Ethics and research governance: the views of researchers,health-care professionals and other stakeholders

Abstract

The objective of this study is to describe researchers', health-care providers' and other stakeholders' views of ethical review and research governance procedures. The study design involved qualitative semi-structured interviews. Participants included 60 individuals who either undertook research in the subspecialty of cancer genetics (n = 40) or were involved in biomedical research in other capacities (n = 20), e.g. research governance and oversight, patient support groups or research funding. While all interviewees observed that oversight is necessary to protect research participants, ethical review and research governance (ERG) arrangements were described negatively throughout these interviews. Interviewees identified a number of problems with ERG, including: over-bureaucratization, over-standardization of information requirements for different types of research, a lack of standardization in the types of information required by different committees for the same research and a lack of consistency in different committees' responses. A number of solutions were proposed including streamlining application procedures and harmonizing committees' responses and information requirements. Recent reports suggest that ethical review procedures and research governance arrangements threaten the possibility of undertaking clinical research in the UK, hence the introduction of the Integrated Research Application System (IRAS) is long overdue. However, while IRAS may solve some of the problems identified by interviewees, it remains to be seen to what extent it will impact upon the very negative perceptions of ethics and research governance procedures reported here.

Introduction

Reports suggest that ethical review procedures and research governance arrangements threaten the possibility of undertaking clinical research in the UK.^1–5 One of the main problems seems to be unnecessarily bureaucratic procedures which are translated into lengthy delays. A debate held at the British Society of Human Genetics in 2004 claimed that research ethics committees (RECs) were impeding genetics research, particularly projects on rare genetic conditions.⁶ In this case, the problem stems from a degree of uncertainty about the nature of certain activities, namely whether they were research and, therefore, need to undergo ethical approval.⁷ Indeed, it has been observed that the ambiguous status of some genetic activities coupled with uncertainty surrounding the definition of ‘research’ versus ‘clinical care’ frequently creates difficulties for researchers, clinicians and RECs.⁸

Recent reviews of the National Health Service (NHS) REC system have addressed some of these concerns and suggested that steps should be taken to streamline ethical approval and research governance procedures.^9,10 Recommendations include: redefining the remit of RECs; introducing new screening or triage procedures to determine which activities require ethical review; designating activities which present ‘no material ethical issues’ as not requiring review; advocating a new simplified application form and common national systems for review; and approval of research.¹⁰ This resulted in the launch of the Integrated Research Application System (IRAS) in January 2008.¹¹ IRAS aims to ‘streamline permissions and the approvals application processes’,¹¹ by introducing an integrated system which allows researchers to submit one application form which captures information required by a number of bodies including National Research Ethics Service (NRES), NHS RECs and NHS Research & Development (R&D).

This paper is based on data collected during the ROCC study. This study aimed to build a comprehensive picture of lay and professional perspectives on practical, ethical and conceptual issues relating to research and clinical practice in cancer genetics within the UK. This paper focuses on a subset of the data, namely, professionals' perceptions of ethics and governance procedures.

Methods

Recruitment

Potential participants were contacted using data available within the public domain (e.g. list serves and websites) or referred to the study by other participants. All were sent an invitation letter or email, a study information leaflet and an expression of interest form to complete and return to the research team. Interviews (face-to-face or telephone) were then arranged.

Participants

A total of 154 individuals involved in undertaking research in cancer genetics (‘researchers’) or who had other interests or roles in the execution of biomedical research (stakeholders [SH]) were invited to participate, and 60 (39%) agreed (Tables 1 and 2). With the exception of seven individuals in the SH group, all had some first-hand research experience. Twenty-eight of 40 ‘researchers’ were employed as health-care professionals (HCPs), 17/28 of these HCPs generated their own research projects, while the remaining 11 were involved in recruitment only. The most frequent reasons given for declining participation were lack of time or relevant experience.

Table 1

Recruitment rates in the stakeholder and researcher groups

	Stakeholders	Researchers	Total
Invited	92	62	154
Declined	31	3	34
Non-responders	41	19	60
Recruited	20	40	60
% recruited	22	65	39

Table 2

Participant characteristics

Researchers		n = 40	%
Characteristics	Age (mean – range)	47, 32–71	–
	Men:women	13:27	32:68
Role	Clinical geneticist	18	45
	Genetic nurse/counsellor	10	25
	Researcher	12	30
HCPs' research involvement	Research generator	17	61
	Recruitment only	11	39
HCPs' research activity	Clinical/epidemiology	19	68
	Molecular science	5	18
	Social science	12	43
	Research coordinator	2	7
	Statistics	1	4
Researchers' specialty	Clinical/epidemiology	1	8
	Molecular science	3	25
	Social science	5	42
	Research coordinator	2	17
	Statistics	1	8
Regulators/stakeholders		n = 20	%
Characteristics	Age (mean – range)	53, 34–69	–
	Men:women	9:11	45:55
Organization	Charity/research funder	6	30
	Academia	2	10
	Support/pressure group	6	30
	Regulatory/ ethics committee/ government	6	30
Current/ previous research experience	Clinical	5	22
	Social science	4	18
	Epidemiological	3	13
	Molecular	5	22
	None	7	30

HCP = health-care professional

Data collection and analysis

The interviews took place between January 2006 and March 2007. Thirty (50%) participants chose telephone interviews, the remaining interviews were carried out at the participant's/interviewer's workplace. Interviews lasted between 1 and 1.5 hours and were tape-recorded.

Interviewees were asked to provide a narrative account of their role in the organization in which they worked and to talk about their clinical practice and/or research, if appropriate. A series of exploratory questions was used, which focused upon research experience, ethical/practical difficulties encountered in undertaking research/clinical work, perceptions of the relationship between research and clinical practice, and views on research governance and regulation. The interview schedule was dynamic; the questions used in later interviews built upon emergent findings.

Verbatim transcriptions were obtained (one tape was inaudible), and these were read to identify recurrent themes within and between participants' accounts. The method of constant comparison¹² was used to develop a coding frame, which was used in the analysis. Emergent codes were discussed and verified at team meetings. QSR N6 (Pugh Computers Ltd., Aberystwyth, UK) was used to manage the data.

Results

The data suggest that carrying out clinical research in the UK is not perceived as a straightforward undertaking. Procedures such as obtaining ethical approval, conforming to research governance or R & D regulations within NHS Trusts and meeting the requirements of pre-existing and new legislation were described by the majority of interviewees as potentially impeding research. It was frequently observed that R&D committees and RECs requested very similar information, commented upon the same issues and employed similar procedures, hence the interviewees rarely distinguished ethical review and research governance (ERG) or R&D procedures, preferring to talk about them as one rather than as distinct activities. We will follow this precedent in the presentation of the data and consider the importance of this observation in the discussion.

Ethics and research governance: a necessary evil

S311: The history of regulation of research starting with the Declaration of Nuremberg, moving to the Declaration of Helsinki, et cetera. The whole purpose was to prevent harm to patients and you will find the medical profession is 100% behind any systems that prevent harm to patients. (Academia)

All the interviewees, like S311, observed that ERG is necessary to safeguard patients and protect them from harm.

H211: I think research governance within hospitals is important to ensure that doctors are doing or not doing research to the right level or too much of it, or that some patients aren't over-exposed and so on. (Clinical geneticist + clinical and epidemiological researcher)

However, although interviewees were convinced of the necessity for some sort of oversight, all viewed ERG procedures as problematic, and described these activities in most unflattering terms (Box 1). Many commented that the excess of ethical codes and governance procedures may result in research being less ethical, as researchers come to see ERG as a rubber-stamping exercise rather than one which safeguards patients. Box 1

Box 1 Descriptions of the ethics and research governance procedures

Cumbersome, bit of a pest – H228	Heavy-handed, cumbersome, a steeplechase – S326
Complete nightmare – H229	Unbelievably laborious, inhibits freedom to think freely – H210
Minefield – H208	A bit hit and miss, pain in the neck – S303
Daunting – H211	Rigmarole – S304
A slog, a grind – H225	Bureaucratic maze – H227
Onerous – H218	Complete nightmare – H229
Stifling research – H231	Cumbersome; bit of a pest – H228
Bizarre – H209	A bit murky, red tape – H320
Substantial hurdles – H216	Absurd, seriously interfering – H206
Nit-picking – H221	Legislation crippling – H236
Bureaucratic maze – H227	Grossly over-complicated – H230
Legalistic and obstructive – H215	Prohibitive – H310
Difficult and unreasonable – H220	Absolute turn-off – H319
Tedious – H212	A practical problem, obstructive – H217
Amount of red tape – S314	Hoops to be jumped through – S312
Hard work – H204	Top-heavy, bit of a machine – S318
A real pain, not very joined-up – H212	Horrendous – H205

H209: …an increasing plethora of codes of research ethics isn't proving helpful to anybody. Because you don't know necessarily which ones to work out, which ones should you prioritize… it ends up paying lip service to research ethics rather than facilitating it. (Genetic nurse counsellor + psychosocial researcher)

A minority commented that even RECs appeared to be less interested in ethical issues than in ensuring that the forms are filled in correctly and competently.

H224: My issues with ethics committees? I don't think what they do is ethics. Most of what they do is correct your grammar [laughing]. (Clinical geneticist + recruitment only)

Ethics and research governance: some problems

The interviewees identified two major problems with ERG – bureaucratization and standardization. With regard to bureaucratization, many commented on the amount of paperwork that must be completed to secure approval.

H223: It is a heck of a lot of work to go through filling in pages and pages and pages and pages of forms… (Clinical geneticist + molecular, epidemiological, psychosocial researcher)

It was observed that the time and effort involved in completing application forms was increasing as the number of different committees that needed to be approached was increasing.

H206: I mean, now I have to go through hell and high water to get permission to do the research in the hospital, it's not just ethics per se, it's all the other things that go with it. The number of committees that seem to be involved is astonishing. (Molecular researcher)

Interviewees also complained about the lengthy delays they had experienced as they waited for committees to respond and suggested that these were primarily due to R&D committees', rather than RECs', prevarication and the lack of standardized R&D procedures.

S326: …NHS R&D has now become the bogey [man] really, because in a sense they are where COREC was in about the year 2000, that they are sort of less mature, their processes are not as sort of – well, they haven't had the rough edges knocked off them, and they've still got a lot of rough edges. (Ethics/government/ regulator)

Many interviewees saw the overly bureaucratic demands of ERG as putting people off doing research and commented that ERG is responsible for ‘… stifling most of the research that we are trying to do in this country’ (H231).

H319: The major concern is the burden of administration, that has now been placed upon us to the point where there is no doubt a significant number of my colleagues now say they just don't want to participate in this [research] because it's just too burdensome to do, the process of getting ethical approval in order to deal with research governance, the oversight that's required… (Clinical geneticist + molecular researcher)

Interviewees also commented upon the lack standardization within and between committees, and complained that different committees routinely require different types of information.

H215: …every Trust has now got its own research and development team. Unfortunately they are not linked together, so we are working with dozens of different hospitals across the UK, and they all have to be dealt with individually. And sometimes they are inventing their own new rules that nobody else has. (Clinical geneticist + molecular and clinical researcher)

Frustration was also expressed at the lack of standardization in committees' responses. Many talked about how one committee may approve an application only for the same application to be rejected by another.

S311: …there are these two parallel systems [R&D and RECs] and they don't … say the same things, second that even within one system the LREC or MREC in one part of the country says different things to another part of the country, and have different rules you know. (Academia)

While many interviewees commented upon the lack of standardization in the ERG process, at the same time they observed that, in some respects, there was too much standardization, and observed that the one-size-fits-all mentality was inappropriate for different types of research.

H209: I think there should be differences, I think the governance is important whatever kind of project you're doing, but the process doesn't have to be the same for all sorts of projects. (Genetic nurse counsellor + psychosocial researcher)

The use of standardized forms, which included a number of redundant questions, for a range of different types of research was particularly criticized.

H206: We fill out forms which are constantly changing, are much larger than need be, with details which are absurd. (Molecular researcher)

However, as many interviewees noted, while these things may impede research these problems are not intractable.

Ethics and research governance: some solutions

H213: …all the MRECs should have the same rules. For example, the issue that we had about family history and hearsay, some of the people [co-investigators] had had the same experience, while others had not had that problem. And I think that's wrong. It's either lawful or it's not lawful. (Clinical geneticist, oncologist + molecular and clinical researcher)

In addition to emphasizing the need for greater harmonization of procedures and responses within and between committees and the accommodation of different research methodologies in ERG procedures, the interviewees suggested that ERG needs to acknowledge and try to balance the needs of researchers and the researched. As noted above, while the interviewees agreed that the regulation and oversight of research is necessary to safeguard research participants' interests, they argued that we also need to safeguard researchers' interests and avoid over-regulation. As H215, a clinical geneticist and molecular and clinical researcher said, ‘You need regulation but you need it not to get in the way’. It was noted that the oversight of research has become more draconian in recent years compared with clinical practice.

S307: ….you can get away with murder when you treat somebody, but if you want to do a research project you have considerably more difficulty. The parameters for giving treatment just as a sort of recommendation, ‘you could try this treatment’, are much easier than a research protocol. (Ethics/government regulator)

Thus, interviewees argued for a need to encourage a sense of proportionality; otherwise, regulation may begin to threaten patients' interests by prohibiting research that is essential to develop the evidence base.

S315: …with the sort of current legislation, current policy, that regulation may indeed become rather over-burdensome and may indeed inhibit research to the benefit of patients. (Patient support group)

It was observed that greater balance could be achieved if greater trust was vested in researchers.

H221: At some point you have to trust that actually the researchers are trying to do things for the benefit of the patients and society. You have to make sure that what they are doing is basically safe, and that they are not going to do your patients any harm. (Clinical geneticist + recruitment only)

Many proposed that researchers should not need to gain approval for every minor protocol modification and should be trusted to make minor adjustments to patient information leaflets.

H201: I think with ethics committees, their remit is a little bit too broad and I think to want to comment every time we change the slightest wording on our invitation letters just seems excessive to me and actually in most cases it has no bearing on the harm that could be caused to research participants. (Genetic nurse counsellor + social science researcher)

They also argued that researchers should not need to produce such complex consent forms, but should be trusted to (verbally) explain the research clearly to participants.

Discussion

This study suggests that those who engage with research in the UK in a professional capacity have overwhelmingly negative perceptions of current ERG arrangements. Indeed, it would appear that ERG is currently perceived by the majority of our interviewees as a time-consuming, box-ticking exercise.^13,14 A number of problems with ERG were identified, including: over-bureaucratization; over-standardization in information requirements for different types of research; a lack of standardization in the types of information required by different committees for the same research; and a lack of consistency in different committees' responses. Some solutions were proposed, namely streamlining of application forms and harmonizing committees' responses and information requirements.

Many of the problems outlined by our interviewees, and the solutions they proposed, have been addressed by the introduction of IRAS. This system uses one electronic application form which covers many different types of approval, and has been designed to accommodate different types of research. Hence, it will no longer be necessary to fill in a range of forms for different committees nor, it is claimed, will the forms be full of inappropriate questions. However, whether the introduction of this new system will be perceived as reducing the bureaucratic load remains to be seen, and clearly there is a need for further research into users' perceptions of IRAS once the system is up and running.

It must be noted that the data reported here may have been generated by a sampling bias, for it is possible that only those individuals who had complaints about the research governance procedures were motivated to accept our invitation to take part in this study. In response, it must be noted that this is just one of a number of studies which have recorded complaints about the review process,^1–5 particularly the amount of bureaucracy involved and its inconsistencies. Indeed, the Warner review⁹ suggested that there is some room for improvement in these respects. However, as Angell et al. ¹⁵ point out the call for greater consistency across committees may be ill-founded. Their systematic study of RECs' decisions revealed some consistency across committees in the things which they see as requiring attention, such as consent procedures, but also, as reported above, some variability in the types of ‘ethical troubles’ they identify. However, in contrast to our interviewees, Angell et al. ¹⁵ contend that inconsistencies across RECs should not necessarily be seen as problematic, but should be seen as a strength – as a marker of the inevitable variability and the flexible nature of moral judgements.

It was noticeable that our interviewees commonly failed to distinguish research governance procedures from ethical review during these interviews, and it is interesting to speculate why. First, it is possible that the way in which we framed the interview questions may have resulted in this confusion; however, the interview data suggest this was not the case for, on occasion, interviewees explicitly differentiated these activities. Second, it may have been due to the seemingly overlapping remit of the different committees. As noted above, many interviewees commented that R&D committees and RECs requested very similar information, commented upon the same issues and had similarly bureaucratic procedures, hence it is not surprising that they failed to distinguish them.

Alternatively, it could be argued that failure to differentiate research ethics from research governance procedures reflects a more widespread (conceptual) confusion about the nature of research and non-research activities (e.g. audit and service evaluations, education), which take place within the NHS. It has been observed that the distinction between research and non-research is imprecise.^16,17 Such observations may have practical implications for researchers when it comes to ERG because although the different activities are subjected to different types of oversight, actually determining the nature of some activities, namely whether they should count as research and thus, what type of approval/oversight they require is difficult. The introduction of IRAS, it is claimed, may solve such problems, for it will use a formal triage system to distinguish research from non-research.¹⁶ However, such a system is only as good as the criteria it uses to distinguish these different activities.¹⁶ As noted above, at times these activities are very difficult to differentiate for researchers and RECs alike, particularly within clinical genetics,^7,8 for example, when patients attend the clinic for genetic diagnosis, but DNA testing is only available and, therefore, can only be undertaken through research protocols. One way in which potential confusions about the nature of clinic activities could be overcome is by paying attention to what is being done to patients – the actual procedures they undergo – rather than how such interventions are described, for example, as audit, care research, et cetera.¹⁶ In other words, if we are concerned with protecting research participants/patients, as many of our interviewees insisted that we should be, then it may be more appropriate to design ERG procedures which consider the harms and benefits associated with the interventions themselves, rather than the motivations for carrying out an intervention.¹⁶

Finally, as noted above, the interviewees observed that greater trust should be vested in researchers. They argued that they should be allowed to make minor protocol amendments (e.g. changes to patient information) without REC approval and could be trusted to explain research procedures in enough detail so that complex (and potentially confusing) consent forms were no longer required. When undertaking non-research activities (e.g. audit), clinician researchers are trusted to behave with patients' best interests in mind, in contrast when doing a very similar activity, which happens to be designated as research, they are no longer trusted to act in patients' best interests and all of their actions are required to be overseen/approved. As we have reported elsewhere, the interviewees described how some clinician researchers would define their activities as non-research (i.e. audit or service evaluation) to avoid the bureaucracy of seeking ethical approval.¹⁸ Redefining their activities in this way requires researchers to assume a greater responsibility for patients' welfare, while at the same time it enables them to avoid oversight procedures. This raises some worrying questions, for while it may, indeed, be important to give researchers greater responsibility for participants' welfare, are participants' interests really compatible with researchers' professional and scientific interests? In other words, can researchers really be trusted to act in the best interests of their research participants at all times? Arguably history (e.g. Tuskeegee, Nuremberg) suggests that this is not the case. So, returning to Yentis and Dawson's¹⁶ argument above, of course it is important to have suitable oversight mechanisms in place when undertaking risky non-therapeutic activities, e.g. stem cell research, or invasive interventions in vulnerable groups, and in many cases of therapeutic research, however, other less risky and non-invasive procedures may require a less bureaucratically loaded form of oversight and arguably, more responsibility for the ethical monitoring of research could be given to researchers themselves.

Conclusions

Problems with the procedures for gaining ethical approval for research in the UK were identified in the Warner report⁹ and practical steps have been taken to address them,¹⁰ with the introduction of IRAS. However, IRAS only addresses the procedural issues described above, not the conceptual ones, and the extent to which these procedural changes will address the problems described by our interviewees remains to be seen. Following Yentis and Dawson,¹⁶ we believe there is a need to take a fresh look at ERG. Rather than regarding harms as primarily associated with doing a particular type of activity, namely doing research versus doing care, perhaps we should be looking at the harms associated with the actual procedures that patients/research participants undergo and design our oversight procedures with these in mind.

Footnotes

Acknowledgements

Ethical approval for this study was granted by MREC Scotland A on 16 December 2005 (Ref: 05/MRE00/112). We gratefully acknowledge the cooperation of the participating interviewees. We would like to thank Julia Lawton for her insightful comments and Lesley Gardner, Janet Hall, Karen Stewart and Ann Hammond for their administrative and secretarial support. This research was funded by Cancer Research UK Grant No. C8671/A5831 awarded to Nina Hallowell, Mike Parker and Anneke Lucassen.

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