The mission of The Wellcome Trust/DBT India Alliance is to establish and nurture talent of the highest international standards, in cutting-edge biomedical research in India, resulting in important scientific breakthroughs and applications to society. In view of the overwhelming evidence that both active and passive smoking of tobacco is injurious to health, the Wellcome Trust/DBT India Alliance is unwilling to fund applications from individuals applying for, holding, or employed under a research grant from the tobacco industry.
The use of independent peer reviewers (to obtain advice from experts knowledgeable in a particular research area) is an intrinsic part of The Wellcome Trust/DBT India Alliance (the ‘India Alliance’) decision-making process when deciding which activities it chooses to fund.
Maintaining confidentiality in the peer review process is central to the India Alliance’s approach because it considers, in line with the majority of scientific research funding organisations worldwide, that the best quality peer review is obtained when the referees can comment candidly, in the knowledge that their comments will be disclosed only to those directly involved in the decision-making process. In addition, the India Alliance maintains the confidentiality of the comments because, in most cases, they relate directly to the work of identifiable individual scientists. However, with the permission of the referees, the India Alliance usually feeds back non-attributed comments to applicants who have submitted full applications. This is particularly useful to applicants who have not been successful, as the comments can assist them in understanding why their application was not supported and how improvements might be made to future applications.
Researchers funded by the India Alliance are expected, if they conduct stem cell research, to do so according to high ethical standards and to comply with all applicable legal and regulatory requirements.
Research should be carried out in accordance to the Department of Biotechnology and Indian Council of Medical Research’s Guidelines for Stem Cell Research and Therapy.
India Alliance funded researchers should deposit viable samples of human stem cell lines derived using India Alliance funding in an internationally recognised stem cell bank.
Stem cell research is funded on merit and scientific excellence after rigorous peer review.
The mission of The Wellcome Trust/DBT India Alliance (the 'India Alliance') is to establish and nurture talent of the highest international standards, in cutting-edge biomedical research in India, resulting in important scientific breakthroughs and applications to society. This is the driving force behind all of the India Alliance’s charitable funding activities, and the basis for its policy on the protection and use of intellectual property rights. The aim of this policy is to provide a clear statement for India Alliance grantholders of the India Alliance’s position on the protection and use of intellectual property through patents.
In developing this policy, the India Alliance has considered a wide range of issues, in particular the role of intellectual property rights in creating the best conditions for research and in translating that research into tangible healthcare benefits. The India Alliance supports the appropriate protection and use of intellectual property where this will maximise healthcare benefits and enable biomedical research to flourish.
In order for research advances to qualify for intellectual property protection, the legal criteria for patent protection must be fulfilled. This means that, to be patentable, the results of research must describe an invention that is:
• Novel, i.e. not described elsewhere before
• Non-obvious, i.e. involving a step sufficiently inventive that most people working in that field could not have predicted it
• Capable of industrial application, i.e. described in such a way that it can be made or used.
Patents, including those covering genes and their products, are no exception, and the India Alliance is supportive of these if there is sufficient information to indicate that the DNA sequences in question can be used to develop healthcare benefits. The India Alliance does not support the patenting of raw DNA sequences in the absence of such information..
The India Alliance is particularly concerned about patents and patent applications that are unreasonably broad and opportunistic, e.g. when there is limited functional data available to support those patent claims. The India Alliance may challenge such speculative patents if it believes that they are being applied for or used in ways that could be detrimental to research or limiting to the development of healthcare benefits.Policy on intellectual property and patenting
• The India Alliance supports the appropriate protection and use of intellectual property rights (IPR) to maximise healthcare benefits and to enable fundamental biomedical research to flourish.
• As such, the India Alliance supports the protection of research findings that meet the legal criteria for the filing of patents -that is, that findings should be novel, non-obvious (i.e. inventive) and capable of industrial application.
• The India Alliance believes that the basic DNA sequence of humans and other organisms should be placed in the public domain as soon as is practical, without any fees, patents, licences or limitations on use, giving free and equal access to all. Subject to this, the India Alliance is supportive of patents encompassing genes and their products when there is research data or information indicating that a particular DNA sequence has a utility such that the legal criteria for patenting can be met.
• All India Alliance grantholders and their host organisations are required to work with the India Alliance in relation to IPR arising from this funding in accordance with the Award conditions
• The India Alliance may challenge the inappropriate use of patents that it considers to be detrimental to scientific endeavour or to advances in healthcare.
• Founding scientists may also receive fixed amounts of cash or equity (or both) in consideration of the transfer of intellectual property to a commercial organisation, subject to compliance with paragraph 9 of the Grant Conditions and the policies of the institution.
The Wellcome Trust/DBT India Alliance (the ‘India Alliance’) is a public charitable trust established under the laws of India that provides support for high quality biomedical research and seeks to promote both basic and applied research. The India Alliance wishes to ensure that the useful results of this research are applied for the public benefit (i.e. the research should give adequate public benefit, with only incidental private benefit). The India Alliance recognises the importance of protecting and exploiting intellectual property arising from research as a means of achieving this public benefit. Accordingly, the India Alliance views it as desirable to encourage, where appropriate, scientifically productive relationships between its Grantholders and commercial organisations. At the same time, it wishes to ensure that the intellectual integrity of Grantholders and their freedom to carry out curiosity-driven research are not compromised by such relationships.
•‘Grantholder’ or ‘grantholders’ means all researchers benefiting from funds in any form from the India Alliance in order to advance their research.
• ‘Consultancy’ means any compensated service for or on behalf of a commercial organisation, including membership of a scientific advisory board or service as an expert witness, but does not include work undertaken for a publisher of academic journals or textbooks as an expert reviewer or author.
• ‘Intellectual property’ is defined in the Grant Conditions.
• ‘Equity’ means shares, share options, warrants, convertible debt or any other contractual or other right to acquire shares or options as an owner, proprietor, partner or beneficiary, or a beneficial interest in any of the foregoing.
• ‘Host organisation’ means the university, institution or other body at which some or all of the research funded by the grant will be carried out or which employs the grantholder or grantholders.
Policy of The Wellcome Trust/DBT India Alliance Consultancies and directorships
1. Grantholders may serve as consultants to commercial organisations. Consultancy is limited to the provision of advice and the exchange of ideas and must not include research or supervision of research. Consultancy must not enable a commercial organisation to gain access to unpublished data, findings or conclusions from grantholders that would give an unfair advantage to that organisation over its competitors in access to the India Alliance-funded research.
2. Subject to the policies of their host organisation, Grantholders may serve as non-executive directors of commercial organisations but may not serve as executive directors, except in exceptional circumstances. A grantholder wishing to accept an executive directorship would have to relinquish all forms of ongoing India Alliance support, or would have to obtain prior permission from the India Alliance' in writing for the India Alliance-funded research to continue with appropriate safeguards to ensure that the research would be brought to a satisfactory conclusion
3. Grantholders in receipt of salary support from the India Alliance must ensure that their time commitments to commercial organisations and other non-research activities are compatible with the policies of the host organisation and any conditions in the India Alliance’s Award Letter.
4. The terms of each consultancy or directorship must be set out in a written agreement between the grantholder and the commercial organisation. Before entering into a proposed consultancy or directorship, the Grantholder must inform the host organisation. The host organisation is required to review in advance all proposed consultancy or director’s service agreements involving grantholders and to ensure that the agreements are consistent with the policies of the host organisation, this policy and paragraph 9 of the Grant Conditions (‘Intellectual property and commercial activities’).
5. Where grantholders are to be involved in relationships with commercial organisations, the arrangements for any transfer of intellectual property arising from the India Alliance-funded research must be in accordance with paragraph 9 of the Grant Conditions and the policies of the host organisation.
Disclosure and management of conflicts of interest
6. Grantholders holding consultancies in, or directorships of, commercial organisations are required to make a declaration of interests to their host organisation. Should no mechanism be in place to do so, the grantholder should notify the India Alliance.
7. The compensation of grantholders for the work they undertake for commercial organisations must be compatible with the rules and regulations of their host organisation. Unless the rules and regulations of their host organisation dictate otherwise, compensation may include fixed amounts of cash or equity (or both).
8. Grantholders must disclose to their host organisation (a) benefits in cash and/or (b) benefits in equity of any level, received either as compensation for work undertaken for a commercial organisation, or in consideration of the transfer of intellectual property.
9. Grantholders holding equity in a commercial organisation must make a declaration of interests to their host organisation if they, together with members of their immediate family, hold, control or manage, directly or indirectly, (a) any level of equity in an unlisted company, or (b) equity in a listed company in excess of 1 per cent of that company's equity interest. ‘Immediate family’ includes spouse or partner; minor children; and adult children (but only in so far as the grantholder has knowledge of the interests of the adult children).
10. Grantholders must notify their host organisation in the event of any substantial upward or downward revision in the level of compensation received or the percentage or value of their equity interests, such as changes resulting from a professional financing round or the listing of the equity of the commercial organisation.
11. The host organisation may require, at its discretion, that lower levels of cash or equity holdings (or both) should be disclosed.
12. Applicants for India Alliance funding will be required to indicate within the grant application form whether they have any consultancies or equity holdings in, or directorships of, commercial organisations that might have an interest in the results of the proposed research. Should they be successful in their application, confirmation may be sought that they comply with the policies of their host organisation or any India Alliance requirements (including this policy, the Award Conditions and the Award Letter).
Responsibility for managing conflicts of interest
13. The India Alliance does not directly employ researchers, but funds them through their host organisation. Therefore, the host organisation is required to have a policy statement covering conflicts of interest and to manage any conflicts of interest arising from disclosures made to it by grantholders because of their involvement with commercial organisations. The India Alliance will wish to review such policy statements as part of its organisational eligibility checking procedures. It should be noted that if the policy statement of an applying organisation is not considered to be compatible with the India Alliance’s policy, or if the organisation lacks the means to monitor or manage the policy, the organisation will be deemed to be ineligible for funding by the India Alliance.
14. In managing a perceived or actual conflict of interest, it is the responsibility of the host organisation to ensure that the India Alliance will not be in breach of Indian charity law or regulation because of the relationship of a grantholder with a commercial organisation. In the event of any doubt, the grantholder should decline the Grant. In particular, the host organisation should act to ensure that the useful results of the India Alliance-funded research are applied for the public benefit, with only incidental private benefit. This might involve requiring a grantholder to relinquish direct control over some, or all, of the assets he or she holds in a commercial organisation or requiring the level of compensation offered to the grantholder to be capped.
15. The India Alliance reserves the right to decide not to proceed with an application or to terminate an award where a host organisation is unable to comply with any India Alliance requirements (including this policy, the AwardConditions and the Award Letter).
16. Where the host organisation has a concern about the commercial relationships of a grantholder, it should seek to rectify that concern. At its discretion, the host organisation may approach the India Alliance for advice.
17. In cases where there has been a breach of the policies of either the host organisation or the India Alliance, the India Alliance should be informed as soon as possible about the issues identified and the actions taken.
18. The India Alliance reserves the right at any time to require host organisations or individuals who hold or are seeking India Alliance funds to provide to the India Alliance current information about consultancies, directorships and equity holdings covered by this policy, copies of all relevant documentation, copies of the host organisation’s policies and details of the host organisation’s monitoring procedures.
19. The India Alliance reserves the right to review the decisions taken by a host organisation in managing conflicts of interest of grantholders in order to judge whether those decisions could have an adverse effect on the India Alliance’s compliance with relevant law or regulation or the India Alliance’s activities or interests.
20. To the extent permissible by law or regulation, all information provided to the India Alliance in order to comply with this policy is treated as confidential.
1. The Wellcome Trust/DBT India Alliance (the ‘India Alliance’) wishes to ensure that the outputs of the research it funds, including research data, are managed and used in ways that maximise public benefit. The India Alliance considers that the benefits gained from research data will be maximised when they are made widely available to the research community as soon as feasible, so that they can be verified, built upon and used to advance knowledge.
2. The guiding principles underlying the India Alliance Grant Conditions are that:
• Research funded by the India Alliance is charitable in nature (i.e. gives adequate public benefit with only incidental private benefit) and is not constrained by commercial or other interests of the researcher
• Discoveries, inventions and other knowledge arising from India Alliance-funded research are made freely available to the wider scientific community (publication can reasonably be delayed to allow for protection of any intellectual property).
3. In support of this position the India Alliance expects its grantholders to maximise the availability of research data with as few restrictions as possible.
4. Therefore, the India Alliance regards it as good research practice for all researchers to consider at the research proposal stage how they will manage and share the data they will generate.
5. In specific cases where applications for India Alliance funding involve the creation or development of a resource for the research community as the primary goal, or involve the generation of a significant quantity of data that could potentially be shared for added benefit, the India Alliance will:
• require that the applicants provide a data management and sharing plan as part of their application
• review these data management and sharing plans, including any costs involved in delivering them, as an integral part of the funding decision.
6. In addition to the responsibilities of those generating data, the India Alliance believes that data sharing for the benefit of the research community as a whole will only proceed if those using the data also adopt good research practice. In recognition of the contribution of the researchers and teams generating data, the India Alliance expects all users of data to acknowledge the sources of their data and abide by the terms and conditions under which they accessed the original data.
For the purposes of this policy statement, the term 'bioinformatics resource' is intended to mean a resource comprising databases of biological data and/or analytical tools for the interpretation of such data
The terms of access to some bioinformatics resources can include restrictions on the use and publication of data and intellectual property that are incompatible with The Wellcome Trust/DBT India Alliance (the ‘India Alliance’) Grant Conditions.
Organisations and their India Alliance-funded grantholders should therefore ensure that when assessing the scientific need to access a bioinformatic resource:
• They consider whether there are any freely available resources in the public domain which would meet that scientific need
• Where access to a bioinformatics resource is necessary, they do not enter into any access agreements that impose restrictions on the use and publication of data and intellectual property that are incompatible with the India Alliance Grant Conditions.
1) The India Alliance considers that it is the responsibility of organisations to enter into any access agreements to bioinformatics resources on behalf of their India Alliance-funded grantholders.
2) Any organisation in receipt of India Alliance funding, which enters into an agreement to access a bioinformatics resource, must ensure that the terms of this agreement do not compromise its ability, or the ability of its India Alliance-funded grantholders,to satisfy the India Alliance Grant Conditions, in particular with respect to the use and/or publication of data and intellectual property.
3) The India Alliance will consider requests for funding the costs of subscriptions to bioinformatics resources only where applicants can demonstrate clearly that the scientific case for utilising these offers a clear advantage over any comparable resources in the public domain, and that the terms of their access are compatible with the India Alliance Grant Conditions.
4) Where there is any uncertainty, the India Alliance should be consulted.
The main output of the research funded by The Wellcome Trust/DBT India Alliance (the ‘India Alliance’) is new ideas and knowledge, which the India Alliance expects its grantholders to publish in high-quality, peer-reviewed journals.
The India Alliance believes that maximising the distribution of these papers - by providing free, online access - is the most effective way of ensuring that the research it funds can be accessed, read and built upon. In turn, this will foster a richer research culture.
The India Alliance therefore supports unrestricted access to the published output of research as a fundamental part of its charitable mission and a public benefit to be encouraged wherever possible.
Specifically, the India Alliance:
• Expects authors of research papers to maximise the opportunities to make their results available for free
• Requires electronic copies of any research papers that have been accepted for publication in a peer-reviewed journal, and are supported in whole or in part by India Alliance funding, to be made available through PubMed Central (PMC) and Europe PMC PubMed Central (Europe PMC) as soon as possible and in any event within six months of the journal publisher's official date of final publication
• May include in the grant funding to contribute to open access charges, where appropriate, in order to meet the India Alliance’s requirements
• Encourages - and where it pays an open access fee, requires - authors and publishers to license research papers such that they may be freely copied and re-used (for example for text and data-mining purposes), provided that such uses are fully attributed
• Affirms the principle that it is the intrinsic merit of the work, and not the title of the journal in which an author’s work is published, that should be considered in making funding decisions.
For further details please read our Award Conditions.
Note: In terms of broad principles the India Alliance’s Open Access Policy is similar to that of The Wellcome Trust.
All research funded by The Wellcome Trust/DBT India Alliance (the ‘India Alliance’) must be fully compliant with the law and all researchers and facilities must have the appropriate regulatory approval. It is the responsibility of the organisation to ensure that India Alliance-funded research that involves the use of animals complies at all times with the relevant laws and regulation in the host country. The relevant Indian standards can be found on the Government of India Ministry of Environment and Forests website..
The India Alliance expects that, as well as being compliant with all local legislation and ethical review procedures, any research involving the use of animals is carried out in the spirit of UK legislation, which the India Alliance considers to provide an appropriate international standard for research involving the use of animals. Information about the code of practice for the housing and care of animals under UK legislation can be found on the Home Office website..
As well as complying with the legislation, all India Alliance grants involving animals are assessed by independent peer reviewers who are asked to ensure that the use of animals in the research is necessary and relevant. In all animal experiments supported by the India Alliance, the principles of the 3Rs .
(Replacement, Refinement and Reduction) apply.
The Wellcome Trust/DBT India Alliance endorses the position statement on bioterrorism and biomedical research published by the Wellcome Trust.
The Wellcome Trust/DBT India Alliance (the ‘India Alliance’) expects all work involving human participants to be undertaken in accordance with the highest ethical standards. All the research involving human participants should be conducted in accordance with the four basic ethical principles, namely autonomy (respect for person / participant), beneficence, non-maleficence (do no harm) and justice. India Alliance-funded grantholders are responsible for ensuring they are aware of the issues surrounding the use of human subjects in research, comply with relevant legislation and have obtained all necessary approvals.
Institutional ethical committees and administrators should have mechanisms in place for protection of human participants, and assessment and analysis in case a serious adverse event is reported. Grantholders, in consultation with ethics committees, are responsible for determining the healthcare standards that would be provided to the participating human subjects.
The India Alliance will consider applications before the consent of the relevant ethics committee is obtained and before statutory procedures have been completed, but no research should begin until all relevant approvals have been granted. The India Alliance reserves the right to view relevant approval documents.
The India Alliance will not be liable in any manner for the Grantholder’s non-compliance with any relevant legislations or rules or for any direct or indirect injury caused to volunteer or any third person during the course of or in relation to a clinical trial.
All trials must be registered before the intervention is started, in line with the Declaration of Helsinki 2013. The ethical guidelines on use of human participants from Indian Council of Medical Research (ICMR) are available here.