Ethical issues in lab and diagnostic testing

malabed
OptoutHIVtesting.pdf

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The End of Written Informed Consent for HIV Testing: Not With a Bang but a Whimper Ronald Bayer, PhD, Morgan Philbin, PhD, and Robert H. Remien, PhD

In 2014, only two states in the United States still mandated specific written informed consent for

HIV testing and, after years of controversy, New York ended this requirement, leaving only Ne-

braska. New York’s shift to opt-out testing meant that a singular feature of what had characterized

the exceptionalism surrounding HIV testing was eliminated. We trace the history of debates on

written informed consent nationally and in New York State. Over the years of dispute from when

HIV testing was initiated in 1985 to 2014, the evidence about the benefits and burdens of written

informed consent changed. Just as important was the transformation of the political configuration

of HIV advocacy and funding, both nationwide and in New York State. What had for years been the

subject of furious debate over what a rational and ethical screening policy required came to an

end without the slightest public protest. (Am J Public Health. 2017;107:1259–1265. doi:10.2105/

AJPH.2017.303819)

In 2014, New York and Nebraska were the only states that still required written

informed consent for HIV

testing, a signature element of

public policy that dated from

the 1980s. New York then

abandoned the requirement.

Remarkably, despite a long and

often bitterly contested past

that engaged public health offi -

cials, clinicians, AIDS advocacy

groups, and civil liberties orga-

nizations, the fi nal elimination

of written informed consent for

HIV testing occurred with little

public debate.

Conventionally, the story of

HIV testing policy involves the

commitments that began when

the evidence for addressing both

the clinical and public health

challenges of AIDS was still very

uncertain. The conventional

narrative argues that public

health offi cials slowly became

convinced by evidence demon-

strating that written informed

consent impeded the rollout of

HIV testing on a mass scale, a

process that culminated in 2006

when the Centers for Disease

Control and Prevention (CDC)

issued recommendations for an

opt-out approach without writ-

ten informed consent. Those

who opposed this opt-out

approach were equally certain

that the evidence did not sup-

port the claim that written in-

formed consent was a barrier to

sound public health practice. In

time, however, the overwhelm-

ing evidence—coupled with

political and funding shifts—

convinced many individuals

who had been most deeply

committed to written consent.

Deeply rooted opposition did

not, however, vanish.

We seek to locate the con-

troversy over written informed

consent in a broad political

context. We take account of

how and why groups that had

confronted each other for years

came to see the evidence so dif-

ferently and why the advocacy

community eventually yielded.

Although the evidence about the

burdens and benefi ts of written

informed consent had not signif-

icantly changed in the last years

of the controversy, the political

confi guration surrounding HIV/

AIDS policy had. What may

appear to be remarkable was, in

fact, a long time in coming.

LOOKING BACK When HIV antibody test-

ing fi rst became possible in

1985, there was considerable

uncertainty about the signifi -

cance of a positive fi nding and

the prognosis of HIV-infected

individuals. Within a year public

health offi cials embraced HIV

testing as a potentially signifi -

cant contribution to confront-

ing the evolving epidemic, but

many of the fi rst generation of

AIDS activists greeted the test

with alarm.1 The psychological

impact of the diagnosis in the

context of therapeutic impo-

tence, coupled with very realistic

concerns about discrimination,

stigmatization, and anxiety

about the prospect of a turn to

coercive public health policy,

shaped the worldview of activists

who sought to protect vulner-

able populations from privacy

intrusions and the deprivation of

the fundamental right to choose

whether to be tested. Advocates

argued that written informed

consent would provide necessary

protection for those who might

otherwise be dragooned by pub-

lic health offi cials. The national

AIDS activist movement quickly

succeeded in making written

informed consent, along with

pre- and posttest counseling, the

standard of care nationwide. The

fi rst ethical framework for con-

fronting the challenge of AIDS

and HIV testing embraced this

position2; HIV exceptionalism

defi ned the moment.3

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New York State’s experi-

ence exemplifi ed the situa-

tion. Looking back after three

decades, the director of New

York State’s AIDS Institute, part

of the State’s Health Depart-

ment, wrote,

New York State was an early

adopter of strong statutory

protections for persons seek-

ing HIV testing, including

required pretest counseling and

written informed consent.4

Under a 1989 law, written con-

sent became the legal norm, and

violations could result in civil

and criminal sanctions, includ-

ing fi nes of up to $5000 and

imprisonment for one year.

By the early 1990s public

health offi cials were increasingly

able to manage opportunistic

infections and create targeted

prevention programs, which

challenged the empirical and

ethical justifi cations for the

protective framework grounded

in written informed consent.

The discovery in the mid-1990s

that highly active anti-retroviral

therapy could prolong the lives

of HIV-infected individuals

shifted the national conversa-

tion. Nevertheless, it would

take years of debate before

the requirements of pre- and

posttest counseling and written

informed consent could be

dislodged.5 In the face of ongo-

ing sociopolitical anxieties and

the persistence of stigmatiza-

tion, evidence alone could not

override the politics of HIV

exceptionalism.

The erosion of the ear-

lier consensus was powerfully

underscored by the 2005 World

AIDS Day editorial by Thomas

Frieden, then commissioner

of health in New York City.

Written fi ve years before the

passage of the Aff ordable Care

Act provided protection against

denial of insurance coverage on

the basis of preexisting condi-

tions, the editorial asserted,

Given the availability of drugs

that can effectively treat HIV

infection and progress on anti-

discrimination initiatives per-

haps society is ready to adopt

traditional disease control prin-

ciples and proven interven-

tions that can identify infected

persons, interrupt transmission,

ensure treatment and case

management and monitor

infection and control efforts

throughout the population.6

Policies that made such identifi -

cation diffi cult could no longer

be justifi ed from the perspec-

tive of public health or clinical

medicine. The failure to adopt

more aggressive testing policies

and eliminate written consent

and routinize opt-out testing

would entail a wholesale denial

of the evidence that, “routine

voluntary screening for HIV is

indicated on the basis of clinical

effi cacy and cost-eff ectiveness.”7

Two months after Frie-

den’s editorial, the New York

City Department of Health

and Mental Hygiene issued a

detailed set of recommendations

that mirrored his views.8 It made

clear that the recommenda-

tions did not call for mandatory

testing but instead proposed the

routinization of HIV testing;

HIV testing laws would con-

tinue to require that all testing

be voluntary with specifi c docu-

mented oral consent. Penalties

for HIV testing without consent

would be increased.

Frieden’s forceful move

received backing from the New

York Times editorial board:

While there is a danger that

some patients might be hood-

winked into taking a test

they would otherwise shun,

it seems reasonable to treat

AIDS like any other infectious

or sexually transmitted disease.

Wider testing might save some

lives and alert people not to

spread the virus. . . . Surely

most patients would rather get

life extending treatments than

languish in neglect.9

Deeply concerned by the esti-

mate that 20% of HIV-

infected Americans did not know

their status, the CDC worked to

update its practices and poli-

cies. In September 2006, after a

careful review of the evidence,

the CDC issued new recom-

mendations for the routinization

of HIV screening that involved

an opt-out approach to consent

and the elimination of specifi c

written informed consent.10

“These new recommendations,”

said Kevin Fenton, director of

the National Center for HIV/

AIDS, Viral Hepatitis, STD,

and TB Prevention, “will make

routine HIV screening feasible

in busy medical centers where it

previously was impractical.”11

Thus the stage was set for a

cascade of regulatory and legisla-

tive changes across the nation.

The speaker of the American

Medical Association’s House of

Delegates called on states “to

reexamine legislation to allow

physicians to carry out the

new CDC recommendation.”12

Before the publication of the

CDC’s recommendations, 20

states required separate writ-

ten informed consent for HIV

testing. A review published in

the Journal of the American Medical

Association in 2011 concluded,

Nearly all states’ laws and

administrative codes were

compatible with current CDC

HIV testing recommendations

on consent and counseling.13

Some individuals, such as Peter

Staley, a founder of the AIDS

Coalition to Unleash Power,

supported this shift:

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I realize that abandoning

written informed consent

raises issues. People are

worried about privacy and

stigma. But the bottom line

is that this would probably

save lives and that’s why I’m

very much in favor of it.14

But many AIDS advocacy

groups dismissed such assess-

ments. After the CDC’s call

for the routinization of HIV

screening, 33 AIDS-related

groups, including the American

Foundation for AIDS Research,

Gay Men’s Health Crisis, the

HIV Law Project, Housing

Works, and Λ Legal, issued a joint challenge.15 Although

acknowledging that expanded

voluntary counseling and testing

was “good public health policy,”

they dismissed the necessity of

such reforms:

An expanded focus on test-

ing without counseling and

written informed consent will

put people at risk for testing

without their prior knowledge

or approval—a clear violation

of medical ethics and human

rights.

One activist claimed,

This is not informed consent,

and it is not even consent, it

was an attempt to ram HIV

testing down people’s throat

without their permission.16

NEW YORK NINE YEARS OF CONTENTION

In the face of such opposi-

tion, legislators in New York

State tried repeatedly from 2006

to 2010 to address the restrictive

legal constraints under which

HIV testing could occur. In this

period, 169 HIV-related bills

were introduced to the state

legislature, 12 of which explicitly

addressed informed consent.17

What unfolded was a mor-

ally charged debate regarding

whether written informed

consent impeded what all agreed

was crucial: that individuals who

were infected but unaware be

able to learn their HIV status.

The New York State Medical

Society, which exemplifi ed one

side of this argument, wrote a

letter to Assemblywoman Nettie

Myerson, a leading proponent of

routinizing HIV testing:

For over 20 years, physicians

and other health care person-

nel have not been allowed to

offer HIV testing as part of the

standard tests that are offered

patients.18

Paradoxically, the very excep-

tionalism that was designed to

protect those at risk had stigma-

tized the test for the disease.

In a New York State Assem-

bly public hearing in 2006,19

Richard Gottfried—who was

the chair of the Assembly’s

Health Committee and had

long-established links to New

York’s lesbian, gay, bisexual,

and transgender community—

continued to defend written

informed consent while making

clear his moral commitment to

both privacy and evidence-based

practice. He proposed an idea

fi rst developed by the Legal Ac-

tion Center called “mandatory

off er,” which required an explicit

off er of HIV counseling and

testing to all patients in health

care facilities without regard

to risks factors while retaining

written informed consent.20

Paradoxically, this new approach

would actually serve to increase

the time burdens associated with

testing in the clinic. Mandatory

off er became the rallying cry

of those who believed that the

protection of individual rights

was not at odds with the public’s

health. Gay Men’s Health Crisis,

among the oldest and most es-

tablished AIDS service organiza-

tion in New York, declared,

There is absolutely no scien-

tific evidence that the statu-

tory requirements of written

informed consent and counsel-

ing pose an actual barrier to

testing.21

Though activists anchored their

opposition in their view of the

evidence, what drove the pas-

sion to retain written informed

consent was a conception of

what respect for autonomy

and human dignity necessi-

tated. Housing Works, another

community-based organiza-

tion, also denounced the 2006

proposals made by New York

City’s health commissioner as

“One of the greatest threats ever

posed in the State of New York

to the privacy rights of people

living with AIDS and HIV.”22

The Long Island Minority AIDS

Coalition asserted that it was

“unconscionable” that patients

would no longer have the right

to written informed consent.23

In 2006 the fi rst crack

emerged in the previously solid

wall of opposition. The avail-

ability of powerful HIV-related

treatments was central to this

change, as was the mission shift

among AIDS advocacy orga-

nizations toward becoming

AIDS services organizations.

Harlem United became the

fi rst community-based AIDS

organization to assert that the

prevailing approach to testing

was inadequate:

It is difficult . . . not to view

separate written consent as

part of a broader practice of

testing that is failing us. . . .

Although our stance may dis-

turb colleagues, new realities

demand new tactics to stop

the spread of HIV and fur-

ther reduce AIDS deaths. We

should routinize HIV testing

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in accordance with CDC’s

new guidelines. . . . [Current]

HIV testing policy, amounts to

arguing that those most at risk

have a civil right to a greater

likelihood of spreading HIV

infection within their own

community or dying sooner of

AIDS.24

At an organizational level, a

striking racial/ethnic divide

had begun to emerge within

the AIDS advocacy community.

Harlem United was joined by

the Latino Commission on

AIDS and the National Black

Leadership Commission on

AIDS, which issued a summary

of evidence that unequivo-

cally demonstrated that written

consent was in fact a bar-

rier to routine HIV testing.25

Their opponents were largely,

although not exclusively, orga-

nizations led by gay White men,

longtime veterans of AIDS-

related battles.

As the legislative battle un-

folded from 2006 to 2010, the

divide between what most AIDS

activist groups held as morally

necessary and empirically un-

ambiguous and the views of the

public health and medical com-

munities continued to widen.

The New York State Associa-

tion of County Health Offi cials

in 200726 and the American

College of Obstetricians and

Gynecologists in 200827 joined

the Medical Society of the State

of New York to call for an end

to the exceptionalism sur-

rounding the state’s HIV testing.

In 2007, the deeply divided

state-appointed AIDS Advisory

Council voted fi ve to three to

support a resolution stating,

“The requirement for written

informed consent for HIV test-

ing in medical settings should be

removed.”28

Despite the certitude with

which opponents of written

consent described the evidence,

the bulk of the AIDS advo-

cacy community continued to

maintain that written informed

consent did not impede testing.

In 2007, a joint statement of the

American Civil Liberties Union

Law Project and Lambda Legal

asserted that a confl ict between

increased testing and strict

consent was “fi ctional.”29 In

2008, a Gay Men’s Health Crisis

commissioned review of the

literature asserted,

Some have cited written

consent as a barrier to testing.

. . . Such claims have proven

baseless and have not been

empirically documented in any

major peer reviewed academic

journal.30

CHANGE COMES TO NEW YORK

After decades of debate,

in 2010 the New York State

legislature voted overwhelm-

ingly to modify the state’s legal

framework for HIV testing;

the assembly voted 97 to 0, the

senate 42 to 10. The result was

a carefully crafted compromise.

The statute required a manda-

tory off ering of testing to people

aged 13 to 64 years in hospitals,

emergency departments, and

primary care settings. Rapid

HIV testing could be conducted

using oral consent except in jails

and prisons. Consent for testing

could be integrated into general

consent as long as a specifi c part

of the form provided the clear

option to decline the HIV test.

It is of singular importance that

once consent had been given

it was to be considered durable

and could be terminated only

when a patient explicitly sought

to withdraw it.31

Although this statute fi nally

permitted New York State to

move forward, the long-fought

controversy was not over. Patrick

McGovern, the chief executive

offi cer of Harlem United,

declared in 2010,

New York’s’ debate on HIV

testing . . . has been passionate

and sometimes contentious . . .

while this legislation falls short

on a true opt out approach,

the required offer of HIV test-

ing in all primary care settings

foretells an end to the current

practice of segregated and stig-

matized HIV testing.32

Gay Men’s Health Crisis, by

contrast, underscored that it had

protected written informed con-

sent under challenging political

circumstances:

For years we have held up the

standard of written informed

consent as a marker for ac-

ceptable legislation to expand

HIV testing. Although GMHC

[Gay Men’s Health Crisis] has

compromised on some long

standing principles to sup-

port this bill we still strongly

believe in the value of written

informed consent. This legisla-

tion contains as many adequate

safeguards to informed consent

as the current environment in

the legislature will allow.33

The compromise of 2010 was

clearly only a fi rst step for those

committed to ending written

informed consent. In 2012, the

state health department issued

a report that concluded that to

increase testing uptake the state

might “consider additional steps

to streamline and fully routin-

ize the off er of HIV testing.”34

One possibility would be to

accept the CDC’s recommenda-

tion for routine HIV screening

without specifi c consent but

with an option for patients to

decline to be tested. Indicative of

the importance of the evidence

derived from clinical experience,

the AIDS Institute concluded,

“Written consent was consis-

tently identifi ed as a barrier to

implementing the 2010 law.”35

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Refl ecting on his own shift,

Dan O’Connell, director of the

AIDS Institute, stressed that

“developments in science,” the

massing of evidence at both

state and national levels, had

compelled him to rethink policy.

For O’Connell, the deeply held

values of his opponents had

become an expression of an

evidence-resistant rigidity:

For a long time advocates were

not grappling with the need to

protect people’s health and get

the care they need. It took a

long time for the community

to catch up.

It was in this context that

Gottfried was noted as having

said how much of an outlier

New York State had become:

“For God’s sake it’s just us and

Nebraska.”36

In 2014, the AIDS Institute

forcefully moved to end written

informed consent through a

provision included (some critics

would say buried) in the gover-

nor’s 2014–2015 executive bud-

get. The more stringent written

requirements were retained only

in the potentially coercive con-

text of correctional settings. The

changed testing regulations were

packaged with other measures of

great importance to AIDS activ-

ists: creating a 30% salary rent

cap for HIV-infected people and

facilitating the sharing of clinical

data among health care providers

to promote “linkage and reten-

tion in care.”37 Commenting on

the milestone, O’Connell stated,

Eliminating most written con-

sent for HIV testing in New

York heralds the end of an

era in the decade’s long fight

against the epidemic.38

That New York took this step

was unsurprising, but that the

ultimate elimination of writ-

ten informed consent occurred

without a public battle was

stunning. The advocates, who

for years described written

consent as a pillar of an eff ec-

tive, rights-informed approach

to public health and who feared

that the elimination of such con-

sent would allow coercion and

mandatory testing, were silent.

Assemblyman Gottfried, a

veteran of the testing wars, noted

his surprise that he “had not

heard a peep” from advocates on

the proposed testing provisions

in the governor’s budget. His

offi ce therefore contacted the

leaders of New York’s advocacy

community:

What we heard back was that

nobody had a problem with

the change. . . . I didn’t re-

ceive a single e-mail or phone

call. [There was] almost a wall

to wall of unbroken silence.39

In large measure, the silence that

Gottfried encountered refl ected

a shift in priorities within the

advocacy community to pressing,

above all else, for programs and

policies to expand care for HIV-

infected persons. Committed to

ending AIDS in New York State,

AIDS advocates now viewed

collaboration with the AIDS

Institute as of central importance.

Most striking in this regard was

Housing Works’s shift after years

of publicly resisting the CDC’s

2006 recommendations and

not joining Harlem Untied, the

Latino Commission on AIDS,

and the Black Leadership Com-

mission on AIDS in their earlier

calls for change. Charles King,

the executive director of Hous-

ing Works, noted that treatment

availability was a “game changer.”

To make the promise of the end

of AIDS real, it was essential to

bring people into care. This was

not, he underscored, a politi-

cal tradeoff to win the support

of the AIDS Institute for the

new radical goal; abandoning a

long-held policy perspective was

not easy. Deeply rooted ideas do

not yield without organizational

strain. With clear reference to

those who had refused to shift, he

said, “We have an emotional at-

tachment to ideas. No one wants

to admit they had been wrong.”

Speaking of himself he continued

“I get a twinge. . . . We are on the

opposite side of an issue than we

were years ago.”40

Ten weeks after this policy

shift, Governor Andrew Cuomo

clarifi ed what the new targets

were: reduce new HIV infec-

tions in New York from 3000 to

750 by 2020 and reduce the rate

at which HIV-infected persons

progressed to AIDS by 50%.

These combined eff orts would

cause the prevalence of AIDS in

New York State to decrease for

the fi rst time since the start of

the epidemic.41

But what of those who had

not publicly embraced an end

to written informed consent but

who chose not to engage in fur-

ther debate? For some, the pros-

pect of battling the AIDS Institute

with whom it would be necessary

to develop programmatic eff orts

over the next years seems stra-

tegically counterproductive. But

much more was at stake.

Corrine Carrie of the New

York Civil Liberties Union

acknowledged that it was

increasingly diffi cult to argue

that written informed consent

did not impede HIV testing and

that instead they should frame

the argument with protecting

people’s right to choose to be

tested. In 2009, she had already

noted, “It’s gotten to the point

where only lawyers and sophisti-

cated advocates understand these

arguments.”42 Because of the

shifting institutional realities of

the AIDS advocacy community

in New York, that constitu-

ency was shrinking. “Lawyers

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funding [has been] decimated,”

said Catherine Hanssens, who

had for years been among the

most vocal opponents of limiting

consent-related protections in

HIV testing.43 Simultaneously,

the HIV Law Project, which had

played such a prominent role in

earlier battles, had been absorbed

by Housing Works. Housing

Works now supported elimi-

nating written consent, while

focusing energy on providing

treatment and ancillary services

to those in need.

It was in this political context

that an urgent online discussion

among those who still supported

written informed consent took

place. None thought a renewed

battle could have a meaningful

impact, “the horse was out

of the barn.” Tracy Gardner

of the Legal Action Center

spoke candidly of being “worn

out, sick of the fi ght.”44 For each

organization that might lead the

battle, however futile, a strategic

decision had to be made. Hans-

sens said,

When you are thinly funded,

thinly staffed you have to

make choices. . . . We have

lost the battle in the context of

HIV testing.45

For Carrie, a new battle

would not be a wise invest-

ment. . . . [We must ask]

which threat is most serious?

Where are we likely to win?46

With no one willing to assume

leadership of a renewed battle, a

collective decision was made to

abandon what had been a defi n-

ing issue for the HIV advocacy

community. By deed if not by

word, the struggle to preserve

written informed consent had

come to an end. With an obvi-

ous need to view this outcome

in its broader contemporary

context and to maintain a sense

that the struggle had not been in

vain, it was possible for some to

say that the legacy of advocates’

work was alive even though

written informed consent was

over.

CONCLUSIONS There is a rich literature on

the history of science-related

controversies that seeks to

explain how they emerge, persist

over time, and are resolved.47

That literature shows that only

part of the story is told by nar-

ratives that frame the end of

such confl icts as the result of the

triumph of evidence in the face

of uncertainty or because of the

emergence of new evidence.48

The careful examination of

scientifi c controversies sug-

gests that, whatever the role of

evidence, more is involved: that

epistemic, political, and social

factors are virtually always at

play. How evidence is under-

stood and indeed disagreement

about what should count as

evidence must be examined in

historical context.

The controversy over written

informed consent did not end

because the evidence had at last

become defi nitive. A similarly

fraught and linked debate oc-

curred on pretest and posttest

counseling for HIV. There was

also a protracted struggle49 for

evidence and ethics, but the

persistence of those arguing

for counseling diff ered greatly

from those arguing for writ-

ten consent. Important funding

streams had long underwritten

support for such eff orts, and a

virtual army of counselors were

employed across the nation with

an institutional commitment to

maintaining their role—and em-

ployment. Institutional resistance

helps to explain the politics of

de-implementation, but the

written consent story was very

diff erent. There was no army

of workers whose professional

identities depended on testing,

and the numbers of individuals

who found the issue of written

consent to be morally compel-

ling had dramatically declined.

Written informed consent could

no longer marshal the numbers

to resist change.

At an individual level, the

controversy ended because of

the exhaustion of those who,

under diff erent circumstances,

might have persisted. New York

was left behind, and so were lo-

cal activists, who knew that their

allies across the nation had also

conceded. A bandwagon-like

process had occurred.50 Those

involved in HIV advocacy, care,

and policy had come to agree on

a new paradigm for testing. On

a political level, AIDS advocates

had concluded that because of

the social and funding context

they should adjust their agendas

to best serve those they were

committed to. In doing so, they

made it clear that despite its cen-

tral role in the formative years of

the AIDS epidemic, both locally

and nationally, written informed

consent for HIV testing was

no longer a priority, no longer

worth the fi ght.

ABOUT THE AUTHORS Ronald Bayer is with the Center for the

History and Ethics of Public Health, Mail-

man School of Public Health, Columbia

University, New York, NY. Morgan Philbin is

with the Department of Sociomedical Sciences,

Mailman School of Public Health. Robert H.

Remien is with the HIV Center for Clinical

and Behavioral Studies, New York State Psy-

chiatric Institute, Columba University Medical

Center, New York.

Correspondence should be sent to Ronald

Bayer, PhD, Center for the History and Ethics

of Public Health, Mailman School of Public

Health, Columbia, University, Professor, 722

West 168th Street, Room R928, New York,

NY 10032 (e-mail: rb8@columbia.edu).

Reprints can be ordered at http://www.ajph.

org by clicking the “Reprints” link.

This article was accepted March 27, 2017.

doi: 10.2105/AJPH.2017.303819

CONTRIBUTORS All authors contributed to the conceptual-

ization, research, and writing of this article.

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9. “Modifying the AIDS Laws,” New

York Times, February 6, 2006:22.

10. Centers for Disease Control and

Prevention, “Revised Recommen-

dations for HIV Testing of Adults,

Adolescents and Pregnant Women in

Health Care Settings,” MMWR Recom-

mendations and Reports 55, no. RR–14

(2006):1–17.

11. V. S. Elliott, “CDC Moves to Put

HIV Testing Into Routine Care,” Amer-

ican Medical News 49, no. 39 (2006):1.

12. Ibid.

13. Bernard Branson, personal com-

munication.

14. S. Sternberg, “CDC: Make HIV

Tests Part of Routine Care for All,”

http://usatoday30.usatoday.com/news/

health/2006-09-21-hiv-testing_x.htm

(accessed August 18, 2016).

15. AIDS Foundation of Chicago,

“Federal HIV Testing Initiatives Can

Only Succeed With Expanded Health-

care, Patient and Provider Education,”

http://www.aidschicago.org/pdf/2006/

adv_testing_statement.pdf (accessed

April 24, 2017).

16. R. Bayer and A. L. Fairchild, “Chang-

ing the Paradigm of HIV Testing—The

End of Exceptionalism,” New England

Journal of Medicine 355, no. 7 (2006):649.

17. O’Connell et al., “Evolution of

Human Immunodeficiency Virus,” S5.

18. Letter to Assemblywoman Nettie

Mayersohn.

19. New York State Assembly Standing

Committee on Health, “HIV Testing,

Counseling and Informed Consent,”

December 20, 2006 [Public Hearing].

20. Ibid., 51.

21. Ibid., 171.

22. Ibid., 65.

23. Ibid., 320.

24. P. J. McGovern and M. G. Farley,

“The Routinization of HIV Testing

as a Civil Right.” [Unpublished

manuscript]

25. “Harlem United, Latino Commission

on AIDS, NBLCA, ‘The Research Shows

. . .’” 2009. [Unpublished manuscript]

26. J. Bennison, “Legislation Implement-

ing the Centers for Disease Control HIV

Testing Guidelines” [Letter to Assembly-

woman Nettie Mayersohn].

27. American College of Obstetricians

and Gynecologists, “An Act to Amend

the Public Health Law, in Relation to

HIV Testing,” June 6, 2008 [memoran-

dum in support].

28. AIDS Advisory Council, “Reso-

lution for Consideration Related to

Proposed Changes to Article 27F of

the Public Health Law,” https://www.

health.ny.gov/diseases/aids/providers/

regulations/testing/section_2781.htm

(accessed April 24, 2017).

29. American Civil Liberties Union,

“Increasing Access to Voluntary HIV

Testing: The Importance of Informed

Consent and Counseling in HIV Testing,”

https://www.aclu.org/increasing-access-

voluntary-hiv-testing-importance-

informed-consent-and-counseling-hiv-

testing (accessed April 24, 2017).

30. D. J. Cochrane, “Gay Men’s Health

Crisis: HIV Testing and Written, In-

formed Consent: An Analysis of Current

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com/gmhc/pdfs/2008_testing_white.pdf

(accessed April 18, 2017).

31. G. S. Birkhead, D. A. O’Connell,

S. Y. Leung, and L. C. Smith, “Evaluat-

ing the New York State 2010 HIV

Testing Law Amendments: Context,

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Acquired Immune Deficiency Syndromes 201,

no. 68 (2015):s1–s4.

32. Harlem United, “Harlem United

Commends the NYS Legislature for

Passing Testing Legislation and Urges

Governor Paterson Sign,” July 1, 2010

[press release].

33. Gay Men’s Health Crisis, “Memo-

randum of Support S8227 (Duane)/

A11487 (Gottfried),” 2010.

34. New York State Department of

Health, “Laws of 2010 HIV Testing

Law: Mandated Report,” https://www.

health.ny.gov/diseases/AIDS/providers/

testing/law/docs/chapter_308.pdf

(accessed April 24, 2017).

35. O’Connell et al., “Evolution of

Human Immunodeficiency Virus,” S7.

36. R. Bayer Interview of Dan

O’Connell, August 19, 2014.

37. New York State Assembly, 2013–

2014 Regular Sessions, http://assembly.

ny.gov/leg/?default_fld=&leg_video=&b

n=A07782&term=2013&Text=Y 

(accessed March 17, 2016).

38. O’Connell et al., “Evolution of

Human Immunodeficiency Virus,” S8.

39. R. Bayer Interview of Richard

Gottfried, September 18, 2014.

40. R. Bayer Interview of Charles King,

August 15, 2014.

41. New York State, Department of

Health, “Get Tested. Treat Early. Stay

Safe. End AIDS,” http://www.health.

ny.gov/diseases/aids/ending_the_epi-

demic/docs/blueprint.pdf (accessed

March 17, 2016).

42. R. Bayer Interview of Corrine

Carrie, September 23, 2009.

43. R. Bayer Interview of Catherine

Hanssens, September 18, 2014.

44. R. Bayer Interview of Tracy

Gardner, August 26, 2014.

45. R. Bayer Interview of Catherine

Hanssens, September 18, 2014.

46. R. Bayer Interview of Corrine

Carrie, September 23, 2009.

47. B. Martin and E. Richards, “Sci-

entific Knowledge Controversy and

Public Decision-Making,” in Hand-

book of Science and Technology Studies,

ed. S. Jassanoff, Gerald E. Markle,

James C. Peterson, and Trevor J.

Pinch (Newbury Park, CA: Sage,

1995), 506–526.

48. S. Sismondo, An Introduction to Sci-

ence and Technology Studies (Oxford, UK:

Wiley, 2009).

49. Johns et al., “Rise and Decline.”

50. J. H. Fujimura, “The Molecular Bio-

logical Bandwagon in Cancer Research:

Where Social Worlds Meet,” Social Prob-

lems 35, no. 3 (1988):261–283.

ACKNOWLEDGMENTS This work was supported by the HIV

Center for Clinical and Behavioral

Studies (grant NIMH P30MH43520);

the National Institute on Drug Abuse

(grant Ko1DA039804A to M. P.); and the

HIV Center for Clinical and Behavioral

Studies (grant NIMHP30MH43520 to

R. H. R.).

ENDNOTES 1. R. Bayer, Private Acts, Social Conse-

quences: AIDS and the Politics of Public

Health (New York, NY: Free Press,

1989).

2. R. Bayer, C. Levine, and S. Wolf,

“HIV Antibody Screening: An Ethical

Framework for Evaluating Proposed

Programs,” Journal of the American Medical

Association 256, no. 13 (1986):1768–

1774.

3. R. Bayer, “Public Health Policy and

the AIDS Epidemic: An End to HIV

Exceptionalism?” New England

Journal of Medicine 324, no. 21

(1991):1500–1504.

4. D. A. O’Connell, E. G. Martin, B.

Culter, and G. S. Birkhead, “The Evolu-

tion of Human Immunodeficiency Virus

Testing Requirements in New York

State, 1989–2013,” Journal of Acquired

Immune Deficiency Syndromes 68, suppl. 1

(2015):S55.

5. D. M. Johns, R. Bayer, and A. L.

Fairchild, “Evidence and the Politics

of Deimplementation: The Rise and

Decline of the Counseling and Testing

Paradigm for HIV Prevention at the

US Centers for Disease Control and

Prevention,” Milbank Quarterly 94, no. 1

(2016):126–162.

6. T. R. Frieden, M. Das-Douglas, S. E.

Kellerman, and K. J. Henning, “Apply-

ing Public Health Principles to the HIV

Epidemic,” New England Journal of Medi-

cine 353, no. 22 (2005):2397–2402.

7. Ibid., 2400.

8. New York City Department of

Health and Mental Hygiene, “Stopping

the HIV/AIDS Epidemic in New York”

(New York, NY; 2006) [PowerPoint

presentation].

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