Award Policies (contd.)

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.

Statement on the handling of allegations of research misconduct
 
The Wellcome Trust/DBT India Alliance (the 'India Alliance') identifies integrity, openness and partnership as key values; this statement has been produced and is intended to be applied in line with those values. The expectation is that the necessity to invoke these procedures will be a rare event but that by following these general principles the process of investigating allegations of research misconduct will be a fair process that protects the interests of all the parties involved.
 
Throughout this statement:
 
• 'CEO' means the Chief Executive Officer of the India Alliance.

• 'Organisation' means any organisation in receipt of India Alliance funds.

• 'The India Alliance’ means the Wellcome Trust/DBT India Alliance, a public charitable trust established under the laws of India that provides support for high-quality biomedical research and seeks to promote basic and applied research.

• 'Grantholder’ or ‘Grantholders’ means all India Alliance-salaried researchers and non-India Alliance-salaried researchers in receipt of funds in any form from the India Alliance in order to advance their research.

1. Definition of research misconduct
 
1.1 Research misconduct is defined by the India Alliance as:
The fabrication, falsification, plagiarism or deception in proposing, carrying out or reporting results of research or deliberate, dangerous or negligent deviations from accepted practices in carrying out research. It includes failure to follow established protocols if this failure results in unreasonable risk or harm to humans, other vertebrates or the environment and facilitating of misconduct in research by collusion in, or concealment of, such actions by others. It also includes intentional, unauthorised use, disclosure or removal of, or damage to, research-related property of another, including apparatus, materials, writings, data, hardware or software or any other substances or devices used in or produced by the conduct of research.
It does not include honest error or honest differences in the design, execution, interpretation or judgement in evaluating research methods or results or misconduct unrelated to the research process. Similarly, it does not include poor research unless this encompasses the intention to deceive.
 
2. Responsibilities of the organization
 
2.1 The India Alliance considers that it is the responsibility of the organisation to investigate all allegations of research misconduct made against its staff and students. Findings of research misconduct may be matters for consideration under the organisation's disciplinary procedures.
 
2.2 Organisations will need to give consideration to the procedures that will apply to visiting researchers while based in the organisation and the organisation’s staff while based in another organisation.
 
2.3 It is the responsibility of the organisation to inform the CEO, in confidence, at the earliest opportunity, about allegations of serious research misconduct that concern grantholders where it seems that there are reasonable grounds to believe that the allegation may be substantiated on investigation. It is at the discretion of the organisation to determine what constitutes 'serious misconduct'. The organisation is also responsible for informing the CEO of the outcome of any such investigation.
 
2.4 It is the responsibility of the organisation to inform the CEO, in confidence, of all instances of research misconduct involving grantholders that have resulted in the allegations being substantiated.
 
2.5 The organisation should have in place a policy statement relating to the treatment of whistleblowers, including a clear statement that research misconduct is taken seriously in the organisation and that any member of staff raising bona fide concerns can do so confidentially, and without fear of suffering any detriment. The statement should include a clear indication of the procedures in which such bona fide concerns by staff may be brought to the attention of a designated individual within the organisation.
 
3. Principles for investigation by organisations of allegations of research misconduct
 
Each organisation must have in place formal written procedures for dealing with allegations of research misconduct against its staff and students. Organisations should, where appropriate, take legal advice on implementing these procedures to ensure that the procedures comply with all legal obligations for the conduct of such investigations from time to time in force.
Organisations should endorse the following principles when implementing these procedures:
 
• the responsibilities of those dealing with the allegation should be clear and understood by all interested parties

• measures should be in place to ensure an impartial and independent investigation and to ensure that line management obligations or other interests of • those dealing with the allegation do not conflict with these procedures

• those undertaking research at the organisation should be contractually obliged to participate in and comply with the procedure

• the organisation should consider the confidential nature of the investigation and how to safeguard the rights to confidentiality of the interested parties

• all interested parties should be informed of the allegation at an appropriate stage in the proceedings

• anyone accused of misconduct should have the right to respond
 
• a policy should be in place to ensure that no employee who makes an allegation in good faith against another employee shall suffer a detriment, but equally that disciplinary procedures are in place to deal with malicious allegations
 
• the allegation should be dealt with in a fair and timely manner
 
• proper records of the proceedings should be kept
 
• the outcome should be made known as quickly as possible to all interested parties
 
• anyone found guilty of misconduct should have the right to an appeal
 
• appropriate sanctions and disciplinary procedures should be in place for cases when the allegation is upheld
 
• if appropriate, efforts should be made to restore the reputation of the accused party if the allegation is dismissed.
 
4. Receipt of allegations at the India Alliance
 
The India Alliance recognises that there may be instances where an allegation of research misconduct is made directly to a member of the India Alliance’s staff or the CEO rather than to an individual within the organisation. In such instances, the CEO will contact an appropriate individual at the organisation and the organisation will then be responsible for taking suitable action in line with its formal written procedures for handling allegations of research misconduct.
 
5. Investigations by the India Alliance
 
As stated above, it is the organisation’s responsibility to investigate allegations of research misconduct made against its staff and students and this would be the India Alliance’s preferred course of action in most cases. In exceptional cases, however, the India Alliance may wish to undertake its own investigation into alleged cases of research misconduct that concern grantholders (for example where the India Alliance’s reputation is at risk or where the India Alliance is dissatisfied with the investigation undertaken by the organisation). Any investigations by the India Alliance would only be undertaken following consultation between the CEO and the appropriate representative(s) of the organisation.
 
6. Sanctions
 
If the organisation or the India Alliance determines that the allegation of research misconduct is substantiated, the India Alliance may consider appropriate sanctions. These may include, but are not restricted to:
 
• a letter of reprimand
 
• the withdrawal of funding
 
• requiring the withdrawal or correction of pending or published abstracts and papers emanating from the research in question
 
• changes to the staffing of the particular project
 
• special monitoring of future work
 
• barring the grantholder from applying for India Alliance funds for a given period
 
• repayment of grant plus interest at the India Alliance’s discretion
 
• discussion with the rganisation on the implementation of appropriate disciplinary procedures.
 
At all times, in line with its award conditions, the India Alliance reserves the right to withdraw funding with immediate effect.