Citing suggestion: Andanda P, Wathuta J and Solveig F (2017) Compliance Failures, a report for

TRUST, available at: http://trust-project.eu/deliverables-and-tools/.

Compliance failures

Deliverable 4.2: Compliance failures

Pamela Andanda, Jane Wathuta and Solveig Fenet

With input from: François Bompart, David Coles, Julia Dammann, François Hirsch, Joshua

Kimani, Klaus Leisinger, Gwenaelle Luc, David Morton, Ngaya Munuo, Vasantha Muthuswamy,

Karin Schmitt, Michelle Singh, Jacintha Toohey, Carel IJsselmuiden, Jaci van Niekerk and

Rachel Wynberg

Project full title: Creating and enhancing TRUSTworthy, responsible and equitable

partnerships in international research

Project acronym: TRUST

Type of funding scheme: Coordination and support action

Work programme topics

addressed:

Reducing the risk of exporting non ethical practices to third

countries, GARRI-6-2014

Deliverable number: 4.2

Date March 2017

Project web-site: www.trust-project.eu/

GRANT AGREEMENT No: 664771

Name of the Coordinator: Prof. Doris Schroeder (dschroeder@uclan.ac.uk)

We gratefully acknowledge the valuable contributions from our partners in the TRUST project. In addition, we

would like to thank Kate Chatfield and Julie Cook Lucas for extensive editorial support.

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Table of Contents Executive Summary ................................................................................................................................. 5

1. Introduction ..................................................................................................................................... 6

2. Specific issues associated with compliance failures and gaps ........................................................ 9

2.1 Compliance Failures ........................................................................................................................ 10

2.1.1 Failures: Regulatory .................................................................................................................. 10

Insufficient follow up and compliance mechanisms ..................................................................... 10

2.1.2 Failures: Institutional ................................................................................................................ 10

Ethics committees functioning below par ..................................................................................... 10

Insufficient training or guidance on research integrity ................................................................. 10

Institutional culture of non-compliance ........................................................................................ 11

Provision of partial information in the informed consent process ............................................... 11

Journal ethics policies, and obstacles encountered by editors ..................................................... 11

2.1.3. Failures: Individual .................................................................................................................. 12

Lack of clarity about what is ethical .............................................................................................. 12

Academic pressure to publish ....................................................................................................... 12

Questionable behaviour of individual researchers ....................................................................... 12

Inadequate responses to research misconduct from the scientific community ........................... 13

2.2 Compliance Gaps ............................................................................................................................. 13

2.2.1 Gaps: Regulatory ...................................................................................................................... 13

Non-existent follow up and compliance mechanisms .................................................................. 13

Lack of national bodies for dealing with research misconduct ..................................................... 14

Lack of regulatory systems for dealing with research misconduct ............................................... 14

Lack of legislation, regulation and governance ............................................................................. 14

2.2.2 Gaps: Institutional .................................................................................................................... 14

Lack of compliance mechanisms ................................................................................................... 14

Lack of reporting requirements / tools ......................................................................................... 14

Institutional ethics committees lack protocols ............................................................................. 15

3. Challenges, gaps and failures in global ethical adherence ............................................................ 16

3.1 International Collaborative Research and Research Involving Third Countries .......................... 16

COHRED’s Research Fairness Initiative (RFI) ................................................................................. 19

3.2 Research with Indigenous Communities ..................................................................................... 20

3.3 Social Science Research ............................................................................................................... 21

3.4 Environment and Agriculture Research ...................................................................................... 23

3.5 Research Involving Animals ......................................................................................................... 24

3.6 Social Media and the Cloud ......................................................................................................... 26

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Analysis of Social Media data: ....................................................................................................... 26

Use of “The Cloud”: ....................................................................................................................... 26

3.7 Dual Use in Research ................................................................................................................... 27

References ............................................................................................................................................. 29

Appendices ............................................................................................................................................ 34

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Executive Summary

A key objective of the TRUST project is to develop a strategy for fostering the convergence of

global ethical research governance to improve adherence to high ethical standards in the

longer term. A core part of this objective is the overarching criterion that all research must,

irrespective of type and where it is conducted, comply with adherence to fundamental ethical

values and principles. Compliance is necessary to avoid situations of “ethics dumping”, which may occur when inconsistent ethical practices are used.

The TRUST project is developing three tools to counter ethics dumping:

1. A Global Code of Conduct for North-South Collaboration in research

2. A Fair Research Contracts Web tool and,

3. A Compliance and Ethics Follow-up Tool.

This report provides the second step towards the Compliance and Ethics Follow-up Tool1 and

presents the results of our work to identify existing failures and gaps in compliance. Five main

questions were developed by the TRUST partners for the fact-finding in this activity:

In this report, section 1 provides the introduction and background.

In section 2 we describe the main specific issues that may lead to compliance failures and

gaps, as identified through our fact-finding.

Section 3 examines selected examples of challenges, gaps and failures in global ethical

adherence.

1 Step one in this process has already been described in National and International Compliance Tools, a report for TRUST available at: http://trust-project.eu/deliverables-and-tools/

Are compliance or auditing mechanisms in place to ensure that

guidelines are followed?

Are sufficiently robust mechanisms in place for informed consent?

Are risk mitigation mechanisms in place?

What is the frequency of updates / review of compliance tools?

What are the different ethical standards in different countries?

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1. Introduction

All tools in TRUST are based on participatory engagement covering all continents, and are

informed by, amongst other things, case studies involving North-South research collaboration.

In this regard, the criteria below were developed collaboratively between all partners in the

TRUST project. This was an important step in the fact-finding mission for the purposes of

reaching a common understanding of the concept of compliance. Notably, in current

literature, the ‘compliance problem’ is often misunderstood to be “any researcher who does

not submit their work for ethical review or otherwise adhere to the institution’s research ethics processes” (Allen 2008 p.107). For our work, we have adopted Shamoo and Resnik’s (2015) broader definition of ‘compliance’ as, “the need to comply with laws, institutional

policies and ethical guidelines related to research”. In using the criteria shown in Diagram 1

(below) as our common criteria, we endorse Allen’s argument that compliance should be “an

ongoing active reflection on important issues and their application to useful practice” (Allen

2008, p.107). Additionally, as demonstrated by Chiumento et al (2015), reflection upon the

empirical evidence of research practice can stimulate important ethical considerations. They

advocate moving away from rigid implementation of ethical principles and instead shifting

towards appreciating the fluid processes of ethical research in practice. Most frequently, the

missing links in compliance literature are the experiences from the ground, which often

receive too little attention when documenting the process of research (Chiumento et al 2015).

Diagram 1. Criteria used for the fact-finding mission

What leads to the risk of non-compliance?

Regulations, international ethics

guidelines, best practice and / or

cultural norms exist, but have been ignored

Compliance failures and

compliance challenges

For example:

- lack of training

- lack of control / audit

- lack of communication between structures

- imposition of the norms of the host

institution

Regulations, international ethics

guidelines, best practice and / or

cultural norms do not exist

Compliance gaps

For example:

- no established structures

- no authorization procedures for research

activities

- no control / clearance

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Risks of non-compliance may relate to different entities:

x persons

x institutions

x local communities

x countries

x animals

x environment

Additionally, there may be a wide variety of contributory factors such as: lack of resources,

inadequate consideration of consequences, no capacity, misconceptions, deliberate

avoidance of normative ethical standards by conducting the research in communities where

regulations do not exist, and so on.

We also take into consideration the three levels at which the governance of ethical conduct in

research operates: regulatory, institutional and individual practitioner level (Farrell, 2005,

p.16). The fact-finding mission used for developing this Deliverable therefore focused on these

three levels (Table 2) in view of the serious consequences of non-compliance at any of these

levels of governance.

Table 2. Compliance failures / challenges and compliance gaps at different levels of

governance

Type of non-compliance Level of Governance

Compliance failures or

challenges

Regulations, international ethics guidelines, best practice and / or cultural norms exist, but have been ignored

Individual

Institutional

Regulatory

Compliance gaps

Regulations, international ethics guidelines, best practice and / or cultural norms do not exist

Institutional

Regulatory

Leading to

consequences for:

x Laws

x Institutional

policies

x Ethical guidelines

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Following analysis of the relevant literature and consultation with the contributing partners,

questions and topics were formulated for the fact-finding mission as detailed in full in

Appendix 1. This helped to structure the exercise and provide consistency in approach.

Compliance failure is deemed to occur wherever and whenever there is a non-adherence to

fundamental ethical principles (EU, Horizon 2020). It also refers to the non-observance of

local and international applicable laws, institutional policies and ethical guidelines related to

research (Shamoo and Resnik, 2015). This may occur at any of the three levels at which the

governance of ethical conduct in research operates, that is, regulatory, institutional and

individual practitioner level (Farrell, 2005, p.16) as shown in Table 2.

Compliance failures and challenges typically occur where regulations, international ethics

guidelines, best practice and / or cultural norms exist, but have been ignored in practice.

However, there may also be situations where such regulations, guidelines or norms do not exist

at all, or the subject matters of research are so new that no clear guidance exists for governing

decision-making. These challenges can create compliance gaps. Compliance gaps may occur at

both regulatory and institutional level as also shown in Table 2.

TRUST has so far highlighted related issues in the completed reports and Deliverables:

� “Ethics Dumping” – Paradigmatic Case Studies (Schroeder et al, 2016);

� National and international compliance tools (Andanda et al, 2016);

� Generic risks of exporting non-ethical practices (Chatfield et al, 2016); and,

� Industry Platform (Leisinger et al, 2016).

This Deliverable both reiterates and expands on the specific issues that could lead to

compliance failures.

In the next section (2), specific issues associated with compliance failures and gaps that

emerged from the fact-finding are described in brief.

In section 3, selected challenges, gaps and failures in global ethical adherence are examined

in greater detail.

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2. Specific issues associated with compliance failures and gaps

Many challenges for compliance were identified during the fact-finding. Table 3 below

summarises the main factors that emerged from the fact-finding. In this table, risks for non-

compliance are divided between failures and gaps and then further sorted by the level of

governance at which they would have greatest impact (regulatory, institutional and

individual). This list is by no means exhaustive; it is intended to highlight the most prominent

concerns related to compliance failures.2

Table 3. Specific issues associated with compliance failures and gaps

Compliance failures

Regulatory Institutional Individual

Insufficient follow up and

compliance mechanisms

Ethics committees

functioning below par

Lack of clarity about what is

ethical

Insufficient training or

guidance on research

integrity

Academic pressure to

publish

Institutional culture of non-

compliance

Questionable behaviour of

individual researchers

Provision of partial

information in the informed

consent process

Inadequate responses to

research misconduct from

the scientific community

Journal ethics policies, and

obstacles encountered by

editors

Compliance Gaps

Non-existent follow up and

compliance mechanisms

Lack of compliance

mechanisms

Lack of national bodies for

dealing with research

misconduct

Lack of reporting

requirements / tools

Lack of regulatory systems

for dealing with research

misconduct

Institutional ethics

committees lack protocols

Lack of legislation,

regulation and governance

2 This list could be cross-matched against other existing resource e.g. Davis et al (2007), DuBois et al

(2012), and Anderson et al (2013).

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2.1 Compliance Failures

2.1.1 Failures: Regulatory

Insufficient follow up and compliance mechanisms

Compliance mechanisms are difficult to establish, fund and monitor. They generally require

multi-stakeholder involvement (funders, regulators, editors, research institutions) due to the

complexity and multi-factorial causes and solutions of research misconduct (Wager 2012).

Even in situations where there are supportive regulatory systems, these difficulties make

compliance difficult to achieve.

2.1.2 Failures: Institutional

Ethics committees functioning below par

There can be many reasons for insufficiencies in the functioning of institutional research ethics

committees (RECs). Some of these reasons are:

x failure or inadequate performance of thorough ethics review, perhaps due to lack of

capacity;

x more scientific review is undertaken rather than ethics review due to lack of training

in ethics;

x failure or inadequate adherence to a particular legal instrument, policy, or rule;

x failure or inadequate compliance with the standard operating procedures (SOPs) of

RECs;

x failure or inadequate monitoring of adherence to ethical principles during or after

implementation of research;

x failure or inadequate application of due / appropriate penalties.

x failure or inadequate upholding of the national standards and established constitution

of ethics review;

x inadequate qualifications and / or experience of REC members;

x inadequate facilities, infrastructure, documentation, etc.

Insufficient training or guidance on research integrity

Institutions have a duty of care to ensure that their staff are sufficiently trained for the roles

that they undertake. Geller et al (2010, p.1301) recommend that training be “specifically and uniquely targeted for different groups of stakeholders based on their status and responsibility

in the research enterprise”. They also recommend a more uniform policy, or the policy of

continuing education for more senior investigators.

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Institutional culture of non-compliance

Culture has been proffered as one of the underlying factors in research misconduct and this

should be factored in during education and training of researchers and administrators (Davis

et al, 2007. Institutions have also been urged, for example by Titus et al (2008), to establish a

culture that promotes safeguards for whistle-blowers, establishes zero tolerance both for

those who commit misconduct and those who turn a blind eye to it.

Provision of partial information in the informed consent process

Provision of partial information compromises honesty and transparency. In collaborative

North-South research, there may be a need to tailor the consent process to meet the needs

of the potential participants (Chatfield et al. 2016). Investigators in LMICs may need additional

training to ensure that the informed consent process is locally, culturally and socially sensitive.

Journal ethics policies, and obstacles encountered by editors

Academic journals have a vital role to play in the maintenance of high ethical standards. When

standards are low, or not implemented fully, journals provide a platform for unethical

research. Failures may arise at various points along the publication chain, and be multi-

faceted. The following list details some of the challenges that were revealed in our fact-

finding:

x lack of detection at publication stage of fabricated / falsified / manipulated /

plagiarized data, or research without consent;

x non-existent / unenforced ethics requirements; narrow policies; inconsistent

definition of research misconduct or absence / scarcity of programs to

comprehensively respond to misconduct, especially in LMICs (Koehlmoos et al, 2013);

x existence or not of qualified ethics reviewers;

x editors who do not question authors where necessary;

� Consent refusals are not documented / reported;

� Risk benefit assessments are not mentioned;

� Recruitment strategies are not elaborated;

x ethical aspects not discussed in paper or subjected to peer review or considerations;

x clinical trial registries are not checked for proper registration;

x integrity of scientific literature requires journal editors to issue a retraction when they

learn that their journal has published a tainted article (Sox and Rennie, 2006);

x Editors may be deterred from reporting misconduct due to challenges such as lack of

confidence in the system, for example, the risk of unfair hearings, non-responsiveness

of relevant authorities, inordinate bureaucracy, cost and time implications, and, the

fear of disproportionate responses if a researcher is innocent (Wager 2012).

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2.1.3. Failures: Individual

Lack of clarity about what is ethical

There are certain situations where the onus is upon an individual researcher to make a

judgement about what is ethically acceptable. Even for those who are adequately trained and

experienced, there can be confusion and disagreements about what is acceptable. One

example of such disagreement is about the use of a placebo arm in a trial when an alternative

treatment is available (Angell, 1997). Angell argued that this situation is unethical but some

disagreed on the basis that the study had been approved in the US by several institutional

review boards. Furthermore, they argued that there was no point in using treatments (in the

control group) that were unaffordable in Africa (Halsey et al, 1997).

A second example concerns confusion about post-trial obligations, an important compliance

issue. In a recent case related to HIV clinical trials, the majority of researchers failed to discern

an ethical dilemma when approached by a big pharmaceutical company to participate in

registration trials to evaluate the safety and efficacy of an entry inhibitor in paediatric patients

in Africa. The ethical concern was that the company had no plans to continue supporting

testing for tropism - a crucial but very expensive test prior to treatment access - outside the

clinical trial settings. Unfortunately, the test would be unaffordable for the majority of

research participants, and any other local community member in the given LMIC context. This

tropism test is the biggest obstacle to access of this drug in LMIC settings to date, even though

research participants, and particularly a vulnerable paediatric population, were to be used to

conduct the trials. The research participants were unaware of the tropism test crisis that could

occur after the trial. In this case, post-trial obligations were overlooked by both the

researchers and the RECs that approved the study in the different countries.

Academic pressure to publish

Many academics have highlighted the fact that those working in academia can face intense

competition and a variety of difficult and even unreasonable regulatory and other demands

(Anderson et al, 2007; Davis et al 2007; Martinson et al, 2005). Consequently, some

researchers may be more inclined to produce “positive” or “significant” results due in part to a competitive academic environment and the pressure to publish, to be cited and to be

accepted in high-profile journals (Fanelli 2010).

Questionable behaviour of individual researchers

The behaviour of some researchers can be less than desirable and extremely damaging for

participants and for science (Fanelli 2009; John et al, 2012). According to Martison et al. (2005), the possibility of compromising scientific integrity extends well beyond falsification or

fabrication. Regular misbehaviours, he asserts, present greater threats to the scientific

enterprise than those caused by high-profile misconduct cases. Kornfield (2012) emphasises

the importance of understanding the root causes of misconduct; issues such as intense fear

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of failure, the lure of financial and / or academic rewards, etc., and addressing these

accordingly.

Inadequate responses to research misconduct from the scientific community

Where misconduct occurs and goes unchecked by members of the same community, the

questionable behaviour of certain individuals is indirectly supported by the failure to act of

other individuals. For example:

x failure to warn people about faked data in a publication;

x failure to verify the integrity of other articles that have been written by the author of a

fraudulent article;

x citation of a retracted or knowingly falsified publication.

Unfortunately, and partly due to a broad diversity in methodologies, many cases of

misconduct are never discovered. They are rarely reported by whistle-blowers, or are hard to

detect in the data. If detected, wilful distortion is hard to prove (Fanelli 2009).

2.2 Compliance Gaps

2.2.1 Gaps: Regulatory

Non-existent follow up and compliance mechanisms

Both Higher Income Countries (HICs) and Low and Middle Income Countries (LMICs) have been

slow to establish follow up and compliance mechanisms that can help to ensure that research

is undertaken as per the approved protocol. For example, the Research Councils UK added ad

hoc audits provisions and a complaints procedure for research participants and for staff only

in 2006. These provisions outlined what is needed for complaints procedures and their timely

address, a conflict of interest policy, and ethics training. Several HICs nonetheless now have

exemplary policies, although more could still be done, according to Resnik and Master (2013).

China is one of the few LMICs that has taken steps to guarantee scientific integrity. The

Chinese Ministry of Science and Technology established the Office of Scientific Research

Integrity Construction, after the National Science Foundation of China found evidence of

misconduct in 60 cases in 2005. This Office of Integrity now investigates allegations of

misconduct. Several Chinese universities also now have policies on research misconduct.

Some argue though that China needs to do more regarding, inter alia, protection of whistle-

blowers (Resnik and Zeng 2010).

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Lack of national bodies for dealing with research misconduct

Aside from China, few countries have national systems for preventing, investigating,

penalising, and correcting research misconduct. Although primarily responsible, large

research institutions often lack the expertise to perform these functions adequately.

Additionally, these institutions have serious conflicts of interest when one of their leading

researchers is accused of research misconduct. A national body can provide support,

leadership and help to manage conflicts of interest (Ana et al, 2013).

Lack of regulatory systems for dealing with research misconduct

As of 2013, only Denmark and Norway had a specific law to deal with research misconduct

(Godecharle et al, 2013).

Lack of legislation, regulation and governance

There are a number of situations where legislation, regulations, guidelines or norms do not

exist at all. This is particularly evident for emerging technologies where the subject matters

of research are so new that no clear guidance exists for governing decision-making; there is a

time lag between development of the technology and development of legislation. This canbe

seen currently with many developments in IT and social media (Schroeder et al 2016)).

Another challenge is posed when national legislation and governance frameworks exist but

they differ between countries. Here the risk of non-compliance stems from a lack of an

international framework. A clear example of this is animal experimentation where lack of

internationally approved standards lead some researchers to migrate their animal

experiments to countries with weaker regimes (Schroeder et al 2016).

The above two examples are further elaborated in the final section of this document,

challenges, gaps and failures in global ethical adherence.

2.2.2 Gaps: Institutional

Lack of compliance mechanisms

Maintaining the integrity of scientific literature requires governmental institutions that have

the authority to investigate scientists, and requires that research institutions investigate

alleged fraud (Sox and Rennie, 2006). Such institutions need the capacity for research

oversight and for conducting investigative procedures (Wager 2012), as well as to cooperate

actively with journal editors where called for (and vice versa) (Wager and Kleinert 2012).

Lack of reporting requirements / tools

Of course, a lack of appropriate tools or processes for enhancing compliance will have an

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impact upon the level of compliance. Some of the factors to take into account are:

x lack of oversight of RECs;

x lack of regulatory inspections;

x lack of connectedness of front-line staff with the researcher team or process (True et al,

2011);

x lack of reporting requirements (such as the COHRED Research Fairness Initiative (see

below);

x lack of relevant benchmarks;

x lack of platform for sharing of best practices.

A related issue is the lack of policies / Standard Operating Procedures (SOPs) for regular on-

site monitoring by RECs, including review of off-site documentation, and interaction with high

risk participants to assess the adequacy of informed consent processes, where the risks can

be physical, social or psychological etc.

Institutional ethics committees lack protocols

Gaps can also exist when institutions simply do not have the relevant regulatory and

governance procedures in place, such as:

x lack of clear guidelines and standards for quality ethics review ;

x lack of proper Standard Operating Procedures (SOPs) for facilitating review.

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3. Challenges, gaps and failures in global ethical adherence

This part of the report offers diverse perspectives and situations in which there may be

challenges, gaps and failures in complying with ethical standards at a global level. We present

here seven selected examples. There are many other examples that we could have selected3

but these seven cover a wide range of issues and types of research and are highly relevant to

collaborative North - South research. The seven topics are:

x International collaborative research and research involving third countries

x Research with indigenous communities

x Social science research

x Environmental and agriculture research

x Research involving animals

x Social media and the cloud

x Dual use in research

3.1 International Collaborative Research and Research Involving Third

Countries

In recent years, international collaborative research has increasingly become a key strategic

approach and driving force for research and innovation. This means that research

collaborations across countries and disciplines are able to work within a larger global network

of opportunities where complex issues in research and development can be addressed. While

there are many benefits to collaborative research (such as access to knowledge, expertise,

equipment, funding, populations, and more), there are also potential risks to both the

partnership and the research. The manner in which global collaborative research is conducted

has been recognised as a key area where laws, policies, compliance guidelines and best

practice mechanisms can be developed or improved, for enhanced ethical, transparent and

regulated research. For example, the Sustainable Development Goals (SDGs) framework, in

particular SGD 174, can be used as a key driver by governments to develop strategic

frameworks at national level for collaborative research. Furthermore, research partnerships

are often characterised by the underlying inequitable features caused by severe constraints

(mostly on the part of the research partner in poorer resourced settings), which may result in

non-compliance and lack of adherence to certain ethical standards.

3 One other topic, the existence of Community Advisory Boards, will be the subject of another TRUST

publication.

4 Goal 17: Revitalise the global partnership for sustainable development. See:

http://www.un.org/sustainabledevelopment/globalpartnerships/

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While there is general agreement that bioethical concerns are global, the formulation of

ethical principles governing collaborative research are viewed by some LMICs as ‘Western’ due to the way they are “theorized, structured, formulated, and practised” (Chattopadhyay

and De Vries 2008). This may lead to compliance failures and challenges due to the commonly

held view that the current approach to bioethics gives rise to “a “one-size-fits-all” set of “principles” “ (Chattopadhyay and De Vries 2008). The challenges usually emerge when the

national codes, procedures or guidelines of the collaborating third countries differ significantly

in their requirements such that they are at variance or contradictory (Interacademy

Partnership 2016, p.97). Ordinarily the parties should agree in advance on the relevant codes

and guidelines that will govern the research but it may not always be possible to foresee

potential contradictions or interpretations. Additionally, the translation of ethical principles

into the contexts of specific projects with different social and cultural settings is a challenge

(Slowther et al., 2006).

The existence of conflicting laws, regulations, and policies relating to research misconduct may

make the investigation and adjudication of research misconduct in international

collaborations difficult (Resnik et al., 2015; Boesz and Lloyd 2008). Due to such conflicts, a

researcher may act out of step with a partner’s (including the sponsor’s) requirements or local

institutional policy requirements. Policies are being developed to facilitate the harmonization

of national systems for dealing with misconduct, and a practical set of general principles

relating to international research misconduct investigations that can be used by countries

(Boesz and Lloyd 2008). Guidelines for dealing with research misconduct have been developed

by organisations such as Global Science Forum, Organization for Economic Co-Operation and

Development (OECD 2009; see also Best practices for Ensuring Scientific Integrity and Preventing Misconduct). Additionally, the European Science Foundation has developed a code

of conduct (2011) as a canon for self-regulation. These guidelines and codes are mostly of an

informative and advisory nature. Consequently, they are non-binding on national

governments and have not been accepted by major world funders (Resnik et al., 2015).

The prevailing situation essentially means that there are several gaps that still exist, as well as

contextual factors that contribute to compliance gaps, failures and challenges in adherence.

Below are examples of some of these factors.

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Diagram 2. Factors leading to compliance gaps, failures and challenges in adherence with

ethical standards in international collaborative research

To remedy some of these issues it has become common practice to develop a Grant

Agreement (GA) between partners to ensure compliance. The H2020 GA has been formulated

to assist in setting up good practice mechanisms for compliance in collaborative research. The

GA may include express provisions for compliance at individual level and institutional level

thereby providing a mechanism to remedy the lack of compliance with international / country

specific norms, regulations and standards. The terms of the GA may include the parameters

of the nature and extent of the partnership, choice of law governing the contract, roles and

responsibilities, scope of work, timelines and financial reporting requirements (which can also

include funder requirements). This mechanism enables prompting of early engagement /

discussions before the contract is concluded and signed. It is a simple framework to implement

as the PI is often involved with the paperwork at this level and will have read the terms of the

agreement. Alternatively, institutional research contracting offices can be used to monitor and

ensure compliance with the local laws and regulations. To ensure compliance with global

ethical principles, it is fundamental that the local regulatory authorities have the opportunity

to scrutinise the research (and research partnership – from a contractual perspective) and

have mechanisms in place to ensure adherence through effective processes. Non-compliance

could still persist where institutions lack research contracting offices or equivalent structures.

Lack of early engagement

with all collaborating

partners to define goals,

expectations, contributions,

roles, responsibilities and

supportive action where

partners are disadvantaged

or in lower resourced

settings

Lack of respect for partner’s local ethics regulatory

authorities

Poor effort of partners to

consider the legal

obligations of researchers in

their local context in varying

jurisdictions

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COHRED’s Research Fairness Initiative (RFI)

The RFI is a reporting system that can make a difference in ensuring global ethics adherence.

It encourages governments, business, organisations and funders to take measures to create

trusting, lasting, transparent and effective partnerships in research and innovation. The

reporting system assists institutions in assessing, identifying and reporting existing

mechanisms at national, institutional and partnership levels, with regard to best practice in

research collaborations in the following domains:

Diagram 3. COHRED’s Research Fairness Initiative (RFI)

The RFI is an initiative which goes well beyond being yet another guideline: the RFI is a reporting

mechanism for institutions, large research programmes and countries, which stimulates use of

and compliance with existing guidelines and best practices; it also constitutes a systematic

global learning platform that will build the evidence-base for fair, sustainable research systems

development. Research ethics is a core-component of such research systems.

The RFI raises awareness of existing best practice standards5 including documents, guidelines

and publications that may not be known beyond a small circle of users. Standards may be

implemented through 15 reporting guidelines that balance fairness, competition, efficiency,

collaboration and impact (CCI) for sustainable development. RFI Topic 8 (“Respect for authority of local ethics review systems”) deals specifically with ethics review at all partner sites. The RFI

provides guidance to institutions and nations on fair approaches, to be applied where such

opportunities arise in research collaborations. The tool also provides best practice guidelines

5 Such as the Commission for Research Partnerships with Developing Countries’ (KFPE) Guide for Transboundary Research Partnerships. More information available here: http://rfi.cohred.org/evidence-base/

CO

HR

ED

'S R

FI

Fair opportunity

Fair process

Fair benefits, costs and outcomes

20 | P a g e

to address capacity building, ethics, transparent financial systems and fair sharing of benefits,

costs and outcomes between partners.

The RFI as a ‘global learning platform’ for research collaboration and partnerships will also show up areas that are not (or not adequately) covered by existing guidelines, and will

therefore stimulate development of new and better guides and better practices. Collaborative

learning does not finish when a project or funding stream ends – the next stage builds on the

previous one, leading towards a global evidence-base on what works, under what conditions,

and where (and when) improvements are needed.

3.2 Research with Indigenous Communities

The San communities of Southern Africa have been of great academic research interest for

many decades. In a previous TRUST project Deliverable - Paradigmatic Case Studies (Schroeder

et al., 2016), a case study referring to an international genomic research project conducted in

2010, highlighted potential areas of exploitation when doing research with indigenous

communities. The following compliance challenges and failures arise from the lessons learned

from this case study.

Diagram 4. Compliance challenges & failures in research involving indigenous communities

In South Africa as well as Namibia and Botswana the seven dominant linguistic San groups

have formed the San Councils, elected organisations acting on behalf of illiterate rural

populations. One of the most important roles of the San Councils is to protect their people

from unwanted, inappropriate or exploitative research. The South African San Council is

(SASC) mandated to give collective permission for all research to be carried out on San

individuals or communities, before individual consent is sought.

In the case of the genomics research project the San Council was not consulted, which resulted

in various exploitative violations. The disregard of the specific cultural context and the lack of

approval through a mandated local organization before commencement of the research, as

well as publication, led to published inappropriate use of terminology and false conclusions.

Compliance challenges & failures in research

involving indigenous communities

disregard of existing

local institutions

insensitivity to

cultural differences

disregard of

research guidelines

on indigenous

populations

21 | P a g e

Even though the researchers did obtain ethical clearance from four separate institutional

RECs, not one of these referred to the available research guidelines on indigenous

populations. Researchers claimed they were not aware of the fact that many aspects of this

research study were deeply problematic from a San point of view.

A gap during the genomics project was therefore a lack of written codes and model contracts

for the communities. In South Africa the San communities have now – with support of the

TRUST project – formulated a San Code of Research Ethics,6 which explains the core values

from the San point of view when conducting research. Researchers have to make themselves

aware of possible different ethical values between the San and themselves. Awareness of

specific cultural differences and how to approach the San communities is mandatory in order

to avoid violations of the Code. Part of the collective informed consent process when doing

research with the San communities is to sign their Media / Research Contract. This includes

consultation of the SASC before publication.

3.3 Social Science Research

The Economic and Social Research Council (ESRC,) describes social science as, “the study of

society and the manner in which people behave and influence the world around us” (ESRC

2017). This definition applies to an extremely wide range of disciplines including sociology,

psychology, education, economics, politics, business studies and social anthropology. Given

the diverse nature of the social science field, one must be careful not to make generalisations

as if it is a single discipline. However, there are some similarities in methodological approach

between the various disciplines of social science, and similarities in methods can lead to

similarities in ethical challenges. Additionally, the various disciplines of social science share

the problems that arise from ethics review procedures that are commonly based upon a

biomedical model. Some social scientists have expressed strong opposition to the subjection

of their research protocols to the same frameworks for ethical review as biomedical and other

natural sciences (Kent et al., 2002).

This sense of frustration with ethics review processes amongst social scientists is not

surprising given that ethical review frameworks, developed for biomedical sciences, are often

applied uncritically to social science protocols. Whilst the ethical principles and concerns that

are applied in biomedical sciences, such as beneficence, non-maleficence, informed consent,

and anonymity, etc. can equally apply to social science research, the nature of the risks and

the measures that are taken to do good and avoid harm, can be quite different.

6 South African San Institute (SASI), San Code of Research Ethics, 2017 http://trust-project.eu/wp-

content/uploads/2017/03/San-Code-of-RESEARCH-Ethics-Booklet-final.pdf

22 | P a g e

The methodological approaches utilised by social scientists have a tendency to be qualitative

rather than quantitative in nature7 and to be conducted in naturalistic settings. For example,

a social anthropologist might undertake fieldwork that includes data collection methods such

as observation and in-depth interviews with members of a specific group or community in

their own locale. In this situation, risk of harm for the participants might arise from lack of

respect for local norms and traditions; lack of sensitivity to the needs and wishes of the

participant and wider group; or lack of transparency on the part of the researcher.

From a compliance perspective, there are many challenges for this type of research. It can be

very difficult to predict and prepare for what might happen in the field. Researchers must be

prepared to use their own judgement when unexpected things happen; they cannot seek

ethical approval for every slight turn of events. Similarly, it would be impossible to inspect or

watch over every field activity. Hence, there tends to be a strong emphasis upon the need for

reflexivity and researcher responsibility in social science research.

There are many existing ethical guidelines and codes of conduct for research across the

various social science disciplines, but internationally agreed regulation and legislation is

currently non-existent. Indeed, only a few countries have, or are working towards, the

implementation of a national governance framework for social science research. In the main,

social scientists rely upon self-regulatory mechanisms such as professional guidelines, peer

review, funding application procedures, and steering and advisory groups (Donovan 2004), as

well as institutional ethics review mechanisms. Consequently, social science research is

subjected to divergent regulatory structures, thus posing compliance challenges due to lack

of ethical review based on ethical principles (Kent et al., 2002).

Whilst there have been attempts to construct internationally applicable guidelines and

frameworks8, there is debate within the social science community itself as to whether or not

this is actually needed. These dynamics are articulated by Boden et al., (2009) who argue that,

although the proliferation of ethical bureaucracies affects all types of research, the impact is

felt most in social sciences. They question why “power [has] been relocated, with managerial

control replacing epistemic self-regulation” (p.736). They do, however, clarify that they “are

not arguing that there should be no accountability – rather, [they] question whether

accountability in any democratic sense is served through the imposition of these new forms

of bureaucratic regulation and control” (Boden et al., 2009, pp.735-6).

Compliance failures in social science research could arise from power dynamics and

7 They can also be of a quantitative nature, especially in economics and psychology, but have a general

tendency to be overall more qualitative in nature than biomedical sciences.

8 For example, the EU-funded RESPECT Project http://www.respectproject.org/main/index.php

23 | P a g e

conceptual misunderstandings regarding the ethics guidelines. For instance, there may be a

perceived legitimacy problem if social scientists do not find the guidelines relevant and

applicable to their practice (Allen 2008). Relevant examples of such guidelines are evident

from the five aspects, which Boden et al., (2009, pp.738-743) have analysed in the United

Kingdom (UK) context to illustrate what they consider to be “new ethical bureaucracies that

reveal something of the hidden operation of power” (p.738). These are related to data

protection, informed consent, the constitution of the vulnerable and perception of risk.

The requirement for informed consent could be particularly problematic in

some circumstances. The UK Data Protection Act does not require “signed

formal written consent to keep someone’s personal data” yet research

ethics committees require this based on the precedent from the medical

profession. Additionally, the contents of what the participants consent to

may not be available, as the social researchers may not know how they will

use the gathered material (Boden et al., 2009, p. 740). Besides, there is fear

that such formalisations may diminish trust between the researcher and

the participants (Boden et al., 2009, p. 741). Other social scientists in other

contexts have found the imposition of a standardized informed consent

process on all research difficult (Israel, 2015; Slowther et al., 2006) and

contentious (Haggerty 2004).

Any requirement for assurance that the participants will not be harmed is

similarly challenged by the nature of some social science research, where

outcomes may be unpredictable and not totally within the control of the

researcher.

Although the above examples have focused on the UK, similar examples exist in literature from

Canada and the United States (Haggerty 2004). Compliance failures due to power dynamics

may result from researchers feeling constrained to tick boxes instead of personally reflecting

on ethical principles that govern their research, and thus subjecting themselves to procedures

that cannot deliver ethical research (Mollet 2011; Boden et al., 2009).

3.4 Environment and Agriculture Research

The field of environment and agriculture is vast. There are many issues, including for example

the way in which Northern research institutions conduct research on indigenous

peoples without sufficient knowledge of customary forms of governance of natural resources,

or the pursuit of environmental research agendas that may be contrary to developing country

priorities. In the field of climate change, priorities of Northern countries and the global South

may be very different, given that many countries of the South may not be the primary

culprits responsible for greenhouse emissions. Mumma (2000) notes that developed

“Failures, challenges

and gaps in social science research" arise from: x A different

professional culture

x Power dynamics and misunderstandings regarding ethics guidelines

x Divergent regulatory structures

x New areas of human research that fall outside the boundaries of traditional governance standards

24 | P a g e

countries have predominantly seen climate change as an environmental issue while the South

presents it as a development issue. Developing countries, speaking through the G77 and China

grouping, have maintained that international climate change mitigation efforts must not

hinder their ability to develop.

Compliance failures can arise in any area of research due to different ways of perceiving a

problem, developing conceptual frameworks and recommending research directions in

developing countries. We illustrate some of the compliance issues that may arise in research

in the field of environment and agriculture through one thematic area:

1. Researchers from the North are able to freely access / acquire developing countries’ genetic resources and associated Traditional Knowledge (TK) due to lack of capacity in

the South to police genetic resource movements and the origins of TK (Andersen

2008).

2. Researchers from the North and South may not cooperate in enacting and enforcing

benefit sharing related laws (Tsioumani 2016).

3. The characteristics of genetic resources influence the research, i.e. a plant-based

sample can be successfully reproduced in the laboratory or created digitally without

undertaking further sample-gathering activity. This situation creates an impediment

for the local community or enforcement agency to monitor the development of

eventual inventions because the research on the samples is rarely done in

situ (Curci 2010).

4. Lack of capacity, i.e. regulators are usually not experts about the many facets of natural

product research and development and therefore are not well placed to guide

equitable agreements. Universities have intellectual property offices and research

ethics committees that can support this process but these institutions are often poorly

developed in the global South (Wynberg et al 2009).

5. Attempts to define what constitutes derivatives, biochemical or metabolic extracts can

result in legal confusion, and this raises the challenge of how to regulate such activities

and products and ensure compliance. The picture is further confused by the grey areas

between commodity trade and bioprospecting (Wynberg and Taylor 2009).

3.5 Research Involving Animals

As mentioned previously, compliance with ethics in animal research is seriously hindered by

the lack of an international framework. While there are some international guidelines on the

use of animals in research, they are drawn up by Northern researchers and only have advisory

status. For instance, CIOMS / ICLAS guidelines (2012) are not signed by countries in any formal

25 | P a g e

way, so they remain voluntary. Formal guidelines that have some legal backing also vary

between the ‘Northern’ countries in important details, and these may influence where

research is done in developed countries, let alone in the LMICs. Nevertheless, as a generality,

it would be true to state that there are stricter controls in the North compared with the South. There are some relatively consistent approaches in the developed countries, compared with

LMICs (e.g. USA and Canada, Australia New Zealand, H2020 and the EU). This situation can be

attributed to the fact that animal research is probably mainly carried out in ‘Northern’ countries aside from some research such as field trials with pesticides, agriculture, vaccines

and treatment of indigenous diseases. Such trials are mainly undertaken in the ‘Southern’ countries as one cannot reproduce their unique conditions in the North.

The following points are elements that lead to compliance failures and / or gaps.

i. Variations in customs, norms and attitudes towards animal welfare and inhumane

practices.

ii. Lack of governance of experimental procedures which cause hunger, thirst, injury,

disease, discomfort, fear, distress, deprivation or pain to keep exposure of animals to

these conditions to the minimum.

iii. Lack of qualified and experienced responsible researchers, educators, and animal care

staff.

iv. Lack of facilities to ensure that all procedures conducted on laboratory animals will be

undertaken by the responsible researcher, educator, and animal care staff with due

discretion and precautions to protect the welfare of the animals.

v. There is no ethical review process for animal research in some jurisdictions.

Additionally, researchers can migrate their animal experiments into countries with

weaker regimes. However, there would be less of a compliance gap if Northern

researchers / companies were obliged to abide by their national requirements.

vi. Inadequate systems to ensure implementation and compliance with animal welfare

standards.

Some of these points arise from the fact that the science of animal welfare and the recognition

and assessment of the degree of animal suffering are often not present or promoted in

educational programmes. The attitude of the people who look after the animals is very

important in determining the level of animal care. Moreover, the applicable laws and

guidelines should regulate the acquisition, capture, import and export, production, breeding,

transport, treatment, and killing of laboratory animals. Uneven terrain in terms of monitoring

compliance will lead to compliance failures.

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3.6 Social Media and the Cloud

The use of emerging technologies which rely on data gathering, processing and analysis for

research purposes is a growing trend. It is also an area where the risks for non- compliance

with ethical principles are extremely high. There are several reasons for this:

- Firstly, the speed with which these technologies are developing make it almost

impossible for effective legislation to keep pace with potential uses and exploitation

of new applications.

- Secondly, the nature and quantity of the data which can be exploited has serious

implications for traditional ethical perspectives on issues of consent and privacy.

Analysis of Social Media data: Applications (Apps) such as Facebook, Twitter, Instagram etc.,

can yield enormous amounts of information, particularly relating to people’s movements, associations and preferences, which is extremely valuable to researchers in many areas of

study of virtual communities which are often geographically diverse. Methodologies, including

ethnographic research methods, are rapidly being developed for effectively extracting

meaningful data relating to communities, social and political groups and even patterns of

behaviour in specific individuals (Maclaren and Catterall 2002). However, the issue of

obtaining informed consent for use of this data, which can be both identifiable and sensitive,

can be extremely problematic. Regulation itself can be particularly vague or unhelpful. Indeed,

there is very little guidance for RECs on evaluating such research (Moreno et al, 2013). Social

media apps often have very detailed Terms Of Use (TOU) which give them effective ownership

of the data; this means they can use it for targeted marketing, usually aimed at specific

individuals. The ability to use an app is tied to acceptance of the TOU). As these are often

many, many pages long and can take hours to read and understand, most individuals simply

tick the box to say that they have read the TOU and consent (to whatever the TOU contains).

Normally this gives consent for the developer or seller of the app to, at the minimum, have

ownership and control of an individual’s data, including the right to pass that data on to third parties. However even the app (as data controllers) has little or no control over who else

might be able to access this data for research purposes, as it exists in the public domain. As

social media is very much a global phenomenon and unrestricted by national borders, national

legislation on data usage is likely to be highly ineffective, therefore, strong yet acceptable

global guidelines are needed.

Use of “The Cloud”: In recent years, the use of “The Cloud” by software developers, businesses, and increasingly by private individuals, provides an extremely rich source of

extensive data. Furthermore, the development of more effective tools for linking queries

across these “Cloud” databases are making it increasingly possible to identify a specific individual from a vast mass of anonymous data. Of course, in many cases the data is not

anonymous in any event. One example which has arisen since 2015 is the building in of AI

27 | P a g e

query systems to for example, operating systems, shopping apps, search engines etc. These

would include initiatives such as Apple’s “Siri”, Microsoft’s “Cortana”, and Amazon’s “Alexa”. These systems gather a lot of information on people’s interests and activities from the questions and commands they issue. They rely mainly on voice input in order to function and

are triggered by a particular word, usually their name. So, for example, use of the word “Alexa” will “wake up” the programme which will respond to a question or command that follows; e.g. “Alexa, what is the weather?”; “Cortana, who won the USA Presidential election”, “Siri, play me a song” etc. These systems are connected to the internet. In order to function they must

always be listening, so that when a question or command is received this is transmitted to a

Cloud server where it is recorded, and along with requests from many thousands of other

users, is also used to enable the AI to learn how to understand questions and find appropriate

answers. It appears that audio and other data is only transmitted when activated by the trigger

word or “name” of the AI system.

“Big Data” is increasingly viewed as a rich and novel source of resources for research. However, it is difficult to see how many of the traditional ethical approaches to research can

be applied to research involving Big Data. Zwitter (2014) says that, “it seems Big Data requires

ethics to do some rethinking of its assumptions, particularly about individual moral agency”,

and goes on to propose “a rethinking in philosophy, professional ethics, policy-making, and

research”.

NB. Research Apps which gather data and include tracking is another area to be discussed separately in a forthcoming publication on mHealth apps.

3.7 Dual Use in Research

The ‘dual-use dilemma’ arises in situations where research can be used for both beneficial and military or biological warfare / bioterrorism purposes (Selgelid 2009; Oltmann 2015). Concerns

have been raised mainly as a result of the publication of results from studies which alert

“bioterrorists to new ways of producing biological weapons and provides them with explicit

instructions for doing so” (Selgelid 2009, p.721). The argument in favour of such publications

is usually that the medical benefits of publication outweigh the potential risks of bioterrorism

(Selgelid 2009).

The mechanisms that are currently used to ensure ethical compliance, particularly at an

international level, rely mainly on formal international agreements that set policies and

standards, as well as international institutions that engage multiple stakeholders to set policy

and guidance (National Research Council of the National Academies of Sciences – NRC 2010,

p.15). Accreditation and compliance with mandatory requirements on specific aspects of

laboratory safety as well as export controls on dual use equipment, pathogens, and toxins with

potential for biological warfare are also in use (NRC 2010). However, compliance failure arises

28 | P a g e

from lack of multilateral consensus on the basic security framework that can foster consistent

application of these controls (NRC 2010, p.16). Self-governance by scientists and journal

editors to ensure that research results with potential dual-use are not published is arguably

ineffective since they do not necessarily understand security issues and they could be more

interested in the publication of the results (Satyanarayana 2011).

The challenge in the governance of dual-use research lies in the fact

that it is difficult to foresee the potential for dual use in some cases,

such as those which have been published and led to controversy

(Selgelid 2009, pp.720-721). This calls for a balance between

promotion of science and protection of security, especially from

ethical, governance and enforcement perspectives. A second

challenge lies in the fact that control over ‘dual-use’ knowledge is contentious since it is viewed as subjecting scientific knowledge to governance and regulation

under the guise of security (Rychnovská 2016). The inconsistent use of the concept in political

and legal discourse raises challenges as it leads to different approaches to governance (Rath

et al., 2014), and the expansion of what may be subjected to security oversight (Rychnovská

2016). Oversight over on-going research and communication of results is difficult to codify and

enforce (Epstein 2012).

The ‘dual-use dilemma’ shows that there is a gap of understanding “in language [and]

goals…between the scientific community and the national security community” regarding

research with the potential for dual use particularly on the need to share information and

undertake international collaborative research (NRC 2010, p.13). Another gap arises from

overlooking other types of sciences that could be involved in dual use research, since there is

currently too much focus on life sciences (Oltmann 2015). Additionally, pre-publication review

of potential dual use research results is well established, while less attention has been paid to

sharing of raw data that is currently made available online for re-use (Bezuidenhout 2013).

The challenge in the governance of dual-use research lies in the fact that it is difficult to foresee the potential for dual use in some cases

29 | P a g e

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Appendices

Appendix 1. Fact-finding questions and concerns

(i) Are compliance or auditing mechanisms in place to ensure that guidelines are followed?

Possible checklist: (a) Which compliance tools exist? Any gaps (including supporting legislation/policies, support

structures/qualified and committed personnel, and universally acceptable definitions and standards)?

If so why, and/or what efforts exist to remedy the situation? Are they in use? If not, why? How effective

are they? Are mechanisms in place to foster receptivity and cooperation in the implementation of the

tool?

(b) Comparison with national and best global practices or identified aspirations.

(c) Extent, nature and outcome of funder and other stakeholder involvement.

(ii) Are sufficiently robust mechanisms in place for informed consent?

Possible checklist:

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(a) Are mechanisms in place to ensure that context‐based and fully informed consent is obtained? E.g.

negotiation of the informed consent process with the community, engaging Community Advisory Boards

(CABs), etc.

(b) Are mechanisms such as collective ‘permission’ incorporated into the informed consent process by obtaining permission from the leadership of vulnerable/indigenous communities, in addition to

informed consent that is normally obtained from individuals?

(c) Are participants informed enough to be able to control what they consent to?

(d) Are local social norms in third countries, respected to ensure proper communication with local

communities?

(iii) Are risk mitigation mechanisms in place?

Possible checklist:

(a) Preparedness, expertise, availability/timely action and professionalism of ethics personnel e.g. appraisal

of performance and output and counterchecking of reviews for thoroughness and no conflict of interest;

(b) Certification of qualifications; how well equipped they are e.g. training and technological facilities to

detect plagiarism.

(c) Establishment of a robust, qualified and independent monitoring and enforcing body e.g. to prevent or

investigate, punish or correct research misconduct.

(iv) What is the frequency of updates / review of compliance tools?

Possible checklist:

(a) Any efforts to incorporate a bottom‐up approach that involves diverse stakeholders in ensuring compliance?

(b) Are frameworks for ensuring transparency of ongoing trials in place?

(v) What are the different ethical standards in different countries?

Possible checklist:

(a) Existence of training/capacity building programs and means to foster awareness and acceptance of

global ethical standards and compliance tools;

(b) Knowledge regarding best practices; Are there significant and ethically relevant differences between

local law, regulations, ethics guidelines and the international understanding about the “right thing to do”?

(c) Means used to deal with a lack of consensus on what should be considered as best practice across

various cultures.

(d) Means to ensure that research priorities are carefully evaluated in terms of local needs, taking into

account social, economic, political and environmental implications.