection 93.104 in order for there to be research misconduct the following conditions must be met: “(a) There be a significant departure from the accepted practices of the relevant research community; and (b) The misconduct be committed intentionally, knowingly, or recklessly; and (c) The allegation be proven by a preponderance of the evidence.” (ref 46)

US Food and Drug Administration (FDA) and research misconduct

The FDA is a part of the U.S. Department of Health and Human Services (DHHS). The FDA derives its authority to establish guidelines for research misconduct from the Public Health Service Policies on Research Misconduct, 42 CFR Part 93. These guidelines apply to employees involved in intramural research or to persons who are agents or affiliated by contract or agreement with the FDA. (ref 47)

Office of Research Integrity (ORI) and research misconduct

The Office of Research Integrity (ORI) is within the Department of Health and Human Services. According to their main webpage, ORI “oversees and directs Public Health Service (PHS) research integrity activities on behalf of the Secretary of Health and Human Services with the exception of the regulatory research integrity activities of the Food and Drug Administration.” (ref 48) ORI develops “policies, procedures and regulations related to the detection, investigation, and prevention of research misconduct and the responsible conduct of research; review[s] and monitor[s] research misconduct investigations . . . “ among other tasks. (ref 48) The Office for Human Research Protections (OHRP) and research misconduct “The Office for Human Research Protections (OHRP) is within the U.S. Department of Health and Human Services. OHRP provides leadership in the protection of the rights, welfare, and wellbeing of subjects involved in research conducted or supported by the U.S. Department of Health and Human Services (HHS).” (ref 10) OHRP provides oversight for 45 CFR 46 by investigating instances of noncompliance. They make a determination if regulatory action needs to be taken to protect human subjects and issue determination letters. They also conduct random surveillance evaluations of institutions. (ref 49) Types of Research Misconduct and Motivations There are three types of research misconduct as defined by the Code: fabrication, falsification, and plagiarism. Fabrication is the making up of data or results and recording or reporting them. In the case of fabrication no data existed and it was in some way created by the researcher. This would happen, for example, if a researcher needed to obtain data from 250 subjects but could only get 200 and decided just to create the rest of the data rather than attempt to recruit more subjects. In falsification, on the other hand, the data exists, but it is somehow altered. Research material, equipment, or processes may be manipulated. So, a scale could be altered so that it weighed all specimens as 10 grams heavier than they actually were at the beginning of an experiment so that when the scale was properly calibrated for the end of the experiment, all specimens would weigh at least 10 grams lighter than they had been at the outset of the experiment. Data or results can also be changed or omitted so that the research is not accurately represented in the research record. For example, if a new procedure is under investigation, the researcher might choose not to use test results that reflected badly on the procedure. The definition of plagiarism in research comes from the concept of plagiarism developed in writing and academia in general. It refers to using another researcher’s ideas, processes, results or words without appropriate citation and referencing. This could happen if a researcher uses a model that he or she was introduced to years earlier in an unpublished paper of a fellow graduate student. While it is perfectly appropriate to extend models that have been developed by others, the researcher cannot take and present the model as an original concept if it is not. Misconduct may occur at any stage of research, beginning with the research proposal, through the conducting of research, into the reviewing of research or in the reporting of research results. In many cases, the misconduct will occur in more than one stage. It is not uncommon to see misconduct occur while the research is being conducted and then again during the reporting of results. Research misconduct may arise from a lack of knowledge, carelessness, or from falsification. In general, for true misconduct to occur, according to the Code, it cannot arise out of honest error or difference of opinion. Research misconduct may also be committed by any member of the research team and it may not necessarily be known to the principle investigator on a study. There are many motivations to commit research misconduct and these motivations can differ depending upon the job of the person who commits the misconduct. So while a principle investigator may commit research misconduct to increase publications or secure grant funding, a postdoc or fellow may commit research misconduct to hurry results. Some individuals may commit research misconduct out of laziness or forgetfulness. Others may commit it because of a lack of understanding of why portions of protocol are important.

Sanctions for Misconduct

There are a variety of types of sanctions that can occur when researcher misconduct happens including administrative, educational and legal (both civil and criminal). In some cases, more than one type of sanction may occur. ORI maintains a listing of case summaries of administration action taken for research misconduct. (ref 98) Download PDF (ref 99) Research misconduct occurs for a number of reasons. In some instances, the researcher intended to falsify, plagiarize or misrepresent the study or findings. However, there are other reasons for research misconduct. The article by Dr. Kornfeld (provided with permission from the author) provides insight as to the contributing reasons for research misconduct as well as potential interventions or preventive steps. Administrative action may be taken against an individual and that individual may be suspended or debarred from receiving federal funding (42 Code 93.400). This sort of action is determined by the funding source, in this case, ultimately, the U.S. Department of Health and Human Services. There are a wide range of other administrative actions that may be taken including imposition of supervision, submission of corrections or retractions of published articles. (ref 50) Educational sanctions may include revocation of a degree or diploma, if the misconduct occurred while collecting data for a degree. This sanction is handled at the level of the educational institution. Most educational institutions have policies dealing with both research integrity and academic integrity and offices that handle such issues. Another educational sanction is the revocation of publications. Richards (ref 52) notes that the number of publications retracted either due to fraud (which accounts for the majority of article retractions at 43%), or plagiarism (which accounts for the fewest retractions at less than 10%) is on the rise. Legal action, both criminal and civil, may also be taken. Criminal action is appropriate if laws within the jurisdiction the research took place in have been broken. Civil action is appropriate when victims seek to recover money for damages that they have incurred. These are most likely to result if injuries or deaths occurred because of the misconduct.

Retractions

Research misconduct may not be identified until after the findings of a study have been disseminated. This creates a dilemma for consumers of peer-reviewed journals and conferences. In the past, peer-review provided a level of authenticity to published studies. However, it may be impossible for journal reviewers and editors to identify misconduct until after publication. Many journals contain articles in traditional print and online formats. Once published it is difficult to remove all sources of the article once a retraction takes place. The original journal may issue a formal statement and retraction but other researchers may have referenced the article prior to the retraction. This creates a dilemma for the research community.

Reporting Requirements

When an investigation into research misconduct is carried out, the institution where the alleged misconduct occurred must provide certain written findings to ORI. According to 42 CFR 93.309 these written findings must be prepared by the appropriate institutional officer. This inquiry report must include the following: name and position of the respondent, description of allegations, the PHS support, basis for recommending that the alleged actions warrant an investigation, any comments on the report from respondent or complainant. Other information that can be requested includes: institutional policies and procedures, research records and evidence, charges for the investigation to consider, documentation of decision to investigate, and notification of special circumstances. (ref 46)

Misconduct Examples

Anderson Cooper Interviews Andrew Wakefield, Fraud (1 of 2) (ref 80) Anderson Cooper Interviews Andrew Wakefield, Fraud (2 of 2) (ref 81) Download PDF Perhaps one of the most egregious cases of research misconduct was committed by Andrew Wakefield. In 1998, findings from a study investigating a link between autism and the Measles, Mumps, and Rubella (MMR) vaccine was published in The Lancet. This study created a firestorm of publicity and alarmed parents of young children. Parents of children with autism began to blame the vaccine while parents of normally developing children questioned the risk of the vaccine. It was not until 2010, following a two and a half year investigation, that action was taken against the authors by the United Kingdom, General Medical Council. He was found guilty of 30 charges. Findings from the General Medical Council included: A failure to obtain informed consent from all parents and no assent from the children. Unethical incentive of £5 paid to each child. Participants were attending his son’s fifth birthday party at Wakefield’s private residence. At which time blood samples were taken. Failure to acquire IRB approval prior to conducting the study. Guilty of data falsification/fabrication. As a consequence, Andrew Wakefield’s medical license was revoked. (ref 51) Read this US News Education article for other cases of academic fraud. (ref 64).

Conclusion

This Course focused on research integrity by examining research misconduct. The definition of research misconduct was presented from the Code of Federal Regulations. This definition influences the work that the Food and Drug Administration, The Office of Research Integrity, and the Office for Human Research Protections perform on behalf of research integrity. Types of research misconduct, motivation to commit research misconduct, and a range of sanctions for research misconduct were discussed. Finally, reporting requirements for institutions where an investigation for misconduct is occurring was presented.