the end of each individual question and a section of References and Resources at the end of the book.
A few notes on what is not covered in this short book. We do not have sufficient space to delve into the rich expanse of philosophical and ethical theory that underpins the guiding principles for human research. Nor do we cover topics related to research integrity and misconduct, such as plagiarism, data falsification, or authorship. We focus specifically on the ethics of conducting research with human beings.
A revision to the federal research regulations (Federal Policy for the Protection of Human Subjects, Text of the Final Common Rule, Part 46, Subpart A, Protection of Human Subjects) was published in the Federal Register (Vol. 82, No. 12) on Thursday, January 19, 2017 (https://www.federalregister.gov/documents/2017/01/19/2017-01058/federal-policy-for-the-protection-of-human-subjects). The final version will be codified at 45 C.F.R. §. 46, Subpart A, on January 19, 2018, soon after this book is published. We reference the new research regulations throughout the book; however, because we wrote the book before the final regulations were published, we used information from the Federal Register when referencing Subpart A of the federal research regulations. Because the Common Rule was revised in January 2017, with changes to go into effect in January 2018, specific guidance from the Office for Human Research Protections (https://www.hhs.gov/ohrp/) will continue to emerge to assist researchers and IRBs in interpreting and applying these revisions.
While we frequently refer to the federal regulations for research (45 C.F.R. § 46, the Common Rule), we want to emphasize that different institutions may have additional policies, and different disciplines have additional standards of practices. We also want to emphasize that following the regulations—compliance—is the minimum for ethical research. We hope the guidance we provide in this volume encourages researchers to be thoughtful in their approaches and strive not only to protect research participants from harm but to treat them with optimal respect and care.
Acknowledgments
SAGE and the authors gratefully acknowledge feedback from the following reviewers:
Wayne A. Babchuk, University of Nebraska–Lincoln
Marilyn Bruin, University of Minnesota
Elizabeth Buchanan, University of Wisconsin–Stout
Robert L. Dahlgren, SUNY Fredonia
Todd M. Freeberg, The University of Tennessee–Knoxville
Debra Osnowitz, Clark University
Dena Plemmons, University of California, Riverside
Kenneth A. Richman, MCPHS University
Artineh Samkian, University of Southern California
Carla J. Thompson, University of West Florida
About the Authors
Emily E. Anderson,PhD, MPH, is an associate professor in the Neiswanger Institute for Bioethics at Loyola University Chicago, Stritch School of Medicine. She teaches courses in research ethics, responsible conduct of research, and empirical bioethics research to a variety of graduate and medical students. Her areas of interest include ethical issues in research with special populations; ethical issues in public health and health disparities research; and the application of qualitative research techniques to the study of research ethics. Dr. Anderson has published articles in numerous bioethics journals, presented at national conferences, and serves in several editorial positions. She has over ten years of experience serving on six different IRBs.Amy Corneli,PhD, MPH, is an associate professor in the Department of Population Health Sciences in the School of Medicine at Duke University. She is also a Faculty Associate in the Trent Center for Bioethics, Humanities, and History of Medicine, and faculty member in the Duke Clinical Research Institute. A social scientist by training, Dr. Corneli has conducted research in health, primarily biomedical HIV prevention, and bioethics in multiple countries in sub-Saharan Africa, the Middle East, South and Southeast Asia, and North America. Her bioethics research has focused on innovative methods for improving informed consent comprehension and shortening consent forms, acceptability of informed assent, and functioning of research ethics committees. Dr. Corneli has also been involved in IRB capacity-building activities in sub-Saharan Africa and serves as an associate editor for a bioethics journal.
Question #1 What Is Ethics, and How Does It Apply to Research With Human Participants?
“Ethics” refers to the study of what ought to (or ought not to) be done. The term also describes a collective body of guidance regarding questions of good or right action. Ethical decision making is the process of identifying, evaluating, and choosing among options regarding a problem that has an ethical dimension. What kinds of problems have ethical dimensions? Those that involve and may impact humans.
Research, or the scientific study of human beings and their behavior, began centuries before there were any formal rules or codes of research ethics written down on paper. However, since ancient times, scholars in philosophy and religion have articulated guiding principles regarding how humans should treat each other. Arguably, there is a fair amount of agreement regarding such treatment, perhaps best evidenced by the Golden Rule: “Do unto others as you would have them do unto you.” Rooted in the Judeo-Christian traditions, this “common morality” is the foundation for codes of ethics for research developed by professional societies like the American Psychological Association as well as the federal research regulations. Research ethics codes and regulations interpret and apply the common morality for the research context by following three key principles: respect for persons, beneficence, and justice. More on these principles throughout the rest of the book.
Research ethics is a form of applied ethics: that is, the study of and rules for what ought to be done in the specific context of research. During the past 50 years, research ethics has developed as a specialized area of study to determine the best courses of action for scientists who conduct research, and in particular, research with humans. Such scholarly analysis has become essential as research with human participants becomes more specialized, complex, and multi- and interdisciplinary. The study of research ethics is devoted to identifying the standards to which researchers should be held, including the parameters that should guide researcher behavior and the practices and processes that best protect human research participants within specific contexts. Such parameters, practices, and processes are articulated in federal research regulations; professional codes of ethics; institutional policies; and various other forms of guidance such as white papers, government reports, reports from nongovernmental organizations, and research ethics scholarship. This book aims to explain in 100 questions and answers the general ethical rules for social and behavioral research with human participants.
More questions? See #2, #5, and #10.
Question #2 What Is the Ethical Justification for Conducting Research With Human Participants?
Although research involving humans began centuries ago, the best known, most often cited ethical justification for including humans in research was first fully articulated by Hans Jonas in his seminal 1969 article, “Philosophical Reflections on Experimenting With Human Subjects.” As described
