Guide for applicants

TDR EMPOWERMENT: RESEARCH CAPACITY AND LEADERSHIP DEVELOPMENT GRANTS 2009 BUSINESS LINE 2: EMPOWERMENT CAPACITY AND LEADERSHIP DEVELOPMENT GRANTS CALL FOR PROPOSALS & GUIDELINES FOR APPLICANTS These instructions were adapted from TDR/RP(A)/FORM/03 and in general apply to MIM/TDR grants  Re Entry Grants for Young Investigators  Institution Strengthening Grants 1 TDR EMPOWERMENT: RESEARCH CAPACITY AND LEADERSHIP DEVELOPMENT GRANTS 2009 DO NOT RETURN THESE INSTRUCTIONS WITH YOUR PROPOSAL FORM 1. Introduction TDR has a long and successful history of developing research capacity among institutions, individuals and networks involving countries where the target diseases 1 are endemic and countries with limited resources and research infrastructure. Building on the achievements over the last 30 years, the work of TDR is based now on three major strategic directions:- Stewardship for research on infectious diseases of poor populations; Empowerment of researchers and public health professionals from Disease Endemic Countries (DECs), to provide support for training and research, and to build leadership at individual, institutional and national levels and; Research on neglected priority needs that are not adequately addressed by other partners. TDR's current vision and strategy is designed to "foster an effective global research effort on infectious diseases of poverty in which disease endemic countries play a pivotal role". Details of the new strategy and the business plan can be found on the TDR website at: http://www.who.int/tdr/svc/about/strategy Within this strategy, the overall objective of TDR Empowerment is to foster leadership in health research and decision making so that high quality institutional and national systems can identify and manage research priorities. The emphasis is on developing the research management and leadership capacities both of individual researchers and their institutions in an integrated manner. The Re-entry and Institution Strengthening grants will aim at long-term sustainability, higher quality processes, and expanded partnerships. The grants will incorporate hypothesis driven research projects that also enhance one or more of the following:  Technical research skills and competences;  Capacity to manage and lead research projects at individual and institutional levels;  Institutional and individual capacity to provide quality assurance, good laboratory standards, and ethical review. The selection of grantees will be based on the recommendation of a scientific research advisory committee (the Research Strengthening Group - RSG) after review of eligible grant applications. The guidelines contained in this document take the applicant through the process of preparing and submitting a proposal in response to a RSG Call for Proposals and is essential reading. Section 2, „Preparation of a proposal,‟ gives important information necessary for applicants to prepare a well-described and focused proposal. Information about the Empowerment research capability strengthening funding scheme, technical (good practice, ethical and regulatory issues) and budget requirements are provided. For some subjects, we refer to the annexes of these guidelines, which are also essential reading. Section 3, „How to fill in the proposal form,‟ gives all the practical information required in order to correctly fill in the proposal form. Section 4 is a checklist of all eligibility criteria and annexes that the applicant should attach to the full proposal. In section 5, „Submitting your proposal,‟ there is information about the required format of the grant application. Section 6 „What happens next‟ describes the evaluation procedure and aims at providing information on the selection criteria and what can be expected if the proposal is selected for funding. Section 7 consists of a provisional timetable that indicates what is expected from the applicant as well as from WHO/TDR and how the different stages in the process from the launch of the call to the funding of a project relate to each other. Finally, the General Conditions for a WHO Technical Service Agreement is included as an annex to these guidelines. 2. Preparation of a proposal 2.1 About the funding scheme General requirements The funding scheme presented here is generally applicable to all TDR Empowerment calls for Capacity and Leadership Development (CLD) grant proposals. For the specific requirements for Re-entry or Institution Strengthening Grants, please read the applicable sections of the call. 1 TDR supports research in a wide variety of diseases and research areas. The current portfolio focus on 10 infectious diseases - African trypanosomiasis, Chagas disease, Dengue, Leishmaniasis, Leprosy, Lymphatic filariasis, Malaria, Onchocerciasis, Schistosomiasis and Tuberculosis. 2 TDR EMPOWERMENT: RESEARCH CAPACITY AND LEADERSHIP DEVELOPMENT GRANTS 2009 The overall objective of these grants is to develop excellence and leadership in health research and decision making. The grant aims at positioning institutional and national systems that can identify and manage research priorities. TDR will provide support through Re-entry and Institution Strengthening Grants to facilitate the establishment of sustainable research capacity development through strategic support for individual researchers and their institutions. DEC researchers will receive intensive support for the development of technical skills and competences in research management. This support will be within the context of strengthening institutional capacity to take responsibility for research, staff development and provision of the required infrastructure and systems for quality in the conduct of research. Four critical areas will be addressed in a) promotion of internationally accepted and validated research projects b) improvement of individual and institutional research management systems c) improvement of the ethical review processes d) development of good quality standards for the technical aspects (e.g. laboratory, data collection, data management) within research grants Eligible scientists and Institutions in Disease Endemic Countries are invited to submit proposals to the Capacity and Leadership Development programme for the following grants:   Re-entry grants for young investigators Institution Strengthening Grants. The proposals must include a plan to develop individual or institutional research and leadership capacity preferably in the context of one of the TDR research priorities2 outlined below: Lead discovery for new drugs for infectious tropical diseases: Research in this area must aim at facilitating and supporting the discovery of new leads (Compounds with drug characteristics that are efficacious in animal models of disease, with no overt toxicity) for the following diseases: Human African trypanosomiasis , Chagas disease, Leishmaniasis, Lymphatic filariasis, Malaria, Onchocerciasis, Schistosomiasis and Tuberculosis. Projects that involve technology transfer and innovative drug discovery in disease endemic countries through North–South and South–South collaboration and partnerships are encouraged. http://www.who.int/tdr/svc/research/lead-discovery-drugs/workplans Innovative vector control interventions: Research in this area aims at building capacity of DEC scientists to develop and evaluate improved and innovative vector control methods for the prevention of neglected diseases. http://www.who.int/tdr/svc/research/vector-control-interventions/workplans Development and evaluation of drugs for helminths and other neglected tropical diseases: TDR is currently supporting research to progress candidate drugs into development; generate evidence on efficacy and safety; and determine field safety and effectiveness of registered drugs and optimize their use ( see http://www.who.int/tdr/svc/research/drug-development-helminths-ntds/workplans) . Applications involving research in this area must be collaborative in nature with North–South and South–South interactions to build capacity where needed to ensure the work meets the highest international standards. Accessible quality-assured diagnostics: Research in this area aims at the development, evaluation and introduction of diagnostic tests for infectious diseases of poverty appropriate for use in developing country settings. http://www.who.int/tdr/svc/research/quality-assured-diagnostics/workplans Evidence for treatment policy for TB patients: Research in this area aims at generating evidence for optimized treatment and case management for all TB patients, including those with HIV or additional co-morbid diseases. http://www.who.int/tdr/svc/research/evidence-treatment-tb-hiv/workplans 2 TDR is supporting innovative research on neglected priority needs for disease control. Through focused, time-limited activities, the goal is to support research in the countries where the diseases are prevalent that fosters innovation for product discovery and development; research on development and evaluation of interventions in real-life settings; and research to increase access to interventions. These activities have been structured into nine research lines, which may vary over time. Some are functionally specific, while others are focused on specific diseases. http://www.who.int/tdr/svc/research 3 TDR EMPOWERMENT: RESEARCH CAPACITY AND LEADERSHIP DEVELOPMENT GRANTS 2009 Evidence for antimalarial policy and access: Research in this area aims at providing evidence for policy – developing strategies for improved access to effective treatment for malaria at all health system levels and by ascertaining safety and efficacy in specific populations and circumstances. http://www.who.int/tdr/svc/research/antimalarial-policy-access/workplans Research to support the elimination of visceral leishmaniasis: Research in this area aims at developing and validating innovative and efficient interventions and strategies for the elimination of visceral leishmaniasis from the Indian subcontinent. http://www.who.int/tdr/svc/research/visceral-leishmaniasis-elimination/workplans Integrated community-based interventions: Research in this area aims at developing innovative, effective and efficient strategies for implementing community-based interventions in poor populations. http://www.who.int/tdr/svc/research/community-based-interventions/workplans 2.2 Who can apply? 2.2.1 Re entry grants ($50,000 maximum over a period of 3 years) 2.2.1.1 Overall requirements: Scientists from disease endemics countries who are no more than 40 years of age and have recently (within 24 months) completed a PhD can submit a proposal. It is strongly recommended that the proposal involves research on one of TDR target diseases. The applicant must be currently employed in a public institution located in a disease endemic country (DEC). The host institution will play a major role in the management of the research project. A collaborator from an institution in the north or an advanced developing country may also be included in the project. This is advisable for studies involving the use of technologies not currently available in the disease endemic country institution. The collaboration must be with the objective of transferring technology to the DEC host institution. The shipment of samples for analysis in the north / advanced laboratory is not permissible under the grant. The collaborator from the more advanced laboratory must be committed to capacity building and indicate the extent of collaboration / support to the DEC institution in a letter addressed to TDR 3. Normally no project funds will be transferred to the more advanced institution. In exceptional cases funds may be transferred to facilitate the purchase of reagents for the DEC investigator. Funds to facilitate collaboration visits (where applicable) will be managed by the DEC institution. Women are especially encouraged to apply for the Re-entry grant. 2.2.1.2 The Principal Investigator (Re entry grants) The Principal Investigator is the coordinator of the project, consisting of the Research and Capacity Building components. The Principal Investigator, submits the proposal and is considered the only contact point with WHO/TDR for the proposed project during the review procedure and contract negotiations. The Principal investigator of the submitted project needs to satisfy the following requirements: • has been awarded a PhD or equivalent no longer than 24 months prior to the submission of the grant application (Please note that TDR may require a copy of your certificate). Individuals with less experience and degree are not eligible. • has to be a DEC national residing in a DEC. • is employed by a research, academic or public health institutions in the DEC. • has experience in the proposed area of research evidenced by a doctoral dissertation and peer reviewed scientific publications in the subject matter of the proposed research. Each grant can have only one Principal investigator. All other researchers are considered collaborators or co-investigators. Approved proposals are funded through a Technical Service Agreement between the World Health Organization and the Institution where the Principal Investigator is employed. If the Principal Investigator leaves the Institution with which the Technical Services Agreement is made or ceases to actively direct the project, the Institution shall promptly inform the Director, TDR of this fact, in which case WHO/TDR shall have the right to terminate the 3 Correspondence should be addressed to - The Manager, Research / Empowerment, Special Programme for Research & Training in Tropical Diseases, World Health Organization, 20 Avenue Appia, 1211 Geneva 27, Switzerland. E mail to: rsgtdr@who.int 4 TDR EMPOWERMENT: RESEARCH CAPACITY AND LEADERSHIP DEVELOPMENT GRANTS 2009 Agreement. No other Principal Investigator can be proposed by the Institution for a re entry grant. The Principal Investigator is the individual who is responsible for all technical aspects of the work referred to in the Technical Services Agreement at the Institution. The Institution is any legal entity, such as a research institute, university, ministry or research council, within which the Principal Investigator is working. 2.2.1.3 Other collaborators In principle, any person from a legal entity from any country may participate as collaborator in a TDR funded Capacity and Leadership Development project. Collaborators need to adhere to the following requirements: • All collaborators involved should hold at least a graduate degree (please note that TDR may require a copy of your certificate). • Any collaborator who knows that he or she will change employment during the course of the grant needs to state his or her new employer and, if applicable, his or her successor, in the project activities. 2.2.2 Institution Strengthening Grants ($70,000 / year over a period of 3 years): 2.2.2.1 Overall requirements Established 4 or advanced researchers 5 preferably from selected countries listed in the table of high priority countries (Below), experienced in research and interested in collaborating with the Research Strengthening Group to establish credible and quality sustainable research systems and structures in their institutions can submit a proposal. It is strongly recommended that the proposal involves collaborations / partnerships, training, quality systems and one of the TDR research priorities6 . The institution must be located in one of the countries listed in the table below, with the capacity to execute the research. This institution will play a major role in the management of the research project. A collaborator from an institution in the north or a DEC not included in the table below may also be included in the project as collaborators / partners. This is advisable for studies involving the use of technologies and skills not currently available in the host institution. The collaboration must be with the objective of transferring technology, skill or competence to the host institution. The shipment of samples or transmission of data files for processing and analysis in the collaborating institution is not permissible under the grant. The collaborator from the more advanced institution must be committed to capacity building and indicate the extent of collaboration / support to the host institution in a letter addressed to TDR7. Normally no project funds will be transferred to the more advanced institution. In exceptional cases funds may be transferred to facilitate the purchase of reagents and bench fees for students from the host institution. Funds to facilitate collaboration visits (where applicable) will be managed by the host institution. Women are especially encouraged to apply for the Institution Strengthening Grant. Proposals for Institution Strengthening Grants must clearly outline the current research capacity available and the areas of need in the institution. A plan of how this needs will be addressed through the grant should be provided under the following headings - human resource, environment and infrastructure. High priority countries for hosting a TDR/RSG Institution Strengthening Grant Afghanistan, Angola, Bangladesh, Benin, Bhutan, Burkina Faso, Burundi, Cambodia, Cape Verde, Central African Republic, Chad, Comoros, Democratic Republic of Congo, Djibouti, Ecuador, Equatorial Guinea, Guyana, Eritrea, Ethiopia, Gambia, Guinea, Guinea Bissau, Haiti, Kiribati, Lao People‟s Democratic Republic, Lesotho, Liberia, Madagascar, Malawi, Maldives, Mauritania, Mozambique, Myanmar, Nepal, Niger, Rwanda, Samoa, São Tomé and Principe, Senegal, Sierra Leone, Solomon Islands, Somalia, Timor-Lesté, Togo, Tuvalu, Vanuatu, Yemen, Zambia. 4 An Established researcher for the purpose of this programme is defined as one who has research credentials (normally a doctorate degree) and can independently formulate research questions, secure funds for research, conduct research within a framework of good practices and has peer reviewed publications of research results. 5 An Advanced researcher for the purpose of this programme is defined as an established researcher who is leading a team of scientists, providing training, is in a position to promote good research practices and quality management in the host institution and communicate research results to potential users. 6 TDR is supporting innovative research on neglected priority needs for disease control. The goals of these research activities areas outlined in section 2.1 above and can be viewed in more detail at http://www.who.int/tdr/svc/research 7 Correspondence should be addressed to - The Manager, Research / Empowerment, Special Programme for Research & Training in Tropical Diseases, World Health Organization, 20 Avenue Appia, 1211 Geneva 27, Switzerland. E mail to: rsgtdr@who.int 5 TDR EMPOWERMENT: RESEARCH CAPACITY AND LEADERSHIP DEVELOPMENT GRANTS 2009 2.2.2.2 The Principal Investigator (Institution Strengthening Grants) The Principal Investigator is the coordinator of the project, consisting of the Research, Capacity Building and Partnership components. The Principal Investigator, submits the proposal and is considered the only contact point with WHO/TDR for the proposed project during the review procedure and contract negotiations. The Principal investigator of the submitted proposal needs to satisfy the following requirements: • has a PhD or equivalent (Please note that TDR may require a copy of your certificate) • has to be a DEC national residing in a DEC. • is employed by a research, academic or public health institutions in the DEC. • has experience in research evidenced by peer reviewed scientific publications in the subject matter of the proposed research Each grant can have only one Principal investigator. All other researchers are considered collaborators. Approved proposals are funded through a Technical Service Agreement between the World Health Organization and the Institution where the Principal Investigator is employed. If the Principal Investigator leaves the Institution with which the Technical Services Agreement is made or ceases to actively direct the project, the Institution shall promptly inform the Director, TDR of this fact, in which case WHO/TDR shall have the right to terminate the Agreement. If another Principal Investigator is proposed by the Institution, the project may be continued, subject to approval of WHO/TDR. The Principal Investigator is the individual who is responsible for all technical aspects of the work referred to in the Technical Services Agreement at the Institution. The Institution is any legal entity, such as a research institute, university, ministry or research council, within which the Principal Investigator is working. 2.2.2.3 Candidates for the MSc studentship, PhD scholarship and Postdoctoral fellowship • Candidates for the MSc-studentship, PhD-scholarship and Postdoctoral fellowship indicated in the proposal as part of the Capacity Building component of the proposal, must be nationals of the host country. •Applicants for the MSc studentship should be in the early stages of their career as researcher. They should hold a BSc degree with honours (first class or upper second class). • Applicants for the PhD scholarship should be in the early stages of their career as researcher. They should have a university degree and preferably hold post-graduate qualifications such as a MD, Pharm D or MSc. • Applicants for the Postdoctoral fellowship should be in the early to midterm stage of their career as a researcher. They should hold an MD or PhD degree. 2.2.2.4 Supervision of the candidates for the MSc studentship, PhD scholarship and/or Postdoctoral fellowship The supervisors of the MSc-student, PhD-scholar and Postdoctoral fellow must be part of the project team. An annual report of progress of the student / fellow with details of work accomplished (research and academic courses) and plan for the next 12 months must be submitted to TDR for all funded projects. 2.2.2.5 Other collaborators In principle, any person from a legal entity from any country may participate as collaborator in a TDR Institution Strengthening Grant The collaborators of the submitted project need to adhere to the following requirements: • All collaborators involved should hold at least a graduate degree (please note that TDR may require a copy of your certificate). • Any collaborator who knows that he or she will change employment during the course of the trial needs to state his or her new employer and, if applicable, his or her successor, in the event they are no longer able to participate in the implementation of the project. 6 TDR EMPOWERMENT: RESEARCH CAPACITY AND LEADERSHIP DEVELOPMENT GRANTS 2009 2.3 How to apply In section 2.3 How to apply all information necessary for the preparation phase of the proposal is provided. Please refer to the annex I for the General conditions relating to the Contractual Agreement concerning WHO/TDR funded research. The work described in the proposal must be is line with the requirements of a Re entry Grant or Institution Strengthening Grant as described above. The proposal has to meet all eligibility criteria described in the call text and other relevant sections of these Guidelines (section 4.1). Proposals that fail to do so will be considered ineligible. The selection criteria (given in section 6.4), against which each proposal will be reviewed, must be taken into account. TDR/RSG aims at supporting research planned and conducted according to the highest international and local quality standards of Good Practice, which comprise the scientific aspects and the management component including the financial and personnel resources. 2.3.1 How to develop the research project 2.3.1.1 Research involving human subjects The WHO Manual (Section XV.2) defines research involving human subjects as: 'Any social science, biomedical, behavioural, or epidemiological activity that entails systematic collection or analysis of data with the intent to generate new knowledge, in which human beings i) are exposed to manipulation, intervention, observation, or other interaction with investigators either directly or through alteration of their environment, or ii) become individually identifiable through investigator's collection, preparation, or use of biological material or medical or other records.' 2.3.1.1.1 Ethical considerations All research involving human subjects that are funded by TDR/RSG must be implemented in accordance with the Declaration of Helsinki (WMA, 20088) and any subsequent amendments, as well as the International Ethical guidelines for biomedical research involving human subjects (CIOMS, 2002 9). It is the responsibility of the Institution and the Principal Investigator to safeguard the rights and welfare of human subjects involved in research supported in whole or in part by funds from WHO/TDR in accordance with the above mentioned international Ethical standards. Funds may be used to support investigations only where: (a) the rights and welfare of the subjects involved in the research are adequately protected; (b) freely given, informed consent has been obtained; (c) the balance between risk and potential benefits involved has been assessed and deemed acceptable by a panel of independent experts at the Institution; (d) any special national requirements have been met Applicants are therefore encouraged to pay due attention to the various ethical aspects in the planning of research involving human subjects including the process of obtaining the informed consent, the obligations of investigators and sponsors, benefits and risks of study participation, recruitment, cultural values, and confidentiality measures in accordance to the World Medical Association Declaration of Helsinki ethical principles for medical research involving human subjects and the International Ethical guidelines for biomedical research involving human subjects (CIOMS, 2002) . You will be asked to identify potential ethical issues in the proposal form. Guidelines for preparation of consent forms and instruments to protect the rights and welfare of the subjects involved in the research can be downloaded from WHO website:(http://www.who.int/rpc/research_ethics/en/) WHO/TDR will, if so requested, advise scientists regarding the ethical aspects of planned research projects. Please note that proposal with research on human subject recommended for funding will receive funds only after clearance by the institutional and/or national ethical review committee as well as by the WHO/Ethical Review Committee. This concerns any proposal which involves: (a) human subjects, 8 9 World Medical Association. Declaration of Helsinki. 2008. www.wma.net/e/policy/pdf/17c.pdf International Ethical Guidelines for Biomedical Research Involving Human Subjects. CIOMS, Geneva, 2002. www.cioms.ch 7 TDR EMPOWERMENT: RESEARCH CAPACITY AND LEADERSHIP DEVELOPMENT GRANTS 2009 (b) biological material obtained from human subjects, (c) accessing records from human subjects or (d) obtaining information from human subjects such as in questionnaires or social science research 2.3.1.1.2 Regulatory Requirements It is the responsibility of the Institution and the Principal Investigator to comply with the relevant national regulations pertaining to research involving human subjects. In instances, where national government approval is required, the Institution and Principal Investigator are responsible for obtaining any review and approval of proposed projects by national authorities. In countries where approval of biomedical research from the National Regulatory Authorities is a prerequisite, TDR will require this clearance before funding this research. Although regulatory capacities in different countries may differ, all TDR supported research must comply with the international ethical and scientific standards (e.g. GCP - Good Clinical Practice). The Institution, where the research will be conducted by the Principal Investigator, will have the responsibility of sponsor of the research and will therefore endorse the Sponsor's responsibilities as described in the Guidelines for Good Clinical Practice - GCLP. A letter from the Institution to confirm that they are willing to take on the task of Sponsor has to be attached to the application. 2.3.1.2 Basic biomedical research All basic biomedical research funded by TDR must be implemented in accordance with quality standards as described in the Handbook on Quality Practices in Basic Biomedical research. 2.3.1.3 Research Involving the Use of Laboratory Animals or Captured Wild Animals The Institution and the Principal Investigator shall be responsible for the conduct of laboratory animal studies in accordance with international quality standard, Good Laboratory Practice (GLP). The Institution shall undertake that living vertebrate animals required for use in research pursued under a Technical Services Agreement with WHO/TDR will be handled in accordance with locally existing statutes and/or generally accepted principles for the humane treatment of animals, as embodied in the Guiding Principles for Biomedical Research involving Animals, published by the Council for International Organizations of Medical Sciences (CIOMS, Geneva, 1985). Links to some relevant guidelines and publications( e.g. Quality Practices in Basic Biomedical research, Good Clinical Practice, Good Laboratory Practice, Ethics, Project planning) can be found at the Training and Guideline publications page of our web site. http://www.who.int/tdr/svc/publications/training-guideline-publications/listpubs ) 2.3.2 How to prepare your budget 2.3.2.1 General requirements Every proposal sent to TDR should be accompanied by the project budget (section V of the proposal form) and a statement that the project can be carried out for the budget requested (including TDR and co funding money if applicable). Ensure that the total value of the requested budget does not exceed the ceiling per grant as stated in the call text. Approved proposals are funded through a Technical Services Agreement between the World Health Organization (WHO) and the Institution responsible for the project. Funding is normally awarded on a yearly basis and may be renewed for up to three years, subject to availability of funds and to satisfactory progress. The schedule of payments is specified in the terms of the Technical Services Agreement. Payments may not be made to any account other than official Institutional accounts Once an Agreement has been signed, any changes proposed in the approved plan of work or in budget allocations must be submitted to WHO/TDR for approval. 2.3.2.2 Funding restrictions Please note the following restrictions which generally apply to TDR grants: 8 TDR EMPOWERMENT: RESEARCH CAPACITY AND LEADERSHIP DEVELOPMENT GRANTS 2009 Salary support for the Principal Investigator: TDR policy does not permit salary support for the Principal Investigator other than in exceptional circumstances, which must be fully justified by the Institution's Responsible Administrative Authority. Overhead, administrative or miscellaneous expenses: TDR will consider financial support for activities, services or materials such as "overhead", "administrative" or "miscellaneous" expenses, e.g., secretarial, clerical, book-keeper salaries, and office supplies and utilities, only if they are directly related to the project, and items are specifically identified. TDR funds may not be used for meetings unless specified in the Technical Services Agreement. Equipment operating costs: Funds provided by TDR may not be used for the running, maintenance, repairs or insurance costs of permanent equipment not purchased with TDR funds or supplied directly by it, except as otherwise agreed with WHO/TDR. Such operating costs may be supported by TDR for equipment purchased with TDR funds. Publication costs: Publication costs, including the preparation of manuscripts and illustrations, will be considered on an ad hoc basis when substantiated by the Principal Investigator. Travel costs: Travel may be paid from TDR funds only if the travel is essential to the successful execution of the proposed work and itemized in the approved budget. TDR does not support travel for the purpose of attendance at scientific meetings. Construction costs: TDR does not fund the cost of construction of new buildings or extensions of buildings, but will consider requests for modest alterations and modifications of existing premises, if such changes are essential to the successful execution of the proposed work. 2.3.2.3 Supplies and equipment Consumable supplies and equipment, including chemicals, reagents, animals, animal food and other special items, may be purchased for the approved project from WHO/TDR funds. Requests for major equipment will be considered if local arrangements for service and maintenance are available. Equipment acquired under a Technical Services Agreement with WHO/TDR normally becomes the property of the Institution. Only in exceptional circumstances and with the consent of the Institution and TDR may equipment be transferred from the Institution prior to the completion of the project. The Principal Investigator and the Institution are responsible for the care and maintenance of equipment provided, unless otherwise specified in the Agreement. WHO/TDR may require in the Agreement that it supplies equipment to the Institution instead of providing the Institution with the funds to make the purchase itself. WHO is obliged to institute certain limitations on the time during which purchases of equipment may be ordered through the Organization with funds made available through a Technical Services Agreement. Accordingly, any balance of such funds which has not been used for purchases within the time specified by TDR (normally one year) will revert to WHO/TDR on 31 December following the year during which funds were awarded, unless special arrangements have been made with TDR. Hence, requests for purchases to be made by WHO should arrive in Geneva before 1 September of each year. 2.3.2.4 Co funding Co funding from partner Institutions or third party is strongly encouraged but not compulsory. The third party may be any non-public funding source including commercial companies, private institutions or foundations or countries. TDR would however, like where possible to demonstrate any direct or indirect financial contribution to the partnership. Applicants are therefore asked to indicate any co funding contributions, whether in cash or in kind or from third parties. A letter from the partner Institution(s) to confirm that they are willing to co-fund the proposal and the nature and/or amount of the co funding has to be attached to the . 3. How to fill in your proposal form 9 TDR EMPOWERMENT: RESEARCH CAPACITY AND LEADERSHIP DEVELOPMENT GRANTS 2009 The Capacity and Leadership development grant (CLDG) supports projects which combine research with capacity building and partnership. We expect the applicant to cover these different subjects in their proposal, including the scientific, ethical, quality, management and budget aspects. The proposal form is designed to help the applicant step by step cover all aspects required for the design of an effective proposal. Please used the attached form or download the same form from the TDR website. The proposal form consists of five sections: 1. Administrative information 2. Research project 3. Capacity Building 4. Partnership 5. Budget Proposals for a Capacity and Leadership Development Grant project must be prepared in accordance with the instructions and guidelines given in this document. Please read all sections carefully before completing the proposal form. The proposal must be written in the English or French language. All sections of the proposal form must be completed, and the page limits imposed for the various sections must be strictly adhered to. To permit efficient processing of your proposal, please do not write on the back of any page of the enclosed proposal form, nor on the back of any pages attached to it. Number any additional pages as instructed in the form itself. The curriculum vitae of the principal investigator must be included in the proposal form. Please also attach the curricula vitae of any named scientist, trainee or fellow who would be involved in the project. Other formats containing the same information requested in Annexes A and B of the proposal form are acceptable but must not exceed the maximum page limitation of one page per individual. Please note that a complete list of publications is not required: ONLY the five most important publications over the last five years should be listed. Please use Arial font 9 pt (or equivalent) for filling the proposal form. Please note that any information that is supplied on a separate sheet (unless specifically required) or that is listed on pages additional to the specified maximum will not be reviewed. 3.1 Administrative information (Section I of the proposal) Note: Selected information from this section may be made available to the general public if this proposal is selected for funding. Principal Investigator: First name(s) should be spelt out in full. Please write the address at which you intend to receive your professional correspondence, which may not be necessarily be the same as the sponsoring Institution's address given in Item 1.6 of the form. TDR aims at gender diversity in its supported projects. Therefore, a balanced representation of women and men at all levels in the project should be sought. For this reason we request that applicants indicate the gender of the project participants in the proposal. TDR encourages diversity in geographical background, however only Disease endemic countries can apply as Principal Investigator and for training in Capacity Building. For this reason, we request that applicants indicate their nationality on the form. The curriculum vitae of the Principal Investigator must be included in the proposal as annex 1 in the format proposed or other format containing the same information and not exceeding one page. Project title: it should reflect the main objective and the methodology of the submitted project and should not consist of more than 120 characters. Application type: Specify if the application is for a RE ENTRY or INSTITUTION STRENGTHENING GRANT. This section must be completed for the application to be processed. Project summary: This section should be no more than half a page and should contain an executive summary of the proposed project with information on the rationale / justification for the project, the objectives of the project, the expected outcome of the project and the added value of the project to the institution or in the case of a re entry 10 TDR EMPOWERMENT: RESEARCH CAPACITY AND LEADERSHIP DEVELOPMENT GRANTS 2009 grant, the career of the principal investigator. Proposed start date/expected duration: Selected proposals are normally expected to be funded within 18 months following the deadline for submission and subsequently may be renewed annually for up to 3 years subject to satisfactory performance and availability of funds. Institution: Provide the name of the institution, contact details, type of organization, legal status (private/public). The proposal must be endorsed by the Responsible Administrative Authority of the Institution (an official of the Institution fully empowered to enter into contractual arrangements on behalf of the Institution) where the project will be conducted. This individual should not be the Principal Investigator. If a dean is submitting an application e.g. for an Institution Strengthening grant, a higher authority must endorse the application. Note: if the Principal Investigator is not a full-time employee of the Institution, the Responsible Administrative Authority should attach a signed statement specifying clearly the Principal Investigator's relationship with the Institution, and indicating the source of the Principal Investigator's salary. 3.2. Research Project description(Section 2 of the proposal) The aim of this section is to provide information about the proposed research activities and provide details on the management of the project. Please note that training and other capacity building elements related to the research project should be presented in the Capacity Building section. The detailed research description should include a critical literature review, objectives, description of the research methods, including: the overall research design and strategy and reasons for choosing the proposed study design, description of the population and sample to be studied, projected study size, statistical precision, and the basis for their determination, and methods to be used in assembling the study data information on data management. Nature of the research project: (Specify type of research proposed e.g. Basic sciences, Behavioral / Social sciences, Clinical research, Clinical trial, Epidemiological study, Health systems, Phase 1 trial, Randomized trial, Survey, Implementation research). Relevance to TDR research priorities: Specify which of TDR current research priorities is addressed through the proposal. The research priorities are: Lead discovery for new drugs for infectious tropical diseases  Innovative vector control interventions  Development and evaluation of drugs for helminths and other neglected tropical diseases  Accessible quality-assured diagnostics  Evidence for treatment policy for TB patients  Evidence for antimalarial policy and access  Research to support the elimination of visceral leishmaniasis  Integrated community-based interventions Scientific objective(s) and rationale: Indicate the purpose of the research. Provide the preliminary data / background information leading to the proposed project: you should provide clear background information on the research and the significance of the proposed study. The Research objective(s) should be accurately described. A distinction should be drawn between the primary and any secondary objective(s). The objectives should be those achievable within a period of no more than three years with annual milestones. The primary objective should be in line with the primary endpoint of your study For each study objective, specify the criteria for evaluation. Study design and Methodology: describe the study design including where applicable, case definition, sampling procedures, data to be collected and plan of analysis. Provide detailed description of methods and procedures to be used in the study. For example in a clinical study all drugs, vaccines and diagnostic or other procedures to be used, regardless of whether these are registered, unregistered, new or already in current use, in the country in question or elsewhere must be listed. For drugs or vaccines which are widely used, provide the proprietary names, composition, doses to be administered and the name and address of the manufacturer. 11 TDR EMPOWERMENT: RESEARCH CAPACITY AND LEADERSHIP DEVELOPMENT GRANTS 2009 For chemical or biological products which are to be used in the general environment, e.g., biological methods to control disease vectors, state clearly any potential risks involved to human populations and to other environmental components. Indicate the measures planned to evaluate possible environmental changes and include any necessary national clearance document. Ethical issues : If you plan to conduct a research involving human subjects (see section 2.3.1.1.1 of this document), please identify and describe potential ethical issues and describe how you intend to address the relevant ethical and safety related issues. If you propose to perform a clinical study in children or other vulnerable subjects, please provide ethical justification for your proposal. Critical assessment and possible limitation of the study design and methodology in relation to project objectives: outline your own critical assessment of the approach taken and its possible limitations in achieving the project objectives. Project Management Please provide a framework under which day-to-day activities of the project will be to be managed and a planning of the activities. This should include information on the following:  Project team: list all scientists, trainees and fellows who will be directly involved in the grant, from the Principal Investigator's Institution and the collaborating institution(s). Define their role and responsibilities in the project. Complete the curriculum vitae page for Principal Investigator and each collaborator (Annex 1). Each CVs should be in the format provided and must not exceed one page for each CV Milestones and Timelines: give milestones and timelines for the research project. Milestones are major achievements towards meeting the objectives of the project. They are clear, relevant and measurable products which indicate the progress of the project and the time at which it is expected to have happened (for example: recruitment of x number of patients by September 2009; Establishment of Anopheles gambiae colony by June 2009).  All information on this section should be confined to 8 pages. Please note that any information that is supplied on a separate sheet (unless specifically required) or that is listed on pages additional to the specified maximum will not be reviewed. All information on this section should be confined to the page limit stipulated on the form and presented using the format of the proposal form. 3.3 Capacity Building (Section 3 of the proposal) - Reentry Grants (Maximum 2 pages) In this section, applicants for a re entry grant should describe   Expected contribution of the project to the development of leadership Proposed developmental activities / acquisition of additional skills. - Institution Strengthening Grants The aim of this section is to provide information on the planned Capacity Building activities including institutional strengthening activities and staff development plan. This section must be completed for all applications for an Institution Strengthening Grant.   Capacity building objective(s) and expected outcome(s): describe objective(s) and expected results by the end of the project. Institution strengthening: Indicate competencies (in the following human resources, research environment and research infrastructure) lacking in the host institution and how these will be developed through the project. For each area, indicate 1 or 2 expected outcomes which represent contribution of the project to development of research capacity and leadership in the institution. 12 TDR EMPOWERMENT: RESEARCH CAPACITY AND LEADERSHIP DEVELOPMENT GRANTS 2009  Training activities proposed: provide title, tentative dates, objective and expected outcome of workshops, seminars and other group learning activities proposed. Depending on the nature of the proposed research and the level of knowledge and expertise, the following training might be considered: • Good Clinical Practice (GCP) training for investigator and study teams • Information Technology (IT), data management and biostatistics training: Training aims at strengthening data management, communication, data analysis and computer networking. • Training of internal clinical research monitors. • Training of nurses/clinicians/scientists to gain experience in human volunteer management, data storage and maintenance of confidentiality. • Laboratory staff: the training of at least one QA/QC staff member and the ongoing training of laboratory staff in general and specialized techniques, standardization of assays, Good Clinical laboratory practice (GCLP), Quality Practices in Basic Biomedical Research (QPBR) • Financial management: the training of program managers on essentials of good accounting procedures • Project management: the training of project managers on project management skills in the context of research project • Training of community representatives for advocacy of intended trials in local communities or trial sites. Staff development: Provide a detailed plan for formal academic training within the project. For each trainee, provide the name, current institution affiliation, proposed level of training (short term, MSc or PhD), proposed training institution, area / subject of training, expected duration and estimated costs. MSc studentship: aims support of an MSc studentship on a project or course that is relevant for the overall project. The candidate for the MSc studentship can either propose to follow a course or a research MSc project. PhD scholarship: aims support of a PhD scholar on a subject that is relevant for the overall project. So called “sandwich” PhD training constructs are strongly encouraged. These involves the trainee carrying out field studies at his or hers home institution or other DEC institution and obtaining skills not locally available from institutions from more advanced countries institutions which offer similar facilities.   Visiting experts: Provide name(s) of expert, their area of expertise, purpose of visit, tentative dates and contribution of the visit to the project objectives. Provide the name of counterpart to be visited at the host institution and expected impact of the visit on institutional capacity. TDR is responsible for the selection of the suitable candidates for the MSc studentship, PhD scholarship and postdoctoral fellowship. Annual progress reports on the supported candidates must be submitted to TDR. 3.4 Partnership (Section 4 of the proposal) In conformity with the principles of enhancing South-South and North-South collaborations, each project should include research collaboration with at the minimum, a DEC or non- DEC research group / institution. The objectives of these partnerships are : 1. To improve connectivity of the principal investigator and host institution through development of new networks or integration into existing ones 2. To establish a quality mentorship programme within the project that would improve skills of scientists and trainees in participating institutions in areas such as review capabilities, proposal writing etc. 3. To facilitate sharing of information including influencing change of policy and practice through organization of meetings and workshops or participation in similar activities. Collaboration with other Scientists and Research Institutions In this section list the names and institutional affiliations of all proposed collaborators and to describe the expected role of each partner and the national control program (if any). Include links with industrial groups (if any). Indicate both the potential and need for such collaboration within the project, and describe the type of collaboration envisaged. This may include direct collaboration with scientists and institutions in other countries, and training for scientists from tropical developing countries. Please indicate those aspects of the project suitable for such training, and their duration. In all cases, collaboration must be based on mutual agreement between the 13 TDR EMPOWERMENT: RESEARCH CAPACITY AND LEADERSHIP DEVELOPMENT GRANTS 2009 parties concerned. Please attach letters of confirmation from scientists and institutions with whom collaboration is proposed. If exchange visits between different institutions in the project are planned, detailed objective and expected outcomes have to be described. Similar details will be required if workshops are proposed. Provide a plan or strategy of communication in the proposed project. This should include a plan on information that will be shared between partners in the project and how project constitutes a new network or fits into an existing one. Links with other projects supported by TDR Indicate here the links that would be established with other TDR research projects (if any). If the proposal is based on, or forms a continuation of a previous or existing TDR project, give the title and identification number of that project. In addition, Provide information on other projects supported by TDR (or WHO departments) in the past 3 years to date where the host institution is the grant recipient or the PI has (or had) a role as grantee, trainee or co investigator. 3.5 Budget (Section 5 of the proposal) 3.5.1 Co funding: Complete sections 5.1 and 5.2 of the proposal form and provide information on the estimated funding requirement for the project over the 3 year period. Indicate the amount of the budget which is being requested from TDR and what is already available (or is expected) from other sources e.g. the host institution, national authorities or other funding agencies (national or international). 3.5.2 Budget Details Budget details should be itemized under the budget lines indicated in the budget table in Item 5.3 of the proposal form, bearing in mind that the amounts for the second and third years are only estimates. Please recall the funding restrictions set out in section 2.3.2.2 of this document. The budget must be submitted in US dollars. Proposals with budgets in other currencies are not acceptable and will not be processed. If any budget line requires funds in any other currency, this should be converted to US dollars for the budget table. The original currency and the conversion rate used may be described under "Budget justification". The principal investigator and chief financial officer of the institution must sign the budget to confirm that the proposed project is possible with the requested budget. The original signed copy of the budget must be sent by mail to TDR along with the administrative pages of the proposal form (pages 1 & 2). The budget should relate directly to the planned activities and the costs of the resources required for carrying out these activities. For example, a drug or vaccine trial could include visits to the subjects' homes to obtain better follow-up. Data analyses will also have to be provided. Such activities may be budgeted on a per patient basis by adding the sub tasks and averaging the cost per patient. Costs, especially for laboratory-oriented research, could be broken down into total numbers of staff-months (e.g., technician, six staff-months), rental or purchase of equipment and its maintenance, purchase of supplies and chemicals, patient costs, transport for follow-up home visits, purchase of animals and their maintenance, etc. If additional space is needed for budget items, expand under "Budget justification". 3.5.3 Amount Intended for Supplies and Equipment to be purchased by WHO through the WHO Trust Fund Mechanism If the Institution so requests, some of the funds awarded for the research project may be held in a WHO Trust Fund for purchase by WHO of supplies and equipment for the proposed work. Although delivery of goods may take from 6 to 12 months from the time the order is placed, some institutions may wish to avail themselves of this service in order to overcome currency problems, prolonged delays in obtaining supplies, and lack of access to a wide variety of suppliers. In addition, WHO may be able to obtain discounts that might not otherwise be available to an institution. 14 TDR EMPOWERMENT: RESEARCH CAPACITY AND LEADERSHIP DEVELOPMENT GRANTS 2009 WHO does not maintain stocks of supplies or equipment but must order them through commercial channels. The prices obtained are generally the most advantageous available. The average processing time from receipt of a request at WHO to shipment by the supplier is three months; substantially longer periods are required if the merchandise is not immediately available from the manufacturer, or if the Institution has not provided a full specification of the required item. If it is desired to take advantage of this service, indicate in the space provided (Item 5.4 of the form) the amount in US dollars intended for supplies and equipment to be purchased through the WHO Trust Fund mechanism, and complete Form WHO 5367E TDR (available on request). It should be noted, however, that WHO is unable to process requisitions totaling less than US $500 and that orders to be paid with funds in trust should arrive in WHO before 1 September following the year during which the Trust Fund was awarded. WHO may act only upon instructions from the Institution, duly signed by the Principal Investigator, as follows: the supplies and equipment to be purchased by WHO must be listed, in order of priority, on Form WHO 5367E TDR. If additional pages are needed, continue the list on additional sheets, using exactly the same format as in form WHO 5367E TDR. It is essential that you follow the instructions for completing that form. You are not required to order all supplies and equipment at once; each order will be handled separately upon receipt, until the funds are exhausted or the Trust Fund expires. However, one advantage of ordering everything at once is savings on freight charges. Items to be ordered by WHO must also be included in the budget justification. When the Agreement is signed and returned, the sum to be kept in trust by WHO for purchase of supplies and equipment must be entered in the appropriate place in the Agreement. Please note that trust funds held by WHO for purchase of supplies and equipment may not be used for any other purpose. After a purchase has been approved, you will receive a copy of the WHO Purchase Order. The delivery date shown on the Purchase Order is the estimated date of shipment, not the date of delivery to the recipient. Experience has shown this estimated date to be optimistic. If a shipment has not been received 60 days after this date and no explanation of the delay has been given, TDR should be informed of this fact. 3.5.4 Budget Justification The budget should clearly reflect the planned activities and the costs required. Justify each and every budget line, stating how the cost figures were derived in relation to the activities to be undertaken. Pay particular attention to major or unusual items. Use a maximum of two additional pages, if necessary, writing on one side only and numbering them as instructed on the form. The following information should be provided for the various budget lines:  Personnel: For each person, give name (if known), position and salary requested, including percentage for fringe benefits if such benefits represent actual costs to the employer of benefits paid to the employee. Please note that TDR funds only research personnel and not administrative staff. Please recall that salary support for the Principal Investigator will be considered only in exceptional circumstances (please refer to funding restrictions in section 2.3.2.2 of this document). Remember to attach the curricula vitae of all named research personnel. Supplies: List separately the costs of the various categories of expendable supplies (e.g., laboratory reagents, glassware, field supplies). The amount entered for supplies to be ordered through the WHO Trust Fund mechanism should include 20% for packing, freight and insurance (PFI) charges. Similarly, the amount entered for supplies to be ordered locally should include, if applicable, local PFI charges. Equipment: Give general justification for minor equipment and identify any piece of equipment costing more than US $1000 (major equipment) and justify its purchase in relation to the work proposed. Give strong technical justification for your choice of equipment costing over US $10,000. The amount entered for equipment to be ordered through the WHO Trust Fund mechanism should include 20% for PFI charges. Similarly, the amount entered for equipment to be ordered locally should include, if applicable, local PFI charges. Animals: Specify species, number, purchase costs and costs of maintenance. 15    TDR EMPOWERMENT: RESEARCH CAPACITY AND LEADERSHIP DEVELOPMENT GRANTS 2009  Patient Costs: Explain the nature of the costs (e.g., transportation, drugs for field trials) and method of calculation. Please note that the Special Programme does not support payment to patients as inducement to participate in research programmes, nor does it provide support for the costs of normal medical care of patients participating in TDR-supported studies. Travel: Include in this item the costs of local transportation and field research expenses necessary for carrying out the proposed research. List separately the costs of transportation, per diem (indicate per diem scale paid by the Institution) and any other costs (specify). Please recall that TDR does not support travel for the purpose of attendance at scientific meetings. Other Expenditures: Itemize under this budget line any other expenditures required for the proposed work.   PLEASE NOTE – THE FOLLOWING ARE ALWAYS REQUIRED: • Statements regarding the provision of co funding from legal constituted funding authority (Annex 3). • A statement that the proposed work can be carried out with the requested budget. 4. Check list 4.1 Is your proposal eligible? The TDR Capacity and Leadership Development Grant criteria for eligibility for review by the Research Strengthening Group (RSG) include: • Submission of the proposal before the deadline (see section 5 of this document) in Word (*.doc) format • Completeness of all the sections of the proposal form and annexes • Compliance with the rules stipulated in these Guidelines for applicants • Compliance with the page limits stipulated on the form and in this document • Submission of the proposal in the stipulated language (English or French) • The legal status and nationality of the applicant • Projects should have a predefined duration provided (usually no more than 3 years) 4.2 Are all annexes included? These are the same as indicated at the end of the proposal form. Please keep the numbering of the annexes the same as below: • Annex 1: Curricula vitae in the requested format of the Principal Investigator, collaborators and candidates for MSc studentship, PhD scholarship and Post Doctoral Fellowship. • Annex 2: Endorsement of the Responsible Administrative Authority of the Institution where the project will be conducted confirming that they are willing to take on the Sponsor task. If the Principal Investigator is not a full-time employee of the Institution, the Responsible Administrative Authority should attach a signed statement specifying clearly the Principal Investigator's relationship with the Institution, and indicating the source of the Principal Investigator's salary • Annex 3: Statement(s) regarding the provision of co funding from legally constituted agencies (where applicable) • Annex 4: Statement confirming institutional support for the proposed project and confirmation that it is feasible within the budget (requested from TDR and available from other sources). 16 TDR EMPOWERMENT: RESEARCH CAPACITY AND LEADERSHIP DEVELOPMENT GRANTS 2009 • Annex 5: If applicable, a recommendation letter from the head of institution employing the proposed MSc student • Annex 6: If applicable, a recommendation letter from the head of institution employing the proposed PhD scholar. • Annex 7: If applicable, a recommendation letter from the head of institution employing the proposed Postdoctoral fellow. 5. Submitting your proposal The proposal must be submitted by email attachment as a "Word" (*.doc) file to rcstdr@who.int with a copy to herinkovam@who.int. Your proposal must be received by TDR Empowerment before the deadline of 15 January 2009. All researchers applying for TDR grants are requested to send a copy of their proposals to the WHO Representative in their country. This will allow Representatives to keep abreast of projects and research progress in their countries, and help them to assist more effectively in any administrative or logistic problems that may arise. 6. What happens next 6.1 Registration & Acknowledgement of receipt All proposals received will be registered in the TDR database. Every proposal will receive a unique Project Identification number, which will be quoted in all correspondence with the Principal Investigator. All future correspondence will contain this unique ID, which facilitates prompt processing of documents by TDR. TDR will acknowledge receipt of proposals within one week of the deadline for submission of proposals. Acknowledgement will be sent by e mail. Principal investigators who do not receive an Acknowledgement within one week after the deadline should contact TDR. The sending of an Acknowledgement of receipt does not imply that a proposal is eligible for evaluation. 6.2 Eligibility check TDR will check whether proposals meet the eligibility criteria as stipulated in the call text and these guidelines (section 4.1). Proposals may be excluded from further processing when they fail to meet any of the eligibility criteria. Applicants will receive a letter on the outcome of the eligibility check within two weeks after the deadline for submission. 6.3 Evaluation procedure Candidates will be recommended for support by a scientific committee (the Research Strengthening Group RSG). Recommendation will be based on merit, applying principles of transparency, equal treatment and ethics. The final decision to support / fund a proposal will be subject to approval by the Director of TDR. Eligible proposals are assigned to two RSG members for review, using a Grant assessment form each proposal will be ranked for scientific merit and capacity building content. Members of the RSG are internationally recognized researchers/scientists in their relevant specialist fields and are knowledgeable with the relevant expertise on the proposals assigned to them for review. In addition, all new proposals are reviewed by two experts outside the committee. 17 TDR EMPOWERMENT: RESEARCH CAPACITY AND LEADERSHIP DEVELOPMENT GRANTS 2009 6.4 Selection criteria Each proposal will be reviewed against the selection criteria listed below: I. Project excellence: objectives, feasibility, impact, innovation, quality and record of investigators, quality of the proposed methodology. II. Relevance: public health relevance for disease endemic countries, adequacy of proposal in context of the call, alignment with the priorities of the TDR. III. Potential impact: need for strengthening, restructuring existing research capacities, knowledge dissemination, sustainability. IV. Compliance with national and international standards of research, Good Clinical Practice, Good laboratory practice, Quality Practices for Basic Biomedical Research, ethics and safety related issues. V. Implementation Plan of Capacity Building: research activities, staff and facilities development, training activities. VI. Partnership plan: involvement of at least one DEC institution or Institution from the North. VII. Project management: organisational structure, decision-making mechanisms, knowledge management IX. Project resources: co funding arrangements, mobilisation of resources - personnel, equipment and finances in accordance with TDR financial requirements X. Gender issues: promotion of gender equality, gender action plan concerning the staff involved in the project. Each criteria will be evaluated and ranked on a scale of 1 to 5 from ´Excellent (1)´ to ´Poor (5)´. TDR has defined an overall threshold for all selection criteria of „Good (3)‟ to ensure that all s meet a minimum level of quality. Gender is exempt from the ranking does not include a threshold. 6.5 Finalization of study protocol Applicants should note that if the proposal is successful, TDR will review the protocol to check adherence to the International quality standards. For research involving human subjects , the contract with WHO cannot be signed until TDR has received confirmation that the research protocol has been approved to all relevant ethical committees (local and WHO/ERC). For additional information, contact: Dr. Olumide Ogundahunsi Manager, Research Empowerment TDR, World Health Organization 1211, Geneva 27, Switzerland Fax: +41 22 791 4854 Email: ogundahunsio@who.int Tel: +41 22 791 3597 18 TDR EMPOWERMENT: RESEARCH CAPACITY AND LEADERSHIP DEVELOPMENT GRANTS 2009 Annex. WHO Technical Service Agreement (TSA) - General conditions The following are the general conditions relating to this Agreement concerning WHO support for research or other technical services. The purpose of such support is to assist an Institution to undertake, for WHO investigations on a particular problem or other work which has been agreed upon by the Institution and WHO. 1. INSTITUTION AND PRINCIPAL INVESTIGATOR 1.1 The Institution and the Principal Investigator (or Responsible Technical Officer), who must be an employee of the Institution, shall be jointly responsible for all the technical and administrative aspects of the work referred to in this Agreement. 1.2 The Institution is required to notify WHO immediately of knowledge that the Principal Investigator will cease or ceases to be an employee of the Institution or is no longer continuing the responsibilities covered by this Agreement. Under such circumstances WHO has the right to : a. cancel this Agreement or b. agree to continue the project under a new Principal Investigator proposed by the Institution and approved by WHO. 2. FINANCIAL ARRANGEMENTS 2.1 Payments shall be made to the bank account(s) of the Institution as specified in this Agreement and in accordance with the schedule of payments contained therein. If, after the submission of the final financial report referred to in paragraph 4.3 below, there remains an unused balance of funds with the Institution, this balance shall be due to WHO. In the event of the Agreement being cancelled under any circumstances, the Institution shall refund to WHO the balance of uncommitted funds. The funds provided under this Agreement shall be spent only in accordance with its terms. 2.2 The funds transferred to the Institution under this Agreement may not be used to meet any form of emoluments, travel costs or any other reimbursements of expenditure to a staff member of WHO. 2.3 Unless otherwise provided in this Agreement the funds may not be used to cover: a. normal administrative and overhead expenses of the Institution b. cost of maintenance, repair, running or insurance of existing equipment and machinery belonging to the Institution. c. cost of construction of new buildings or alterations and modifications of existing buildings and premises, d. salary support of the Principal Investigator. 3. EQUIPMENT AND SUPPLIES 3.1 Unless otherwise agreed, and subject to subparagraph 3.2 below, any equipment acquired under this Agreement shall become the property of the Institution. The Institution and the Principal Investigator shall be jointly responsible for the proper safeguard, maintenance and care of all equipment acquired under this Agreement. 3.2 Notwithstanding subparagraph 3.1 above, the Institution shall transfer ownership of any equipment acquired under this Agreement to WHO, if so requested by WHO, upon termination or expiry of this Agreement. In such the Institution shall dispatch the equipment to any destination chosen by WHO, the cost of which will be borne by WHO. 4. REPORTS The Institution shall submit technical and financial reports to WHO on the work as required, or at least annually, in accordance with the following provisions: 4.1 Technical reports shall be prepared by the Principal Investigator and forwarded through and countersigned by the authorized official of the Institution or his authorized representative. Each annual report shall summarize the results of the project and give in sufficient detail its positive and negative findings so that the value of the work can be assessed. 4.2 Financial reports shall be forwarded after being jointly certified by the Institution's Chief Financial Officer and the Principal Investigator, using form WHO 782. The reports must show the use of the funds provided by WHO compared with the original budget expenditure pattern agreed between the Institution and WHO. 19 TDR EMPOWERMENT: RESEARCH CAPACITY AND LEADERSHIP DEVELOPMENT GRANTS 2009 4.3 All Financial and Technical reports are subject to audit by WHO, including examination of supporting documentation and relevant accounting entries in the Institution's books. In order to facilitate such reporting and audit, the Institution shall ensure that accurate and systematic accounts and records are kept in respect of the project. The final Technical and Financial reports must be submitted within 90 days after the expiry of this Agreement. 5. RELATIONSHIP AND RESPONSIBILITY OF PARTIES The relationship of the Institution to WHO shall be that of an independent contractor. The employees of the Institution are not entitled to describe themselves as staff members of WHO. The Institution shall be solely responsible for the manner in which work on the project is carried out and accordingly shall assume full liability for any damage arising from research or other technical services under this Agreement. No liability shall attach to WHO, its advisers, agents or employees. 6. USE OF RESULTS, EXPLOITATION OF RIGHTS, AND PUBLICATION 6.1 The results of the project funded under this Agreement may be freely used or disclosed by either party provided that, without the consent of the other party, no use may be made for commercial purposes and confidentiality shall be maintained with respect to results that may be eligible for protection by proprietary rights. The Institution shall provide WHO with the results, in the form of relevant know how and other information, and to the extent feasible, tangible products. 6.2 The industrial or commercial exploitation of any intellectual property rights, including the ownership of know-how, arising from the project shall be designed to achieve, in so far as circumstances permit, the following objectives in the following order of priority: a. the general availability of the products of creative activity, b. the availability of those products to the public health sector or preferential terms, particularly in developing countries, c. the grant to each party of additional benefits, including royalties, account being taken of the relative value of each party's financial, intellectual and other contribution to the research. 6.3 The rights referred to in para 6.2 shall belong to the Institution, or to the Principal Investigator if the Institution and WHO so agree. To the extent that the former do not intend to exercise them, the rights shall be promptly transferred to WHO, if it so requests. Each party shall provide the other with its full cooperation to permit the effective exercise of the rights. The party in which the corresponding rights are vested may file applications for industrial property protection, promptly furnishing copies of the applications and other patent documents to the other party. All rights other than the right to file applications shall be exercised in accordance with an agreement which shall be negotiated in good faith between the Institution and WHO. 6.4 In any publication by the Institution or the Principal Investigator relating to the results of the project, the responsibility for the direction of the work shall not be ascribed to WHO. Unless WHO advises otherwise, all publications shall include a notice indicating that the underlying investigation received financial support from WHO. Two off-prints or copies shall be sent to WHO unless another number is stipulated. WHO funds may not be used for publication costs unless specifically authorized. 7. RESEARCH INVOLVING HUMAN SUBJECTS 7.1 Ethical Aspects It is the responsibility of the Institution and the Principal Investigator to safeguard the rights and welfare of human subjects involved in research supported in whole or in part by funds from WHO, in accordance with the appropriate national code of ethics or legislation, if any, and in the absence thereof, the Helsinki Declaration and any subsequent amendments. Such funds may be used only to support investigations where (a) the rights and welfare of the subjects involved in the research are adequately protected, (b) freely given informed consent has been obtained, (c) the balance between risk and potential benefits involved has been assessed and deemed acceptable by a panel of independent experts appointed by the Institution and (d) any special national requirements have been met. 7.2 Regulatory Requirements It is the responsibility of the Institution and Principal Investigator to comply with the relevant national regulations pertaining to research involving human subjects. 7.3 Protection of Subjects Without prejudice to obligations under applicable laws, the Institution shall make appropriate arrangements to eliminate or mitigate the consequences to subjects or their families in the case of death, injury or illness resulting from the conduct of research referred to in paragraph 7.1. Such arrangements shall, to the extent feasible, include medical treatment and financial relief. The Institution and Principal Investigator undertake to protect the 20 TDR EMPOWERMENT: RESEARCH CAPACITY AND LEADERSHIP DEVELOPMENT GRANTS 2009 confidentiality of the information relating to the possible identification of subjects involved in the research involving human subjects conducted under the auspices of this Agreement. 8. RESEARCH INVOLVING THE USE OF LABORATORY ANIMALS The Institution undertakes that living vertebrate animals, required for use as laboratory animals for the research to be carried out under this Agreement, shall be handled in accordance with generally accepted principles for the humane treatment of such animals and the avoidance of unnecessary suffering. 9. RESEARCH SAFETY It is the responsibility of the Institution to establish and implement policies and practices to assure and provide for the safety of its employees, the public, and the environment during the conduct of the supported research. If the supported research involves the use of dangerous biological agents, the Institution shall establish and implement an appropriate safety plan. 10. PUBLICITY The Institution and the Principal Investigator shall not refer to the relationship of WHO to the project, or to products or processes connected with the project, in any statement or material of a publicity or promotional nature issued for commercial purposes, or with a view to financial benefit. 11. CHOICE OF LAW AND SETTLEMENT OF DISPUTE The Agreement shall be construed in accordance with the law of Switzerland. Any dispute relating to the interpretation or execution of this Agreement shall, unless amicably settled, be subject to conciliation. In the event of failure of the latter, the dispute shall be settled by arbitration. The arbitration shall be conducted in accordance with the modalities to be agreed upon by the parties or, in the absence of agreement, with the Rules of Arbitration of the International Chamber of Commerce. The parties shall accept the arbitral award as final. 21