3. Human and Animal Subjects

Because research—exploration of the unknown—often involves uncertainties and risk, we ought to be especially careful when collecting data from human and animal subjects, for humans and animals have “moral standing.” That is, when they are involved in research activities, the wellbeing of human and animal subjects can be impacted by the researcher’s decisions and actions. In the United States, use of humans and animals in research is governed not only by ethical principles but also by laws and regulations.

3.1 Human subjects: The Common Rule and IRB

Human subject research is regulated by the Federal Policy for the Protection of Human Subjects, also known as the “Common Rule.” The “Common Rule” is codified in “separate regulations by 15 Federal departments and agencies,” including some of the most common federal funders of research, such as DoE, NASA, DoD, EPA, and NSF. The Common Rule defines human subject as “a living individual about whom an investigator (whether professional or student) conducting research obtains (1) Data through intervention or interaction with the individual, or (2) Identifiable private information.” Note that this definition does not take into consideration the possible ethical issues associated with using existing data or personal information that is labelled “public.” We will consider the significance of these omissions later in this unit when we examine “additional ethical concerns.”

The pivot of the Common Rules is an institutional review board (IRB) that reviews and approves human subject research. An IRB is established at each research institution (e.g., university) to implement federal policies for the protection of human subjects in research. The IRB reviews, approves, requires modification of, or disapproves proposed research that will involve human subjects. The criteria for IRB approval include:

• Minimized risk for research subjects;
• Reasonable risks in relation to anticipated benefits and the importance of knowledge resulted from the research;
• Fair selection of subjects;
• Informed consent;
• Protection of the safety and privacy of the subjects (Office for Human Research Protections, 2017).

These criteria embody three basic ethical principles that govern human subject research: respect for persons, beneficence, and justice. These ethical principles, elaborated in the Belmont Report, were developed by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (1979). Respect for persons requires researchers to treat all individuals as autonomous agents; to be specific, adequate information about the research should be given to any individual prior to their decisions on whether or not to participate in the research, and such decisions should be completely voluntary. Beneficence means researchers have an ethical obligation to maximize the possible benefits while minimizing the possible harms to the research subjects and to humanity. The principle of justice requires a fair distribution of the burdens and benefits generated by the research. For example, people who are equally qualified as research subjects should have an equal chance of being selected to participate in the research.

In most cases, IRB requires researchers to acquire and document informed consent from the human subjects who participate in the research. The basic elements of an informed consent include:

• A statement of the purposes, expected duration, and procedures of the research;
• A description of foreseeable risks;
• A description of anticipated benefits for the subjects and for others;
• A description of alternative procedures;
• A description of how the subjects’ identifiable information will be managed;
• A description of the existence and types of compensation or medical treatment available for the subjects;
• Information about persons to contact for questions about the subjects’ rights;
• A statement that participation in the research is voluntary (Office for Human Research Protections, 2017).

Penn State University has one IRB at University Park which “oversees human subjects research at all University colleges and campus locations except the College of Medicine and the Pennsylvania College of Technology” (Office of the Vice President for Research, 2017). The Penn State IRB is managed through the Centralized Application Tracking System (CATS). Penn State IRB provides an Investigator Manual for download. The Manual details the scope, requirements, and procedural of submitting a research for an IRB review as well as the process and types of IRB decisions.

3.2 Additional ethical concerns for collecting data from human subjects

The Common Rule has several limitations when it comes to protect human subjects, especially when it is applied to data collection outside traditional biomedical or social scientific research. One such limitation stems from the Common Rule’s restrictive definition of “human subjects” from whom researchers collect “data through intervention or interaction” or “identifiable private information” (Department of Health and Human Services, 2009). This definition weakens the protective function of the Common Rule because the development of data science, and especially, big data, has made it possible to collect data without “intervention or interaction” with the humans from whom information is acquired. As a result, Metcalf, Keller, and Boyd (2016) argue, big data makes much of our traditional oversight of ethical research outdated. For example, information about our locations can be collected automatically through surveillance cameras or through our wireless devices without us realizing it. A professor of computer science was recently alerted when ads of a property he had visited showed up in his Internet browser. To his knowledge, the visit to the property was completely “offline”: he had contacted the real estate agent using a land phone, and he never visited any websites that featured this property. In retrospect, he recalled checking social network sites with his cellphone while touring the property, and information about his location was captured and recorded. This incident raises an ethical question that is currently beyond the jurisdiction of the Common Rule; that is, should researchers and developers of data technologies be hold accountable for the impact of their work, for example, when a data technology impinges on other humans’ privacy, even when the developers did not intend to do so?

Similarly, the Common Rule’s focus on “identifiable private information” also faces challenges from complex analytics that mine personal data and use it in unexpected ways. For example, one’s profile data on Facebook is certainly identifiable, but is it “private” information when the account owner has labeled it “public” on Facebook? Perhaps not, you might say, for the owner apparently wants visitors of her Facebook page to see such information. But does that mean the owner wants her potential employers to use this information in screening job applicants? Or, does she want companies to use such data to create customized advertisements for her? When data that is declared “public” for one purpose is used for many different purposes, a lot of which we don’t necessarily agree with or even know about, should we also require informed consent for using “identifiable information,” regardless of whether it’s “private?”

Figure 6 The Boundary Between Private and Public on Social Networks Can Be Blurry.
(Public Domain)

Furthermore, the oversight of Common Rules exempts research that uses “existing data.” Traditionally, analyzing existing data poses little risk to the data contributors. For example, if physical samples from patients have been properly collected during previous research, merely doing additional analysis, which requires no physical contact with the data contributors, is unlikely to cause them harm. However, big data analytics sometimes reveal surprising patterns by mining numerous and unrelated datasets. For example, Chicago police department has used big data analysis to predict victims and perpetrators of violent crime (Blanc, 2016). Under the circumstances, new analysis of existing data can lead to people being targeted by the police (for protection or crime prevention), and the risk of “false alarm” is certainly more than minimum.

Additional ethical questions can be asked about using existing data, even in cases where data collection is monitored by IRB and informed consent has been acquired from the human subjects. For example, should the human participants who contribute data to a research project have any say in how the data will be used? To be sure, research involves a lot of uncertainties. Therefore, it is reasonable to expect that data collected from one research project might be useful for answering other questions, and researchers naturally would want to exploit these opportunities. Many humans who participate in research for the advancement of knowledge might also welcome reuse of their personal data for new discoveries. In general, current laws tend to support the researchers’ (or their sponsors’) ownership of research data. However, reuse of research data can have ethical ramifications. For example, researchers would fail to follow the ethical principle “respect for persons,” if a research participant finds that her information is reused for purposes that violate her fundamental cultural or ethical values (a hypothetical, but not improbable, example is using data from ethnic minorities to demonstrate biological differences in races).

The ethical principle of “justice” also calls into question the researchers’ or their sponsors’ exclusive “ownership” of research data. Existing intellectual property laws are created primarily to protect the rights of the discoverers or inventors. Unless an agreement is made in advance, the economic benefits resulted from a research discovery are usually not shared with the participants who contribute data. The legal arrangement, however, cannot completely replace ethical reasoning. In The Immortal Life of Henrietta Lacks, Skloot (2010) documents the history of the HeLa cell line, which is widely used in medical research and has generated enormous economic value. Skloot’s book reveals that the HeLa cell line was originally derived from cancer cells taken from Henrietta Lacks, a patient who died of cancer at the Johns Hopkins Hospital in the 1950s. Despite the great scientific and economic values of the HeLa cells, Lacks’ family did not receive any compensation until Skloot investigated this case, nor was the family informed of Henrietta’s contribution to the HeLa cells for decades. The case of the HeLa cells raises the following question: is it fair for participants to get nothing in return if the data they have contributed generates a lucrative business?