Write Q&A Questions based to the readings

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25, 2022
Are The Belmon Repor Principle S ill Rele an for
Toda Re earch?
The Belmont Report, published 42 ears ago, is the seminal document credited with
creating the ethical foundation for research involving human participants in the United
States. But new technologies have transformed the research world since then. Does the
Belmont Report remain relevant toda ?
Wha Led o De elopmen of he Belmon Repor ?
The Tuskegee Stud of Untreated S philis in the Negro Male, conducted b the U.S.
Public Health Service and the Centers for Disease Control and Prevention between 19321972, was designed to observe the effects of s philis when left untreated. The men
participating in the stud were not informed about its purpose, and over 100 of the 400
subjects died from s philis or its complications, despite the availabilit of penicillin b
1947 to effectivel treat their disease. It has been cited as arguabl the most infamous
biomedical research stud in U.S. histor (1).
The Tuskegee E periment led to the creation of the National Commission for the
Protection of Human Subjects of Biomedical and Behavioral Research, charged with
identif ing the basic ethical principles for the conduct of research involving human
participants. After nearl four ears of meetings and discussions, the Commission
released the Belmont Report (named for the conference center site of a ke meeting) in
The ethical principles outlined in the Belmont Report were used to develop the federal
regulations for the protection of human subjects now referred to as the Common
Most considerations of ethical issues in human subjects research toda are e amined
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through the lens of the Belmont Report principles. Indeed, our human subjects research
courses, HSRT and HSRT SBER, are organi ed around the three main Belmont Report
principles of Respect, Bene cence, and Justice.
he Belmon Repor S ill Rele an Toda ?
Societ and science have evolved signi cantl in the 40-plus ears since the Belmont
Report was published. For e ample, the proliferation of detailed data about individuals
from health care and other sources along with anal tic methods and computer technolog
to handle large data sets; the widespread use of the internet, personal computer
technolog , and electronic devices; and the use of comple imaging modalities for
disease diagnosis and treatment have transformed biomedical and behavioral research. Ô
Current clinical trials are usuall multi-site, are often designed to change as a trial
progresses, take advantage of virtual and electronic methods, and can involve
randomi ation at a group level (practice or facilit ) rather than at the individual level. Work
done to improve health care deliver has led to debates about what is research and what
is qualit improvement. The evolution of genetic technologies has raised a number of
ethical issues such as the meaning of identi abilit for human specimens.
Because of this evolution in research technologies, there are questions about whether the
Belmont Report principles are still relevant for guiding current research ethics. Some have
called for a complete re-do of the Report while others believe the framework just needs
some moderni ation (2,3). We believe that the main Belmont Report principles are still
ver relevant but there needs to be continued discussion of how to appl them to research
as it evolves.
Ho Co ld he Belmon Repor Be Upda ed o Mee Toda
Re earch Challenge ?
The Belmont Report was conceived in response to studies like Tuskegee where
individuals were clearl mistreated. Thus, the Belmont Report principles are primaril
focused on the rights of individuals in research. As Friesen and her colleagues argue, one
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focused on the rights of individuals
inP research.
As Friesen
and her
argue, one
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area where the Belmont Report ma fall short is in consideration of societal or communit
harms which ma not be addressed b the Report s primar focus on individual subjects
rights (such as voluntariness and informed consent) (4). For e ample, the e perience of
the Havasupai tribe in the earl 2000 s in which de-identi ed data from the tribe was used
in other research that the tribe did not approve, demonstrated the failure of the Common
Rule de nition of research to consider cultural norms and wishes. Although the principle
of Justice does address some aspects of communit considerations, this is an area that
ma need further ethical development.
We believe that the Belmont Report has proven to be remarkabl robust, largel because
of its focus on underl ing ethical principles that can be broadl applied. But we also
endorse continued ethical discussion to determine how to appl the Belmont Report
principles in the future and whether additional principles are needed.
Reference :
1. Kat , Ralph V.; Green, B. Lee; Kressin, Nanc R.; Kegeles, S. Stephen; Wang, Min Qi;
James, Sherman A.; Russell, Stefanie L.; Claudio, Cristina; McCallum, Jan M. The legac of
the Tuskegee S philis Stud : assessing its impact on willingness to participate in
biomedical studies. Journal of Health Care for the Poor and Underserved. 2008 Nov:
19(4):1168 1180.
2. Ra mond N. Safeguards for human studies can t cope with big data. Nature World View
April 15, 2019.
3. Brothers, KB, et al. A Belmont Reboot: Building a normative foundation for human
research in the 21st centur . J. Law Med. Ethics. 2019 Mar:47(1): 165-172.
4. Friesen, P, et al. Rethinking the Belmont Report? Amer. J. Bioethics. 2017 17(7): 15-21.
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Safeguards for human studies can’t cope with big data
WORLD VIEW 15 April 2019
Safeguards for human studies can’t
cope with big data
Forty years on from a foundational report on how to protect people
participating in research, cracks are showing, warns Nathaniel
Nathaniel Raymond
One of the primary documents aiming to protect human research participants was
published in the US Federal Register 40 years ago this week. The Belmont Report was
commissioned by Congress in the wake of the notorious Tuskegee syphilis study, in
which researchers withheld treatment from African American men for years and
observed how the disease caused blindness, heart disease, dementia and, in some cases,
The Belmont Report lays out core principles now generally required for human research
to be considered ethical. Although technically governing only US federally supported
research, its influence reverberates across academia and industry globally. Before
academics with US government funding can begin research involving humans, their
institutional review boards (IRBs) must determine that the studies comply with
regulation largely derived from a document that was written more than a decade before
the World Wide Web and nearly a quarter of a century before Facebook.
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Safeguards for human studies can’t cope with big data
It is past time for a Belmont 2.0. We should not be asking those tasked with protecting
human participants to single-handedly identify and contend with the implications of the
digital revolution. Technological progress, including machine learning, data analytics
and artificial intelligence, has altered the potential risks of research in ways that the
authors of the first Belmont report could not have predicted. For example, Muslim cab
drivers can be identified from patterns indicating that they stop to pray; the Ugandan
government can try to identify gay men from their social-media habits; and researchers
can monitor and influence individuals’ behaviour online without enrolling them in a
Consider the 2014 Facebook ‘emotional contagion study’, which manipulated users’
exposure to emotional content to evaluate effects on mood. That project, a
collaboration with academic researchers, led the US Department of Health and Human
Services to launch a long rule-making process that tweaked some regulations governing
A broader fix is needed. Right now, data science overlooks risks to human participants
by default. In 2016, data scientists Jacob Metcalf and Kate Crawford first articulated an
inherent flaw in the protection of human research participants: guidelines wrongly
assume that data that are already public cannot pose new threats and so exempt the use
of such data from review ( J. Metcalf and K. Crawford Big Data & Society January–June;
2016). Recently, a council convened by the US National Science Foundation to lay
groundwork for big-data ethics concurred. It concluded that technology had created
“mismatches” between conventional ethical paradigms for protecting individuals and
new sorts of “informational harm”.
Data science can aggregate publicly available data to create and classify new groups of
individuals. That can pose threats to privacy, security and dignity. For example,
purchasing patterns can allow retailers such as Target to identify women who might be
pregnant, and researchers have been able to re-identify individuals almost 90% of the
time from supposedly anonymized credit-card data.
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Safeguards for human studies can’t cope with big data
Two new types of group data are inappropriately exempted in some cases by current
guidelines. The first is demographically identifiable information — data that allow
inferences to classify, identify or track people (named or unnamed) or groups of people
according to ethnicity, economic class, religion, gender, occupation, health status or
other combinations of factors. The second is what I call action-based information, such
as mobile-device data that reveal time and place-specific behaviour.
IRBs need help to assess these risks. How do Belmont principles apply to methods that
use publicly available data to identify people who died from opioid overdoses? What
new machine-learning methods for leveraging mobile-phone data to trace contacts
might expose vulnerable populations, such as people with HIV, to social stigma and
exclusion from services if the data become public?
The scientific community needs agreed-on frameworks to cope with these sorts of
group data. Tweaks to existing rules are not sufficient. Nor is another round of working
groups and ‘call to action’ articles. The European Union’s General Data Protection
Regulation provides some defence (in some countries) against misuse of online data,
but protection for research is sorely lacking.
Continued acceptance of the lack of guidelines is an abrogation of the research
community’s ethical duties. We should call on Congress, in parallel with international
bodies such as the World Health Organization, to authorize a national commission to
write another Belmont Report to deal holistically with applications of data science that
will only become more complicated as technology progresses. IRBs can help by
capturing what big-data research has and has not been considered exempt, and
publishing cases of how specific ethical challenges might best be addressed. This will not
eliminate risks or rein in all bad practice. But it would be a pivotal step towards
encouraging international harmonization of disparate approaches to difficult questions
that face researchers around the world.
9/14/22, 11:42 AM
Safeguards for human studies can’t cope with big data
Belmont 2.0 can ensure the clear benefits of big-data research are adequately balanced
against poorly understood risks and harms. It should not require abuses on the scale of
the Tuskegee syphilis study to prompt us to create guidelines fit for the digital world.
Nature 568, 277 (2019)
doi: https://doi.org/10.1038/d41586-019-01164-z
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© 2022 Springer Nature Limited

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