Maintaining Privacy and Confidentiality of Data in Modeling HIV Transmission

M.J. Conaway, Ph.D.

Journal of Intended Publication: Epidemiology
Revised Thesis statement: In preventing Human Immunodeficiency Virus (HIV) transmission,
maintaining privacy and confidentiality among participating stakeholders in obtaining behavioral data
can be achieved in several ways without generating inaccuracies or skewing mathematical models.
Word Count: 4440 words

Introduction
An ethical public health action or intervention must determine population-level utility of the
proposed action, demonstrate evidence of need and effectiveness of action, establish fairness of goals
and proposed implementation strategies, and demonstrate accountability.1 Further, such an action
would assess expected efficiencies and costs and consider political feasibility and community
acceptance.1,2 The work of theoretical epidemiologists3-5 certainly demonstrates utility and evidence of
need. However, due to the mathematical and theoretical nature of the work, effectiveness of action,
accountability, costs, as well as political feasibility or community acceptance are not directly addressed
or incorporated into the activity. In preventing Human Immunodeficiency Virus (HIV) transmission,
maintaining privacy and confidentiality among participating stakeholders when obtaining behavioral
data can be achieved in several ways without generating inaccuracies or skewing mathematical models.
Background
Surveillance vs research
According to Childress et al1, public health is primarily concerned with the health of
the entire population, rather than the health of individuals. Its features include an
emphasis on the promotion of health, prevention of morbidity, and collection and
use of epidemiological surveillance and other forms of quantitative assessment.1
Other components include a recognition of the multivariate factors of health in
developing effective interventions.
In developing such interventions, therefore, the moral considerations
include balancing burdens and benefits, and ensuring participation of affected
parties. Other considerations are honoring autonomy and protecting privacy and
confidentiality, and building and maintaining trust.1 However, Childress and

colleagues1 assert that the relation of public health to the considerations is

complex, which can generate conflict among the considerations.
Clearly distinguishing between public health research and public health surveillance is crucial to
this analysis. According to the Centers for Disease Control and Prevention, the purpose of public
health research is develop or contribute to generalizable knowledge in the aggregate scientific literature
-to improve public health practice.2 Intended benefits of public health research usually extend beyond
the study participants to society from data collected that exceeds requirements for care of the study
participants.1,2 Frequently, data collection outcomes extend far beyond the scope of the original
research activity.1,2 For public health research, generalizable knowledge denotes novel information,
collected with systematic efforts to mitigate bias, that remains applicable if extended to populations or
interventions beyond the original scope of the initial study.2
Meanwhile, public health surveillance is a series of ongoing systematic activities, including
collection, analysis, and interpretation of health-related data.2 Whether the surveillance is used for
research or nonresearch purposes, such activities are essential to planning, implementing, and
evaluating public health programs.1,2 Hence, surveillance is predicated inextricably on the need to
prevent and control injury and disease as well as to maintain population health.1,2
Nevertheless, public health surveillance systems are more likely to be nonresearch when they
involve regular collections of data to manage public health programs.1,2 These systems can trigger
public health mechanisms that are invested in the state.1 Such mechanisms prevent or control disease
or injury based on data collected for a defined population in response to an event such an epidemic or a
natural disaster in a locality.2
The science of characterizing infection transmission systems
According to Koopman3, infection transmission systems, such as those associated with HIV,
circulate infection through complex contact patterns. These patterns are described by nonlinear
3

dynamics related to both contact patterns and patterns of factors that affect the risk of transmission
given contact. Elucidating these phenomena in different communities help make necessary inferences
for constructing the theoretical base and making decisions about infection control.3 For example, one
such HIV transmission system in a specific community was modeled by Alam et al4 with eight
compartments defined by four behavioral groups. The compartments had different anal-insertive and
anal-receptive combinations and two stages of infection. The effects of fluctuating behavior on
endemic prevalence and the transmission fraction from primary HIV were explored along with varying
rates of transition to develop a theoretical understanding on how behavioral fluctuation affects patterns
of infection. Using the transition rates in a Netherlands cohort of gay men to evaluate global effects in
real time, the time-varying behavior-group status change observed in the Netherlands cohort amplifies
the endemic prevalence and the transmission fraction from primary HIV, as was found by Alam et al4.
Such change resulted in the largest proportions of transmissions being from people with primary HIV,
due to fluctuation between dual- or receptive-role periods and periods with no anal sex. Although the
dual-role risk group is dominant in terms of total transmissions, it was found that fluctuation, albeit
infrequently observed, between receptive and insertive roles decreases the transmission fraction from
primary HIV3, which usually causes Acquired Immune Deficiency Syndrome (AIDS). Therefore, Alam
et al4 concluded that, in addition to biology, behavior patterns and social contexts within a community
of gay men who switch sexual roles between insertive, receptive, and insertive-receptive also
contribute to the transmission fraction from primary HIV.
Further, Romero-Severson et al5 observed a high level of movement between roles denoted as
insertive/receptive, protected/unprotected, anal/oral, and partner HIV status. Indeed, this suggests that
HIV transmission models should account for heterogeneity between and within individuals with respect
to sexual contact rates as well as sexual roles.5 Hence, this demonstrates the vital need to access
behavioral data in order to inform epidemiological theory. The sensitive nature of collecting data
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relating to sexual behavior, necessitates safeguards to maintain privacy and confidentiality to protect
those who participate in such research.
Privacy
Some definitions of "privacy" focus on the control by an agent over access
to and information about himself or herself.6 However, this is wholly distinct from
the right to privacy, which involves the right of an agent to control such access.
Hence, Beauchamp and Childress6 propose a form of privacy, considered to be
relational or associational privacy. It includes the family and similarly intimate
relations, within which individuals make decisions in conjunction with others.
Indeed, standard conceptions of privacy are too restrictive if they exclusively
focus on limited access to personal information about an individual. Privacy, as
defined to be of limited access, extends as well as to intimate relationships with
friends, lovers, spouses, physicians, and others.1,6
Confidentiality
Confidentiality could be considered a branch or subset of informational
privacy6,,which is the right of an agent to control access to any type of information
about himself or herself. It prevents redisclosure of information originally disclosed
within a relationship in which the confider reasonably and legitimately expects
that the confidant will not further disclose the information to anyone without the
authorization or permission of the confider.6 In the healthcare setting, if a patient
or research participant authorizes of permits release of the information to others,
then no violation of privacy or loss of rights of confidentiality occurs.1,6

Clinical Ethics vs. Research Ethics

According to Beauchamp and Childress,6 bioethics has long demarcated
between clinical and research ethics. The research-practice demarcation is
important for many reasons, but one key distinction is that it determines the
applicability of governmental regulations.5
According to Lawlor and Stone8, public health researchers may rely on access to medical
records for epidemiological research. Assuming that individual patient informed consent is required for
access to such records, the effect on the quality of the research will be a function of the proportion of
individuals who refuse consent or are not otherwise contactable, and any marked differences between
those individuals those who do give consent.
Record linkage provides a powerful tool for the study of the natural history of diseases.8
However, the process of linkage of individual data from a number of sources, such as primary,
secondary, and tertiary care records, prescribing records, and mortality data, requires explicit
identification of patients.7,8 In many countries, such action is not permitted because this is thought to
breach data protection laws.7,8 Hence, according to Lawlor and Stone8, the problems of accessing nonanonymous medical information for research purposes could be solved by encouraging healthcare
providers to become co-investigators in research studies, for example, by extracting and anonymizing
data upon initial contact with patients. Given that many healthcare providers do not have the time,
skills or interest to devote to research,8 proper training and appropriate incentives, such as continuing
education units, must be provided to them to encourage their interest and participation. However,
safeguards must be in place to prevent the unauthorized use of data, even if anonymized, from patients
who do not wish to participate in research.8
Analysis of Ethical Issues

According to Kass,9 to advance traditional public health goals while maximizing individual
liberties and furthering social justice, public health interventions and programs should reduce morbidity
or mortality. Such programs, supported by data, must be implemented fairly with procedures used to
ascertain acceptable burdens to a particular community.9 To achieve this, Kass9 proposed an ethical
framework that asks the following questions:
1) What are the goals of the program?
2) How effective is the program in achieving its stated goals?
3) What are the known and potential burdens of the program? Can the
burdens be minimized?
4) Are there alternative approaches?
5) Is the program implemented fairly?
6) How can the benefits and burdens of a program be fairly balanced?
Kass9 argues that because such power is vested in public health through the
state, an ethics framework designed specifically for public health is crucial to
fairly and appropriately preserve the negative rights of citizens. However, to
facilitate the social justice functions of public health, an ethics framework must
incorporate positive rights as well, so that the health of the public is improved and
various social inequities are mitigated.1,9
Meanwhile, Callahan and Jennings10 assert that public health poses myriad moral problems that
extend beyond the earlier boundaries of bioethics and demand an unique form of ethical analysis. One
reason is the fact that since infectious disease has not actually been eradicated, the need for surveillance
is continual and must be balanced against maintaining privacy and confidentiality.10 Given that the
privacy protections afforded to research participants do not extend to surveillance1,5,6, another reason is
the recognition that population health is more a function of good public health measures and improved
socioeconomic conditions than of advances in medical science. Nevertheless, through disease
screening programs and the techniques they require, public health still needs medical science to fully

function. Further, the stigmatization of HIV/AIDS and those with the disease, the need for a unique
ethical analysis cannot be overestimated.10
According to Callahan and Jennings,10 the tension produced by the favoring of civil liberties and
individual autonomy of principlist bioethics, as opposed to the utilitarian, paternalistic, and
communitarian orientation of public health ethics is difficult to reconcile. The ethical issues associated
with HIV/AIDS have forced public health ethics into the crux of this conflict between value systems of
principlism and communitarianism. Stemming from the admonitions of civil libertarians at the
forefront of the AIDS epidemic in the 1980s, a rights-based orientation has made inroads towards
resolutionof fundamental dilemmas in the relationship between individual and society while
ascertaining novel ways to more effectively balance health needs of the community and the rights of
individual citizens.10
Data protection
According to Lawlor and Stone8, however, much of the current debate on data protection policy
assumes that the public prioritizes confidentiality and privacy above all else. In the area of public
health research and practice, this assumption has been tested infrequently and may indeed be incorrect.
Carter et al11 assert that by ascertaining that patients understand how data from medical records could
be used given the protections that are in place, might be vital to bolstering their confidence that such
uses are legitimate and well-regulated. However, as patients become research participants, even when
patients consent to participate in specific studies, the detail of consent forms and informational
materials matters less to participants than having general faith in the legitimacy of the study, respect for
their vulnerability, and protection from harm and exploitation.1,2,8,11
In the US, Federal legislation places stringent limitations on the non-consensual use of health
information and broadens protection from only electronic data to all types of personal health
information, including oral and paper communications. Under current public health law, disclosure of
8

information without consent is permitted.12 However, according to Federal regulations, including the
Health Information Privacy Authorization Act (HIPAA), a waiver of privacy is not permitted except in
cases of public health research and authorization for disclosure.5,12 In the case of research, the Federal
regulations, specifically 45 CFR 46, allow for a consent waiver.13 This can only be done in case of a
clear public health importance to the research in which obtaining consent is impossible or would
seriously bias or skew the results of the study.1,2,13
Huff and colleagues14 applied a social-ecological interpretive framework to understand the
dynamics between patient privacy and confidentiality, mental health, social stigma, and continuity in
care in the HIV/AIDS treatment systems in the rural southeastern US. They found that spatial,
institutional, and interpersonal aspects of the system of care work at cross purposes to patient privacy
and confidentiality, psychological health, and social stigma. These system-wide bottlenecks constituted
barriers to long-term care by which persons living with HIV are exposed to stigma regarding their
health status with inadequate access to mental health services.11,14
Challenges and tensions
Confidentiality is, according to Waters15, one of the major ethical challenges in epidemiology. It
involves the ascertainment of health data about individuals and the disclosure of this information
including physical, psychological, sexual, and other functional or behavioral statuses with the minimal
or least possible risk to them, given that it may be infeasible to contact the individuals to obtain their
consent. Further, there are many different safeguards that must be considered. These include
identifying all who might have access to and the potential uses of such information and
implementation of data management systems that control such information. A further safeguard is to
keep physical data files under lock and key which are only accessible to the research personnel who
are authorized for a given research study. Epidemiological information may also include small groups
of individuals who live in a specific area or certain minority groups.15 Depending on the study, it may
9

even be necessary to protect the identity of groups of healthcare providers, the medical institutions, or
the geographic region served by them.15 Foster et al16 suggest that studies in which targeted
communities are identified in research communications may inadvertently bolster prevalent
stereotypes about aa given community and its constituents and foster social disruption. For example,
studies of HIV or AIDS may reinforce local biases and prejudices about such a disease-specific
community as unsafe or unhealthy.
Such social disruption may be mitigated by community advisory boards (CABs) which serve as
bridges between local communities and research teams.16 Evidence to counteract this has been
demonstrated by Morin and colleagues17in their study to better understand how community advisory
boards (CABs) can be used to improve the quality of HIV transmission prevention trials from data
collected at six sites of the HIV Prevention Trials Network, with locations ranging from Alabama to
Zimbabwe. Among other things sanctioned by the study protocol, activities included descriptive and
epidemiologic reports and face-to-face semistructured qualitative interviews with 67 CAB and research
team members. 17 It was found that, when both "broad community" and "population-specific" models
were used as strategies for CABs to represent potential participants in HIV prevention trials, this
improved the clinical trials significantly by assisting in development of protocols, recruitment and
retention of participants, as well as assisting with the resolution of ethical issues in the clinical trials. 17
Notwithstanding the social disruption that might result from epidemiological research to improve the
health of the targeted community, which may be considered to be one particularly significant harm16.
Nevertheless, the method of Morin et al17 has the potential to build sustainable capacity to identify and
address ethical issues in research as well as community needs.
Questions to be addressed
Many questions arise in determining the best way to maintain community-level privacy and
confidentiality of data used in research to model HIV transmission. The first question is whether the
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public health goal is likely to be accomplished. The syllogism of Mann18 is appropriate to address this
question. That is, if the mission of public health is to assure the conditions for the health of a given
population, and socioeconomic vulnerability and disparity are vital causes of morbidity and premature
mortality, then public health must address the fundamental determinants of ill health.1,9,18 Hence, the
novel work of theoretical epidemiologists like Koopman3 and others4,5 in the modeling of HIV
transmission is consistent with the syllogism of Mann because it seeks to determine how HIV infection
transmits throughout a targeted community and which variables contribute to stopping the
transmission.
Meanwhile, the second question to address is whether the benefits and burdensare distributed
fairly.1,9,10 This is especially important in targeted communities where research, which may be based on
increased surveillance activity, may in fact harm a given community or subcommunity given that
stereotypes of lack of health or cleanliness or decorum may be very much reinforced by research
findings.16 It is typical that the group of hemophiliacs are exclusive to the group of men who have sex
with men or men and women (MSMW).12,16 Yet, both groups are substantial subcommunities of the
targeted disease-specific community of HIV/AIDS.16 Certainly, the ethical challenge of fair
distribution of burdens and benefits in research is congruent with respect to the syllogism of Mann. A
possible way to ensure such a fair distribution of benefits and burdens would be to engage each
subcommunity within the targeted disease-specific community of HIV/AIDS in community-based
participatory research (CBPR) projects16,17 that are tailored specifically to each individual
subcommunity. Many different variables play out in groups such as hemophiliacs in rural settings and
men who have sex with men or men and women in urban settings. Thus, such participatory activities
that directly involve a subcommunity would address the fundamental determinants of ill health in each
targeted subcommunity within the HIV/AIDS disease-specific community.16

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A third crucial question in maintaining privacy and confidentiality of data in modeling HIV
transmission is whether the probable benefits of the action will outweigh the infringed moral
considerations. In the framework articulated by Baum et al19, an ethical public health action or
intervention must determine population-level utility of the proposed action, demonstrate evidence of
need and effectiveness of action, establish fairness of goals and proposed implementation strategies,
demonstrate accountability, assess expected efficiencies and costs, and consider political feasibility and
community acceptance. To ensure that the use of surveillance or clinical health data in modeling HIV
transmission remains ethical, local health departments must continue to engage members of the
different HIV subcommunities to acquire and maintain their trust to share sensitive information such as
health history and/or sexual contact patterns.20 Legal, policy and governance infrastructure must be
strengthened to hold strictly accountable those who may violate fiduciary confidentiality and leak such
sensitive information to the public in any manner. Finally, protocols that protect privacy and give
patients control over their data must be developed further.21,22
Stakeholder analysis
Stakeholder analysis in public health is the process of identifying the individuals or groups that
are likely to affect or be affected by a proposed project, policy, program or other action, and weighing
them according to their influence on the action and the influence the action will have on them.2,16,20
Hence, a stakeholder analysis of a public health intervention consists of weighing and balancing
all of the competing demands on the state by each of those who have an interest in it so that the state
may fulfill its obligation to protect the health of the community. However, a stakeholder analysis does
not necessarily prohibit the interests of some stakeholders overriding the interests of other stakeholders
affected. Rather, it guarantees that all stakeholders will be considered fairly.2,916,20
As a demonstration of the ongoing ethical tension between public health research and public
health surveillance, Waters15 posits that the needs of society, which is itself a stakeholder, as a whole
12

can conflict with the needs of individual citizen stakeholders. Waters states, A fundamental insistence
on absolute secrecy can be as harmful as an overriding concern with value to the community.15
Hence, excess confidentiality concerns can block the use of anonymized information even where the
identities of patients and providers have been removed if the information was originally collected for
another reason and informed consent for an epidemiological study was not explicitly obtained. Such
restrictions would delay knowledge regarding the health risks to individuals who engage in particular
behaviors.15,16
Further, Foster et al16 articulate a major problem in research with targeted communities such as
persons with HIV/AIDS. Such research findings may imply an inappropriate homogeneity and thus
increase societal demand for surveillance of targeted community under study. A typical targeted
community, such as persons with HIV/AIDS, is heterogeneous. Thus, there is usually a range of
variables that may associate with an increase in health risks. Prejudices and biases are therefore
reinforced when studies, as well as increased surveillance, of targeted communities present data
suggesting an association between one part of the community and a common health risk to the targeted
community in its entirety.10,16 According to Foster et al16, notions of collective authority have been
broadened to include the common interests of population groups defined by a disease such as
HIV/AIDS. To engage these stakeholders, community consultation may be appropriate for this group.
That is because the particular group, given its heterogeneity and diversity, has strong collective
interests in the risks and benefits of the research. The very conduct and/or outcome of the research may
significantly impact their health statuses and their lives.1,9,16
Historically, according to Sweeney and colleagues21, surveillance-based public health
intervention with individuals to control HIV infection and transmission has been problematic due to
concerns that risks to privacy and individual autonomy could outweigh the benefits of surveillance.
However, putting the public at unnecessary risk or denying appropriate essential health services, by not
13

using HIV surveillance data to maximize the benefits from medical care and treatment as well presents
myriad ethical issues. Indeed, local health departments have laid the foundation for these surveillance
activities. The heath departments have engaged stakeholders to acquire their trust to share sensitive
information, such as sexual preferences and history, current intimate partnerships, and HIV status.
Legal, policy and governance infrastructure have been established or strengthened.20,21 And,
communication and follow-up protocols that protect privacy have been developed.20,21
However, Leventhal and colleagues22 articulate the perspective of the providers. Indeed,
electronic health records (EHRs) are proliferating and their use is encouraged by financial incentives.
Applying data regulation principles to EHRs requires a balance between the rights of patients to control
their personal information with information needs of healthcare providers to deliver care that is safe
and of the highest quality. Hence, there many technical and organizational challenges faced in an
electronic health record system11,22 that could potentially provide data for epidemiologic studies.
However, privacy in public health surveillance is markedly different than in
public health research. In general, public health surveillance infringes on the right
to privacy in considering whether individuals explicitly consent to the collection,
analysis, use, and storage personal information for public health purposes. Hence,
for the most part identifier-based surveillance occurs in public health, without
individual consent.1 This differs markedly from the collection of information for
purposes of research.6
In contrast, public health research is stringently regulated because
participants are subjected to more than minimal risk for the benefit of others and
to investigate unconfirmed hypotheses about various diagnoses and treatments.6
Rather, given that the specific objective of research is the scientific design and

14

testing of a hypothesis with the aim of contributing to "generalizable knowledge7,

valid, informed consent must be obtained from each participant in most studies.13 Further, research
participants have the right to withdraw from a given study at any time.13
In a hypothetical online system for capturing preferences of patients who could view their
EHRs, all participating clinic providers individually and categorically-physicians, nurses, other staff
were listed.22 In addition, patients could also restrict access to all EHR data or any or all of five
categories of sensitive data. The five categories were mental and reproductive health, sexually
transmitted diseases, HIV/AIDS status, and substance abuse, as well as for specific patient ages.22
Unless patients specified restrictions, all requested data were displayed to all providers by default. In
the event of an emergency, the program allowed providers to hit a "Break the Glass" button to override
the restrictions specified by any given patient. That feature recorded the date, time, and subsequent
screen viewed.22
Conclusion
In this analysis, the question that is most fundamental arises about whether public health agents
can offer public justification that citizens, and particularly those most affected, would find acceptable.
The work of theoretical epidemiologists like Koopman3 and others4,5 certainly demonstrates utility and
evidence of need. However, due to the mathematical and theoretical nature of the work, effectiveness
of action, accountability, costs, as well as political feasibility or community acceptance are not directly
addressed or incorporated into the activity. In addition to obtaining the strongest valid, informed
consent possible from patients to use their data for research purposes on first contact with a health
clinic, a possible solution to this conundrum is to apply data regulation principles to health records,
electronic or otherwise. Therefore the rights of patients to control their personal information is
equilibrated with the information needs of healthcare providers to deliver exceptional care.21,22. If the
data needs of epidemiologic researchers are included such records would be linked8 to the local health
15

department. Another way to guarantee the rights of patients who have HIV/AIDS would be to involve
community advisory boards (CABs) that are germane to and representative of the various diverse,
heterogeneous subcommunities.16,17 . The subcommunities would range from hemophiliacs to men who
have sex with men and women.16
Further, in effort to prevent HIV transmission with the maximal ethical protections, another way
to strike a balance between clinical care, public health surveillance, and research activity is to make all
requested data displayed to all providers, and by extension researchers or public health officials who
solicit HIV data, by default unless patients specify restrictions.12,13,22 In the event of a public health
emergency, a program designed and implemented with these and other features should allow providers,
researchers, or public health officials to activate a "Break the Glass" button to override the restrictions
specified by any given patient as is specified by different investigators.21,22
Certainly, if efforts are not made to maintaining the privacy and confidentiality for those
research participants who provide data for use in HIV transmission modeling, then no epidemiologic
research on this disease could be considered ethical. The HIV/AIDS community and its diverse
composite subgroups could suffer egregious harm as a result of such a breach of ethics.

16

References
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Childress JF, Faden RR, Gaare RD, Gostin LO, Kahn J, Bonnie RJ, Kass NE, Mastroianni
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Centers for Disease Control and Prevention.Policy 557: Distinguishing Public Health Research
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Alam SJ, Romero-Severson E, Kim JH, Emond G, Koopman JS. Dynamic sex roles among
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Emanuel, Ezekiel J.; Grady, Christine; Crouch, Robert A.; Lie, Reidar; Miller, Franklin;
Wendler, David (ed.). The Oxford textbook of clinical research e4thics. Oxford University
Press. Kindle Edition, 2008.

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Morin SF, Maiorana A, Koester KA, Sheon NM, Richards TA. Community consultation in HIV
prevention research: a study of community advisory boards at 6 research sites. J Acquir Immune
Defic Syndr. 2003 Aug 1;33(4):513-20.

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Gostin LO. Public health, ethics, and human rights: a tribute to the late Jonathan Mann. Journal
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Baum NM, Gollust SE, Goold SD, and Jacobson PD. Looking ahead: addressing ethical
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Sweeney P, Gardner LI, Buchacz K, Garland PM, Mugavero MJ, Bosshart JT, Shouse RL,
Bertolli J. Shifting the paradigm: using HIV surveillance data as a foundation for improving
HIV care and preventing HIV infection. 2013 Sep;91(3):558-603.

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Leventhal JC, Cummins JA, Schwartz PH, Martin DK, Tierney WM. Designing a system for
patients controlling providers' access to their electronic health records: organizational and
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