Interviewing experts

Interviews constitute the core of my fieldwork, and my engagement with themes of risk and regulation draws heavily on these data. A total of 69 semi-structured interviews was conducted, 63 of which took place as part of the data collection for the ESRC project. These included expert interviews (see: Flick 1998: 91-92) with stakeholders and key informants involved in scientific, clinical, regulatory and commercial activity in tissue engineering.

The aim of the interviews was to find out the views and experiences of a diverse group of stakeholders in the tissue engineering field, mostly in Europe and at EU level, and to a lesser extent specifically focused on the UK. Initially six primary constituencies were identified: regulators, manufacturers, clinicians, scientists, consumers/patient groups, and EU advisory groups. Furthermore this sample aimed to reflect product types representing ‘adopted’ (skin systems and knee cartilage processes), ‘emerging’ (bone) or ‘experimental’ (e.g.

vascular prostheses) positions. Also a good balance was sought in the different implications of ‘autologous’ and ‘allogeneic’ products or processes, which

27 S e e http://w w w .euractiv.com /en/

seemed to be emerging as important in regulatory policy statements and in the identification of different levels of risk.

Topic lists and interview guides were developed, based on initial understanding of what was problematic and interesting about tissue engineering regulation, that were adjusted during the piloting phase of interviewing (one interview in each category). Most interviews took place face-to-face in the work

environment of the interviewee, and some over the phone. The vast majority of these interviews was conducted between December 2002 and March 2004 for the first phase of data collection, while follow-up interviews and email

exchanges were undertaken in 2005 specifically for the PhD research (see later under phase 2).

The tables below demonstrate the number of interviews (63) conducted under the ESCR project at UK and EU level per stakeholder category (table 1), the distribution over telephone and face-to-face contacts (table 2), and the geographical distribution (table 3).

TABLE 1:

Overview UK and EU and total number of interviews, per category

Regulators 3 6 9

Manufacturers 3 11 14

Clinicians 6 6 12

Scientists 8 2 10

Consumers 5 0 5

EU advisory 0 9 9

Other 4 0 4

TOTAL 29 34 63

TABLE 2:

Distribution telephone interviews and face-to-face discussions:

Regulators 3 0 5 1 9

Manufacturers 3 0 6 5 14

Clinicians 5 1 4 2 12

Scientists 8 0 0 2 10

Consumers 4 1 0 0 5

EU advisory 0 0 7 2 9

Other 4 0 0 0 4

TOTAL 27 2 22 12 63

TABLE 3:

Distribution per country for UK and EU interviews

Austria 0

Belgium 1 2 1 1 5

Denmark 1 1

France 1 1 2 4

Germany 4 1 5

Italy 1 1 2

Luxembourg 1 1

Netherlands 1 2 2 5

Spain 1 1

Sweden 2 1 3

Switzerland 1 1

UK (EU)

i—

1 5 6

TOTAL 6 11 6 2 0 9 0 34

UK (UK) 3 3 6 8 5 0 4 29

TOTAL 9 14 12 10 7 9 4 63

Response rates

Overall the response rate was high, although precise figures are difficult to estimate. A ‘long-list’ of names was created of potential interviewees per category, with some key figures but also many ‘reserves’. Names were added along the interview process, based on recommendations by interviewees and from documentary sources. Invitation letters were sent out to some 80 people.

About 30 of these did not participate personally (out of time restraints,

unwillingness, unavailability during data collection period of the project, illness and leave etc) but most people did pass the interview request on to colleagues in the organisation or other professionals in the field. In this way the response rate was only marginally affected, although in some cases it can be argued that the specific expertise or status of the respondent was not equalled. Especially EU officials and patient organisations were difficult to get involved, for different reasons. Also a large proportion of manufacturers did not respond to the request for interview, or found more or less valid excuses not to participate.

Given this category was over-represented in the research sample, the absolute number of commercial providers participating was high.

Accountability and additional interviews

The interviews as described in this section were all conducted within the framework of the ESRC project. I was responsible for arranging most of the fieldwork (making appointments and organise travel), but the interviews were carried out by different team members, and some interviews (especially the pilot and EU level ones) were carried out by two members of the team. Below is an overview of the interviews that I conducted myself or together with another member of the team. Out of a total of 63 interviews, 34 were (co-)conducted by myself (IG).

Regulators 1 2 3 3 4 5 9

Manufacturers 2 1 6 5 8 6 14

Clinicians ^{2 4 6 0 8 4} 12

Scientists 5 3 1 1 6 4 10

Consumers 2 3 0 0 2 3 5

EU advisory 0 0 5 4 5 4 9

Other ^{1 3 0 0 1 3} 4

TOTAL 13 16 21 13 34 29 63

Beyond the scope and timeframe of the ESRC project, additional interviews took place. This included a round of follow-up telephone conversations with two key informants at EU level, taking place over the course of 2005, mainly to get an update on regulatory developments in the field and more specific guidance on EU procedures. Also three commercial informants in the field were

contacted again to keep abreast with regulatory developments, and one new one. The richest source of additional data collection took place during a

stakeholders meeting in Brussels organised by trade association EuropaBio, as also discussed later (under phase 2).

Characteristics of interviewees

While it was helpful to make an initial classification of different stakeholder groups, it should be noted that this interview sample is affected by the observation that many respondents occupy different roles. The tissue engineering field is very interdisciplinary, and professionals move between different settings with different hats on. For example, scientists work in academic labs, in clinical settings and in industry, and regulatory affairs

professionals in industry are often trained in the life sciences and/or have had previous careers in government agencies (or vice versa). Clinicians in this sample are based in hospitals and academic labs, but do not always practise as physician. Furthermore, many scientists have close links with industrial partners, if they are not heading university spin-offs themselves. The revolving door between academia, industry and government is a fast moving one.

This does have repercussions for the representation of these stakeholder groups, and makes a typology based on just professional background or affiliation problematic.

I have organised my interview quotes in a manner to reflect the professional background of respondents as accurate as possible and meaningful for the given context. The appendix gives a full list of descriptions and codes of my interviewees.

In terms of boundary objects, the interviewees in this sample have multiple memberships of many social worlds simultaneously. Interviewees occupy a number of roles and positions, associated with a variety of institutional and organisational settings in academia, science, government, and industry.

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Because of these hybrid careers and identities (Geesink 1998) these actors are able to translate and exchange their work and ambitions across different

settings. In other words, these actors can be seen as ‘boundary people’

between the different social worlds of tissue engineering.

Unstructured interviews and participant observation

In addition to these semi-structured and previously arranged interviews, some unstructured interviewing took place as part of participant observation

exercises and my attendance at expert meetings and fieldwork conferences.

These included a regulatory affairs workshop during an industry-sponsored scientific conference,28 engagement in the local tissue engineering community via several meetings and annual conferences of the Cardiff Institute for Tissue Engineering and Repair (CITER), and attendance of an industrial stakeholders meeting in Brussels where the Commission presented the final proposal for a Regulation on tissue engineering products.29 In addition I had access to fieldwork data collected by my fellow-researchers of the ESRC project.30

Extensive field notes were produced based on observation and participation in these meetings and conferences, and documents collected in the form of speakers’ presentations, papers and associated materials. This generated a large and complex amount of data in relation to tissue engineering science, industry activities, regulatory issues, and ethical debates in the development of regulatory policy. In this way I had access to information that was not otherwise available; some of this was commercial or scientific information not in the public

28 Tissue Engineering Regulatory Affairs W orkshop. Organiser Smith & Nephew, at Georgia Tech, Atlanta, USA, October 2 00 2.

29 EuropaBio Industry Hearing: Tissue engineering and advanced therapies. Radisson SAS Brussels, 9 N ovem ber 2 00 5. In order to get access to this meeting without having to pay a substantial fee I agreed with the organisers to produce a written report of the meeting. I audio recorded and fully transcribed the presentations and discussions of this meeting, and provided a sum m ary report which is published on the website of trade organisation EuropaBio:

w w w .europabio.org/events/lndustryH earing/ R E P O R T % 2 0 o f% 2 0 H e a rin g -0 5 1 206.doc

30 European level sources included a Public Hearing on Quality and Safety of Human Tissues and Cells (European Parliam ent, January 2 003, Brussels) and a m ulti-stakeholder meeting at the European Commission D G Enterprise to discuss proposed new Tissue Engineering Products/Approval Directive (Brussels, 16 April 2004). A national level source included: UK Medical D evices A gency Annual Stakeholders Meeting (October 2 00 2, London). Conferences included: ‘Discussion Forum: D evelopm ent and Regulation of C ell-based and related

T h erap ies,’ organised by Regulatory Affairs Professional Society (M arch 2003, London); and T h e Com m ercialisation of Tissue Engineering and Regenerative M ed icin e,’ organised by Marcus Evans Conferences, supported by the International Society for Cellular Therapy (April 2003, London).

domain yet, but quite often these meetings were excellent opportunities for an analysis of stakeholders’ networks (who knows who), and for extending my own contacts database. Thus the more ‘hidden’ processes and relationships

between actors in regulatory decision making were revealed by observation of the context in which they engage as part of their professional roles. This also informed the analysis of interviews and key documents, as discussed next.