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Instructions to applicants for completing collaborative applications

 

Contents

Instructions to applicants for completing collaborative applicationsNotes to Applicants

Process for UK only applications

Please refer to Section A of these notes.

Process for joint UK and Australian applications

Please refer to Section A for guidance notes for the UK based research and Section B for the guidance notes for the Australian based research. These should be read in conjunction with each other. Please also note the following points:

• A Stage 1 application must be made via the NIHR HTA programme using the online application form, outlining the UK & Australian research and the benefits of the joint approach. Please insert the UK only research costs in the estimated costs box on page 1 of the application form. The full cost of the project as well as the amounts to be allocated for UK & Australian funding should be included in the Research Plan.
• Short listed applicants will subsequently be invited to submit a stage 2 application to the HTA programme. Please insert the UK costs only into the main body of the application form. The full cost of the project as well as the amounts to be requested through UK & Australian funding should be included in the Justification of Costs section. Costs for the Australian component of the research must agree with those submitted to the NHMRC.
• The Australian team on a short-listed application will be required to submit an application to the NHMRC via its Research Grants Management System (RGMS) for the purpose of review of the requested budget for the Australian part of the collaboration. The Stage 2 application submitted to the NIHR is required to be uploaded to RGMS (as a .pdf) as part of the Australian application.
• The UK based research will be funded by the HTA programme and the Australian based research by the NHMRC.
• Australian based researchers must be affiliated with an NHMRC approved Australian Administering Institution.
• The NIHR application form requires one chief investigator who will be based in the UK. For collaborative applications, an Australian chief investigator will be required for the NHMRC application, who should be included on the HTA application as a co-applicant with no costs associated. 
• For Australian collaborations, an Australian clinical trials sponsor is required. Refer Section B for further information.
• The NHMRC will contact the lead applicants with further details.
• Australian applicants should refer to Section B for eligibility criteria.


Making an application

If you wish to apply for a collaborative call, complete the on-line application form via the  funding opportunities page (search for the specific call using the call number) and submit it on line by the date given on the advert. Stage 1 applications will be considered by the HTA Funding Committee at its next meeting.
Following Stage 1, short listed investigators will be given eight weeks to submit a full proposal. Stage 2 proposals will be considered by the HTA Funding Committee at the subsequent meeting.
Applications received after 13:00 (UK time) on the due date will not be considered.

Section A - Guidance notes for the UK based research (to be read in conjunction with Section B for joint UK and Australian applications)

The HTA Programme is funded by the NIHR, with contributions from the CSO in Scotland, Health and Care Research Wales, and the Public Health Agency in Northern Ireland.
A randomised controlled trial (RCT) is often the most appropriate methodology for HTA commissioned research. Suggestions for efficient study designs are encouraged. Where the study design has been left open for applicants to specify, please note that the HTA Programme welcomes any study design which is well justified as the most appropriate approach to answer the research question.


Applicants are asked to:


1. Follow the Medical Research Council’s (MRC) Good research practice: Principles and guidelines  when planning how studies, particularly RCTs, will be supervised. Further advice specific to each application will be given by the HTA Programme at stage 2 and contracting.


2. Note that trials involving medicinal products must comply with "The Medicines for Human Use (Clinical Trials) Regulations 2004". In the case of such trials, the UK Department of Health & Social Care (DHSC) expects the employing institution of the chief investigator to be nominated as the sponsor. Other institutions may wish to take on this responsibility or agree co-sponsorship with the employing institution. The DHSC is prepared to accept the nomination of multiple sponsors. Applicants who are asked to submit a full proposal will need to obtain confirmation of a sponsor(s) to complete their application. The DHSC reserve the right to withdraw from funding the project if they are not satisfied with the arrangements put in place to conduct the trial.

The MHRA (email: info@mhra.gov.uk) can provide guidance about whether your trial would be covered by the regulations. The NIHR Clinical Trials Toolkit  also contains the latest information about Clinical Trials regulations and helpful FAQ and glossary pages.

Applicants should seek advice from suitable methodological support services. It is advisable to make contact as early in the application as possible to allow sufficient time for discussion and a considered response.
The NIHR Research Design Service can advise on developing and designing high-quality research grant applications.

Clinical Trials Toolkit

Researchers designing clinical trials are encouraged to use the Clinical Trials Toolkit. This NIHR resource is designed to help researchers with the challenges of setting up and managing clinical trials in line with regulatory requirements. Although mainly aimed at those involved in publicly funded Clinical Trials of Investigational Medicinal Products (CTIMPs), the Toolkit will also benefit researchers and R&D staff working on trials in other areas, as the information and guidance is relevant to the wider trials environment.

Research networks
The HTA Programme expects that where appropriate, applicants will work with the relevant research network.

Australian applicants should refer to Section B for equivalent information to the above, relevant to conducting clinical trials in Australia.

Section B - Guidance notes for the Australian based research (to be read in conjunction with Section A)1

The information in this section is to assist researchers proposing joint applications with UK investigators.


The NHMRC has allocated a total of up to AU$ 3 million to support Australian-based components of projects funded collaboratively between the NHMRC and NIHR HTA Programme for up to 5 years. 

The NIHR reserves the right to fund only the UK component of joint UK/Australian collaborative study, judged on a case-by-case basis, if the Australian arm cannot be funded by the NHMRC. The NIHR will not fund the international component of collaborative studies.


Australian Partner Investigators

The Australian Investigator named in the application to the HTA programme will be required to be the Chief Investigator A (CIA) on the NHMRC application. The CIA takes the lead role in the Australian component of the research project, and is responsible for completion and submission of the NHMRC application. The CIA will be given the opportunity to list key members of the research team based in Australia as Chief Investigators B-J.


At the time of application and for the duration of a grant, the CIA must be an Australian or New Zealand citizen, a permanent resident of Australia or have an appropriate work visa. The CIA must also be based in Australia for at least 80% of the funding period.


Applications must be submitted through the Research Administration Office (RAO) of an NHMRC approved Administering Institution.


NHMRC Funding is provided by the Australian Government and administered in accordance with the NHMRC Funding Agreement. Funding is provided to the Administering Institution, which is responsible for the administration of the grant.

Australian based research proposal and budget

Details of the Australian components of the project are to be included in the Stage 1 proposal and any subsequent stage 2 application submitted to the HTA Programme. Submission of the NIHR joint Stage 1 and 2 proposals and an additional upload containing the Australian budget are the responsibility of the Chief Investigator.


The Australian CIA on an application short listed by the HTA programme will also need to submit a formal application through the NHMRC’s RGMS for the purpose of reviewing the requested budget for the Australian part of the collaboration. The NHMRC application should justify the requested budget including Personal Support Packages (PSP), Direct Research Costs (DRCs) and Equipment. This budget will be reviewed by NHMRC and may by adjusted as appropriate2.

Applicants should ensure that the budget submitted to the HTA programme for the Australian component of is compatible with standard NHMRC budget requirements as outlined at:


• Download NHMRC direct research costs guidelines 2019
NHMRC Funding Agreement and Deeds of Agreement


Enquiries regarding NHMRC funding should come from the RAO of the CIA’s Administering Institution. If further assistance is required, please contact the NHMRC Research Help Centre in Australia.


Please Note:


Compared to the NHMRC, the HTA programme has additional monitoring requirements which will be communicated to successful applicants. These include:

1. Six monthly progress reporting to the HTA programme including data for patient recruitment to trials. If a recruitment issue is identified, the frequency of reporting may be increased. The NIHR also requires a mechanism to halt/terminate trials that are not on track.
2. Publication of research findings (peer reviewed final reports) in the NIHR HTA journal.

Requirements for conducting clinical trials in Australia

For full details, please refer to the Australian Clinical Trials website.

All proposals to conduct a clinical trial in Australia require ethical review and approval by a registered Human Research Ethics Committee (HREC). Review by an Australian HREC is likely to be required, even if the study has approved by an overseas ethics committee, however, some HRECs will accept a previous ethics review.

Therapeutic Goods Administration - Trial compliance

Australia-based clinical trials involving the administration of drugs, chemical agents or vaccines to humans may require approval by the Therapeutic Goods Administration (TGA), which administers the Clinical Trials Notification (CTN) Exemption (CTX) Schemes. This does not apply to clinical trials in which registered or listed medicines or medical devices are used within the conditions of their marketing approval.

For further information on the regulation of clinical trials in Australia, please visit the TGA website.

The Australia Clinical Trials Handbook (TGA Health and Safety Regulation)

It is recommended that applicants for funding to support clinical trials research in Australia consult the following resources for additional information:

• The Australian clinical trial handbook

• The Australian Clinical Trials Toolkit

Good Clinical Practice (GCP) guidelines

The GCP Guidelines represent an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve human participants. The TGA has adopted the European Union version of GCP guidelines in Australia, with some modifications to accommodate the provisions of the National Statement on Ethical Conduct in Human Research (2007). The guideline should be followed when submitting clinical trial data to the TGA.

• ICH Guideline for Good Clinical Practice annotated with TGA comments

• National Statement on Ethical Conduct in Human Research (2007), updated 2018

Safety monitoring and reporting in clinical trials involving therapeutic goods (2016)

Trial Sponsor(s)

Applicants asked to submit a stage 2 application will need to obtain confirmation of a sponsor(s) to complete their application. All trials must have an Australian sponsor. Please note that a UK sponsor will also be required by the NIHR HTA programme. The sponsor is that person, body, organisation or institution which takes overall responsibility for the conduct of the trial. The sponsor usually initiates, organises and supports a clinical study and carries the medico-legal responsibility associated with the conduct of the trial.

Trial registration

All NHMRC funded clinical trials must be registered in the Australia and New Zealand Clinical Trials Registry (ANZCTR)


1 Australian applicants should also ensure they read and understand the GrantConnect Terms of Use and the specific instructions on the NHMRC-NIHR Collaborative Research Grant Scheme.

2 The NHMRC reserves the right to adjust requested budgets of Australian-based components depending on available funds and the number of applications received.