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.]
Podcast: The future of brain health with Percy Griffin
Percy Griffin, director of scientific engagement for the Alzheimer’s Association, joins Leaps.org to discuss the present and future of the fight against dementia.
Today's guest is Percy Griffin, director of scientific engagement for the Alzheimer’s Association, a nonprofit that’s focused on speeding up research, finding better ways to detect Alzheimer’s earlier and other approaches for reducing risk. Percy has a doctorate in molecular cell biology from Washington University, he’s led important research on Alzheimer’s, and you can find the link to his full bio in the show notes, below.
Our topic for this conversation is the present and future of the fight against dementia. Billions of dollars have been spent by the National Institutes of Health and biotechs to research new treatments for Alzheimer's and other forms of dementia, but so far there's been little to show for it. Last year, Aduhelm became the first drug to be approved by the FDA for Alzheimer’s in 20 years, but it's received a raft of bad publicity, with red flags about its effectiveness, side effects and cost.
Meanwhile, 6.5 million Americans have Alzheimer's, and this number could increase to 13 million in 2050. Listen to this conversation if you’re concerned about your own brain health, that of family members getting older, or if you’re just concerned about the future of this country with experts predicting the number people over 65 will increase dramatically in the very near future.
Listen to the Episode
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4:40 - We talk about the parts of Percy’s life that led to him to concentrate on working in this important area.
6:20 - He defines Alzheimer's and dementia, and discusses the key elements of communicating science.
10:20 - Percy explains why the Alzheimer’s Association has been supportive of Aduhelm, even as others have been critical.
17:58 - We talk about therapeutics under development, which ones to be excited about, and how they could be tailored to a person's own biology.
24:25 - Percy discusses funding and tradeoffs between investing more money into Alzheimer’s research compared to other intractable diseases like cancer, and new opportunities to accelerate progress, such as ARPA-H, President Biden’s proposed agency to speed up health breakthroughs.
27:24 - We talk about the social determinants of brain health. What are the pros/cons of continuing to spend massive sums of money to develop new drugs like Aduhelm versus refocusing on expanding policies to address social determinants - like better education, nutritious food and safe drinking water - that have enabled some groups more than others to enjoy improved cognition late in life.
34:18 - Percy describes his top lifestyle recommendations for protecting your mind.
37:33 - Is napping bad for the brain?
39:39 - Circadian rhythm and Alzheimer's.
42:34 - What tests can people take to check their brain health today, and which biomarkers are we making progress on?
47:25 - Percy highlights important programs run by the Alzheimer’s Association to support advances.
Show links:
** After this episode was recorded, the Centers for Medicare and Medicaid Services affirmed its decision from last June to limit coverage of Aduhelm. More here.
- Percy Griffin's bio: https://www.alz.org/manh/events/alztalks/upcoming-...
- The Alzheimer's Association's Part the Cloud program: https://alz.org/partthecloud/about-us.asp
- The paradox of dementia rates decreasing: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7455342/
- The argument for focusing more resources on improving institutions and social processes for brain health: https://www.statnews.com/2021/09/23/the-brain-heal...
- Recent research on napping: https://www.ocregister.com/2022/03/25/alzheimers-s...
- The Alzheimer's Association helpline: https://www.alz.org/help-support/resources/helpline
- ALZConnected, a free online community for people affected by dementia https://www.alzconnected.org/
- TrialMatch for people with dementia and healthy volunteers to find clinical trials for Alzheimer's and other dementia: https://www.alz.org/alzheimers-dementia/research_p...
Employers can create a culture of “Excellence From Anywhere” to reduce the risk of inequality among office-centric, hybrid, and fully remote employees.
COVID-19 prompted numerous companies to reconsider their approach to the future of work. Many leaders felt reluctant about maintaining hybrid and remote work options after vaccines became widely available. Yet the emergence of dangerous COVID variants such as Omicron has shown the folly of this mindset.
To mitigate the risks of new variants and other public health threats, as well as to satisfy the desires of a large majority of employees who express a strong desire in multiple surveys for a flexible hybrid or fully remote schedule, leaders are increasingly accepting that hybrid and remote options represent the future of work. No wonder that a February 2022 survey by the Federal Reserve Bank of Richmond showed that more and more firms are offering hybrid and fully-remote work options. The firms expect to have more remote workers next year and more geographically-distributed workers.
Although hybrid and remote work mitigates public health risks, it poses another set of health concerns relevant to employee wellbeing, due to the threat of proximity bias. This term refers to the negative impact on work culture from the prospect of inequality among office-centric, hybrid, and fully remote employees.
The difference in time spent in the office leads to concerns ranging from decreased career mobility for those who spend less facetime with their supervisor to resentment building up against the staff who have the most flexibility in where to work. In fact, a January 2022 survey by the company Slack of over 10,000 knowledge workers and their leaders shows that proximity bias is the top concern – expressed by 41% of executives - about hybrid and remote work.
To address this problem requires using best practices based on cognitive science for creating a culture of “Excellence From Anywhere.” This solution is based on guidance that I developed for leaders at 17 pioneering organizations for a company culture fit for the future of work.
Protect from proximity bias via the "Excellence From Anywhere" strategy
So why haven’t firms addressed the obvious problem of proximity bias? Any reasonable external observer could predict the issues arising from differences of time spent in the office.
Unfortunately, leaders often fail to see the clear threat in front of their nose. You might have heard of black swans: low-probability, high-impact threats. Well, the opposite kind of threats are called gray rhinos: obvious dangers that we fail to see because of our mental blindspots. The scientific name for these blindspots is cognitive biases, which cause leaders to resist best practices in transitioning to a hybrid-first model.
The core idea is to get all of your workforce to pull together to achieve business outcomes: the location doesn’t matter.
Leaders can address this by focusing on a shared culture of “Excellence From Anywhere.” This term refers to a flexible organizational culture that takes into account the nature of an employee's work and promotes evaluating employees based on task completion, allowing remote work whenever possible.
Addressing Resentments Due to Proximity Bias
The “Excellence From Anywhere” strategy addresses concerns about treatment of remote workers by focusing on deliverables, regardless of where you work. Doing so also involves adopting best practices for hybrid and remote collaboration and innovation.
By valuing deliverables, collaboration, and innovation through a focus on a shared work culture of “Excellence From Anywhere,” you can instill in your employees a focus on deliverables. The core idea is to get all of your workforce to pull together to achieve business outcomes: the location doesn’t matter.
This work culture addresses concerns about fairness by reframing the conversation to focus on accomplishing shared goals, rather than the method of doing so. After all, no one wants their colleagues to have to commute out of spite.
This technique appeals to the tribal aspect of our brains. We are evolutionarily adapted to living in small tribal groups of 50-150 people. Spending different amounts of time in the office splits apart the work tribe into different tribes. However, cultivating a shared focus on business outcomes helps mitigate such divisions and create a greater sense of unity, alleviating frustrations and resentments. Doing so helps improve employee emotional wellbeing and facilitates good collaboration.
Solving the facetime concerns of proximity bias
But what about facetime with the boss? To address this problem necessitates shifting from the traditional, high-stakes, large-scale quarterly or even annual performance evaluations to much more frequent weekly or biweekly, low-stakes, brief performance evaluation through one-on-one in-person or videoconference check-ins.
Supervisees agree with their supervisor on three to five weekly or biweekly performance goals. Then, 72 hours before their check-in meeting, they send a brief report, under a page, to their boss of how they did on these goals, what challenges they faced and how they overcame them, a quantitative self-evaluation, and proposed goals for next week. Twenty-four hours before the meeting, the supervisor responds in a paragraph-long response with their initial impressions of the report.
It’s hard to tell how much any employee should worry about not being able to chat by the watercooler with their boss: knowing exactly where they stand is the key concern for employees, and they can take proactive action if they see their standing suffer.
At the one-on-one, the supervisor reinforces positive aspects of performance and coaches the supervisee on how to solve challenges better, agrees or revises the goals for next time, and affirms or revises the performance evaluation. That performance evaluation gets fed into a constant performance and promotion review system, which can replace or complement a more thorough annual evaluation.
This type of brief and frequent performance evaluation meeting ensures that the employee’s work is integrated with efforts by the supervisor’s other employees, thereby ensuring more unity in achieving business outcomes. It also mitigates concerns about facetime, since all get at least some personalized attention from their team leader. But more importantly, it addresses the underlying concerns about career mobility by giving all staff a clear indication of where they stand at all times. After all, it’s hard to tell how much any employee should worry about not being able to chat by the watercooler with their boss: knowing exactly where they stand is the key concern for employees, and they can take proactive action if they see their standing suffer.
Such best practices help integrate employees into a work culture fit for the future of work while fostering good relationships with managers. Research shows supervisor-supervisee relationships are the most critical ones for employee wellbeing, engagement, and retention.
Conclusion
You don’t have to be the CEO to implement these techniques. Lower-level leaders of small rank-and-file teams can implement these shifts within their own teams, adapting their culture and performance evaluations. And if you are a staff member rather than a leader, send this article to your supervisor and other employees at your company: start a conversation about the benefits of addressing proximity bias using such research-based best practices.