human curiosity that drives us to learn more about ourselves and our environment. This desire leads us to conduct research through observation and experimental techniques, not only for the sake of knowledge but also with the ultimate goal of improving the human condition and our planet. As a society, we need research with human participants to learn more about ourselves; learning more about how humans behave and interact is necessary to improve the human condition. Therefore, including humans in research is justified by the potential for the common or collective good. However, all research requires the balance of two important goals: protecting participants from exploitation and harm, and providing equal access to the direct and indirect benefits of research. Ideally, all will benefit from discoveries made by research. Research with humans poses a tension between individual welfare and the common good. Therefore, parameters must be set on research practices. Determining and articulating these limits is the focus of research ethics scholarship and the aim of professional ethics codes and federal research regulations.
More questions? See #3, #8, and #10.
Question #3 What Broad Ethical Principles Apply to Research With Human Participants?
The ethical framework that underpins the federal research regulations as well as most professional codes of research ethics does not privilege any one ethical theory or approach but rather articulates a set of overall principles: respect for persons, beneficence, and justice. These principles are outlined in the Belmont Report (1979), a key U.S. research ethics document. The principle of respect for persons demands that individuals control what happens to them. Beneficent research promotes good and avoids harm. Justice requires fairness in the selection of research participants. It also requires an equitable distribution of the benefits and burdens of research so that no one group disproportionately bears the burden or receives the benefits of research.
These three principles must be balanced in all research with human participants. For example, sometimes risks must be taken in order to attain the potential benefits. However, there is no hard-and-fast rule regarding the appropriate weighting of principles in specific situations. Reasonable people may disagree about how best to weigh the risks and benefits of a particular research study based on whether they prioritize respect for persons or beneficence. This is arguably both a strength and a weakness of the Belmont research ethics framework.
More questions? See #4, #7, and #10.
Question #4 What Ethical Guidance and Regulations Inform Research With Human Participants, and What, If Anything, Has Changed Over Time?
For many centuries, research and researchers’ behavior was not systematically regulated by any laws. Although informal standards of conduct existed within certain circles, until quite recently, there were no normative rules or formal mechanisms for guiding, monitoring, or enforcing ethical scientific behavior, or for punishing those who engaged in behavior that we would now consider unethical. In the early 20th century, the first professional codes of ethics, primarily targeting medical researchers, were written in response to the discovery of—and public outrage over—significant harms to research participants. These include the Nuremberg Code, written in 1947 after Nazi doctors were tried in a court of law and found guilty of conducting harmful experiments on prisoners in concentration camps; and the Declaration of Helsinki (2013), first issued by the World Medical Association in 1964, which expanded on the principles outlined in the Nuremberg Code and linked them to the responsibilities of physicians who conduct research. Although at the time they were developed these codes reflected basic, agreed-on best practices for research involving human participants, they were not (and still are not) enforceable.
Ultimately, as more instances of disrespect and abuse of human research participants became known, the American public demanded that the federal government step in and do something. In 1974, President Nixon established the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. This was in response to a national news story about a government-funded study in Tuskegee, Alabama. Hundreds of Black men with syphilis were followed for decades; but they were neither told they had the disease nor treated, despite the availability of affordable and effective medication. In 1979, the National Commission issued the Belmont Report, which details the three foundational principles for ethical research—respect for persons, beneficence, and justice.
Now, all research funded by the U.S. government must follow federal regulations that were subsequently developed based on these principles. These regulations are published in the Code of Federal Regulations (CFR), which contains all rules and regulations issued by the U.S. government. Several of the CFR’s 50 sections (called “titles”) include subsections relevant to the conduct of research with human participants, such as Title 45 Public Welfare, Part 46 Protection of Human Subjects (issued by the Department of Health and Human Services [DHHS]). Although not mandated by the U.S. government, some academic and other research institutions extend these rules to all research conducted by their employees and students, regardless of funding source.
Federal guidance is regularly reviewed and updated. In January 2017, revisions to 45 C.F.R. § 46 were published by the Office of Human Research Protections (OHRP), the DHHS office responsible for the oversight of human research (http://www.hhs.gov/ohrp/). Title 45 C.F.R. § 46 defines “research” and “human subject.” It also outlines ethical criteria for research conducted with human participants, such as the information that must be told to participants about the research so they can make an informed decision about participation; and the structure, function, and registration of institutional review boards.
More questions? See #3, #8, and #9.
Question #5 What Is the Relationship Between Ethics and Compliance?
Ethics requires thoughtful consideration of the range of possible options in a given situation. For a researcher, ethics also requires a professional commitment to put the safety and well-being of research participants and their communities first, and to strive always to maximize benefits and minimize harm in research activities. To be ethical or to make an ethical (good) decision is to consider the viewpoints of and potential outcomes for all affected stakeholders—including participants, researchers, and the general public as future beneficiaries of the research. Ethical researchers aim to make decisions that are good for everyone involved in the research but that are first and foremost good for participants.
Compliance refers to following the rules. As a researcher, it is necessary, but not sufficient, to know and follow the rules. When it comes to determining what is right and wrong in research, compliance with regulations and attention to ethics go hand in hand. As we will discuss throughout this book, there are rules for researcher behavior, and some of them even have the force of law. However, how to apply the rules may not be obvious in every unique situation. Therefore, researchers must have a good understanding of ethics—ethical principles, theories, and frameworks—to help them determine what to do when the federal research regulations and professional ethics codes are not specific enough.
More questions? See #1, #3, and #7.
Question #6 What Are the Potential Consequences of Ignoring Ethical Principles and Regulations?
When ethical standards are ignored, the potential consequences to participants and their communities, researchers, institutions, and the scientific record are myriad. Not complying with research regulations may increase the potential for participants to be harmed—physically, socially, or psychologically (see much more on potential harms in Part 2). For example, if guidelines for protecting the confidentiality of sensitive research data are not followed, there is a greater chance of a data breach, which could result in potential social, economic, or legal harms.
Serious
