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Table of Contents   
GUEST EDITORIAL  
Year : 2011  |  Volume : 14  |  Issue : 3  |  Page : 205-207
Ethical issues in biomedical research and publication


Department of Conservative Dentistry and Endodontics, Centre for Dental Education and Research, All India Institute of Medical Sciences, New Delhi - 110 029, India

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Date of Web Publication10-Oct-2011
 

How to cite this article:
Shah N. Ethical issues in biomedical research and publication. J Conserv Dent 2011;14:205-7

How to cite this URL:
Shah N. Ethical issues in biomedical research and publication. J Conserv Dent [serial online] 2011 [cited 2014 Oct 30];14:205-7. Available from: http://www.jcd.org.in/text.asp?2011/14/3/205/85787
Research and publication play a very vital role in progress of sciences in any field. Therefore, it is heartening to note that volume of research and publication of scientific data has increased manyfold in the past two decades in dental sciences. Not only the print copies but also free online journals have made publication of this enormous volume of scientific data and literature possible. Earlier few international and national journals are now substituted with regional, state, and local level journals and various other publications sponsored by large dental manufacturing companies. Apart from this, recently many dental colleges have started publishing their own in-house journal to provide a platform to their own faculty and students to publish their work.

As publication of scientific papers is now linked to professional career upgradation as per the new DCI rule, the pressure for publication of papers is tremendous. Also, the number of postgraduate seats in various dental colleges, specially the private dental colleges, has increased very significantly in the past 7--10 years. Not only the student:teacher ratio is grossly inadequate, often the postgraduate teachers lack adequate experience themselves and time to guide the students into research design, its execution, analysis, and more importantly, into research norms and ethics.

In this current scenario, there is a real danger of compromising the scientific quality of research papers. There is increased temptation to deviate from the ethical norms for research and publication.

Hence, it is felt that awareness needs to be generated among scientific community: teachers, postgraduate, and graduate students and professionals engaged in sponsored or self-sponsored research about what constitutes "research misconduct" and "deviations," so that one can guard against these and follow the ethical norms while perusing research/publication as well as while reviewing articles submitted for editorial review.
"Ethics" in simple terms is defined as "norms for conduct" that distinguishes between acceptable and unacceptable behavior. Though ethical norms are learnt since childhood at home, school, religious places, etc., it is influenced throughout the life, impacted by various life experiences which explains the large variations in interpretation of ethical norms among individuals. [1]

Ethical norms related to biomedical research and publication are laid down by various national and international agencies. Some of these are as follows: (i) National Institute of Health, (ii) National Science Foundation, (iii) FDA, etc. The Nuremberg Code and Declaration of Helsinki by World Medial Association is the landmark in ethical standards followed the world over for biomedical research and uniform requirements for manuscripts submitted to biomedical journals (formulated by International Committee of Medical Journal Editors) for publication in biomedical journals.

Basically, the ethical norms comprise honesty, integrity, and social responsibility in very general common sense. But in relation to biomedical research and publication, it has several perspectives for which a researcher needs to be knowledgeable and sensitive. Some of these are highlighted below:

  1. Careful approach to research design, data collection and interpretation.
  2. Maintaining confidentiality of research subjects and personnel records.
  3. Always acknowledging the source; using scientific materials without acknowledging the source amounts to plagiarism.
  4. Aim to advance knowledge and research and not one's career. Avoid temptation for duplicate publication of the same research in different journals or in different languages, without proper declaration to the effect.
  5. Protect the subjects/patients included in the research study, minimizing risks and maximizing benefits, specially the vulnerable population. Informed consent of the patient/guardian (in the case of minors) in the presence of witness is absolutely essential to protect the interests of the human subjects enrolled in the study.
  6. Design animal experiments only if absolutely necessary and meaningful. Show proper care and compassion and minimize pain and suffering during the experiments.


Not following the above ethical norms and scholarly conduct with an intent to deceive is termed "research misconduct." It comprises "fabrication, falsification, or plagiarism (FFP) (National Science Foundation of US).

Fabrication is making up results and reporting. Falsification is the manipulation of research; materials, equipments, or processes and changing or omitting the data. Plagiarism is appropriation of another person's idea, processes, results, text, or illustration/clinical photographs, etc. without its acknowledgement. Plagiarism could also be "self-plagiarism" or "multiple publication" also termed as salamis," i.e., identical slices as described by Medial Journal Editors (MJE). One more category in this is "redundant publication" in which already published work is republished with new additional data. This has few undesirable effects; it may overemphasize the importance of the findings by its appearance more than once and can interfere with the process of metaanalysis, besides infringe on the International Copyright Law.

Some definitions of "research misconduct" are given as follows:

  1. Intentional or gross negligence leading to fabrication of scientific message or a false credit or emphasis given to a scientist.
  2. Intentional distortion of the research process by fabrication of the text, hypothesis, or methods from another researcher's manuscript or publication or distortion of the research process in other ways.


Apart from research misconduct "other deviations" are activities that are considered unethical, though not strictly taken as misconduct. These are more rampant in today's scientific scenario where "publish or perish" often drives an individual to engage in such deviations.

Some of these deviations are as follows

  • Giving authorship to a colleague or relation who has not contributed substantially to the research study.


NIH in its "Guidelines for Conduct of Research" have recommended that designated authors should have contributed significantly in conceptualization design, execution, and/or interpretation of the study and should be willing to take responsibility for the study. Those who do not meet these criteria but have still helped in some way to the study like providing technical help, writing assistance, or Department/Institutional head for providing access to the institutional infrastructure for the conduct of the research study, etc. should be relegated to the acknowledgement section.

An approach suggested to resolve the conflict between credit and responsibility for any research study is to designate "authors" as "contributors," each required to list their specific role in the study with one of them taking up "Guarantorship," i.e., accountability for veracity of data and ethical conduct of all aspects of the study. Many reputed international journals like JAMA, Nature, BMJ, etc. have adopted this approach.

  • "Suppression" of unfavorable data which are in conflict with the researcher's or sponsor's (of the study) interest or an adverse event in a clinical research.
  • Deliberate omission of contributions by other researchers to increase the importance of their own research study.
  • Applying inappropriate statistical techniques to enhance the significance of one's own research.
  • Deviating from the research protocol approved by the Institutional Ethical Committee.
  • Not reporting an adverse event in a human research experiment.


It is important to understand why researchers indulge into scientific misconduct/ deviations. According to the "stressful" or "imperfect" environment theory, various institutional pressures, incentives, career ambitions, pursuit of fame, etc. can be the causes for misconduct. Poor supervision of junior researchers by teachers and guides is one of the contributing factors in scientific misconduct.


   Responsibility of A Reviewer Top


It is the professional obligation and essential duty toward science to accept to review the manuscript pertaining to one's discipline. It is an honor and a privilege to be asked to review a manuscript and should not be taken as a burden. Reviewing involves evaluating the (i) scientific content and quality of research, (ii) clarity and logic of presentation, and (iii) ethical validity of the study.

It is not only the researcher but also the reviewer who should adhere to high ethical standards. The reviewer should provide accurate, courteous, unbiased, and justifiable report on the submitted manuscript in a timely manner. It is unbecoming of a reviewer to make derogatory comments and personal attacks in review of author's submission and rejecting a manuscript for publication even without reading it, may be due to bias against the region/country of manuscript submission or for any other reasons. Still worse, some unethical, unscrupulous reviewer can even try to block the publication and steal the idea and then take credit by publishing it themselves.

To guard against these possibilities, most journals send the manuscript to 2 or 3 reviewers. It is also expected that the manuscript copy is not retained and the data or its interpretation is not used before the publication of manuscript, without prior permission of the authors. However, the most important fact is that the reviewer has highest standard of integrity and ethical principles.

After discussing all the negative aspects related to scientific research and publication, here is some good news: the best evidence shows that misconduct is a very rare occurrence in research and there is no evidence that science has become ethically corrupt. The rate of misconduct has been estimated to be as low as 0.01% to as high as 1% of researchers per year.

According to the "bad apple" theory, most scientists are highly ethical. Only those who are morally corrupt, economically desperate (in cases of grant application), or psychologically disturbed will commit misconduct. [2]

It is hoped that this editorial would contribute toward further lowering the already small percentage of scientific misconduct!!!

 
   References Top

1.Resnik DB. What is Ethics in Research and Why is it Important? Available from: http://www.niehs.nih.gov/research/resources/bioethics whatis.cfm. [Last accessed on 2011 July 17].   Back to cited text no. 1
    
2.Available from: http://en.wikipedia.org/wiki/Research_ethic. [Last accessed on 2011 July 17].  Back to cited text no. 2
    

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Correspondence Address:
Naseem Shah
Department of Conservative Dentistry and Endodontics, Centre for Dental Education and Research, All India Institute of Medical Sciences, New Delhi - 110 029
India
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DOI: 10.4103/0972-0707.85787

PMID: 22025818

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