Human Subjects Research CST Presentation
Human Subjects Research CST Presentation
Human Subjects Research CST Presentation
● 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:
Alteration of behavior
“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
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
● 1981
● Common Rule
○ 20 agencies
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. (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.