Society Needs Regulations to Prevent Research Abuses
A tension exists between scientists/doctors and government regulators.
[Editor's Note: Our Big Moral Question this month is, "Do government regulations help or hurt the goal of responsible and timely scientific innovation?"]
Government regulations help more than hurt the goal of responsible and timely scientific innovation. Opponents might argue that without regulations, researchers would be free to do whatever they want. But without ethics and regulations, scientists have performed horrific experiments. In Nazi concentration camps, for instance, doctors forced prisoners to stay in the snow to see how long it took for these inmates to freeze to death. These researchers also removed prisoner's limbs in order to try to develop innovations to reconnect these body parts, but all the experiments failed.
Researchers in not only industry, but also academia have violated research participants' rights.
Due to these atrocities, after the war, the Nuremberg Tribunal established the first ethical guidelines for research, mandating that all study participants provide informed consent. Yet many researchers, including those in leading U.S. academic institutions and government agencies, failed to follow these dictates. The U.S. government, for instance, secretly infected Guatemalan men with syphilis in order to study the disease and experimented on soldiers, exposing them without consent to biological and chemical warfare agents. In the 1960s, researchers at New York's Willowbrook State School purposefully fed intellectually disabled children infected stool extracts with hepatitis to study the disease. In 1966, in the New England Journal of Medicine, Henry Beecher, a Harvard anesthesiologist, described 22 cases of unethical research published in the nation's leading medical journals, but were mostly conducted without informed consent, and at times harmed participants without offering them any benefit.
Despite heightened awareness and enhanced guidelines, abuses continued. Until a 1974 journalistic exposé, the U.S. government continued to fund the now-notorious Tuskegee syphilis study of infected poor African-American men in rural Alabama, refusing to offer these men penicillin when it became available as effective treatment for the disease.
In response, in 1974 Congress passed the National Research Act, establishing research ethics committees or Institutional Review Boards (IRBs), to guide scientists, allowing them to innovate while protecting study participants' rights. Routinely, IRBs now detect and prevent unethical studies from starting.
Still, even with these regulations, researchers have at times conducted unethical investigations. In 1999 at the Los Angeles Veterans Affairs Hospital, for example, a patient twice refused to participate in a study that would prolong his surgery. The researcher nonetheless proceeded to experiment on him anyway, using an electrical probe in the patient's heart to collect data.
Part of the problem and consequent need for regulations is that researchers have conflicts of interest and often do not recognize ethical challenges their research may pose.
Pharmaceutical company scandals, involving Avandia, and Neurontin and other drugs, raise added concerns. In marketing Vioxx, OxyContin, and tobacco, corporations have hidden findings that might undercut sales.
Regulations become increasingly critical as drug companies and the NIH conduct increasing amounts of research in the developing world. In 1996, Pfizer conducted a study of bacterial meningitis in Nigeria in which 11 children died. The families thus sued. Pfizer produced a Nigerian IRB approval letter, but the letter turned out to have been forged. No Nigerian IRB had ever approved the study. Fourteen years later, Wikileaks revealed that Pfizer had hired detectives to find evidence of corruption against the Nigerian Attorney General, to compel him to drop the lawsuit.
Researchers in not only industry, but also academia have violated research participants' rights. Arizona State University scientists wanted to investigate the genes of a Native American group, the Havasupai, who were concerned about their high rates of diabetes. The investigators also wanted to study the group's rates of schizophrenia, but feared that the tribe would oppose the study, given the stigma. Hence, these researchers decided to mislead the tribe, stating that the study was only about diabetes. The university's research ethics committee knew the scientists' plan to study schizophrenia, but approved the study, including the consent form, which did not mention any psychiatric diagnoses. The Havasupai gave blood samples, but later learned that the researchers published articles about the tribe's schizophrenia and alcoholism, and genetic origins in Asia (while the Havasupai believed they originated in the Grand Canyon, where they now lived, and which they thus argued they owned). A 2010 legal settlement required that the university return the blood samples to the tribe, which then destroyed them. Had the researchers instead worked with the tribe more respectfully, they could have advanced science in many ways.
Part of the problem and consequent need for regulations is that researchers have conflicts of interest and often do not recognize ethical challenges their research may pose.
Such violations threaten to lower public trust in science, particularly among vulnerable groups that have historically been systemically mistreated, diminishing public and government support for research and for the National Institutes of Health, National Science Foundation and Centers for Disease Control, all of which conduct large numbers of studies.
Research that has failed to follow ethics has in fact impeded innovation.
In popular culture, myths of immoral science and technology--from Frankenstein to Big Brother and Dr. Strangelove--loom.
Admittedly, regulations involve inherent tradeoffs. Following certain rules can take time and effort. Certain regulations may in fact limit research that might potentially advance knowledge, but be grossly unethical. For instance, if our society's sole goal was to have scientists innovate as much as possible, we might let them stick needles into healthy people's brains to remove cells in return for cash that many vulnerable poor people might find desirable. But these studies would clearly pose major ethical problems.
Research that has failed to follow ethics has in fact impeded innovation. In 1999, the death of a young man, Jesse Gelsinger, in a gene therapy experiment in which the investigator was subsequently found to have major conflicts of interest, delayed innovations in the field of gene therapy research for years.
Without regulations, companies might market products that prove dangerous, leading to massive lawsuits that could also ultimately stifle further innovation within an industry.
The key question is not whether regulations help or hurt science alone, but whether they help or hurt science that is both "responsible and innovative."
We don't want "over-regulation." Rather, the right amount of regulations is needed – neither too much nor too little. Hence, policy makers in this area have developed regulations in fair and transparent ways and have also been working to reduce the burden on researchers – for instance, by allowing single IRBs to review multi-site studies, rather than having multiple IRBs do so, which can create obstacles.
In sum, society requires a proper balance of regulations to ensure ethical research, avoid abuses, and ultimately aid us all by promoting responsible innovation.
[Ed. Note: Check out the opposite viewpoint here, and follow LeapsMag on social media to share your perspective.]
Friday Five: These boots were made for walking, even for people who can't
New boots could have you moving like Iron Man, based on research this month by Stanford scientists.
The Friday Five covers important stories in health and science research that you may have missed - usually over the previous week but, today, we're doing a lookback on breakthrough research over the month of October. There are plenty of controversies and troubling ethical issues in science – and we get into many of them in our online magazine – but this news roundup focuses on scientific creativity and progress to give you a therapeutic dose of inspiration headed into the weekend.
Listen on Apple | Listen on Spotify | Listen on Stitcher | Listen on Amazon | Listen on Google
This Friday Five episode covers the following studies published and announced over the past month:
- New boots could have you moving like Iron Man
- The problem with bedtime munching
- The perfect recipe for tiny brains
- The best sports for kids to avoid lifelong health risks
- Can virtual reality reduce pain?
Should egg and sperm donors reveal their identities? The debate pivots on genetics and medical history.
Cassandra Adams performs on stage at the Jersey City Theater Center in March 2019 to raise awareness about traumatic experiences that she and others have had with anonymous donor conception.
Until age 35, Cassandra Adams assumed her mother and father were her biological parents. Then she took saliva tests through two genealogy databases—23andMe and AncestryDNA—and discovered a discrepancy in her heritage. In bringing up the matter with her parents, she learned that fertility issues had led the couple to use a sperm donor.
“Most people my age were not told,” said Adams, now 40 and a stay-at-home mom in Jersey City, New Jersey, who is involved with donor-conception advocacy. “Even now, there’s still a lot of secrecy in the industry. There are still many parents who aren’t truthful or planning not to be truthful with their children.”
While some of those offspring may never know a significant part of their medical history, Adams is grateful that she does. Surprisingly, the DNA test revealed Jewish ancestry.
“There are a lot more genetic conditions that run in Jewish families, so it was really important that I get my medical history, because it’s very different from my dad who raised me,” said Adams, who has met her biological father and two of three known half-siblings. As a result of this experience, she converted to Judaism. “It has been a big journey,” she said.
In an era of advancing assisted reproduction technologies, genetics and medical history have become front and center of the debate as to whether or not egg and sperm donations should be anonymous – and whether secrecy is even possible in many cases.
Obstacles to staying anonymous
People looking to become parents can choose what’s called an “identity-release donor,” meaning their child can receive information about the donor when he or she turns 18. There’s no way to ensure that the donor will consent to a relationship at that time. Instead, if a relationship between the donor and child is a priority, parents may decide to use a known donor.
The majority of donors want to remain anonymous, said reproductive endocrinologist Robert Kiltz, founder and director of CNY Fertility in Syracuse, New York. “In general, egg and sperm donation is mostly anonymous, meaning the recipient doesn’t know the donor and the donor doesn’t know the recipient.”
Even if the donor isn’t disclosed, though, the mystery may become unraveled when a donor-conceived person undergoes direct-to-consumer genetic testing through ancestry databases, which are growing in number and popularity. These services offer DNA testing and links to relatives with identifiable information.
In the future, another obstacle to anonymity could be laws that prohibit anonymous sperm and egg donations, if they catch on. In June, Colorado became the first state in the nation to ban anonymous sperm and egg donations. The law, which takes effect in 2025, will give donor-conceived adults the legal authority to obtain their donor’s identity and medical history. It also requires banks that provide sperm and egg collection to keep current medical records and contact information for all donors. Meanwhile, it prohibits donations from those who won’t consent to identity disclosures.
“The tradition of anonymous sperm or egg donation has created a vast array of problems, most significantly that the people thus created want to know who their mommy and daddy are,” said Kenneth W. Goodman, professor and director of the Institute for Bioethics and Health Policy at the University of Miami Miller School of Medicine.
“There are counter arguments on both sides. But the current situation has led to great uncertainty and, in many cases, grief,” Goodman said.
Donors should bear some moral responsibility for their role in reproduction by allowing their identity to be disclosed to donor-conceived individuals when they turn 18, Goodman added, noting that “there are counter arguments on both sides. But the current situation has led to great uncertainty and, in many cases, grief.”
Adams, the Jersey City woman who learned she was Jewish, has channeled these feelings into several works of art and performances on stage at venues such as the Jersey City Theater Center. During these performances, she describes the trauma of “not knowing where we come from [or] who we look like.”
In the last five years, Kathleen “Casey” DiPaola, a lawyer in Albany, New York, who focuses her practice on adoption, assisted reproduction and surrogacy, has observed a big shift toward would-be parents looking to use known sperm donors. On the other hand, with egg donation, “I’m not seeing a whole lot of change,” she said. Compared to sperm donation, more medical screening is involved with egg donation, so donors are primarily found through fertility clinics and egg donor agencies that prefer anonymity. This leads to fewer options for prospective parents seeking an egg donor with disclosed identity, DiPaola said.
Some donors want to keep in touch
Rachel Lemmons, 32, who lives in Denver, grew interested in becoming an egg donor when, as a graduate student in environmental sciences, she saw an online advertisement. “It seemed like a good way to help pay off my student loan debt,” said Lemmons, who is married and has a daughter who will turn 2-years-old in December. She didn’t end up donating until many years later, after she’d paid off the debt. “The primary motivation at that point wasn’t financial,” she said. “Instead, it felt like a really wonderful way to help someone else have a family in a few weeks’ time.”
Lemmons originally donated anonymously because she didn’t know open donations existed. She was content with that until she became aware of donor-conceived individuals’ struggles. “It concerned me that I could potentially be contributing to this,” she said, adding that the egg donor and surrogacy agency and fertility clinic wouldn’t allow her to disclose her identity retroactively.
Since then, she has donated as an open donor, and kept in touch with the recipients through email and video calls. Knowing that they were finally able to have children is “incredibly rewarding,” Lemmons said.
When to tell the kids
Stanton Honig, professor of urology and division chief of sexual and reproductive medicine at Yale School of Medicine, said for years his team has recommended that couples using donor sperm inform children about the role of the donor and their identity. “Honesty is always the best policy, and it is likely that when they become of age, they might or will be able to find out about their biological sperm donor,” he said. “Hiding it creates more of a complicated situation for children in the long run.”
Amy Jones, a 45-year-old resident of Syracuse, N.Y., has three children, including twins, who know they were conceived with anonymous donor eggs from the same individual, so they share the same genetics. Jones, who is a registered nurse and asked for her real name not to be published, told them around age seven.
“The thought of using a known donor brought more concerns—what if she wanted my babies after they were born, or how would I feel if she treated them as her own every time I saw her?” said Jones.
“I did a lot of reading, and all psychologists said that it is best to start the conversation early,” she recalled. “They understood very little of what I was telling them, but through the years, I have brought it up in discussion and encouraged them to ask questions. To this day, they don't seem to be all that interested, but I expect that later on in life they may have more questions.”
Jones and her husband opted to use a donor because premature ovarian failure at age 27 had rendered her infertile. “The decision to use an egg donor was hard enough,” she said. “The thought of using a known donor brought more concerns—what if she wanted my babies after they were born, or how would I feel if she treated them as her own every time I saw her?”
Susan C. Klock, a clinical psychologist in the section of fertility and reproductive medicine at Northwestern University Feinberg School of Medicine, said, “Anonymity is virtually impossible in the age of direct-to-consumer genetic testing.” In addition, “selecting an identity-release donor is typically not the first thing parents are looking at when they select a donor. First and foremost, they are looking for a donor with a healthy medical background. Then they may consider donor characteristics that resemble the parents.”
The donor’s medical history can be critical
Donor agencies rely on the self-reported medical history of egg and sperm donors, which can lead to gaps in learning important information. Knowing a donor’s medical history may have led some families to make different or more well-informed choices.
After Steven Gunner, a donor-conceived adult, suffered from schizophrenia and died of a drug overdose at age 27 in 2020, his parents, who live in New York, learned of a potential genetic link to his mental illness. A website, Donor Sibling Registry, revealed that the sperm donor the couple had used, a college student at the time of donation, had been hospitalized during childhood for schizophrenia and died of a drug overdose at age 46. Gunner’s story inspired Steven’s Law, a bill that was introduced in Congress in July. If passed, it would mandate sperm banks to collect information on donors’ medical conditions, and donors would have to disclose medical information the banks weren’t able to find.
With limited exceptions, the U.S. Food and Drug Administration requires donors to be screened and tested for relevant communicable disease agents and diseases such as HIV, hepatitis viruses B and C, the Zika virus and several STDs. With current technology, it is also impossible to screen for thousands of rare genetic diseases. “If a couple is using IVF (in vitro fertilization) to conceive with the donor gamete, some may opt for pre-implantation genetic testing to assess for chromosomal abnormalities,” Klock said.
Even these precautions wouldn't cover every disease, and some would-be parents don't get the genetic screening. In a situation where one donor has a large number of offspring, it is concerning that he or she can spread a rare disease to multiple people, said Nick Isel, 37, of Yorkville, Illinois, who was conceived with donor sperm due to his parents’ fertility issues. They told him the truth when he was a teenager, and he found his biological father with a journalist’s help.
Since 2016, Isel, who owns a roofing company, has been petitioning the FDA to extend the retention of medical records, requiring the fertility establishment to maintain information on sperm and egg donors for 50 years instead of the current 10-year mandate.
“The lack of family health information,” he said, “is an ongoing, slow-motion public health crisis since donor conception began being regulated by the FDA as a practice.”