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The Competing Demands of Patient Privacy and Clinical Research Volume 43, Number 1 • January-February XXXXXXXXXX Jane received a letter from a researcher who works in the same academic medical center...

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The Competing Demands of Patient Privacy and Clinical Research
Volume 43, Number 1 • January-Fe
uary XXXXXXXXXX
Jane received a letter from a researcher who works in
the same academic medical center as she does, inviting
her to participate in a study “targeting” ways to improve
early diagnosis of uterine cancer for individuals diag-
nosed with endometrial cancer. Jane recently had gyne-
cological surgery at this academic medical center (and,
as part of her preadmission testing, had a chest x-ray).
As you might imagine, she did not disclose or release
information related to her gynecological care and treat-
ment at the hospital to her colleagues and expected it to
emain private. What a surprise, then, to receive an in-
vitational research letter at her home that identified her
private health information, including her name and her
cancer diagnosis, along with incidental lung nodule find-
ings from the chest x-ray of which she was not aware.
In the letter, the study team, some of whom she knows
as colleagues, noted that they had already contacted
her surgical oncologist to obtain through the electronic
medical records system her personal medical history that
they needed for the research. The institutional review
oard (IRB) had approved the study and the invitational
letter. Jane subsequently spoke to the chair of the IRB,
the hospital’s privacy officer, and a colleague who is a
ioethicist, asking how to note in her medical record to
not allow researchers access to her personally identifi-
able information without her explicit permission. She
was told that this was not possible given that this was an
academic medical center and that, by agreeing to receive
care within the system, she was agreeing to allow her
ecords to be used for IRB-approved research.
Confidentiality of personal medical information is a cornerstone of ethical clinical care and ethi-cal research. Indeed, codes of ethics published
y professional societies, federal and local rules, hospi-
tal practices, and other guidance require clinicians and
esearchers to protect the confidentiality and privacy of
their patients and research participants. Federal guid-
ance defines private information as “information about
ehavior that occurs in a context in which an individual
can reasonably expect that no observation or recording
ABSTRACT Privacy and confidentiality of personal medical information are cornerstones of ethical clinical care and
ethical research. But real-world research has challenged traditional ways of thinking about privacy and confidentiality of
information. In today’s world of “big data” and learning health care systems, researchers and others are combining mul-
tiple sources of information to address complex problems. We present a case study that highlights the ethical concerns
that arise when a patient who is employed by an academic medical center learns through a research invitational letter
that her private information was accessed at this center without her consent. We discuss the ethical challenges of balanc-
ing patient privacy with advancing clinical research and ask, what level of privacy and confidentiality can and should
patients expect from their clinician providers, fellow research colleagues, and institutions?
KEYWORDS ethics, learning health system, employees, privacy, research
Ulrich, C. M., et al., “The Competing Demands of Patient Privacy and Clinical Research,” Ethics & Human Research 43, no XXXXXXXXXX): XXXXXXXXXXDOI:
10.1002/eahr.500076
The Competing Demands of Patient Privacy
and Clinical Research
Connie M. Ulrich, Christine Grady, George Demiris, and Therese S. Richmond
26
E RHE RH&
is taking place, and information which has been pro-
vided for specific purposes by an individual and which
the individual can reasonably expect will not be made
public (e.g., a medical or education record).”1 Most of
us expect that our personal medical information will
not be made public, as it is private and may be sensi-
tive information and evoke a sense of privacy and own-
ership.2 We also expect that health care providers will
protect the confidentiality of our medical and personal
information when we discuss health status or other
personal concerns and that such protections apply to
our medical records as well. Many Americans feel that
they have a moral right to their medical privacy.3 Fed-
eral and state laws are also in place to protect patients’
privacy and the confidentiality of medical information
and records.4 Federal research regulations also protect
the confidentiality of identifiable health information
for all research participants and offer guidance on data-
protection measures and who has access to this infor-
mation.5
For research, IRBs review plans to protect the con-
fidentiality of personal health information and assess
how proposed safeguards will be implemented. But
eal-world research has challenged traditional ways of
thinking about privacy and confidentiality of informa-
tion. Today, we live in the world of “big data” and learn-
ing health care systems, where researchers and others
combine multiple sources of information to address
complex problems. Electronic health records and other
internal and external sources of clinical data are efficient
means of gathering data to address recalcitrant health
problems and precisely target diseases.
Although electronic health records and other types
of clinical data (e.g., clinical notes) present many posi-
tive opportunities, this information also raises a host of
ethical issues for patients, clinicians, researchers, insti-
tutions, and other key stakeholders. In the case above,
the patient’s personal medical information was made
accessible to researchers, with IRB permission, but
without the patient’s knowledge. Would most people be
concerned or upset to learn that researchers were read-
ing their medical records to study what is happening to
them or to determine whether to send them an invita-
tion to participate in research? Kim and colleagues6 sur-
veyed patients in adult outpatient clinics about the use of
their data and biospecimens and their preferences about
sharing data with different types of researchers. Al-
though most patients in this study agreed to share their
data and biospecimens, nearly three-quarters of patients
wanted to share selectively, choosing not to share at least
one item with a particular type of researcher. They also
prefe
ed to share data within their care institutions.
Preferences about selective sharing may be magnified,
however, when the patient receives care at a facility
where she is also an employee. In other work, Mello et
al.7 focused on clinical trial participants and their views
on sharing data. Here again, most patient-participants
were willing to share their data and found benefit in do-
ing so, but participants raised some concerns about how
data sharing might deter others from participating in
clinical trials. Participants in this study also perceived
that data sharing might lead to a lower incentive on the
parts of scientists and companies to conduct clinical
trials, to the use of information for marketing purpos-
es, to reidentification of the patient from anonymized
data, and to information theft. In Jane’s case, however,
the data were not deidentified; the researcher, who was
also a colleague, had access to her name and home ad-
dress. In a study by Kim and colleagues8 of 800 Califor-
nia adults, most respondents agreed with the statement
that research benefits are more important than privacy,
ut most also agreed that individual rights, including
control over whether personal data are shared, are more
important than the benefits of research.
Advances in imaging accuracy and sensitivity have
also increased the occu
ence of incidental findings that
are outside the original procedural or testing purpose,
such as lung nodules, masses, kidney stones, cysts, and
enlarged lymph nodes.9 Detection of incidental findings
can be both beneficial and burdensome for patients; this
type of discovery can preemptively identify significant
or life-threatening diseases but can also lead to unnec-
essary hospitalizations and invasive measures.10 Most
people would be alarmed to learn that they have a par-
ticular health condition by opening a letter that invites
them to participate in research on that condition. While
Jane knew about her uterine cancer diagnosis, she was
unaware of the incidental finding from her preadmis-
sion testing; to find that out in a letter inviting her to
participate in a research study was understandably dis-
concerting.
Volume 43, Number 1 • January-Fe
uary XXXXXXXXXX
ETHICAL CONCERNS
Many organizational health systems—whether medical departments, universities linked to an
academic medical center, or national networks with
access to millions of data points—use data to improve
their outcomes.11 Broadly defined, these learning
health systems use both technical and social approach-
es aimed at improving processes that affect their prac-
tice activities; they can also readily take advantage of
modeling data to forecast future demands to allocate
esources more efficiently.12 The National Academy of
Medicine defines the learning health system as a system
in which “science, informatics, incentives, and culture
are aligned for continuous improvement and innova-
tion, with best practices seamlessly embedded in the
delivery process and new knowledge captured as an
integral by-product of the delivery experience.”13 In
providing guidance on operationalization of a learn-
ing health care system, Psek et al. stress the importance
of engaging patients in decisions about clinical care,
discovery, and research, guided by a defensible ethical
framework and a flexible regulatory structure.14
Faden and colleagues state that “we should assess
whether a learning activity unduly limits the choices of
patients and the value of those choices to patients. Many
decisions in health care are not likely to engage values of
central importance to the patient.”15 But whose respon-
sibility is it to make that assessment and determine what
is of central value to the patient? We traditionally rely on
IRBs, which include public members, to make research
enefit-risk determinations. The IRB in the case above
may have assessed the research as posing minimal harm
to participants, but the patient did not perceive it in the
same way. Jane perceived it as an intrusive violation of
her privacy and a negation of her expectation of confi-
dentiality. A learning environment includes many dif-
ferent actors with the possibility of sharing, transfe
ing,
and disseminating information among and across vari-
ous stakeholders, technological devices, and situations.
In fact, Kamleitner and Mitchell16 note that because
many people have personal information about others,
privacy and protection of personal information cannot
depend simply on the actions of one person (such as
one’s physician) but must instead depend on the choices
and behaviors of multiple people who can
Answered Same Day Feb 23, 2022

Solution

Insha answered on Feb 24 2022
112 Votes
Privacy and confidentiality             1
Privacy and confidentiality                         2
Privacy and confidentiality 
Table of Contents
Introduction    3
Question 1    3
Ethical Consideration    3
In Research    3
In IRB    3
Question 2    4
Privacy    4
Confidentiality    5
To Research Subjects    5
Importance in contrast to Patients and HIPPA    6
Conclusion    7
References    9
Introduction
This paper is discussing about the importance of privacy and confidentiality in matter of research and IRB. Further it will also be discussed about the importance of it in research subject in contrast to patients and HIPPA. All this will be highlighted with an example of tissue simulation and evidences of various articles and published information’s regarding the topic.
Question 1
Ethical Consideration
In Research
“Research of biomedical is ca
ied out with the goal of analysing the data gathered in a methodical manner. From this, generalizable conclusions may be derived that will help in the future to improve the treatment of presently unknown beneficiaries. Many ethical difficulties cross over between clinical medicine and research; however the ethical considerations that arise in research on human subject are not the same as those that arise in therapeutic and diagnostic settings. The primary function of human volunteers in research is to provide essential data. This is not the same problem that arises in clinical practise (Rice, 2008).
The use of human subjects in research presents a number of ethical concerns, ranging from non-maleficence to trust and loyalty within the fiduciary participant /investigator relationship. Human subjects’ research is governed by a complex regulatory structure that addresses these concerns. The philosophical and historical context that led to the cu
ent American system of government control and command regulation is well documented elsewhere.
In IRB
The federal Department of Health and Human Services released regulations governing the conduct of biomedical scientific research involving volunteers in 1981. The majority of US health-care research institutes have now committed to follow these government requirements in all of their study protocols. The FDA regulates research involving the testing of experimental medications or medical devices at the same time. The requirements of the Common Rule and the FDA are similar but not identical (H. H. S., PART 46).
In the United States, an institutional review board (IRB) is formed to monitor the conduct of research. The IRB must assess that each of the following conditions is met before approving a protocol: Subjects' psychologically and physical dangers are minimised, and subjects are chosen fairly (H. H. S., PART 46). Provisions pertaining to the confidentiality of research documents; without penalty, you have the right to stop participating at any moment.
Some states have established legislation that includes safeguards for human participants, including as mandating some form of monitoring and prior approval. The substance of these state statutes varies. A participant may file a private legal case against protocol sponsors and researchers for violations of common...
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