Program description and rules

The following rules apply to all proposals received from and grants awarded to researchers as part of the Grant for Fertility Innovation (GFI) program. The grant rules and procedures may be changed by EMD Serono for projects based in the United States and by EMD Serono KGaA, Darmstadt, Germany to those based in the rest of the world at any time, without notice, in order to comply with applicable laws, rules, regulations, company policies or industry codes. 

If you have any questions regarding the grant rules please contact gfi@emdserono.com.

1. Program description?

As part of EMD Serono’s commitment to advance science and medicine, the GFI was launched in 2009. The selection of the GFI awards is based on the goal that research projects should demonstrate innovation and relevance to real-world practice for the benefit of couples seeking fertility assistance. With our long-term commitment to addressing infertility, EMD Serono is dedicated to integrating both drugs and technologies within fertility management strategies, in a patient-centred way, to ultimately reduce the time to live birth. Our focus on innovation, both through our own sponsored research, and that supported by GFI, drives our aim to answer key research questions in fertility, which will enable clinicians to improve outcomes for couples following assisted reproduction techniques.

EMD Serono and its affiliates believe that medical research and dissemination of scientific and educational information are worthy undertakings deserving support. Support for research, however, must be carried out in an appropriate manner. Research grants awarded by the company must be consistent with all applicable laws, rules, regulations, company policies and industry codes and may not be used as a price concession, reward or inducement to prescribe or purchase our company products.

2. Award criteria

The following criteria must be met for all GFI awards:

• The research must take the form of short-term research with relevance to clinical practice. Some examples of this would include biomarkers for treatment response, development of new targeted treatments or technology platforms for the routine analysis of molecular biomarkers
• The research must be of legitimate scientific value to the company or the medical/scientific community at large and must be designed to provide meaningful information or conclusions
• The research must be innovative, feasible, have a strong scientific rationale, have the potential for practical utility and the potential for personalisation
• The research must not compete with any research and development or clinical projects sponsored by EMD Serono or any of its global affiliates
• No preference will be given to individuals or entities for prescribing or purchasing EMD Serono products or to induce the prescription or purchase of EMD Serono products in the future. Grant recipients are not expected or obliged to prescribe or purchase EMD Serono products
• The amount awarded for the research must not exceed the legitimate costs to be incurred in carrying out the research to be funded by the grant, and must be commensurate with and not exceed fair market value for the research activities
• All applicable regulatory requirements must be observed, including, as appropriate, regulatory filings and ethics committee/Institutional Review Board review and approval
• The selected researchers must not be currently excluded, debarred, suspended or otherwise ineligible to participate in their respective countries of citizenship, residence and/or practice. Any selected U.S.-based researcher must not be currently excluded, debarred, suspended or otherwise ineligible to participate in currently any U.S. Federal healthcare programs or in Federal procurement or non-procurement programs by the Office of Inspector General or the General Services Administration
• The selected researchers must have the appropriate training and expertise to conduct the research, as determined by the GFI Scientific Steering Committee
• Awarding research grants to an individual researcher not affiliated with an institution, as opposed to an institution or organisation with a tax identification number, is discouraged but not prohibited, provided all other requirements of the innovation award are followed
• In addition to the rules set forth above, all grants must comply with all applicable laws, rules or regulations
• Partial funding declaration: if partial funding of the project has been obtained, the applicant(s) must declare the source and amount of funding already available
  If no other source of funding is available at the time of this application and the applicant is awarded a grant sum, which does not cover the full project costs (as cited in the submitted proposal), then the applicant must provide documentation confirming that the remaining, necessary funds will be obtained from an additional source/sources before the first milestone payment can be disbursed 
  This partial funding declaration is intended to ensure that the applicant(s) has/have all necessary funding to cover the cited budget and will be able to successfully complete the research project

3. Audit and monitoring

All research activities carried out in connection with a GFI are subject to audit and monitoring by EMD Serono to help ensure that the research programs comply with law and applicable EMD Serono policy. In addition, the name of the grant recipient and amount of the grant will be publicly disclosed to the extent required by law and applicable EMD Serono policy.

In order to ensure the appropriate progress of innovation award research projects, grant recipients must provide the company with periodic updates on the progress of each project, as outlined in their Grant Agreement.  These reports (Interim Reports and the Final Report) must include updated budget information and substantiation of expenses, before any relevant milestone payments are made.

If a research project is not progressing satisfactorily, appropriate action will be taken, including, but not limited to, withdrawing any remaining funding and terminating the research project.

Final report and publication

EMD Serono desires to ensure that research undertaken as part of the GFI program is completed and analysed. All grant recipients must provide the company with final study results in the form of a Final Report as well as a Final Certification, as outlined in their Grant Agreement. Publication (manuscripts or abstracts) of the research results in peer-reviewed journals is also to be strived for, as outlined in the Grant Agreement.

EMD Serono supports the exercise of academic freedom by researchers and expects the results of research to be published, whether or not the results are favourable to EMD Serono.

5. Certification

When a research project is completed or terminated, the researcher and/or institution conducting the research must certify to EMD Serono that: (i) the research was conducted in accordance with the terms of the Grant Agreement; (ii) any unused funds provided by EMD Serono have been returned to the company; (iii) all safety reporting obligations were met; and (iv) if required, a manuscript or abstract has been submitted for publication, or the research was terminated early and a publication is not appropriate.

6. Reconciliation

At the end of the research project, reconciliation will take place to ensure that funds were used solely for the purpose stated in the GFI application and any unused funds are returned to EMD Serono.