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Ethical Issues in Nursing Research

Discussion for MAN - Methods in Nursing Research
by

Jenny Cabanto

on 30 July 2013

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Transcript of Ethical Issues in Nursing Research

Ethical Issues in Research
EXAMPLES OF ETHICAL DILEMMAS IN CONDUCTING RESEARCH
APPLICATION
Arellano University
Florentino Cayco Graduate School of Nursing

Methods of Research in Nursing

Jennylyn C. Cabanto, RN

Rm 313 RH Building
June 29, 2013


OBJECTIVES
After 1 hour and 30 minutes of discussion, my colleagues will be able to:
1993 – U.S Federal agencies had sponsored radiation experiments since the 1940s on hundreds of people (prisoners/elderly hospital patients)
Injection of Live Cancer Cells into elderly patients at the Jewish Chronic Disease Hospital in Brooklyn
TRUE OR FALSE
: systematic violations of moral principles within a research context occurred centuries ago rather than in recent times
HISTORICAL BACKGROUND
A victim of Nazi medical experiments. Buchenwald concentration camp, Germany, date uncertain.
— US Holocaust Memorial Museum
Seven-year-old Jacqueline Morgenstern, later a victim of tuberculosis medical experiments at the Neuengamme concentration camp. She was murdered just before the liberation of the camp. Paris, France, 1940.
— Guenther Schwarberg
Victims of Dr. Josef Mengele's medical experiments at Auschwitz-Birkenau. Poland, 1944.
— National Museum of Auschwitz-Birkenau
Research question:
How empathic are nurses in their treatment of patients in the intensive care unit (ICU)?
Research question:
Does a new medication prolong life in patients with cancer?
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:
Awareness of the subjects --> normal vs. controlled behaviour --> invalid findings
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 ange
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
Ethical Dilemma:
close involvement of researcher to participants --> sharing of secrets
RESEARCH MISCONDUCT
FABRICATION
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 NURSES 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 COMMISION 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
Articulated three primary ethical principles on which standards of ethical conduct in research are based: beneficence, respect for human dignity, and justice.

The Belmont Report
Primary Ethical Principles
THE PRINCIPLE OF BENEFICENCE
THE PRINCIPLE OF RESPECT FOR HUMAN DIGNITY
THE PRINCIPLE OF JUSTICE
"Above all, do no harm"
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
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 information for local service providers who could assist with any issue about which a participant mentioned a need for help.
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.
Freedom from Exploitation
Research study should not place participants at a
disadvantage
or
expose them to situations for which they have not been prepared
.
Participants need to be
assured
that their participation or information they might provide, will not be used against them in any way.
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
Nurse researchers may have a
nurse-patient
(in addition to a researcher-participant) relationship.
Qualitative research: Emergence of
pseudotherapeutic relationship is uncommon
--> imposes additional responsibilities to researchers – and additional risks that exploitation could inadvertently occur.
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”

Benefits from Research
Participants may perceive
direct personal benefits
Any benefits from the research accrue to
society
in general or to other individuals
Researchers should strive insofar as possible to
maximize benefits
and to communicate potential benefits to participants’

The Risk/Benefit Ratio
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
The selection of a significant topic that has the potential to improve patient-care is the first step in ensuring that research is ethical
Minimal Risk
– risks anticipated to be no greater than those ordinarily encountered in daily life or during routine physical or psychological tests or procedures
Quantitative studies vs. Qualitative studies

Right to Self-Determination
Prospective participants have the right to decide
voluntarily
whether to participate in the study, without risking any penalty or prejudicial treatment
People have the right to
ask questions
, to
refuse
to give
information
, to ask for
clarification
, or to determine their
participation
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)

Right to Full Disclosure
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

There is often a
need for further disclosure
at a later point of the study, either in debriefing sessions or in written communication.
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
(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)

“Participants’ right to fair treatment and their right to privacy”
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.

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
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 need-to-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
BUILDING ETHICS INTO THE DESIGN OF THE STUDY
External Reviews and
The Protection of Human Rights
TOPICS
INFORMED
CONSENT
VULNERABLE
SUBJECTS
EXTERNAL REVIEWS AND
PROTECTION OF HUMAN RIGHTS
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 (Polit and Beck, 2004)
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
11. Compensation
12. Confidentiality Pledge
13. Voluntary consent
14. Right to withdraw and withhold information
15. Contact information

SAMPLE
***PROCESS CONSENT
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
"incapable of giving fully informed consent or may be at high risk of unintended side effects because of their circumstances"
(Polit and Beck, 2004)
Pregnant Women
Institutionalized People
EXAMPLE
Severely ill or physically disabled people
Mentally or emotionally disabled people
vulnerable groups
CHILDREN
- informed consent of children’s parents or legal or legal guardians should be obtained
- obtain the child’s (at 7 years old) assent as well
Assent:
child’s affirmative agreement to participate.

- Researchers should obtain the written consent of a legal guardian (may not necessarily have the person’s best interest in mind)
- 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
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

researchers need to emphasize the
voluntary
nature of participation
- requirements reflect to safeguard both the
pregnant women
and the
fetuses
- 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.
Anderson, Nyamathi, McAvoy, Conde, and Casey (2001) conducted a study to explore perceptions of risk for human immunodeficiency syndrome among adolescents in juvenile detention.
- Institutional Review Board
- Philippine Health Research Ethics Board
- Philippine Council for Health Research and Development

• 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?

Research Design

• It the intervention designed to maximize good and minimize harm?
• Under what conditions might a treatment be withdrawn or altered?

Intervention
• 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?

Sample
• 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?

Data Collection
Will participants’ identities be adequately protected?
Reporting
FALSIFICATION
PLAGIARISM
FABRICATION
making up data or results and recording or reporting it.
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
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.

EXAMPLES OF FABRICATION
FALSIFICATION
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;
• Falsifying
research accomplishments
by publishing the same research results in multiple papers (self-plagiarism);
• 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
• 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
- the appropriation of another person’s ideas, processes, results, or words without giving
appropriate credit
- the theft of intellectual property and is not unlike stealing from a commercial business
A special case of plagiarism is the unacceptable practice of
"self-plagiarism"
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
SOME (IN)FAMOUS EXAMPLES OF RESEARCH MISCONDUCT
WHY DO WE HAVE TO STUDY RESEARCH MISCONDUCT
It happens, we need to be realistic
Serves as warning: demonstrates points where acceptable action has been breached
Classify the three primary principles of research ethics and their importance in formulating a research design.
Be familiar with the contents of an informed consent and how to properly utilize it in actual setting.
Be knowledgeable of the different research misconduct and their examples
Discuss with the class the different cases encountered wherein research misconduct occurred

Long term:
Apply the principles of research ethics in choosing a thesis topic
Create a research design guided by the principles of ethics
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