Research Unit II

8/3/2019 Research Unit II

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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



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)



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



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



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).



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



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



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



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.



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



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.



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.



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.



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.



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.



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.



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.



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.



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.



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



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



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



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



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).



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)



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



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



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



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.



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



References

Polit, D.F., and Bech, C.T. “Nursing

Research; principles and Methods” 7th

edition, LWW. Burns, N., and Grove, S.K. (2007).

“

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building an evidence based practice” 4th

edition, New Delhi, Elsevier.

Research Unit II

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