"Scientific misconduct." Almost every time I hear these words, I think of a mad scientist in a laboratory somewhere creating a new Frankenstein, or sometimes, I see a picture in my mind of a student misbehaving during a science class. While these interpretations may be amusing, scientific misconduct in the real world is not. As a researcher and an editor, I am always concerned about scientific misconduct and very dismayed when I hear that it has occurred. As critical care nurses, we should be concerned about scientific misconduct because it can and does impact our practice and our patients.
There are several types of scientific misconduct.1 Scientific misconduct can occur any time before, during, and after a clinical trial or research study. Scientific misconduct includes but is not limited to (1) falsification of records, (2) enrollment of unqualified participants, (3) failure to follow the research protocol, (4) plagiarism, (5) failure to obtain permission to conduct the trials or to inform and/or obtain informed consent from each subject, and (6) unethical conduct by any member of the research team.1-3 Any of these can lead to serious consequences which can impact the participant, researcher, institution, funding, and any future research endeavors. In some cases, legal action may be sought.
Unfortunately, there have been many incidents of scientific misconduct recently. In 1 case, a researcher posed as a physician and then falsified data concerning the participants in the clinical trial. One participant died during this period, and the researcher was charged and found guilty of criminally negligent homicide.1
Ethical guidelines must be followed. All steps necessary to protect the participants in clinical research must be taken. Unfortunately, there have been some unethical practices, such as failing to keep records confidential or not explaining the study as well as it should be explained.2 Fortunately, these incidents are few and far between.
One study surveyed a group of research coordinators (N = 1645) about their experience with scientific misconduct.4 The researchers found low perceptions on the frequency of misconduct. However, 18% of the respondents did have primary knowledge of a misconduct, and some of them felt pressured not to report the misconduct.
Other issues on scientific misconduct have been reported as well. In some cases, these involved the falsification of data.1,5,6 In other cases, a researcher submitted the same paper to multiple journals for possible publication. Still others published incorrect findings in reputable journals.1,5,6
Although most research is conducted properly according to guidelines, there is still some scientific misconduct present. As researchers and consumers of research, we all must make an effort to prevent scientific misconduct. In 1989, the National Institutes of Health formed the Office of Research Integrity. This branch of the National Institutes of Health has several responsibilities which include the following1:
1. Develop procedures and policies to identify and prevent scientific misconduct.
2. Monitor research sites.
3. Educate the researcher on proper technique and conduct of research.
Other organizations have been founded to help identify and/or decrease the incidence of scientific misconduct. The Data Safety Monitoring Board monitors studies while they are still in progress. Any irregularities are reported to the study's sponsor and the Food and Drug Administration (FDA).1 The FDA has a bioresearch monitoring program that reviews every study protocol and data submitted to the FDA for possible new products. This is another organization that works to protect the rights of participants.1
However, monitoring of scientific misconduct is not solely the responsibility of these organizations. Researchers, clinical research coordinators, clinical research assistants, monitors, and staff must be alert for any possible actions which could lead to scientific misconduct. If anyone suspects scientific misconduct, it must be reported to an appropriate group such as an institutional review board, a regulatory agency, the study's sponsor, or the FDA.1,3,5
Critical care nurses are consumers of research. We need to be able to trust the data reported in published studies. Also, many critical care nurses may conduct their own studies or participate in a clinical trial. If you are planning to conduct your own study or help in the research of others, be sure that you are aware of the following1,2,7:
1. your institution's policy on research,
2. making certain that the research has been approved by a governing body such as an institutional review board,
3. your role in obtaining informed consent from the participants,
4. what you should do if you suspect an adverse event,
5. your role in the collection of data,
6. how to report any suspicion of scientific misconduct,
7. the ethical principles of research, and
8. making certain that all measures have been taken to protect the rights and safety of the participants.
As critical care nurses become more active in research studies, we must remember that our first priority is the patient. The patient (or an approved delegate) must be able to choose whether to participate in a research. Patient confidentiality and anonymity must be maintained. All efforts must be taken to protect the patient from harm. We must examine the possible risks and potential benefits.2
Remember, most clinical research is conducted according to all safety policies and guidelines, but all of us must be knowledgeable on the research process and our role in clinical trials. After all, our patients are the ones who are most affected, and we must take measures to protect the rights of participants in clinical trials. We all must be aware of scientific misconduct.
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