These frequently asked questions have been developed to help you to apply the requirements of the Preventing Harm in Research and Innovation (Safeguarding) Policy to your research project.
The policy will be reviewed after a period of one year and will be updated to provide any necessary clarity in any areas identified by researchers.
Within the “key groups” considered under the policy, family members of research participants/subjects and their wider communities are listed. Does this include descendants of family members or members of a wider community who may take offence of how their forebears are represented within historical research?
No, the policy is intended to refer to family members, members of households, or members of a local community who may actually be present during the research activities, or with whom members of the research team may come into direct contact, during fieldwork.
It does not apply to any effects caused by a reaction to the research outputs.
The definition of “harm” within the policy includes “negative psychological impact” which may cause “reputational damage which could impact upon tourism”. Could this apply to individuals, groups or communities within nation states, and prevent researchers from presenting a critique of past or current of national policies, for example, which may create a negative psychological impact amongst members of such states?
No, the policy is intended to refer to harm caused as a direct result of the research activities (i.e. fieldwork/data collection), rather than any potential distress/harm experienced by someone reading the research outputs.
The reference to “reputational damage which could impact upon tourism” is intended to refer to instances where the research activities themselves may have a negative impact (eg if there were news reports of abuse which had taken place during fieldwork in a particular place).
Financial abuse is not included under the definition of "harm". Should the policy cover this?
Although there is no explicit reference to financial abuse within the policy, the coercion and exploitation inherent in such actions is a clear cause of psychological distress as defined in the policy's definition of "harm".
Should the DSC be a specific person in each Department or will it change from project to project?
The DSC should be an appropriate person within the research team, so it could be the Principal Investigator, or someone they nominate from the research team.
There may need to be more than one DSC, particularly in the case of collaborative and overseas projects (please see additional questions relating to this below).
Also, there should always be an alternate route for reporting a safeguarding incident/concern which by-passes the DSC (just in case the incident/concern related to them), so people involved in/potentially affected by the research activities should also be able to contact someone outside the research team (usually the HoD, or the Research Ethics & Integrity Manager in Research Services).
Does the DSC have to be different from and in addition to the two routes for reporting concerns about the research?
No, the DSC should be from within the research team, so the same as one of the reporting routes.
Who would take the role of DSC in student projects?
This would normally be a supervisor. The requirement of the policy to have two routes for people to report incidents/concerns also applies to student projects; the alternative contact would usually be the HoD, or the Research Ethics & Integrity Manager in Research Services.
Do projects dealing with post mortem human tissue samples require a DSC?
The safeguarding policy states that a DSC 'is likely to be necessary' where the project involves human participants, personal data or human tissue.
However, if tissue samples are being collected post mortem and there is no involvement of external organisations/people/communities, only University staff/students, then it is reasonable to proceed without a specific DSC.
Who is the best person to fulfil the role of DSC for overseas projects?
For overseas projects it would be sensible to nominate a DSC who is based locally in a partner organisation within the country in question, to negate any language barriers and/or potential power imbalances.
In such instances, it would also be necessary to also have a University DSC to liaise with the "in country" DSC in order to triage and process any reported safeguarding incidents/concerns.
Will safeguarding plans need to be included within formal collaboration agreements with partner organisations?
This is not currently a compulsory requirement, but will be down to the specifics of individual projects and how the PI wishes to manage and document the safeguarding requirements.
It would be acceptable for these requirements to be covered outside of the formal collaboration agreement.
Will the safeguarding requirements be incorporated into an IRAS ethics application for NHS projects?
No, they will not form a part of the IRAS approval process, so safeguarding requirements will have to be documented separately, for example by completing the template safeguarding plan.
Does there need to be a single Designated Safeguarding Contact for a collaborative project, or will their need to be one for each research site?
For collaborative projects, it is important that an open discussion takes place with all partners to agree a safeguarding plan that meets the requirements of the University policy, and those of the partner institutions.
For projects with separate ‘strands’ of research, each conducted by a different partner organisation, it would be sensible to have a named safeguarding contact for each ‘strand’.
However, clarity for people potentially wanting to report a concern is crucial, so it may be beneficial to communicate a single point of contact from the lead institution who would then triage to the agreed safeguarding contact of the relevant ‘strand’ of the research where the safeguarding concern/incident originated.
This “whole project” approach to safeguarding should be applied to collaborative projects, even where University researchers are only contributing to a small element of the research.
On a project where the lead organisation is working with human participants, but the University is only receiving fully anonymised data, or is giving general advice on the project by eg attending advisory meetings, is a safeguarding contact/safeguarding plan needed because the overall project is working with human participants, or is the University concerned only with its own element of the research?
A designated safeguarding contact and plan should be required for the project as a whole, and not just relating to the University element.
This is required not just because there are human participants but also as there are other organisations involved and the potential safeguarding risks to staff (eg in attending external meetings).
Does the policy apply when the research involves purchasing a service from an external company or sub-contracting out an element of the research?
Purchasing a service (eg translation or transcription) does not constitute a research partnership, but subcontracting a part of the research may do.
There should be a discussion with the sub-contractor, and a plan put in place, that relates to the sub-contractor's activities within the particular project. If the sub-contractor also has their own safeguarding policies/procedures, these should be referred to within the plan.
What if a partner organisation refuses to engage in a conversation about safeguarding?
This situation is certainly not ideal and the researcher should reflect on whether to continue with the project, but a potential solution could be would be a project Safeguarding Plan that takes that into account: so any complaints about the activities of the partner would have to be made to Sheffield, or a third party.
There might be challenges here about how to communicate the safeguarding arrangements to those who come into contact with the research if the partner refuses to do so, but I suppose the solution to that problem would be so specific to the project that it's hard to give a general answer.
If an ethics application has been submitted, but not approved, prior to the policy coming into force, will the application have to be amended?
It is not expected that applicants should retrospectively amend submitted ethics applications if at the time of submission the new requirements for safeguarding were not in place.
However, we would recommend that the applicant still considers how the project would deal with safeguarding concerns or incidents, as per the policy.
Do ethics applicants have to include an 'action plan' for handling reported incidents – can this be stated in the ethics application or does a separate document need to be uploaded?
No, it is not mandatory to upload a plan as well as filling in the safeguarding questions on the ethics application form.
The questions on the ethics application form mirror the questions on the template safeguarding plan, so the applicant would complete one or the other.
For new clinical trials within the university, who would approve the safeguarding plans?
If University ethics approval is needed for the study, the application form covers equivalent questions to those in the safeguarding template plan, so the plan will be approved as part of the overall ethics approval.
However, if the study does not need University ethics approval, then the safeguarding plan does not require formal approval - it is a tool to help researchers reflect on potential safeguarding risks and document arrangements for addressing these (in particular for ensuring there are routes available for those involved in/coming into contact with the research activities to raise a safeguarding concern if they need to), and should be kept under review/updated if arrangements need to be altered during the course of the project.
A researcher is developing an idea for a project and is involved with a particular organisation to foster contacts, gain insight (volunteering at a refuge or doing youth work) but is not planning to obtain data for analysis. Is a safeguarding plan necessary?
A specific safeguarding plan should be in place for this type of activity, even though it is not at the ethics approval stage.
Safeguarding issues could certainly arise at this stage, and the policy states that a plan should be put in place where the research involves external partner organisations or engaging with and/or coming into contact with and/or impacting upon members of the public, communities and/or other stakeholders, as well as if it involves human participants.
Any plan should reference any relevant safeguarding policies in place at the partner organisation.
A researcher is holding a focus group off campus to evaluate Learning and Teaching quality, and ethical approval is not needed because the data is only being obtained for the purposes of internal quality assessment. But the researcher might go on to publish in this area at a later date. Should a safeguarding plan be put in place?
Teaching evaluation in itself is not research so would not formally come under the policy, but there may still be safeguarding considerations when working with members of the public.
However, if the researcher intends to potentially use this data in the future, then ethics approval would be required before the data are collected. In such a case a safeguarding plan would be required.
Is a safeguarding plan necessary when communicating research to the public?
If the public engagement activity is linked directly to a research project (where findings are being presented, or data collected which will be used for analysis as research), then it would come in scope of the policy.
Research funding often includes a 'pathways to impact' requirement where the findings need to be presented to businesses or the public, and therefore it is foreseeable at the start of a project and should be incorporated into the safeguarding plan.
Does information on how to report a safeguarding concern or incident need to be included within the participant information sheet?
Yes, this is a requirement and suggested text has been included within the recently updated “Completing an Information Sheet” guidance document that can be found on this page.
What is the best way of communicating how to report a safeguarding concern or incident with the wider community who might not be present during the research but may be affected by it?
The best method of communicating with wider communities or groups will need to be considered on a case by case basis, taking into account the specific details of the project and context.
The participant information sheet may not be adequate for this purpose due to the limited dispersal, so other methods should be explored.
For example, if fieldwork was taking place within a community or organisation, more general information could be provided giving details of the project and how to report any safeguarding incidents or concerns, using appropriate language for the intended audience
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