Clinical Trials and Cohort Studies Grants

For Funding Commencing in 2021

Research Office Contact:
research-applications@newcastle.edu.au

This Scheme is CLOSED. 

The Clinical Trials and Cohort Studies Scheme 2021 round is expected to open on Wednesday 30 June 2021 and close Wednesday 25 August 2021. An indicative timeline for the 2021 round is listed below.

Clinical Trials and Cohort Studies Grants aim to support high-quality clinical trials and cohort studies that address important gaps in knowledge, leading to relevant and implementable findings for the benefit of human health. This grant opportunity is open to research proposals for clinical trials and/or cohort studies of any size – that is, they may be large or small clinical trials or cohort studies.

The desired outcomes of the scheme are improvements in health and well-being, health care practice or policy, resulting from:

  • high-quality clinical trials that provide reliable evidence of the effects of health-related interventions on health outcomes (or appropriate surrogates), and/or
  • high-quality cohort studies that provide reliable evidence on the relation of important risk factors and other exposures to health-related outcomes.

The provisional funding allocation for the 2019 scheme is estimated to be up to $70 million. The amount of funding provided will be based on assessment of the requested budget. Funding can be requested for between one and five years.

Please note: It is strongly recommended all applicants subscribe to the Research Office NHMRC mailing list for up to date information on this scheme.


Key Dates

The below timeline is indicative only and may be subject to change

It is strongly recommended all applicants subscribe to the Research Office NHMRC mailing list for up to date information on this scheme.

Scheme Opens in SapphireWednesday 30 June 2021
UON Online Booking System OpensThursday 1 July 2021
UON Eligibility and Compliance Check PeriodThursday 22 July - Wednesday 11 August 2021
Minimum Data Requirements due in Sapphire5:00 pm Wednesday 28 July 2021
UON Deadline for Final Application9:00 am Wednesday 18 August 2021
NHMRC Scheme Closes5:00 pm Wednesday 25 August 2021
  • Applicants are strongly encouraged to commence their application in Sapphire ASAP after the scheme opens so that they can:
    • book their preferred day for an Eligibility and Compliance Check.
    • receive a copy of the scheme Essential Instructions developed by the Research Office to assist you in the completion of your application.
  • To enable the allocation of appropriate resourcing, bookings must be made prior to the defined scheme Eligibility and Compliance Check period. Access to book an Eligibility and Compliance Check will no longer be available once the Eligibility and Compliance Check period has commenced. This does not apply for schemes with continuous rounds (i.e. ARC Linkage Projects and NHMRC Partnership Projects).
  • The UON deadline for final application (the internal deadline) requires the provision of a submission-ready proposal to the Research Grants Office submitted via Sapphire, as well as a fully signed application coversheet.

Clinical Trials and Cohort Studies Grants may be funded by or in conjunction with other organisations. These grants offer opportunities to researchers whose work is particularly relevant to the priorities and research interests of the partner organisations. Some funding partners may require a separate application to be provided to them, or may have specific criteria and requirements, in addition to NHMRC. Applicants may contact the funding partner to identify any additional requirements.

Current NHMRC Clinical Trials and Cohort Studies Grant Funding Partners are:


Preparing an NHMRC grant

The NHMRC is required to publish Grant Guidelines and all associated scheme documents on GrantConnect, the Australian Government whole-of-government, web-based, grant information system. You will need to sign in or create a User Registration account in GrantConnect to access all relevant documentation for NHMRC applications.

Once you have signed in to GrantConnect, the essential documents can be found by searching for the relevant scheme under ‘grant opportunities’ (open schemes) or ‘forecast opportunities’ (upcoming schemes). As the NHMRC often updates documents after the scheme opens, it is highly recommended that you sign up for alerts by editing your profile.

If you encounter any problems accessing or downloading these documents please contact research-applications@newcastle.edu.au or 4921 7733.

UON Documents

The Research-NHMRC mailing list is managed by the Research Office and is used to communicate essential information regarding grant opportunities offered by the National Health and Medical Research Council (NHMRC). Information regarding opportunities offered through the Medical Research Future Fund (MRFF), regardless of who administers the grant (i.e NHMRC, Department of Health, Depart of Industry, Science, Energy and Resources), are also communicated via this list.

Internal EOI processes for limited round MRFF opportunities are also be advertised via this list.

Information about applying, minimum data deadlines, eligibility information, changes to guidelines and conditions of award, progress report requirements etc. are communicated via this list.

If you currently hold an NHMRC/MRFF grant or fellowship, or intend applying for one, the Research Office strongly recommends subscribing to this list.

Subscribe to the Research-NHMRC Mailing list (UON staff and students only)

NHMRC uses Sapphire for all grant rounds.

Resources are available to assist in navigating Sapphire, such as how-to videos.The NHMRC will update Sapphire’s web page with latest news and other relevant information. Applicants are encouraged to check back regularly to keep informed of any updates.

Researchers should confirm all Profile data is complete and up-to-date prior to submitting an application.

A summary of the key changes for Sapphire Profile and NHMRC’s recommendations for checking your profile data is available on the NHMRC Sapphire - Profile Update webpage. If you have any questions or concerns about your migrated profile data, please contact the NHMRC.

CI Eligibility Limits and Sapphire

Unlike RGMS, Sapphire does not contain the functionality to perform validations checks to alert the applicant or the Research Office to potential eligibility issues. Instead it relies on each CI to ensure they are not exceeding the eligibility requirements for the scheme.

The Research Office strongly recommends that CIAs ensure that their entire CI team carefully check to ensure they meet the eligibility requirement for the specific scheme – noting that for some schemes eligibility is limited to one application as CI. Please contact the Research Office if you are unsure of your eligibility so we can assist.

The NHMRC will rule all applications ineligible in instances where any CI (CIA-CIJ) is in excess of the maximum number of grants they are eligible to apply for or hold.

Eligibility for schemes is outlined in the scheme specific Guidelines.  CIs are advised to carefully review this information to ensure that all members of the research team to be named on an application, meet the scheme specific eligibility requirements.

CIs may submit a total of two applications across the Ideas, Investigator, and Synergy Grant schemes in any given funding round dependent on the number of grants already held.

It is important to note:

  • That the Investigator Grant 2021 (internal deadline 24 March) and Ideas Grant 2021 (internal deadline 28 April) are considered the same funding round;
  • An Investigator Grant 2021 application will count as one of the maximum two applications across the three schemes;
  • If the Investigator Grant 2021 is successful, any Ideas Grant the Investigator Grant applicant is listed on as a CI, irrespective of whether it is CIA-CIJ, will be removed and excluded from consideration.

If any CI (CIA-CIJ) submits an Ideas, Investigator or Synergy Grant application(s) in excess of the maximum for which they are eligible to apply or hold, all Ideas, Investigator, or Synergy Grant applications on which that CI is named may be ineligible and excluded from consideration, irrespective of the scheme to which they have applied, and that CI’s position or role on the application.

The Research Office recommends that applicants carefully review the NHMRC eligibility tool and the specific scheme Guidelines, to determine eligibility prior to commencing an application or agreeing to be a CI on an application.  Please contact our office at research-applications@newcastle.edu.au if you are unsure of your eligibility so we can assist.

For further information please see:

If you have further questions about your eligibility, please contact research-applications@newcastle.edu.au.

Minimum data must be entered in Sapphire by the scheme-specific deadline to allow the NHMRC to find suitable peer reviewers for the application. Applicants must complete the required fields with correct information. Using placeholder text such as “text”, “synopsis” or “xx” etc. is not acceptable as minimum data. Minimum data requirements for each scheme are specified in the scheme Grant Guidelines.

Failure to meet the Minimum Data deadline will result in the application not proceeding.

The Research Office uses an online booking process to manage optional Eligibility and Compliance Checks on applications for NHMRC Schemes. Scientific content is not reviewed. It is recommended that you see Peer Review of your application also either via your faculty or through the UON Academy of Reviewers where available.

A booking must be made within the allocated E&C Check period for each scheme. Applicants are strongly encouraged to commence their application in Sapphire ASAP after the scheme opens so they can book their preferred day for an E&C Check. Bookings without a Sapphire application ID will be cancelled.

Appointed by the DVCRI and nominated by UON College Pro-Vice Chancellors, the UON Academy of Reviewers is a select and esteemed group of highly experienced researchers who will act as a reference group for the Research and Innovation Division providing comment on strategic matters as they arise.

A key strategic role for members of the Academy will be the review of draft UON grant applications in the major grant rounds, to provide tactical feedback and advice to applicants. An internal Expression of Interest (EOI) process will be used by the Research Office to facilitate this valuable scientific content review.

Please visit the UON Academy of Reviewers webpage for a list of members of the Academy as well as a timeline for ARC/NHMRC scheme reviews.

Please see the NHMRC Submission Procedure on the NHMRC Grants webpage and the Online Booking System User Guide for instructions on how to make a booking for an Eligibility and Compliance Check.

Once complete, the CIA must certify and submit the application in Sapphire via the Certification page. To do this, select the ‘Certification’ page in Sapphire, select ‘Certify and submit to RAO'. This will result in the status changing to 'Submitted to RAO' - which equates to 'Research Administration Office' (NOT the NHMRC).

For NHMRC applications involving Hunter New England Local Health District (HNELHD) patients, sites and/or HNELHD Chief or Associate Investigator(s) it is important to ensure that the appropriate HNELHD manager(s) approval has been obtained prior to the University of Newcastle internal deadline.

The HNELHD process for approval requires the completion of the HNELHD Brief Approval Template signed by the appropriate HNELHD manager(s). HNELHD recommend that applicants commence this process as soon as possible to ensure approvals are obtained prior to the University internal deadline.

Please contact the HNELHD Research office if you have any questions relating to their processes or research involving HNELHD patients or sites.

Please note that applicants who are proposing to access HNELHD patients or sites but who do not have a formal affiliation with HNELHD, will need to ensure the application team includes a HNELHD investigator in accordance with HNELHD requirements.

The NHMRC has released a Toolkit for Consumer and Community Involvement in Health and Medical Research to ‘provide practical advice on engaging with consumers and the community to undertake high quality and relevant research’.

The Toolkit comprises of five individual resources available for download from the Consumer and community engagement page.

The Toolkit has been designed by the NHMRC and its Community and Consumer Advisory Group to complement the 2016 Statement on Consumer and Community Involvement in Health and Medical Research

Impact Case Studies

The assessment criteria for some NHMRC schemes now include research impact wherein applicants are required to demonstrate the impact of a project or program of research.

Applicants will be assessed based on:

  • The significance and reach of their claimed research impact
  • The contribution of their research program to the research impact

NHMRC defines the impact of research as the verifiable outcomes that research makes to knowledge, health, the economy and/or society. Impact is the effect of the research after it has been adopted, adapted for use, or used to inform further research. Research impact is the verifiable outcomes from research and not the prospective or anticipated effects of the research. Research impact also includes research that leads to a decision not to use a particular diagnostic, treatment or health policy.

Engagement and Impact Toolkit

Research Services has developed an Engagement and Impact Toolkit which helps to provide:

  • a comprehensive overview of how research engagement and impact is increasingly influencing researcher practice, institutional strategies and practices as well as research funding;
  • strategies to support research impact at the institutional, faculty and individual level;
  • resources to support data capture and effectively communicate research impact.

A series of tiles on the EI Toolkit homepage link visitors to information and resources across major themes including An introduction to the EI Toolkit, Resources, ARC Engagement and Impact assessment, Promoting your research impact and Collecting EI data.

Citation metrics

One aspect of impact evidence is represented by the recognition of scholarly research outputs. Citation metrics are a significant part of this evidence. Please see the UON Library Guides for a more detailed breakdown of this aspect of research impact.

Research Services can provide researchers with access to view successful applications where the lead Chief Investigator has provided consent. Applications must be viewed in hard copy in the Research Services office or by arrangement at HMRI.

How to Arrange to View a Successful Application

Contact research-applications@newcastle.edu.au to request access to view successful applications for a specific scheme. Please include preferred date(s), time(s) and location.

Confirmation of the date, time and venue will be provided to you by Research Services staff.

Presentations

Grant Accelerator Session Recording and Presentations - available via the Research Advantage Resources Hub

Please note a University login is required to access presentation resources

All research projects that are either partially or fully supported by NHMRC funding are required, by the NHMRC Funding Agreement, to appropriately acknowledge the NHMRC contribution to research and other activities in any correspondence, public announcement, advertising material, research report or other material produced for the research project.

The acknowledgement should mention the NHMRC as a funding body, include the Grant Identification Number for the Research Activity and specify that the contents of the published material are solely the responsibility of the research institutions involved or individual authors and do not reflect the views of NHMRC.

Whilst this acknowledgement most often occurs within research outputs, such as journal publications, efforts should also be made if participating in dissemination activities such as conferences or interviews with media outlets.

The University of Newcastle acknowledges the traditional custodians of the lands within our footprint areas: Awabakal, Darkinjung, Biripai, Worimi, Wonnarua, and Eora Nations. We also pay respect to the wisdom of our Elders past and present.