Evaluators and researchers have an obligation to create, implement and report findings with integrity and honesty. The American Evaluation Association guiding principles state: Evaluators display honesty and integrity in their own behavior, and attempt to ensure the honesty and integrity of the entire evaluation process (http://www.eval.org/p/cm/ld/fid=105).
The Code of Federal Regulations defines misconduct 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.” (Part III – Department of Health and Human Services 42 CFR Parts 50 and 93 Public Health Service Policies on Research Misconduct; Final Rule). 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.
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 principal 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 principal 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.
It is important that evaluators and researchers work to promote research integrity. Understanding what constitutes research misconduct is important for everyone in the field. The vast majority of evaluators and researchers work diligently to protect participants and conduct projects with integrity and ethics. When others do not, challenges may be created for all of us.
Author: Dana Barber Gonzales, PhD, MHSA, CIP
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