Science and Technology CommitteeWritten evidence submitted by Christopher Lawrence Roy-Toole

Executive Summary

The Joint Committee on the draft Care and Support Bill has already produced a report on the role of the Health Research Authority in ensuring transparency in research. But the ill-considered nature of its findings makes it more of a hindrance than a help to the Select Committee looking at Clinical Trials.

The Joint Committee’s recommendation to place a statutory duty on the HRA to police research transparency overlooks the impact of the UK Freedom of Information Act and its exemptions from publication. The Information Commissioner makes decisions regarding FOI. So why is the Information Commissioner not being put at the centre of this? An expanded role for ICO would sit well with the recent recommendations of the House of Commons Justice Committee.

The Select Committee should hear evidence from members of research ethics committees before saddling them with any fruitless obligation to ensure research publication.

Any attempt by any agency to compel research publication is hampered by the lack of statutory powers. So this means that a consideration of US legislative solutions is central to this debate.

Lord Warner and the Joint Committee failed to spot the real solution to the problem. Unless ethics committees are put at the centre of the regulatory process, then the UK will be inefficient in competing with European rivals and it will be ineffective in protecting its patients. A proper and full inquiry into the Northwick Park Disaster might have revealed why ethics committees are still unfit for purpose. So the Select Committee should ask some probing questions about TGN1412.

The solution now is to examine real single regulator models that allow ethics committees and competent authority to work together within the narrow timeframe set by the proposed EU Regulation. Looking at streamlining NHS R&D processes is a quixotic distraction that we can ill afford.

Evidence

1. This is additional written evidence to the Commons Select Committee, to be read alongside my original submission. These are the reasons behind it. On 19 March 2013, the Joint Committee examining the draft Care and Support Bill published its report [HL Paper 143 HC 822]. In it, the Joint Committee made recommendations affecting the roles of the Health Research Authority and the research ethics committees in the context of transparency in research. So I sent emails to the Clerks to both Committees expressing my concern at these recommendations. Amongst other matters, I thought that there was an obvious overlap between the work of the two Committees and a clear risk that each might arrive at an inconsistent or erroneous result. On the strength of these concerns, Victoria Charlton, the Committee Specialist, has allowed me to make an additional submission to the Select Committee about those matters that fall within its terms of reference. I also include reference to recent publications and events that are relevant to this Inquiry. I would like this submission to be published if possible.

2. I challenge some of the comments and conclusions that were made in the course of the Joint Committee’s oral evidence sessions and its report on the draft Care and Support Bill. Specifically:

(a)That under the draft Bill, the HRA should be given a “statutory objective” to ensure full publication of research results, consistent with the legal duty of patient confidentiality [Report paragraph 335]. The HRA is the wrong body to do it because it does not have the right legal powers.

(b) That under the draft Bill, the research ethics committee must be given guidance that places them under an obligation to ensure that ethical approval conditions for the publication of research are complied with [Report paragraph 336]. The REC has neither the opportunity nor the resources to do it.

(c)That research ethics committees are guilty of “mission creep” when they engage in their own review of the scientific merits of a research proposal and that steps must be taken to stop them, by legislative provision under the Bill if necessary [Lord Warner Q.299]. This is a complete fallacy. The REC should be given support in this aspect of their work by ensuring closer collaboration with the MHRA. If we do not do it, then the UK’s competitors may well take the lead.

3. The Joint Committee has stated that the HRA should have a statutory objective to ensure publication of research results. By statutory “objective”, I assume that means a statutory duty. If there is to be a statutory duty then there must be penalties that can be put upon the HRA if it fails to comply with that duty to ensure research publication. But the HRA and the REC cannot compel anyone to publish anything without a legislative power to penalise the research sponsor who fails to publish research results without good reason. And this they do not currently have. The need for legislative support was hinted at in the responses to Question 31 of the oral evidence on the draft Care and Support Bill. But no one mentioned the US experience with the Food and Drugs Administration Amendments Act 2007. So this question should now be at the centre of the Select Committee’s inquiry into transparency in research.

4. By implication, if the HRA must be penalised for failing to ensure transparency in research, then those penalties must also be visited upon the unpaid volunteers in the research ethics committees. This is a prospect that can only set back future recruitment to the committees. So it would have been more useful for the Joint Committee to have taken evidence from members of research ethics committees as to whether they considered themselves to be capable of discharging this suddenly emerging burden. It is significant that in her haste to build a small administrative empire for the HRA, its Chief Executive did not bother to consult with the rank and file REC membership as to whether they thought that they could ensure transparency for a research sector in which other institutional players had already failed. And the members of research ethics committees were absent from the Department’s circulation list of stakeholders who were consulted on the content of the draft Care and Support Bill. So if the Select Committee are insistent on following the Joint Committee’s recommendation to make a small monthly committee of part-time volunteers responsible for policing the publication ethics of the global pharmaceutical industry, then I suggest that they first hear oral evidence from some members of those research ethics committees about what can and cannot be done. The point is that the research ethics committee has already finished its job and has exhausted its effective powers by the time that one might expect publication to occur.

5. The Joint Committee’s recommendation to make the HRA responsible for publication of research results demonstrates a lack of knowledge of the legal impediments that stand in the way of it. The guarded enthusiasm of the HRA Chief Executive for a statement to that effect to be included in the Bill demonstrates a lack of facility with the legislative environment in which she and her subordinates are now expected to operate [Oral Evidence Q.291]. The Select Committee must undo the damage that the Joint Committee and the HRA Chief Executive have done by re-examining the legal fundamentals of the problem of compelling transparency in research.

6. As I have stated in my first submission to the Select Committee, the HRA is not a suitable choice to police the publication of research results because it has no powers of inspection, seizure or audit of any document or person outside an ethics committee. This is why I have recommended that the MHRA should be the prime choice to police the publication of research. But the real problem is that a duty to publish research results cannot be separated from the countervailing legal duty to protect the intellectual property rights of the sponsor or the researcher. This balancing of competing interests is already reflected in and managed by the UK Freedom of Information Act 2000. The Information Commissioner has the legal responsibility to decide whether information should be disclosed to the public or withheld pursuant to a FOI request. Any decision to publish research results would first have to consider whether there is material in it that the law requires to be withheld. So there is no sense in giving the HRA prime responsibility to ensure transparency when it has no legal powers to decide what can and cannot be published pursuant to a FOI request. FOI was never mentioned in the course of the Joint Committee’s deliberations on the role of the HRA in research transparency. Recent cases commenced before the European Court of Justice by Abbvie and Intermune might go on to clarify the limits of transparency when measured against the protection of private legal interests [Cases T-44/13, T-73/13, T-29/13].

7. The need to police transparency in research raises the distinct prospect of an expanded role for the Information Commissioner or his Office. In the most recent time, the House of Commons Justice Committee has published its report on the functions and powers and resources of the Information Commissioner [HC 962]. The Select Committee need to take account of recommendations that the Information Commissioner be funded by Parliament and made directly accountable to Parliament, and that the Information Commissioner be given powers to compel a data audit of NHS organisations. All this supports the case for placing the Information Commissioner and the MHRA, not the HRA, at the centre of plans to compel research transparency. Expanding the role of the HRA without the support of relevant statutory powers is merely to create another puffed-up Quango that is likely to fail to deliver and within a short time.

8. My key recommendation is for something akin to a true single regulator for clinical trials that can combine the role of ethics committee and national competent authority to deliver a decision within the fastest time. The comments made by Lord Warner in the Joint Committee Inquiry seem to overlook this possibility entirely and in fact to work against it. Remember that Lord Warner chaired the review that produced the Report of the Ad Hoc Advisory Group on the operation of NHS Research Ethics Committees in 2005. This report was predicated on the wrong-headed assumption that the ethics committee should not reach decisions based on scientific review. The Warner review assumed that there could be a functional separation between the people examining the scientific merits of the research and the people who examine the ethical implications of it. Lord Warner and the other apologists for functional separation have never, as far as I am aware, cited any authority for their assumption and have never satisfactorily justified it.

9. The “Northwick Park Disaster” occurred soon after the publication of the Warner report. The worst clinical accident in over two decades would have been a timely opportunity to test the assumptions about the role of the ethics committee in dealing with scientific review. Given the management breast-beating that followed the NHS Mid-Staffs Inquiry, it is noteworthy that no public autopsy was held to examine the role of the Brent MEC in the approval that it gave to the TGN1412 protocol. I want the Select Committee to ask the Department of Health and HRA/NRES why no such public inquiry was held, or why no public report was issued, that put the role of the research ethics committees and the quality of their management into the media spotlight. If the Select Committee concludes that there has been a lack of transparency over Northwick Park, then we are faced with the grim irony that the institution or institutions that might be found to be at fault could in substance be the same as those now charged with the task of overseeing transparency in others.

10. The true significance of TGN1412 is therefore at risk of being buried and overlooked. It is that research ethics committees cannot do a proper job unless they are put at the centre of the information flow about the safety of test drugs and the “state of play” about existing research already conducted into those drugs. Only in this way can unsafe and unnecessary research be weeded out. This means close cooperation with the national competent authority that is the first and best source of this information. If the Select Committee reads the Duff Report, they will see that improving the information flow between ethics committees and regulators was one of the prime issues identified for further action. Yet this is the one thing that the HRA currently overlooks. There is no real initiative to enable REC and MHRA to share information in real time. The HRA Chief Executive confirmed to the Joint Committee that less than 5% of ethics committees have any sort of scientific review before them when they deliberate on a research application. This should have been the core priority and core function of the people who are meant to run the research ethics committees. But they have neglected this in favour of other “collaborative stakeholder initiatives” that make for better sound-bites. There is indeed “mission creep”, but the ethics committees are not the ones engaged in it.

11. The delivery of close collaboration between ethics committee and competent authority is the most important strategic element of the research governance framework. But the Department, the HRA, and the Joint Committee have all overlooked this fact. Others have not. The Belgian competent authority has stated publicly that “ethical and scientific reviews of clinical trials must be run simultaneously” and it called for the inclusion of ethics committees in the Part I assessments of clinical trials under the proposed EU Clinical Trials Regulation. FAMHP sees the proposed regulation as an opportunity for competent authorities and ethics committees to reorganise themselves to be responsible for clinical trials “hand in hand” [see comments of Dr. Greet Musch at the EuropaBio Conference The Future of Clinical Trials on 28 January 2013].

12. The amendments to the EU Clinical Trials Regulation put forward in the ENVI report of 31 January 2013 demand that the ethics committee be included in the Part 1 assessment procedure. The turnaround time for completion of the Part 1 assessment is very short: in any case no more than 30 days. It is hard to see how any EU member state could comply with the ENVI proposals unless ethics committee and competent authority are cooperating right from the start. The single regulator concept is the obvious way to do this. But because of their skewed priorities, those in charge risk putting the United Kingdom at the bottom of the league table when it comes to the rapid start up of multi-national clinical trials.

13. If there is any ray of sunshine in this, it is that the draft Care and Support Bill allows for any group of persons to apply to the HRA to be approved as a research ethics committee [Draft Bill clause 71]. In theory, the MHRA could seize the initiative and seek to establish its own internal research ethics committees in order to better comply with the new requirements emerging from Europe. If the HRA refused to recognise these ethics committees, perhaps because of a perceived threat to its own monopoly in this area, then it might be possible to subject the HRA to legal challenge by way of judicial review. The Select Committee should put these propositions to the MHRA in terms.

April 2013

Prepared 16th September 2013