Human Resources Good Practice Resource Pack
The Initial Assessment and HRA and HCRW Approval letters will confirm whether a Letter of Access (LoA), Honorary Research Contract (HRC) or neither would be appropriate for the research activities specified in the IRAS application, were these to be undertaken by non-commercial research staff not already holding a substantive or honorary contractual relationship with the NHS organisation responsible for the activities. The Initial Assessment and HRA and HCRW Approval letters will also specify the appropriate pre-engagement checks, in accordance with the HR Good Practice Resource Pack.
For clarity, the term ‘if in NHS facilities’, used in the Algorithm of Research Activity and Pre-Engagement Checks for the purposes of specifying when a Letter of Access is expected for research involving staff or their data, should be taken as referring to areas within NHS premises where care is provided. Offices and other non-care areas should be regarded as business premises and letters of access will therefore not be expected for access to such locations for staff research. External researchers working under such arrangements are expected to comply with the off-site working policies and procedures of their employing organisation.
In commercially sponsored studies, commercial research staff should not be given a Research Passport or issued with an HRC or LoA or any other document that could be construed as indicating that the NHS organisation is accepting liability for their actions. With the exception of clinical study data monitors, the model agreements do not cover issues relating to commercial organisations providing staff to undertake commercial research activities in the NHS (e.g. commercial research nurses). Therefore, the NHS organisation needs to ensure that a contract for the provision of these services is put in place with the commercial organisation. This contract should address all issues relating to the activities and suitability of the commercial staff, for example, pre-engagement check requirements (Disclosure and Barring service (DBS), occupational health, professional registration, right-to work, qualification etc, training, accountability and management arrangements, insurance for negligent actions. For access by commercial staff to NHS facilities the Initial Assessment and HRA and HCRW Approval letters will be clear where such other arrangements are appropriate
Oversight Arrangements
The Initial Assessment and HRA and HCRW Approval letters will confirm, for each group of organisations that are identified in the application as undertaking different activities within the study, whether those activities should be overseen by a Principal Investigator and, if so, whether the Principal Investigator should hold a contract of employment with the participating organisation or may provide effective oversight from another organisation. Where oversight by a Principal Investigator is not needed, the letters will set out the appropriate alternative arrangements to be made at the participating organisation, for example, support by a Local Collaborator.
Non-commercial sponsors are expected to state their intentions through the outline Organisational Information Document/s in their IRAS submission. The HRA/HCRW will assess the appropriateness of the sponsor’s proposal and confirm expectations by group of organisations in the Initial Assessment and HRA and HCRW Approval letters. Where there should be Principal Investigators, Co-Investigators and/or Local Collaborators, the sponsor should be clear as to whether these have been identified or whether they require local assistance in identifying suitable staff.
Where there should be a Principal Investigator HRA and HCRW assessment will ensure that any specific training expectations of the sponsor for them and/or their team are clear. Where a Principal Investigator will be locally employed it is the responsibility of each participating NHS organisation to assess the suitability of the individual selected, in line with the general and specific training expectations outlined by the sponsor and to consider any possible conflict of interest. Where requested, the NHS organisation should support the sponsor in identifying an appropriate Principal Investigator. In the case of a remote Principal Investigator, it is the responsibility of the NHS organisation at which the Principal Investigator is physically present to assess the suitability of the Principal Investigator and to provide appropriate assurances to other relevant NHS organisations that it has done so in line with the UK Policy Framework for Health and Social Care Research.
By confirming the Organisational Information Document and Schedule of Events/SoECAT (or agreeing the site agreement) the participating NHS organisation will be taken to have confirmed the suitability and appropriateness of any Principal Investigator selected.
Interventional Research Studies
Sponsors should refer to the Set-up of Interventional Research guidance, for information on risk assessment of oversight arrangements. The guidance sets out principles and examples relating to whether different activities require Principal Investigator oversight, locally or from a distance, and details other arrangements to be made in relation to such oversight (for example, relating to the type of contracting and capacity and capability confirmation that should be in place). IRAS submissions should specify oversight arrangements for participating organisations in the study, in accordance with the guidance. Where applicable, a copy of the relevant parts of the sponsor risk assessment should be provided to facilitate HRA and HCRW review of the proposed arrangements. HRA and HCRW assessment will be undertaken accordingly.
Non-Interventional Research Studies
A Principal Investigator should be in place where oversight is required of local staff conducting activities in relation to the research study. The Principal Investigator may be locally employed, or may provide oversight from another organisation, depending on the ability of the PI to effectively oversee the work being conducted, as determined by the sponsors risk assessment.
Where local staff will not be conducting activities in relation to the research study. but where central study staff will be present at the participating organisation to undertake research procedures, it is expected that a Local Collaborator will be identified. The role of the Local Collaborator is to support practical arrangements to facilitate the presence of the external research staff, for example by making appropriate arrangements as per the HR Good Practise Resource Pack.
IRAS submissions should specify oversight arrangements for participating organisations in the study. HRA and HCRW assessment will be undertaken accordingly.
Further guidance on the set up of non-interventional research is currently in preparation.
Level of capacity and capability assessment expected of participating organisations
NHS organisations in England or Wales should assess, arrange and confirm their capacity and capability to undertake a study in a manner proportionate to the nature of the study and their specific roles and responsibilities within it. Not all organisations connected with the management of a participant in a study are considered to have a role in the study, particularly if they are not processing personal data under the instruction of the sponsor and are undertaking no activities beyond standard of care.
In most cases, the mechanism for formal confirmation of capacity and capability is the participating NHS organisation entering into the site agreement with the sponsor (providing to the sponsor, i. the agreed Organisation Information Document for a non-commercial, non-interventional study, or, for all interventional studies; ii. the NHS organisation signed agreement). Where a participating NHS organisation is also the sponsor, confirmation is not by contract exchange (as a legal entity cannot contract with itself) and local arrangements will be in place to confirm when the study may start.
The agreement (including, where applicable, the Organisation Information Document), used to confirm that the NHS organisation has made the necessary arrangements to deliver the study, should be used without modification to its templated elements. Sponsors should include in their IRAS submissions the template of each site and/or PIC agreement that they intend to use for the study. Where the sponsor is proposing modifications to a template agreement, each proposed modification should be highlighted and justified. Where the sponsor is of the opinion that no suitable template agreement exists for their study, or for some sites within their study, this should be explained in the application. The HRA and HCRW assessment will consider the suitability of any proposed modifications and the Initial Assessment and HRA and HCRW Approval letters will detail the arrangements agreed with the sponsor.
NHS organisations in England are obliged by their standard form provider contracts with NHS England to use only the appropriate unmodified model agreement for commercial contract research. NHS organisations in Wales are under an equivalent policy expectation. This requirement/expectation may only be set aside if expressly waived in the letter of HRA and HCRW Approval. The negotiation of proposed modifications prior to any such waiver is likely to cause significant delay.
In some cases, it is not necessary for an NHS organisation to formally confirm its capacity and capability, by provision of an agreed Organisation Information Document or signed contract, prior to research activity commencing at that organisation. In other cases, whilst formal confirmation is needed prior to research activity commencing, the nature of the activity means that this confirmation should be given within a specified timeframe. Sponsors should give consideration as to whether some or all sites within their study should be regarded as not requiring confirmation of capacity and capability, or whether some or all sites within their study should be given confirmation within a specified timeframe. Sponsors should include within their application an explanation and justification for their plans. This will be assessed, and appropriate arrangements confirmed in the Initial Assessment and HRA and HCRW Approval letters.
The list below provides an example of some common scenarios in which different levels of assessing, arranging and confirming may be expected and should be used by sponsors to guide their own risk assessment and statement of intent and justification in their IRAS submission. The Initial Assessment letter will provide initial instructions regarding whether formal confirmation of capacity and capability is expected by participating organisations (including, where applicable, when different organisation are delivering different research activities within the study), the likely extent of any assessment and key considerations for arranging capacity and capability. These instructions will be finalised and explicitly stated in the HRA and HCRW Approval letter. Sponsors and participating NHS organisations should note that it is possible that these instructions will change between these communications if further information about the study becomes available.
Assessing and arranging capacity and capability
- Full: In terms of the ‘assess’ and ‘arrange’ steps of assessing, arranging and confirming capacity and capability, it is expected that the organisation will need to fully consider the implications of participating in the study and put specific arrangements in place to be able to undertake their activities
- Minimal: In terms of the ‘assess’ and ‘arrange’ steps of assessing, arranging and confirming capacity and capability, it is expected to be relatively straightforward for organisations to consider the implications of participating in the study, and that minimal arrangements would need to be in place to be able to undertake the activities: for example, ‘do we have the staff/resources to undertake the activities?’, ‘do we hold the data being requested?’, ‘will the systems in place locally make it easy or difficult to undertake the activities?’ (for example, accessing electronic vs. hard copy records)
Confirmation of capacity and capability
- Formal confirmation of capacity and capability will be expected: The organisation will formally confirm that it has capacity and capability in place to undertake the activities by entering into an agreement with the sponsor. Even where there is no expected timeframe stated for the organisation to assess, arrange, and provide formal confirmation of capacity and capability, organisations should arrange the capacity and capability to deliver the study as soon as is possible, in accordance with timelines agreed with the sponsor, and formally confirm as soon as they have done so
- Formal confirmation of capacity and capability will be expected within a specified timeframe: The organisation will formally confirm that it has capacity and capability in place to undertake the activities by entering into an unmodified model agreement with the sponsor. However, due to the nature of the activities involved, organisations will be expected to provide that confirmation to the sponsor within a specified timeframe (usually 35 days from receipt of the local information pack but may be less, as specified in the Initial Assessment and HRA and HRA Approval letters). Where the sponsor proposes use of any agreement other than an unmodified model agreement, formal confirmation of capacity and capability will usually be expected (as it would not usually be appropriate to expect an NHS organisation to review a non-standard agreement within an expedited timeframe) and no time limit will be specified (option 1). The timeframe will be specified during assessment and detailed in the Initial Assessment and HRA and HCRW Approval Letters. If the organisation is not able to formally confirm capacity and capability within this timeframe, a justification for this must be provided to the sponsor within the specified timeframe. If the sponsor is not satisfied with the justification, then the sponsor may escalate to the HRA and / or HCRW as appropriate
- No formal confirmation of capacity and capability is required: In circumstances where no study agreement is expected, because there is no expectation that the NHS organisation needs to undertake significant assessing or arranging and because it will not be processing personal data under the instructions of the sponsor, the organisation may be given a set amount of time (usually 35 days from receipt of the local information pack, but may be less) to consider the expected activities and to opt out if they are not able to participate. The sponsor may assume that capacity and capability has been confirmed if the organisation does not raise any objections within the given time. Even in such cases, organisations are encouraged to informally confirm capacity and capability to the sponsor (or their delegate) at the earliest opportunity, rather than unnecessarily waiting for the specified number of days to elapse. In some cases, Participating organisations will be informed of the study, but the specified study activity may commence.
Common scenarios for differing levels of assess, arrange and confirm expectations
1. Participating organisations will be conducting activities outside of usual care competence
This includes activities such as:
- recruitment and consent of participants
- activities not within usual care competence such as specialised tissue collection, imaging, or other protocol specific measurements/assessments
- study specific visits
- administration of IMP not within usual care competence (or within usual care competence, but the risk assessment requires that this is done only at a Trial Site with a locally employed PI)
- accountability of IMP is required for overall evaluation of results
- complex data collection and transfer where monitoring is required or use of participant recorded outcomes that may need support from the study team for training
In this scenario:
- full assess, arrange and confirm processes are expected
- formal confirmation of capacity and capability will be expected
2. PIC activity involving the identification of potential participants for a study
This is done by means of study specific data processing under the controllership of the sponsor. Potential participants are then put in touch with the recruiting site. The PIC site does not do any specific consent or recruitment.
In this scenario:
- minimal assess and arrange processes are expected by the PIC site
- formal confirmation of capacity and capability will be expected
- where an appropriate unmodified model agreement is proposed formal confirmation of capacity and capability will be expected within a specified timeframe
3. Organisation is responsible for taking blood or other tests within usual care competence but are not part of standard of care
This would cover any activities part of usual care competence but would not be performed if the participant was not in the trial. This includes when samples are collected and sent to a central laboratory using a trial-specific kit provided by the sponsor.
In this scenario:
- no assess and arrange processes are expected by the site
- no formal confirmation of capacity will be required when:
- such activity falls within usual care competence and therefore does not need PI oversight, nor detailed instruction from the sponsor (such that the participating organisation should be regarded as the data processor of the sponsor
- where the sponsor will make payment for the activity, a contract or other mechanism for payment may still be appropriate (but may be negotiated in good faith without delaying the activity in question)
4. Use of organisations as continuing care Investigator Sites
This would be when participants are recruited at a specialist centre (Organisation A) and undergo the research intervention there. However, participants may have care continued at a hospital closer to their home (Organisation B) which would be required to undertake research specific activity in addition to standard of care outside of usual care competence (such as continued administration of the IMP. In some instances, Organisation B is known prior to participant recruitment, in other instances the organisation will not be identified until the participant is recruited or transferred [26].
In this scenario:
- full assess and arrange processes are expected at the continuing care Investigator Site
- formal confirmation of capacity and capability will be expected
- where an appropriate unmodified model agreement is proposed formal confirmation of capacity and capability will be expected within a specified timeframe [27]
5. Activities performed by a contracted service provider on behalf of another organisation
In this example, the activities are performed on behalf of Organisation A, under the usual care competence of a contracted service provider (Organisation B). This includes where Organisation B is an NHS Organisation and undertakes the activities to be performed as usual as part of normal care pathways.
In this scenario:
- no assess and arrange processes are expected by Organisation B
- no formal confirmation of capacity and capability is required from Organisation B
- it is assumed that confirmation of capacity and capability has already been provided by Organisation A
- Organisation A should have considered that the applicable Service Contract is suitable to cover the activities in question as research activities
- study activities can commence once HRA and HCRW Approval is in place and Organisation A has provided its confirmation, as applicable
6. Questionnaire or focus group study where no study specific data processing is required
In this example, there would be no study specific data processing to identify potentially eligible participants. An opportunity to take part in the study could be brought to the attention of staff through:
In this scenario:
- no assess and arrange processes are expected
- no formal confirmation of capacity and capability is required
- the organisation will be given a set amount of time to opt out if they are not able to participate (if for example they do not have eligible staff to participate)
- the sponsor may assume that capacity and capability has been confirmed if the organisation does not raise any objections within the given time
7. Questionnaire or focus group study that does require study specific data processing
In this example, there would be study specific data processing on the part of participating NHS organisations. For example this could be to identify and approach specific participant groups.
In this scenario:
- minimal assess and arrange processes are expected
- formal confirmation of capacity and capability will be expected
- where an appropriate unmodified model agreement is proposed formal confirmation of capacity and capability will be expected within a specified timeframe
8. No change to local activity but automated data extraction by central team
In this scenario:
- no assess and arrange process is expected
- no formal confirmation of capacity and capability is required
- the organisation will be given a set amount of time to opt out if they are not able to participate (if for example they do not have the right patient population)
- the sponsor may assume that capacity and capability has been confirmed if the organisation does not raise any objections within the given time
9. Data extraction by central research team where the central research team require access to the organisation to undertake the data extraction
It is important to consider in this scenario the central research team’s legal basis under the common law duty of confidentiality if the data extraction activity will require disclosure of confidential personal information.
In this scenario:
- minimal assess and arrange process are expected
- no formal confirmation of capacity and capability is required
- the organisation will be given a set amount of time to opt out if they are not able to participate (if for example they do not have the right patient population)
- the sponsor may assume that capacity and capability has been confirmed if the organisation does not raise any objections within the given time
10. Provision of existing data, or data collected through the course of routine care by the staff at Organisation A to the central study team or provision of personal data following processing (e.g. extraction, anonymisation, etc.)
In this scenario:
- minimal assess and arrange processes are expected
- No formal confirmation of capacity and capability is required
- the organisation will be given a set amount of time to opt out if they are not able to participate (if for example they do not have the right patient population)
- the sponsor may assume that capacity and capability has been confirmed if the organisation does not raise any objections within the given time
11. Transfer, including processing for the purposes of transfer, of existing data, or data collected through the course of routine care, which is not considered to be personal data by the staff at Organisation A to the central study team
An example of the data collected could be data that relates to service users who are deceased. In this scenario:
- minimal assess and arrange processes are expected
- no formal confirmation of capacity and capability is required
- the organisation will be given a set amount of time to opt out if they are not able to participate (if for example they do not have the right patient population)
- the sponsor may assume that capacity and capability has been confirmed if the organisation does not raise any objections within the given time
12. Rare genetic disease study under the Musketeers Memorandum Consortium Agreement [28]
In this scenario:
- no assess and arrange processes are expected
- no confirmation of capacity and capability is required
- studies covered by the consortium agreement are within the capacity and capability of consortium member Trusts
- the study may commence locally once HRA Approval is in place and in line with the timelines set out in the consortium agreement
13. Provision of previously collected tissue samples that have personal data associated with them to another organisation for a specific study
In this scenario:
- minimal assess and arrange processes are expected
- formal confirmation of capacity and capability will be expected
- where an appropriate unmodified model agreement is proposed formal confirmation of capacity and capability will be expected within a specified timeframe
14. Provision of previously collected tissue samples that do not have personal data associated with them to another organisation for a specific study
In this scenario:
- minimal assess and arrange processes are expected
- no formal confirmation of capacity and capability is required
- the organisation will be given a set amount of time to opt out if they are not able to participate (if for example they do not have samples/resources available)
- the sponsor may assume that capacity and capability has been confirmed if the organisation does not raise any objections within the given time
15. Processing or analysing tissue samples for a specific study received from another organisation [29]
In this scenario:
- minimal assess and arrange processes are expected
- formal confirmation of capacity and capability will be expected
- where an appropriate unmodified model agreement is proposed formal confirmation of capacity and capability will be expected within a specified timeframe
Organisations considered to have no role in the study
16. Referral activity not involving Participant Identification Centres (PICs)
This would be activities such as
- organisation A wants Organisation B to display a poster and advertising materials about the study
- a consultant at Organisation C becomes aware of the study and has a patient with the relevant condition. The consultant mentions the study taking place at Organisation A and the patient is interested in participating. The consultant refers the patient to Organisation A to explore treatment options available there
In this scenario:
- organisations B and C have no role in the study as they are undertaking no activities beyond standard of care and are not acting as data processors of the sponsor by processing personal data under sponsor instruction
- the concepts of assessing, arranging and confirming capacity and capability are not expected to apply as HRA and HCRW Approval is not required in relation to these organisations
17. Organisation is undertaking only activities that are part of standard of care
This would be activities such as
- blood or other tests taken at a GP site, satellite clinic or local hospital, by staff that are part of standard of care
- recording of visits and results in the patients’ medical records as part of standard of care
- this would include treatment of a patient in hospital, for example in an emergency setting, where the data is retrieved by the PI to ensure safety
- staff who visit patients at home to provide standard of care, for example district nurses or part of a contracted service provider
In this scenario:
- the organisation has no role in the study as they are undertaking no activities beyond standard of care
- the concepts of assessing, arranging and confirming capacity and capability are not expected to apply as HRA and HCRW Approval is not required in relation to these organisations
18. Activities under the duty of care of one organisation that are physically embedded at another organisation
This would be activities such as satellite clinics, for example
- Organisation A acts as the regional centre for treatment of patients. The regional centre has network clinics embedded in other organisations (Organisation B).
- Patients are considered to be patients of Organisation A but they may be seen at the geographical location of Organisation B in order to receive their care from Organisation A
In this scenario:
- If staff from Organisation A undertake all protocol related procedures and take full responsibility for all Research specific activity undertaken with the study participants then Organisation B is considered to have no role in the study
- the concepts of assessing, arranging, and confirming capacity and capability are not expected to apply as HRA/HCRW Approval is not required in relation to this organisation
19. Provision of surveillance data to Organisation A
This activity could be surveillance data collected through the orange or yellow card reporting systems and would include the provision of further routine non-identifiable data once a card has been returned.
In this scenario:
- This activity falls within the definition of ‘usual practice’ according to the HRA’s Defining Research table
- As this is not research activity, it is outside the remit of the approval processes in England and Wales so the concepts of assessing, arranging and confirming capacity and capability are not expected to apply
- Where NHS organisations need to undertake additional activities to the monthly returns then it would be considered if that additional activity is significant enough to constitute ‘research’ activity, or just an extension of the standard surveillance programme. Examples of additional activity are providing data from notes, samples, approaching patients etc.
- If it is considered a research study by the sponsor, then participating NHS organisations are participating organisations and the above examples should be followed (dependent on activities)