Technical Assurance Payments Framework Guidance

1. Introduction

1.1.  The purpose of this web page is to give guidance for funders, sponsors, HRA registered reviewers and their employers (where applicable) as to how payment for HRA Radiation and Pharmacy Technical Assurance reviews should be made. It also includes advice on budgeting for review costs and payment for amendments.

1.2  Prior to the implementation of Technical Assurance, there has been no national payment framework for the completion of technical reviews within the NHS for research purposes. Each trust/health board or private contractor set its own payment structures and these differed significantly between organisations. For Radiation, the review fee could range from no charge at all, to upwards of £700 per review.  In terms of Pharmacy, reviews had not been charged for specifically, but had been included as part of a fixed site set-up fee. Similarly, review fees for amendments for Radiation vary significantly across trusts/health boards, again, ranging from no charge at all, through to hourly rates and fixed rate fees.

1.3  Following the evaluation of the Technical Assurances pilots, it was agreed that a standardised review fee should be introduced for both Pharmacy and Radiation Assurance, and that £500 per reviewer for new studies was an appropriate fee to reflect the workload required of a reviewer. The introduction of a standardised fee also enables sponsors and funders to consider the correct payment in the grant. This agreement was reached during discussions between the HRA’s Collaboration and Development Forum and major funders, and feedback from the Radiation and Pharmacy Guardian groups.

1.4  The decision was also taken to standardise the review fee for amendments submitted to Radiation Assurance and that £250 per reviewer of each amendment was an appropriate fee, except in the situations described further in amendments. 

1.5  Both the review and amendment fees have been classified as a Part A research cost and are exclusive of VAT.

1.6  The HRA cannot specify which trust/health board budget the review fee is paid into; this is an internal matter for the trust/health board, though the HRA does recommend that the reviewer’s employing department is reimbursed accordingly.

1.7  The review fee payments made to trusts/health boards are additional to any site set-up fees charged by participating sites.

1.8  All payments to trusts/health boards or private individuals for completion of the technical reviews include funding for the completion of quality assurance checks. No separate or additional payment is required by sponsors or applicants to cover this activity.

1.9  The review fee and amendment fee are subject to periodic review due to changes in inflation rates.

1.10  The HRA will indemnify the completion of HRA-managed reviews, but not the payment aspect of the process. Indemnification of self-managed reviews should be provided by the reviewing trust/health board and/or reviewer (depending on local arrangements). The HRA will not indemnify any aspect of self-managed reviews.

1.11  An overview of the entire payments process can be found in the Appendix.

2. Definitions and Responsibilities 

2.1 Applicant 

The individual (or organisation) who submits the application to either Pharmacy or Radiation Assurance and corresponds with the Health Research Authority about the submission. The applicant may be the sponsor or a representative of the sponsor (for example contract research organisation, chief investigator (CI), member of the research team or research and development (R&D) office).

2.2 Agreement

An agreement between a sponsor and a trust/health board to confirm as a minimum the service to be provided by the trust/health board, the payment required, and how and when the payment will be made. It is up to the sponsor and trust/health board to agree the most appropriate form of agreement for completion of the review and payment.

2.3 Funder

The organisation which, upon its approval, provides funding to the sponsor for a research study.

2.4 Health Research Authority (HRA)

The HRA manages the Radiation Assurance review process and reviewers on behalf of the UK, and the Pharmacy Assurance review process and reviewers throughout England and Wales.

The Pharmacy Assurance review process and reviewers in Northern Ireland and Scotland are managed by the respective nations.

2.5 HRA-managed study 

A study which goes through Radiation or Pharmacy Assurance where the selection and management of reviewers is conducted by the HRA.

For simplicity, studies going through Pharmacy Assurance where the lead nation is Northern Ireland or Scotland, and where the selection and management of reviewers is conducted by that nation are included in this definition for the purposes of this guidance.

2.6 HRA registered reviewer/reviewer 

A Clinical Radiation Expert (CRE), Medical Physics Expert (MPE), Pharmacist, Pharmacy Technician or Radiopharmaceutical Scientist who has been recruited and trained to the agreed UK-wide standards to conduct technical radiation or pharmacy reviews in their area of expertise. A list of HRA registered reviewer registration numbers and employing trusts/health boards is available on the applicable Assurance pages of the HRA website.

2.7 NHS Trust/Health Board 

The employer of the HRA registered reviewers; in England this is an NHS trust and in Wales and Northern Ireland this is a health board. The trust/health board confirms to the Sponsor how payment should be made and receives the payment for the completion of their reviewers’ reviews. Where the applicant confirms that the study will be self-managed, the trust/health board should follow its local procedures to agree any fees necessary for the completion of the technical review.

It should be noted that some HRA MPE and CRE registered reviewers may be employed by private institutions, work as a sole trader or on behalf of their own business. Where this guidance refers to the NHS trust/health board or the employer it may be taken to mean NHS trusts/health boards, any private institutions which employ reviewers, the reviewer's own business or the reviewer themselves where they are a sole trader.

2.8 Pharmacy Assurance 

The centralised review by a HRA registreed pharmacy reviewer(s) of the technical pharmacy aspects of a clinical trial of investigational medicinal product (CTIMP).

2.9 Radiation Assurance 

The centralised review by a HRA registered CRE and MPE reviewer(s) of the radiation aspects of clinical trials, for inclusion in Part B Section 3 of the IRAS form. Radiation Assurance also includes a consistency review by the HRA, which involves confirming consistency of radiation research exposures within and between study documents.

2.10 Review completion 

The review process may include alterations as a result of queries from reviewers and/or clarifications provided by the sponsor.

A review will only be considered complete once the HRA has issued an email to the sponsor confirming either Pharmacy or Radiation Assurance is in place.

2.11 Self-managed study 

A study which goes through Radiation or Pharmacy Assurance where the selection and management of reviewers is conducted by the applicant. Self-managed submissions will only be accepted where the reviewers conducting the review are registered to conduct Radiation or Pharmacy Assurance reviews, as applicable. In order for studies to be processed through the self-managed option, the following criteria need to be met:

a) the reviewers conducting the review are registered to conduct Radiation or Pharmacy Assurance reviews; and

b) additionally, for Pharmacy Assurance:

i) the reviewing trust/health board is also acting as sponsor (or co-sponsor, including those with joint research office arrangements in place)

ii) The reviewers should have had input into the development of the protocol and associated documents.

c) Additionally, for Radiation Assurance, the sponsor is expected to already have an agreement in place with the reviewing trust/health board, organisation or private reviewers.

2.12 Service Level Agreement (SLA)

See 2.2 Agreement.

2.13 Sponsor 

The organisation which is responsible for seeking and securing funding for the research study; this organisation is also responsible for paying the trust/health board for completion of the Pharmacy and Radiation Assurance review in line with the method agreed with the trust/health board. In some instances the trust/health board may also be the sponsor.

3. Seeking Funding 

Basic Principles 

3.1  Funding for the review fee must be sourced from study budgets or from grant funding. It is the responsibility of the Sponsor to seek appropriate funding, including that required for any potential amendments to be submitted at a later date.

3.2  From 01 April 2020 the HRA expects that all grant applications will have the set Technical Assurance review fees included where applicable to the study type.

3.3  The review fee for all new studies being processed through Radiation or Pharmacy Assurance as a HRA-managed study is £500 per reviewer, excluding VAT. Where applicable for the vendor, VAT should be added to the review fee at the current rate.

3.4  The review fee for most amendments being processed through Radiation Assurance as a HRA-managed study is £250 per reviewer, excluding VAT. Where ionising radiation exposures are being added to the study for the first time, the full review fee of £500 per reviewer excluding VAT applies. In both cases VAT should be added to the review fee at the current rate, where applicable.

3.5  Amendments will not be reviewed through Pharmacy Assurance and therefore there is no associated review fee.

3.6  The standardised review fee has been classified as a Research Cost (Part A) as per AcoRD guidelines.

3.7  The review fee for Pharmacy Assurance may be included in the industry costing template in the future, but the fee for Radiation Assurance will not be included in this template.

3.8  The standardised review fee is not payable for self-managed studies; however, sponsors should note that payment may be expected as part of local practices. In particular, where a sponsor who is not also the reviewing trust/health board submits a self-managed study for Radiation Assurance, the HRA recommends that any fee paid to the reviewing trust/health board is, as a minimum, the standardised review fee.

3.9  The HRA recommends that sponsors seek funding based on the study being processed as HRA-managed in case it is not possible for the study to be self-managed.

Specialisms 

3.10  When securing funding, sponsors should be mindful of the number of reviewers which may be required for each study based on the specialisms involved as each reviewer needed will incur an additional review fee as described in 3.3-3.6.

3.11  Reviewers may be available who cover multiple specialisms but as availability may not be known until the review commences, sponsors are advised to seek funding for the maximum number of reviewers required.

3.12  The HRA will ensure that reviewers of appropriate specialisms are assigned to each study review, even if the applicant is choosing the reviewers who will conduct the review.

Pharmacy Assurance 

3.13  The specialisms included in Pharmacy Assurance are: 

a) adult oncology

b) paediatric oncology

c) adult non-oncology

d) paediatric non-oncology 

e) radiopharmacy

f) advanced therapy IMPs (ATIMPs) 

Radiation Assurance 

3.14  The modalities used for Medical Physics Experts (MPEs) are: 

a) radiology 

b) nuclear medicine (diagnostic tests)

c) nuclear medicine (therapeutic treatments)

d) radiotherapy. 

3.15  The clinical specialisms used for Clinical Radiation Experts (CREs) are:

a) oncology

b) cardiology

c) paediatrics

d) vascular specialities 

e) neurology 

f) gastroenterology

g) rheumatology 

h) general radiology (see 3.17 for further details).

Additionally, CREs may have particular expertise in one or more of the following modalities: 

a) radiology

b) nuclear medicine (diagnostic tests)

c) nuclear medicine (therapeutic treatments)

d) nuclear medicine (standard - please refer to the CRE Review Procedure for details on what is considered standard)

e) radiotherapy

It should be noted that due to the range of clinical specialisms this list is not exhaustive, but is based on the most common types of research submitted for ethical review. Care should therefore be taken in particular when estimating the number of CRE reviewers required.

3.16 General radiology procedures are those which can be justified and authorised by any Clinical Radiation Expert (CRE). They can be used and/or requested in a variety of settings, for example GP surgeries or A&E. General radiology does not include procedures which are more specialist in nature and require a CRE with particular expertise in that area.

General radiology covers:

• most plain film radiography (for example chest x-rays, hip x-rays)
• CT head scans for common problems such as stroke, headaches or head injury
• low dose procedures (such as plain films and DEXA)
• safety tests (for example CT chest scan to preclude infection, post tumour image-guided biopsy)

General radiology does not include more specilaist radiology exposures such as:

• angiography
• fluoroscopy
• mammography
• scans to check for the location and/or size of tumours

Please note that neither list is exhaustive. General radiology does not include any exposures to radioactive substances (nuclear medicine) or radiotherapy and any assocaited planning or on-treatment scans. For guidance on whether a radiology procedure can be considered general radiology please contact a CRE (if you have access to one) or radiation.assurance@hra.nhs.uk.

4. Self-Managed Studies 

Eligibility 

4.1  As defined in definitions and responsibilities, self-management of a study is currently only available as an option to those studies listed in 2.11. 

Payment Requirements and Agreements

4.2  As described in seeking funding, there is no set review fee for self-managed studies. Agreement should be reached between the sponsor and trust/health board for an appropriate fee to develop the study protocol etc. and conduct the technical review.

4.3  It is recommended that where the sponsor is not the reviewing trust/health board and a self-managed submission is being made to Radiation Assurance, the minimum fee set for completion of the review is the standard review fee of £500 per reviewer. The fee to be charged should be included in the agreement between the sponsor and the reviewing trust/health board. It is also recommended that the agreement includes clarification of where indemnity will lie; the HRA will not indemnify the completion of self-managed reviews.

4.4  An agreement for the completion and payment of the review is recommended between the non-commercial sponsor and trust/health board where the trust/health board is a co-sponsor. It is for the sponsor and the trust/health board to agree what form this will take and how it will be managed.

4.5 Where the sponsor and trust/health board are the same organisation there may be no requirement for an agreement for the conduct or payment of the review. Payment may still be required according to local practices.

Cancelling the review 

4.6  In some instances the applicant may plan to use the self-management route but later find that this is not possible, for example the registered reviewer they were going to use is unavailable due to long-term sickness and the applicant’s timelines will not be met. In these cases the applicant can:

a) use the HRA-managed process if they decide it will be beneficial, though payment will then be managed in accordance with HRA-managed studies or;

b) decide not to proceed through Technical Assurance at all. For Radiation Assurance, applicants should seek MPE and CRE reviews themselves. For Pharmacy Assurance, applicants should follow the alternative site approval process for participating nations. Payment for these reviews will be managed directly with sites according to their processes and this guidance should not be used further.

5. HRA-Managed Studies 

Assigning Reviewers 

5.1  When the HRA is assigning reviewers (as described in the below sections) it will do so by using the fewest number of reviewers and employing trusts/health boards wherever possible. This is to reduce the administrative burden on trusts/health boards and sponsors in processing payments.

5.2  Specialisms required will always be taken into consideration when assigning reviewers.

5.3  Where the lead nation is Scotland, reviewers will be chosen from that nation in the first instance. Equally, where the lead nation is England, Northern Ireland or Wales, reviewers will be chosen from one of these nations in the first instance to ensure that appropriate funding is available for them.

5.4  Where no reviewers are available to undertake the review from the applicable nations as given in 5.3 the HRA will choose a registered reviewer from another nation in line with its internal processes. Alternatively, the sponsor will have the option to wait for registered reviewers to be available from the nation(s) given in 5.3. Where there are implications for payment, the HRA will liaise with the sponsor to seek advice as to how it would like to manage the selection of reviewers. Please refer to 5.10 for further details.

5.5  Reviewers do not have to be from participating sites.

5.6  Where the sponsor has previously worked with certain trusts/health boards (e.g. to undertake an MPE review), they should check the registered reviewer list to identify whether these trusts/health boards have a reviewer registered with the HRA and specify to the HRA (upon submission) their choice of reviewing trust/health board. The sponsor will be able to choose up to three reviewing trusts/health boards and may also request particular reviewers at those sites, all of which must be specified at the time of submission.

5.7  Where a specific reviewer or trust/health board is identified from the list and requested by the sponsor, the HRA will allocate the study to that reviewer or another reviewer at that site, where availability allows.

5.8  Where no reviewers are available to undertake the review at the requested trusts/health boards, the HRA will choose a registered reviewer from another site from its list in line with its internal procedures. Alternatively, the sponsor will have the option to wait for registered reviewers to be available at the request trusts/health boards.

Payment Arrangements

5.9  Where the study is being processed through the HRA-managed route and the reviewer is based in England, Northern Ireland or Wales, the standard review fee will be applicable. Where a reviewer has been assigned from Scotland the review fee which is specified by the reviewer will be applicable.

5.10  In instances where the lead nation is England, Northern Ireland or Wales and the reviewer is based in Scotland, the fee for the review will be specified by the reviewer. In instances where the lead nation is Scotland but the reviewer is based in England, Northern Ireland or Wales, the standardised review fee will be applicable.

5.11  It is up to the sponsor and trust/health board to agree the most appropriate form of agreement for completion of the review and payment. This process will vary dependent on local policies and procedures.

5.12  The HRA will provide the reviewer with the contact details of the applicant to make the arrangements for payment.

5.13  Payment should be made to the trust/health board after the applicant has received confirmation of technical review completion from the HRA except where a review is cancelled, in which case payment should be made in line with Cancellation of the Review.

5.14  The HRA recommends that payment should be made from the sponsor to the trust/health board within 30 days of receipt of confirmation of technical review completion (or cancellation).

Radiation Assurance - Specific Payment Arrangements for Private Reviewers 

5.15  In some instances, reviewers may wish to act as private individuals. This would be appropriate where the reviewer is retired, for example, and is no longer working on behalf of their local NHS/HSC organisation, or where reviewers conduct reviews outside of the time spent working for their employer. Where this is the case, sponsors and reviewers who act as private individuals should note the following:

a) Payment for completion of the review should still be made in line with the Payments Framework Guidance.

b) If reviewers who are employed spend time completing reviews outside of their normal working hours, it is up to them and their employer to agree whether payment for completion of the review may be made to the reviewer from the sponsor via the employer into the reviewer’s wages or whether it should be made directly to the reviewer.

c) It is the sponsor's responsibility to check with their finance departments the arrangements for making payments to sole traders and limited companies, to ensure that they are made within HMRC rules. The HRA is not responsible for checking the payment arrangements comply with HMRC rules.

d) There may be implications for reviewers’ tax and national insurance contributions. Guidance is available from HMRC.

6. Amendments 

Radiation Assurance 

6.1  The HRA will process amendments through Radiation Assurance as requested by the sponsor. Further guidance on what changes to the study would lead to a review through Radiation Assurance can be found on the IRAS website.

6.2  Amendments to ionising radiation exposures of studies which already have Radiation Assurance will be processed in line with HRA processes and will incur a fee of £250 plus VAT per reviewer where the study is HRA-managed.

6.3  Where an amendment is to add ionising radiation exposures for the first time and Radiation Assurance is being applied for, the full review fee of £500 plus VAT per reviewer will apply where the study is HRA-managed.

6.4  Where an amendment is being reviewed as self-managed, the sponsor and the trust/health board should agree an appropriate fee for the completion of the review.

6.5  Payment should be managed and made in line with the processes set out in section 4 (self-managed studies) and section 5 (HRA managed studies) as applicable.

6.6  Where amendments are submitted as a result of the outcome of a quality assurance check, payment may not be required for the completion of the amendment review. Further information is available in Quality Assurance. 

Pharmacy Assurance 

6.7  In line with the Pharmacy Assurance amendments guidance the HRA will not review any amendments to the technical pharmacy review.

7. Cancellation of the Review 

7.1  No payment will be required when: 

a) the technical review is cancelled by the applicant before it is sent to the reviewer

b) the technical review is cancelled by the applicant after it is sent to the reviewer, but no work has commenced on the review. 

7.2  In some cases, the technical review may be cancelled after it has been sent to a reviewer and work has begun on the review but it is not completed. Reasons for cancellation of the technical review under this case may include, but are not limited to:

a) the study is cancelled in the UK and technical review is therefore no longer required;

b) the sponsor is amending the study design and/or documents so substantially that the completion of the review with the submitted documents would not be useful.

7.3  Where 7.2 applies, it will be the responsibility of the trust/health board and the sponsor to agree an appropriate fee for works already undertaken. This may be a partial re-imbursement to the trust/health board, or the full payment, depending on how much work the reviewer has undertaken prior to the review being cancelled.

7.4  The HRA is unable to mediate payment discussions regarding what would be considered an appropriate fee for a partially-completed review, as it will not have received information other than queries about the review and is not able to assess the level of input each reviewer has given into the review.

7.5  If 7.2b applies and the applicant is ready at a later date to re-submit the study for review, a new application should be made. Where the study will be HRA-managed, the appropriate review fee will be payable to reviewers conducting the review in line with HRA-Managed Studies and Amendments.

8. Quality Assurance 

8.1  The HRA is committed to ensuring quality within the completed technical reviews and has implemented a quality assurance programme to assure stakeholders of our commitment. Quality is monitored based on feedback from sites, applicants, Research Ethics Committees (RECs), and the Administration of Radioactive Substances Advisory Committee (ARSAC). Further information on how the HRA manages quality assurance for the Technical Assurance programme is available on the Pharmacy or Radiation Assurance pages of the website.

8.2  Payment for quality assurance checks to be conducted by reviewers is incorporated into the review fees and no separate payment is required for this activity.

8.3  In some instances feedback from stakeholders may raise issues with the quality of the information provided within the review. In most of these cases they can be resolved without the content of the review changing and therefore there will be no impact on the payment already made.

8.4  Where further investigation or assurance is required because the issue cannot be resolved between the applicant and the reviewer, a quality assurance check may be conducted. Payment for quality assurance checks to be conducted by reviewers is incorporated into the review fees and no separate payment is required for this activity.

8.5  In very rare instances as a result of issues being raised by stakeholders or quality assurance checks being conducted, the content of the Radiation Assurance review may need to be amended. In this case the following will apply:

a) The original reviewer will amend the review in line with the findings of the quality assurance check; no additional payment will be required.

b) If the original reviewer is not available (e.g. they are on long-term sick leave), the HRA will attempt to assign the review to another reviewer with the requisite specialism within the same trust/health board; no additional payment will be required.

c) If the applicant requests to use another reviewer, or if point b is not possible, payment will be required to the employing trust/health board of the new reviewer in line with the details in Amendments.

9. Appendix 

Payments Flowchart