ETHICS IN NURSING RESEARCHNURS 3010

Principles and Issues Pauline Anderson-Johnson, MSc, BScN, RN 2011, edited Jascinth Lindo 2012 & 2013

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CLASS OBJECTIVES

1. Discuss the historical background that guaranteed the development of codes of ethics

2. Identify the 3 primary ethical principles of the Belmont Report and the important dimensions of each

3. Identify procedures for adhering to ethical principles and protecting human participants

4. Develop consent forms for use in research studies

5. Assess the ethical aspects of a research report

6. Define and use new terms

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WHY ETHICAL APPROVAL???

Research - includes any social science, biomedical epidemiological activity that entails systematic collection or analysis of data with the intent to generate new knowledge, in which humans: Are exposed to manipulation, intervention,

observation, or other interaction with investigators either directly or thru alteration of their environment

Become individually identifiable thru investigators collection , preparation or use of biological material or medical or other records (Casebook on ethical issues in international health research, 2004)

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HISTORICAL BACKGROUND

1930s & 1940s – Germany - research on humans testing their endurance and reaction to disease and drugs – humans exposed to permanent physical harm and death, participants could not refuse to be part (Nazi medical experiments)

1930-1972 – USA – medical treatment deliberately withheld in order to study the course of untreated disease – (Tuskegee Syphilis study, sponsored by US Public Health service)

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HISTORICAL BACKGROUND

1960’s – USA - injection of live cancer cells in elderly patients without their consent ( Jewish Chronic disease Hospital, Brooklyn)

1960’s – USA – children infected with the hepatitis virus

1980s – New Zealand – patients with carcinoma in situ were not given treatment in order to study the natural progression of the disease (Dr Herbert Green of National Women’s Hospital, Aukland)

Many more, maybe not as large or obvious

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CODES OF ETHICS

Codes of Ethics have been developed in response to these violations of human rights

1949 – Nuremburg code

1964 – Declaration of Helsinki accepted by the World medical Assembly

2000 – Declaration of Helsinki revised

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CODES OF ETHICS

Many organizations or disciplines have established their own code of ethics

Nurses have developed their own Code

ANA – Ethical Guidelines in the Conduct , Dissemination and Implementation of Nursing Research

ICN – Code for Nurses

The Belmont Report – a model for many guidelines

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CODE OF ETHICS

The Belmont Report

Code of Ethics which was adopted by the National Commission for Protection of Human Subjects by the Federal Govt of the USA.

Used widely and many of the guidelines adopted

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ETHICAL PRINCIPLES

THREE (3) primary ethical principles according to the Belmont Report

1. Beneficence

2. Respect for Human Dignity or Autonomy 3. Justice

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ETHICAL PRINCIPLES - BENEFICENCE

Researcher should:

minimize harm and Maximize benefits

Dimensionsa. The right to protection from harm and

discomfort (Nonmaleficence)b. The right to protection from

exploitation

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ETHICAL PRINCIPLES – BENEFICENCE

DimensionsThe right to protection from harm and

discomfort (Nonmaleficence)Researcher has a duty to avoid, prevent or

minimize harm to participantsShould not be subjected to unnecessary

risks of harm or discomfort Participation must be essential to achieving

scientifically and societally important aimsHarm can be – physical, emotional, social or

financial(Polit & Beck, 2006)

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ETHICAL PRINCIPLES – BENEFICENCE

DimensionsThe right to protection from

exploitationWhat does this mean?

(Polit & Beck, 2006)

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ETHICAL PRINCIPLES – RESPECT FOR HUMAN DIGNITY

Includes:the right to self determination

the right to full disclosure

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ETHICAL PRINCIPLES - RESPECT FOR HUMAN DIGNITY

Right to self determinationRight to voluntarily decide on

participation – without prejudiced treatment

Right to ask questionsFreedom from coercion – explicit and

implicit threats of penalty from failing to participate or excessive rewards as a benefit to participate

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ETHICAL PRINCIPLES - RESPECT FOR HUMAN DIGNITY

Right to full disclosureFull disclosure is required for participants to make informed voluntary decisions

Researcher should describe the nature of the study fully, persons right to refuse, the risks and benefits.

Full disclosure may create biasDeception

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ETHICAL PRINCIPLES - RESPECT FOR HUMAN DIGNITY

Full disclosure may cause bias Bias – affect accuracy Bias – affect recruitment of participants

Researchers may use:ConcealmentDeception

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ETHICAL PRINCIPLE - JUSTICE

The principle of justice is synonymous with fairness and equity and researchers are obliged to treat participants fairly and equitably before, during and after the research Study.

(ABA, A. B. A. 2007)..

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VERACITY

Veracity involves the concepts of truth about the research study and the absence of deception.

Individuals have the right to be told the truth and not to be deceived about any aspect of the research.

All aspects of a research project require explanation by the researcher, who must make every effort to ensure the participants understand the implications throughout the study.

The principle of veracity is linked with respect forautonomy (Gillon, 1994).

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FIDELITY AND CONFIDENTIALITY

Fidelity involves the concept of trust (ICN, 1996). Participants place trust in researchers

and this necessitates a commitment to protect them. The researcher must ensure that the

participants have an understanding of the risks, and thus foster a trusting relationship.

The researcher is responsible for ensuring confidentiality and privacy of the research

participants and the data obtained from them. Personal information obtained by the

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REVIEW CLASS EXERCISE

1. Explain the THREE (3) primary ethical principles according to the Belmont Report

2. Describe two historical events which have shaped the discussion regarding medical and research ethics and state the year they occurred

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PROTECTION OF STUDY PARTICIPANTS

1. Respect for Persons1. Treated as autonomous

agents2. Vulnerable persons

should be protected

2. Beneficence1. Participants should not

be harmed2. Benefits should be

maximized and harms minimized to participants

3. Justice1. Benefits and risks must

be distributed fairly

1. Obtain informed consent1. Give participants the

opportunity to choose what will happen to them. Include:

1. Information2. Voluntariness3. comprehension

2. Conduct risk/benefit assessments – should be done in a systematic manner. Review of the study by Ethics Committee.

3. Selection of participants – establish fair procedures for the selection of participants

Principle Application

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(I)INFORMED CONSENT

Central to this process is that individuals have the right to decide for themselves (principle of Respect for persons)

This means: Adequate information has been given to

participants They understand the information – simple

language They have the power to make a free choice They can consent voluntarily

This process is documented by means of a Informed Consent Form

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CONSENT FORM

Should be divided into sections Should exclude medical/nursing jargon –

should be clear and readable Should include the following info:1. Title of the study2. Persons engaged in the study (PI, Co.I, RA)3. Invitation to participate (You are invited to

participate in the ….) and explain the purpose of the study

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CONSENT FORM

4. Reason the person is being asked to participate

5. Explain clearly the purpose of the study

6. Detailed description of the procedures (describe what will happen in the study, amt of time required, if hospitalization is required, if blood will be taken or any lab procedures will be done, how long it will take, instruments to be used, etc)

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CONSENT FORM

7. Potential risks to the subjects (psychological, social, physical). Explain likely severity and steps taken to protect them

8. Potential benefits of the study (desired benefits to society and individuals)

9. Economic considerations (any additional cost to persons as a result of participating)

10.Confidentiality considerations

11.Freedom of persons to ask questions and withdraw from the study at any time without penalty

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(II)ETHICS COMMITTEE

Major responsibility of com’t’e or IRB Review research proposals at convened meetings

to ensure that ethical guidelines are followed Ensures no violation of human participant The committee will include scientists, research

experts, lay persons, lawyers, ministers of religion

Review procedures of selection, protection, voluntary consent, confidentiality

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(III)RISK/BENEFIT ASSESSMENTSUsed to assess the ethical aspects of the study by

reviewerDetermine if the benefits of participating

are in line with the physical, emotional and financial cost

(see doc with major benefits and risks – p92)

Determine if risks to participants are commensurate with the benefits to society and the profession

Minimal risk – those anticipated; ordinary risks encountered in daily life or during routine tests

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• Right to anonymity and confidentiality

• Freedom for coercion and deception

• Voluntary participation

Informed consent

Institutional review board /Ethics committees

Privacy and dignity

Freedom from injury

Rights of individuals

Source: ANA guidelines for protecting human rights

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ETHICAL DILEMMA

NB: research that violates ethical principles are most times not done to harm the subjects but is due to a conviction that new and beneficial knowledge will be gained

The right of the participant and the demands of the research are put in direct conflict = ethical dilemma

REFERENCES

1. ABA, A. B. A. (2007). Guidance to nurses and midwives regarding ethical conduct of nursing and midwifery research.

2. Polit, D.F., & Beck, C.T. (2010). Essentials of nursing research: Appraising the evidence for Nursing practice. Philadelphia: Lippincott, Williams & Wilkins. (Chap 5)

3. Gerrish, K., & Lacey, A. (2010). (Eds.), The research process in Nursing. UK: Wiley-Blackwell. (Chap 8)

4. James A Fain. (1999). Reading, understanding, and applying nursing research: A text and workbook. Philadelphia, FA Davis Co.

5. http://www.emro.who.int/publications/pdf/healthresearchers_guide.pdf (chap 3.1)