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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

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. Understanding the informed consent and its process. Discuss the benefit- risk ratio of the study. Understand about ethical information. Examine the use of animals in research

Ethics
Definitions

The moral code which guides the members of the profession in proper conduct of their duties & obligations. 2. The philosophical study of moral values and rules 3. Ethics is central to the way we care, and to the way we envision ourselves as professionals...
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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) 3

Elements of Ethical research


Protecting subjects/human rights Obtaining informed consent Obtaining institutional approval of

research Balancing the benefits and the risk in the study

Understanding scientific misconduct


It may define as fabrication,

falsification, plagiarism, or other practices, that seriously deviated from those, that are commonly accepted with in the scientific community for proposing conducting or reporting research. Research never occurred, but data reported finding were consciously distorted

Understanding Scientific Misconduct


Right to Anonymity & Confidentiality Anonymity (Ambiguity) has been taken care if the subjects identity is not linked with their data they haven given. A breach (break) of confidentiality can occur when a researcher, by accident or direct action, allows an unauthorized person to gain access to raw data of a study. Confidentiality can also be breached in reporting or publishing a study if a subject is accidentally revealed (exposed), violating the subject's right to anonymity (Ramos, 1989).
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Understanding Scientific Misconduct


Predict the outcome of the study Assess benefits Assess risks

Benefit risk ratio

Benefit are great or equal to risk

Risks outweigh benefits

Approved study
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Reject study

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 If benefit and risk equals see that the researcher is able to take care of the risk o with proper consent signed

Historical contexts for development of Ethical codes and regulation


Nazi medical experience. Nuremberg Code Declaration of Helsinki Tuskegee Syphilis study Willow brook Study Jewish Chronic Disease Hospital Study Department of health education and

welfare 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 unethical

experiments done to people who had no choice. The program of Nazi regime included sterilization, euthanasia, and medical experimentation for the purpose of producing a population of racially pure Medical experiments conduct on prisoners of war and persons considered to be racially valueless who were confined in concentration camps Experiments involved exposing subjects to high altitudes, freezing temperature, malaria, poisons or untested drugs and performing surgical 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 a

study of syphilis in African Americans men in the small town Tuskegee, Alabama. Continue and blocked for 40 years to look a natural course of syphilis Subjects did not know the purpose of the study and some didnt even know they were in the study, did not receive history for syphilis and information. Subjects examined periodically but not treated for syphilis even penicillin was effective treatment for disease in 1940 History/ findings was/were deliberately withheld this went on for 40 years until stopped by a newspaper article and the public 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 mentally retarded children in New York. Children deliberately infected with hepatitis Researchers thought the children would get hepatitis when admitted.

Jewish Chronic Disease Hospital Study


Study Conducted in Jewish Chronic Disease

Hospital New York in 1960's, looking at patients rejection responses to live cancer cells, injected into patients that had been generated from human cancer tissues Patients not informed that they were in study so infected with live cancer cells. The physicians caring for the patients were unaware.
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Codes of Ethics
Definition 1. 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 codes of ethics have been developed. First internationally recognized efforts to establish ethical standards is referred to as the Nuremberg Code
developed after Nazi atrocities (slaughter, violence)

Other most notable is Declaration of

Helsinki

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Adopted in 1964 by the World Medical Association and then later revised, most recently in 2000.

Continue
Most disciplines established their own code 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 published a revised Code of Ethics in 1997. 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 14 justice.

Ethical Principles
In undertaking research, certain ethical

principles are used as a framework to guide the researcher through the research process and its subsequent use. They help to ensure the highest possible standards in every aspect of research. The Belmont Report (1978) articulated three primary ethical principles on which standards of ethical conduct in research are based: 1. Beneficence 2. Respect for human dignity 3. 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 need to be assured that their participation, or 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 participants might experience should be shared with them so that they can evaluate whether it is in their best interest to participate.
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2. Respect for Human Dignity


People should be treated as autonomous agents

with the right to self determination and the freedom to participate or not in research. The right to self-determination and the right to full disclosure are the two major Elements on which informed consent is based The Right to Self-Determination Humans should be treated as autonomous agents, capable of controlling their own activities. The principle of self-determination means that prospective participants have the right to decide voluntarily whether to participate in a study, without risking any penalty or prejudicial treatment The Right to Full Disclosure Full disclosure means that the researcher has fully described the nature of the study, the persons right to refuse participation, the researchers responsibilities, and likely risks and benefits.
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3. Justice
Human subjects should be treated

fairly in terms of the benefits and the risks of research It includes participants right to fair treatment and their right to privacy. 1. The Right to Fair Treatment Study participants have the right to fair and equitable treatment before, during, and after their participation in the study. 2. The Right to Privacy Participants have the right to expect that any data they provide will be kept in strictest confidence. This can occur either through anonymity or through other 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 and to determine the degree and duration of that participation without negative consequences. 2. Prevents harm, minimizes harm, and/or promotes good to all research participants, including vulnerable groups and others affected by the research. 3. Respects the personhood of research participants, their families, and significant others, valuing their diversity. 4. Ensures that the benefits and burdens of research are 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 research process by use of appropriate checks and balances throughout the conduct, dissemination, and implementation of the research. 7. Reports suspected, alleged, or known incidents of scientific misconduct in research to appropriate institutional officials for investigation. 8. Maintains competency in the subject matter and methodologies of his or her research, as well as in other professional and societal issues that affect nursing research and the public good. 9. Involved in animal research maximizes the benefits of the research with the least possible harm or suffering to the animals.
From Silva, M. C. (1995). Ethical guidelines in the conduct, 20 dissemination, and implementation of nursing research (pp. v vi). Washington, DC: American Nurses Association.

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 protection in research are as under. 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 capable of 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 not participate Allow them to withdraw from the study at any time with out penalty Coercion occurs when an overt threat of harm or an excessive reward is intentionally presented by one person to another to obtain compliance Covert data collection subjects are unaware that research data are being collected Deception misinforming 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

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 the research is therapeutic the researchers are willing to use vulnerable 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 or withheld from others Invasion of privacy: information is 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 private information shared by the subject ( provide ID number).
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4. Right to Fair Treatment


It means that the participants receive

equitable treatment before, during, & after their participation in the study It includes aspects; fair and nondiscriminatory selection of participants, non prejudicial treatment of individuals, honoring of all the agreements made between the researcher and the participants 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 intervention Randomization 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 balance

high risk harm could be physical, social, economical Reynolds 1972 identified five categories for the level of discomfort
No 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 subjects

agreement to participate in study as a subject. It is a conversations between study subject and the research team. In which he/she decide to participate in the research study and consent by signing the document. Participant will be given a copy of the informed consent document. He/she can use it as an information resource throughout study. Both written consent and verbal consent for participation in research must involve an informed consent process. Informed consent involves an education and information exchange that takes place between the researcher and the potential subject. Elements of Informed Consent Essential Information for Consent Comprehension of Consent Information Competency to give consent Voluntary consent
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Informed Consent-Essential Information


Informed consent requires researcher disclose specific information to all prospective subjects, which is as follow; Introduction of research activities. Purpose of the research Why they were selected as potential subjects Procedure is explained Potential Risks, cost and Benefits described Disclosure of alternatives Assurance of anonymity and confidentiality Offer to answer question Voluntary participation Contact information Opinion to withdraw Consent to incomplete disclosure

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Informed ConsentEssential Information


What is involved in a letter: Non coercion with discussion

participation is voluntary Option of withdraw If information being deliberately withheld need to inform that certain information is withheld with the study.

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Elements of Informed Consent


Comprehension of Consent

Information teach about the study discuss the purpose and outcome advocate for subject for potential risk and benefit for him/her 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
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References
Polit, D.F., and Bech, C.T. Nursing

Research; principles and Methods 7th edition, LWW. Burns, N., and Grove, S.K. (2007). Understanding Nursing Research; building an evidence based practice 4th edition, New Delhi, Elsevier.

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