Public Health Research Ethics Committee
Frequently asked questions
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Here you can find a list of questions which have been submitted to the Public Health Research Ethics Committee. The answers to these questions have been published to help clarify the remit of the committee and how the ethics review process works. If you have a question which has not been answered below, or if you would like any further information relating to the answers provided, please contact phethics@soton.ac.uk.
Council employees are often leading and carrying out the research rather than standalone researchers. How can we maintain a duty of care to local residents and ensure the research does not jeopardise this?
Council employees are often leading and carrying out the research rather than standalone researchers. How can we maintain a duty of care to local residents and ensure the research does not jeopardise this?
Research is conducted using a pre-determined protocol with a methodology that attempts to remain as unbiased as possible. As a consequence, a good research project, while informed by researchers’ professional experience, should have measures in place to recognise and minimise potential conflicts of interest. Recognition and assessment of suitable measures is something the ethics committee can assist with. Care also needs to be taken to recognise conflicts caused by time allocation so that researchers are able to clearly identify when they are working on their research and when they are working in their professional role. The Research Support Service is able to provide advice on research design and methodology. Please contact phethics@soton.ac.uk if you would like to access this service for support.
Research in councils is not always a linear approach, with projects being refined or adjusted when early findings are received and decisions made about next steps. How can this be managed through the Public Health Research Ethics Committee review process?
Research in councils is not always a linear approach, with projects being refined or adjusted when early findings are received and decisions made about next steps. How can this be managed through the Public Health Research Ethics Committee review process?
Not all research is hypothesis driven, and this is recognised by the ethics committee. Nevertheless, research aims, objectives and methodologies should be pre-determined as much as possible, and if circumstances change any modification needs to be recorded and reviewed by the committee. Similarly multi-stage projects that rely on the completion of one phase prior to starting a second or subsequent phase must also plan to notify the ethics committee as milestone related decisions come up (whether anticipated or not).
Applications are welcome to be updated and resubmitted for consideration by the committee, if there are significant changes to the design of the study and the research question(s). Please contact phethics@soton.ac.uk to discuss the resubmission process if you would like to consider resubmitting an application.
The Research Support Service can help with building uncertainties into study design. If you would like to be linked into this service, please contact phethics@soton.ac.uk.
For academics, the research is the main focus of their work, whereas for council employees, research might constitute part of their working role. There might be challenges about a blurred boundary between the two, and the council researcher might see or have access to wider information from clients, which is not relevant to the research but could influence thinking. How can potential research drift be managed, and ensuring that information governance rules are not compromised?
For academics, the research is the main focus of their work, whereas for council employees, research might constitute part of their working role. There might be challenges about a blurred boundary between the two, and the council researcher might see or have access to wider information from clients, which is not relevant to the research but could influence thinking. How can potential research drift be managed, and ensuring that information governance rules are not compromised?
Details on explicitly recognising and managing the impact of this would be encouraged in the ethics application. Ensuring that council policies and procedures regarding information governance are adhered to and referenced in the application is important. Similarly working to a pre-specified research protocol can help minimise the effect of such conflicts.
Most councils work in a ‘trauma-informed’ way and will anticipate taking this approach with their research activities. Where council staff undertake this research, they will not only be the researcher but will also need to activate the support plan. For example, when research might lead to a re-traumatisation of the victim, the council will need to be clear in how the support package will be provided, and it might require lowering referral criteria to access services. How should this be articulated, as it might challenge council principles of fairness and equity?
Most councils work in a ‘trauma-informed’ way and will anticipate taking this approach with their research activities. Where council staff undertake this research, they will not only be the researcher but will also need to activate the support plan. For example, when research might lead to a re-traumatisation of the victim, the council will need to be clear in how the support package will be provided, and it might require lowering referral criteria to access services. How should this be articulated, as it might challenge council principles of fairness and equity?
Duty of care is a primary concern for both researchers and care providers. Care must be taken to understand how research, or participation in research, may influence the care provided or received. It is a significant ethical issue if participation in research affects the standard of care or support, especially if standard processes are being replaced with untested (research) interventions. This is an issue that the ethics committee can assist in helping researchers identify and address.
Council-led research is always undertaken to influence and has the added value of being able to immediately / rapidly change or adapt service delivery or people’s experience in a way that academic research might not always be able to do. Because of the rapid adoption of findings which might be expected as a consequence of the research, the exploration of potential impact, consequences and unintended consequences need to be articulated carefully and addressed very early on. There might be examples which go against perceived best practice in academia – how should this be articulated?
Council-led research is always undertaken to influence and has the added value of being able to immediately / rapidly change or adapt service delivery or people’s experience in a way that academic research might not always be able to do. Because of the rapid adoption of findings which might be expected as a consequence of the research, the exploration of potential impact, consequences and unintended consequences need to be articulated carefully and addressed very early on. There might be examples which go against perceived best practice in academia – how should this be articulated?
Researchers are encouraged to contemplate consequences and potential impact when designing a study, to identify and mitigate risk. Justification should be provided for the study taking place within the ethics application, along with plans to address intended or unintended consequences. The Research Support Service can help researchers to design their research using the appropriate study methodology. We would advise early contact with this service. Please contact phethics@soton.ac.uk to link in with this service.
Council employees are likely to be undertaking research in the context of their work, and this is likely to be driven by exploring how to improve services and quality of life for residents, understanding why or how service provision is successful, supporting peers with knowledge in other similar services, and bidding for funding to enhance service availability. As these drivers often differ from those of academics, is this recognised within the Public Health Research Ethics Committee review process?
Council employees are likely to be undertaking research in the context of their work, and this is likely to be driven by exploring how to improve services and quality of life for residents, understanding why or how service provision is successful, supporting peers with knowledge in other similar services, and bidding for funding to enhance service availability. As these drivers often differ from those of academics, is this recognised within the Public Health Research Ethics Committee review process?
The Public Health Research Ethics Committee has been established with a specific remit to review public health research not led by academic institutions. The aim is to encourage, support and enable this research to take place in an ethical way. Membership of the committee includes public health consultants within local authorities and public contributors actively involved in co-production of research, who understand the nuances of council and community led research. The academic members on the committee help to ensure the committee operates procedurally in line with other research ethics committees and best practice.
Councils understand it is important that research findings are shared, but because of the nature of the sensitivity of some work, council-led research might be commissioned with the full knowledge that findings are not widely disseminated but are used in very managed ways. Alternatively, they might be fed externally and confidentially to inform national policy development. How might this impact the career progression of embedded researchers if their outputs might not be so explicit?
Councils understand it is important that research findings are shared, but because of the nature of the sensitivity of some work, council-led research might be commissioned with the full knowledge that findings are not widely disseminated but are used in very managed ways. Alternatively, they might be fed externally and confidentially to inform national policy development. How might this impact the career progression of embedded researchers if their outputs might not be so explicit?
Wherever possible findings should always be shared. This is often referred to as ‘Open Research’. Nevertheless, there may be very legitimate reasons why findings should not be shared, and as such the principle of ‘as open as possible, as closed as necessary’ should be followed. There are also multiple ways to share research that should be explored alongside traditional formats such as academic publication. The Public Health Research Ethics Committee is exploring suitable repositories for local authority research and will provide further information on this in due course. Embedded researchers are encouraged to speak with their line managers about career progression and feedback through appropriate channels e.g. HDRCs.
Councils have clear and specific policies for data management, information governance, and safeguarding. Rather than describe these in detail for each study applying for an ethics review, is it possible for councils to log their standard processes? We acknowledge that stating business as usual is insufficient.
Councils have clear and specific policies for data management, information governance, and safeguarding. Rather than describe these in detail for each study applying for an ethics review, is it possible for councils to log their standard processes? We acknowledge that stating business as usual is insufficient.
Organisational policies can be referenced within the application. These policies do not need to be described in detail, but the committee will need assurance that work is being carried out in accordance with these. Linking to relevant documents or websites can be helpful in this regard. However, it is important that any data related risks within the study are identified and plans put in place to mitigate these. Copies of polices can be attached to applications where appropriate, and if they are able to be shared.
Much activity in the council could be described as research, or research related, but is business as usual for us because of safeguards. Provided there is an internal check and audit process within the council, there is no need to ask anyone for external approval. This ‘business as usual’ isn’t always understood externally. Local examples have included a request to employ VCSE researchers, expectation of organising gatekeeping roles in councils for simple communication and dialogue etc. Will the Public Health Research Ethics Committee take council processes into account during their review?
Much activity in the council could be described as research, or research related, but is business as usual for us because of safeguards. Provided there is an internal check and audit process within the council, there is no need to ask anyone for external approval. This ‘business as usual’ isn’t always understood externally. Local examples have included a request to employ VCSE researchers, expectation of organising gatekeeping roles in councils for simple communication and dialogue etc. Will the Public Health Research Ethics Committee take council processes into account during their review?
It is acknowledged that the word ‘research’ can be used quite loosely. The Public Health Research Ethics Committee has been established with a specific remit to review public health research not being led by academic institutions. The aim is to encourage, support and enable this research to take place in an ethical and robust way. Membership of the committee includes public health consultants within local authorities and public contributors actively involved in co-production of research, who understand the nuances of council and community led research. The committee would like to support and encourage research taking place in local authorities and voluntary, community and social enterprise organisations, but importantly also facilitate better research and more informed researchers. Although this could potentially clash with ‘business as usual’, the hope is that engaging with the ethics committee will lead to a better research culture, producing more reliable research outcomes.
We would benefit from clarity around service evaluation and whether this needs ethics approval, from our perspective not usually, as this is normal business practice. But universities seem to err on the side of caution and want these to get ethical approval.
We would benefit from clarity around service evaluation and whether this needs ethics approval, from our perspective not usually, as this is normal business practice. But universities seem to err on the side of caution and want these to get ethical approval.
The committee is open to reviewing service evaluations and audits, particularly if this falls outside of a researcher (or member of council staff’s) usual role, and outside of normal practice. The committee will, however, review all work where those involved may consider there to be ethical implications e.g. includes a vulnerable population, and they would like this to be reviewed independently. The committee would like to support and encourage research taking place in local authorities and voluntary, community and social enterprise organisations. If researchers are not sure whether their evidence gathering activity is a service evaluation or research, they are encouraged to speak with the Research Support Service who are able to provide advice on research design and methodology. Please contact us at phethics@soton.ac.uk if you would like to be linked in with this service.
Council concerns about reputation management might be far wider than other organisations. This is because of the consequences directly to the council itself as a governing body responsible for enacting legislation, and the views of local residents about the capability or otherwise of elected councillors and council officers to manage allocated funding. The impact of politics in the local and national context is also relevant. How will this be managed within the Public Health Research Ethics Committee?
Council concerns about reputation management might be far wider than other organisations. This is because of the consequences directly to the council itself as a governing body responsible for enacting legislation, and the views of local residents about the capability or otherwise of elected councillors and council officers to manage allocated funding. The impact of politics in the local and national context is also relevant. How will this be managed within the Public Health Research Ethics Committee?
The committee is interested in how organisational risk will be managed within a political context, and there is a question on the application form regarding this. The committee will need to be reassured that the work will be undertaken robustly and transparently, regardless of any political influences. Any recommendations from the committee can be used to reinforce requirements to ensure best practice in the work. In this sense, the ethics committee can provide an important independent accountability opportunity for both the researchers, and the council(s) involved.
The council will be very keen to ensure that, from an ethical and moral standpoint, funding is only being received from reputable sources. Will this form part of the ethics review process?
The council will be very keen to ensure that, from an ethical and moral standpoint, funding is only being received from reputable sources. Will this form part of the ethics review process?
The application form asks for details of the funding source of the work. The name of the funder and research programme if appropriate, should be included within the application form. The committee will ask for clarification or reassurance if there is any uncertainty as to the reputability of the funding.
Councils have been reviewing their responsibilities under the Procurement Act 2023 legislation. We have ascertained that whilst many of the bids for funding constitute grants and not contracts, there will be some components which might need to undergo a formal procurement and tendering process. Will the consideration to tender and the decision reached be acknowledged within the ethics review process?
Councils have been reviewing their responsibilities under the Procurement Act 2023 legislation. We have ascertained that whilst many of the bids for funding constitute grants and not contracts, there will be some components which might need to undergo a formal procurement and tendering process. Will the consideration to tender and the decision reached be acknowledged within the ethics review process?
Procurement policies and procedures should be held at the organisational level and form part of the governance framework. The committee will want assurance that the relevant policies are being followed with regard to the work being undertaken.
For very large bids (for example, over £3million), the council will need to approve the acceptance of the funding through a formal process. We need to complete an internal governance process, which requires an Equality Impact Assessment and a Climate Impact Assessment as part of the process. It would be helpful if this was logged as being needed as part of the ethics process, in due course. This could be done by making reference to it for a council officer to confirm the specifics for their own council. It is important to note that these large decisions also need to be in the public domain, i.e. published by the council and also subject to FOI requests, so they have to be explicit and transparent in demonstrating the decision-making processes. How will the ethics review process support this?
For very large bids (for example, over £3million), the council will need to approve the acceptance of the funding through a formal process. We need to complete an internal governance process, which requires an Equality Impact Assessment and a Climate Impact Assessment as part of the process. It would be helpful if this was logged as being needed as part of the ethics process, in due course. This could be done by making reference to it for a council officer to confirm the specifics for their own council. It is important to note that these large decisions also need to be in the public domain, i.e. published by the council and also subject to FOI requests, so they have to be explicit and transparent in demonstrating the decision-making processes. How will the ethics review process support this?
Once a request for an ethics review has gone through the process, an outcome letter will be issued with a set of recommendations and ultimately, an ethics opinion of the work. Organisations are welcome to cite the ethics opinion from the committee and to provide reassurance for governance and publication processes. The Public Health Research Ethics Committee is also planning to publish outcomes on the RSS Specialist Centre for Public Health, delivered by the University of Southampton and Partners website, in the interest of transparency.
Councils will use other colleagues to undertake research; they might access local people, colleagues in commissioned services or partner organisations, as well as council employees. The impact of this on processes needs to be factored in, and councils will need to work through this relationship and assure itself of the activity of others where they do not directly employ them. Ethics processes need to check that this has been addressed correctly.
Councils will use other colleagues to undertake research; they might access local people, colleagues in commissioned services or partner organisations, as well as council employees. The impact of this on processes needs to be factored in, and councils will need to work through this relationship and assure itself of the activity of others where they do not directly employ them. Ethics processes need to check that this has been addressed correctly.
The Public Health Research Ethics Committee application form requests details of all people working on the study and their affiliated organisation. These collaboration arrangements will need to be documented and agreed by the sponsor / host organisation of the study. Any concerns raised by the committee when reviewing the application, will be noted in the outcome letter, with recommendations provided to the lead researcher.
Our local experience has been that each faculty in the university has a slightly different ethics process it follows, which has led to inconsistency. We understand that some of this difference might be linked with separate evaluations of risk, but it also causes internal challenges when more than one faculty is involved in some of our work, for example, contextual inequality work cuts across all fields of academia. The council will undertake research that cuts across all of the university's faculties and needs one consistent process for all aspects of research. Will a separate RSS approach address this?
Our local experience has been that each faculty in the university has a slightly different ethics process it follows, which has led to inconsistency. We understand that some of this difference might be linked with separate evaluations of risk, but it also causes internal challenges when more than one faculty is involved in some of our work, for example, contextual inequality work cuts across all fields of academia. The council will undertake research that cuts across all of the university's faculties and needs one consistent process for all aspects of research. Will a separate RSS approach address this?
The Public Health Research Ethics Committee has been established with a specific remit to review public health research not led by academic institutions. Applications are welcome from local authorities, voluntary, community and social enterprise organisations, and other organisations which do not have an established ethics review process. The committee will review all aspects of research within this context, with the capacity to invite expert advice on specific areas if required. A consistent process for application and review is in place, noting that this is being managed flexibly to make improvements and deliver a service which is effective and supportive for users.
Timescales for decision making are as important as a consistent approach. Often, as research might be associated with operational imperatives, the need to move at pace with the research is important (although not compromising any of the principles). A commitment to a timescale and creation of dedicated capacity of sufficient calibre is important so as to not rely on goodwill for formalised assurance and ethics processes.
Timescales for decision making are as important as a consistent approach. Often, as research might be associated with operational imperatives, the need to move at pace with the research is important (although not compromising any of the principles). A commitment to a timescale and creation of dedicated capacity of sufficient calibre is important so as to not rely on goodwill for formalised assurance and ethics processes.
The Public Health Research Ethics Committee will meet monthly to review and discuss applications. Applications and any resubmissions received, will be reviewed at the earliest opportunity, noting that time will need to be provided for prior review by committee members. The aim is to provide feedback and recommendations to the lead researcher within 14 days of the meeting taking place. Feedback will be provided by an outcome letter and there will be an opportunity to meet with a sub-group of the committee to discuss the feedback, if this would be helpful for the researcher.
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