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Welcome to our Ethical Considerations in Research for Human Particiapnts page. This webpage will walk you through the essential principles of ethics for human subjects. Our aim is to help you navigate the ethical complexities of research, empowering you to conduct both responsible and impactful research studies.*
Along your educational journey, supplemental material (external to this website) may be linked for additional clarification or consideration. This supplemental material is recommended but not required. At the end of the module please choose one of two options, to move to the next module (Research Methodology) or take the Ethical Considerations Human Subjects Exam.
There is a table of contents to improve the navigability of this material.
If you have questions about the material provided please email irb@transy.edu.
TABLE OF CONTENTS
Human Subject Research
Human Subject Research
Ethical considerations in human subject research are paramount to ensuring the dignity, rights, and welfare of participants are respected and protected. Adhering to ethical guidelines safeguards participants from harm and enhances the credibility and integrity of research findings. By understanding and implementing ethical principles, researchers can foster trust, uphold the highest standards of scientific inquiry, and contribute to the advancement of knowledge responsibly and respectfully.*
In the following two presentations, you will be introduced to human subject research, the research process, and special considerations related to human subject research. Use the buttons below each presentation to navigate through the slides or open them in a new window using the button in the top right-hand corner.
Unethical Research in the Early 20th Century
Unethical Research in the Early 20th Century
Before the mid-20th century, research in the United States was largely unregulated, allowing for unethical studies to be conducted without proper oversight or consideration for the well-being of participants. These studies often targeted vulnerable populations and caused significant harm to those involved. Some of the most notorious examples of unethical research practices during this time include:
Tuskegee Syphilis Study (1932-1972): The U.S. Public Health Service conducted a study on African American men with syphilis, withholding treatment and allowing the disease to progress unchecked, even after penicillin became the standard treatment for syphilis in 1947.
Stanford Prison Experiment (1971): In order to study the impact of situations on people's capacity to engage in antisocial behavior Stanford students were recruited to live in a mock prison for two weeks, with participants being randomly assigned to the role of prisoner or prison guard. Through the encouragement and suggestion of those running the experiment, several participants assigned the role of prison guard grew increasingly aggressive and sadistic in their behavior towards those in the prisoner role. The situation quickly got out of hand, and the study was halted after six days.
Willowbrook State School Experiments (1956-1970): Researchers intentionally infected children with intellectual disabilities with hepatitis at the Willowbrook State School in New York to study the disease and test potential treatments.
Jewish Chronic Disease Hospital Study (1963): Researchers injected live cancer cells into elderly patients at the Jewish Chronic Disease Hospital in Brooklyn, New York, without informed consent.
Monster Study (1939): Researchers at the University of Iowa conducted an experiment on orphan children to study the effects of positive and negative speech therapy. Some children received negative therapy, causing them to develop speech problems and psychological issues.
These unethical studies, among others, highlighted the need for stronger regulations and oversight in research involving human subjects, ultimately leading to the development of the Belmont Report and the establishment of institutional review boards (IRBs) to protect participants' rights and well-being during the research process.* For more information on some of the research above see the YouTube links below.
The Tuskegee Study
(1932-1972)
The Monster Study
(1939)
The Stanford Prison Experiment
(1971)
the-belmont-report-508c_FINAL.pdfThe Belmont Report
The Belmont Report
The Belmont Report, published in 1979, outlines the ethical principles and guidelines for research involving human subjects. Commissioned by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, the report was developed in response to the historical ethical abuses in research listed above. This document emphasizes three core principles: respect for persons, which includes obtaining informed consent and acknowledging autonomy; beneficence, which involves maximizing potential benefits while minimizing harm to participants; and justice, which ensures a fair distribution of the benefits and burdens of research. These principles continue to underpin contemporary ethical standards and Institutional Review Board (IRB) practices, ensuring the protection and ethical treatment of research participants.*
Reading the report is highly encouraged.
Click on the three PDFs below for more information on the three ethical principles outlined in the Belmont Report.
The Common Rule
The Common Rule
The Common Rule is a set of federal regulations created in 1991 (revised in 2018) by the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA). It provides guidelines for the ethical conduct of research involving human participants. It aims to protect the rights and welfare of research subjects by ensuring that they are treated with respect and fairness. Key aspects include obtaining informed consent from participants, reviewing research proposals through Institutional Review Boards (IRBs), and ensuring that the risks to participants are minimized and justified by the potential benefits of the research. Essentially, the Common Rule helps make sure that research is done ethically and responsibly.
It is closely connected to the Belmont Report. The Belmont Report outlines three core principles: respect for persons, beneficence, and justice. These principles serve as the ethical foundation for the Common Rule. The Common Rule operationalizes these principles by providing specific regulations and guidelines for conducting research with human participants. For instance, respect for persons is reflected in the requirement for informed consent, beneficence is addressed by ensuring that research risks are minimized and benefits are maximized, and justice is ensured by fair selection and treatment of research subjects. In these ways, the Common Rule translates the ethical principles of the Belmont Report into practical rules for researchers to follow. *
See below for a bit more elaboration on the three core principles.
Respect for persons infographic.pdfRespect for Persons
Respect for Persons
Right to autonomy
"Respect for persons incorporates at least two ethical convictions: first, that individuals should be treated as autonomous agents, and second, that persons with diminished autonomy are entitled to protection." - The Belmont Report
Beneficence infographic.pdfBeneficence
Beneficence
Minimizing costs, maximizing benefits
"Two general rules have been formulated as complementary expressions of beneficent actions in this sense: (1) do not harm and (2) maximize possible benefits and minimize possible harms." - The Belmont Report
Justice infographic.pdfJustice
Justice
Justice requires the fair distribution of the burdens and benefits of research
"An injustice occurs when some benefit to which a person is entitled is denied without good reason or when some burden is imposed unduly." - The Belmont Report
About IRB's
About IRB's
Institutional Review Boards (IRBs) play a critical role in overseeing the ethical conduct of research involving human subjects. IRBs can be found at universities, hospitals, and private organizations. If a researcher is affiliated with a university it is typically free to apply for IRB approval before conducting research. However, there are instances where IRB approval can be obtained from a private company, for a fee, if the researcher does not have ready access to a university IRB.
Examples of University IRBs include Transy and the University of Kentucky. Examples of private IRBs where researchers pay for IRB approval are PearlIRB and Advarra.
Click the button below to continue learning about the Transy IRB and how you can apply for approval.
About IRBS Flyer.pdfWhat's Next... Learn more about Transy's IRB!
What's Next... Learn more about Transy's IRB!
Note: References are hyperlinked to original sources. Written text that ends with an "*" was created in part using OpenAI. (2023). ChatGPT 4o [Large language model]. https://chat.openai.com/chat or Anthropic. (2023) Claude Opus [Large language model]. https://claude.ai/chats
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