Post on 06-Apr-2018
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Unit – II
Ethics in Nursing Research
Dileep kumar
(R.N, CHN, Post R.N BScN)
Lecturer, Ilmiya Institute of Nursing,
Karachi
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Objectives By the end of this session the students will be
able to:-
Define ethics and scientific misconduct
List elements of ethical research
Explain the historical context for
development of ethical codes and regulations.Describe ethical principles
Discuss about humans rights.
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n ers an ng e n orme consen an sprocess.
Discuss the benefit- risk ratio of the study.Understand about ethical information.
Examine the use of animals in research
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EthicsDefinitions
1. The moral code which guides the membersof the profession in proper conduct of their
duties & obligations.
2. The philosophical study of moral values and
rules3. Ethics is central to the way we care, and to
the way we envision ourselves as
“
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pro ess ona s...
Scientific misconduct
Scientific misconduct or fraud involves such
practices as Fabrication (untruth), falsification
(deception), or forging (copy) of data;
dishonest manipulation of the designs and
methods with protocols violations;
misrepresentative of findings; and plagiarism
(Rankin & Esteves, 1997)
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Elements of Ethical
research
Protecting subjects/human rights
Obtaining informed consentObtaining institutional approval of
research
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Balancing the benefits and the risk in
the study
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Understanding scientific
misconduct
It may define as fabrication,
falsification, plagiarism, or other
practices, that seriously deviated fromthose, that are commonly accepted
with in the scientific community for
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proposing conducting or reporting
research.Research never occurred, but data
reported
finding were consciously distorted
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Understanding Scientific
Misconduct
Right to Anonymity & Confidentiality
Anonymity (Ambiguity) has been taken care if the subjects
identity is not linked with their data theyhaven given.
A breach (break) of confidentiality
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,or direct action, allows an unauthorized
person to gain access to raw data of astudy.
Confidentiality can also be breached in reporting or
publishing a study if a subject isaccidentally revealed (exposed), violatingthe subject's right to anonymity (Ramos,1989).
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Understanding Scientific
Misconduct
Predict the outcome of the study
Assess benefits Assess risks
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ene r s ra o
Benefit are great or
equal to risk
Approved study
Risks outweigh
benefits
Reject study
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Examine the benefit-risk
Ratio of a study
Balance or risk benefit ratio
sampling method, consent process,
procedures, and potential outcomes
Therapeutic is benefit, helps in add the
knowledge
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ene t an r s equa s
see that the researcher is able totake care of the risk
owith proper consent signed
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Historical contexts for development
of Ethical codes and regulation
Nazi medical experience.
Nuremberg Code
Declaration of Helsinki
Tuskegee Syphilis study
Willow brook Study
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ew s ron c sease osp a u y
Department of health education andwelfare regulation
National Commission for the
protection of Human Subjects of Bio
medical and Behavioral research
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Nazi Medical Experience
1935-45, inhuman, deadly unethicalexperiments done to people who had nochoice.
The program of Nazi regime includedsterilization, euthanasia, and medical
experimentation for the purpose of producinga population of “racially pure”
Medical experiments conduct on prisoners of war and ersons considered to be raciall
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valueless who were confined in concentrationcamps
Experiments involved exposing subjects tohigh altitudes, freezing temperature, malaria,poisons or untested drugs and performingsurgical procedures without anesthesia.
Nazi experiments violated human rights of the
research subjects Selection of subjects were racially based and
unfair.
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Tuskegee Syphilis study
US Public Health Services in 1932 did astudy of syphilis in African Americans menin the small town Tuskegee, Alabama.
Continue and blocked for 40 years to looka natural course of syphilis
Subjects did not know the purpose of thestudy and some didn’t even know theywere in the study, did not receive history
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. Subjects examined periodically but not
treated for syphilis even penicillin waseffective treatment for disease in 1940
History/ findings was/were deliberatelywithheld this went on for 40 years untilstopped by a newspaper article and thepublic became upset
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Continue
Willow brook Study 1950's-70's a doctor conducted a study at
willow brook, an institute for mentallyretarded children in New York.
Children deliberately infected with hepatitis
Researchers thought the children would get
hepatitis when admitted. Jewish Chronic Disease HospitalStud
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Study Conducted in Jewish Chronic Disease
Hospital New York in 1960's, looking atpatients rejection responses to live cancercells, injected into patients that had beengenerated from human cancer tissues
Patients not informed that they were instudy so infected with live cancer cells.
The physicians caring for the patients wereunaware.
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Codes of Ethics
Definition1. The set of standards that a professional is bound
to observe.
2. A set of ethical behavioral rules developed by an
organization or a professional society.
During the past 04 decades, largely in
response to human rights violations, various
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First internationally recognized efforts to
establish ethical standards is referred to as theNuremberg Code
– developed after Nazi atrocities (slaughter, violence)
Other most notable is Declaration of
Helsinki – Adopted in 1964 by the World Medical
Association and then later revised, most
recently in 2000.
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Continue
Most disciplines established their owncode of ethics
The American Nurses’ Association (ANA) put
forth a document in 1995 entitled Ethical
Guidelines in the Conduct, Dissemination, and
Implementation of Nursing Research
The American Sociological Association
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Guidelines for psychologists were published
by the American Psychological Association(1992) in Ethical Principles of Psychologists and
Code of Conduct.
The Belmont Report articulated three primary
ethical principles on which standards of ethical conduct in research are based:
beneficence, respect for human dignity, and
justice.
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Ethical Principles
In undertaking research, certain ethicalprinciples are used as a framework toguide the researcher through theresearch process and its subsequent use.
They help to ensure the highest possiblestandards in
ever as ect of research.
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The Belmont Report (1978)
articulated three primary ethicalprinciples on which standards of ethicalconduct in research are based:
1. Beneficence
2. Respect for human dignity3. Justice.
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1. Beneficence
Encourages the researcher to do good and“above all, do no harm”.
It contains multiple dimensions.
1. Freedom From Harm: - Physical (e.g., injury,fatigue), psychological (e.g. stress, fear), social
(e.g. loss of friends), and economic (e.g. loss of Wages).
2. Freedom From Exploitation: - Participants
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,information they might provide, will not be used
against them in any way.3. Benefits From Research: Maximize benefits &
to communicate potential benefits to participants
4. The Risk/Benefit Ratio
risks and benefits that individual participantsmight experience should be shared with them sothat they can evaluate whether it is in their bestinterest to participate.
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2. Respect for Human Dignity
People should be treated as autonomous agentswith the right to self determination and thefreedom to participate or not in research.
The right to self-determination and the right tofull disclosure are the two major Elements onwhich informed consent is based
The Right to Self-DeterminationHumans should be treated as autonomous agents,capable of controlling their own activities. The
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-prospective participants have the right to decide
voluntarily whether to participate in a study,without risking any penalty or prejudicialtreatment
The Right to Full Disclosure
Full disclosure means that the researcher has
fully described the nature of the study, theperson’s right to refuse participation, theresearcher’s responsibilities, and likely risks and
benefits.
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3. Justice
Human subjects should be treatedfairly in terms of the benefits and therisks of research
It includes participants’ right to fairtreatment and their right to privacy.
1. The Right to Fair Treatment
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and equitable treatment before,
during, and after their participation inthe study.2. The Right to Privacy
Participants have the right to expectthat any data they provide will be keptin strictest confidence. This can occureither through anonymity or throughother confidentiality procedures.
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Ethical Principles in Nursing
Research
THE INVESTIGATOR . . .1. Respects autonomous research participants’
capacity to consent to participate in research andto determine the degree and duration of thatparticipation without negative consequences.
2. Prevents harm, minimizes harm, and/orpromotes good to all research participants,includin vulnerable roups and others affected
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by the research.
3. Respects the personhood of researchparticipants, their families, and significant others,valuing their diversity.
4. Ensures that the benefits and burdens of researchare equitably distributed in the selection of
research participants.5. Protects the privacy of research participants to
the maximum degree possible.
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Ethical Principles in Nursing Research
6. Ensures the ethical integrity of the researchprocess by use of appropriate checks and
balances throughout the conduct,dissemination, and implementation of theresearch.
7. Reports suspected, alleged, or knownincidents of scientific misconduct in researchto appropriate institutional officials for
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nves ga on.
8. Maintains competency in the subject matterand methodologies of his or her research, aswell as in other professional and societalissues that affect nursing research and thepublic good.
9. Involved in animal research maximizes the benefits of the research with the least possibleharm or suffering to the animals.
From Silva, M. C. (1995). Ethical guidelines in the conduct, dissemination, and implementation of nursing research (pp. v–vi). Washington, DC: American Nurses’ Association.
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What are Human Rights & how they
protected during research?
Human rights are claims and demands
that have been justified in the eyes of
an individual or by the consensus
(Agreement) of a group of people. According to (ANA, 2001 and APA,
2002) Human rights that require
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.
1. Right to self-determination
2. Right to privacy
3. Right to anonymity & confidentiality
4. Right to fair treatment
5. Right to protection from discomfort
and harm
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1. Right to self-determination Based on the ethical principle of respect for
persons and it indicates that humans are capableof controlling their own destiny
Human should be treated as an autonomous agents If the researcher has; informed them about the study
allow them to choose to participate or notparticipate
Allow them to withdraw from the study atan time with out enalt
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Coercion
occurs when an overt threat of harm or anexcessive reward is intentionally presented byone person to another to obtain compliance
Covert data collection subjects are unaware that research data are
being collected Deceptionmisinforming the subjects for the research
purposes
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Persons with diminished
autonomy
Neonates and children
Mentally or physically disabled
Institutionalized persons
coerced to participate due to lack of care
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or loss of job.
Pregnant women and fetuses
Terminally ill patient
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Autonomy
Self-determination (Participation &
withdrawing)
No coercion
Full disclosure, no deception Voluntary consent
Conduct research on them only if
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the research is therapeutic
the researchers are willing to usevulnerable and non-vulnerable subjects
the risk is minimize
the consent process is strictly followed to
insure the rights of the prospective
subjects
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Protecting Human Rights
3. Right to Privacy
Privacy is the freedom an individual has to
determine the time, extent, and general
circumstances under which private
information may be shared with orwithheld from others
Invasion of rivac : information is
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shared with out subjects will.
4. Right to Anonymity &Confidentiality
When the data is not linked with the
personal responses
Is the researchers management of privateinformation shared by the subject (
provide ID number).
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4. Right to Fair Treatment
It means that the participants receiveequitable treatment before, during, & aftertheir participation in the study
It includes aspects; fair and non-discriminatory selection of participants,non prejudicial treatment of individuals,honoring of all the agreements made between the researcher and the artici ants
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and respectful and courteous (polite)
treatment at all time. It comes under principle of Justice
Injustice in selection especially suitable for research e.g. poor
favorite patients receives the interventionRandomization
benefits should be provided (promised)
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5. Right to Protection from
Discomfort and Harm
Beneficence
Freedom from harm
Freedom from exploitation
Risk/benefit ratios
High anticipated benefit may balancehigh risk
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economical
Reynolds 1972 identified fivecategories for the level of discomfortNo anticipated effects
temporary discomfort
unusual level of temporary discomfort
risk of permanent damage
certainty of permanent damage
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Informed Consent Process
Consent is the prospective subject’s
agreement to participate in study as asubject. It is a conversations between study subject
and the research team. In which he/shedecide to participate in the research studyand consent by signing the document.
Participant will be given a copy of theinformed consent document. He/she can useit as an information resource throughoutstudy.
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participation in research must involve aninformed consent process.
Informed consent involves an education andinformation exchange that takes place
between the researcher and the potentialsubject.
Elements of Informed Consent
Essential Information for ConsentComprehension of Consent InformationCompetency to give consentVoluntary consent
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Informed Consent-Essential
Information
Informed consent requires researcherdisclose specific information to allprospective subjects, which is asfollow; Introduction of research activities.
Purpose of the researchWhy they were selected as potential
subjects Procedure is ex lained
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Potential Risks, cost and Benefits
describedDisclosure of alternativesAssurance of anonymity and
confidentialityOffer to answer question
Voluntary participationContact informationOpinion to withdrawConsent to incomplete disclosure
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Informed Consent-
Essential Information
What is involved in a letter:
Non coercion with discussionparticipation is voluntaryOption of withdraw
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withheld need to inform that
certain information is withheldwith the study.
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Elements of Informed Consent
Comprehension of Consent
Information
teach about the study
discuss the purpose and outcomeadvocate for subject for potential
risk and benefit for him/her
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Competency to give consent
use competent person for consent
in case of presence of less
autonomous subject e.g. child,
terminally ill, disabled
Voluntary consent
consent with out coercion