The Wellcome Trust/DBT India Alliance (the ‘India Alliance’) expects its grantholders to adhere to the highest standards of integrity. To facilitate this it provides guidelines on good research practice and a statement on the handling of allegations of research misconduct. Organisations are expected to have in place their own published standards of good research practice and formal written procedures for the investigation of allegations of research misconduct.1. Introduction
The India Alliance cannot be prescriptive about individual approaches taken by its grantholders to solving particular research problems. But the India Alliance expects organisations to ensure that an adequate structure exists to promote and promulgate good research practice, emphasising integrity and rigour in research, and to create a culture in which the following general principles can be understood and observed.2. Integrity
• Grantholders should be honest in respect of their own actions in research and in their responses to the actions of other researchers. This applies to the whole range of research work, including experimental design, generating and analysing data, applying for funding, publishing results, and acknowledging the direct and indirect contribution of colleagues, collaborators and others.
• Plagiarism, deception or the fabrication or falsification of results should be regarded as a serious disciplinary offence.
• Grantholders are encouraged to report cases of suspected misconduct and to do so in a responsible and appropriate manner.
• Grantholders should declare and manage any real or potential conflicts of interest.3.Openness
• While recognising the need for scientists to protect their own research interests, the India Alliance expects its grantholders to be as open as possible in discussing their work with other scientists and with the public in order to help foster an informed public climate within which biomedical science can flourish.
• Once results have been published, the India Alliance expects its grantholders to make available relevant data and materials to other researchers, on request, provided that this is consistent with any ethics approvals and consents that cover the data and materials and any intellectual property rights in them.
• The India Alliance recognises that publication of the results of research may need to be delayed for a reasonable period pending protection of intellectual property arising from the research. Any such periods of delay in publication should, however, be kept to a minimum.4. Guidance from professional bodies
• Where available, the India Alliance expects its grantholders to observe the standards of research practice set out in guidelines published by scientific and learned societies, and other relevant professional bodies.
• All grantholders should be aware of the legal requirements that regulate their work.5. Leadership and cooperation
• Heads of organisations and their senior colleagues should ensure that a research climate of mutual cooperation is created in which all members of a research team are encouraged to develop their skills and in which the open exchange of ideas is fostered.6. Supervision
• Organisations should ensure that they provide an appropriate direction of research and supervision of researchers. Training in supervisory skills should be provided where appropriate.
• A code of responsibilities should be available for supervisors indicating, for example, the frequency of contact, responsibilities regarding scrutiny of primary data, and the broader development needs of research trainees.
• The need should be stressed for supervisors to supervise all stages of the research process, including outlining or drawing up a hypothesis, preparing applications for funding, protocol design, data recording and data analysis.7. Training
• Organisations should have in place systems that allow students and new researchers to understand and adopt best practice as quickly as possible.
• All grantholders should undertake appropriate training, for example in research design, regulatory and ethics approvals and consents, equipment use, confidentiality, data management, record keeping and data protection.8. Primary data/samples
• There should be clarity at the outset of the research programme as to the ownership of, where relevant:
- data and samples used or created in the course of the research
- the results of the research.
• Grantholders should keep clear and accurate records of the procedures followed and the approvals granted during the research process, including records of the interim results obtained as well as of the final research outcomes. This is necessary not only as a means of demonstrating proper research practice, but also in case questions are subsequently asked about either the conduct of the research or the results obtained.
• Data generated in the course of research should be kept securely in paper or electronic format, as appropriate. The India Alliance considers a minimum of ten years to be an appropriate period, but research based on clinical samples or relating to public health might require longer storage to allow for long-term follow-up to occur.
• Back-up records should always be kept for data stored on a computer.
• Organisations should have guidelines setting out responsibilities and procedures for the storage and disposal of data and samples (including compliance with the requirements of any ethics committee)9. Ethical practice
9.1 Research involving human participants
• Approval is required from an appropriate ethics committee for all research funded by the India Alliance involving human participants or biological samples. Approval should also be sought from other appropriate regulatory bodies.
• Grantholders should ensure the confidentiality of personal information relating to the participants in research, and that the research fulfils any legal requirements.9.2 Research involving animals
• Research involving animals should have approval through the appropriate ethical review process, and must be fully compliant with any local legislation.
• Grantholders should consider, at an early stage in the design of any research involving animals, the opportunities for reduction, replacement and refinement of animal involvement (the three Rs).9.3 Risks of research misuse
• In progressing their scientific investigations, grantholders should actively consider any risks that their research will generate outcomes that could be misused for harmful purposes. Where such risks exist, they should seek advice and take active steps to minimise them.
• Organisations should have in place mechanisms to ensure that risks of misuse associated with ongoing research programmes are identified and managed, and to provide advice to the researchers that they employ on these issues.10. Publication practice
• Results should be published in an appropriate form, usually as papers in refereed journals, with copies being made available through PubMed Central (PMC) and UK PubMed Central (UKPMC) as soon as possible and in any event within six months of the journal publisher’s official date of final publication.
• Anyone listed as an author on a paper should accept responsibility for ensuring that he/she is familiar with the contents of the paper and can identify his/her contribution to it. The practice of honorary authorship is unacceptable.
• The contributions of formal collaborators and all others who directly assist or indirectly support the research should be properly acknowledged.
• To assist the India Alliance in tracking the outputs of research to which it has contributed either wholly or in part, the India Alliance’s contributions must be acknowledged in all publications.
The Wellcome Trust/DBT India Alliance (the ‘India Alliance’) has a duty to ensure that applications for funding are assessed expertly, objectively and impartially; review by an appropriately constituted body is therefore seen as an essential element of the India Alliance's decision-making process. For this reason, the India Alliance's Trustees delegate their authority to make decisions on applications to their selection committees. The India Alliance relies heavily on the willingness of members of the scientific community to give their time to sit on these selection committees, and the India Alliance is most grateful to them for the vital role they play in the grant-giving process.
The India Alliance also recognises the need to protect and preserve the integrity of the India Alliance’s grant-giving processes, and is concerned that selection committee members may be placed under pressure to breach confidentiality and provide information on committee discussions and recommendations. To assist selection committee members in these situations, the India Alliance has set down a code of conduct for those who serve on its selection committees.
For the protection of other selection committee members and referees, and to ensure the impartiality of the peer-review process, if the India Alliance has reason to believe that a member of an India Alliance selection committee has breached the following code of conduct, then he/she may be asked to resign his or her membership.Code of conduct
1. Selection committee members should be aware that:
1.1 they are covered by the India Alliance’s policy on conflicts of interest and are required to declare any interests that could give rise to a conflict of interest with their India Alliance role
1.2 they should not offer advice to members of the scientific community on the India Alliance’s policy and practices, for example on application procedures - all such enquiries should be directed to the staff of the India Alliance.
2.The following are strictly confidential:
2.1 selection committee's discussions (including the reasons for decisions to fund or not to fund)
2.2 the contents of papers and correspondence relating to applications for funds.
3.Selection committee members and referees also have a right to expect that their comments will be treated in confidence, by both the India Alliance’s staff and other members of the selection committees. For that reason:
3.1 papers must be kept secure and not disseminated to anyone
3.2 applications must not be discussed with anyone else (including colleagues based at the member's host organisation and referees) without prior permission from the India Alliance.
3.3 members of selection committees must not inform candidates of the composition of a selection committee or details of other applicants: if it is appropriate that the candidate should have this information, India Alliance staff will provide details.
3.4 members of selection committees who are connected* in any way with an application must absent themselves from the meeting room during discussion of the application, and must not be informed of the outcome of the application by other members - they will be informed by India Alliance staff in due course.
3.5 no aspect of the deliberations or recommendations regarding an application should be discussed with applicants, either in connection with their own application, or any other application. Feedback will be provided as appropriate by India Alliance staff, in accordance with India Alliance practice. Selection committee members should refuse any requests for information or for an explanation of how a particular decision was reached - all such requests must be referred to the staff of the India Alliance.
3.6 the identity of referees must be kept confidential at all times.Footnote
An individual will be connected with a grant application if he or she is:
• an applicant or a named collaborator
• a relative or member of the household of one of the applicants (including but not limited to spouse, child, sibling, or parent)
• a business partner of one of the applicants; a member or employee of the same university, or other organisation, as one of the grant applicants.
Policy on conflicts of interest for individuals involved in The Wellcome Trust/DBT India Alliance decision makingI. Preamble
This policy sets out principles for minimising and managing potential conflicts of interest for individuals involved in Wellcome Trust/DBT India Alliance (the ‘India Alliance’) decision making.
The India Alliance has established a register for disclosable interests, covering general, academic and scientific interests, to help the India Alliance achieve its policy objectives.
While the India Alliance has endeavoured to identify the main potential conflicts of interest that may arise for individuals covered by the policy, it is impossible to foresee every eventuality. The India Alliance therefore expects all such individuals to comply with the spirit of the policy as well as its content.
The India Alliance also has separate gift and hospitality policies applicable to Trustees and staff.II. Objectives of the policy
The objectives of the policy are:
1. to maintain the integrity and good standing of the India Alliance
2. to protect the India Alliance against conflicts of interest that may be detrimental to its activities, by
(a) ensuring that, in principle, individuals covered by the policy make decisions free from any external influences, either personal or fiduciary, whilst recognising that it is precisely their position and expertise external to the India Alliance that enables certain individuals to make valuable contributions to its work; and
(b) adhering to the rule that those who work on behalf of a charity should not be enabled to make a personal profit as a result of that work, for example, by using information confidential to the India Alliance for personal gain.
3. to protect the India Alliance’s reputation against conflicts of interest that may arise as a result of the positions, both internal and external, held by individuals who contribute to the India Alliance’s work in their area of specialisation.
4. to protect the India Alliance and those individuals covered by the policy against impropriety or the appearance of impropriety, including reputational risk.III. Main issues A. Who is covered 1. Individuals covered by the policy
1.1 The India Alliance's policy on conflicts of interest applies to the following persons:
(b) members of the India Alliance staff and those working for the India Alliance
(c) members of the India Alliance's committees
(d) any other person the India Alliance notifies as being covered by this policy.
1.2 It is the responsibility of each individual covered by the policy to observe its terms. If individuals are in any doubt as to its application to them, they should discuss this with the chief executive officer ('CEO') or his authorised representative.B. Disclosures 2. Declarations - general
2.1 Each individual covered by the policy must declare all of his or her disclosable interests, including all consultancies or appointments (see paragraph 4.1) and relevant equity holdings (see paragraph 2.5). Declarations must be made on taking up an appointment (or change of role or position) with the India Alliance or at such time as a disclosable interest arises. Subsequently, the individual must confirm the state of his or her disclosable interests once a year. Declarations will be made using a disclosure form.
2.2 It is the responsibility of each individual covered by this policy to ensure complete disclosure of all activities and interests covered by this policy (at the time such an activity or interest arises), and any other matters that they believe might influence, or be perceived to influence, their judgement. If an individual is in doubt as to whether to declare a particular activity or interest, the activity or interest should be declared.
2.3 The responsibility remains at all times with the individual to take steps to deal with any conflict of interest, or potential conflict of interest, as set out within this policy.
2.4 Declared information, including the data held on the Disclosure Register, will be treated in strict confidence. Declared information will be made available within appropriate peer groups only as necessary to prevent or minimise possible conflicts of interest, and to facilitate consistency in the level of declarations made. In the majority of cases information on disclosures will be anonymised and summarised, and named information will be on a strict need-to-know basis. The India Alliance reserves the right to provide declared information to the relevant authorities in India if required to do so by law or regulation.Declarations - equity holdings
2.5 Each individual covered by the policy must declare any interest he or she has in the share capital of any company (whether or not publicly listed) involved in pharmaceuticals, biotechnology, biosciences, healthcare or similar activities, where that interest totals 1 per cent or more of the issued share capital or is currently worth the equivalent of 1 000 000 Indian Rupees or more. The calculations will take into account all options or convertible securities held as if the options were exercised and the securities converted into shares. Declarations must also cover any interest as a partner or proprietor in any business operating in these areas and any indirect holding in non-discretionary private investment entities.
2.6 If an interest is required to be disclosed, the declaration must include the following information:
(a) the name of the company
(b) the nature of the shares, including any associated voting rights
(c) the current value of the shares held, by specifying the range from the list below -
• less than the equivalent of 1 000 000 Indian Rupees
• the equivalent of 1 000 000 Indian Rupees to 19 999 999 Indian Rupees
• the equivalent of 20 000 000 Indian Rupees or greater.
(d) the percentage of shares held, by specifying the range from the list below
• less than 1 per cent
• 1 per cent to 4.99 per cent
• 5 per cent or greater.
2.7 Investments managed by third parties on a discretionary basis, such as investment trusts, life assurance funds or unit trusts, will be exempted from any controls imposed by the India Alliance
2.8 The India Alliance acknowledges that, in certain other cases (for example, in the case of investments made through an entity such as a limited partnership), an individual may not have immediate knowledge of investments made by that entity, even though the interest is immediately attributed to him or her. In such cases, the individual should make disclosure at such time as he or she receives the necessary information from the entity in question.
Members of household; investments managed for other persons
2.9 The requirement to make declarations of relevant interests extends to the interests of members of the individual’s household.
2.10 In the case of their adult children, individuals need only make declarations insofar as they normally have knowledge of the children’s investments or relevant appointments. Individuals need not make any special request for information.
2.11 Declarations should also be made about investments that individuals manage or control, whether this is on behalf of family members or others.
The disclosure register
2.12 All disclosed interests will be noted on the disclosure register maintained by the CEO or an authorised representative.3. Resolution of identified conflicts
3.1 Potential conflicts of interest highlighted by declarations of interest, including consultancies and appointments, may normally be resolved by the individual concerned not participating in the relevant decision and being restricted in access to information. But for individuals mentioned in 1.1(a) and (b), there may be extreme cases where the only resolution to the conflict may be for the Board of Trustees on the advice of the CEO to ask the individual concerned to give up the particular interest.C. Consultancies and other external appointments 4. General
4.1 Each individual covered by this policy must declare all consultancies and other external appointments (paid and unpaid directorships and charitable trusteeships, positions with funded institutions such as universities, and positions with funding bodies, government departments and agencies), together with full details of the remuneration and benefits received in respect of each consultancy and appointment. Examples of consultancies and external appointments can be found at Annexe A.
Prior approval for Trustees and India Alliance staff
4.2 When a Trustee or member of India Alliance staff is offered a consultancy or appointment, he or she should seek confirmation that the position may be accepted. Confirmation will be given by
(a) the CEO of the India Alliance (in the case of India Alliance staff)
(b) the Programme Advisory Committee (in the case of Trustees, including the chairman and CEO).
The CEO will consult with the Programme Advisory Committee where appropriate in the best interests of the India Alliance. Any breaches of the policy will be reported to the Board of Trustees.
4.3 Where a proposed consultancy or appointment proves controversial, it may b
Prior approval in other cases
4.4 When a member of the India Alliance’s committees is offered a consultancy with, or appointment to, another organisation, he or she need only seek confirmation that the position may be accepted if it raises a direct and obvious conflict of interest, or where the other organisation has an important role in the funding of science (see Annexe A). Confirmation will be given by the CEO, countersigned by the Board of Trustees. Disclosure of all interests is still required.
4.5 The India Alliance will notify any persons falling within paragraph 1.1(d) whether they will be covered by paragraph 4.2 or 4.4.
D. Minimising conflicts of interest in the decision-making process
5. Through membership of the India Alliance's committees
5.1 'Charitable Committees' shall include the Programme Advisory Committee, the Selection Committees and any other body involved in the award of grants or other charitable funding on behalf of the India Alliance.
5.2 The general principle is that Charitable Committees should be chaired by a person external to the India Alliance.
Trustees - general
5.4 The general principle is that Trustees should not seek to influence, or be seen as having influence over, the decision-making process outside of formal meetings of the Board of Trustees or the relevant committee. In particular, Trustees should not seek to influence any decisions relating to the eligibility or funding of other Trustees at any time.
5.5 Trustees who are approached by individuals or organisations for advice on an application for a specific grant or on the preparation, status or outcome of their specific applications should always refer all such enquiries to the relevant staff members of the India Alliance, unless the Trustee is already excluded from the decision-making process in relation to that application by reason of an existing conflict of interest, in which case he or she may give such advice as he or she is in a position to.
5.6 The CEO will be ineligible to apply for India Alliance funding.
Trustees - selection committees
5.7 A Trustee should not chair or normally be a member of a Selection Committee. Any such Committee should be chaired by a person external to the India Alliance.
5.8 A Trustee should not normally chair a site visit of a Committee, but a Trustee may be present. A Trustee should not be present at a site visit relating to another Trustee.
5.9 A Trustee may attend meetings of any Committee subject to compliance with any guidelines for attendance of individual Trustees at meetings that may be approved by the Board of Trustees from time to time. A Trustee should refrain from influencing any recommendations where he or she might be construed as having a conflict of interests.
5.10 Save in exceptional circumstances, a Trustee must not, prior to a meeting of any Committee, discuss any application to be considered at that meeting with any Committee member responsible for reviewing that application.
5.11 A Trustee should not question or attempt to overturn any decision that has been reached by a Committee. If a Trustee believes that such a decision raises serious issues, then he or she should raise the issues with the CEO of the India Alliance.
6. Composition of charitable committees
6.1 The Chair of each Charitable Committee will, subject to the above, be a person external to the India Alliance. The Charitable Committees may not be chaired by a member of the India Alliance’s staff.
6.2 A person may be appointed as Chair for a period not normally exceeding three years.
6.3 The Chair is appointed by the Board of Trustees.
6.4 The Chair has the authority to appoint a Vice Chair from the non-staff membership, if required, at the start of each meeting. A Trustee may not be appointed as Vice Chair. In the absence of the regular Chair, the Vice Chair will act as Chair.
6.5 The Secretary to each Charitable Committee is appointed from the India Alliance’s staff. Unless otherwise specified, the Secretary is a member of the Committee.
6.6 The Secretary should not, in the absence of the Chair or Vice Chair, take the chair at any time.
6.7 Other than as specified above under paragraphs 6.1 to 6.6, Charitable Committee members are appointed by the Board of Trustees, normally for a three-year term renewable for up to a maximum total term of five years. During the initial term and any extension, the member may serve as Vice Chair or Chair. A member may return to serve on a Committee for a second term after a gap of normally at least three years.
6.8 A person may serve consecutively as a member and/or as Chair of the same Committee, provided that a person’s consecutive membership of the Committee in any capacity shall not normally exceed six years.
7. Discussion of applications outside meetings
7.1 Save in exceptional circumstances, a Committee member (including a Trustee but excluding the Secretary) must not, prior to a meeting of that Committee, discuss any application which is to be considered at that meeting with any other Committee member responsible for reviewing that application. If a Committee member does have any such discussion, this must be reported to the Chair and Secretary of the Committee at or before the start of the meeting.
7.2 Members of Committees who are approached by individuals or organisations for advice on a specific funding proposal or on the preparation, status or outcome of their specific applications should always refer all such enquiries to the relevant staff members of the India Alliance.
7.3 If an individual is approached for technical advice on an application in his or her area of specialisation, the individual may provide such advice but must disclose this fact to the Secretary of any Committee of which he or she is a member and which is considering the application. The individual may be excluded from all or part of the meeting at which the application is considered, under paragraphs 8.6 to 8.8.
8. Exclusion from grant decisions
Automatic exclusion from grant decisions
8.1 References to 'grant' shall include any charitable funding of any type.
8.2 Individuals must absent themselves from the relevant part of any meeting where matters concerning a grant proposal with which they are connected are discussed. They may not take part in any decisions taken in relation to such a grant proposal, and should not receive any papers relating to it. In exceptional circumstances, where the exclusion of a particular member would compromise the efficient working of a Committee, the Chair may override the automatic exclusion provided that he is satisfied that there is no significant conflict of interests for the Committee member. Where there are justifiable reasons for not excluding such a member, these reasons will be declared and minuted.
8.3 An individual will be connected with a grant proposal in any of the following cases, if the individual is:(a) the sole applicant
Exclusion at the India Alliance's discretion
8.4 The chair will exclude an individual if he or she:(a) holds (or is seeking), from the India Alliance or another funding agency, a research grant on a similar topic to a proposal that is due to be considered at a particular India Alliance meeting, such that the individual could be considered to be a direct competitor of the applicant
8.5 The Secretary (or where there is doubt as to whether an individual should be excluded, the Secretary in consultation with the Chair) will determine whether the individual should:(a) be permitted to take a full part in the meeting
A unanimous decision of the Chair and Secretary will be final. If a unanimous decision cannot be reached, the individual must absent himself or herself from the relevant part of the meeting.
8.6 The following guidance should be noted:(a) An individual who has acted as an external referee to a similar proposal submitted to another funding body may be invited to take a full part in the meeting.
Further guidance will be issued to Secretaries as to the application of these paragraphs 8.4 to 8.6.
8.7 Paragraphs 8.4 to 8.6 apply even where a proposal has been rejected by another funding body. The India Alliance is committed to considering each proposal on its merits.
8.8 The Secretary should bring to the Chair’s attention all relevant information concerning any form of connection between an application and a member of the Committee.
Cases of uncertainty
8.9 If an individual is in any doubt as to the relevance of an interest that he or she has, such interest should be disclosed to the Secretary before the meeting or, if not practicable, as soon as the potential conflict becomes apparent at the meeting. The Secretary will consult as necessary and the Chair and Secretary shall determine whether the individual should absent himself or herself from the relevant part of the meeting in accordance with the provisions of paragraph 8.7 above.
8.10 Any potential conflict of interest involving the Secretary should be referred in the first instance for a decision by the Chair. If further guidance is required, advice should be sought from the Compliance Officer.
Committees other than those considering grant applications
8.11 Except to the extent permitted explicitly by any other part of this policy, individuals must absent themselves from the relevant part of any meeting where matters concerning their disclosable interests are discussed and may not take part in any decisions taken relevant to such interests.
9. Raising concerns about the conflicts of interest of other individuals
9.1 An individual who is concerned about another individual’s potential or actual conflicts of interests should raise the matter as set out below.
9.2 Issues concerning the CEO of the India Alliance should be raised with the Board of Trustees.
9.3 Issues concerning the Board of Trustees, or India Alliance staff should be raised with the CEO of the India Alliance.
9.4 Issues concerning a member of a Committee should be raised with the Chair or Secretary of that Committee.
9.5 If an individual is in doubt about how to raise a concern, he or she should seek advice from the CEO or his authorised representative.
Wellcome Trust/DBT India India Alliance Policy on Conflicts of Interest
Examples of different types of consultancies and external appointments
This annexe sets out examples of consultancies and external appointments that are, and are not, covered by the requirements of the policy. These lists are indicative only and are not exhaustive. They apply to such positions either in India or abroad.
what constitutes a consultancy or external appointment?
The following would constitute a consultancy or external appointment that has to be disclosed:(a) Trusteeship of any charity
What does not constitute a consultancy or external appointment?
The following would not constitute a consultancy or external appointment that has to be disclosed:
(a) Provision of professional services, on a non-recurring basis, not giving rise to fees exceeding the equivalent of 1 000 000 Indian Rupees from a single source in a calendar year
(b) Receipt of fees or honoraria for a lecture, provided that it does not give rise to fees exceeding the equivalent of 1 000 000 Indian Rupees from a single source in a calendar year;
What is a direct and obvious conflict of interest?
A direct and obvious conflict would arise, for example, for:(a) any appointment to a body funding research in fields that may also be funded by the India Alliance
Individuals uncertain whether a particular appointment would give rise to a direct and obvious conflict should contact the CEO for guidance.