University College of Nursing Ethical Consideration for Research Prof (Mrs. Bhupinder Kaur)...

University College of Nursing

Ethical Consideration for Research

Prof (Mrs. Bhupinder Kaur)Professor University College of Nursing Faridkot-151203, Punjab


Ethical Consideration for Research 2

Agenda for Discussion After completing this, participants should be able to know

What is Ethics, Need for Ethical Guidelines Ethical Dilemma’s in Conducting Research Plagiarism Designing Consent Form Building Ethics into design of the Study

Nursing Research and Ethics

Guidelines

Consent Form

Building Ethics

Ethical Committee



What is Ethics?

Ethics are--- Study of right and wrong From Ethos, meaning cultural customs or

habit System of moral principles and values Principles of conduct that help govern

human behaviors, determine which acts are right and which are wrong, and are used by society for evaluating the behavior of individuals and groups.

Means of regulating and setting limits on behavior.



Ethics at all levels of life

Normative ethics---practical guidelines or norms Personal ethics---cultivating a virtuous character

and develop proper self-esteem Interpersonal ethics---moral obligations toward

others and ourselves Environment ethics—moral obligation toward the

environment Classroom ethics---how to behave in the

classroom Professional ethics---moral guide of profession Clinical ethics---day-to-day moral decision making

or those caring for clients Theoretical ethics---or theoretical morality—

argues everyone already knows what is right and wrong



Ethics- Definitions

Ethics is

“the study of standards of right and wrong; that part of science

and philosophy dealing with moral conduct, duty and judgment”



Need of Ethical Guidelines

For the Protection of Rights of Human under study

Ethical Conduct need to be Mandatory in all discipline of research

Always Ethical Consideration have not been given adequate importance


Historical Background



Nazi Germany Experimentation

Charges brought against 23 German physicians in the Nuremberg War Crime Trials for their medical experiments – included:

1. Freezing Experiments2. Malaria Experiments3. High-Altitude Experiments

Led to the development of Nuremberg Code

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Jewish Chronic DiseaseStudies were conducted at the Jewish Chronic

Disease Hospital in New York City to develop information on the nature of the human transplant rejection process. Chronically ill patients who did not have cancer were injected with live human cancer cells.

The physicians did not inform the patients as to what they were doing. The physicians’ rationalization for their actions was as follows:

(i) they did not want to scare the patients and

(ii) (ii) they thought the cells would be rejected

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Historical Standards of Ethics CIHR (2001)

Nuremberg Code (1947): principles to satisfy moral, ethical, and legal concepts in human experimentation, with voluntary consent being absolutely essential.

Universal Declaration of Human Rights (1948): is a recognition of and pledge to basic human rights for the international community; human rights are protected by law

Declaration of Geneva (1948): is a physician’s oath to devote life to the service of humanity

Declarations of Helsinki (1964, 1975, 2000): Ethical Principles for Medical Research Involving Human Subjects(research procedures, risk assessment duties, issues of informed consent)

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Belmont ReportNational Commission for the Protection of Human Subjects

of Biomedical and Behavioral Research published report (1978) under National Research Act affecting government research.

Three principles became pillar of ethics standards: 1. Beneficence,

• Respect persons’ decisions and protect from harm

• maximize possible benefits and minimize possible harms

2. Respect for human dignity, and • Autonomy of individuals • Persons with diminished autonomy are entitled

to protection3. Justice.

• Benefits and risks of research must be distributed fairly

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Code of Ethics

Professional Ethics Medical Ethics Nursing Ethics International Council of Nurses Code Others Ethical responsibilities toward

state licensing laws Statuary Laws Common Law Professional Code of Ethics Law of Privacy Protection Act about Fundamental right

of every Citizen



Nurses’ Codes for Practice & Research

American Nurses Association (1995) – Ethical Guidelines in the

Conduct, Dissemination, & Implementation of Nursing Research

. Nurse researcher must

- respect autonomous research participants’ capacity to consent to

participate… without negative consequences

- prevent or minimize harm, & promote good to all participants

- respect personhood or diversity of participants

- ensure burdens and benefits of research are equitably distributed

amongst participants

- protect privacy of participants to maximum degree

- ensure ethical integrity of research process

- report suspected, alleged or known scientific misconduct



Canadian Nurses’ Codes for Practice and Research

CNA – www.cna-nurses.ca/CNA/practice/ethics/guidelines

Nursing Values & Research, Safe, competent & ethical research & practice

health & well-being choice dignity confidentialityjustice accountability and quality research environments.

http://www.cna-nurses.ca/CNA/practice/ethics/guidelines


Indian Nurses’ Codes for Practice and Research

Code of ethics Uniqueness of individual Rights of individuals Rights to privacy Quality nursing care Practice with in boundaries Work harmoniously with health

team.

Ethical Consideration for Research16



Risk/Benefit Ratio

Predict the Outcome of the study

Assess the benefits Assess the risks

Benefit- Risk Ratio

Benefits are greater than the risks

Risks outweigh the benefits

Approve the Study Reject the Study



Potential Risks/Benefits

RISKS: Physical harm; side effects Physical discomfort, fatigue,

etc Psychological or emotional

distress Social risks – stigma, loss of

status, effect on personal relationships, etc.

Loss of privacy Loss of time Monetary costs (e.g. child

care, transportation, time lost from work or family, etc).

BENEFITS: Access to intervention(s)

otherwise unavailable Comfort in discussing issues

with objective person interested in area of concern

Increased knowledge about themselves & their condition

Escape from normal routine – exciting to be part of ground-breaking initiative

Satisfaction that information from study may help others

Direct monetary or material gains through stipends, incentives, or products



Why Nurse Researcher Need to be Particularly Vigilant about Ethics

Dealing with vulnerable populations Very young, Very Old and Mentally ill

Safety from physical & Psychological Harm Trust and Nurse-Patient Relationship Risk of Monocultural Approach and issues are

bi-cultural and multicultural Recognized code of ethical Practice and it

should be Clear to Public Ethics and Quality are inextricably linked Social Scientists have paid for more

attention to Ethical aspects in compare to Health Professionals


Ethical Dilemmas in Conducting Research



How Emphatic are Nurses in Their Treatment of Patients in the Coronary Care Unit? Ethical Dilemma Participant be aware of their role If researcher inform nurses

participating in this study that their degree of empathy in treating CCU patient will be under screening Will there behavior be “Normal”? Here lies the dilemmas that usual behavior

of nurse is altered because of the known presence of research observer.E

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Does a new medication prolong life in patient?

Ethical Dilemma

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Ethical Principles in Research Freedom from Harm Freedom from Exploitation Benefit from Research The Risk/Benefit ratio Respect for human dignity Right to self determination Right to full disclosure Justice Anonymity and confidentiality



Need to maintain Confidentiality at all Cost by the following

Obtain identification (ID) information Assign an ID Number Maintain ID information in a locked file Restricted Access Do not enter ID information into

computer files Destroy ID information as quickly as

possible


Plagiarism

•Plagiarism is the "wrongful appropriation" and "stealing and publication" of another author's "language, thoughts, ideas, or expressions" and the representation of them as one's own original work.

It is derived from Latin word plagiarius (literally kidnapper) to denote stealing someone else‘s work.


Plagiarism contd….

• The modern concept of plagiarism is immoral. • Plagiarism is considered academic dishonesty and a

breach of journalistic ethics. • It is subject to sanctions like penalties, suspension,

and even expulsion. • Plagiarism is not a crime but in academia and

industry, it is a serious ethical offense, and cases of plagiarism can constitute copyright infringement.


Plagiarism contd….

Plagiarism is also considered a moral offense against anyone who has provided the plagiarist with a benefit in exchange for what is specifically supposed to be original content (for example, the plagiarist's publisher, employer, or teacher).


Plagiarism in academics


Common forms of student plagiarism

• Submitting someone’s work as their own.

• Taking passages from their own previous work without adding

citations.

• Re-writing someone’s work without properly citing sources.

• Using quotations, but not citing the source.

• Interweaving various sources together in the work without

citing.

• Citing some, but not all passages that should be cited.

• Melding together cited and uncited sections of the piece.


Self-plagiarism

Self-plagiarism (also known as "recycling fraud" is the reuse of significant, identical, or nearly identical portions of one's own work without acknowledging.

Articles of this nature are often referred to as duplicate or multiple publications.

In addition there can be a copyright issue if copyright of the prior work has been transferred to another entity.


Informed Consent



Informed Consent

What is informed consent? Informed consent means that participants are told

enough about the nature of surveillance to enable them to make an informed decision about whether or not to take part.

The decision to participate should be voluntary. Project staff should try to ensure that respondents are

not pressurized.



Content of Informed Consent What information should be provided during informed consent?

1. Participant Status2. Study Goal: The nature of the survey (e.g., length of interview

and type of question)3. Types of Data4. Procedures5. Nature of Commitment 6. Sponsorship7. Participant selection8. The potential risks and benefits9. Alternative10. Compensation11. Confidentiality 12. How the information will be used13. How privacy will be protected14. That participation is voluntary15. That participants have the right to refuse to answer any

questions or stop the interview at any time

16. Participants should also be given a chance to ask questions

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Building Ethics into the Design of the Study

Research DesignInterventionSample

Data CollectionReporting



Building Ethics into the Design of the Study

Before building ethics in the study design researcher required to be careful during planning of a research project.

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Research Design

Will participants get allocated to different treatment groups fairly?

Will research control the risks participants will incur?

Will the setting for the study be selected to protect against participant discomfort?

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Intervention

Is the intervention designed to maximize good and minimize harm?

Under what conditions might a treatment be withdrawn or altered?

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Sample

Is the population unnecessarily exclude important segments of people (e.g. women, minorities)?

Is the population defined in such a way that especially high-risk people (e.g. unstable patients) could be excused from the study?

Will potential participants be recruited into the study equitably?B

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Data Collection

Data should be collected in such a way, to minimize respondents burden.

Data collection procedures should maintain confidentiality.

Data collection team should be appropriately trained.

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Ethical Committee/ Ethical Review Procedure



Ethical Committee/ Ethical Review Procedure

The need for evaluation of research proposals has been emphasized under the Statement of Specific Principles at item no. 5 of ICMR Ethical Guidelines pertaining to precaution and risk minimisation.

It is mandatory that all proposals on biomedical research involving human participants should be cleared by an appropriately constituted Institutional Ethics Committee (IEC).

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Composition of Institutional Ethics Committees

1. Chairperson2. One - two persons from basic medical science

area3. One - two clinicians from various Institutes4. One legal expert or retired judge5. One social scientist/ representative of non-

governmental voluntary agency6. One philosopher/ ethicist/ theologian.7. One lay person from the community8. Member Secretary

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Monitoring

Once IEC gives a certificate of approval it is the duty of the IEC to monitor.

Actual site visits can be made especially in the event of reporting of adverse events or violations of human rights.

Additionally, periodic status reports must be asked for at appropriate intervals based on the safety concerns

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Conclusion It is important that nursing research is

undertaken with a clear ethical concerns. Ethical component is not enough to protect a

study. A more overt and less immature approach to

access for fieldwork is required.


Thanks………

University College of Nursing Ethical Consideration for Research Prof (Mrs. Bhupinder Kaur)...

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