Academic Research: Research Ethics

Ethical Principles in Conducting Research for Protection of Human Subjects of Research

1. 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 principle of respect for persons thus divides into two separate moral requirements: the requirement to acknowledge autonomy and the requirement to protect those with diminished autonomy.

2. Beneficence - Persons are treated in an ethical manner not only by respecting their decisions and protecting them from harm, but also by making efforts to secure their well-being. Such treatment falls under the principle of beneficence. The term "beneficence" is often understood to cover acts of kindness or charity that go beyond strict obligation. In this document, beneficence is understood in a stronger sense, as an obligation. 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.

3. Justice - Who ought to receive the benefits of research and bear its burdens? This is a question of justice, in the sense of "fairness in distribution" or "what is deserved." An injustice occurs when some benefit to which a person is entitled is denied without good reason or when some burden is imposed unduly. Another way of conceiving the principle of justice is that equals ought to be treated equally. However, this statement requires explication. Who is equal and who is unequal? What considerations justify departure from equal distribution? Almost all commentators allow that distinctions based on experience, age, deprivation, competence, merit and position do sometimes constitute criteria justifying differential treatment for certain purposes. It is necessary, then, to explain in what respects people should be treated equally. There are several widely accepted formulations of just ways to distribute burdens and benefits. Each formulation mentions some relevant property on the basis of which burdens and benefits should be distributed. These formulations are (1) to each person an equal share, (2) to each person according to individual need, (3) to each person according to individual effort, (4) to each person according to societal contribution, and (5) to each person according to merit.

Code of Federal Regulations. Title 45 Public Welfare. Department of Health and Human Services. Part 46. Protection of Human Subjects. Courtesy of HHS.

Ethics of Human Subject Research 
 

• Belmont Report, 1974 - HHS Office for Human Research Protection resources 
• Declaration of Helsinki, 1964 - World Medical Association resources about Declaration of Helsinki 
• International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) (1990)
• Nuremberg Code, 1947
• The Common Rule - Federal Policy for the Protections of Human Subjects
• Presidential Commission for the Study of Bioethical Issues

Research Ethics
 

• Research Ethics: How to Treat People who Participate in Research 
• Code of Federal Regulations. Title 45 Public Welfare. Department of Health and Human Services. Part 46. Protection of Human Subjects. 
• Subpart B. Additional Protection for Pregnant Women, Human Fetuses and Neonates Involved in Research.
• Subpart C. Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects.
• Subpart D. Additional Protections for Children Involved as Subjects in Research.

Informed Consent 

• Informed Consent - AMA Code of Medical Ethics 
• Informed Consent - HHS 

Defense Health Agency

• DHA human subject protection resources 
• Human Subject and Research Determinations
• Electronic Research Protocol Management System 
• DHA Data Sharing Agreement Application. Stages of Review 
• DHA Data Sharing Application 

Articles

• Crawford, Kate and Jacob Metcalf. 2019. “Where are Human Subjects in Big Data Research? The Emerging Ethics Divide.” Council for Big Data, Ethics, and Society. Accessed October 10, 2019. 
• Kramer, A. D., Guillory, J. E., & Hancock, J. T. (2014). Experimental evidence of massive-scale emotional contagion through social networks. Proceedings of the National Academy of Sciences, 111(24), 8788-8790.
• Editorial Expression of Concern: Experimental evidence of massive scale emotional contagion through social networks. (2014). Proceedings of the National Academy of Sciences, 111(29), 10779.
• Editorial Expression of Concern and Correction. Psychological and cognitive sciences. 
• Poor, Nathaniel and Roei Davidson. 2019. “Case Study: The Ethics of Using Hacked Data: Patreon’s Data Hack and Academic Data Standards.” Council for Big Data, Ethics, and Society. Accessed October 10, 2019. 
• Mehlman, M. J., & Li, T. Y. (2015). Ethical, legal, social, and policy issues in the use of genomic technology by the US military. Case Western Reserve Journal of International Law, 47, 115.
• Mehlman, M. J., & Li, T. Y. (2014). Ethical, legal, social, and policy issues in the use of genomic technology by the US Military. Journal of Law and the Biosciences, 1(3), 244-280.
• Metcalf, Jacob, Emily F. Keller, and Danah Boyd. 2019. “Perspectives on Big Data, Ethics, and Society.” Council for Big Data, Ethics, and Society. Accessed October 10, 2019. 
• Norrgard, K. (2008). Ethics of genetic testing: medical insurance and genetic discrimination. Nature Education, 1(1).
• Otlowski, M. F., Taylor, S. D., & Barlow-Stewart, K. K. (2003). Genetic discrimination: too few data. European Journal of Human Genetics, 11(1), 1.
• Ursic, Helena. 2019. “The Right to be Forgotten or the Duty to be Remembered? Twitter data reuse and implications for user privacy.” Council for Big Data, Ethics, and Society. Accessed October 10, 2019.