Socios en Salud Sucursal del Peru awarded grant up to $270,000 CAD for 24 months. Grant is to support work that is called Community-based Family Coaching for Children with Developmental Risks in Lima, Peru. Grant funds may only be used for the Project. Any grant funds unexpended or uncommitted at the end of the Grant Period must be promptly returned to Grand Challenges Canada.
Socios en Salud Sucursal del Peru awarded grant up to $270,000 CAD for 24 months. Grant is to support work that is called Community-based Family Coaching for Children with Developmental Risks in Lima, Peru. Grant funds may only be used for the Project. Any grant funds unexpended or uncommitted at the end of the Grant Period must be promptly returned to Grand Challenges Canada.
Socios en Salud Sucursal del Peru awarded grant up to $270,000 CAD for 24 months. Grant is to support work that is called Community-based Family Coaching for Children with Developmental Risks in Lima, Peru. Grant funds may only be used for the Project. Any grant funds unexpended or uncommitted at the end of the Grant Period must be promptly returned to Grand Challenges Canada.
Dr. Leonid Lecca Director Socios en Salud Sucursal del Per Av. Merino Reyna N 575 Carabayllo Lima 41, Peru
Dear Dr. Lecca,
Re: Grand Challenges Canada Grant Number 0351-03 Saving Brains: Community-based Family Coaching for Children with Developmental Risks in Lima, Peru
Grand Challenges Canada is pleased to award Socios en Salud Sucursal del Per (the Grantee) a grant up to the amount of $270,000 CAD for the period beginning September 30, 2013 (the Start Date) for 24 months (the "Grant Period"). This agreement (the "Grant Agreement") contains the terms and conditions of this grant.
The Grantee agrees that the payment of any funds under the Grant Agreement is subject to its compliance with the conditions set out herein, including those in Attachments A, B, C, D, E, F, G, H, I, J and K, which form an integral part of this Grant Agreement.
A. Purpose of the Grant The purpose of this grant is to support work that is called Community-based Family Coaching for Children with Developmental Risks in Lima, Peru, as described in the Grantee's proposal (the "Proposal") submitted in response to a Grand Challenges Canada Request for Proposals, with a deadline of February 11, 2013, and a final negotiated budget dated September 4, 2013 (the Budget), and Project Framework and Results-based Management Accountability Framework (RMAF) dated September 3, 2013, (together, the "Project"). For interpretive purposes, this Grant Agreement supersedes any attached documents. B. Use of Grant Funds Grant funds may only be used for the Project. Any grant funds unexpended or uncommitted at the end of the Grant Period must be promptly returned to Grand Challenges Canada. Any Budget category change of more than 10% and equivalent to $10,000 CAD or more must be
Grant Number: #0351-03
2 approved in writing by Grand Challenges Canada in advance. The Grantee may not use the grant funds to reimburse any expenses incurred prior to the Start Date and after the conclusion of the Grant Period. In regards to travel, the use of grant funds must be consistent with the Grand Challenges Canada Travel Policy (Attachment F), provided that, in all instances, all Grantee airline travel must be through economy class or equivalent. If the Grantee has its own travel policy, the Grantee will use the lower cost policy. The Grantee hereby represents and warrants that the specific activities funded pursuant to this Grant Agreement are not already funded by another Grand Challenges Canada grant or funding agreement. C. Investment of Grant Funds Grant funds must be invested in highly liquid investments (such as interest-bearing bank accounts) with the primary objective of preservation of principal, so that they are available for the Project. Grand Challenges Canada requires the Grantee to report the amount of any interest or other income generated by the grant funds, including currency conversion gains (collectively "Interest"). Any Interest must be used for the Project. At the end of the Grant Period, any remaining Interest must be applied to another Grand Challenges Canada-funded project (current or under consideration), or returned to Grand Challenges Canada if no other Grand Challenges Canada-funded projects exist with the Grantee's institution. D. Compliance with Anti-Terrorism Principles The Grantee acknowledges that Grand Challenges Canada is subject to and must comply with Canadas Anti-Terrorism Act 2001, c.41 (hereinafter ATA), including the provisions of the Criminal Code of Canada R.S.C. 1985, c. C-46 (hereinafter Code) brought into effect by the ATA, namely Part II.1 of the Code (see http://laws.justice.gc.ca/en/C-46/index.html), which Code provisions create offences related to the participation in, financing, facilitation and carrying out of terrorism and support for entities affiliated with terrorism. Grand Challenges Canada is committed to adhering to the provisions and principles of the ATA in all work it undertakes and supports. During and after the term of this Grant Agreement, with regard to the Project and all Property provided by Grand Challenges Canada to the Grantee pursuant to this Grant Agreement, the Grantee shall ensure that the Property is not used in any manner that would constitute a breach of the ATA or the Code. The Grantee further agrees to comply with any other instructions regarding compliance with the terms and conditions of this Section, which Grand Challenges Canada may be required to issue during the term of this Grant Agreement in response to changes to Canadian law. For the purposes of this Section, the term Property includes real and personal property of every description, and deeds and instruments relating to or evidencing the title or right to property, or giving a right to recover or receive money or goods, and all funds transferred from Grand Challenges Canada to the Grantee pursuant to this Grant Agreement by whatever means of transfer.
Grant Number: #0351-03
3 E. Anti-Corruption The Grantee declares and guarantees that no offer, gift or payment, consideration or benefit of any kind, which constitutes an illegal practice, has been or will be made to anyone by the Grantee, either directly or indirectly, as an inducement or reward for the award or execution of this Grant Agreement. Any such practice is grounds for terminating the Grant Agreement or taking any other corrective action as required. The Grantee shall declare in writing to Grand Challenges Canada if the Grantee, its officers, employees or independent contractors included in the project: were convicted during a period of three years prior to the signing of the Grant Agreement by a court of law in Canada or in any other jurisdiction for an offence involving bribery or corruption, or are under sanction for an offence involving bribery or corruption, imposed by a government, a governmental organization or an organization providing development assistance. The Grantee shall require its subcontractors to declare to the Grantee in writing if they or any of their officers, employees or independent contractors involved in the project: were convicted during a period of three years prior to the submission of the Project proposal by a court of law in Canada or in any other jurisdiction for an offence involving bribery or corruption, or are under sanction for an offence involving bribery or corruption, imposed by a government, a governmental organization or an organization providing development assistance. The Grantee shall make such declarations it receives from its subcontractors known to Grand Challenges Canada by providing Grand Challenges Canada with a copy of such declarations. Grand Challenges Canada may terminate this Grant Agreement forthwith for default where it is found that the Grantee has made a false declaration. F. Compliance with National Laws In carrying out this project, the Grantee shall, subject to its privileges and immunities, be responsible for complying with all applicable laws and regulations of the countries in which the Project will be carried out and to which Project personnel may have to travel as part of the Project. G. Indemnification a) Assumption of Risk and Indemnification General The Grantee shall indemnify and hold harmless Grand Challenges Canada, the consortium members (Canada's International Development Research Centre and the Canadian Institutes of Health Research) and the Government of Canada or their affiliates
Grant Number: #0351-03
4 or the officers, employees, agents, independent contractors, subcontractors or licensees of any of them (the Indemnified Parties), against, and assumes the risk of, any claims, actions, losses, expenses (including legal fees and disbursements) and damages arising out of or resulting from, or that are alleged to arise out of or result from, a breach of any material term or representation or warranty of this Grant Agreement, or any other claim by a third party arising out of or resulting from, or that are alleged to arise out of or result from, Project activities or use of Project outputs conducted by the Grantee or its affiliates, or their officers, employees, independent contractors, subcontractors and subgrantees, agents, or licensees. b) Assumption of Risk and Intellectual Property Indemnification The Grantee assumes the risk of claims, actions, losses, expenses (including legal fees and disbursements) and damages arising out of actual or alleged infringement of intellectual property rights committed in the course of or in relation to the Project by the Grantee or its affiliates or the officers, employees, independent contractors, subcontractors, subgrantees, agents, or licensees of any of them, and shall indemnify and hold the Indemnified Parties harmless against same. c) Insurance The Grantee will acquire and maintain reasonable insurance to cover its indemnification obligations, as would be acquired and maintained by a reasonable and prudent organization carrying on a similar line of activities in the relevant market. H. Warranty To the best of the knowledge of the Principal Investigator and his or her team, having not performed a patent or other intellectual property search, neither the outputs of the Project nor the use of the outputs of the Project by the Grantee is or will violate or infringe upon the intellectual property of any third party. To the best of the knowledge of the Principal Investigator and his or her team, neither the outputs of the Project nor the use of the outputs of the Project by the Grantee is or will violate the privacy rights of anyone, nor will they defame anyone. I. Insolvency At the discretion of Grand Challenges Canada, this Grant Agreement shall immediately terminate without notice if the Grantee (i) ceases to operate, (ii) commits an act of bankruptcy within the meaning of Canadas Bankruptcy and Insolvency Act, R.S. 1985, c.B-3, as amended, or under any comparable legislation in any other jurisdiction, (iii) is deemed insolvent within the meaning of Canadas Winding Up and Restructuring Act, R.S. 1985, c. W-11, as amended, or under any comparable legislation in any other jurisdiction, (iv) makes an assignment for the benefit of creditors or has a receiving order made against it, him or her under applicable bankruptcy or insolvency legislation in any jurisdiction, or in respect of whom a receiver, monitor, receiver-manager or the like is appointed, or (v) becomes insolvent or makes an application to a court for relief under Canadas Companies Creditors Arrangement Act, R.S. c. C-25, as amended, the Bankruptcy and Insolvency Act, the Winding Up and Restructuring Act or under any comparable legislation in any other jurisdiction
Grant Number: #0351-03
5 (collectively or severally referred to as Act of Insolvency). In the event Grand Challenges Canada does not terminate this Grant Agreement as a result of an Act of Insolvency, it shall be entitled, in its sole discretion, to suspend or modify its payment obligations under this Grant Agreement. In the event of termination arising out of an Act of Insolvency, the Grantees ownership rights in any intellectual property and other Project outputs funded by Grand Challenges Canada and developed in pursuit of the Project objectives shall be deemed to have automatically transferred to Grand Challenges Canada on the date immediately preceding the actual Act of Insolvency and will be subject to Grand Challenges Canadas Global Access Policy. J. Sufficiency of Funds Notwithstanding anything to the contrary contained in this Grant Agreement, Grand Challenges Canadas obligations herein are subject to sufficient funds being made available to Grand Challenges Canada by the International Development Research Centre (IDRC) during the Grant Period. For purposes of clarity, third-party donor funds that are contributed to Grand Challenges Canada in relation to the Project and which are to be provided by Grand Challenges Canada to the Grantee would necessitate the negotiation of an amendment to this Grant Agreement, or a separate agreement, as between Grand Challenges Canada and the Grantee, in order to supplement the Grantee funds provided to the Grantee pursuant to this Grant Agreement. It is understood that, on receipt of reliable information indicating that sufficient funds may not be made available to Grand Challenges Canada in relation to the Project, Grand Challenges Canada shall immediately notify the Grantee in writing. In any such event, Grand Challenges Canada and the Grantee shall work together to develop a plan for the orderly management of the Project in light of any financial shortfalls, including ensuring that irrevocable commitments to third parties made in good faith before the date of any written notice from Grand Challenges Canada to the Grantee are met. K. Environmental Assessment Under the Canadian Environmental Assessment Act ("CEAA"), aspects of this Project may be required to undergo an environmental assessment before financial assistance is provided to carry out such aspects of the Project by Grand Challenges Canada. A determination as to whether an environmental assessment is required will be made by Grand Challenges Canada. Should an environmental assessment be required, the Grantee shall conduct such an assessment, upon direction from Grand Challenges Canada, and prepare a report in accordance with the CEAA. Grand Challenges Canada reserves the right to take any action necessary to ensure compliance with the requirements of the CEAA or to ensure environmental protection more generally, including but without being limited to the termination of the Grant Agreement or the imposition of any mitigation or follow-up measures necessary to reduce, eliminate or control any adverse environmental effects of the Project. If an environmental assessment is required, Grand Challenges Canada shall determine whether the Project is likely to cause significant adverse environmental effects on receipt of the environmental assessment report provided by the Grantee, and any other information that Grand Challenges Canada deems to be relevant. The Grantee shall not in any way
Grant Number: #0351-03
6 implement or carry out the aspects of the Project covered by an environmental assessment report until Grand Challenges Canada has provided its authorization to do so in writing. L. Subgrants and Subcontracts The Grantee has the exclusive right to select subgrantees and subcontractors for the Project, with the exception of considerations related to Canada's Anti-Terrorism Act 2001 referenced in Section D above. All subgrantees and subcontractors shall become a party to an agreement with the Grantee that is substantially consistent with the Grantees obligations under this Grant Agreement. The Grantee recognizes that the selection, removal or replacement of a subgrantee, subcontractor, Co-Principal Investigator or Co-Investigator can represent a significant change within the meaning of Section Q (Termination) below, and thus can be sufficient grounds for termination or suspension of the grant or withholding of payment by Grand Challenges Canada. Grand Challenges Canada has not earmarked the use of the grant funds for any specific subgrantee or subcontractor. The Grantee, and not Grand Challenges Canada, is responsible for ensuring that all subgrantees and subcontractors' use of grant funds is consistent with this Grant Agreement and the Proposal. Neither the Grantee nor subgrantees nor subcontractors may make any statement or otherwise imply to donors, investors, media, the general public or any other party that Grand Challenges Canada directly funds the activities of any subgrantee or subcontractor. At the discretion of the Grantee, an individual or organization involved in this project may state publically:
______________________ is a _______________________ on the Project Insert name of individual Insert name of role
Community-based Family Coaching for Children with Developmental Risks in Lima, Peru funded by Grand Challenges Canada to the Grantee Socios en Salud Sucursal del Per.
Any agreements with subgrantees and subcontractors the Grantee engages to assist with the Project must include the following language: "Your organization has been selected to participate in this Project at our discretion. You may not make any statement or otherwise imply to donors, investors, media, the general public or any other party that you are a direct Grantee of Grand Challenges Canada. You may state that Socios en Salud Sucursal del Per is a Grantee of Grand Challenges Canada and that you are a subgrantee or subcontractor of Socios en Salud Sucursal del Per for the Project. You are subject to the same grant clauses as the original grant to Socios en Salud Sucursal del Per. This subgrant agreement is subordinate to the original grant to Socios en Salud Sucursal del Per by Grand Challenges Canada. By signing this agreement, you admit notice of the original grant to Socios en Salud Sucursal del Per by Grand Challenges Canada. To the extent that this subgrant agreement conflicts in any way with the obligations of the Grantee under the original grant agreement, the Grantee shall act in accordance with its obligations under the original grant agreement and may modify the terms of the subgrant agreement without the subgrantee's consent to ensure that they are consistent with the terms of the Grant Agreement. In addition, any agreements with the subgrantee or subcontractors may include the following language with respect to Co-Investigators and Co-Principal Investigators:
Grant Number: #0351-03
7 You may state: ______________________ is a _______________________ on the Project Insert name of individual Insert name of role
Community-based Family Coaching for Children with Developmental Risks in Lima, Peru funded by Grand Challenges Canada to the Grantee Socios en Salud Sucursal del Per.
M. Payments and Reports Please refer to Attachment A for the Project Framework, Attachment B for the Results-based Management Accountability Framework (RMAF) and Attachment E for the Schedule of Reports and Payments. Where indicated, Grand Challenges Canadas payment is contingent on satisfaction of the listed deliverable and/or milestone. Grand Challenges Canada may authorize changes to the payment and reporting schedules from time to time, where appropriate. Grand Challenges Canada will confirm any such changes in writing. Grand Challenges Canada expects its grantees to be focused on results. The RMAF approach to project management is designed to help outline the expected results of a project and to allow the Grantee and Grand Challenges Canada to monitor progress in achieving project results. Grantee will be required to complete and update the RMAF table semi- annually, and upon request. N. Report Templates
The Grantee is required to submit one or more reports regarding the expenditure of grant funds and your progress on the Project. Please refer to Attachment D for the Reporting Progress Guidelines. Grand Challenges Canadas progress report templates and submission guidelines for this grant will be provided to the Grantee at an appropriate time.
These templates and guidelines are subject to change. Please submit reports electronically to your Project Coordinator. Grand Challenges Canada will send the Grantee an email with the contact information for these individuals. The Grantee also agrees to submit such other reports that Grand Challenges Canada may reasonably request from time to time. O. Record Maintenance and Inspection Grand Challenges Canada requires that the Grantee maintain adequate records for the Project, to enable Grand Challenges Canada to easily determine how the grant funds were expended. These records are to be maintained for a minimum of two years after the conclusion of the Grant Period. The Grantees books and records must be made available for inspection by Grand Challenges Canada or its designee at reasonable times, to permit us to monitor and conduct an evaluation of operations under this grant. At the request of Grand Challenges Canada, the Grantee will permit representatives of Grand Challenges Canada or its designees to visit the Grantees premises and any Project sites at times convenient to the parties concerned, and will facilitate the discussion of the results and progress of the Project between Grand Challenges Canada representatives and Project personnel.
Grant Number: #0351-03
8 P. Change of Principal Investigator Grand Challenges Canada shall receive prior notice in writing of any proposed change in the Principal Investigator for the Project. Grand Challenges Canada shall be consulted and provided the opportunity to provide input on the selection of any new Principal Investigator for the Project. Q. Termination
Grand Challenges Canada has the right, at its discretion, to terminate or suspend the grant or withhold payment if (i) Grand Challenges Canada is not reasonably satisfied with the Grantee's progress on the Project, (ii) significant leadership or other changes occur that Grand Challenges Canada believes may threaten the Project, (iii) Grand Challenges Canada does not approve any change in the Principal Investigator of the Project (the applicant who generated the idea that forms the basis of this Project), (iv) the Grantee or Grand Challenges Canada receives a complaint, including a legal claim, that in the opinion of Grand Challenges Canada raises a risk of liability, (v) the Grantee fails to comply with any term or condition of this Grant Agreement, (vi) any of the representations or warranties of the Grantee set forth in Attachment K is not true, correct and complete in all material respects, or (vii) activities funded by this Grant Agreement are taking place in, or relate to, countries not on Grand Challenges Canadas Country Eligibility List. On termination, if requested by Grand Challenges Canada, the Grantee agrees to promptly return to Grand Challenges Canada any unspent and uncommitted grant funds (as of the date of termination) previously distributed to the Grantee by Grand Challenges Canada for the Project.
R. Publication The Grantee agrees that it will make available to the public through open access channels the results of the research emerging from the Project, or any reports or other publications regarding the Project funded by this grant (collectively, the "Materials"), and anticipates that the Materials will be published in a treatise, thesis, trade publication or in any other format that is available for the interested public as soon as practical, consistent with the need to first secure intellectual property rights in a manner that maximizes the benefits to developing world interests. 1 Specifically, the Grantee is expected to use good faith efforts and work in a collaborative fashion with its subcontractors and funders associated with the Project to facilitate broad dissemination and accessibility of the Materials in the developing world. S. Global Access, Ethics and Data The Grantee acknowledges that it understands and commits to compliance with the Grand Challenges Canada Ethics Policy, Grand Challenges Canada Global Access Policy and Grand Challenges Canada Data Access Policy, which are integral parts of this Grant Agreement and have been included as Attachments G, H and I.
1 For the purposes of this Grant Agreement, developing world will be defined as the countries listed as low-, lower-middle- and upper-middle-income countries in the World Banks Income Classification Scheme at the time of implementation or commercialization.
Grant Number: #0351-03
9 The principles of the Global Access Policy are (1) making Project technologies and solutions accessible, both in terms of price and availability, to those in need, particularly in the developing world, (2) broadly and promptly disseminating knowledge and information gained through the Project to the global scientific community and beyond, and (3) commercialization of any Project outputs is encouraged but must be done in a manner consistent with the principles of the Global Access Policy. The Grantees commitment to Global Access with regard to Project technologies and information survives the Grant Period and will last indefinitely. The principles of the Grand Challenges Canada Ethics Policy are (1) research involving human participants will be conducted in a manner that demonstrates, protects and preserves respect for persons, concern for the welfare of individuals, families and communities, and justice, (2) research involving animals must be conducted in a manner that ensures their humane care and treatment, and (3) certain research endeavours, including but not limited to research with recombinant DNA, biohazards and genetically modified organisms, may be subject to enhanced regulation and oversight. The principles of the Data Access Policy are (1) Data will be shared as broadly and as promptly as possible to foster innovation and optimize prospects for the translation of knowledge into life-saving solutions. Data access should enhance the value of research and advance the objectives of Grand Challenges programs; (2) Respect for cultural diversity, scientific integrity, and the privacy of individuals and communities that contribute data will be ensured in all data access activities. Respect must also be given to matters of attribution as they pertain to researchers and institutions that share data; (3) Those who collect, produce, share and use data are responsible for ensuring data quality, security, and modes of access and use that are consistent with applicable laws, regulations, and standards of ethical research conduct as outlined in Grand Challenges Canada Ethics Policy; (4) A proportional approach will be adopted when balancing the needs of investigators against those of communities and sponsors that expect health benefits to arise from the activities to which they contribute data or resources. The risks and benefits of data access will be considered and accounted for when sharing data; and (5) The aim of benefitting the individuals and communities who enable and support inquiry, be they research participants or investigators, should be furthered to the extent possible and is of particular importance when involving individuals and communities from developing countries. The sharing of data that can be used to foster breakthrough solutions to global challenges is one way to ensure benefits are returned. T. Non-exclusive License
In furtherance of your commitment to the Global Access Policy, you hereby grant to Grand Challenges Canada a non-exclusive license and an agreement not to assert, as set out in Attachment J. You hereby acknowledge that the consideration for this license and agreement not to assert is the monies forwarded, or to be forwarded, to you under this Grant Agreement, the sufficiency of which is hereby acknowledged by you.
You will have the Principal Investigator, and all your employees, collaborators, contractors, subcontractors, subgrantees, consultants, partners, investors and/or affiliates who will be involved in this Project, review Attachment J and execute the undertaking therein.
Grant Number: #0351-03
10 You also agree to assist Grand Challenges Canada in perfecting or confirming this non- exclusive license, by executing any documents that may be required, including but not limited to a confirmatory license, for filing with national regulatory authorities, such as intellectual property offices. Should it be necessary, you agree to negotiate in good faith and execute a detailed license agreement containing at least the terms set out at Attachment J.
U. Grant Announcements, Public Reports and Use of Grand Challenges Canadas Name and Logo Grand Challenges Canada will include information on this grant in its periodic public reports, and may make grant information public at any time on its web page and as part of press releases, public reports, speeches, newsletters and other public documents. In all of the Grantees publications and presentations, the Grantee will acknowledge the support of Grand Challenges Canada. If the Grantee wishes to use Grand Challenges Canadas logo in any publications, presentations, materials, videos or any other public documents, the Grantee must obtain and use an unaltered digital copy of the logo from the website www.grandchallenges.ca/brandguidelines and comply with all terms and conditions set out on that website. If the Grantee wishes to issue a press release or announcement regarding the award of this grant, it must obtain advance approval from Grand Challenges Canada of the press release and the date of release. Please note that Grand Challenges Canada will ensure that all consortium members of the Development Innovation Fund will be appropriately credited. The Grantee also agrees to obtain advance approval from Grand Challenges Canada for any other use of Grand Challenges Canada's name or logo. The Grantee agrees to contact info@grandchallenges.ca at least two weeks before any press release, announcement or other publication date. V. Representations and Warranties Grand Challenges Canada is entering into this Grant Agreement in reliance upon your representations and warranties set forth in Attachment K, which representations and warranties shall be continuing beyond the term of this Grant Agreement except for those that, by their terms, are limited to a specific date. W. Counterparts: Original This Grant Agreement, including any amendments, may be executed in counterparts which, when taken together, will constitute one Grant Agreement. Copies of this Grant Agreement will be equally binding as originals, and faxed or scanned and emailed counterpart signatures will be sufficient to evidence execution, though Grand Challenges Canada may require the Grantee to deliver original signed documents. X. Assignment Clause This Grant Agreement or any of the rights or obligations under this Grant Agreement may not be assigned without Grand Challenges Canadas prior written consent. An assignment includes (i) any transfer of the Project, (ii) an assignment by operation of law, including a merger or consolidation, or (iii) the sale or transfer of all or substantially all of the Grantees assets.
Grant Number: #0351-03
11 Y. Entire Agreement, Severability and Amendment This Grant Agreement is our entire agreement and supersedes any prior oral or written agreements or communications between us regarding its subject matter. The provisions of this Grant Agreement are severable so that if any provision is found to be invalid, illegal or unenforceable, such finding shall not affect the validity, construction or enforceability of any remaining provision. This Grant Agreement may be amended only by a mutual written agreement of the parties. Z. Governing Law The construction, enforceability, validity and interpretation of this Grant Agreement shall be in accordance with the laws of the Province of Ontario and the laws of Canada. AA. Relationship The Grantee undertakes the Project on its own behalf and not on behalf of Grand Challenges Canada or any institutions providing Grand Challenges Canada with funding, and this Grant Agreement and the funds flowing from it shall in no way be construed as creating the relationship of principal and agent, of partnership in law, or of joint venture as between the Grantee and Grand Challenges Canada or any institutions providing Grand Challenges Canada with funding, including but not limited to Canada's International Development Research Centre. Neither Grand Challenges Canada nor any institutions providing Grand Challenges Canada with funding assume any liability with respect to any accident to any person or any loss or damage to any person or property arising from the Project. BB. Survival The terms of this Grant Agreement shall remain in full force and effect during any period in which Grand Challenges Canada has suspended the grant or withheld any payment. Following the termination of the grant, this Grant Agreement shall terminate and be of no further force and effect, provided that the following sections shall survive and continue in full force and effect indefinitely: Section G (Indemnification), Section O (Record Maintenance and Inspection), with respect to record maintenance only, Section R (Publication), Section S (Global Access, Ethics and Data), Section T(Non-exclusive License), Section U (Grant Announcements, Public Reports and Use of Grand Challenges Name and Logo), Section V (Representations and Warranties) and Section Z. (Governing Law). CC. Special Clause Indirect Costs The Grantee will provide an overview (no more than one page) by the first financial report on how the indirect costs associated with this grant agreement will be used during the course of the Project.
Grant Number: #0351-03
12 This grant award offer is only valid 10 days from the date of this offer (September 17, 2013). Therefore, the Grantee must sign and return this letter to Janne Dingemans, Project Coordinator, Grand Challenges Canada, no later than September 27, 2013 to receive a Saving Brains grant award. Please keep a copy for your records. If you have any questions, please contact Janne Dingemans by email at janne.dingemans@grandchallenges.ca or by telephone at +1 (416) 673- 6558. On behalf of Grand Challenges Canada, may we extend every good wish for the success of your work.
Sincerely GRAND CHALLENGES CANADA
By:______________________
By:___ ___________________ Karlee Silver Director of Targeted Challenges Grand Challenges Canada Claude Briand Director of Finance and Administration Grand Challenges Canada
Accepted and agreed to by:
Socios en Salud Sucursal del Per
______________________
Date:_________________ Leonid Lecca Director Socios en Salud Sucursal del Per
Acknowledged by:
__________________________ Date:__________________ Leonid Lecca Principal Investigator
__________________________ Date:__________________ Llubitza Maribel Muoz Valle Co-Principal Investigator
Grant Number: #0351-03
13 Attachment A: Project Framework
Objectives Activities Critical milestones Estimated dates Estimated Cost (CAD) Objective 1: Development of a community-based group intervention to coach caregivers of children at risk for NDD and provide caregivers with meaningful social support, encouragement and social connectedness Activity 1.1: Review group interventions aimed at child development for the target age range. Brief report on key features of evidence-based group interventions aimed at child development compiled and presented to the Peru team. Month 1-2 $1,779 Activity 1.2: Develop group community based early intervention (GROUP-CBEI) model and supporting implementation materials Intervention model designed for (i) delivery by a CHW and peer facilitator as 12 weekly sessions over 3 months to groups of 4-10 dyads, across a diverse spectrum in terms of age and developmental status and (ii) retain core elements and sequential steps of the SPARK approach to early intervention (eg, coaching parents on stimulation of their childs development, and providing parents with social support and encouragement.)
Finished "tool kit" for community-based group early intervention, including training manual, fidelity and monitoring protocol, CHW manual, & supplies for each session. (Month 8) Month 1-8 $11,520 Objective 2: Implement & evaluate proposed interventions to three study arms. Activity 2.1: Seek ethics approval from the National Institute of Health in Peru Proof of ethics approval from the National Institute of Health in Peru submitted to Grand Challenges Canada (Month 4). Month 4 Activity 2.2. Train field supervisor, study coordinator, and data collector to deliver the EEDP, and EASQ as well as HOME and GROUP CBEIs. Field supervisor, study coordinator, and data collector competent to deliver the EEDP, EASQ, HOME and GROUP CBEIs as measured by written exams, inter-rater agreement between trainee and trainer, video review of intervention delivery simulations. Month 1-3 & Month 9 $12,532 Activity 2.3. Train community health workers (CHWs) in CBEI and EEDP through workshop-style training sessions (2 days on EEDP, 4 days on HOME CBEI, 4 days on GROUP CBEI). 2 CHWs trained in HOME-CBEI (Month 4). Sufficient training indicated by fidelity assessment protocol (trainers review a video-recorded mock CBEI session delivered to a volunteer family using the fidelity assessment form)
2 CHWs trained in GROUP-CBEI (Month 9). Competency will be assessed as a team with field supervisor following fidelity assessment protocol. Trainers will review a video- recorded mock CBEI group session delivered to a volunteer group of families and evaluate using the fidelity assessment form.
4 CHWs trained in EEDP and EASQ. Competency indicated by 100% agreement between written assessments of the trainer and trainee.
Trainees who do not demonstrate competency receive additional coaching and feedback and mock role-play until competency is established. Month 4 & Month 9 $17,402 Activity 2.4: Enroll 60 children from health six health centers/community botiquins/home visits in Carabayllo, Peru for HOME-CBEI
60 children 6-24 months of age screened using the EEDP and enrolled into the study according to eligibility criteria: 1) Age between 6 24 months of age; 2) EEDP assessment; 3) Known primary caregiver (parent or legal guardian) living with child; 4) Living within the catchment area of the 6 Health Centers that comprise the study zone.
30 of the at-risk children and their primary caregivers are enrolled into HOME-CBEI intervention arm based on health centre catchment area and according to additional eligibility criteria (Month 6): 5) No known medical condition that would make the child unresponsive to early intervention; 6) Family does not anticipate moving within the next three months.
Month 5-6 $31,505
Grant Number: #0351-03
14
Activity 2.5: Enroll 60 children from health six health centers/community botiquins/home visits in Carabayllo, Peru for GROUP-CBEI 60 children 6.24 months screened using the EEDP and enrolled into the study according to eligibility criteria listed for Activity 2.4.
30 of the at-risk children and their primary caregivers are enrolled into GROUP- CBEI intervention arm based on health centre catchment area and according to additional eligibility criteria listed for Activity 2.4 (Month 11). Month 10-11 $36,395 Activity 2.6: Deliver CBI and monthly nutritional support to participants. 20 dyads received nutritional assistance (monthly food packet) alone for 3 months
20 dyads received HOME-CBEI
20 dyads received HOME-GROUP + nutritional assistance for 3 months Month 5 - 14 $47,417 Activity 2.7: Collect and analyze data. Complete baseline data (demographics, anthropomorphic & health data, HOME, ASQ) entered into database within 3 weeks of participant enrollment.
Tables and brief report produced.
Complete 3-month follow-up data (anthropomorphic & health data, HOME, ASQ) entered into database within 3 weeks of last participant completing the study Month 5- Month 14 $69,997 Objective 3: Obtain multi-sector support for programmatic implementation of pilot strategy. Activity 3.1: Meet with local stakeholders to introduce pilot and obtain support for scale up. Four meetings held to present the study plan and invite input from 1) Peruvian Ministry of Health leaders Jose Luis Sebastian Mesones, National Coordinator Prevention and Control of STIs, HIV and AIDS Strategy, and Estela Roeder Carbo, Director- Department of Communications, Ministry of Health, Peru; 2) leaders at the level of lima, 3) municipality leaders in Carabayllo Rafael Alvarez Espinoza, Mayor of Carabayllo; 4) Flix Rodriguez Crdenas, General Coordinator, Carabayllo Health Coordinator (COSACA) and 5) CHWs.
Leaders at the level of Lima and/or Carabayllo support programmatic dissemination (Month 12) Month 1- 12 $9,501 Activity 3.2: Prepare for scale-up Revise and submit Theory of Change document to Grand Challenges Canada (Month 6) Month 6 Activity 3.3: Disseminate findings to international colleagues. Web-conference to discuss findings with Haitian and Rwandan health care providers, leaders, and CHWs held. Priorities and common strategies between international sites identified.
Four academic articles written: 1) performance of evaluation instruments in this cohort, including EASQ and EEDP; 2) process evaluation of delivery of CBEI by CHWs; 3) factors associated with NDD in Carabayllo (baseline); 4) final outcome results and descriptions of populations that benefit most from which intervention. Month 22-23 $6,953 Activitiy 3.4: Develop an implementation plan in Lima or Carabayllo. Draft implementation plan clearly defining resources, roles, and monitoring activities for scale-up developed jointly by Socios En Salud and leaders of the city of Lima and/or Carabayllo Month 24 $4,999 Total Cost: 250,000 *Please note that the total cost does not include the amount ($20,000 CAD, including indirect costs) provided by Grand Challenges Canada for participation in our community meetings.
Description of Outcome/ Output Description of Indicator PROJECT RESULTS - EXPECTED Data Source # / % Indicator U l t i m a t e
O u t c o m e s
A. Lives saved and improved in low- and middle- income countries (LMICs) Changes in percentage (x% to y%) of people with improved health outcomes 32 Children with any developmental improvement in intervention arm after 3 month intervention. (assuming 80% or 32 of the 40 children in the intervention arm meet indicator). To assess the impact of CBEI on NDD risk among 60 at-risk children, we will compare change in age-adjusted EASQ Z-score (i.e. change from month 0 to month 3) among CBEI versus control groups (from Peru findings in Fernald et al). Areas of development to be measured include the Core Metrics Areas of: general cognition, reception and expressive language, fine and gross motor skills, and general socio-emotional development. Methodology: EASQ will be administered by CHWs during patient home visits. Source: We will apply EASQ to 120 kids enrolled prospectively through 10 Carabayllo health centers and botiquines. Of those, 60 with delay in at least one area will be enrolled in the observational study. Remaining 60 children will be tested using the EASQ and EEDP at baseline and 3 months to understand correlation between instruments among non-delayed children. Measuring endpoints at 3 months will assess for on-intervention effects. We will use "intention-to-treat" analyses. Sample size: Calculations for recruitment size were based on 71% delayed as reported by Socios En Salud child development project in Carabayllo.) Note that Home and GROUP CBEIs will be compared as a single group with the control group for these analyses. # people with improved health outcomes I n t e r m e d i a t e
O u t c o m e s
A. Changes in access for BENEFICIARIES to products or services Change in percentage (x% to y%) of BENEFICIARIES who have access to products and / or services 36
34 Children who experience improved quality of interaction with their parent. (assuming 90% or 36 of 40 children in intervention group meet indicator)
Increase in children exposed to cognitive stimulation (assuming 85%, or 34 of 40 of children in intervention group meet indicator) Quality of parent-child interactions will be evaluated by videotaped home visits and reviewed using pre-selected criteria standardized to Peru. A selection of total visits (20%) will be videotaped to measure quality of parent-child interactions. A member of the field team will join the CHW to manage the video camera and ensure informed consent. B. Changes in knowledge, attitudes or behaviours of BENEFICIARIES Change in percentage (x% to y%) of BENEFICIARIES with improved knowledge, attitudes or behaviours
# of BENEFICIARIES with improved knowledge, attitudes or behaviours
C. Changes in knowledge, attitudes or behaviours of INTERMEDIARIES/ PROVIDERS Change in percentage (x% to y%) of INTERMEDIARIES/PROVIDERS with improved knowledge, attitudes or behaviours 34 Parents with increase in HOME score, parent responsivity and parent involvement (assuming 85%, or 34 of 40 intervention recipients meet indicator). HOME: The HOME global score will assess quality of parent-child interactions and home environment for early stimulation by comparing 3 month mean scores to baseline scores in intervention vs. CBEI. This instrument is designed to measure the quality & quantity of stimulation & support available to a child in home environment. Parent responsivity, parent involvement, and cognitive stimulation are subscales in the HOME questionnaire at 3 months intake compared to baseline. Used in Latin-American cohorts, including urban Peru. Takes 45-90 minutes to administer. HOME: Methodology: CHWs will administer HOME during home visits. Power calculations: Power depends on standard deviation, but detecting statistically significant impact is not our primary objective. Note that HOME and GROUP CBEIs will be compared as a single group with the control group for these analyses.
32 Caregivers with improved knowledge on child development, parenting behaviour change, self- efficacy and perceived social support (i.e., ranked at 4 questions as either very effective or effective) (assuming 80%, or 32 of 40 intervention recipients meet indicator)
Four Likert-response questions and two open-ended questions administered by CHW after each CBEI session to assess caregiver knowledge on child development, parenting behavior change, self-efficacy and perceived social support. Surveys questions will be entered into excel database and analyzed using variables - "very effective", "effective", "moderately effective", and "not effective". D. Changes in skills/training of INTERMEDIARIES/ PROVIDERS
# of INTERMEDIARIES/PROVIDERS with increased training or skills
E. Changes in awareness of INTERMEDIARIES/ PROVIDERS and BENEFICIARIES Change in percentage (x% to y%) of people reached through awareness- building outputs
# of people reached through awareness- building outputs F. Changes in policy, legislation and/or regulation # of policies developed through the project # of policies adopted as a result of the project
Grant Number: #0351-03
16 O u t p u t s
A. Building Tools and Capacity to Execute 1. # of innovative prototypes and/or service delivery models developed 1 Group CBE intervention model 2. # of curriculum changes recommended 3. # of policy recommendations developed 2 policy recommendations in the form of implementation plans (if political leaders show interest): 1) Political leaders in Lima; 2) municipality leaders in Carabayllo
4. # of patents filed (expected) / granted (achieved)
5. # of public awareness outputs (videos, news releases, radio shows, etc.) 2 1 interview on television news channel
1 web-conference will be held to present and discuss findings with Haitian and Rwandan health care providers, leaders,
6. # of analytical models developed 7. # of papers (expected ) / published (achieved) 4 Papers drafted for publication on 1) performance of evaluation instruments in this cohort, including EASQ and EEDP; 2) process evaluation of delivery of CBEI by CHWs; 3) factors associated with NDD in Carabayllo (baseline); 4) final outcome results and descriptions of populations that benefit most from which intervention.
8. $ Funds leveraged $8,000
9. # of total members of project team 18 10. # of total members of project team in LMIC 12
Grant Number: #0351-03
17 Attachment C: Budget 2
2 Please note that more detailed project budget information is contained in a separate Excel file, with a document title of (20130904_Detailed_Budget_0351-03), sent in the same email with this final Grant Agreement. Budget category Year 1 Year 2 Total Total Personnel (Direct FTE Costs) 126,711 126,711 253,422 Total Travel (Direct Travel Costs) 24,303 24,303 48,606 Total Consultants (Direct Consulting Costs) 41,685 41,685 83,370 Total Direct Supplies and Services (Direct Supplies) 17,085 18,630 35,715 Total Equipment (Direct Equipment) 0 0 0 Total Other Research (Direct Research) 66,855 20,161 87,016 Total Sub-grants and Subcontracts 74,114 75,249 149,364 Total Indirect project costs 44,813 39,149 83,962 Total Project in Local Currency 395,565 345,889 741,454 Total Project in CAD 144,045 125,955 270,000 Indirect Costs % (must be 13% or less) 12.8% 12.8% 12.8%
Grant Number: #0351-03
18 Attachment D: Reporting Progress Guidelines
The overall purpose of progress reporting is to ensure that your project stays on track and that Grand Challenges Canada can effectively assist you in identifying and resolving any issues/barriers/gaps as they emerge.
Progress against Project milestones (Attachment A) and results achieved (Attachment B) will be reported regularly to Grand Challenges Canada through video/teleconferences/in-person meetings with your Program Officer(s), the submission of semi-annual progress reports, and a final report. Grant expenditures against the Project budget (Attachment C) will be reported regularly as per the Schedule of Reports and Payments (Attachment E). Payment of grant installments is conditional upon satisfactory progress and reporting.
Below we summarize the elements of these reports; templates will be provided to assist you with the submission of formal reports. Please note that Grantees are encouraged to reach out to their Program Officer(s) proactively and as needed outside of defined reporting structures to discuss any developing issues or opportunities.
PROGRESS AGAINST PROJECT MILESTONES
Quarterly Updates When requested by either the Grantee or their Program Officer(s), Grantees will meet with their Program Officer(s) on a quarterly basis via video/teleconference/in-person meetings to discuss progress, challenges and gaps in project execution. No formal report or presentation is required, although you may, at your discretion, submit a summary document in advance of the discussion. Topics to be covered during the meeting shall include: a. Progress against anticipated results, critical milestones and associated budget as outlined in the Results-based Management Accountability Framework (RMAF) and Project Framework, including explanation of any variances; b. Major achievements/outcomes in this quarter (e.g. conference posters/presentations; invited talks; publications; citations; participation in media/public events; patents; etc) and anticipated achievements/outcomes for the upcoming quarter; c. Key learnings over the past quarter; d. Current thinking on Path to Scale/Theory of Change and any progress against initial plan. Have partners/consultants (business, technical, social, as appropriate) been engaged to promote advancement along Path to Scale/Theory of Change? e. Re-examination and ranking of risks associated with the Project Framework and Path to Scale/Theory of Change, and potential mitigation strategies, including action steps; f. Any proposed changes/amendments to any aspect of the project; g. Areas where Grand Challenges Canada can help.
Grant Number: #0351-03
19 Semi-Annual Reporting The Grantee is expected to submit a written progress report to Grand Challenges Canada every six months. A report template will be provided for this purpose. The content of these reports will be used by Grand Challenges Canada to assess progress, extract lessons and tailor community meetings to effectively support the success of your project and that of the portfolio of projects. The reporting template, which will be provided by Grand Challenges Canada, shall include the following elements: a. Progress and key accomplishments against: Anticipated results Critical milestones and associated budget; Path to Scale / Theory of Change; b. Description of project plan for the next 6 months and anticipated outcomes; c. Re-examination and ranking of risks associated with the project, and potential mitigation strategies, including action steps; d. Areas where Grand Challenges Canada can help; e. Input and considerations relevant to the community of innovators (key research findings, input from solution end-users, lessons learned, developments in the field, etc.); f. Questions/issues relevant to the community of innovators that should be addressed / discussed.
Go/No-go Milestones The Grantee is expected to submit sufficient evidence of successful completion of all Go/No-go Milestones to Grand Challenges Canada. Payments linked to Go/No-go Milestones will not be released until sufficient evidence to support their successful completion has been submitted. Go/No-go Milestones are highlighted in bold in the Critical Milestones column within the Project Framework (Attachment A). They are also referenced in the Schedule of Reports and Payments (Attachment E), which outlines the deadlines for submission of evidence and the payment they are associated with.
FINANCIAL REPORTING
Periodic Reporting The Grantee will be provided with a financial reporting template to be completed and submitted on a periodic basis as defined in the Schedule of Reports and Payments (Attachment E). The reporting template, which will be sent to the Grantee, will include the following elements: a. Budget for the reporting period, by category and line item; b. Actual expenses for the reporting period, by category and line item; c. Variance between budget expenses and actual expenses, and by category and line item;
Grant Number: #0351-03
20 d. Explanations for major variances (+/- 10%) by line item; e. Forecasts for the subsequent reporting period; f. Confirmation of payment(s) received, by date and amount
The analysis of the financial report will allow Grand Challenges Canada to assess how the project funds have been used in relation to the progress reports against project milestones. The analysis will also allow Grand Challenges Canada to estimate the subsequent payment to be made to the Grantee.
FINAL REPORT The Grantee will be provided with a reporting template detailing project achievements and expenditure, to be completed and submitted within 30 days of project completion (details to follow). Please note that 5% of project funding will be withheld pending submission of a satisfactory Final Report.
Grant Number: #0351-03
21 Attachment E: Schedule of Reports and Payments
This table outlines when financial reports, progress reports and a milestones proof of completion must be submitted. It also outlines when payments will be issued and any associated specific conditions for payment. Note that all payments are conditional upon satisfactory financial report and progress against project milestones.
Payment No. Report Period End Report/ payment Due Date Payment Amount Financial Report Progress Report Specific conditions for payment Go / no go milestone?
1
5,613 CAD (1)
2
September 30, 2013 113,000 CAD 3 March 31, 2014 April 30, 2014 57,000 CAD Yes Proof of ethics approval from the National Institute of Health in Peru submitted to Grand Challenges Canada (Month 4) 2 CHWs trained in HOME- CBEI (Month 4) 30 of the at-risk children and their primary caregivers are enrolled into HOME-CBEI intervention arm based on health centre catchment area and according to additional eligibility criteria (Month 6) Revise and submit Theory of Change document to Grand Challenges Canada (Month 6) Yes
Yes
Yes
Yes
Yes 4 September 30, 2014 October 31, 2014 Based on analysis of financial Yes Yes Finished ""tool kit"" for community-based group early intervention, including training Yes
Grant Number: #0351-03
22 report (2) manual, fidelity and monitoring protocol, CHW manual, & supplies for each session. (Month 8) 2 CHWs trained in GROUP- CBEI (Month 9) 30 of the at-risk children and their primary caregivers are enrolled into GROUP-CBEI intervention arm based on health centre catchment area and according to additional eligibility criteria listed for Activity 2.4 (Month 11). Leaders at the level of Lima and/or Carabayllo support programmatic dissemination (Month 12)
Yes March 31, 2015 April 30, 2015 Yes 5 September 30, 2015 October 31, 2015 Up to 13,500 CAD Based on analysis of final financial report (3)
Yes Yes .
* Notwithstanding the proposed payment schedule set forth above, payments may be accelerated, delayed or withheld, and the amount of any payment may be changed, in each case at the sole discretion of Grand Challenges Canada ** Financial report must be submitted within 30 days after the end of each reporting period
(1) Calgary meeting expenses (June 2013) paid by Grand Challenges Canada. The amount should be recorded as a payment received from Grand Challenges Canada and as actual expenses under Travel category (GCC Community meetings) (2) Payment amount will be determined based on analysis of the funds available at the end of the previous reporting period and the funds needed for the subsequent period (3)Final payment amount will be determined based on analysis of the actual expenses incurred versus the approved budget
Grant Number: #0351-03
23 Attachment F: Extract of Travel Policy 3
The following policy is based on the principles and guidelines of the respective travel policies of the Treasury Board of Canada Secretariat, the International Development Research Centre and Genome Canada.
The specific rates associated with the provisions in this policy will be outlined in the Grand Challenges Canada Travel Expenses Claim Form and will be based on the rates provided by the Treasury Board of Canada Secretariat.
1. INTRODUCTION All individuals who travel on approved Grand Challenges Canada business are entitled to the reimbursement of travel expenses as outlined in the travel policy. This travel policy reflects Grand Challenges Canadas responsibility to have in place provisions and guidelines which are reflective of accepted travel expenses reimbursement practices.
2. PURPOSE The purpose of this travel policy is to facilitate travel in support of Grand Challenges Canadas mission while maintaining effective controls and promoting accountability.
This is achieved by: a) Ensuring employees, consultants and participants travel securely, comfortably in a cost- effective manner; b) Facilitating the travel process so that travellers can focus their efforts on core responsibilities; and c) Providing senior management and travellers with the proper guidelines and tools to manage and control their business travel-related expenses.
3. APPLICATION, AUTHORIZATION AND APPROVAL OF TRAVEL This travel policy applies to all individuals travelling on Grand Challenges Canada business, including non-employees of Grand Challenges Canada and recipients of Grand Challenges Canada funding.
All travel must be authorized prior to the travel being undertaken. Travel approval (verbal approval is deemed acceptable) implies that consideration has been given as to the necessity of the travel, and that travel arrangements accommodate both the travellers needs and Grand Challenges Canadas operational requirements. Prior approval by the Chief Finance Officer must be provided for deviations from the provisions stated in this policy.
Exceptions to the policies below maybe approved in special cases and with appropriate documentation from the Chief Executive Officer (and in the case of the Chief Executive Officer, the Chair of the Board).
3 Grand Challenges Canada also refers to this Travel Policy as the Expense Policy
Grant Number: #0351-03
24 4. USE OF A DESIGNATED TRAVEL AGENCY Travellers are permitted to make their own travel arrangements or use the services of Grand Challenges Canadas designated travel agency which is authorized to handle travel reservations under specific directives and guidelines.
5. MODE OF TRANSPORTATION General allowances for private, non-commercial accommodation, meals and incidentals provided for in this policy will be reviewed and confirmed April 1 of each year.
Travellers have the option of selecting a preferred mode of transportation as long as the choice is based on cost, duration, safety, convenience, practicality, and represents good value to Grand Challenges Canada. Travellers are encouraged to book as far in advance as is reasonable to take advantage of travel discounts.
a. Air The standard fare class for air travel is economy.
Personal Upgrades Personal miles or coupons can be used to upgrade to business class, or a traveller may opt to pay personally for the price difference between economy and business class.
Documentation of the fare differentials must be clear, specific, maintained by the employee, and included with the receipts.
Air Mileage Programs Frequent flyer upgrades are facilitated by the traveller. Any associated costs are at the travellers expense. Managing the travellers air miles accounts is the responsibility of the traveller. Airline miles earned while travelling on Grand Challenges Canada business are retained by the traveller. Frequent flyer miles or benefits are not reimbursable by Grand Challenges Canada, even if they are used on Grand Challenges Canada business.
Grand Challenges Canada travellers are ultimately accountable for the class of ticket issued. They must be prepared to justify the purchase of non-refundable or otherwise restrictive low-fare tickets when such tickets are later cancelled or changed, resulting in additional expenses. Accordingly, due diligence is required so as to promote proper planning.
Exceptions to this policy and purchase of business class fares must be approved by the Chief Finance Officer of Grand Challenges Canada.
b. Rail First class rail travel is permitted with roomette or equivalent accommodation being provided for overnight travel. For rail travel outside of Canada, the standard for rail travel would be the equivalent to first class rail travel in Canada.
c. Ground Travellers may rent cars to their destination. Travellers have the option of renting a car at their destination when it is more cost-effective and convenient than other local ground transportation modes such as taxis, limousine services and airport shuttles.
Grant Number: #0351-03
25
For travel outside of Canada, the kilometric rates and other general allowances including per diems for meals and incidentals will be applied.
Private Car Travellers may use their personal car for Grand Challenges Canada approved travel. It is the travellers responsibility, as the owner of the vehicle being used for business, to carry adequate insurance coverage for their protection and for the protection of any passengers.
Travellers will be reimbursed the kilometric rate posted on the Grand Challenges Canada Travel Expense Reimbursement Form. This rate is reviewed and confirmed April 1 of each year.
Rental Car The recommended standard for rental cars is up to a mid-size vehicle. Rental cars beyond the recommended standard shall be authorized based upon factors such as, but not limited to, safety, the needs of the traveller and the bulk or weight of goods transported. It is the travellers responsibility to have adequate insurance coverage for their protection and for the protection of any passengers. Collision and damage insurance for the car rental must be purchased at the time of the rental if this coverage is not provided through a credit card. Reimbursement shall include the cost of the car rental including gas charges and the insurance purchase.
Taxis For local ground transportation, taxis, airport shuttles and limousine services are acceptable modes of transportation. Reimbursement will be for actual expenses including gratuity. All original receipts are required.
Parking Parking charges shall be reimbursed where it is practical and economical to leave a private vehicle at the public carrier's terminal during the period of absence.
6. RECEIPTS In order to facilitate the processing of expense claims, Grand Challenges Canada travellers must submit original receipts with their expense claim to justify allowable expenses in excess of $20 CDN. Where the traveller certifies that the receipt was lost, accidentally destroyed or unobtainable, a personal declaration may replace the receipt.
7. TRAVEL ADVANCES If requested, Grand Challenges Canada employees can be provided with a travel advance to cover travel expenses where Grand Challenges Canada approved services and products are not prepaid.
8. TRAVEL HEALTH REQUIREMENTS Grand Challenges Canada bears the costs incurred in obtaining immunizations, prophylactic medication, and medical consultations required for Grand Challenges Canada-related travel.
Grant Number: #0351-03
26 9. MEDICAL TRAVEL INSURANCE AND PASSPORTS/VISAS All Grand Challenges Canada approved travellers must be covered by medical travel insurance. If not included in the Grand Challenges Canada employer group medical insurance, the cost of medical travel insurance will be reimbursed by Grand Challenges Canada.
Grand Challenges Canada approved travellers will be reimbursed the costs incurred in obtaining required passports, visas, and related photographs.
10. ACCOMMODATION Grand Challenges Canada will reimburse expenses for accommodation. The standard for accommodation is a single room, in a safe environment, conveniently located and comfortably equipped. A variety of options for accommodation are available for travel. Generally these include hotels, motels, corporate residences, apartments, private non-commercial accommodation, and government and institutional accommodation.
Although travellers generally stay in commercial accommodation, private non-commercial accommodation is encouraged. Cost effectiveness shall be determined by comparing the total cost of accommodation and transportation in the private non-commercial accommodation with available commercial or government and institutional accommodation and the associated transportation costs. A traveller who chooses private non-commercial sleeping accommodation will be reimbursed as per the rate posted on the Grand Challenges Canada Expense Claim form. This rate is reviewed and confirmed April 1 of each year.
For periods of travel status of more than 30 consecutive calendar days at the same location, accommodation at corporate residences, apartments, private non-commercial accommodation or government and institutional accommodation is encouraged. Travellers who choose to stay in a hotel after the 30 th day when apartments or corporate residences are available in the area surrounding the workplace shall be reimbursed up to the cost of the average apartment or corporate residence available.
Grand Challenges Canada will often arrange accommodation for Grand Challenges Canada approved activities in Toronto, with the basic room charge plus taxes being charged to a master account. If an individual makes their own accommodation arrangements, hotel receipts (originals) are required.
11. MEALS For each calendar day, a traveller shall be reimbursed the applicable meal allowance for breakfasts, lunches and dinners taken while on Grand Challenges Canada approved business. Meal allowances shall be reimbursed as per the rates posted on the Grand Challenges Canada Expense Claim form. These rates are reviewed and confirmed April 1 of each year
In the event that a meal is provided at no cost to the traveller, the corresponding per diem cannot be claimed.
12. INCIDENTALS An incidental expense allowance is an allowance to cover the costs of items that can be attributed to a period in travel, but for which no other reimbursement or allowance is provided under this directive, and which helps offset some of the expenses incurred as a result of having
Grant Number: #0351-03
27 to travel. The allowance is provided to cover the costs of items which can be attributed to a period in travel, and includes but is not limited to such items as gratuities, business centre expenses, bottled water, phone calls home, and shipping of some personal effects.
Business related calls, either local or long-distance, and internet connections are not included in the incidental expense allowance and will be reimbursed with presentation of appropriate invoices or receipts. Reasonable expenses for personal calls will be reimbursed with presentation of appropriate invoices or receipts. An incidental expense allowance will be reimbursed as per the rates posted on the Grand Challenges Canada Expense Claim form. These rates are reviewed and confirmed April 1 of each year.
13. HOSPITALITY Reasonable hospitality-type expenses may be incurred by Grand Challenges Canada employees while conducting Grand Challenges Canada business. The actual amount plus gratuities may be claimed. The submission of receipts should indicate the purpose of the expense, date, and number/name of participants and will exclude alcohol.
14. PREPARATION AND SUBMISSION OF AN EXPENSE CLAIM Grand Challenges Canadas travel expense claim form must be used for the submission of an expense claim on Grand Challenges Canada approved travel. Travellers are encouraged to submit their expenses claims as soon as possible after the end of the trip. All expenses must be supported by original receipts if over $20 CDN, as applicable, except for meal expenses which are reimbursed according to a per diem allowance.
Receipts should indicate the purpose of the expense, the date and the location. In instances where there are a significant number of receipts, they should be affixed to a letter-sized page to ensure that they are not lost. Where the nature or reason for the expense is not self-evident, a description of the reason for the expense should be included on the receipt.
For Grand Challenges Canada personnel, all travel expense claims signed by their supervisor denotes authorization for reimbursement of the expenses. The expense claims of the Chief Executive Officer will be signed by the Chair of the Audit and Finance Committee or Chair of the Board of Directors of Grand Challenges Canada. Non-employee travel expense claims will be signed by a designated Grand Challenges Canada officer.
Grant Number: #0351-03
28 Attachment G: Ethics Policy
It is the policy of Grand Challenges Canada that research involving human participants, research with animals, and research subject to additional regulatory requirements must be conducted in accordance with the highest internationally recognized ethical standards. The purpose of this policy is to set out clear protocols for the ethical conduct of research funded by Grand Challenges Canada. In order to receive funds from Grand Challenges Canada, initially and throughout the course of a research project, researchers must affirm and document compliance with the ethical principles and standards outlined below.
A. GUIDING PRINCIPLES
1. Research involving human participants must be conducted in a manner that demonstrates, protects and preserves respect for persons, concern for the welfare of individuals, families and communities, and justice. 4
2. Research involving animals must be conducted in a manner that ensures their humane care and treatment.
3. Certain research endeavours, including but not limited to research with recombinant DNA, biohazards, and genetically modified organisms, may be subject to enhanced regulation and oversight.
B. RESEARCH INVOLVING HUMAN PARTICIPANTS
Research ethics guidelines and oversight mechanisms are intended to ensure that research involving human participants is conducted in a manner that demonstrates, protects and preserves respect for persons, concern for the welfare of individuals, families and communities, and justice.
Ethical requirements for health research involving human participants in low and middle income countries (LMIC) 5 :
1. If and when conducted or supported by researchers and/or sponsors based in industrialized nations (e.g., Canada), research involving human participants in LMIC must constitute a collaborative partnership between the researchers and/or sponsors in industrialized nations and researchers and/or policy makers and communities in LMIC;
2. Prospective research participants must provide voluntary and informed consent to participate;
4 Modified from the core principles articulated in the draft second edition of TCPS 2 (http://www.pre.ethics.gc.ca/eng/policy-politique/initiatives/tcps2-eptc2/chapter1-chapitre1/#toc01-1b) 5 Modified from Emanuel EJ, Wendler D, Grady C. (2000) What Makes Clinical Research Ethical? JAMA. 283(20): 2701-11; and, Emanuel EJ, Wendler D, Killen J, and Grady C. (2004) What Makes Clinical Research in Developing Countries Ethical? The Benchmarks of Ethical Research. J Infect Dis. 189(5): 930-7.
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29
3. The proposed research must be designed in a manner that demonstrates and preserves respect for potential and enrolled participants;
4. Prospective research participants must be selected fairly, and no individual or group should be disproportionately burdened by or excluded from participation without justification;
5. Individuals involved in the conduct and/or support of research are obligated to avoid, if possible, and disclose and appropriately address any financial or personal conflicts of interest germane to the research project (please see Grand Challenges Canada Policy on Conflict of Interest);
6. The proposed research must be scientifically valid, have potential social or scientific value, and have a favourable ratio of potential benefits to risk of harm; and,
7. Research proposals must undergo independent review by an appropriately constituted research ethics committee 6 .
Which Standards? Grantees must follow local research ethics processes and conform to local research ethics standards at the site where the research is being conducted. These local processes, where they exist, must meet internationally recognized standards; however, all research should conform to the Council for International Organizations of Medical Sciences (CIOMS) International Ethical Guidelines for Biomedical Research Involving Human Subjects 7 (CIOMS Guidelines). To the extent that research is not strictly biomedical in nature, but rather more broadly health related, the principles of the CIOMS Guidelines should be adhered to, to the extent to which they can be applied. In circumstances where GCC co-funds a grant with another funding organization, GCC and the other funder will work together to align the research ethics requirements of both funders.
Research to be carried out at Canadian institutions, or outside of Canada by individuals under the auspices of a Canadian institution 8 , must conform to Canadian Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans 9 (TCPS). GCC will conduct due diligence to ensure the project is consistent with Canadian ethics guidelines.
6 Review should be performed by a committee at the site where the research is to be conducted and at the investigators home institution(s) if different from the institution where the research will take place (see, for example, TCPS 2 Chapter 1 Section C at http://www.pre.ethics.gc.ca/eng/policy-politique/initiatives/tcps2- eptc2/chapter1-chapitre1/#toc01-1c); if no such committee is available at the research site, review may be provided by an appropriately constituted external committee. 7 http://www.cioms.ch/publications/layout_guide2002.pdf) ; NOTE: a particular aim of the CIOMS Guidelines is to reflect the conditions and the needs of low-resource countries, and the implications for multinational or transnational research in which they may be partners. 8 http://www.pre.ethics.gc.ca/eng/policy-politique/initiatives/tcps2-eptc2/chapter1-chapitre1/ 9 TCPS 2 (http://www.pre.ethics.gc.ca/pdf/eng/tcps2/TCPS_2_FINAL_Web.pdf)
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30 Documentation Grantees must provide Grand Challenges Canada with documentation of approval obtained from an appropriately constituted research ethics review committee 10 before any human participants are enrolled to participate and/or human materials requiring oversight are utilized in the research project. Documentation of ongoing approval must be provided to Grand Challenges Canada in semi-annual and/or annual project reports.
C. RESEARCH WITH ANIMALS
Grantees using animals 11 in their research must follow local processes and conform to local standards for the humane care and treatment of animals at the site where the research is being conducted. These processes must meet internationally recognized standards. In the absence of a relevant national standard, research should, at minimum, conform to the CIOMS International Guiding Principles for Biomedical Research Involving Animals 12 .
Grantees at Canadian institutions including Canadian researchers conducting research outside of Canada must, at a minimum, conform to the policies 13 and guidelines 14 of the Canadian Council on Animal Care (CCAC). Multi-institutional animal research involving Canadian researchers must conform to the CCAC guidelines for Animal-Based Projects Involving Two or More Institutions 15 .
Documentation Grantees must provide Grand Challenges Canada with documentation of approval from the relevant institutional animal care committee 16 at the time of grant award or before animal research can be initiated. Documentation of ongoing review and approval must be provided to Grand Challenges Canada in semi-annual and/or annual project reports.
10 i.e., a Research Ethics Board (REB) in Canada or an Institutional Review Board (IRB), Research Ethics Committee (REC) or independent ethics committee (IEC) outside of Canada, that meets the aforementioned minimum standard. 11 Defined as any live, vertebrate animal used or intended for use in research, research training, experimentation, biological testing or for related purposes. 12 http://www.cioms.ch/publications/guidelines/1985_texts_of_guidelines.htm; NOTE: International guidelines for the use of animals in research developed by the World Organization for Animal Health are expected to come into effect in 2010; once in force, these will supersede the CIOMS Guidelines as the minimum acceptable standard. 13 http://www.ccac.ca/en/CCAC_Programs/Guidelines_Policies/POLICIES/policy.htm 14 http://www.ccac.ca/en/CCAC_Programs/Guidelines_Policies/GDLINES/Guidelis.htm and, in particular, http://www.ccac.ca/en_/standards/policies/policy-ethics_animal_investigation. 15 http://www.ccac.ca/en/CCAC_Programs/Guidelines_Policies/GDLINES/ProjectsInvolvingTwoorMoreInstit utions.htm 16 Institutional Animal Care Committee (ACC) in Canada or Institutional Animal Care and Use Committee (IACUC) or equivalent abroad
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31 D. RESEARCH SUBJECT TO ADDITIONAL REGULATORY REQUIREMENTS
Certain research endeavours may be subject to enhanced regulation and oversight. Examples include, but are not limited to, research involving recombinant DNA, biohazards 17 , human pluripotent stem cells, or the release of genetically modified insect vectors, genetically altered plants, or other genetically modified organisms into the environment. All such research must be conducted in accordance with relevant national and/or international guidelines and may be subject to enhanced oversight by relevant institutional, regional or national regulatory bodies.
Research conducted by grantees at or affiliated with Canadian institutions must be in compliance with the Human Pathogens and Toxins Act 18 and/or the Canadian Institutes of Health Research (CIHR) Guidelines for Human Pluripotent Stem Cell Research 19 . Grantees at non-Canadian institutions must be in compliance with recognized international standards for research identified as posing biosafety and/or biosecurity risks 20 in addition to institutional and/or jurisdictional laws, regulations and/or guidelines applicable at the site where the research is being conducted.
Research involving the import or export of genetically modified organisms must be conducted pursuant to the Cartagena Protocol to the United Nations Convention on Biological Diversity 21 , in addition to any local standards at the site of the research.
Documentation Grantees must inform Grand Challenges Canada of the relevant standard(s) with which they will comply and their justification for choosing those standards. Furthermore, grantees must provide Grand Challenges Canada with documentation of approval from any and all relevant oversight bodies 22 before research can be initiated; documentation of any required ongoing review and approval must be provided to Grand Challenges Canada in semi-annual and/or annual project reports.
17 i.e., biological agents and toxins that have the potential to pose a severe threat to public, animal or plant health, or to animal or plant products (e.g., select agents as designated by the US government: http://www.selectagents.gov/) 18 An Act To Promote Safety And Security With Respect To Human Pathogens And Toxins, the purpose of which is to establish a safety and security regime to protect the health and safety of the public against the risks posed by human pathogens and toxins; available at: http://www2.parl.gc.ca/HousePublications/Publication.aspx?Docid=3865169&file=4 19 http://www.cihr-irsc.gc.ca/e/34460.html; Note: these guidelines will be incorporated by reference into the second edition of TCPS; once that edition is in force, the specific reference herein to these guidelines will become redundant, as Canadian grantees already will be required under this policy to follow TCPS. 20 For example: the Human Pathogens and Toxins Act (Canada), the National Institutes of Health (NIH) Guidelines for Research Involving Recombinant DNA Molecules (US; http://oba.od.nih.gov/rdna/nih_guidelines_oba.html), World Health Organization (WHO) biosafety guidelines (http://whqlibdoc.who.int/publications/2004/9241546506_partI.pdf). 21 http://www.cbd.int/biosafety/articles.shtml?a=cpb-01 22 Research involving biohazards must be reviewed and approved by an Institutional Biosafety Officer (BSO) or Institutional Biosafety Committee (IBC), or relevant local equivalent, operating in accordance with relevant national or international standards (e.g., in Canada, BSOs and IBCs must function in accordance with the Public Health Agency of Canadas Laboratory Biosafety Guidelines (http://www.phac- aspc.gc.ca/ols-bsl/lbg-ldmbl/index-eng.php))
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32 Attachment H: Global Access Policy
In the 2008 Federal Budget, the Government of Canada announced the creation of the Development Innovation Fund (DIF) to support the best minds in the world as they search for breakthroughs in global health and other areas that have the potential to bring about enduring changes in the lives of the millions of people in poor countries. The DIF provides a total investment of $225 million over five years, subject to appropriation by Parliament.
The initial activities of the DIF, to be supported by the Government of Canada through the International Development Research Centre, would be in global health. The DIF would be delivered by Grand Challenges Canada working within a consortium that includes the International Development Research Centre and the Canadian Institutes of Health Research.
Grand Challenges Canadas mission is to identify global grand challenges, fund a global community of researchers and related institutions on a competitive basis to address them, and support the implementation / commercialization of the solutions that emerge.
GUIDING PRINCIPLES OF GLOBAL ACCESS
Grand Challenges Canadas Global Access Policy in relation to the DIF is grounded in the following three principles:
1. Breakthrough solutions to global challenges are made accessible to those in need, particularly in the developing world. Accessibility relates to both price and availability.
2. Knowledge gained through discovery is broadly, and as promptly as possible, distributed between related projects and to the global scientific community.
3. Commercialization of resulting outputs is encouraged, as long as the first two principles are achieved.
REQUIREMENT TO ENTER INTO AGREEMENT(S) TO FULFILL GLOBAL ACCESS
Grantees will be required to enter into some form of global access agreement with Grand Challenges Canada at a specified milestone date, or as part of the grant agreement. Such an agreement may be in the form of: a) a non-exclusive license agreement for the use of intellectual property and other outputs related to the grant; b) a general commitment to global access; and/or, c) a separate global access agreement that will detail how knowledge will be disseminated broadly, how intellectual property and other know-how will be protected in furtherance of global access, and how commercialization will be achieved in accordance with global access, among other things.
Global access agreements with Grand Challenges Canada, in line with the Guiding Principles above and the guidelines below will be a condition of receiving funding.
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33 OBJECTIVES OF THE AGREEMENT(S) TO FULFILL GLOBAL ACCESS
The following list of elements outlines important aspects of the agreement(s) with Grand Challenges Canada to fulfill global access. The goal is that a mutually acceptable document (or documents) will be developed jointly to take into account the needs and objectives of all organizations involved.
1. Broad dissemination of knowledge. All research-related outputs, results, publications and reports should be disseminated as broadly as possible to the scientific community. 23
Grand Challenges Canada requires open access publication. Mechanisms to facilitate this objective could include digital libraries, including, where appropriate, via the International Development Research Centres open access Digital Library platform. In the case of software, dissemination should be on the basis of open source software principles. However, disclosure, both written and oral, may be withheld for a period of time sufficient to permit patent applications to be filed.
2. A collaborative process is required. Grantees will work with Grand Challenges Canada on an ongoing and continuous basis to ensure that the grantees are able to achieve their objectives in line with the Guiding Principles and these guidelines throughout the life of the funding process, and in perpetuity in relation to any products or outputs from the funding. Grand Challenges Canada may require sharing of intellectual property among a collection of related projects.
3. The development and protection of intellectual property is encouraged when appropriate. Grantees should consider including costs in their Global Access Agreement associated with seeking and maintaining patents in relevant countries in the project budget. Procuring and maintaining the intellectual property should be done in accordance with the Guiding Principles, and should be generally outlined in the Global Access Agreement.
4. Commercialization that promotes affordable and widespread access. Grantees will be encouraged to commercialize any products or services resulting from the generation of intellectual property in a manner that ensures widespread and affordable access. Grantees may achieve such goals by way of partnerships, license agreements, or other arrangements with for-profit or not-for-profit entities, so long as the underlying objective of access is achieved for those in need in developing countries, and where possible, for vulnerable communities in Canada.
5. Control over intellectual property shall rest with the grantee, or the grantees chosen collaborators. Generally, ownership and control of the intellectual property shall remain with the grantee, or other collaborating organizations or institutions as agreed with the grantee, subject to any applicable local policies and the collaborative process described above, including arrangements between the grantee and other individuals or institutions. The general approach is that the grantee will be able to retain ownership and control over intellectual property and Grand Challenges Canada will not own such rights, so long as global access is being achieved. However, Grand Challenges Canada will
23 This objective should be read in conjunction with Grand Challenges Canadas Research Ethics Policy.
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34 often require access to intellectual property and other outputs and know how arising from the grant to ensure that the Guiding Principles will be achieved. This may be achieved by way of a non-exclusive license agreement.
6. Revenues remain with the grantee, or the grantees chosen collaborators. Generally, revenues generated from the sale of products and services resulting from inventions or other outputs may remain with the grantee, subject to any applicable local policies and the collaborative process described above, including arrangements between the grantee and other individuals or institutions.
7. Grand Challenges Canada will conduct appropriate due diligence. Grand Challenges Canada will conduct due diligence to determine the viability of the project and to ensure that the project conforms to the Guiding Principles and these guidelines. This will often be conducted with reliance on and in conjunction with the grantee. Due diligence will include inquiries into important background technologies and how they will be accessed, the management structure of the project, including how intellectual property will be managed and protected, what collaborations may be involved, and how these collaborations will be managed.
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35 Attachment I: Data Access Policy
Grand Challenges Canada is committed to optimizing the use of data to translate knowledge into life-saving solutions. To fulfill this objective, data must be made widely and rapidly available to the Grand Challenges Canada research community and the broader global health community through ethical and efficient data access practices. 24
GOAL OF DATA ACCESS
The goal of data access is to promote:
Innovation, by encouraging diversity of analysis and opinion; facilitating evaluation of alternative hypotheses, meta-analysis, and synthesis of results from individual projects into a larger whole; and permitting the coordinated application of scientific, social, and business knowledge to generate solutions to complex challenges.
Collaboration, between related projects and Grand Challenges programs, researchers and institutions, and among diverse disciplines to foster greater productivity and creativity.
Efficiency, by preventing unnecessary duplication of effort, and enabling secondary analyses and enhancement of existing data, permitting the redirection of resources to the most promising endeavours to maximize the impact of investments.
Accountability, by encouraging independent verification and analysis, thereby improving data quality and outputs.
Capacity Strengthening, by facilitating the education of new researchers, and enabling broader access to data for secondary analysis and stimulation of bold and innovative ideas, which is of particular importance to researchers in developing countries.
GUIDING PRINCIPLES OF DATA ACCESS
Data access will be facilitated in accordance with the following principles:
Promotion of the Common Good Data will be shared as broadly and as promptly as possible to foster innovation and optimize prospects for the translation of knowledge into life-saving solutions. Data access should enhance the value of research and advance the objectives of Grand Challenges programs.
24 Data access represents an elaboration of the second guiding principle of the Global Access Policy which states that knowledge gained through discovery is broadly, and as promptly as possible, distributed between related projects and to the global scientific community. Grand Challenges Canada Global Access Policy: http://www.grandchallenges.ca/wp-content/uploads/globalaccesspolicy_2012Apr04_EN.pdf
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36
Respect Respect for cultural diversity, scientific integrity, and the privacy of individuals and communities that contribute data will be ensured in all data access activities. Respect must also be given to matters of attribution as they pertain to researchers and institutions that share data.
Stewardship Those who collect, produce, share and use data are responsible for ensuring data quality, security, and modes of access and use that are consistent with applicable laws, regulations, and standards of ethical research conduct as outlined in Grand Challenges Canada Ethics Policy. 25
Proportionality A proportional approach will be adopted when balancing the needs of investigators against those of communities and sponsors that expect health benefits to arise from the activities to which they contribute data or resources. The risks and benefits of data access will be considered and accounted for when sharing data.
Reciprocity The aim of benefitting the individuals and communities who enable and support inquiry, be they research participants or investigators, should be furthered to the extent possible and is of particular importance when involving individuals and communities from developing countries. The sharing of data that can be used to foster breakthrough solutions to global challenges is one way to ensure benefits are returned.
REQUIREMENTS The requirement of data access applies to data collected and generated from research sponsored in whole or in part by Grand Challenges Canada. Data refers at minimum to final, annotated quantitative and qualitative datasets and accompanying information such as metadata, codebooks, data dictionaries, questionnaires and protocols. 26
All grantees are subject to the terms of this policy; however, those in receipt of $500,000 or more will be required, as a condition of the award, and in fulfillment of the Global Access agreement, to develop and submit a Data Access Plan (DAP) that specifies how data access will be implemented and the timeframe for data release. Where deemed appropriate, grantees in receipt of awards less than $500,000 may also be required to develop a DAP 27 . At its sole discretion, Grand Challenges Canada may require that grantees enter into a specific Data Access Agreement that is consistent with this policy and the principles and objectives of Global Access. In developing the DAP, grantees should ensure that relevant aspects of their grant proposal are conducive to data access, i.e. permissions to share data are included in informed consent documents, and in collaboration and consortia agreements. The financial costs related to
25 http://www.grandchallenges.ca/wp-content/uploads/ethicspolicy_2012Jul18_EN.pdf 26 Exclusions: laboratory notebooks, partial datasets, preliminary analyses, communication with colleagues, drafts of scientific papers, unpublished research protocols, future research plans, and physical objects such as laboratory specimens. Note, in certain cases some of these items may be applicable under the Global Access Policy. 27 As directed by the Program Officer.
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37 making data accessible may be included in the proposed budget and will be subject to review and approval.
Data should be deposited into public access repositories whenever possible. When relevant public access repositories are not available for a given dataset, grantees should propose alternatives for access, with consideration given to ease of discovery of the dataset and sustainability of long-term access. Grantees are encouraged to consult Databib (http://databib.org) and similar catalogues to identify suitable repositories for the placement of data.
Grand Challenges Canada recognizes the value of intellectual property and commercialization and the benefits of first and continuing use of data, but not prolonged or exclusive use. In some cases, intellectual property protection, laws, or regulations may delay or preclude access to data. In such cases, the grantee will provide justification to warrant a partial or complete waiver of the data access requirement. 28 For additional guidance on fulfilling the requirements of data access, grantees should refer to the program specific FAQ and consult with their Program Officer.
28 For example, trade secrets developed in the course of grant-funded activities would qualify for exemption from early disclosure requirements.
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38 Attachment J: Non-Exclusive License Granted in Furtherance of Global Access
Whereas Socios en Salud Sucursal del Per [Grantee] is the recipient of a Saving Brains Scaling Impact grant (the Grand Challenges Canada Grant Agreement) from Grand Challenges Canada, the purpose of which is to contribute to global health and ensure that breakthrough solutions to global challenges are made accessible to those in need, particularly in the developing world. Accessibility relates to both price and availability;
Whereas Socios en Salud Sucursal del Per [Grantee] has agreed to grant and hereby grants a non-exclusive license to Grand Challenges Canada to any outputs, including intellectual property, information and data that may be developed in the course of research funded by Grand Challenges Canada, or is required for the research funded by Grand Challenges Canada in this Grand Challenges Canada Grant Agreement, as set out below;
Whereas the purpose of this non-exclusive license agreement is to ensure global access to the outputs should the Grantee, or the Grantees licensees, collaborators or partners, fail to make them widely available at a reasonable price for the benefit of people in Developing Markets (defined below).
Essential terms of this license grant are:
1. License Grant: Grantee hereby grants to Grand Challenges Canada (GCC) a non- exclusive, perpetual, irrevocable, royalty-free, fully-paid, sub-licensable, and assignable license in respect of all Outputs, defined below, arising from the work carried out by Grantee, or at the Grantees direction, in connection with this Grand Challenges Canada Grant Agreement, to permit Grand Challenges Canada (and its sub-licensees) to use, educate, conduct research, develop, make, have made, import, export, sell, offer for sale, or distribute products, processes or solutions in Developing Markets.
a. Outputs: Outputs means all intellectual property (including but not limited to patents, trademarks, copyrights, design rights, inventions, know-how and source code), as well as information and data (including but not limited to raw data and all information required for regulatory approval) developed as a result of or in connection with this Grand Challenges Canada Grant Agreement, and includes any data that was previously developed by Grantee and is required for the research funded by Grand Challenges Canada in this Grant Agreement.
b. Developing Markets: Developing Markets is defined in the chart below.
2. License Grant to Outputs by Involved Parties: Grantee will have the Principal Investigator, and all Grantees employees, collaborators, contractors, sub-contractors, sub-grantees, consultants, partners, investors, affiliates that are directly involved in the work of the Grand Challenges Canada Grant Agreement (Involved Parties) agree to grant to Grantee a non-exclusive license to Outputs by Involved Parties,
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39 under the same terms as provided in this Attachment J. This shall be done by having all Involved Parties sign a copy of the Undertaking at the end of this Attachment J. Grantee hereby grants to Grand Challenges Canada a non-exclusive license to the Outputs by Involved Parties under the same terms as provided in this Attachment J. For greater clarity, anyone not directly involved in the work of the Grand Challenges Canada Grant Agreement and who has no rights to the Outputs, shall not be required to sign the Undertaking.
3. Agreement Not to Assert Background IP: Grantee agrees not to assert any Background IP against Grand Challenges Canada, or Grand Challenges Canadas sub-licensees that is necessary to allow Grand Challenges Canada, or Grand Challenges Canadas sub-licensees, to use the Outputs in Developing Markets.
a. Background IP: Background Intellectual Property shall mean intellectual property owned or controlled by, or licensed to, the Grantee or Involved Parties that are necessary to use the Outputs.
4. Agreement by Involved Parties Not to Assert Background IP: Grantee will have the Involved Parties agree to not to assert any of their Background IP against Grand Challenges Canada, or Grand Challenges Canadas sub-licensees, that is necessary to allow Grand Challenges Canada, or Grand Challenges Canadas sub-licensees, to use the Outputs in Developing Markets. This shall be done by having all Involved Parties sign a copy of the undertaking at the end of this Attachment J.
5. Ownership: Nothing in this license agreement shall change any right, title or interest that the Grantee or Involved Parties have, or shall establish, in or to, the Outputs or Background IP.
6. Notice to Grantee & Grantees Option to Respond: Grand Challenges Canada must provide written notice to Grantee prior to any sub-license or assignment of this license grant to a third party in a Developing Market. At this point, Grantee will have the right to demonstrate to Grand Challenges Canada (by way of a proposal) that it has or will make the Outputs accessible in that Developing Market, whether by way of an agreement with the third party or otherwise. If Grand Challenges Canada agrees that global access is or will be attained in a reasonable time by way of the Grantees proposal, Grand Challenges Canada will not provide the sub-license or assignment. It is in Grand Challenges Canadas discretion whether global access is being or will be achieved by the Grantees proposal.
7. Assignment or Succession of License or Outputs: If Grantee elects to assign its rights to the Outputs to a third party, or the Outputs pass to a successor, Grantee must notify this third party assignee or successor of the existence of this license, and obtain in writing this third party assignees or successors agreement to be bound by the license.
8. Disclaimer of Warranty: Grantee makes no representations, conditions or warranties, either express or implied, regarding the Outputs aside from what is set out in Attachment K of the Grant Agreement with Grand Challenges Canada. Grantee
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40 specifically disclaims any implied warranty, condition or representation that the Outputs: a. correspond with a particular description; b. are of merchantable quality; c. are fit for a particular purpose; d. are durable for a reasonable period.
9. Indemnification: a. If License is Used by Grand Challenges Canada: Should Grand Challenges Canada itself use the license set out in Term 1 above (i.e. use other than by way of a sub-license), Grand Challenges Canada shall indemnify and hold harmless the Grantee against all claims related to the use of the license by Grand Challenges Canada, except to the extent that harm was caused as a result of gross negligence or willful misconduct by the Grantee. Should Grand Challenges Canada itself use the license set out in Term 1 above, it will acquire and maintain reasonable insurance coverage, as would be acquired by a reasonable and prudent business carrying on a similar line of business.
b. Mandatory Sublicense Provision: Should Grand Challenges Canada sub- license to third parties pursuant to this license agreement, that sub-license agreement shall include a requirement that the sub-licensee indemnify and hold harmless the Grantee and Grand Challenges Canada against any or all claims arising out of the exercise of any rights under the sub-license, except to the extent that harm was caused as a result of negligence or fault by the Grantee. Grand Challenges Canada will also require the sub-licensee to acquire and maintain reasonable insurance coverage for such indemnification, as would be acquired by a reasonable and prudent business carrying on a similar line of business.
10. Governing law: This license agreement shall be governed and interpreted in accordance with the laws of the province of Ontario, in the country of Canada.
11. Dispute Resolution: In the event of a controversy or dispute between the parties arising out of or in connection with this license agreement, or regarding its interpretation or operation, the parties shall take all necessary steps to resolve the dispute themselves. Where such efforts are unsuccessful, the parties may refer the dispute to a third party mediator mutually agreeable to the parties for resolution. Should mediation be unsuccessful, the parties agree to submit the dispute to arbitration administered by the International Chamber of Commerce International Court of Arbitration in accordance with its rules and judgment upon the award rendered by the arbitrator may be entered in any relevant court.
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41 DEVELOPING MARKETS
Low-income economies ($1,035 or less) Afghanistan Gambia, The Myanmar Bangladesh Guinea Nepal Benin Guinea-Bissau Niger Burkina Faso Haiti Rwanda Burundi Kenya Sierra Leone Cambodia Korea, Dem Rep. Somalia Central African Republic Kyrgyz Republic South Sudan Chad Liberia Tajikistan Comoros Madagascar Tanzania Congo, Dem. Rep Malawi Togo Eritrea Mali Uganda Ethiopia Mozambique Zimbabwe 48 Lower-middle-income economies ($1,036 to $4,085) Armenia India Samoa Bhutan Kiribati So Tom and Principe Bolivia Kosovo Senegal Cameroon Lao PDR Solomon Islands Cape Verde Lesotho Sri Lanka Congo, Rep. Mauritania Sudan Cte d'Ivoire Micronesia, Fed. Sts. Swaziland Djibouti Moldova Syrian Arab Republic Egypt, Arab Rep. Mongolia Timor-Leste El Salvador Morocco Ukraine Georgia Nicaragua Uzbekistan Ghana Nigeria Vanuatu
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42 Guatemala Pakistan Vietnam Guyana Papua New Guinea West Bank and Gaza Honduras Paraguay Yemen, Rep. Indonesia Philippines Zambia 55 Upper-middle-income economies ($4,086 to $12,615) Angola Fiji Palau Albania Gabon Panama Algeria Grenada Peru American Samoa Hungary Romania Argentina Iran, Islamic Rep. Serbia Azerbaijan Iraq Seychelles Belarus Jamaica South Africa Belize Jordan St. Lucia Bosnia and Herzegovina Kazakhstan St. Vincent and the Grenadines Botswana Lebanon Suriname Brazil Libya Thailand Bulgaria Macedonia, FYR Tonga China Malaysia Tunisia Colombia Maldives Turkey Costa Rica Marshall Islands Turkmenistan Cuba Mauritius Tuvalu Dominica Mexico Venezuela, RB Dominican Republic Montenegro Ecuador Namibia
Source: World Bank country classification as of July 1, 2013
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43 Undertaking for Non-exclusive License
I, _______________________ [Name, Printed] hereby acknowledge that I am about to participate in activities funded by Grand Challenges Canada related to funding from Grand Challenges Canada to ____________________ (Grantee).
I hereby acknowledge that I have read and understand the terms of the non-exclusive license agreement between Grand Challenges Canada and Grantee as set in Attachment J: Non- exclusive License Granted in Furtherance of Global Access, as enclosed to this Undertaking (Non-exclusive License Agreement).
I hereby agree to be bound by the terms and conditions of the Non-exclusive License Agreement, including but not limited to: i) the grant of a license to Grantee, and ii) the agreement not to assert background intellectual property.
I acknowledge that the purpose of the Non-exclusive License Agreement and my participation in activities funded by Grand Challenges Canada is to contribute to global health and ensure that breakthrough solutions to global challenges are made accessible to those in need, particularly in the developing world. Accessibility relates to both price and availability.
1. Please confirm that Socios En Salud Surcursal Peru is committed to fulfilling the Principles of Global Access, as set out in Grand Challenges Canadas Global Access Policy and Data Access Policy.
Socios En Salud is committed to fulfilling the Principles of Global Access, as set out in Grand Challenges Canadas Global Access Policy and Data Access Policy.
2. Please confirm that you own (or have the ability to legally access) all necessary background intellectual property with respect to any technologies and any raw data that you will rely upon to fulfill this project.
Socios En Salud owns all necessary background intellectual property with respect to technology and raw data we will rely on to fulfill this project.
3. Please outline the expected outputs including intellectual property from this funding Agreement that may result in patents, trade secrets or other forms of intellectual property.
The property titles, author rights and all other rights brought on by the realization of the projects are those of the participating parties, whose names will be specifically indicated, acknowledging their collaboration with Grand Challenges for its intellectual donation.
4. Who will own the expected output(s) (i.e. intellectual property, raw data, etc.) of your grant?
Socios En Salud, the non-governmental organization, and ultimately, the two Principal Investigators on the grant will collectively own the rights to all expected output. Sonya Shin also will have equal rights to the intellectual property as Maribel Munoz and Leonid Lecca.
Output Type of Output Ownership All raw data, including qualitative transcripts, photographs, video, observational notes, raw data on forms or stored in a database Data Socios En Salud (Maribel Munoz and Leonid Lecca) and Sonya Shin Adapted individual and group interventions and all supplemented materials and instructions Educational materials Socios En Salud (Maribel Munoz and Leonid Lecca) and Sonya Shin Adapted ASQ instrument Diagnostic materials Socios En Salud (Maribel Munoz and Leonid Lecca) and Sonya Shin All academic articles Copyright Authors
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45 5. Please confirm that all individuals and organizations listed in your answer to question 4 above are committed to fulfilling the Principles of Global Access. Please also confirm that all potential collaborators or partners will be made aware of Grand Challenges Canadas Global Access Policy.
All individuals are committed to fulfilling the Principles of Global Access and all potential collaborators or partners will be made aware of Grand Challenges Canadas Global Access Policy.
6. Is there anything preventing you from making all resulting outputs of your grant available to Grand Challenges Canada for the purpose of Global Access (e.g. local laws, regulations, policies or any previous contracts, stipulations by project collaborators or partners)? Outputs include but are not limited to your raw data, technologies, intellectual property and any business models developed.
There is nothing preventing us from making all resulting outputs of the grant available to GCC for the purpose of Global Access.
7. Are there any computer programs, software, systems or other such technologies on which you will be relying to complete your project? Please describe what these are and detail the legal permission you have to use such resources (i.e. licenses, open access permission, etc.).
Respective licenses will be obtained for computer programs, software, systems or other technologies, in order that they be used without any type of restriction.
8. Please detail your plan for widely disseminating the knowledge generated during the course of your project, such as data, methods, results, research papers, guidelines and/or written products.
The data will be managed confidentially and will be entered in a protected database with a secure Internet connection before being analyzed. This will allow us to write four publishable articles in peer-reviewed journals: 1) adapting and validating the ASQ instrument; 2) process evaluation of delivery of CBEI by CHWs; 3) factors associated with NDD in Carabayllo; 4) final outcome results and descriptions of populations that benefit most from which intervention. Study experience and results will be filmed and we will work with the Communications team at Socios En Salud to create several short videos, with the consent of the participants, to be aired on local television. We will submit to Open Access journals, in the case that prestigious journals of this nature are available, and otherwise will deposit a proofed copy into PubMed Central upon the end of the journals stated. embargo period. This will allow us to increase policy makers' awareness of the issues at hand and to disseminate our intervention and findings to other interested parties. Additionally, we will present our results in four meetings with the Peruvian Ministry of Health clinicians, municipality leaders in Carabayllo, COSACA, our local ally, and the community health workers. We will
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46 hold a web-conference to present and discuss findings with Haitian and Rwandan health care providers, leaders and CHWs to explore multi-site collaboration.
9. With respect to your answer to question 4, please clarify what is meant by the application field of the National Institute of Defense of Competence and Intelectual Property (INDECOPI). Please outline any relevant implications for your ability to fulfill the Principles of Global Access.
We have taken out the mention of INDECOPI from question 4. We will have no problems fulfilling the Principles of Global Access.
10. With respect to your answer to question 8, please identify any potential authors, owners or rights-holders of the short videos you intend to air on local television. Please confirm that these individuals are committed to fulfilling the Principles of Global Access.
As an institution, Socios En Salud as an institution will be the author and own the rights to these videos. We are committed to fulfilling the Principles of Global Access.
11. Grand Challenges Canada expects all of its grantees to recognize and respect intellectual property (i.e. copyright) ownership and seek permission from any copyright owners for the precise nature of any intended use of any copyrighted work. This includes the use and potential adaptation of assessment tools and tests. Accordingly, please complete the chart below:
Owner of Assessment Test/Tool (i.e. company name) Name of Assessment Test/Tool Current or Expected Use of Tool and/or Related Tests Adaptation to be Made (if any) Permission Sought from Owner for Precise Use?
Yes / No Nature of Permission Required Permission Granted?
Yes/No 1 Lia Fernald, University of California, Berkeley, USA. EASQ Child development assessment tool, to track improvement over 3 month period NONE Yes Use only Yes 2 Ministry of Health of Peru EEDP Child development screening tool to screen for children with delays and compare with EASQ at NONE Available to public free of charge. NONE N/A
Grant Number: #0351-03
47 baseline and 3 months 3 Ministry of Health of Peru TEPSI Child development screening tool to screen for children with delays and compare with EASQ at baseline and 3 months NONE Available to public free of charge. NONE N/A 4 HOME INVENTORY LLC, Distribution Center, 2627 Winsor Drive, Eau Claire, WI 54703 HOME To test the quality of parenting and home environment and its effect on child development We have previously translated into Spanish and used in previous projects Yes Use only, we received prior permission for translation Yes 5 Food and Nutrition Technical Assistance (FANTA) Household Food Insecurity Access Scale (HFIAS)
The scale consists of 18 items (9 items to measure increasing level of food insecurity and 9 items to measure the frequency of those occurrences). We have previously translated into Spanish and used and published in projects. Available to public free of charge. NONE N/A 6 Duke and University of North Carolina Duke UNC Social Support Questionnair e Perceived functional social support: 10 item- scale (confidant support and affective support). In addition, we retained several original items related to instrumental support (i.e. help with transportation, money in an emergency) No. Utilized in Spanish population s with HIV. Have used in previous projects. Available to public free of charge in Spanish online. NONE N/A 7 Dr. Sheldon Perceived 14-item No. Available to NONE N/A
Grant Number: #0351-03
48 Cohen, Carnegie Mellon University stress scale instrument to measure a global level of perceived stress. Recall over past month explores degree to which respondent finds life to be unpredictable, uncontrollable and overloading. Validated in Spanish population s, including among HIV- positive individuals . Used in previous projects. public free of charge on owners website in Spanish. 8 Western Psychologica l Services 625 Alaska Ave. Torrance, CA 90503-5124 Conflicts Tactics Scale (CTS2-S) The CTS2-S is a 20-item scale to measure conflict within couples by asking individuals who have had a relationship within the last 12 months about the frequency of minor and extreme physical/emoti onal assault, injury, sexual coercion. Translated to Spanish, used in previous projects. Yes Use and translation Yes 9 Belen Zorilla at: Servicio de Epidemiolog a, Instituto de Salud Pblica, Consejera de Sanidad de la Comunidad de Madrid, Spain; Juanjo Medina-Ariza, University of Manchester. Controlling Behaviors For additional psychological violence questions (9 items) associated specifically with controlling behavior, we chose 8 items utilized by Zorilla et al (some first used in national survey of violence against women Yes. Controllin g behavior items were validated in Spanish by Zorilla et al and Medina et al. Used in previous projects. Yes Use of selected questions in both cases. Yes
Grant Number: #0351-03
49 in France) and 1 item from Medina et al. 10 Grameen Foundation Progress out of Poverty Index Measuring poverty level. No. This scale is specific to Peru and has been validated there. Available to public free of charge. NONE N/A