Appendix III. Detailed Positions on AC …...Research on Housing-Related Health Hazards Involving Children (2005): Chapter 7 and Recommendation 7.3 Advance planning is required, as

Health Researchers’ Ancillary-Care Responsibilities in Low-Resource Settings:

The Landscape of Institutional Guidance Carleigh B. Krubiner, Raafay H. Syed, and Maria W. Merritt

1 Bold font in the right-most column tracks position taken, if any. If the issuing institution takes no formal position

in the document, we use bold font only for the designation “No position,” leaving in standard font any reports of

recommendations or requirements entertained within the document in the absence of formal institutional

endorsement.

Appendix III.

Detailed Positions on AC Responsibilities by Institution and Document Institution Documentation Positions on Specific Ancillary-Care

Responsibilities1

AstraZeneca PLC “Research Ethics” webpage,

accessed 15 Jan. 2013

No position: no mention of any specific AC

responsibility

AstraZeneca Global Policy:

Bioethics, accessed online

15 Jan. 2013


responsibility

Australian National

Health and Medical

Research Council

Challenging Ethical Issues

in Contemporary Research

on Human Beings (2006)


responsibility

National Statement on

Ethical Conduct in Human

Research (2007)


responsibility

CIOMS International Ethical

Guidelines for Biomedical

Research Involving Human

Subjects (2002): Guidelines

7 and 21 with commentary

Advance agreement with the “sponsor,

officials of the host country, other interested

parties, and, when appropriate, the community

from which subjects are to be drawn” is

recommended regarding all health care

services, including AC, that will be made

available during the research.

AC referral is recommended.

Direct provision of AC is recommended

(“morally praiseworthy” although not

obligatory) under Guideline 21 (and, in

addition, under Guideline 7, is explicitly

permitted as a form of compensation, so long

as medical services provided free of charge are

not so extensive as to be undue inducement.)

Democratic Rep. of

Congo: Groupe

Interproject de

Reflexion et

d’Intervention en

Ethique (GIRIE)/

Centre

Interdisciplinaire de

Bioethique pour

L’Afrique

Francophone

(CIBAF)/Kinshasa

School of Public

Workshop documented in

paper titled “Engaging with

research ethics in central

francophone Africa:

reflections on a workshop

about ancillary care,” by

Tshikala et al. (2012), and

resulting in “Statement

Issued by the Workshop on

the Ethics of Ancillary Care

in the Context of Research

Conducted in the

Democratic Republic of the

Advance planning and agreement are

recommended (p. 4-5).

AC referral and direct provision of AC are

required (a) under “the ‘duty to rescue’:

“when a research participant urgently needs

medical help, . . . the researchers should

respond as any human being would to the

suffering and helplessness of another person”

(p. 5); and (b) under specified conditions as

determined by an ancillary care committee to

be constituted as a subcommittee of a research

ethics committee, as part of the prospective

and continuing ethical review of each research

Health (KSPH) Congo” to be presented to

the National Health Ethics

Committee of the DR

Congo and to the DR

Congo Ministry of Health

protocol (p. 5 and Figure 1, p. 6).

Capacity development is recommended as a

means of meeting AC needs: “When specific

ancillary care needs can be clearly anticipated,

researchers should work with local

communities to create or bolster existing

services to meet those needs, and the service

costs should be reflected in the research

budget” (p. 5).

Dutch Ministry of

Foreign Affairs—

Directorate General

of Development

Cooperation

No publicly available

guidance No position

Eisai Co. Ltd. No publicly available


Eli Lilly &

Company “Principles of Medical

Research” webpage,



responsibility

European

Commission Ethics for Researchers

(2007)

Ethics in research and

international collaboration

(2009)


responsibility


responsibility

European Group on

Ethics in Science

and New

Technologies to the

European

Commission

Opinion on the ethical

aspects of clinical research

in developing countries

(2003)


responsibility

Gates Foundation No publicly available


Gilead Sciences No publicly available


GlaxoSmithKline No publicly available


Global Campaign

for Microbicides Mapping the Standards of

Care at Microbicide

Clinical Trial Sites (2008):

Executive summary with

consensus

recommendations


recommended by consensus (p. 21).

AC referral is required by consensus under

the conception of “assisted referral” as a

“minimum standard” (p. 21).

Direct provision of AC in the form of “safe,

appropriate contraception” for trial participants

is required by consensus under a “special

obligation” on the part of microbicide trials “to

attend to the sexual and reproductive health

needs of trial participants” (p. 17). Similarly,

direct provision of AC in the form of

screening for cervical cancer is required by

consensus as a “minimum” service to be

offered in settings where follow-up diagnosis

and treatment are available through publicly

supported services (p. 15).

More broadly (as a GCM recommendation

developed by the authors after the workshop,

but not a consensus recommendation)

“[d]onors should make funding available,

within reason,” for possible instances of direct

provision of AC (p. 21).

Capacity development is recommended by

consensus in the form of “offering training to

public-sector providers in screening

colposcopy” (p.15) as a means of improving

participants’ access to public services.

HIV Prevention

Trials Network

(HPTN)/Family

Health

International (FHI)

Partnering for Care in HIV

Prevention Trials: A How-

To Manual (2008): pp. vii

and ix; Chapter 4


required.

Executive summary states, “Ensuring the

effective care and treatment of people who are

HIV positive is a critically important

counterpart to the search for methods to

prevent the spread of the virus” (p. vii). AC

referral and direct provision of AC are thus

implicitly required where necessary to

develop a system of effective care, with the

understanding that case-by-case decision

making will be sensitive to any countervailing

considerations (p. 30-32; p. 43-44).

Capacity development sensitive to local

context is implicitly recommended as an

aspect of building relationships with nearby

resources (Step 6) in support of “better health

care for the participants” (p. 33).

Advance planning through “pre-research

community consultation and systematic

assessments” is recommended “in order for

investigators to anticipate at least some of the

ancillary care needs of study participants” (p.

37).

General agreement across the HPTN

regarding “standards for the provision of care

during all HPTN research” is also

recommended.

HPTN

HIV Prevention Trials

Network (HPTN) Ethics

Guidance for Research

(2009): Guidance Point 10

“Investigators, research sponsors, local

governments and international agencies should

strive to provide access to antiretroviral

treatment for those who seroconvert during

HPTN trials, albeit in ways that do not worsen

in-country inequalities.” AC referral and

direct provision of AC are thus implicitly

recommended.

HIV Vaccine Trials

Network (HVTN) “Participants’ Bill of Rights

and Responsibilities”

webpage (revised 2007,

accessed 15 Jan. 2013)

Language addressed to participants in all

HVTN studies asserts that they have the right

to “[r]eferral to available counseling, support,

medical, and treatment services for illnesses

you suffer during the study, including HIV.”

By logical implication, AC referral is

required in such cases.

Indian Council of

Medical Research Ethical Guidelines for

Biomedical Research on

Human Participants (2006)

Advance planning is recommended

regarding AC (p. 15-16, item 12).

AC referral and direct provision of AC are

permitted as forms of compensation so long

as such medical services are not so extensive

as to bring about undue inducement (p. 25);

compare CIOMS Guideline 7 (cited above).

Inserm No publicly available


Institute of

Medicine Ethical Considerations for

Research on Housing-

Related Health Hazards

Involving Children (2005):

Chapter 7 and

Recommendation 7.3

Advance planning is required, as a “role-

specific obligation” (p. 137) on the part of

researchers “to anticipate the risks and

behaviors that may be observed in the home,

including observations that are not part of the

research protocol, develop anticipatory plans

that specify how to assess and respond to risks

when they are identified, and educate their

staffs about the plan” (Recommendation 7.3).

AC referral (e.g., referral to the local housing

authority or local community services) and

direct provision of AC (e.g., an educational

discussion with the head of household) in

response to relevant risks observed in the

home (e.g., mold) are required where

necessary to fulfill the researcher’s “obligation

to do what is reasonable under the

circumstances” (p. 138), with the

understanding that “[t]he appropriate course of

action will depend on the specific situation: the

type of risk identified, who experiences the

risk, the nature of the research project, and the

availability of community resources” (p. 138).

Institut Pasteur The Ethics Charter of the

Institut Pasteur (2009),

Chapter 2: Research on

human subjects


responsibility

International AIDS

Vaccine Initiative

(IAVI)

Clinical Guidance:

Essential Approaches for

the Conduct of IAVI

Clinical Research (2012):

Sections 8 and 9

According to these “essential processes and

practices required to conduct IAVI-sponsored

research” (Introduction), participants who

become infected with HIV while on study

“will receive referrals to a reputable HIV

treatment centre or institution of [their] choice

for a full discussion of treatment options,

including antiretroviral therapy (ART) when

medically indicated. Alternatively, research

partners may provide a comprehensive

package of HIV care, support, and treatment at

the study centre. Referral systems will be

prearranged, ideally in writing, with HIV and

AIDS treatment centres, and IAVI and its

research partners will work to facilitate

effective referrals” (Section 8). Thus, advance

planning and agreement are required, AC

referral is required, and direct provision of

AC is permitted with explicit availability of

funding (Section 8: “IAVI will provide free

ART [as per national ART protocols] for

clinical trial volunteers who seroconvert

during a trial for up to five years after

treatment is initiated, if not available from

other sources free of charge”).

In addition, IAVI-sponsored researchers

“should ensure robust referral mechanisms”

for “other health issues” (Section 9). AC

referral for conditions other than HIV is thus

recommended.

International AIDS

Vaccine Initiative

(IAVI) with

affiliated Research

Centers (RC) in

Eastern and

Southern Africa

Group discussions and

interviews conducted by

IAVI to reach consensus on

expected standards of care

at participating RCs,

documented in paper titled

“Developing standards of

care for HIV prevention

research in developing

countries—a case study of

10 research centers in

Eastern and Southern

Africa,” by Ngongo et al.

(2012)

Advance planning is recommended for

services to be provided, implicitly including

some AC services (p. 1286).

“A set of required and recommended services

to be provided on-site or by referral was

developed” (p. 1277, Abstract) and listed (p.

1287, Table 4). AC referral and direct

provision of AC are thus implicitly required

in relevant instances.


potential means of meeting some AC-type

needs when the needed referral services (e.g.,

“services sensitive to the needs of criminalized

populations”) “are not widely available”

(p.1286).

International

Conference on

Harmonization of

Technical

Requirements for

Registration of

Pharmaceuticals for

Human Use (ICH)

Guideline for Good Clinical

Practice (1996): 4.3.2

No position: It is recommended that the

investigator inform subjects when medical

care is required for “intercurrent illness(es) of

which the investigator becomes aware.” Some

“intercurrent illnesses” might involve needs

for AC. Nonetheless, the document makes no

mention of any specific responsibility for

advance planning, referral, or direct provision

of needed care.

Johnson & Johnson Our Ethical Code for the

Conduct of Research and

Development, accessed


responsibility

online 15 Jan. 2013

Kenya, National

Council for Science

and Technology

Guidelines for Ethical

Conduct of Biomedical


Subjects in Kenya (2004):

Guideline 7

“The extent of the investigator’s responsibility,

if any, to provide medical services to the

subject” is explicitly listed as an item of

“essential” information with which the

prospective research subject “must be

provided” as part of the informed consent

process (pp. 11-12). Thus, advance planning

regarding subjects’ foreseeable needs for

medical services, which might include AC, is

required, and direct provision of AC

implicitly permitted.

Merck & Co. Inc. Public Policy Statement:

Clinical Trial Ethics (2012)

No position: AC is specifically mentioned, but

Merck will address the issue on a “situational

basis.”

Merck KGaA No publicly available


National Health

Research Ethics

Committee of

Nigeria

National Code of Health

Research Ethics (2007)


responsibility

Nepal Health

Research Council National Ethical Guidelines

for Health Research in

Nepal (2011): Section C,

5.3.5

Guidance on documentation required for

ethical review states that “[a]ny compensation

to be given to the research participants should

be clearly mentioned” in the application for

ethical review, and “free health care” is given

as an example of such compensation. Advance

planning regarding AC is thus implicitly

recommended and direct provision of AC

implicitly permitted.

Novartis AG Clinical trials in developing

countries (2011)


responsibility

Novo Nordisk A/S “Clinical trial ethics”

webpage (2012, accessed

29 January 2013)


responsibility

“Clinical Trials in

developing countries”

webpage, accessed 14

January 2013


responsibility

Nuffield Council The ethics of research

related to healthcare in

developing countries

(2002): paragraphs 7.33,

7.34, 7.35, 10.34, and

10.35

Advance agreement is recommended (7.35;

10.35).

Paragraphs 7.35 and 10.35 state that “where it

is feasible for researchers to diagnose and treat

an illness which arises, or to ensure that

effective treatment is available at a local level,

they have a duty to do so.” AC referral and

direct provision of AC are thus required

“where it is feasible” and with the

understanding that “[t]his is a complex issue

and decisions will need to be made on a case-

by-case basis following discussion with

clinicians, researchers and representatives of

government and health authorities within the

host country.” (In addition, at 7.33 and 10.34,

the Nuffield Council endorses and generalizes

UNAIDS [2000] Guidance Point 16; it thus

implicitly recommends AC referral and

direct provision of AC where indicated, in the

form of care for the condition being studied,

including HIV, in preventive research.)

A follow-up discussion

paper (2005) 3.18 – 3.28

No position: document contains disclaimers

stating that it “does not reconsider specific

ethical issues addressed in the 2002 report”

(1.6) and that “not all of the views reported in

the Paper were necessarily shared by all of the

delegates or the Nuffield Council” (1.8). It is

nonetheless of note that delegates discussed

specific AC responsibilities as follows:

“Delegates suggested that, in general, there

would be a clear obligation on the researchers

to provide care for the condition under study”

(3.24). For cases in which such care is not

otherwise required to ensure scientific validity

and safety, direct provision of AC would thus

be implicitly required. In the application of

this point to the provision of antiretroviral

therapy (ART) for participants who

seroconvert during HIV intervention trials

(Box 3.5), advance planning and agreement

would be recommended, AC referral would be

implicitly required, and capacity development

as a means of meeting AC needs would be

recommended.

Where a condition unrelated to that directly

under study was present in a participant,

delegates agreed that a suitable referral to the

local health services may be appropriate”

(3.25).

Pfizer, Inc. MRCT Project Report

(2010), p. 52

AC is mentioned specifically, and advance

agreement is implicitly recommended in the

form of negotiation that may include “contract

provisions.”

Direct provision is permitted with a “pre-

determined pool of funds” for AC as a possible

option.

“Compensation to Human

Research Subjects in

Clinical Studies” webpage,

accessed 15 January 2013


responsibility

“Global Standards for No position: no mention of any specific AC

Interventional Clinical

Studies” webpage, accessed

15 January 2013

responsibility

The Globalization of

Clinical Trials (2009)


responsibility

Statement on the

Declaration of Helsinki and

the Ethical Conduct of

Clinical Studies (2008)


responsibility

Roche Holdings

Ltd. Roche Position on Clinical

Research (2012)


responsibility

Roche Clinical Trials Policy

in Low and Middle Income

Developing Countries

(2008)


responsibility

Roche Global Position on

Human Subject Research

(2004)


responsibility

Sanofi-Aventis No publicly available


Singapore Bioethics

Advisory

Committee

Ethics Guidelines for

Human Biomedical

Research (2012): paragraph

2.11

Paragraph 2.11 states that justice “mandates

careful consideration of the arrangements in

place for ancillary care or follow-up in the

case of research participants located in regions

that may be resource-poor relative to the

initiating country.” Advance planning

regarding participants’ potential AC needs is

thus required, and AC referral and direct

provision of AC are implicitly permitted.

South Africa

Department of

Health

Ethics in Health Research:

Principles, Structures, and

Processes (2004)


responsibility

Guidelines for Good

Practice in the Conduct of

Clinical Trials with Human

Participants in South Africa

(2006): 3.4

No position: It is recommended that the

“PI/investigator/ institution should inform a

participant when medical care is needed for

intercurrent illness(es) of which the

PI/investigator becomes aware.” Some

“intercurrent illnesses” might involve needs

for AC. Nonetheless, the document makes no

mention of any specific responsibility for

advance planning, referral, or direct provision

of needed care.

South African MRC Guidelines on Ethics for

Medical Research: General

Principles (2002): points

11.3.1 and 11.4.4.vi

The relevant points pertain explicitly to

“international collaborative research.” Prior

agreement “on all aspects of the research” is

required (11.3.1); thus, advance agreement

regarding AC is implicitly required.

According to point 11.4.4.vi, “Participants

should be provided with care or treatment they

would not normally obtain.” Direct provision

of AC is thus recommended.

Guidelines on Ethics for

Medical Research: HIV

Preventive Vaccine

Research (2003): point

3.4.3 and Section 16

“All the principles governing international

collaborative research identified in Book 1,

11.1-4 apply to HIV vaccine development

activities in South Africa” (3.4.3) Thus, as for

South African MRC (2002) cited above,

advance agreement regarding AC is

implicitly required, and, in general, direct

provision of AC is recommended. In

addition, “[s]ponsors and investigators must

ensure that treatment and care for HIV

infection is provided to participants who

become HIV-infected during the course of an

HIV vaccine trial” (16.1). Thus, advance

planning is required, and AC referral and

direct provision of AC are implicitly

required where indicated to ensure the

provision of HIV treatment and care. Capacity

development is recommended (16.4.8) as a

means of meeting such AC needs.

Sudan, National

Ministry of Health National Guidelines for

Ethical Conduct of


Subjects (2008): 5.2

“The extent of the investigator’s responsibility

to provide medical services to the participant”

is explicitly listed as an item of information

that “the investigator must provide” as part of

the informed consent process (pp. 36-40).

Thus, advance planning regarding subjects’

foreseeable needs for medical services, which

might include AC, is required, and direct

provision of AC implicitly permitted.

Tanzania National

Health Research

Ethics Committee

Guidelines on Ethics for

Health Research in

Tanzania (2001)


responsibility

Tanzania National

Institute for

Medical Research

Standard Operating

Procedures for the National

Health Research Ethics

Review Committee (2007)


responsibility

Uganda National

Council for Science

& Technology

National Guidelines for

Research Involving

Humans as Research

Participants (2007): 2.2 and

7.4.

In general, investigators are required to “refer

all research participants whose conditions may

not be managed adequately” with the human

and material resources available at the study

site (7.4). AC referral is thus implicitly

required where applicable under this

guidance.

Research “should aim at improving the

wellbeing of research participants and their

communities”; “[p]rovision of health care

beyond research related care” is listed as one

of several means by which to thus aim (p. 3).

Direct provision of AC is thus permitted.

U.K. Department

for International

Development

DFID Ethics Principles for

Research and Evaluation

(2011)


responsibility

U.K. MRC

Policy on antiretroviral

therapy for people infected

with HIV and involved in

research in developing

countries (2003)

Advance Agreement is required (p. 7). AC referral and direct provision of AC are

implicitly permitted (p. 8).

Research involving human

participants in developing

societies (2004)


responsibility

“Ethics and research

guidance” webpage,



responsibility

UNAIDS

Ethical considerations in

HIV preventive vaccine

research (2000): Guidance

Point 16 and commentary

Document is included here

as a point of historical

interest, but is neither

counted as currently

applicable nor shown in

Table 1 because it was

revised and updated in the

form of UNAIDS/WHO

(2007a); see below.

“Sponsors need to ensure care and treatment

for participants who become HIV infected

during the course of the trial” (p. 41).

Advance planning and agreement about

such care and treatment are explicitly

recommended in the form of “consensus” that

“should emerge from an extended dialogue”

(p. 43). AC referral and direct provision of

AC are implicitly required where necessary to

ensure such care and treatment.


required in the form of “consultation with the

community in order to determine what items

of care might be needed during the course of

the study” (p. 12, Appendix I, point IV).

Meeting on care within the

context of HIV/AIDS-

related research in

developing countries (2002)

No position: document contains disclaimer (p.

11) that states, “The views expressed are not

necessarily those of UNAIDS.” It is

nonetheless of note that meeting participants

recommended “that a comprehensive care

package should be implemented during any

HIV-related interventional research in

developing countries” (p. 8). AC referral and

direct provision would thus be implicitly

recommended if necessary to provide specific

AC-type components in the package where

indicated (p. 11, Appendix I, point II).

UNAIDS/ WHO Ethical considerations in

biomedical HIV prevention

trials (2007a): Guidance

points 9, 12, & 14 with

commentaries

Guidance Point 14 endorses an “obligation on

the part of sponsors and investigators to ensure

access to HIV care and treatment, including

antiretroviral treatment, for participants who

become infected” (p. 48). Advance planning

“for logistics and implementation” is required

(p. 49), and documented advance agreement

“on who will finance, deliver, and monitor

care and treatment” is also required

(“critically important”) (p. 49). AC referral

and direct provision of AC are implicitly

required where necessary to fulfill the

sponsors’ and investigators’ obligations to

ensure access to HIV care and treatment.


means of meeting participants’ AC needs for

HIV care and treatment (p. 50).

In addition, direct provision of AC is

recommended in the form of family planning

services to be provided in the context of

reproductive and sexual health counseling

(Guidance Point 9), and advance planning

and agreement are generally recommended

for any “ancillary interventions provided in the

course of the research” (Guidance Point 12)

Meeting report documented

in paper titled “Ethical

considerations related to the

provision of care and

treatment in vaccine trials,”

by Tarantola et al. (2007b)

No position: document contains a disclaimer

(p. 4874) stating, “This paper does not present

an official position of the World Health

Organization or of any of the institutions that

participated in the consultations.” It is

nonetheless of note that meeting participants

discussed specific AC responsibilities as

follows:

Advance planning and agreement would be

recommended regarding trial-specific

decisions on the issue of “access to care in the

context of vaccine trials” (p. 4867).

AC referral, direct provision of AC, and local

capacity development as a means of meeting

AC needs (p. 4869) would be permitted.

UNAIDS/ AVAC Good participatory practice:

Guidelines for biomedical

HIV prevention trials

(2011) : 3.11, 3.12

“Trial sponsors and implementers are ethically

obligated to ensure that participants who

acquire HIV during trial participation have

access to clinical evaluation, and stage-

appropriate HIV care and treatment” (3.11.B).

Thus, advance planning is implicitly

required, as is advance agreement where

necessary to secure clinical evaluation, care,

and treatment through other providers; AC

referral and direct provision of AC are

implicitly required where necessary to

provide specific AC-type components in the

care and treatment package where indicated.

In addition, advance planning and

agreement are recommended regarding

“[n]on-HIV related care” such as “provision of

female or male sexual and reproductive health

care, management of infectious diseases,

nutritional health, psychiatric care, and

psychosocial services” for trial participants

(3.12.A). AC referral and direct provision of

AC are thus implicitly recommended if

necessary for provision of the locally agreed

on non-HIV-related care package.

USAID

Procedures for Protection of

Human Subjects in

Research Supported by

USAID (current as of 29

Jan. 2013)


responsibility

USAID Research: Policy

Framework, Principles, and

Operational Guidance

(current as of 29 Jan. 2013)


responsibility

U.S. Department of

Defense Federal Policy for the

Protection of Human

Subjects (‘Common Rule’)

(1991)


responsibility

U.S. Ethical

Advisory Bodies NBAC: Ethical and Policy

Issues in International

Research (2001)


responsibility

Presidential Commission

for the Study of Bioethical

Issues: Research across

Borders: Proceedings of the

International Research

Panel (2011)

No position: The Commission acknowledges

AC as a significant but controversial issue and

deliberately takes no position on any specific

AC responsibility.

U.S. Food and Drug

Administration Federal Policy for the

Protection of Human


(1991)


responsibility

U.S. NIH Federal Policy for the

Protection of Human


(1991)


responsibility

NIH Grants Policy

Statement (2012): 16.6;

19.4

No position: In Section 16, regarding grants to

foreign institutions, international

organizations, and domestic grants with

foreign components, the document alludes

broadly to “patient care costs” as being

“provided only in exceptional circumstances”

(16.6); in Section 19, regarding allowable

costs, the document states, “Patient care costs

for individuals who are receiving accepted

treatment according to standard regimens

would not ordinarily be acceptable charges to

an NIH grant” (19.4). While “patient care

costs” might in some cases include

expenditures for AC, and the restriction on

funds is consistent with permitting AC to be

funded by other sources, the document is silent

about whether any specific AC responsibility

ever obtains.

Guidelines for Conduct of


Subjects at NIH (2004)


responsibility

U.S. Office of

Human Research

Protections—

Department of

Health and Human

Services

Federal Policy for the

Protection of Human


(1991)


responsibility

Wellcome Trust Research involving people

living in low and middle

income countries (2010):

Section 5. Collateral

benefits

Advance planning for any AC interventions

to be offered is implicitly recommended as

part of formulating the research protocol (p.

10).

AC referral, direct provision of AC, and

local capacity development as a means of

meeting AC needs are implicitly permitted as

among several kinds of “collateral benefits”

that the Wellcome Trust “will consider

supporting” provided that certain ethically

important conditions (e.g., no “undue

influence,” no “adverse effect on the local

research environment”) are satisfied (p. 10).

WHO

Standards and Operational

Guidance for Ethics Review

of Health-Related Research

with Human Participants

(2011)


responsibility

Ethical considerations

arising from vaccine trials

conducted in pediatric

populations with high

disease burden in

developing countries,

WHO/IVR ethics meeting

26-26 November 2002,

Accra, Ghana (document

issued Jan. 2004): Ch. 12

Advance agreement (similar to CIOMS,

above) is recommended regarding the types,

level, and standard of care, including AC, to

be provided by the study. Direct provision of

AC is thus implicitly permitted.

World Medical

Association Declaration of Helsinki

(2008)


responsibility

Zimbabwe, Medical

Research Council Conducting Health

Research in Zimbabwe:

What researchers need to

know (2004)


responsibility

SUMMARY:

Documents reviewed: 71

Institution sources reviewed: 57

Documents coded with “no position”: 54

Institutional sources with “no position”: 34