Human Subjects Research

Jordan Barzensky, Hannah Judy, Lauren Kosslow, Sierra Luzier, and

Allison Pavlan
What is Human Subjects Research?

● Research involving living individuals

○ An investigator that is conducting the study can obtain
data from the individuals
Background
Conducting human subjects research?

● DHHS & FDA defined research

○ Follows the Federal Food, Drug, and Cosmetic Act
● Human subject to obtain data from
○ Intervention
○ Interaction
○ Identifiable private information
● IRB approval
How is it Performed Today?
● Human Subjects
● Test Article
○ Drug
○ Medical device
○ Human food additive, & other articles subject to regulation
● Systematic Investigations
○ Surveys & questionnaires
○ Epidemiological studies
○ Interviews & focus groups
○ Medical chart review studies
○ Cognitive & perceptual experiments
○ Evaluations of social or educational programs
○ Analyses of existing data or biological specimens
Case Study: Smallpox Vaccination
● Development of the smallpox vaccination is one of the earliest human studies
○ Performed by Edward Jenner in 1796
● Inoculated 8 year old James Phipps with cowpox lesions followed by
smallpox lesions
○ Subject did not develop smallpox
● Called the procedure “vaccination”
○ Vaccinia is Latin for cowpox

The National Library of Medicine.

(2005). The Hand of Sarah Nelms.
Retrieved from
https://www.ncbi.nlm.nih.gov/pmc/a
rticles/PMC1200696/
Case Study: Lobotomy
● Freeman & Watts (1942)
○ Completed approximately 200 lobotomies using the “icepick” method and extracting pieces of
the brain
○ 14% of patients experienced severe postoperative deficits or death
● Experimented on mentally ill individuals
● Alice Hood Hammatt
○ Suffered from depression
○ Tried to withdraw her consent
○ Experienced language difficulties, disorientation, and agitation
■ Freeman considered this operation a success
● Taught a lot about the brain
○ Development of new treatments
Ethical Guidelines
● The Belmont Report
○ Boundaries between practice & research
○ Basic ethical principles
■ Respect for persons
■ Beneficence
■ Justice
○ Applications
■ Informed consent
■ Assessment of risks and benefits
■ Selection of subjects HHS.gov. (2018). The Belmont Report. Retrieved from
https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/index.html

● Declaration of Helsinki
● Council for International Organizations of Medical Sciences
Where do you think our research would be today
if there weren’t so many regulations & ethical
guidelines to follow when performing human
subject research? Do you think this would benefit
science or would it cause more harm than good?
Human Studies for Benefits of Society
● Social benefits
● Practical applications
○ New drugs, medical therapies, biologics, & surgical techniques
○ Nutrition & exercise
○ Environmental regulations
○ Psychological & social work
○ Food, recreation & consumer products
● Human Genome Project
○ Effort to sequence & map an entire human genome (1990-2002)
○ Taught researchers a lot about DNA
Ethical Considerations
Cases of large-scale human rights violation:

1. Nazi Germany (1933-1945)

a. Rise of Eugenics - control of breeding in order to increase the chance of obtaining desired
heritable characteristics
i. American Eugenics Society (1907-1939)
ii. Goal to sterilize 1/10 of U.S. population
b. “Without patient consent or safeguards”
c. 7000 cases of abuse in Third Reich
Nazi Germany
● Violated the morals of medical ethics
● Zero regard for patient suffering
● Death was deliberate end result
● Josef Mengele
○ Twin experiments
● Karl Brandt
○ Reich Commissioner of Sanitation and Health
○ Nerve regeneration, drinkable salt water, high altitude chamber
(68,000 ft)
 Case Study: United States of America vs. Karl
Brandt, et al.
● Nuremberg Trials - August 19th, 1947
○ Problem: no laws clearly defined legal and illegal human subject experimentation
○ Dr. Leo Alexander
■ Outlined 6 characteristics of acceptable medical research
https://paulkiser.com/2018/01/17/should-the-
■ Nuremberg Code: defining document of the Doctors Trial nuremberg-code-be-applied-to-data-collection/

● Key features of Nuremberg Code

○ Voluntary consent of human subjects is necessary
○ Human subject has ability to bring experiment to end
○ Degree of risk should never exceed importance of problem
○ Any reason to believe death or disability can result →
physicians can serve as their own subjects
Risks of Human Subjects Research
Hindrance of the mental and physical state of the human person

Alteration of behavior

2. Project MK-Ultra (1953-1973)

a. Allen Dulles (Director of CIA)
b. Top-secret program in response to growing threat of
Communism
c. Mind control experimentation: electroshock therapy, hypnosis,
radiation, injection with lysergic acid diethylamide
d. Took advantage of America’s most vulnerable
Case Study: Frank Olson
● Over 150 human experiments
● Scientist Frank Olson
○ Effects of LSD unknown
○ CIA employees’ drinks spiked without consent
○ Committed suicide November 28th, 1953

“Precautions must be taken not only to protect operations from exposure to enemy forces but also to
conceal these activities from the American public in general.” - Inspector General, 1957
Do you think that this research would be more
acceptable if it were performed on death row
inmates or individuals sentenced to prison for
life?
Catholic Social Teaching
Life and Dignity of the Human Person

- Human life is sacred

- Losing lives for a cause which may not succeed
- Tests could also have success and save lives
- Treat people as people
- Enhancing or threatening life and dignity
- Aggressive human subject research
Catholic Social Teaching
Rights and Responsibilities

- Healthy community - human rights are protected

- Rights to human decency

Option for the Poor and Vulnerable

- Put the needs of the poor first

- Poor may be more subject to testing
Catholic Social Teaching
Solidarity

- One human family

- Care for our brothers and sisters

Care for God’s Creation

- Called to protect the people and the planet

- Protect people from harsh trials
- Save people through trials
Do you think that research performed on animals
would be more acceptable than research
performed on humans in the eyes of the Catholic
Church? What is your opinion?
Legal Issues
Why is it important to have laws pertaining to human subject research?
● Stop scandals/ abuse of research
○ Eva Mozes Kor
■ Auschwitz concentration camp
■ Joseph Mengele
■ Twin
● Consent
● Uninformed subjects

In result:
● Laws:
○ Nuremberg Code of international ethics
○ 1962 Kefauver-Harris amendments
■ Thalidomide
Legal Issues
Timeline:
Legal Issues
Timeline continued:
Legal Issues
Timeline continued:
Legal Issues
● 1974 National Research Act

○ National Commission for the Protection of Human Subjects in Biomedical

○ Behavioral Research (the Belmont Commission)

● 1981

○ Department of Health and Human Services (DHHS)

■ Department of Health, Education and Welfare
○ U.S. health care
Legal Issues

● Common Rule
○ 20 agencies

● Food and Drug Administration (FDA)

○ Not a Common Rule agency

● Institutional review board (IRB)

○ Office of Human Research Protections (OHRP)
■ Department of Health and Human Services (DHHS)
● Requirements for approval
Legal Issues
Requirements:
● All risks that could bring danger or negative results to the subject are reduced as much as possible
● The risks to the subject are not unreasonable in compare to the expected benefits
○ Ex: Benefit you will be never get the chickenpox, risk death.
● Subjects are not being forced into research (valid)
● All factors pertaining to research are explained to the subjects
○ Purpose of research
○ Risks and benefits
○ Confidentiality
○ Treatment for research related injuries
○ The right to not participate or stop participating at any time without consequences
● The procedures for informed consent are appropriately conducted
Based upon the information that we have given
you, would any of you participate in human
subjects research?
Is there a certain amount of money that could
persuade you to participate?
Volunteer?
Thank you!
References
Farber, S. (2008). U.S. scientists' role in the eugenics movement (1907-1939): a contemporary biologist's perspective. Zebrafish, 5(4),
243-5.

History.com Editors. (2018). The CIA's Appalling Human Experiments With Mind Control | HISTORY. Retrieved from
https://www.history.com/mkultra-operation-midnight-climax-cia-lsd-experiments

History.com Editors. (2017, June 16). MK-Ultra. Retrieved November 4, 2018, from https://www.history.com/topics/us-
government/history-of-mk-ultra

Jewish Virtual Library: A Project of AICE. (2018). Medical Experiments. Retrieved from https://www.jewishvirtuallibrary.org/the-
holocaust

LOOKING BACK 1953: CIA doses men with LSD at Deep Creek Lake (Part 1). (2015, September 10). Retrieved from
https://historyarchive.wordpress.com/tag/frank-olson/

Nofil, B. (n.d.). The CIA's Appalling Human Experiments With Mind Control | HISTORY. Retrieved from
https://www.history.com/mkultra-operation-midnight-climax-cia-lsd-experiments

Office for Human Research Protections, & OHRP. (2018, January 15). Read the Belmont Report. Retrieved from
https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/read-the-belmont-report/index.html
References
Resnik, D. B. (2008, November 01). Social Benefits of Human Subjects Research. Retrieved from
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3920587/

Riedel, S. (2005, January). Edward Jenner and the history of smallpox and vaccination. Retrieved from
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1200696/

UCI. (2015). Activities that Require IRB Review. Retrieved from https://www.research.uci.edu/compliance/human-research-
protections/researchers/activities-irb-review.html

United States Holocaust Memorial Museum. Deadly medicine. Retrieved from

https://encyclopedia.ushmm.org/content/en/article/deadly-medicine-creating-the-master-race?series=19222

United States Holocaust Memorial Museum. (2018). Nuremberg Code. Retrieved from
https://www.ushmm.org/information/exhibitions/online-exhibitions/special-focus

The University of Texas at Austin. (n.d.). What is Human Subjects Research. Retrieved from https://research.utexas.edu/ors/human-
subjects/what-is-human-subjects-research/
References
Pathol , J Clin. “Ethical and Legal Issues in Research Involving Human Subjects: Do You Want a Piece of Me?” Journal of Clinical
Pathology, BMJ Group, Apr. 2006, www.ncbi.nlm.nih.gov/pmc/articles/PMC1860367/.

Pathol , J Clin. “Ethical and Legal Issues in Research Involving Human Subjects: Do You Want a Piece of Me?” Journal of Clinical
Pathology, BMJ Group, Apr. 2006, www.ncbi.nlm.nih.gov/pmc/articles/PMC1860367/.

Caruso J P, Sheehan J P. Psychosurgery, ethics, and media: a history of Walter Freeman and the lobotomy. Journal of Neurosurgery,
2017;43(3), https://thejns.org/focus/view/journals/neurosurg-focus/43/3/article-pE6.xml

United States Conference of Catholic Bishops. Seven Themes of Catholic Social Teaching, 2005, www.usccb.org/beliefs-and-
teachings/what-we-believe/catholic-social-teaching/seven-themes-of-catholic-social-teaching.cfm.