UK policy framework for health and social care research:
call for comments
Please send your comments by 1st May 2015. The HRA would find it particularly helpful to receive comments on the following issues:
1.Is there anything more the policy framework should say in order to meet the ambitions set out in the “Purpose” section?
☒Yes ☐No ☐Undecided
Please provide details:
The purpose section outlines some laudable aims including quick decision-making on research applications and a focus on using money from funders in conducting the research rather than getting through ‘unnecessary hoops’ before it starts. Given these aims, it would be helpful if more detail could be provided on the way the framework may help to streamline processes, and hence achieve those aims.2.The policy framework will be implemented by operational arrangements that reflect and embed the principles it sets out (e.g. in England, guidance for HRA Approval, which will be made available later). Is the level of detail in the policy framework sufficient for it to be implemented? If not, how could this be rectified?
☒Yes ☐No ☐Undecided
Please provide details:
Regarding item 2.2 and footnote 5 on page 3:it would be useful if HRA could elaborate on this to clarify the meaning and its expectations of institutions if poor quality research is identified. Universities will generally have codes of conduct and policies relating to research governance and integrity along with specific policies and processes for handling research misconduct, particularly in the context of the Concordat to Support Research Integrity. Might this be referenced as good practice, and should similar expectations be placed on other organisations?3.Are there any issues (e.g. obstacles to research) that the policy framework does not address? If so, what are they and how could they be addressed?
☒Yes ☐No ☐Undecided
Please specify:
The University has identified the following issues:(1)Throughout the document there is no mention of monitoring, oversight or audit requirements, especially from the perspective of a sponsor. The 2005 (2nd) edition of the Research Governance Framework stated: “Satisfying itself that arrangements are kept in place for good practice in conducting the study, and for monitoring and reporting, including prompt reporting of suspected unexpected serious adverse events or reactions.” The draft policy omits expectations around monitoring, reporting adverse events or a requirement for sponsor oversight. As a sponsor of research the University is keen to understand if oversight will remain a requirement although the policy doesnot acknowledge this explicitly. If so, how is that communicated to sponsors so that their responsibilities are clear; for example, will there be a guide to accompany it?
(2)The University would welcome further clarification about whether 'indirect research' projects (2.1) require ethical approval. We note that we areencouraged by the increased emphasis on using previously collected data.
(3)The University would appreciate clarification (2.) that the framework also covers organisations that are providing services for health andsocial care organisations. The requirement for 'research sites' to be aware of their capacity and capability to host research (8.19) can be a concern when the potential research site is a small local provider / charity, or indeed whether such small organisations would be able to undertake the other responsibilities of 'research sites'.
(4)Given some attempts by researchers to claim their research is an "audit" (2.2) (thereby avoiding NHS ethics processes) when it is not,the University would welcome further clarity about audits based entirely on existing data, and suggests thatanything involving systematic collection of new data not routinely collected should be considered research.
4.Do you think the principles that apply to all health and social care research are right?
☒Yes ☐No ☐Undecided
Please provide details:
The University is pleased to see the additions in item 1.1 relating to retention of data or tissue for future analysis. The University is encouraging researchers to maximise the value of data and tissue and our researchers are advised to seek consent for future unspecified (but appropriate) uses, particularly in clinical research where the collection of samples takes place.The University was also pleased to see that the summarisation to research participants of research findings isencouraged.Patient and public involvement, by engaging with research outputs, maximises the value of research as the public are the ultimate beneficiaries of our research.
The University agrees with item 5.2, which clarifies expectations of compliance with commissioned health and social care providers.
Regarding item 7.11, it is surprising that voluntary participation is not framed as the normative expectation – as currently phrased it implies that voluntary participation is necessary only when required. This contrasts with the ESRC Framework for Research Ethics (FRE) (2015), which has as its first principle voluntary participation, free from coercion and undue influence – unless exception can be justified. This would seem to be a more robust starting point for research in health and social care, given the power relationships and potential vulnerabilities for service user and professional participants.
5.Do you think the principles that apply to interventional health and social care research are right?
☒Yes ☐No ☐Undecided
Please provide details:
Regarding these principles, and those for all health and social care research, it would be helpful to include an explicit statement that these principles are intended to apply to all those who take part in research under the policy framework, including children and adults who lack capacity to consent. Researchers should be expected to adapt as appropriate to ensure, for example, that children are appropriately informed, given the opportunity to consent (or not), and given information about study findings. It may also be useful to have access to the exploratory work that the University(with others) conducted for the Nuffield Council on Bioethics, on children’s views of research ethics, which addresses these considerations:6. Do you think the policy framework adequately addresses the needs of social care research? If not, what needs to be covered?
☐Yes ☒No ☐Undecided
Please provide details:
There is continued ambiguity about the status of evaluation studies within the definition of research. Much evaluation is conducted that specifically aims to provide an evidence base for (continuing, expanding or revising) service provision and in this sense is quite clearly intended to provide generalizable or transferrable knowledge beyond the bounds of the study itself. Evaluation and other research which does not meet the criterion of generalizability (which invokes a particular research paradigm, rather than necessarily being an indicator of quality) may nevertheless incur significant ethical issues which governance systems (and requirements for scrutiny of research ethics) need to address.Footnote 7, p4, needs to highlight the potential for identification through data linkage, e.g. across datasets.
7.Do you agree with the responsibilitiesstated for chief investigators?
☒Yes ☐No ☐Undecided
Are there any responsibilities that you think should be added or removed? Please provide details:
The University agrees that students should not normally take on the role of chief investigator at any level of study, for all research requiring a Sponsor; though PhD students may act as the principal investigator (but not the chief investigator).Footnote 14, p8, stated that ‘exceptions may be made’ for doctoral researchers under certain circumstances. It would be helpful if this statement was amended to allow definite exceptions (and the proposed exceptions seem appropriate), given potential ambiguity about how, and by whom, exceptions would be made. If this has to be done by the REC, for example, it could cause significant delays to a project. If necessary, the supervisor could act as formal Co-Investigator as an additional safeguard for these doctoral projects.
Additionally, we note that Fellowships are not normally associated with students, but with staff at postdoctoral level and above.
The University ensures appropriate and adequate supervision is provided to a student. The University disagrees with the expectation expressed in 8.3,as the student should be allowed to lead a project under supervision as part of learning and training to become an established researcher, particularly for post graduate research students.
With respect to items 8.4 and 8.5, p8, the description of research protocols (here or elsewhere in the document) needs to recognise that research involving methodological approaches such as ethnography, or other forms of participatory and qualitative research, may not operate under procedural protocols of the kind envisaged in this description. The policy framework must be explicit that the proposal or protocol provides detailed information appropriate to the methodological approach of the research, otherwise there is a risk that the framework assumes and privileges certain methodologies.
8.Do you agree with the responsibilities stated for research teams?
☐Yes ☒No ☐Undecided
Are there any responsibilities that you think should be added or removed? Please provide details:
The University queries whether it is appropriate for research teams to be responsible for ensuring participants’ welfare (item 8.6c) – this implies a broader responsibility than may be appropriate given their remit and expertise. This could be more specifically phrased to indicate that they are responsible for taking appropriate steps to ensure that participants are not exposed to risk of harm associated with their participation in the study, beyond such risks that have been justified and approved by an ethics committee.In item 8.7 there is an assumption that an information sheet (and the simple provision of this) is enough to ensure appropriately informed consent, and this is likely to be problematic in creating an expectation that providing a highly detailed information sheet is adequate to fulfil researchers’ responsibilities in relation to voluntary participation and appropriately informed consent. Either this section needs to give more detail of appropriate forms of information and consent recording (e.g. DVDs, web resources, audio-recorded consent), or it should be less specific and focus on the principles of the researchers’ responsibilities – for example, to ensure sufficient informationdelivered in an appropriate way that participants can keep, adequate time to decide and ask questions, appropriate recording of consent. Again, the ESRC FRE provides a useful example of this.
9.Do you agree with the responsibilities stated for funders?
☒Yes ☐No ☐Undecided
Are there any responsibilities that you think should be added or removed? Please provide details:
No comments.10.Do you agree with the responsibilities stated for sponsors?
☐Yes ☐No ☒Undecided
Are there any responsibilities that you think should be added or removed? Please provide details:
This section was particularly pertinent to the University, and the following responses are identified:(1)Throughout the document there is no mention of monitoring, oversight or audit requirements, especially from the perspective of a sponsor. The 2005 (2nd) edition of the Research Governance Framework stated: “Satisfying itself that arrangements are kept in place for good practice in conducting the study, and for monitoring and reporting, including prompt reporting of suspected unexpected serious adverse events or reactions.” The draft policy omits expectations around monitoring, reporting adverse events or a requirement for sponsor oversight. As a sponsor of research the University is keen to understand if oversight will remain a requirement although the policy doesnot acknowledge this explicitly. If so how is that communicated to sponsors so that their responsibilities are clear; for example, will there be a guide to accompany it?
(2)Regarding item 8.7, autonomy, the right to withdraw and informed consent are key to good research practice. However, in some research environments and research paradigms alternative approaches may be appropriate in terms of the cohort, e.g. low literacy or research naive communities, or the chosen methodology, e.g. deception and debrief.
(3)Regarding item 8.10, footnote 15,“the employer or funder is not automatically the sponsor” clarification about the meaning of this point would be appreciated.
(4)Item 8.10c that the sponsor is responsible for establishing mechanisms to identify and address poorly planned research / poor quality research proposals and applicationsis noted as a new sponsor requirement. The ethical review procedure does include looking at validity of research and research objectives, however guidance on what an appropriate mechanism would be to address poorly planned research would be appreciated.
(5)Item 8.10f thatthe CI has made appropriate arrangements for making information about the study available is noted as a new sponsor requirement but is in line with the University practice in terms of open access, research data management and encouraging tissue and data to be used for future unspecified purposes, providing there is consent to do this from the research participants.
(6)Regarding item 8.12,universities should accept the role of sponsor for all educational research conducted by their own students, unless the student’s employment mean it is more appropriate for a health or social care provider to do so:this is problematic for students intending to undertake research in an NHS Trust.
- The University has agreed with its local acute NHS Trust partner that research involving the Trust’s patients should be sponsored by the Trust. The new requirement thus undermines the strong working relationship between us and our partner Trust. We imagine this will be the same of many such partnerships. We also believe that many Trusts will prefer to be sponsor for studies involving their patients.
- The term “conducted by” is rather ambiguous in this context. Currently, where undergraduate students have a role in designing research involving NHS patients, this is undertaken in conjunction with an appropriately experienced member of staff, in the (usually NHS) healthcare organisation who may or may not have an academic contract. The NHS member of staff initiates the topic by proposing it as an option for students to choose from, and this process, including approvals, is supported by the Medical School in close partnership with the NHS Trust. In these circumstances, we believe that the NHS Trust should accept the role of sponsor.
- We also consider that it is good practice in supporting an understanding of the context, and conducive to research governance, for a member of NHS staff to have an active advisory role in all educational research. Where there is such involvement, University considers that it is appropriate for the academic and NHS organisation to agree which of the two is best placed to sponsor and to ensure the obligations of sponsorship are fulfilled.
(8)The importance of supervisors developing research projects to which students can contribute may be applicable at Undergraduate, Masters and Doctoral levels.
(9)Regarding item 8.14, we agree with this proposal, butfurther explanation of what is meant by batching may be useful; for example,to what extent do the projects have to be similar? There also needs to be clarity and good communication on REC requirements for updating the participation of different “generations” of named students, without undue bureaucracy.
(10)With respect to 8.15, we agree that Undergraduate students should not normally lead such projects. There does, however, need to be scope for exceptions. For example, it is important that more graduate medical students (some of whom come from another health profession) can make the most of their research experience from a more mature perspective.
(11)Regarding 8.16, non-health related courses, there is ambiguity about what might constitute a ‘health-related’ course, and also what might comprise appropriate expertise for a Co-Supervisor. There are significant workload implications for university staff in this requirement, and it could function as a barrier to research training for important health-related work in interdisciplinary contexts.
11.Do you agree with the responsibilities stated for research sites?
☒Yes ☐No ☐Undecided
Are there any responsibilities that you think should be added or removed? Please provide details:
Regarding item 8.19f, it would be useful for the HRA to suggest how to undertake expedited review where there is an urgent need to ensure the correct permissions/approvals are sought and to show due process and diligence around the project in a very short timeframe. A university will require processes to undertake this kind of urgent review. How does HRA anticipate universities doing this and simultaneously demonstrating due diligence and process?12.Do you agree with the responsibilities stated for professional bodies?
☒Yes ☐No ☐Undecided
Are there any responsibilities that you think should be added or removed? Please provide details:
Regarding item 8.20, in cases where there is the potential of both research misconduct and professional misconduct,HRA advice on the communication that should take place between employers, professional bodies, etc. would be helpful.13.Do you agree with the responsibilities stated for regulators?
☒Yes ☐No ☐Undecided
Are there any responsibilities that you think should be added or removed? Please provide details:
No comments.14.Do you agree with the responsibilities stated for employers?
☒Yes ☐No ☐Undecided
Are there any responsibilities that you think should be added or removed? Please provide details:
No comments.15.Do you agree with the responsibilities stated for health and social care providers?
☒Yes ☐No ☐Undecided
Are there any responsibilities that you think should be added or removed? Please provide details:
No comments.16. Do you think the policy framework will help make the UK a better place to do research?
☒Yes ☐No ☐Undecided
Please provide details:
The current Research Governance Framework has been a significant step forward in identifying and implementing standards of research. Whilst evolution is necessary, it needs to ensure that it is positive, and that current progress is not undermined. The move to make the Framework UK-wide is positive and welcomed. Consistency across the UK is essential.The overarching opening statement about the importance of research and the need to ensure that research governance systems do not act as a barrier to research is very welcome. However, there is a need to do more to ensure that the policy framework is appropriate for the diversity of research in health and social care, including different participant populations and disciplinary and methodological approaches.
The continued omission of evaluation research from the framework, while expedient, neglects the fact that evaluation commonly involves research methodologies, and hence needs to address common issues in terms of ethics and quality. In addition, the nature of evaluation research incurs additional ethical concerns relating to over-research and risk of coercion with vulnerable groups of service users. Whilst evaluation studies are scrutinised within the University REC system, regardless of the DH/HRA policy framework, it is of significant concern that this activity could go ahead without ethics scrutiny in other organisations.
17. Is there anything more it could say in order to achieve this?