Injection of Live Cancer Cells into elderly patients at the Jewish Chronic Disease Hospital in Brooklyn, without the consent of those patients 1993 – U.S Federal agencies had sponsored radiation experiments since the 1940s on hundreds of people (prisoners/elderly hospital patients)
EXAMPLES OF ETHICAL DILEMMAS IN CONDUCTING RESEARCH
1. Research question: How empathic are nurses in their treatment of patients in the intensive care unit (ICU)?
Ethical Dilemma: Awareness of the subjects normal vs. controlled behaviour invalid findings
2. Research question: What are the coping mechanisms of parents whose children have a terminal illness?
Ethical Dilemma: probing into the psychological state of parent at a vulnerable time in their lives = traumatic vs. identifying coping mechanisms used that will help design more effective ways of dealing with grief and anger.
3. Research question: Does a new medication prolong life in patients with cancer? Ethical Dilemma: control vs. experimental group – exposing the group receiving the medication to potential hazard while group NOT receiving the drug may be denied a beneficial treament
4. Research question: What is the process by which adult children adapt to the day-to-day stresses of caring for a terminally ill parent?
Ethical Dilemma: close involvement of researcher to participants sharing of secrets It is precisely because of such conflicts and dilemmas that codes of ethics have been developed to guide the efforts of researchers.
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CODE OF ETHICS
1. Nuremberg Code
a. developed after the Nazi atrocities were made public in the Nuremberg trials. b. One of the first internationally recognized efforts to establish ethical standards 2. Declaration of Helnski
a. Adopted in 1964 by the World Medical Association
b. Revised in 2000
3. American Nurse Association
a. Ethical Guidelines in the Conduct, Dissemination, and Implementation of Nursing Research (Silva, 1995)
4. American Sociological Association
a. Published a revised Code of Ethics (1997)
5. American Psychological Association
a. Ethical Principles of Psychologists and Code of Conduct (1992) 6. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (1978)
a. Belmont Report – served as the basis for regulations affecting research sponsored by the federal government
i. Articulated three primary ethical principles on which standards of ethical conduct in research are based: beneficence, respect for human dignity, and justice.
THE PRINCIPLE OF BENEFICENCE
“Above all, do no harm”
1. Freedom from harm
a. Physical
b. Psychological
c. Social
d. Economic
e. Minimize all types of harm and discomfort
f. Achieve balance between potential benefits and risks of being a participant g. Qualified people only to conduct potentially dangerous technical equipment or specialized procedures
h. Termination of research: injury, death, disability, undue distress i. Experiment with animals or tissue cultures prior human testing
Example of RISK REDUCTION
1. Varda and Behnke (2000) studied the effect of the timing of an initial bath (1 hour vs. 2 hours after birth) on newborn temperature.
2. Psychological consequences/harm debriefing sessions
Example of REFERRALS
1. Study by Polit, London, and Martinez (2001) of the health of nearly 4000 poor women in 4 major cities interviewers had an information sheet w/ contact
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information for local service providers who could assist with any issue about which a participant mentioned a need for help.
> Qualitative researchers, regardless of the underlying research tradition, must thus be especially vigilant in anticipating such problems (Polit and Beck, 2004)
Example of an ISSUE OF RISK IN A QUALITATIVE STUDY:
Caelli (2001) conducted a phenomenological study to illuminate nurses’ understandings of health, and how such understandings translated into nursing practice. One participant, having explored her experience of health
with the researcher over several interview sessions, resigned from her city hospital job as a result of gaining a new recognition of the role health played in her life. 2. Freedom from Exploitation
a. Research study should not place participants at a disadvantage or expose them to situations for which they have not been prepared.
b. Participants need to be assured that their participation or information they might provide, will not be used against them in any way.
c. Study participants enter into a special relationship with researchers, and it is crucial that this relationship not be exploited
i. Exploitation may be overt and malicious, but it might also be more subtle d. Nurse researchers may have a nurse-patient (in addition to a researcherparticipant) relationship. e. Qualitative research: Emergence of pseudotherapeutic relationship is uncommon imposes additional responsibilities researchers – and additional risks that exploitation could inadvertently occur.
f. Munhall (2001) – qualitative nurse researchers have the responsibility of ensuring that the “therapeutic imperative of nursing (advocacy) takes precedent over the research imperative (advancing knowledge) if conflict develops” 3. Benefits from Research
a. Participants may perceive direct personal benefits
b. Any benefits from the research accrue to society in general or to other individuals c. Researchers should strive insofar as possible to maximize benefits and to communicate potential benefits to participants’
4. The Risk/Benefit Ratio
a. The degree of risk to be taken by those participating in the research should never exceed the potential humanitarian benefits of the knowledge to be gained b. The selection of a significant topic that has the potential to improve patient-care is the first step in ensuring that research is ethical
c. Minimal Risk – risks anticipated to be no greater than those ordinarily encountered in daily life or during routine physical or psychological tests or procedures
c. Quantitative studies vs. Qualitative studies
THE PRINCIPLE OF RESPECT FOR HUMAN DIGNITY
1. Right to Self-Determination
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a. Prospective participants have the right to decide voluntarily whether to participate in the study, without risking any penalty or prejudicial treatment b. People have the right to ask questions, to refuse to give information, to ask for clarification, or to determine their participation
c. Freedom from coercion of any type
– explicit or implicit threats of penalty from failing to participate in a study or excessive rewards from agreeing to participate
– position of authority
– generous monetary incentive (or stipend)
2. Right to Full Disclosure
a. The researcher has fully described the nature of the study, the person’s right to refuse participation, the researcher’s responsibilities, and likely risks and benefits. b. There is often a need for further disclosure at a later point of the study, either in debriefing sessions or in written communication.
3. Issues Relating to the Principle of Respect
a. Inability of some individuals to make well-informed judgements about the risks and benefits of study participation
b. Full disclosure can sometimes create two types of bias:
i. subjects provide inaccurate information
ii. representative sample is not recruited
EXAMPLE:
Research Study: Relationship between high school students’ substance abuse and their absenteeism
Hypothesis: Students with a high rate of absenteeism are more likely to be substance abusers than students with a good attendance record c. Techniques that researchers sometimes use in conflicting situations i. Covert data collection or concealment
ii. Deception
ANA Guidelines offer advice about deception and concealment: The investigator understands that concealment or deception in research is controversial, depending on the type of research. Some investigators believe that concealment or deception in research can never be morally justified. The investigator further understands that before concealment or deception is used, certain criteria must be met:
(1) The study must be of such small risk to the research participant and of such great significance to the advancement of the public good that concealment can be morally justified.
(2) The acceptability of concealment or deception is related to the degree of risks to research participants
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(3) Concealment or deception are used only as last resorts, when no other approach can ensure the validity of the study’s findings
(4) The investigator has a moral responsibility to inform research participants of any concealment or deception as soon as possible and to explain the rationale for its use (Silva, 1995)
d. Collection of data from people over the internet.
EXAMPLE: Some researchers are analyzing the content of messages posted to chat rooms or listserves.
ISSUE: Whether such messages can be used as data without the authors’ permission and their informed consent.
– Researchers, before collecting electronic data, negotiate their entry into an electronic community (e.g., chat room) with the list owner (Schrum, 1995) – Obtaining consent from list moderators does not necessarily mean that every member of the listserve or chat room has provided consent (Sixsmith and Murray, 2001)
THE PRINCIPLE OF JUSTICE
“Participants’ right to fair treatment and their right to privacy” 1. The Right to Fair Treatment – Participants have the right to fair and equitable treatment before, during and after their participation in the study (Polit and Beck, 2004). Fair treatment includes the following features:
The fair and non-discriminatory selection of participants
– participants should be selected based on research requirements and not on the vulnerability or compromised position of certain people.
Respect for cultural and other forms of human diversity
The nonprejudicial treatment of those who decline to participate or who withdraw from the study after agreeing to participate
The honoring of all agreements between researchers and participants, including adherence to the procedures described to them and payment of any promised stipends. Participants’ access to research personnel at any point in the study to clarify information Participants’ access to appropriate professional assistance if there is any physical or psychological damage
Debriefing, if necessary, to divulge information withheld before the study or to clarify issues that arose during the study Courteous and tactful treatment at all times.
2. The Right to Privacy
– participants have the right to expect that any data they provide will be kept in strictest confidence
a. Anonymity – occurs when even the researcher cannot link participants to their data
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EXAMPLE: Thomas, Stamler, Lafrenier, and Dumala (2001) used the Internet to gather data from an international sample of women about their perceptions of breast health education and screening. A website with a questionnaire was established. No identifying information was sought from respondents, and so their anonymity was guaranteed.
b. Confidentiality Procedures – implemented when anonymity is impossible. – A promise of confidentiality is a pledge that any information participants provide will not be publicly reported in a manner that identifies them and will not be made accessible to others
– Research information should not be shared with strangers nor with people known to the participants (e.g. family members, physician, other nurses) unless the researcher has been given explicit permission to share it. > Steps to avoid occurrence of breaches of confidentiality:
Obtain identifying information (e.g., name, address) from participants only when essential
Assign an identification (ID) number to each participant and attach ID number rather than other identifiers to the actual data.
Maintain identifying information in alocked file.
Restrict access to identifying information to a small number of people on a needto-know basis. Enter no identifying information as quickly as practical.
Make research personnel sign confidentiality pledges if they have access to data or identifying information
Report research information in the aggregate; if information for a specific participant is reported, take steps to disguise the person’s identity, such as through the use of a fictitious name.
INFORMED CONSENT
– participants have adequate information regarding the research, are capable of comprehending the information, and have the power of free choice, enabling them to consent to or decline participation voluntarily.
The Content of Informed Consent
1. Participant Status
2. Study Goals
3. Type of data
4. Procedures
5. Nature of the Commitment
6. Sponsorship
7. Participant selection
8. Potential risks
9. Potential benefits
10. Alternatives
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11. Compensation
12. Confidentiality Pledge
13. Voluntary consent
14. Right to withdraw and withhold information
15. Contact information
> In some Qualitative studies, especially those requiring repeated contact with the same participants, it is difficult to obtain a meaningful informed consent at the outset. Qualitative researchers do not always know in advance how the study will evolve. Process Consent: researcher continually renegotiates the consent, allowing participants to play a collaborative role in the decision-making process regarding ingoing participation.
Comprehension of Informed Consent
– normally presented to prospective participants while they are being recruited, either orally or in writing – a written notice should not, however, take the place of spoken explanations – researchers must assume the role of teacher in communicating consent information – written statement should be consistent with the participants’ reading levels and educational attainment (For participants from a general population (e.g., patients in a hospital), the statement should be written at about seventh or eighth grade reading level. Documentation of Informed Consent
– signing a consent form
– document should be signed by the researcher, and a copy should be retained by both parties Guidelines in developing a consent form:
1. Organize the form coherently so that prospective participants can follow the logic of what is being communicated.
2. Use a large enough font so that the form can be easily read, and use
spacing that avoids making the document appear too dense.
3. In general, simplify. Use clear and consistent terminology, and avoid technical terms if possible
4. If possible, use a readability formula to estimate the form’s reading level, and make revisions to ensure an appropriate reading level for the group under study. 5. Test the form with people similar to those who will be recruited, and ask for feedback VULNERABLE SUBJECTS
– may be incapable of giving fully informed consent or may be at high risk of unintended side effects because of their circumstances
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1. Children
– informed consent of children’s parents or legal or legal guardians should be obtained – it is appropriate, however to obtain the child’s (at 7 years old) assent as well Assent: child’s affirmative agreement to participate.
2. Mentally or emotionally disabled people
– Researchers should obtain the written consent of a legal guardian (may not necessarily have the person’s best interest in mind)
3. Severely ill or physically disabled people
– assess their ability to make reasoned decisions about study participation EXAMPLE: Assessment of decisional capacity of mechanically ventilated patients (Higgins and Daly, 1999)
– special procedures for obtaining consent from participants with certain disabilities EXAMPLE: Deaf participants, People with physical impairment, Participants who cannot read and write
4.The terminally ill
– careful assessment of risk/benefit ratio
– health care and comfort of participants are not compromised – special
procedures in obtaining consent if mentally/physically incapacitated 5. Institutionalized people
– researchers need to emphasize the voluntary nature of participation 6. Pregnant women
– requirements reflect to safeguard both the pregnant women and the foetuses. – a pregnant woman cannot be involved in a study unless the purpose of the research is to meet the health needs of the pregnant woman and risks to her and the fetus are minimized or there is only a minimal risk to the fetus.
EXAMPLE: Anderson, Nyamathi, McAvoy, Conde, and Casey (2001) conducted a study to explore perceptions of risk for human immunodeficiency syndrome among adolescents in juvenile detention.
EXTERNAL REVIEWS AND THE PROTECTION OF HUMAN RIGHTS
– Institutional Review Board
– Philippine Health Research Ethics Board
– Philippine Council for Health Research and Development
BUILDING ETHICS INTO THE DESIGN OF THE STUDY
Research Design:
Will participants get allocated to different treatment groups fairly? Will research controls add to the risks participants will incur? Will the setting for the study be selected to protect against participant discomfort?
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Intervention:
It the intervention designed to maximize good and minimize harm? Under what conditions might a treatment be withdrawn or altered?
Sample:
Is the population defined so as to unwittingly and unnecessarily exclude important segments of people
Is the population defined in such a way that especially high-risk people could be excused from the study?
Will potential participants be recruited into the study equitably?
Data collection:
Will data be collected in such a way as to minimize respondent burden? Will procedures for ensuring confidentiality of data be adequate? Will data collection staff be appropriately trained to be sensitive and courteous?
Reporting:
Will participants’ identities be adequately protected?
RESEARCH MISCONDUCT
Fabrication – making up data or results and recording or reporting it. Examples of Fabrication: According to Assessing Research Misconduct Allegations Involving Clinical Research, fabrication would be alleged in the following scenarios: Completing a questionnaire for a fictitious subject that was never interviewed Creating a data set for an experiment that was never actually conducted; Adding fictitious data to a real data set collected during an actual experiment for the purpose of providing additional statistical validity; and
Inserting a clinical note into the research record to indicate compliance with an element of the protocol. Fabrication of data is rendered punishable when the false data is incorporated into the official study notebook; submitted to a funding agency; or publicly disseminated through the process of publication, patent application, or at a public forum such as a professional meeting, seminar, or symposium; regardless of whether the data is subsequently published or not. Falsification is 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. Falsification also includes the selective omission/deletion/suppression of conflicting data without scientific or statistical justification.
Examples of Falsification:
Altering data to render a modification of the variances in the data; Falsifying dates and experimental procedures in the study notebook; Misrepresenting results from statistical analysis;
Misrepresenting the methods of an experiment such as the model (e.g., cell line) used to conduct the experiment;
Adding false or misleading statements in the manuscript or published paper; for example, the misrepresentation of “n;”
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Falsifying research accomplishments by publishing the same research results in multiple papers (self-plagiarism);
Falsifying data in a continuation application for research supported by U.S. Public Health Service (PHS) funds;
Misrepresenting the materials or methods of a research study in a published paper; Providing false statements about the extent of a research study in an abstract submitted for publication and oral presentation at a professional society meeting; and Falsifying telephone call attempts to collect data for a survey study such as in a federally funded program to determine risk factors for new mothers and babies.
Examples of Falsification in Clinical Studies: According to Assessing Research Misconduct Allegations Involving Clinical Research, fabrication would be alleged in the following scenarios: Substituting one subject’s record for that of another subject; Falsely reporting to a data coordinating center that certain clinical trial staff, who were certified to perform the procedures on the subjects, had done so, when they had not; Altering the dates and results from subjects’ eligibility visits; Altering the dates on patient screening logs and/or submitting the same log with altered dates on multiple occasions;
Failing to update the patients’ status and representing data from prior contacts as being current;
Altering the results of particular tests on blood samples to show that the test accurately predicted a disease or relapse;
Backdating follow-up interviews to fit the time window determined by the study protocol; and
Falsifying the times that blood samples were drawn from human subjects. Plagiarism is the appropriation of another person’s ideas, processes, results, or words without giving appropriate credit. Plagiarism is the theft of intellectual property and is not unlike stealing from a commercial business. A special case of plagiarism is the unacceptable practice of “selfplagiarism” in which an author will use segments of his/her own
published material (e.g., the methods section of a scientific paper) in a new publication without reference. References:
Polit, D., Beck, C. (2004) Nursing Research: Principles and Methods. Lippincott Williams & Wilkins.
University of Miami (2013). Research Misconduct. Retrieved from http://uresearch.miami.edu/?p=175
Willmoth, C. (2011) You Don’t Want to do it Like That. Retrieved from http://www.slideshare.net/cjrw2/infamous-cases-of-research-misconduct
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