Scientific and Medical Ethics:

Protecting People While Enhancing Autonomy and Justice

Ethical lapses and emerging quandaries in biomedical research and practice have provided continual reminders of the need to emphasize scientific and medical ethics in the training of students and the oversight of researchers and health care providers. Today, hospitals and research institutions maintain ethics committees to provide researchers and physicians with consultation and guidance, and bioethics education has become a strong component of training and research programs.

1972

Research Misconduct Exposed in the Tuskegee Syphilis Study

For 40 years, a group of 600 African American men from Tuskegee, Alabama—about 400 with syphilis and 200 who did not have the disease—were unknowing subjects in a study of the effects of syphilis sponsored by the U.S. Department of Health, Education, and Welfare (today the U.S. Department of Health and Human Services). Administrators misinformed study subjects about the purpose of the research and withheld penicillin, a widely available and effective treatment. After a news story alerted the public and Congress about this misconduct in 1972, the study was found to be “ethically unjustified” and was ended. Although victims of the Tuskegee Syphilis Study eventually received a settlement and health benefits from the U.S. government, the incident led to long-lasting mistrust of public health officials among many African American communities.

1973

After Tuskegee: Putting Human Subjects Research Guidelines in Place

In 1973, Congress passed the National Research Act, which called for the development of regulations on research with human subjects, required institutions to form Institutional Review Boards to oversee these regulations, and formed a new commission to shape bioethics policy in the United States. In 1978, this commission was replaced with the President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research, which was charged with creating recommendations for policymakers, practitioners, and the public on such issues as health care access, the definition of death, patient consent, human research subjects, genetic engineering, and the terminally ill.

1970s

The Birth of Clinical Medical Ethics

Prior to 1970, little research and guidance existed to help physicians deal with the ethical dilemmas they faced in daily clinical practice. In response to this need, the field of clinical medical ethics emerged in the 1970s to provide a platform for research, education, and evaluation around ethical decision-making in clinical care. In contrast to the broader focus of bioethics, clinical medical ethics seeks to help physicians and other health professionals identify and respond to ethical challenges that arise in the ordinary care of patients, including truth telling, informed consent, confidentiality, surrogate decision making, and end-of-life care.

1991

Bolstering Regulation of Research

Reports of research misconduct in the 1980s led to the creation of the Office of Research Integrity within the U.S. Department of Health and Human Services, which works to investigate scientific misconduct and provide support to universities conducting research using human subjects. In 1991, a new regulatory framework dubbed the “Common Rule” added protection of human subjects in almost all government agencies. Among other requirements, the Common Rule provides special protections for pregnant women, children, and incarcerated people.

2000

Fabrication, Falsification, or Plagiarism of Research

The White House Office of Science and Technology Policy finalized a federal definition of research misconduct in 2000 as “fabrication, falsification, or plagiarism” in proposing, performing, or reviewing research, or in reporting research results. The definition does not include “honest error or differences of opinion.” Misconduct must be proved to have been committed knowingly, intentionally, or recklessly, or with a significant departure from accepted practices of the relevant research community. Overseen by a federal Office of Research Integrity, this process built on a 1992 report on responsible research from the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine.

2001

Preventing Data Suppression in Clinical Trials

For decades, drug companies were reported to have suppressed data about dangerous side effects of popular medications, both in publications and in seeking approvals by the U.S. Food and Drug Administration (FDA) for new drugs or new uses of drugs. In 2001, reports of propensity for heart attack and stroke associated with the pain reliever Vioxx and increased suicidality among children and young adults taking certain antidepressants prompted action. The FDA and academic journals began to require that the initiation of clinical trials and the availability of results from clinical trials be registered on a publicly available website and also implemented the Sentinel System for real-time monitoring of new therapeutics.

2005

Added Oversight for Potentially Harmful Research

In response to recommendations from the 2004 National Research Council report Biotechnology Research in an Age of Terrorism, the U.S. Department of Health and Human Services established the National Science Advisory Board for Biosecurity in 2005. The goal was to provide advice and guidance to federal agencies, scientists, and journals concerning oversight and public availability of research in biotechnology or biomedicine that has the potential to be a threat to public health, agriculture, the economy, or national security. A high-profile example involved the decision by Science magazine to publish the molecular methods for recreating and studying the strain of influenza virus that caused the 1918 pandemic that killed tens of millions of people.

2010

The Origin of HeLa Cells

In 2010, a widely acclaimed book recounted the story of Henrietta Lacks, an African American woman who provided the tissue from which HeLa cells, an immortal cell line widely used in biomedical research, were derived in 1951. In an echo of the Tuskegee Syphilis Study, the public learned that researchers had used Lacks’s cells without her consent and without providing the family any compensation. In 2013, criticisms concerning privacy and informed consent intensified after the online publication of the whole genome sequence of one strain of HeLa cells. Though the sequence was quickly removed from the public domain, controversy continues over whether consent should be required for the use of biospecimens in research.

2010s

Addressing Structural Racism and Health Inequities

In addition to gender and other inequities, addressing ongoing racial disparities must be intentionally integrated into the movement toward health equity and high-quality care for all. The Black Lives Matter movement, increased large-scale demonstrations and national dialogue around the material impacts of structural racism, and disproportionately high levels of COVID-19 infection and mortality in communities of color have demonstrated the critical need to address inequities and structural racism in the health and medicine fields today and into the future. Ensuring racial equity will be a focus of scientific and medical ethics in the coming years.

2017

#MeToo and #TimesUp in Science and Medicine

Starting in 2017, the #MeToo and #TimesUp movements brought the scope and severity of sexual harassment and gender inequity to the forefront of public consciousness—extending to the experiences of women in the sciences, engineering, and medicine. In 2018, a report from the National Academies of Sciences, Engineering, and Medicine identified sexual harassment of women as an enduring problem in academia, and the following year each of the National Academies adopted a code of conduct establishing standards for personal and professional conduct.

2018

Genetically Modified Babies in China

In defiance of an unofficial international moratorium on editing human embryos intended for a pregnancy, a Chinese scientist announced in 2018 that he had edited the genomes of twin girls in an attempt to make them immune to human immunodeficiency virus. His actions sparked international outrage and caused many scientists and policymakers to call for an official ban on human germline genome editing. A 2020 National Academy of Medicine/National Academy of Sciences report, Heritable Human Genome Editing, detailed the scientific, medical, ethical, moral, and societal issues that need to be addressed before heritable genome editing could be permitted.