Ethics of doing Health Research,

Rules, and the Governance Process to

Protect Independent Research

John Porter

Presentation

1) Ethics of doing Health Research: the LSHTM Research Ethics Committee

(REC).

2) Governance: what it is and who is responsible for ensuring an appropriate

governance system?

3) Conflict of interest: accountability, transparency and values.

Ethics of doing Health Research:

the role of the Ethics Committee

The Purpose of a Research Ethics Committee

(REC)

• ‘The purpose of a Research Ethics Committee (REC) in reviewing biomedical research is to contribute to safeguarding the dignity, rights, safety and well-being of all actual or potential research participants. A cardinal principle of research involving human participants is respect for the dignity of persons’.

• The goals of research, while important, should never be permitted to override the health, well- being and care of research participants.

(The Role of an Ethics Committee page 506 Manual for Research Ethics Committees. Editor Sue Eckstein. Cambridge University Press 2003)

The Purpose of a Research Ethics Committee

(REC)

• Ethics Committees should also take into consideration the principles of

justice. Justice requires that the benefits and burdens of research be

distributed fairly among all groups and classes in society, taking into account

age, gender, economic status, culture and ethnic considerations’.

(The Role of an Ethics Committee page 506 Manual for Research Ethics Committees. Editor Sue Eckstein. Cambridge

University Press 2003)

Additional Purpose…..

• Researchers:

‘REC’s are responsible for acting primarily in the interest of potential research

participants and concerned communities, but they should also take into account

the interests, needs and safety of researchers who are trying to undertake

research of good quality’

(Governance Arrangements for NHS Research Ethics Committees July 2001 paragraph 2.3: In Research Ethics Committees and the Law, Ian

Kennedy and Phil Bates).

Additional Purpose…..

• The Law:

Once a REC has constituted itself and begins to review research proposals, it

takes on legal duties for the institution and for the State . These duties derive

from the central purpose of the Committee: to protect the dignity, rights, safety

and well-being of all actual or potential research participants, while ensuring

that valid and worthwhile research is carried out’. (Legal requirements of REC (page 16). Manual

for Research Ethics Committees)

LSHTM Governance

The London School of Hygiene and Tropical Medicine (LSHTM) Research Ethics Committee (REC)

• There are 3 ethics committees and they are sub-committees of the LSHTM Council: an observational committee, an intervention committee and an ethics committee for the Master Programme for students (MSc Committee).

(http://www.lshtm.ac.uk/research/governanceandresearchintegrity/ethicscommittees/index.html#sthash.7FlcOAcx.dpuf)

LSHTM Research Ethics Committees

• Observational Research Ethics Committee: Chair (appointed by the

Director); 4 staff with epidemiological, clinical, biomedical and social science

expertise, (2 medically qualified); a nurse; 1 lay member.

• Interventions Research Ethics Committee: Chair, 2 medical, 1 statistical, 1

social science, 1 laboratory science and 1 lay member (with non scientific

backgrounds).

• MSc Research Ethics Committee – covering MSc students’ research projects.

Online Applications

LSHTM Ethics Online

• Online ethics application system

• Used for staff and students at LSHTM

Website link: https://leo.lshtm.ac.uk

The Internal Structure and Process of the

Committee: the internal system

• There is an internal structure to an ethics committee. This internal structure relates to: individuals; relationship; group dynamics; the decision making process; feedback and follow up.

• Training and Education (guidelines, declarations, education, group process)

• The internal aspects: The LEO System: ‘LSHTM ethics online’

Guidelines and Training (See Operational Guidelines for ethics committees that review biomedical research UNDP/World Ban/WHO Special Program for Research and Training in Tropical Diseases TDR 21 February 2000. Version 1.8: In Manual for Research Ethics Committees. Edited by Sue Eckstein. Cambridge University Press 2003 page 505-515).

The External System of which the REC is a

Part

• Ethics Guidelines and Declarations: information and training from the external system affects the internal system (Training and Guidelines)

• The Institution: governance processes and where the Ethics Committee sits in the governance processes. (Governance)

• The Values and Mission of the Institution (Values)

• The Political System that supports the Institution (Partnership)

• The Legal System that is part of the State (The Law)

Research Ethics Committees and institutional

values; are they linked?

1. Does this committee have a broader role in terms of ensuring or reflecting the values of the institution or organisation?

2. Does the work of this committee in some way mirror the values of the organisation, and if so, are the processes of the REC a useful way for an institution to determine how well it is doing in terms of upholding and maintaining its values? (A potential role for Health Policy and Systems Research (HPSR)).

Governance and Values

Governance

• “The complexity of governance is difficult to capture in a simple

definition. The need for governance exists anytime a group of

people come together to accomplish an end. Though the

governance literature proposes several definitions, most rest on

three dimensions: authority, decision-making and accountability.

(Governance Institute Ottawa, Canada (http://iog.ca/defining-governance/)

Governance

• ‘Governance determines who has power, who makes decisions,

how other players make their voice heard and how account is

rendered’.

• Ultimately, the application of good governance serves to realize

organizational and societal goals.

(Governance Institute Ottawa, Canada (http://iog.ca/defining-governance/)

Values, Organisations and Governance

• There is a link between an organization’s values, its’ strategy and its’ partnerships, but despite being at the core of management, they are not

given much attention as they are considered ‘soft’ (Padaki, 2000).’

• Theorists have suggested that values are viewed as the bedrock of an

organization and best if held stable over time, and therefore in need of

governance (Gehman et al., 2013).

Organisational Governance

• Understanding governance structures and mechanisms, and how

they relate to an organization’s values are a means through which to understand how an organization governs itself and conducts its

work. Values – both individual and collective – are thought to

have an impact on how people deal with colleagues and clients,

and go about their work (Roe and Ester, 1999).

Governance Structures around Ethics

Committees

• The ‘governance structures’ that support the work of an ethics committee are very important and reflect the values and mission of the institution. This is part of the external structure around the committee, the processes and also the detail of how the ethics committee is expected to operate within the organisation.

LSHTM Vision and Mission Statement

• Vision: Our vision is to be a world-leading school of public and global health, working closely with partners in the UK and worldwide to address contemporary and future critical health challenges.

• Mission: Our mission is to improve health and health equity in the UK and worldwide; working in partnership to achieve excellence in public and global health research, education and translation of knowledge into policy and practice.

LSHTM Values

• Values: The School seeks to foster and sustain a creative and supportive working environment based upon an ethos of respect and rigorous scientific enquiry. We are committed to: excellence and creativity; maximising synergies between research, education and knowledge translation and innovation; sharing expertise to strengthen capacity globally; partnerships based on mutual respect and openness; equity and diversity; financial and environmental sustainability (May 2012, p. 448)

LSHTM and Conflicts of Interest:

accountability, transparency and values

Accountability, Transparency, Values

• Accountability: the REC reports to LSHTM Council. The Chair is appointed

by the Director

• Transparency: LEO system, Research Governance Committee……

• Values: ?REC reflects the morality of ‘the system’ and the values of the institution…..

• Work on ‘Conflicts of Interest at LSHTM’ – Patricia Henley, Quality and

Governance Manager

Values and Organisations

• According to Padaki, values form the core of an organization’s culture (Padaki, 2000) and can be defined as, “...an enduring belief that a specific mode of conduct or end-state of existence is personally or socially preferable

to an opposite or converse mode of conduct or end-state of existence

(Rokeach, 1973, p. 5).

• ‘There is a link between an organization’s values, its’ strategy and its’ partnerships, but despite being at the core of management, they are not

given much attention as they are considered ‘soft’ (Padaki, 2000).

Our Inner Code and Governance

• ‘So in the place of our inner code, we have regulatory

authorities…when self-imposed restraint disappears, external

constraint must take its place’.(David Riesman. The Lonely Crowd: a study of the changing American character. Yale University Press, New Haven 1961). Quoted in:Sacks J. The Great Partnership: God, Science and the Search for Meaning. Hodder and Stoughton London 2011; page 149)

• Internal v External

Organisations and Values

• Organizations are social systems with specific goals and

procedures that are established overtime and become value laden; a process that is referred to as ‘institutionalization’ (Scott, 2008c).

• Values have a strong link to performance in deciding which

behaviours are acceptable and what good performance entails and

influence staff and stakeholders to contribute to organizational

goals (Padaki, 2000, Roe and Ester, 1999).