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Research Ethical Issues in Research

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Page 1: Research 04   ethical issues in research

Research

Ethical Issues in Research

Page 2: Research 04   ethical issues in research

• Research is always based on the expectation that researchers undertake and report their work in the premise of fairness, honesty, and accuracy.

A researcher who fails to fulfill these expectations lacks the integrity and can be accused of engaging in research misconduct.

Danilo B. Largo, Director, USC Research Office

Page 3: Research 04   ethical issues in research

Code of conduct in research

• The guiding principle by which all research should abide with

• Embodied in the Research Policy Manuals of every academic and research institutions

Danilo B. Largo, Director, USC Research Office

Page 4: Research 04   ethical issues in research

Principle #1: Protection from harm

• Participant should not be exposed to undue physical and psychological harm

• Any risk involved should not be appreciably greater than the normal risk or day-to-day living.

• Participant should know ahead of time if some degree of discomfort is expected.

• Debriefing and counselling should immediately follow the research procedure.

Leedy & Ormrod, 2005

Page 5: Research 04   ethical issues in research

Principle #2: Informed consent

• Any participation in a study should be strictly voluntary.

• Some degree of deceit may be necessary to validate the research. In this case, the participant must be informed immediately after the study is over.

• Unobstructed measure is allowed for as long as participants are not made to do more than their daily routine and that it is not invasive.

• Consent form required.

Leedy & Ormrod, 2005

Page 6: Research 04   ethical issues in research

Principle #3: Right to privacy

• Strict confidentiality

• Use codes or pseudonyms to identify people

Leedy & Ormrod, 2005

Page 7: Research 04   ethical issues in research

Principle #4: Honesty w/ professional colleagues

• Complete and honest reporting, no misrepresentation

• Give credit where it is due

Leedy & Ormrod, 2005

Page 8: Research 04   ethical issues in research

Summary

• Principles• Protection from harm

• Informed consent

• Right to privacy

• Honesty with professional colleague

Leedy & Ormrod, 2005

Page 9: Research 04   ethical issues in research

Internal Review Board

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Internal Review Board

• An ethics committee reviews any research proposal. No study can begin without the go signal of this review board.

Danilo B. Largo, Director, USC Research Office

Page 11: Research 04   ethical issues in research

Ethics Review

• Ethics Review Applies to:

• the design and implementation of research involving the use of humans in research (Human Subject Research or HSR) either as: • subject in experiments (biomedical research)

• participants in experiments using mental exercises (behavioral/ psychological research)

• the use of living animals as subject in experiments (e.g. drug testing investigations by pharmaceutical companies)

Danilo B. Largo, Director, USC Research Office

Page 12: Research 04   ethical issues in research

Ethics Review

• started in the medical field;

• anchored on • Nuremberg Code (1946)

• Helsinki Declaration (1964)

Danilo B. Largo, Director, USC Research Office

Page 13: Research 04   ethical issues in research

1946 Nuremberg Code

• Medical experiments by Nazis on Jews which involved torture

• Vaccination trials in 1700’s by physicians either using themselves or their slaves as the test subjects.

• Dr. Edward Jenner, who first introduced smallpox vaccines, used his son and neighbor’s kids as the test subjects.

• The basis of the Nuremberg Code is that the benefits of the research must outweigh the risks.

Danilo B. Largo, Director, USC Research Office

Page 14: Research 04   ethical issues in research

Helsinki Declaration

• Developed by the World Medical Association as a code of research ethics

• A reinterpretation of the Nuremberg Code with an eye to medical research with therapeutic intent

• Journal editors require that research be performed in accordance with the Declaration, setting the stage for the implementation of the Institutional Review Board (IRB) process (Shamoo & Irving 1993

Danilo B. Largo, Director, USC Research Office

Page 15: Research 04   ethical issues in research

Rules on Human Subject Research (Schutt 2006)

1. Research should cause no harm to subjects, at no point should subjects feel distressed.

2. Deception needs to be left out of the research process, under no circumstance should a researcher lie to their subjects.

3. Participation in research should be voluntary, and therefore subjects must give their informed consent to participate in the research.

4. Researchers should be very cautious when dealing with vulnerable clients (persons who are mentally ill, incarcerated people, or minors they should make sure to get the proper consent).

Danilo B. Largo, Director, USC Research Office

Page 16: Research 04   ethical issues in research

Rules on Human Subject Research (Schutt 2006)

5. Researchers should fully disclose their identity.

6. Anonymity or confidentiality must be maintained for individual research participants unless it is voluntary and explicitly waived.

7. Actively attempt to remove from the research records any elements that might indicate the subjects identities.

8. Finally, benefits from a research project should outweigh any foreseeable risks.

Danilo B. Largo, Director, USC Research Office

Page 17: Research 04   ethical issues in research

Misconduct in Research

Page 18: Research 04   ethical issues in research

Misconduct in research

• Happens during:• Research proposal writing stage

• Conduct or performance of research

• Peer-review process of research report, or

• Reporting the research results

• Does not include honest errors or honest differences in interpretations or judgments of data

Danilo B. Largo, Director, USC Research Office

Page 19: Research 04   ethical issues in research

Misconduct in research

• At UC Berkeley, findings of research misconduct requires that:• There be a significant departure from accepted

practices of the relevant scientific/research community;

• The misconduct be committed intentionally, knowingly, or recklessly; and

• The allegation be proven by a preponderance of the evidence

Danilo B. Largo, Director, USC Research Office

Page 20: Research 04   ethical issues in research

Misconduct in research

• The US National Science Foundation defines three types of misconduct:• Fraud or Fabrication

• Falsification

• Plagiarism

• Others may include:• Professionally unacceptable practices in performing

research and/or reporting the results of research

• Willful failure to comply with government and other requirements

Danilo B. Largo, Director, USC Research Office

Page 21: Research 04   ethical issues in research

Fraud or fabrication

• is making up data or results and recording and reporting them

• e.g. South Korean scientist Hwang Hoo Suk’s (born Jan. 29, 1953) claimed to have succeeded in creating human embryonic stem cells by cloning

Danilo B. Largo, Director, USC Research Office

Page 22: Research 04   ethical issues in research

Falsification

• Manipulation of research materials, equipment, or processes, or changing or omitting data or results such that the research is not accurately represented in the research record.

• Falsification is committed if there is:• undisclosed selective reporting and rejection of

unwanted results

• manipulation of a representation or illustration

Danilo B. Largo, Director, USC Research Office

Page 23: Research 04   ethical issues in research

Plagiarism

• the appropriation of another person’s ideas, processes, results, or words without giving appropriate credit.

• the use of another’s original words or ideas as though they were your own

• theft or misappropriation of IP and the substantial unattributed textual copying of another's work

Danilo B. Largo, Director, USC Research Office

Page 24: Research 04   ethical issues in research

“A plagiarist is ostracized by the academic community, ridiculed by peers, refused tenure or awards, demonized by history”

– Isagani Cruz, linguist, columnist

Danilo B. Largo, Director, USC Research Office

Page 25: Research 04   ethical issues in research

Professionally unacceptable practices

• Examples: • research fund mishandling

• use of prohibited chemicals/drugs in experimental research

• violating ethical standards

Danilo B. Largo, Director, USC Research Office

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Willful failure to comply with laws

• e.g. not following Ethics Review requiring the protection of human and animal research subjects, permits, authorization to carry out scientific research

Danilo B. Largo, Director, USC Research Office

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Other Unethical Issues Related to Research

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• Issue on authorship in publication – who should be authors?

• Issue on duplicate publication

• Issue on premature release of information about to be published

• Issue on self-citation

• Issue on data ownership (IP issue)

• Conflict of interest

Danilo B. Largo, Director, USC Research Office

Page 29: Research 04   ethical issues in research

Issue on authorship in publication –who should be authors?

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Issue on authorship in publication –who should be authors?

• Publication must give appropriate credit to all authors for their roles in the research.

• The decision of which names are to be listed as co-authors should reflect the relative contributions of various participants in the research.

• A person's name should not be listed as author without his or her knowledge, permission, and review of the final version of the manuscript, which includes the names of all co-authors.

Danilo B. Largo, Director, USC Research Office

Page 31: Research 04   ethical issues in research

Issue on authorship in publication –who should be authors?

• Many professional associations and research journals have specified criteria for authorship. One common standard followed by journals is that each author:• should have participated in formulating the research

problem,

• should have participated in interpreting the results,

• should have participated in writing the research paper, and

• should be prepared to defend the publication against criticisms.

Danilo B. Largo, Director, USC Research Office

Page 32: Research 04   ethical issues in research

Issue on authorship in publication –who should be authors?

• Co-authorship should be named even in oral presentations

• Authorship entitlement should be given to a person whether or not he/she is still at the original location of the research when a paper is submitted for publication.

• Honorary authors who do not meet the criteria for authorship should be avoided.

Danilo B. Largo, Director, USC Research Office

Page 33: Research 04   ethical issues in research

Issue on authorship in publication –who should be authors?

• Giving technical assistance, providing research materials or facilities, do not merit co-authorship; credits for such must use alternative forms of acknowledgment within the paper such as in Acknowledgement.

• To avoid misunderstandings and even recriminations, the inclusion and exclusion of names of research participants as co-authors should be made clear to all participants in the research prior to submission of the manuscript

Danilo B. Largo, Director, USC Research Office

Page 34: Research 04   ethical issues in research

Issue on authorship in publication –who should be authors?

• Order sequence of Authors’ names:• Customs regarding the order in which co-authors'

names appear vary with the discipline. Whatever the discipline, it is important that all co-authors understand the basis for assigning an order of names and should agree in advance to the assignments.

• Corresponding, or senior author – is usually the first or last of the listed names in a multi-authored manuscript who is designated for every paper, who will be responsible for communicating with the publisher

Danilo B. Largo, Director, USC Research Office

Page 35: Research 04   ethical issues in research

Issue on duplicate publication

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Issue on duplicate publication

• Publishing the same article in two different places without very good reason to do so is inappropriate, unless appropriate citation is made in the later publication to the earlier one, and unless the editor is explicitly informed.

• If there is unexplained duplication of publication, a reader may be deceived as to the amount of original research data.

Danilo B. Largo, Director, USC Research Office

Page 37: Research 04   ethical issues in research

Issue on duplicate publication

• An author should not divide a research paper which is a self-contained integral whole into a number of smaller papers (“Chop-chop”) merely for the sake of expanding the number of items in the author's CV.

• Publication of two papers representing different interpretations of the same data by different participants in the research is confusing to readers. The participants with differing interpretations of the same data should attempt to reconcile their differences in a single publication or present their alternative interpretations in the same paper.

Danilo B. Largo, Director, USC Research Office

Page 38: Research 04   ethical issues in research

Issue on premature release of information about to be published

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Issue on premature release of information about to be published

• It is unethical to release to the media scientific information contained in an accepted manuscript prior to its publication.

• An exception may be made if a public health issue is involved and the editor agrees to an advance release

Danilo B. Largo, Director, USC Research Office

Page 40: Research 04   ethical issues in research

Issue on self-citation

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Issue on self-citation

• In citing one's own unpublished work, an author must be careful not to imply an unwarranted status of a manuscript.

• A paper should not be listed as “submitted”, in anticipation of expected submission.

• A paper should not be listed as “accepted for publication” or “In Press” unless the author has received Galley Proof or Page Proof or has received a letter from an editor or publisher stating that publication has been approved, subject perhaps only to copy-editing

Danilo B. Largo, Director, USC Research Office

Page 42: Research 04   ethical issues in research

Issue on data ownership (IP issue)

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Issue on data ownership (IP issue)

• Research data obtained in studies performed in the University and/or by employees of the University are not the property of the researcher who generated or observed them, or even of the principal investigator of the research group - they belong to the University, which can be held accountable for the integrity of the data even if the researchers have left the University.

Danilo B. Largo, Director, USC Research Office

Page 44: Research 04   ethical issues in research

Conflict of interest

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Conflict of interest

• Conflicts of interest could compromise the integrity of research or even lead to research misconduct, Example: the distortion of research outcomes as a result of personal financial interests of a researcher.

• University researchers should not allow their names to be used as “ghost” authors of manuscripts written by commercial sponsors.

Danilo B. Largo, Director, USC Research Office

Page 46: Research 04   ethical issues in research

Conflict of interest

• Unless with permission by designated University officer, in no case are University facilities be used in the conduct of an outside activity, and the University name and logo be used by outside entities

• Our USC logo is now Trademark protected, its use may require permission from USC authority

Danilo B. Largo, Director, USC Research Office

Page 47: Research 04   ethical issues in research

Other matters

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Some reasons why fraudulent acts happen:

• inadequate mentoring of researchers

• veneration of a high volume of published research

• chases for grants

• personal glory

• political pressures for practical results

Danilo B. Largo, Director, USC Research Office

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“Practicing the Code of Conduct is a step towards promoting a culture of research - it starts with YOURSELF.”

“Let it flourish in your department, and eventually to your University you hold with high esteem !"

Danilo B. Largo, Director, USC Research Office

Page 50: Research 04   ethical issues in research

References

• Paul Leedy and Jeanne Ellis Ormrod, PRACTICAL RESEARCH: PLANNING AND DESIGN, Pearson Prentice Hall, 2005, New Jersey

• Danilo B. Largo, Lecture Slides: CODE OF CONDUCTS IN RESEARCH FOR SOLG, Aug. 14, 2012