Directed Grant: Funding Guidelines

Program Name: Canadian Longitudinal Study on Aging (CLSA)

Program Launch Date: 2008-12-04

Table of Contents

• Description
• Objectives
• Eligibility
• Guidelines and Conditions
• Performance Measurement
• Oversight and Monitoring
• Contact Information

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Description

This document is intended to inform the research community, potential research collaborators, and partners of the funding guidelines that apply to the Directed Grant allocated to the Canadian Longitudinal Study on Aging (CLSA). These guidelines also form part of the more detailed CIHR-McMaster Funding Agreement on the CLSA which was formalized between CIHR, the Nominated Principal Investigator (NPI), and the host institution of the NPI. This document is not intended to replace the agreement.

The purpose of this Directed Grant is to support the CLSA Research Team in their implementation of a national data and biobank resource for researchers, decision-makers and other stakeholders in the area of adult development and healthy aging. This national resource will enable the CLSA Research program and other projects initiated by the broader research community.

The Directed Grant funding process was selected by CIHR because of the nature and scope of this research initiative and its evolution. The CLSA was conceived and championed in 2001 by the Institute of Aging, who mobilized experts in the research community to design the CLSA Protocol. The CLSA's development was driven by the research community and led by a CLSA Research Team, who effectively engaged stakeholders and successfully passed three international peer reviews. In 2008, as the outcome of these efforts, the CLSA was adopted as one of CIHR's Major Strategic Initiatives and the CLSA Research Team was awarded a Directed Grant to implement the initiative.

Funds Available

CIHR and partner contributions to the amount available for this initiative are subject to availability of funds. Should CIHR or partner dollars not be available or are decreased for some unforeseen circumstance, CIHR and any partners reserve the right to defer or suspend payments to this Directed Grant.

The Directed Grant is valued at $23.5 million to support the five-year implementation phase of the CLSA, namely, Phase III: Initial Tracking and Comprehensive Cohorts. This amount may increase if funding partners decide to participate.

CIHR may review, annually or as it deems necessary, the progress of the CLSA and may, at its discretion, modify the funding conditions and the level and duration of this Directed Grant.

The Directed Grant supports a portion (approximately 86%) of the actual costs of the CLSA Protocol implementation, based on the expectation that Partner funds will be secured by the NPI.

Objectives

The objective of this Directed Grant is to support the CLSA Research Team to generate a national data and biobank resource for researchers, decision-makers and other stakeholders in the area of adult development and healthy aging. This national resource is expected to enable the achievement of the overall aims of the CLSA Protocol, which are as follows:

1. To examine aging as a dynamic process.
2. To investigate the inter-relationship among biological, disease, psychological, and social factors from mid life to older age.
3. To capture the transitions, trajectories and profiles of aging.
4. To provide infrastructure underpinning multidisciplinary research and evidence-based decision making in aging.

The CIHR funding will enable the CLSA Research program and other projects initiated by the broader research community in the area of adult development and healthy aging.

Eligibility

Eligibility criteria for all CIHR research funding programs apply. The business office of the institution of the NPI administers CIHR funds. Please refer to the Individual Eligibility Requirements for eligibility requirements for individuals and institutions.

Specific Eligibility Requirements

The NPI is Dr. Parminder Raina, McMaster University, and the co-Principal Investigators are Dr. Christina Wolfson, McGill University, and Dr. Susan Kirkland, Dalhousie University. They have assembled a research team of Co-investigators.

Guidelines and Conditions

Those persons receiving funds under this Directed Grant and any other persons working on the project must fully comply with the "Policies and guidelines in the conduct of research". These requirements and additional special financial requirements are stipulated in the CIHR-McMaster Funding Agreement on the CLSA.

The release of funds must be in accordance with the terms and conditions of the CIHR-McMaster Funding Agreement on the CLSA and the eligible expenses under this Directed grant, which include allowable costs and activities as described in the Use of Grant Funds section of the Tri-Agency (CIHR, NSERC and SSHRC) Financial Administration Guide, and follow CIHR policies outlined in the CIHR Grants and Awards Guide. The Guides, and the interpretation and application of policies therein, are updated from time-to-time.

Additional guidelines for this Directed Grant that prevail over the Guides are outlined below.

Allowable Costs

This Directed Grant is to support the 5-year implementation phase of the CLSA which includes the first wave of recruitment and data collection on the initial tracking cohort of 20,000 participants and comprehensive cohort of 30,000 participants, follow-up on the initial tracking cohort, and management of CLSA data, biological samples, infrastructure, and research activities.

The allowable costs guidelines apply to CIHR funds and any partner funds contributing to the value of this Directed Grant.

Eligible expenses:

Research

• Funds may be used to cover research operating costs for the CLSA implementation and/or pilot and feasibility studies deemed critical to implementation. This may include the development or maintenance of research tools such as: i) frameworks for interpreting relevant phenomena; ii) approaches for analysis, measurement and reporting of data and information; and iii) approaches to measurement validation, policy/program evaluation, and knowledge translation.

Research resources not supported by the Canada Foundation for Innovation

• Purchase of equipment and maintenance contracts for common services and shared facilities;
• Contracting of services only where necessary to provide services and expertise not available within the CLSA;
• Costs of data and biological material collection, database and maintenance of information holdings and banked biological specimens directly related to the CLSA implementation;
• Costs related to travel and accommodation for CLSA Personnel and CLSA Researchers, and members of CLSA governance committees and working groups, for the specific purpose of conducting CLSA business.

Knowledge Translation

• Costs of regional, national and international networking activities, including collaboration, planning, and knowledge exchange activities, directly related to the CLSA implementation;
• Costs involved in linking with, and communicating/disseminating research findings to, End-users (including other researchers, the public, practitioner and policy communities, and the industrial sector).

Personnel

• Salaries for staff of the CLSA National Coordinating Center and other specialized Centers, including a National Manager, professional and communication coordinator and/or administrative assistant;
• Salaries of research assistants, technicians and other personnel who will enhance the scientific, management and partnerships of the CLSA;
• Release time payments to enable employees of community partners to participate actively in the CLSA's implementation, limited to 50% of salary costs, and an overall maximum of $100,000 per year;
• Salaries for early career independent researchers. As such, CIHR eligible institutions can offer faculty appointments to independent researchers paid from the Directed Grant. In such cases, those paid from the Directed Grant cannot also hold a Canada Research Chair or other salary award. Those paid from the Directed Grant can not be listed as co-investigators on the Directed Grant; however they can be considered members of the CLSA team. The definition of an early career independent researcher is a person who has held a full time research appointment (e.g., faculty appointment providing eligibility to apply for Federal Granting Agency grants and/or supervise trainees) for a period of 0 to 60 months as of the start date of the appointment

Ineligible expenses:

The CLSA's own research program is not supported by this Directed Grant.

While the CLSA, as a resource, is poised to be responsive to stakeholder needs by increasing, as required, the breadth or depth of the currently supported core CLSA research activities and infrastructure operations, this Directed Grant cannot be redirected to support such expansion, including add-on or sub-studies, unless otherwise approved in advance and in writing by CIHR.

Research resources supported by Canada Foundation for Innovation funding are ineligible under this Directed grant. These ineligible expenses include:

• Infrastructure Acquisition & Development expenses such as purchase/lease of equipment or facility (including shipping, taxes and installation; lease of equipment or facility; travel (infrastructure related); software; extended warranties; service contracts; and initial training of infrastructure personnel.
• Infrastructure Operations & Maintenance expenses such as related personnel, supplies, maintenance and repairs, Services, Training Software and Licenses.

Access to Information Act and Privacy Act, and the Personal Information Protection and Electronic Documents Act (PIPEDA)

All personal information collected by CIHR about applicants is used to review applications, to recruit reviewers, to administer and monitor grants and awards, to compile statistics, and to promote and support health research in Canada. Consistent with these purposes, applicants should also expect that information collected by CIHR may be shared as described in Use and Disclosure of Personal Information Provided to CIHR for Peer Review.

CIHR as a federal entity is subject to the Access to Information Act and the Privacy Act, therefore the requirements of these two statutes will apply to all information located in CIHR's premises including, without limitation, cost-sharing agreements related to this Funding opportunity and all matters pertaining thereto.

While respecting the application of the Privacy Act to federal entities, all signing parties involved in a collaborative agreement will also be bound by the Personal Information Protection and Electronic Documents Act (PIPEDA). All personal information (as identified by the PIPEDA) collected, used or disclosed in the course of any commercial activity under collaborative agreements related to the Funding opportunity will be collected, used and disclosed in compliance with the PIPEDA.

Open Access Policy

CIHR believes that greater access to research publications and data will promote the ability of researchers and knowledge users in Canada and abroad to use and build on the knowledge needed to address significant health challenges. Open access will promote accessibility to CIHR-funded research and will serve to increase the international visibility of Canadian research. As of January 1, 2008, CIHR grant recipients are reminded to adhere with the responsibilities outlined in the CIHR Open Access Policy. Under this policy, grant recipients must make every effort to ensure that research papers and bio-molecular data generated from CIHR funding are freely accessible online.

In the context of the objectives of this Directed Grant, the term "research output" in this policy would be equivalent to "project output", which, for the CLSA includes the primary outputs of the CLSA activities supported by this grant, these being the data and biological samples collected from the CLSA study participants for the purposes of generating the CLSA national data and biobank resource. As such, to ensure optimal use by the broader research community, including the CLSA researchers, of the CLSA data and biological samples, the decision process and applicable policies developed by the Nominated Principal Investigator for CLSA data and biological sample access, sharing and utilization must be in accordance with CIHR's values and standards for public interest and transparency, Guidelines for conflict of interest and for Ethics. Alignment with CIHR's values, standards and guidelines will be ensured through:

• the oversight responsibility of the CIHR-appointed International Oversight Committee on the CLSA, which includes the CLSA data and biological samples access and use, and
• the required approval by CIHR of the CLSA's decision process and applicable policies and criteria for data and biological sample access, sharing and utilization.

Responsibilities of the institution of the Nominated Principal Applicant

McMaster University shall make payments a Secondary Institution only if it is the host institution of a CLSA Researcher and only if the Secondary Institution has agreed to a CLSA Data/Materials Custody, Release and Access guidelines and to a CLSA Intellectual Property policy.

McMaster University shall house the National Coordinating Centre of the CLSA and ensure that this centre has reasonable accommodations adequate to the needs of the CLSA project, including communication, computer and financial administration systems.

McMaster University shall be the custodian of all the data and biological samples collected from the CLSA participants for the purposes of generating the national data and biological sample resource. McMaster University shall be responsible for the preservation, retention, and protection, according to applicable and up-to-date standards, of these samples over the course of the funded portion of the study (or else negotiated between CIHR and McMaster University) and for 25 years, thereafter for the data and subject to shelf life of the biological samples.

Conflict of Interest

The NPI is required to adopt and implement a Code of Conduct for the CLSA and its committees to adequately prevent conflict of interest with respect to use of this Directed Grant. This Code must be in accordance with CIHR's policies and those of all Primary and Secondary institutions involved.

Intellectual Property

The NPI is required to develop and adopt an Intellectual Property policy for the CLSA that, at a minimum: encourages and facilitates commercialization for the greatest benefit to Canada, includes policies conducive to partnerships with various organizations, is agreed upon by all CLSA Researchers and their host institutions, and is in accordance with the policies of CIHR and the Primary and Secondary institutions involved.

Recognition and Public Disclosure

The NPI is required to ensure that all CLSA Researchers and the Primary Institute Paid shall, unless otherwise directed by CIHR, acknowledge this Directed Grant and CIHR in any published paper, report, promotional activity and material (e.g., letterhead), public presentation and electronic material related to the CLSA.

The NPI is required to develop a publications policy in conjunction with the CLSA Data Access and Release guidelines. At a minimum, all studies involving CLSA data, biological and other resources must acknowledge CIHR and the CIHR Funding Reference Number LSA 94473 as well as CLSA support. The NPI shall use best efforts to track these outputs.

Official languages

The NPI is required to provide information in both official languages in accordance with the Official Languages Act , when such information is destined to persons outside the team of CLSA Researchers (i.e., not deemed internal communications), including but not limited to, general information to the public and national media, documentation provided to Study participants, instructions to the broader research community and others on how to access the different CLSA resources (data, biological samples, and infrastructure), and other efforts, such as appointing a Francophone media contact, that are aimed at minimizing barriers for French speaking Canadians in their understanding and accessing of the CLSA resource.

Randomized Controlled Trials

Any Randomized Controlled Trials supported by CLSA data, biological samples and/or infrastructure are subject to Trial Registration.

Performance Measurement

CIHR is committed to collecting and disseminating information on the outputs and impacts of the research it funds. This information is an important part of CIHR accountability within the Federal Government and to Canadians.

With respect to performance measurement, the following requirements apply to this Directed Grant:

• The NPI and McMaster University shall provide any information that CIHR may at any time request, the NPI shall attend and participate in meetings, and the NPI and the Host shall make reasonable efforts to make available to CIHR any other CLSA Researcher, when requested by CIHR.
• The NPI is required to submit an annual progress report. The CLSA's performance will be evaluated by a CIHR-appointed International Oversight Committee.
• The NPI is required to contribute to the monitoring, review and evaluation of CIHR's programs, policies and processes by participating in evaluation studies, surveys, workshops, audits and providing data or reports as required for the purpose of collecting information to assess progress and results;
• The NPI is required to encourage all associates, trainees and administration to participate in the monitoring, review and evaluation of CIHR's programs, policies and processes as required.

Oversight and Monitoring

With the aim to effectively conduct oversight and performance measurement activities, CIHR has adopted the following approaches:

• A CIHR-appointed International Oversight Committee is mandated to provide CIHR with expert advice as well as independent ongoing oversight and evaluation of the CLSA according to internationally recognized standards of excellence for science and leadership. Formal reviews on CLSA's progress will occur at least annually.
• A CIHR staff person shall be an observer at every meeting of the CLSA's Primary and Secondary Data Access and Utilization Committee. CIHR reserves the right to appoint an observer to any other committee established within the governance structure of the CLSA.
• CIHR may visit periodically with 48-hours notice, unless otherwise negotiated, the CLSA National Coordinating Centre, other CLSA Centres and McMaster University, and access any documents or data (exceptions relate to respecting the privacy and confidentiality of CLSA Study participants) in any medium.

Annual Reporting Requirements

The NPI is required to provide CIHR with an annual progress report, the requirements of which are subject to additions or modifications by CIHR. Specific progress reporting requirements related to targeted activities supported by funding partners are addressed through the existing annual reporting schedule or as per the funding partners' schedule, as appropriate.

The first complete annual progress report for the period of January 2009 to March 31, 2010 must be submitted on May 1, 2010. Future submissions will be required annually thereafter on May 1. CIHR is to provide the template for such a report, namely the Annual Report on Progress and Future Plans.

The annual progress report will provide information on the progress made against scientific and operational milestones and budget (as described in the 2009 CLSA Final Protocol or most recent Annual Progress report). More specifically, the Annual Progress report should provide at least the following information:

1. Plans and expected outcomes for the reporting year;
2. Actual activities and outcomes within the reporting year;
3. Explanation of any course corrections or deviations from the original (or previous Annual Progress report's) plans and expected outcomes;
4. Plans and expected outcomes for the upcoming year.

The annual progress report will include the following key areas of reporting:

Project Implementation

• Objectives and activities related to CLSA's implementation (i.e., the collection of data and biological samples and obtaining and integrating research personnel and any new infrastructure);
• An up-to-date list of CLSA Researchers as of the end of the reporting year, with New Investigators identified.

Governance

• The objectives and activities related to governance and management (e.g., establishing committees, assigning senior management roles, staffing, developing policies, etc.);
• Challenges and risks:
  1. Challenges: leadership/management challenges faced during the reporting year and the status and/or process of the resolution of these challenges;
  2. Risks: Description of identified risks and mitigation strategies;
  3. Internal monitoring: Description of internal CLSA processes and measures;
  4. Conflict of Interest: Report of conflict of interest matters;
  5. Audits: Summary of the results of independent or internal audits and evaluations.

Research Inputs and Outputs

• Research projects led by CLSA researchers and others that are based on CLSA data and biological samples and infrastructure;
• Research outputs that were based on CLSA data and biological samples and infrastructure:
  1. A list of all publications published, in press, or submitted for publication, and invited presentations during the reporting year which were based on CLSA data and biological samples and/or aimed at promoting the CLSA;
  2. A list of all tangible outputs, such as patents, licenses, spinoffs, new or improved policies, practices and programs, during the reporting year resulting from findings that were based on analyses of CLSA data and biological samples;

Collaborations and Partnerships

• Objectives and activities related to Collaborations and Partnerships;
• List all Researcher Partners and Organization Partners newly engaged in the CLSA during the reporting year through formal and informal arrangements and in what role.

Training and Mentoring

• Objectives and activities related to training, mentoring and engaging additional highly qualified personnel and New Investigators in the CLSA.
• List all highly qualified personnel who are i) currently engaged, and ii) newly engaged during the reporting year, in the CLSA (PDFs, PhD's and Masters Students) and undertaking Research Training projects that are specifically and significantly CLSA supported (i.e., based on CLSA data, biological samples and/or infrastructure).
• List all New Investigators not originally part of the CLSA team, newly engaged during the reporting year in the CLSA and directing research that is specifically and significantly based on CLSA data, biological samples and/or infrastructure. Provide: Last name, First name, Academic title, Institution, Province, Research project/area, and if applicable, Role/Title within CLSA.

Financial

• Expenses under the Directed Grant.
• Revenues and cash and in-kind contributions received from other non-CIHR sources (e.g., user and service fees, Institutional, Federal Granting Agencies, Other Federal sources, Provincial, Industry, International, Non-governmental Organization/charity/foundation).
• CIHR grants and awards successfully applied for the support of research and training based on CLSA data and biological samples and infrastructure and that have a start date during the reporting year.

Contact Information

For questions about this initiative and research objectives contact:

Erica Dobson
Initiative Officer
Canadian Longitudinal Study on Aging
Canadian Institutes of Health Research
Telephone: 613-946-7656
Fax: 613-954-1800
Email: erica.dobson@cihr-irsc.gc.ca

For questions about the International Oversight Committee contact:

Isabelle Schmid, Ph.D
Deputy Director, Program Delivery
Targeted Initiatives Branch
Canadian Institutes of Health Research
Telephone: 613- 954-6643
Fax: 613-954-1800
Email: isabelle.schmid@cihr-irsc.gc.ca