Open Elective: DESIGN RESEARCH ETHICAL GUIDELINES

UNIT VI

We are frequently faced with ethical and legal issues that govern our actions. A knowledge of ethical
standards, rights and legal issues are important

Ethics:

• Moral Philosophy

• Discipline concerned with right or wrong conduct

• Guides to moral behavior

• Making choices or judgments

Morals- Rules that define what is right and wrong

Ethics- Process of examining moral standards and looking at how we should interpret and apply such
standards in real world situations

Differences between Law and Ethics:

Law:

 A law is a rule of conduct or action.

 Governments enact laws to maintain order and public safety.
 Criminal and civil laws, Organizational pertain to health-care practitioners and individuals.

Ethics:

 Ethics is a standard of behavior.

 Moral values serve as the basis for ethical conduct.
 Family, culture, and society help form an individual’s moral values.

Moral Values:

• Show respect for each other as an individual

• Understand the limits of our roles:

– Perform only acts for which adequately prepared

– Perform acts only within legal scope..

• Be loyal and carry out assignments to best of ability

 • Maintain a positive attitude toward institution that employs you

• Support co-workers

• Be responsible citizen at all times

• Respect others, Respect values that differ from yours

• Information if required should be kept confidential

• Respect personal religious beliefs and Respect privacy of others

• Put others needs ahead of your own

• Be sincere, honest, caring, concerned and trustworthy in performance of duties

Ethics is different from morals. Ethics tries to probe the reasoning behind our moral life, by
examining and analyzing the thinking used to justify our moral choices and actions in particular
situations

Bioethics:

• Discipline dealing with the ethical implications of biological research and the applications of that
research
• Deals with the questions relating to the appropriate use of new technologies

New Technology= New Innovative Ethical Boundaries

Over the past several decades, technology has advanced at an amazing rate.

As new technology develops, we are challenged to create new and innovative ethical boundaries to
accommodate the advancement.

New Technology = New Ethical Problems

Traditional rules of conduct are not always applicable to a new medium. A question that often arises:

Should a device, a technique or technology be restricted because people can use it for illegal or
harmful actions as well as beneficial ones?
Ethical Principles

 Autonomy
 Beneficence
 Non-maleficence
 Justice
 Fidelity

Do these principles relate to research?

History of unethical Research:

 Tuskegee Experiment (1932-1972) - American researchers purposely withheld treatment for

399 African-American people with syphilis for the sole purpose of studying the long term effects
of the disease.

 Willowbrook Study (1963-1966) - Children with developmental disabilities were deliberately

infected with Hepatitis (some were even fed fecal matter). Purpose of the study was to examine
the course of the disease and to test a potential immunization

 Human radiation experiments by the US Department of Defense & Atomic Energy Commission.

 Zimbardo’s Stanford Prison Experiment (1971). Study had to be ended prematurely because
of abusive behaviors generated participants who where assigned as guards over those
subjects that were assigned as prisoners.

Responses to unethical research

 Nuremberg created as a result of cruel experiments the Nazis conducted on humans during
WW - II.

 NIH Ethics Committee (1964)

 Declaration of Helsinki (1964, ’75, ’83, ’89, ’00)

 Beecher “Ethics & Clinical Research” (1966) [NEJM, 274, 1354-60].

 National Research Act of 1974: April 1979 – Belmont Report

 Established the IRB system.

The Nuremberg Code: Although it did not carry the force of law, the Nuremberg Code was the first
international document which advocated voluntary participation and informed consent.

 Voluntary informed consent

 Likelihood of some good resulting

  Based on prior research (animal models)

 Avoidance of physical or psychological injury or harm

 Benefits should outweigh risks

 Proper experience of researcher

 Right to withdraw consent

 Research must stop if harm is resulting

 (no specific mention of children, unconscious people, or others who may not be competent to
give consent)

The Belmont Report

The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research
April 18, 1979

1. Boundaries Between Practice and Research

2. Basic Ethical Principles

3. Applications (of Principles)

The Belmont Report (1979) is the major ethical statement guiding human research in the United States.

1. Boundaries Between Practice and Research

IRB must determine that the researcher (and through informed consent, the subject) distinguishes
practice from experiment in both social science and medical science research

2. Basic Ethical Principles

– Respect for Persons

• Individual autonomy

• Protection of individuals with reduced autonomy

– Beneficence

• Maximize benefits and minimize harms

– Justice

• Equitable distribution of research risks and benefits

3. Application

– All principles are essential to sound ethical research

 – Principles carry equal moral weight

– Ethical conduct is expected

Four Principles of Ethics

1 - Autonomy (Respect for the person)

2 - Beneficence (Do Good)
3 - Non-malfeasance (Do No Harm)
4 - Justice

Autonomy (Respect for Persons):

• Treat individuals as autonomous agents

• Do not use people as a means to an end

• Allow people to make choices for themselves

• Provide extra protection to those with limited autonomy

 Voluntary Participation

 Informed Consent

 Protection of Privacy & Confidentiality

 Right to Withdraw without Penalty

Beneficence

• Acts of kindness or charity that go beyond duty

• Obligations derived from beneficence

 Do no harm

 Prevent harm

 Prevent evil

 Promote good

 Risks are justified by the benefits

 Risks are minimized

 Conflicts of interest are managed to avoid bias

Justice :

• Treat people fairly

• Fair sharing of burdens and benefits of research

• Distinguish procedural justice from distributive justice

 Vulnerable subjects are not targeted for convenience

 People are not selected as subjects because of their ease of availability or

compromised position

 People who are likely to benefit are not excluded

Ethics and Research: Areas of Focus

• Harm

• Informed Consent

• Confidentiality

• Deception

• Reporting Results and Plagiarism

Harm:

• Researchers should take every precaution to ensure that participants are not subjected to
undue harm or stress

Informed Consent:

• Voluntary Informed Consent is essential for research involving human subjects

• Informed Consent should include:

 Description of the nature of the research

 Statement that the research is voluntary and participants can withdraw at any time

 Identification of Risks and Benefits

 Description of how confidentiality will be protected

 Description of compensation

 Description of what info researchers will share with participants

 Identification of who is responsible for research with contact information

Confidentiality

• All information collected in a research should remain confidential

 Participants should be assigned a compliant code

 Data should be locked away in a secure setting

 Electronic Databases should also be protected

Deception:

• At times, researchers may choose to hide from participants the true nature of the study

• Deception by Omission

– Withholding important facts from the participants

• Deception by Commission

– Lie to or purposely mislead research participants

Reporting Research Results

• Results of research studies should be reported in a honest, accurate manner

– Researchers cannot “massage” data to fit their hypotheses

– Researchers cannot make up or report false results

– Researcher must report what they find, even if the data does not support their initial
hypotheses

– Researchers should ensure that data is being collected consistently (do checks of
research assistants)

– Researchers should give the proper credit (authorship) to those who have earned it

Plagiarism

• Comes from the Latin word meaning “to kidnap”

• Examples of plagiarism:

– Copying someone else’s words without proper citation

– Stealing someone else’s ideas

– Stealing someone else’s intellectual property

Important: Cite sources properly and minimize quotations in research reports

What is a Conflict of Interest?

• Professionals have a primary interest—the goal of their profession

For researchers:

 Producing generalizable knowledge

 Ensuring the safety of research subjects

 Disseminating research results

Professionals also have secondary interests beyond their professional goals

 Publishing

 Spending time with his/her family

 Obtaining a good income

 Political activism or volunteerism

 Obtaining future research funding

 Pursuing other interests such as religion, traveling, social activities, etc.

• It is important to note that secondary interests on their own are not bad or unethical

• Usually these secondary interests are good and often praiseworthy

 Time devoted to one’s family

 Local charity

• What makes secondary interests problematic is their ability to unduly influence decisions about
an individual’s primary interest

• The key ethical issue is the relationship between a primary and a secondary interest

• A conflict of interest occurs when a secondary interest distorts or has the potential to distort
a judgment related to a primary interest

• A professional’s judgment does not necessarily have to be biased in order for that researcher
to have a conflict of interest — even the appearance of a conflict of interest is ethically
worrisome

• Researcher Conflicts of Interest

• For researchers, concern that some secondary interest might threaten:

 Valid research design Data integrity

 Researchers’ interpretation of data Dissemination of results

  Patient safety

• Do not necessarily realize that your judgment is biased or that a conflict is occurring

• It happens to everyone

Conflict of Interest

In case of suspicion about the conflict, report it.

Do my actions feel right? Do they reflect

a basic understanding of generally
accepted standards of right and wrong?

Are my actions in alignment with my

personal values and those of the
institution I represent?

Am I being honest about all facets of

the situation? Do the right people
know what’s going on?

Regardless of whether it’s real or perceived, a conflict is a conflict.

• As soon as conflict is suspeced, a conflict exists:

– Disclose it: Transparency is key.

– Talk with supervisor before taking action if there’s any risk of a conflict.

– Mitigate the conflict by taking steps to ensure a fair and level playing field among
multiple qualified vendors,

– Abstain from decisions or other involvement where there is a risk of bias – real or
perceived.

Research Misconduct:

Fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in

reporting research results.

(a) Fabrication is making up data or results and recording or reporting them.

(b) Falsification is manipulating research materials, equipment, or processes, or changing or omitting

data or results such that the research is not accurately represented in the research record.
 (c) Plagiarism is the appropriation of another person's ideas, processes, results, or words without
giving appropriate credit.

Sources and Acknowledgements

 Various Articles ; Internet Presentations and their Authors