Research Ethics Mind Map

Research Ethics and Regulations History Timeline

More detailed list, see also:

https://sites.radford.edu/~spj/Timelinepage.html

Nuremberg Code - from judges

1980s

1947

Review boards at Universities

1984

800 BCE

Beaumont / Childress -

4 Principles Research Ethics

Adab al-Tabib

1985

2018

1979

45 CFR 46 -

IRB Exempt Common Rule

45 CFR 46 - Substantially Revised

Belmont Report -

3 Principles Research Ethics

1932 - 1972

1945

Tuskegee Syphilis Study

Declaration of Geneva - Hippocratic Oath

1947

Penicillin recommended for syphilis

500 BCE

1400s - 1600s

Hippocratic Oath

Renaissance & re-evaluate ethics

1964

Helsinki Accords (IRB process)

2005

Draft Model Bioethicits Code

1933 - 1945

Nazi Holocaust

Philosophy - 4 branches

Meta-ethics

Philosophy - 4 branches

Big Picture Questions

What is Morality? What is Justice? Is there truth?

How can I justify my beliefs as better than... others?

Applied Ethics

Normative Ethics

Applied to Specific Dilemas

Specific, practical issues (e.g., war, capital punishment, lie to help a friend).

"Axiology"

Moral Philosophy - 3 branches

A Practical Framework

What ought we do? Framework for differentiating right and wrong.

Deontology; Utilitarianism; Virtue Ethics

3

1

2

Watch Video Here (<2 min):

https://www.youtube.com/watch?v=9TqJrvtt9ws

Rationality and Arguments

What is sound reasoning?

Formalism; Mathematics Foundations; Proofs; Sets

Reality and Being

What exists? What does it mean to exist?

Ontology; Space and Time; Modality; Consilience

Logic

Metaphysics

2

1

Philosophy Branches

Philosophy

4

3

Axiology

Epistimology

Knowledge

What is knowledge? How do we know?

Truth; Skepticism; Justification; Hypothesis Testing

Nature of Values

What is good? What should be?

Ethics; Normativity; Aesthetics; Social and Political Theory

History

4 Branches of Philosophy

Individual and Social Morality

Changes over time

Informed by the evolution of research ethics

A

Ethics, Law, and Institution Policy

Differences (principles, regulations, codified laws, spirit of the law).

"Individual morality provides the basis of decisions of and judgments by the individual: honesty, loyalty, good faith, being responsible. Social morality means fairness, which is one basis of law, which helps to govern society and to control individual behavior.."

B

https://phdcentre.com/phd-thesis-epistemology-guide/

https://www.tanmanho.com/e-journal/ejournalimages/subjective-objective1.jpg

Place-Based

Regulatory Processes

Differences by geographic location and governing bodies

C

https://www.samyoung.co.nz/2017/07/how-research-components-fit-together.html

https://twitter.com/WriteThatPhD/status/840377315163033600

1942 - 1945

Nazi concentration camp experiments

Reg:

Regulatory Processes

Considerations for Submitting an IRB Application

When submitting an IRB study application for the first time there are seven (7) general steps involved in the overall process:

1) writing the research study proposal and protocol,

2) obtaining accounts with the CITI program and ERICA,

3) creating a new study application within ERICA,

4) validating the study in ERICA,

5) submitting the study for review,

6) making any pre-board review suggested corrections from the IRB administrators, and

7) creating and maintaining a regulatory binder for the study.

The first two steps (1 and 2) are done as preparation before starting a study application with the IRB and the last step (7) is done as part of ongoing demonstration of regulatory compliance with the IRB and University policies.

Asset library

ResReg

A

(IRB) Institutional Review Board - Study Application

Research Processes

(as relates to research integrity and ethics)

Consenting Form/Coverletter Example

What needs to be considered and why?

B

Informed consent

Research Integrity

P:

Philosphy

RegE

C

D

Animal Welfare / Ethical Treatment

C

Study design, methodology, and statistics

Res:

Research Processes

ResE

(Right and Wrong Conduct)

E:

Ethics

Special Populations (Diminished Autonomy)

• Ability to understand and give consent, without coercion?
• A representative may be able to give consent for them.

SPECIAL POPULATION DETERMINATIONS

The Department of Health and Human Services (HHS) regulation 45 CFR part 46 subparts B, C, and D, as well as 21 CFR part 56 subparts 107(a) and 111(b) define special populations as those who “… are likely to be vulnerable to coercion or undue influence, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons, additional safeguards have been included in the study to protect the rights and welfare of these subjects” (45 CFR 46.111[b]). The Federal Drug Administration (FDA), in 21 CFR 56.107[a] and 56.111[b]), gives further guidance on "mentally disabled persons" specifying that additional IRB oversight is warranted. While our proposed study does involve children, defined as “persons who have not attained the legal age for consent to treatments or procedures involved in the research…”, NIH policies state that “…studies should not be designed to exclude women, minorities, and individuals based on age unless there is a scientific or ethical reason not to include them” (Clinic, 2021; HHS, 2023; NIH, 2019).

Kim Ito and Kaila Christini

College of Nursing, University of Utah

NURS 7101: Human Subjects Protections and Research Ethics

Clinic, M. (2021). Special Categories of Research: Vulnerable Human Subjects Policy Scope. https://www.mayo.edu/research/documents/32-special-categories-participants-vulnerablepdf/

HHS. (2023). 45 CFR 46. U.S. Department of Health and Human Services Retrieved from https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html

NIH. (2019). Vulnerable and Other Populations Requiring Additional Protections. grants.nih.gov. https://grants.nih.gov/policy/humansubjects/policies-and-regulations/vulnerable-populations.htm

The Researcher

"Setting off on the road to the responsible conduct of research"

(https://ori.hhs.gov/content/chapter-1-rules-road-introduction)

Incapacitated

Those with intellectual disabilities

Prisoners

Children

Laws, Regulations vs. Ethical Principles

B

Research Ethics: "...the application of fundamental ethical principles to research activities..."

Differences (principles, regulations, codified laws, spirit of the law).

Variations by culture and by geography (international, country, local/state)

Principles

A

Basic Principles of Research Ethics:

Beauchamp / Childress

See also 'Regulatory Processes' in blue.

Beauchamp/Childress - 4

HHS (Belmont Report) - 3

View Details Here:

Beauchamp/Childress -

• https://www.uc.edu/content/dam/refresh/cont-ed-62/olli/22-winter/bioethics%20four%20principles.pdf
• Beauchamp, T. L. (1984). On eliminating the distinction between applied ethics and ethical theory. The Monist, 67(4), 514-531.
• Beauchamp TL, Childress JF. Principles of biomedical ethics. 3rd. New York, Oxford: Oxford University Press; 1989.

HHS (Belmont Report)-

https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/read-the-belmont-report

Ethics in Research

(with human participants)

C

History of Research Ethics

Ethics and regulations have changed and evolved over time

Research Ethics and Integrity Mind Map

See also 'Regulatory Processes' in blue.

It is important to "...adhere to ethical principles in order to protect the dignity, rights and welfare of research participants."

4) Justice

1) Autonomy

3) Beneficence

2) Non-Maleficence

University of Stirling

(https://www.stir.ac.uk/research/research-ethics-and-integrity/understanding-ethics/)

WHO

https://www.who.int/activities/ensuring-ethical-standards-and-procedures-for-research-with-human-beings

Beauchamp/Childress

HHS

Beauchamp/Childress

HHS - "Respect of Persons"

Beauchamp/Childress

HHS

The right of self-governance

Do no harm / Hippocratic Oath

Do not - kill, pain, suffering, incapacitate, offense, deprivation)

Mercy, kindness, generosity, charity

Acting with best-interest of participant in mind.

Fairness / Equality

Fair treatment, equitable allocation (benefits / burdens)

(Focus on research with human subjects)

Research Ethics Principles

Research Integrity: "...conducting research in a way which allows others to have trust and confidence in the methods used and the findings that result..."

Kaila Christini, MsPH, MS

PhD Student | College of Nursing | University of Utah

Program Manager | Kepka Research Lab | Huntsman Cancer Institute

Kaila.Christini@hci.utah.edu

_University of Bath

(https://www.bath.ac.uk/corporate-information/definition-of-research-integrity/)

NIH

1. Social/Clinical Value

2. Scientific Validity

3. Fair subject selection

4. Favorable risk-benefit ratio

5. Independent review

6. Informed consent

7. Respect for... subjects

Guiding Principles for Ethical Research. (2015, June 3). National Institutes of Health (NIH). https://www.nih.gov/health-information/nih-clinical-research-trials-you/guiding-principles-ethical-research0

Summary

1. Truth and Honesty

2. Objectivity

3. Ethical Standards

4. Respect for Participants

5. Accountability

6. Communication / Transparency

7. Responsible Authorship

8. Responsible Mentoring

‌

Literature Synthesis

1. Honesty

2. Objectivity

3. Morality

4. Prudence

5. Openness

6. IP Respect

7. Confidentiality

8. Publication Responsibility

10. Mentor Responsibility

11. Colleague Respect

12. Social Responsibility

13. Anti-discrimination

14. Competence

15. Legitimacy

16. Respect/Security for Participants

Pranas Žukauskas, Jolita Vveinhardt, & Andriukaitienė, R. (2018). Research Ethics. InTech EBooks. https://doi.org/10.5772/intechopen.70629