David B. Resnik, J.D., Ph.D., Bioethicist, NIEHS/NIH
Note: This list is the author’s own interpretation of some important events in the history of research ethics and does not include every event that some people might regard as important. I am open to suggestions for additions, revisions, etc.
Francis Bacon publishes The Novum Organon, in which he argues that scientific research should benefit humanity.
Galileo Galilea publishes his Dialogue on Two World Systems, in which he defends a heliocentric theory of the solar system, a view that contradicted the Catholic Church’s position that the Earth does not move but that the Sun moves around it. In 1633, Galileo appeared before an inquisitor from the Catholic Church. He was forced to recant his views and was sentenced to house arrest for the remainder of his life. The Church banned his book. In 1992, 359 years after Galileo’s arrest, Pope John Paul II formally apologized for its treatment of Galileo.
The Royal Society of London institutes peer review procedures for articles submitted to The Philosophical Transactions of the Royal Society of London. The Philosophical Transactions, the world’s first scientific journal, was first published in 1665.
Edward Jenner inoculates eight-year-old James Phipps with fluid from a cowpox pustule to immunize him against smallpox.
Charles Babbage publishes Reflections on the Decline of Science in England, And Some of Its Causes, in which he argues that many of his colleagues were engaging in dishonest research practices, including fabricating, cooking, trimming, and fudging data.
Charles Darwin and Alfred Wallace publish The Origin of Species, which proposes a theory of evolution of living things by natural selection. The book generates a great deal of controversy because it proposes that human beings were not created by God (as most religions claimed) but descended from apes. Darwin collected most of the data for the theory while serving as the ship’s naturalist on the voyage of the HMS Beagle (1831-1836). He waited over twenty years to publish his ideas because he knew they would meet with strong opposition and he wanted to ensure that he could back up his claims with evidence and arguments. George Lyell urged Darwin to publish his theory after reading a paper by Alfred Wallace that proposed a theory similar to Darwin’s, so that Darwin could establish precedence. Instead, Darwin shared credit with Wallace.
Louis Pasteur administers an experimental rabies vaccine to nine-year-old Joseph Meister without testing it on animals first.
Robert Bartholomew inserts electrodes into a hole in the skull of Mary Rafferty caused by a tumor. He notes that small amounts electric current caused bodily movements and that larger amounts caused pain. Rafferty, who was mentally ill, fell into a coma and died a few days after the experiment.
Giuseppe Sanarelli injects the yellow fever bacteria into five patients without their consent. All the patients developed the disease and three died.
Walter Reed experiments to determine the cause of yellow fever. Thirty-three participants, including eighteen Americans and six Cubans, were exposed to mosquitoes infected with yellow fever or injected with blood from yellow fever patients. Six participants died, including two researcher-volunteers. The participants all signed consent forms, some of which were translated into Spanish.
Robert Millikan performs oil drop experiments to determine the charge of an electron. Millikan received a Nobel Prize for this research in 1923. Historians and journalists who studied Millikan’s notebooks discovered that he did not report 33 out of 149 oil drop observations that he had marked as “fair” or “poor.” Millikan also did not name his student, Harvey Fletcher, as an author on the paper that reported the results of these experiments, even though Fletcher made important contributions to the design of these experiments, such as suggesting that Millikan use oil droplets instead of water droplets.
Museum curator Charles Dawson discovers a skull in at Piltdown gravel bed near Surrey, U.K. It was thought to be the fossilized remains of a species in between humans and apes (i.e. “a missing link”). A controversy surrounded the skull for decades and many scientists believed it to be fake. Chemical analyses performed in 1953 confirmed these suspicions by showing that the skull is a combination of a human skull and orangutan jaw, which had been treated with chemicals to make them appear old. The identity of the forger is still unknown, though most historians suspect Dawson.
The University of Wisconsin establishes the Wisconsin Alumni Foundation (WARF), an independent organization that manages intellectual property (e.g. patents) and investments owned by the university and supports scientific innovation and discovery on campus. At that time, few universities owned or managed patents that were awarded to their researchers. WARF helps Harry Steenbock develop his invention for fortifying fats with vitamin D.
The Tuskegee Syphilis Study, sponsored by the U.S. Department of Health, Education and Welfare, begins in 1932. The study investigated the effects of untreated syphilis in 400 African American men from the Tuskegee, Alabama area. The researchers did not tell the subjects that they were in an experiment. Most subjects who attended the Tuskegee clinic thought they were getting treatment for "bad blood." Researchers withheld treatment for the disease from participants even when penicillin, an effective form of treatment, became widely available in the 1950s. The study ended in 1972, after a news story from the Associated Press alerted the public and Congress to the ethical problems with the research. The U.S. government settled a lawsuit brought by the participants and their families.
Japanese scientists working at Unit 731 performed morally abominable experiments on thousands of Chinese prisoners or war, including biological and chemical weapons experiments, vaccination experiments, and wound-healing and surgical studies, including vivisections. The U.S. government agreed to not prosecute the scientists for war crimes in exchange for data from the biological and chemical weapons research. Unit 731 of the Imperial Japanese Army also conducted research on Korean prisoners/civilians (such as Dong Ju Yoon (arguably the most famous modern era Korean poet) and Chung-Chun Lee (a Korean national hero and freedom fighter)), as well as Mongolians, Manchurians (separate from Chinese), and Russians.
German scientists conducted morally abominable research on concentration camp prisoners, including experiments that exposed subjects to freezing temperatures, low air pressures, ionizing radiation and electricity, and infectious diseases; as well as wound-healing and surgical studies. The Allies prosecuted the German scientists for war crimes in the Nuremberg Trials. The Nuremberg Code provided the legal basis for prosecuting the scientists.
Two German refugee scientists, Frisch and R.E. Peierls, warn the U.S. about Germany's nuclear weapons program. Albert Einstein sends a letter to President Roosevelt warning him about the threat posed by Germany. The letter, which was written by Leó Szilárd in consultation with Edward Teller and Eugene Wigner, was signed by Einstein. The letter suggested that the U.S. should develop a nuclear weapons program.
The U.S. conducts the $2 billion Manhattan Project to develop an atomic bomb. General Leslie Groves direct the Project and physicist Robert Oppenheimer oversees the scientific work.
The U.S. Department of Energy sponsors secret research on the effects of radiation on human beings. Subjects were not told that they were participating in the experiments. Experiments were conducted on cancer patients, pregnant women, and military personnel.
The U.S. drops atomic bombs on Hiroshima and Nagasaki, Japan, killing an estimated 200,000 civilians.
Led by President Eisenhower and atomic bomb scientist Robert Oppenheimer, the "atoms for peace" movement begins.
Vannevar Bush writes the report Science: The Endless Frontier for President Roosevelt. The report argues for a major increase in government spending on science and defends the ideal of a self-governing scientific community free from significant public oversight. It advocates for investment in science and technology as a means of promoting national security and economic development.
The Nuremberg Code, the first international code of ethics for research on human subjects, is adopted.
Norbert Wiener, the founder of cybernetics, published an article in the Atlantic Monthly titled "A Scientist Rebels" in which he refuses to conduct research for the military.
Alfred Kinsey publishes Sexual Behavior in the Human Male. Five years later, he publishes Sexual Behavior in the Human Female. These books were very controversial, because they examined topics which were regarded as taboo at the time, such as masturbation, orgasm, intercourse, promiscuity, and sexual fantasies. Kinsey could not obtain public funding for the research, so he funded it privately through the Kinsey Institute.
The Soviet Union tests an atomic bomb; the Cold War begins.
James Watson and Francis Crick propose a model for the structure of DNA, for which they eventually would share the Nobel Prize in 1962. They secretly obtained key x-ray diffraction data from Rosalind Franklin without her permission. Franklin was not named as an author on Watson and Crick’s paper. She was not awarded a Nobel Prize because she died in 1953 from ovarian cancer (at age 37), and the prize is not awarded posthumously.
Saul Krugman, Joan Giles and other researchers conduct hepatitis experiments on mentally disabled children at The Willowbrook State School. They intentionally infected subjects with the disease and observed its natural progression. The experiments were approved by the New York Department of Health.
The CIA begins a mind control research program, which includes administering LSD and other drugs to unwitting subjects.
The Soviets launch Sputnik, the first satellite, which triggers the U.S. government to increase its investments in science and technology to avoid falling behind in the space race.
In 1957, thalidomide is marketed in West Germany as medication to treat morning sickness during pregnancy. About 10,000 infants, mostly in West Germany, are born with severe birth defects as a result of exposure to this drug. 2,000 children die from thalidomide exposure. In 1960, Frances Kathleen Oldham Kelsey, a drug reviewer for the FDA, refused to approve the drug. Soon, countries around the world ban the drug. Kelsey is awarded the President's Award for Distinguished Federal Civilian Service in 1962.
President John F. Kennedy commits the U.S. to the goal of putting a man on the moon by the end of the decade.
Rachel Carson publishes Silent Spring, which alerts people to the harmful effects on the environment of various toxins and pollutants, including DDT. Her book launches the environmentalist movement.
Stanley Milgram conducts his "electric shock" experiments, which proved that people are willing to do things that they consider to be morally wrong when following the orders of an authority. The experiments, which had several variations, included a learner, a teacher, and a researcher. The learner was connected to electrodes. If the learner gave an incorrect response to a question, the researcher would instruct the teacher to push a button on a machine to give the learner an electric shock. Teachers were willing to do this even when the dial on the machine was turned up to “dangerous” levels and the learner were crying out in pain and asking for the experiments to stop. In reality, no shocks were given. The purpose of the experiments was to test subjects’ willingness to obey an authority figure. Since then, other researchers who have repeated these experiments have obtained similar results.
The World Medical Association publishes Declaration at Helsinki, Ethical Principles for Research Involving Human Subjects. The Helsinki Declaration has been revised numerous times, most recently in 2013.
The U.S. Surgeon General's office issues its first of several reports on health problems related to smoking.
Henry Beecher publishes an article in the New England Journal of Medicine alerting scientists and doctors to 22 unethical studies, including the Tuskegee syphilis study and the Willowbrook hepatitis study.
The animal rights movement impacts scientific research. The U.S. Public Health Service publishes its Guide for the Humane Care and Use of Laboratory Animals in 1963. The Guide requires research institutions to form Institutional Animal Care and Use Committees (IACUCs) to review and oversee animal experiments. The U.S. Congress adopts the Animal Welfare Act in 1966, which protect animals used in research, excluding rodents and birds. Various states adopt or revise animal cruelty laws, which also protect animals used in research. In 1975, Peter Singer publishes Animal Liberation, which provides a philosophical defense of the animal rights movement. Singer argues that most animal research is immoral.
The U.S. lands the first man on the moon.
After conducting hearings on unethical research involving human subjects, including the Tuskegee study, Congress passes the National Research Act in 1973, which President Nixon signs in 1974. The Act authorizes federal agencies (e.g. the NIH and FDA) to develop human research regulations. The regulations require institutions to form Institutional Review Boards (IRBs) to review and oversee research with human subjects.
William Summerlin admits to fabricating data by using a marker to make black spots on white mice at Sloan Kettering Cancer Institute. He was developing a technique for transplanting skin grafts.
Monsanto and Harvard reach a deal for the first major corporate investment in a university.
Scientists gather at Asilomar, California to discuss the benefits and risks of recombinant DNA experiments and agree upon a temporary moratorium for this research until they can develop biosafety standards. The NIH forms the Recombinant DNA Advisory Committee to provide guidance for researchers and institutions. Research institutions form Institutional Biosafety Committees (IBCs) to review and oversee research involving hazardous biological materials.
E.O. Wilson publishes Sociobiology, which reignites the centuries-old "nature vs. nurture" debate. His book proposes biological and evolutionary explanations of human behavior and culture.
Louise Brown, the world’s first baby conceived by in vitro fertilization, is born in the U.K. She is currently alive and healthy.
The National Commission for the Protection of Human Subjects in Biomedical and Behavioral Research publishes The Belmont Report: Principles of Ethical Research on Human Subjects. The Report provides the conceptual foundation for a major revision of the U.S. research regulations in 1981.
Congress passes the Bayh-Dole Act, which allows researchers to patent inventions developed with government funds; the Act is amended by the Technology Transfer Act in 1986.
In Diamond v. Chakrabarty, the U.S. Supreme Court rules that a genetically modified bacterium can be patented because it is the product of human ingenuity. This sets a precedent for patents on other life forms and helps to establish solid intellectual property protection for the new biotechnology industry.
The Whitehead Institute is established at MIT, another major private investment in a university.
The Department of Health, Education, and Welfare conducts major revisions of the federal human research regulations for human subjects research.
John Darsee, a postdoctoral fellow at Harvard, is accused of fabricating data. 17 of his papers were retracted.
William Broad and Nicholas Wade publish Betrayers of Truth. The book claims that there is more misconduct in science than researchers want to admit and suggests that famous scientists, including Isaac Newton, Gregor Mendel, and Robert Millikan were not completely honest with their data. Their book helps to launch an era of "fraud busting" in science.
Luc Montagnier accuses Robert Gallo of misappropriating an HIV strain. Gallo is found innocent of misconduct. Gallo and Montagnier also have a dispute about who should be credited with discovering HIV and who can patent a test for the virus. The U.S. and French governments reach an agreement to settle the controversy.
Roger Boisjoly warns NASA about possible O-ring failure, due to cold weather, in the space shuttle Challenger. NASA decides to go ahead with the launch, and the Challenger explodes, killing the entire crew.
A NIMH panel concludes that Steven Breuning fabricated and falsified data in 24 paper. Breuning is convicted of defrauding the federal government in 1988.
Martin Luther King is accused of plagiarizing his Ph.D. dissertation.
Margot O'Toole, a post-doctoral student at the Whitehead Institute, has some questions about data in a paper authored by six of her colleagues and published in the journal Cell in 1986. She asks to examine Thereza-Imanishi-Kari's lab notebooks, which seem to be inconsistent with published results. She accuses Imanishi-Kari of fabricating and falsifying data. The ensuing investigation leads to inquiries by MIT and Tufts as well as the NIH and a Congressional committee chaired by Rep. John Dingell. Nobel Prize winner David Baltimore is one of the co-authors on the disputed paper. Although he was not accused of misconduct, Baltimore resigns as President of Rockefeller University. He described the investigation, which was covered by the New York Times, as a "witch hunt." An appeals board at the DHHS eventually exonerated Imanishi-Kari, who admitted only to poor record keeping.
Harvard and Dow Chemical patent a genetically engineered mouse used to study cancer.
The PHS forms two agencies, the Office of Scientific Integrity and the Office of Scientific Integrity Review to investigate scientific misconduct and provide information and support for universities. It also amends its definition of misconduct. The two agencies are reorganized in 1992 as the Office of Research Integrity (ORI).
The NIH requires that all graduate students on training grants receive education in responsible conduct of research.
Stanley Pons and Martin Fleischmann hold a press conference at the University of Utah to announce that they have discovered a way to produce nuclear fusion at room temperatures. Dozens of labs across the world fail to reproduce their results. They are accused of fraud, sloppiness, and self-deception.
The NAS publishes On Being A Scientist (revised in 1994 and 2009), which is a free, short book on research ethics for scientists in training.
The U.S. launches the Human Genome Project, a $20 billion effort to map and sequence the human genome.
W. French Anderson begins the first human gene therapy clinical trial on patients with ADA deficiency, a genetic disease that affects the immune system.
In Moore v. Regents of the University of California, the California Supreme Court rules that researchers have intellectual property rights in a cell line derived from Moore's tissue, but that Moore did not have any property rights in his own tissue. The Court also rules that the researchers violated Moore's right to informed consent by not disclosing their commercial interests in his tissue sample to him. Most courts have followed this ruling by holding that patients no longer have rights to tissues leftover from surgeries or procedures or donated to researchers.
Congress investigates conflicts of interest involving Pharmatec and the University of Florida.
Europeans oppose the introduction of genetically manipulated foods and crops. Consumers in the U.S. are more receptive to GM plants and animals. Europeans finally allow GM foods but require them to be labeled as such. The U.S. does not mandate labelling of GM foods, but many manufacturers and suppliers voluntarily label foods as “no GMOs” or “not GM.”
U.S. federal agencies revise their human research regulations. All U.S. government agencies, except the EPA, now accept one basic regulatory framework, known as "the Common Rule" (45 CFR 46).
NAS publishes Responsible Science: Ensuring the Integrity of the Research Process. The book estimates the incidence of misconduct, discusses some of the causes of misconduct, proposes a definition of misconduct, and recommends some strategies for preventing misconduct.
The Public Health Service (PHS), which funds NIH research, consolidated the Office of Scientific Integrity and the Office of Scientific Integrity Review into the Office of Research Integrity (ORI). ORI develops policies, procedures, policies, and regulations for preventing, reporting, and investing research misconduct; reviews and monitors misconduct investigations conducted by PHS-funded institutions and makes recommendations concerning misconduct findings and administrative; provides technical assistance to institutions that are responding to misconduct allegations; and supports research, conferences, and education on the responsible conduct of research.
In Daubert v. Merrell Dow Pharmaceuticals the U.S. Supreme Court rules that judges serve as the gatekeepers for admitting scientific testimony in court and that they can use a variety of criteria, including testability, reliability, peer review, and general acceptance for determining whether testimony is scientific.
Fertility researchers successfully clone human embryos.
Harvard psychologist Richard Herrnstein and Charles Murray publish The Bell Curve, a controversial book that reignites the centuries old debate about biology, race and intelligence.
Roger Poisson admits to fabricating and falsifying patient data in NIH-funded breast cancer clinical trials in order allow his patients to qualify for enrollment and have access to experimental treatments.
The NIH applied for patents on thousands of gene fragments in order to undercut private efforts to patent gene fragments. The Patent Office rejected the NIH's applications.
The Ryan Commission, convened by NIH, holds meetings on scientific misconduct.
The Clinton Administration declassifies information about secret human radiation experiments conducted from the 1940s-1980s and issues an apology.
Two scientists who worked at Philip Morris, Victor DeNobel and Paul Mele, testify before Congress about secret research on the addictive properties of nicotine. If the research had been made public, the FDA or Congress might have taken additional steps to regulate tobacco as a drug. Many states and individuals brought litigation against tobacco companies, which led to a $206 billion settlement between tobacco companies and 46 states. The scientific community also publishes more data on the dangers of second-hand smoke.
Boots Pharmaceuticals pressures Betty Dong to withdraw a paper from publication in JAMA showing that its drug, Synthroid, is not more effective than generic equivalents at treating hypothyroidism.
Dozens of studies are published in biomedical journals which provide data on the relationship between the source of research funding and the outcomes of research studies, the financial interests of researchers in the biomedical sciences, and the close relationship between academic researchers and the pharmaceutical and biotechnology industries.
The NIH and NSF revise their conflict of interest policies.
Scientists and defense analysts become concerned about the use of chemical or biological weapons by a terrorist group after Aum Shinrikyo, a Japanese doomsday cult, releases sarin gas in a Tokyo subway, killing 12 people and sending 5,500 to hospitals. The group also attempted (unsuccessfully) to spray anthrax spores over Tokyo. In 1998, terrorism experts warn about the use of biological or chemical weapons by Osama bin Laden and Saddam Hussein.
Over 200 religious leaders, led by biotechnology critic Jeremy Rifkin, protest the patenting of plants, animals, and human body parts in Washington, D.C.
Dolly, the world's first cloned sheep, is born; her birth is announced in 1997. Several European nations ban human cloning. Congress considers a bill to ban all human cloning but decides not to after scientists argue that the bill would undermine biomedical research.
The ICMJE, representing over 400 biomedical journals, revises its authorship guidelines.
In an article published in New England Journal of Medicine, Peter Lurie and Sidney Wolfe accuse the NIH, WHO, UN and CDC of designing and conducting unethical studies on the prevention of mother-child transmission of HIV in developing countries. The dispute spurs a closer examination of international research ethics codes and guidelines.
Scientists perfect methods for growing human embryonic stem cells. Some countries ban the research; others promote it.
Craig Venter forms Celera Genomics and begins a private effort to sequence the human genome, using dozens of automated sequencing machines.
Apotex forces Nancy Olivieri, a clinical researcher at the University of Toronto, to withdraw a paper that exposes safety concerns about its drug deferiprone, which is used to treat thalassemia. The company tries to discredit Olivieri and have her fired.
Jessie Gelsinger dies in a human gene therapy experiment at the University of Pennsylvania. The event triggers heightened scrutiny of conflicts of interest in human subjects research, including institutional conflicts of interest. Penn settles a lawsuit brought by the Gelsinger family for an undisclosed amount of money.
Human research lawsuits increase dramatically. Alan Milstein, from the law firm Sherman, Silverstein, Kohl, Rose & Podolsky, P.A., instigates 13 lawsuits against researchers, universities, pharmaceutical companies, and Institutional Review Board members.
The U.S. NIH and OHRP require all people conducting or overseeing human subjects research to have training in research ethics.
The U.S. Office of Science and Technology Policy finalizes a federal definition of misconduct as "fabrication, falsification or plagiarism" but not "honest error or differences of opinion.” Misconduct must be committed knowingly, intentionally, or recklessly.
ORI proposes mandatory training in responsible conduct of research (RCR) for all researchers on PHS grants, including junior senior investigators, students, and technicians. Several scientific associations and universities oppose the policy as an unnecessary and un-funded mandate. The Bush Administration suspends the ORI proposal in 2001 on the grounds that the agency failed to follow proper procedures for proposing new government regulations. Many research institutions voluntarily expand their RCR training programs.
Celera and the Human Genome Project both complete 99% complete drafts of the human genome and publish their results in Science and Nature.
Congress debates legislation on human cloning.
Several journals, including Nature and JAMA, experiment with requiring authors to describe their responsibilities when publishing research.
The Bush Administration announces that the NIH will only fund human embryonic stem cell research on approximately 64 cell lines created from leftover human embryos.
Terrorists hijack 3 airplanes on September 11 and kill over 5,000 people. Several weeks later, someone send four letters containing anthrax, killing 5 people and infecting 23. U.S. Army medical researcher Bruce Ivins, who committed suicide, is the prime suspect.
Bell Labs determines that Jan Hendrick Schön, a rising star working in condensed matter physics and nanotechnology who published dozens of articles in a short period of time in prestigious journals, had fabricated and falsified data. 28 papers authored by Schön were retracted.
The President's Council on Bioethics recommends that the U.S. ban reproductive cloning and enact a moratorium on research cloning.
Historian Stephen Ambrose is accused of plagiarism.
The NAS publishes Integrity in Scientific Research, which recommends that universities develop programs for education in responsible conduct of research (RCR) as well as policies and procedures to deal with research ethics.
North Korea declares that it has a secret nuclear weapons program and warns that it has other "more powerful" weapons.
Scientists publish several papers in prominent journals with direct implications for bioterrorism. A paper published in the Journal of Virology described a method for genetically engineering a form of mousepox virus that is much deadlier than the naturally occurring strain. A paper published in Science showed how to make the poliovirus by obtaining supplies from a mail-order company. A paper published in PNAS develop a mathematical model for showing how many people would be killed by infecting the U.S. milk supply with botulinum toxin. In 2003, the American Society for Microbiology (ASM), the National Academy of Sciences, and the Center for Strategic and International Studies held a meeting to discuss the censorship biological research that poses security risks. Journals agree to self-censor some research.
The U.S. invades Iraq with the stated purpose of eliminating its chemical, biological, and nuclear weapons programs. The U.S. found evidence of weapons programs but no actual weapons.
The EPA suspends the CHEERS study due to criticism from advocacy groups and members of Congress, who claimed that the study was intentionally exposing children to pesticides. The EPA revised its human subjects rules in response to a Congressional mandate to strengthen protections for children and pregnant or nursing women.
Ronald Reagan, Jr. makes a presentation in support of federal funding for embryonic stem cell research to the Democratic Convention. Stem cell research (and therapeutic cloning) become hot issues in the 2004 Presidential election.
Merck withdraws its drug Vioxx from the market, due to safety and liability issues. As many as 50,000 people had a heart attack or stroke while take the drug, and thousands sued the company. As early as 2001, Merck scientists suspected that Vioxx could increase the cardiovascular risks, but researchers funded by Merck did not publish some of the data that would support these suspicions, even though they reported it to the FDA. In 2001, the FDA warned Merck that it had misrepresented Vioxx’s safety profile to the public and in 2002 it issued a black box warning for the drug. A systematic review of antidepressant medications known as selective serotonin uptake inhibitors (SSRIs) found that some of these drugs increase the risks of suicide in adolescents and children. The review included data from the U.K.’s Committee on Safety in Medicines, which had not been previously published. Patients, parents, researchers, and policymakers accused companies intentionally hiding this data from the public, and New York Attorney General Eliot Spitzer sued Glaxo for fraud. As a result of these problems related to data suppression, government agencies (including the FDA) and journals now require clinical trials to be registered on a publicly available website. Registration includes important information about the studies, including research design, interventions, and methods; research sites and personnel; contact information; and research results (but not raw data).
In response to criticism from Congress, the NIH revises its conflict of interest rules for intramural research. NIH researchers cannot hold stock in pharmaceutical or biotech companies or consult with these companies for pay.
Seoul University research Woo Suk Hwang admits to fabricating data in two papers published in the journal Science. In the papers, Hwang claimed that he had used nuclear transfer techniques to develop patient-specific human embryonic stem cells.
University of Vermont researcher Eric Poehlman admits to fabricating or falsifying data in 15 federal grants and 17 publications. Poehlman served a year and day in federal prison and agreed to pay the U.S. government $180,000 in fines.
In response to recommendations from a National Research Council report titled “Biotechnology in the Age of Terrorism,” the Department of Health and Human Services establishes the National Science Advisory Board for Biosecurity (NSABB) to provide advice and guidance to federal agencies, scientists, and journals concerning oversight and public of research in biotechnology or biomedicine which can be readily applied to cause significant harm to public health, agriculture, the economy, or national security (i.e. “dual use” research).
Someone hacked into the email server at the University of East Anglia Climatic Research Unit (CRU) and posted on the internet thousands of emails exchanged between climate change researchers at the CRU and researchers around the world. The emails showed that the researchers refused to share data and computer codes with climate change skeptics, who called the incident "climategate." The Intergovernmental Panel on Climate Change (IPCC), which relies heavily on data and models from CRU researchers, vowed to promote greater openness in climate research.
The Obama Administration announces it will significantly expand NIH funding of human embryonic stem cell research which had been restricted under the Bush Administration.
The National Science Foundation (NSF) announces RCR training requirements for funded investigators, students, and trainees. The NIH expands and strengthens its RCR training requirements.
While doing research on the Tuskegee Syphilis Study, Susan Reverby, Professor of Women’s Studies at Wellesley College, uncovered documents concerning unethical research experiments on human subjects conducted by the U.S. government in Guatemala from 1946 to 1948. The research involved intentionally infecting over 1300 subjects with syphilis to test the effectiveness of penicillin in preventing this disease. Only 700 subjects were given penicillin and 83 died as a result of the study. The subjects were not informed that they were participating in an experiment.
Lancet retracts a paper for fraud, published in 1998 by Andrew Wakefield and colleagues, linking autism to vaccine for measles, mumps, and rubella. Members of the anti-vaccine movement cited the paper as proof that childhood immunizations are dangerous. Vaccination rates in U.K., Europe, and the U.S. declined after Wakefield’s study was published. An investigation by journalist Brian Deer found that Wakefield had not disclosed a significant financial interest and had not obtained ethics board approval for the study. Wakefield’s research had been supported by a law firm that was suing vaccine manufacturers. A lawyer for the firm had helped Wakefield recruit patients. Wakefield did not disclose his relationship to the law firm in the 1998 paper. In 2010, the U.K.’s General Medical Council (GMC) revoked Wakefield’s license to practice medicine following an investigation which concluded that he had not disclosed a significant financial interest and had performed risky procedures, such as colonoscopies and lumbar punctures, without appropriate pediatric qualifications or ethics committee approval.
Jeffrey Beale publishes a list of what he calls “predatory journals.” Predatory journals are profit-driven journals that charge high fees for open access publication, promise rapid publication, and have poor (or nonexistent) standards for peer review. Beale later withdraws his list due to pressure from journals.
Ivan Oransky and Adam Marcus launch Retraction Watch, a blog that post retractions of scientific papers and articles related to research integrity.
The World Conference on Research Integrity releases the Singapore Statement on Research Integrity, a code of ethics for scientists in various disciplines.
The NIH and NSF revise their conflict of interest rules for funded research.
The Office of Human Research Protections announces proposed changes to the Common Rule to enhance human subject protections and reduce investigator burden. The Common Rule has not been changed significantly since 1981.
Journalist Rebecca Skloot publishes a widely-acclaimed book about Henrietta Lacks, an African American woman who provided the tissue for a widely-used cell line known as HeLa (an abbreviation of her name). In 1951, Lacks underwent treatment for cervical cancer at Johns Hopkins Hospital and died later that year. Researchers discovered that they were able to culture the cells from Lacks’ tumor and keep them alive, which was the first time that scientists had been able to grow a human cell line. HeLa cells have been used in thousands of laboratories around the world in various biomedical experiments. Skloot was interested in finding out where the HeLa cell line came from, and she discovered that it came from Henrietta Lacks. Skloot interviewed Lacks’ family and learned that researchers had grown her tumor cells without her consent and without providing the family any compensation, which was a common practice at that time. Skloot decided to share profits from her book with the family. In 2013, the NIH reached an agreement with Lacks’ family concerning access to genomic data from the cell line. The agreement gives the family control over access to the data and acknowledgment in scientific papers. In 2021, the Lacks family sued Thermo Fisher Scientific, a company that commercialized them the cell line. The lawsuit claims that the company unjustly profited from Lacks' tissue without her consent.
Several authors publish papers documenting a dramatic increase in the number of retracted papers since 2001. A majority of the retractions are due to research misconduct.
Two papers embroiled in controversy were published in Science and Nature after several months of debate about their implications for bioterrorism. The papers reported results of NIH-sponsored research conducted by a team working in the Netherlands, led by Ron Fouchier, and a team working at the University of Wisconsin, led by Yoshihiro Kawaoka. The researchers were able to genetically modify an H5N1 avian flu virus so that it can be transmitted by air between mammals, including humans. Currently, avian flu can only be contracted through direct contact with birds. The virus is highly lethal, with a mortality rate of over 50%. Over 300 people have died from the virus since 1997. The National Science Advisory Board for Biosecurity (NSABB) initially recommend that the papers be published in redacted form, with key details removed and only made available to responsible scientists, so the terrorists or others could not use the information to make deadly bioweapons. However, the NSABB changed its mind and recommended full publication of both papers after learning more about the value of the research for public health (e.g. monitoring of bird populations, vaccine development), biosafety measures, how difficult it would be for terrorists to replicate the work, and problems with redacted publication.
The NIH launches the reproducibility initiative in response to problems with the reproducibility of scientific research.
In Association for Molecular Pathology et al. v. Myriad Genetics, the U.S. Supreme Court rules that isolated and purified DNA cannot be patented. Only DNA that has been modified by human beings can be patented. The ruling invalidates Myriad’s patents on BRCA1 and BRCA2 genes and creates uncertainty concerning the legal validity of other types of patents on isolated and purified chemicals.
Haruko Obokata, a biochemist at the RIKEN Center for Developmental Biology in Kobe, Japan, and coauthors published two high-profile papers in Nature describing a method for converting adult spleen cells in mice into pluripotent stem cells by means of chemical stimulation and physical stress. Several weeks after the papers were published, researchers at the RIKEN Center were unable to reproduce the results and they accused Obokata, who was the lead author on the papers, of misconduct. The journal retracted both papers in July after an investigation by the RIKEN center found that Obokata had fabricated and falsified data. Later that year, Obokata’s advisor, Yoshiki Sasai, committed suicide by hanging himself.
Various funding agencies and journals, including the NIH, Science, and Nature, take steps to promote reproducibility in science in response to reports that many published studies in the biomedical, behavioral, and physical sciences are not reproducible.
17 federal agencies publish a Notice of Proposed Rule-Making (NPRM) for revisions to the Common Rule. The changes would increase oversight of human biological samples, expand the categories of research exempted from the rule, enhance informed consent requirements, require a single IRB for multisite research, and reduce some regulatory burdens on researchers and institutions.
The NIH places a temporary moratorium on funding for experiments involving human-animal chimeras while it revises existing rules that govern this research.
17 federal agencies publish the Final Rule for revisions to the Common Rule. The Final Rule eliminates controversial provisions that would have required prior consent for all research involving human biological samples. The rule became effective in 2019.
In October, He Jiankui, a scientist of the Southern University of Science and Technology in Shenzhen, China, announces the birth of the world’s first gene edited babies, both girls. He claims that he used CRISPR-Cas 9 technology to modify the CCR5 gene to give the girls immunity to HIV. The announcement generates outrage around the world and many scientists and policymakers call for a ban on human germline, genome editing.
During the COVID-19 pandemic, which killed millions of people around the world, scientists worked feverishly to conduct research that could help combat this public health crisis. To make data and results available as quickly as possible, many journals expedited their peer review process for COVID-19 submissions and scientists published articles on pre-print servers before undergoing peer review. Unfortunately, the rush to publish led to the dissemination of invalid, irreproducible, and falsified results in some cases. Dozens of COVID-19 papers had to be retracted or withdrawn. Two prominent biomedical journals, the New England Journal of Medicine and the Lancet, retracted papers after the editors learned that the healthcare analytics company Surgisphere, which provided the data used in the studies, was not making the raw data available to independent scientists who found inconsistencies in the data and wanted to do an audit. The journals also learned that Surgisphere did not make all the data available to the scientists who authored the papers.
In early 2020, at the beginning of the COVID-19 pandemic, US scientists claimed that the SARS-CoV-2 virus that causes the disease probably moved from horseshoe bats into the human population via an undetermined intermediate host species. Others believed that SARS-CoV-2 was a genetically engineered pathogen that had escaped from a laboratory at the Wuhan Institute of Virology (WIV) in China. The World Health Organization attempted to investigate the origins of the virus by interviewing scientists at WIV and inspecting facilities, but they were unable to obtain all the information they needed. During 2020, there was a scientific consensus that SARS-CoV-2 probably had a natural origin. Opinions began to change in 2021, however, when highly respected science writer Nicholas Wade published several articles critically examining the two competing hypotheses: natural origin vs. laboratory escape. Wade argued that there was substantial evidence supporting the laboratory escape hypothesis, because an intermediate host species had not been found despite intense searching and a key part the protein that the virus uses to infect cells, known as the furin cleavage site, does not occur in related coronaviruses. After Wade’s articles were published, many scientists started publishing papers examining evidence concerning the origins of SARS-CoV-2. However, the origins of SARS-CoV-2 remain a mystery.