CIHR Clinical Trials Network in HIV/AIDS

Institute of Infection and Immunity - HIV/AIDS Research Initiative

Request for Proposal

Important Dates
Opportunity Launched	July 2007
Content Last Updated	2007-07-27: How to Apply
2007-10-01	Full application must be courier stamped by this date.
2008-02-01	Anticipated notification of decision.
2008-04-01	Anticipated start date.

Description
Objectives
Eligibility
Guidelines
Performance Measurement
Review Process and Evaluation
How to Apply
Contact Information
Partner/Collaborator Description
Additional Information

Description

Part of CIHR's mandate is to promote research that addresses the HIV/AIDS epidemic in Canada and globally. The purpose of this funding opportunity is to further strengthen clinical research in HIV/AIDS by providing funding for the enhancement, operation and maintenance of infrastructure for a national HIV clinical trials network. It is expected that this targeted investment will lead to a collaborative and productive environment and the conduct and application of high-quality, ethically sound HIV/AIDS clinical trials in Canada and internationally.

Background

This funding opportunity is announced under the Strategic Initiative CIHR HIV/AIDS Research Initiative.

The HIV/AIDS pandemic is one of the greatest health challenges of our times. Since the first case of HIV/AIDS more then two decades ago, the pandemic has claimed the lives of over 25 million people. In its path remain individuals (partners, children, parents and friends), communities and whole countries changed forever by the health, social and economic consequences of this deadly virus. Although Africa remains the continent most severely affected, HIV/AIDS reaches all corners of the globe - developed country, developing country, north, south - no matter the combination of features, all countries are affected.

In Canada, by the end of 2005, HIV/AIDS had killed approximately 20,800 people and an estimated 58,000 were living with the infection. Like elsewhere, the virus penetrates all aspects of society but it is having its greatest impact on populations that are vulnerable to a range of health, human rights, social and economic inequities. Men who have sex with men remain the population in Canada with the highest rates of infection, but HIV/AIDS is increasingly reaching other populations including Aboriginal people, women, injection drug users, inmates, youth and people from countries where HIV/AIDS is endemic.

Canada has had a national HIV/AIDS strategy since 1990 in order to direct its response to the epidemic. In 2005, the Federal Government announced an enhanced and refocused strategy, the Federal Initiative to Address HIV/AIDS in Canada, which is striving for a fully integrated Government of Canada strategy and the direct involvement of people living with and at risk of HIV/AIDS. The Federal Initiative demonstrates the Government of Canada's commitment to fight the HIV/AIDS epidemic both in Canada and globally. The partners in the Federal Initiative, which include CIHR, the Public Health Agency of Canada, Health Canada and Correctional Service Canada, strive to work together in collaboration with our partners and stakeholders, to achieve the following goals:

Prevent the acquisition and transmission of new infections;
Slow the progression of the disease and improve quality of life;
Reduce the social and economic impact of HIV/AIDS; and
Contribute to the global effort to reduce the spread of HIV and mitigate the impact of the disease.

The Federal Initiative recognizes the importance of a strong research agenda to guide Canada's response to HIV/AIDS and provides funding for the CIHR HIV/AIDS Research Initiative. CIHR, led by the Institute of Infection and Immunity, provides leadership for the Federal Initiative in the area of research; it identifies priorities, builds partnerships and develops strategic funding initiatives in order to advance the Canadian HIV/AIDS research agenda. The relationship between CIHR and the Federal Initiative sets HIV/AIDS apart from other areas of health research within CIHR, with a dedicated strategic research envelope of $22.6 million per annum by 2008-09.

In all disciplines of health research, clinical research plays a vital role in the health research continuum and the translation of new knowledge into improved health products, services and policy; acting as a bridge between basic science and patient care. Randomized controlled trials in particular are essential for proving the safety and efficacy of new prevention strategies or therapeutics. CIHR has identified clinical research as a key priority and through the Clinical Research Initiative (CRI) aims to enhance the environment for clinical research in Canada by building and supporting clinical research teams, strengthening clinical research infrastructure and increasing support for the training and careers of researchers.

The Canadian HIV Trials Network (CTN) has been a key feature of the Government of Canada's national strategy on HIV/AIDS since its beginnings in 1990. CIHR and the Federal Initiative have identified that maintaining and enhancing the infrastructure for HIV/AIDS clinical trials is a key component of a comprehensive and strong research response to the epidemic.

On May 7-8, 2007, CIHR hosted a consultation with members of the CTN, national and international HIV/AIDS researchers and clinical trial network experts, representatives of the HIV/AIDS community and relevant federal government agencies. The purpose of the workshop was to inform the development of this funding opportunity on issues such as expectations for a network in the next funding period, factors for success in operating national clinical trial networks and criteria for evaluation.

The intention of this Request for Proposal is to define CIHR's key objectives in funding a national HIV/AIDS clinical trials network, to challenge the CTN to set an innovative and strategic plan for its future and provide the opportunity to potentially renew the network infrastructure funding.

It is expected that the Network will position itself to leverage the significant core funding offered through this initiative to capitalize on other funding opportunities from the private sector, foundations, the CRI, the CIHR HIV/AIDS Research Initiative or others and maximize its potential impact nationally and globally.

Funds Available

CIHR's contribution to the amount available for this initiative is subject to availability of funds voted annually to CIHR by parliamentary appropriations, and the conditions that may be attached to them.

The total amount available for this initiative is $22.73 million.
The maximum amount awarded for a single grant is $4.546 million per annum for up to five years. CIHR anticipates that one network will be funded through this initiative.
Continuation of funding is subject to satisfactory annual progress review as determined by CIHR.

Objectives

CIHR's goals in funding the CIHR Clinical Trials Network in HIV/AIDS Program are:

To position Canada as a global leader in HIV/AIDS clinical research; and
To have in Canada a network and strong research infrastructure that enables Canadian researchers to collaboratively and efficiently conduct excellent, ethically sound HIV/AIDS clinical trials across Canada and internationally.

The Network is expected to:

Engage clinical researchers from across Canada;
Foster the development and conduct of clinical trials relevant to the needs of diverse communities, including vulnerable communities, in Canada affected by HIV/AIDS;
Provide a superior research training and mentorship environment to support capacity building;
Facilitate the translation of research findings into improvements in the health of Canadians living with or at risk of HIV/AIDS, health policy and/or the Canadian health care system;
Build strong partnerships with other Canadian and international organizations in order to leverage funding and maximize the potential impact of the network;
Foster an environment in which various stakeholders (including researchers, community, and partners) have an active and influential role in network activities including prioritization of trials, trial protocols and application of research findings; and
Be strategic and make the most of Canadian expertise in order to have a global impact on the treatment and management of HIV/AIDS and/or the prevention of new infections.

Relevant Research Areas:

The CIHR Clinical Trials Network in HIV/AIDS Program will provide clinical trials infrastructure funding for a network of researchers and research initiatives addressing issues of importance for Canadians living with and at risk of HIV/AIDS and that have the potential for significant impact on the HIV/AIDS epidemic globally. It is recognized that a national network in Canada cannot have a substantial impact on all important areas of HIV/AIDS clinical research. A clinical trials network is strongly encouraged to be strategic, focus its efforts and, building upon existing strengths, address key area(s) where Canadian expertise can have the greatest impact nationally and internationally. In alignment with the goals of the Federal Initiative to Address HIV/AIDS in Canada and priorities of the CIHR HIV/AIDS Research Initiative, areas in which the Network could focus its efforts include:

Treatment of HIV/AIDS
Given major advancements in the treatment of HIV/AIDS since the mid 1990's, HIV/AIDS has changed from a certain death sentence into a chronic condition. Treatment advancements have saved millions of lives and improved quality of life for people infected with HIV/AIDS. However, key issues in the treatment of HIV/AIDS remain including antiretroviral resistance, drug toxicity and appropriate treatment regimes. Further research, and clinical trials in particular, are required in order to develop treatments for individuals who are failing to respond to current therapies; inform clinical management (e.g., when to start and stop treatment); improve treatment outcomes for populations for whom current treatments are not performing well (e.g., women); reduce the negative side-effects of HIV treatments; and develop new classes of HIV therapies.

HIV Prevention
Enhanced strategies for the prevention of HIV are greatly needed. HIV continues to spread at alarming rates globally and incidence rates in Canada appear to be increasing¹. Effective HIV vaccines have the greatest potential to dramatically alter the course of the HIV/AIDS epidemic. As vaccine candidates become available they will need to be moved through the various stages of testing and development, including the critical phases of clinical trials, as quickly possible so that, if effective, they can be made available to populations at risk and start saving lives. Many other technologies and strategies can also contribute significantly to the prevention of HIV as recently evidenced by the trials that found circumcision has a protective effect against HIV infection for heterosexual men^2,3. Research on prevention strategies ranging from mother-to-child transmission, pre- and post-exposure prophylaxis and microbicides all have the potential to protect individuals and communities and benefit from national clinical trials research infrastructure.

Co-infection in HIV/AIDS
People living with HIV/AIDS are vulnerable to a range of other infections due both to the presence of HIV/AIDS (i.e., heightened susceptibility) and common risk factors for the transmission of a variety of diseases. Co-infection may alter the course of HIV/AIDS and other infections and limit the effectiveness of treatments, thus impacting the quality and duration of life for people living with HIV/AIDS. Further research and clinical trials are required to advance knowledge of effective strategies and drugs to treat HIV/AIDS and opportunistic infections in the presence of the other and improve health outcomes for those living with, and at risk of, co-infections.

Eligibility

Eligibility criteria for all CIHR research funding programs apply. The business office of the institution of an eligible Nominated Principal Applicant generally administers CIHR funds. Please refer to the Eligibility Requirements for CIHR Grants and Awards regarding the eligibility requirements for individuals and institutions.

CIHR anticipates that a single application, that engages all relevant researchers and research groups, will be submitted to this competition.

In order to be eligible, the application must include:

A network leader who meets the criteria of "Principal Applicant" as described in the Participant Categories for CIHR Grants. The network leader (Nominated Principal Applicant) must be a researcher with proven leadership capabilities and experience who will act as the network director and who will assume administrative responsibility for the grant.
At least two additional independent investigators who have established research track records in areas related to the Network proposed as Principal Applicants, who together with the network leader will form an integrated and effective scientific leadership team.
Overall, the team is encouraged to include both experienced and productive investigators as well as promising new investigators. The specific contribution of each team member and community partner must be described.

In addition, the following special conditions apply:

The members of the team may pursue other avenues of research in addition to their commitment to the Network; however, each individual investigator must contribute sufficient time to Network-supported initiatives to ensure the achievement of its objectives.
Members of the team must be located in multiple CIHR-eligible institutions across Canada.

Guidelines

This funding opportunity will follow the 6">CIHR Guidelines for Grant Programs. Applicants are encouraged to demonstrate the use of Gender and Sex-Based Analysis in applications.

Allowable Costs

Applicants should review the Use of Grant Funds section of the Tri-Agency (CIHR, NSERC ad SSHRC) Financial Administration Guide for a complete listing and description of allowable costs and activities.

The full application must provide a detailed justification of all costs.

Funding can be used to support:

Salaries of Network personnel including corporate staff (e.g., Chief Science Officer, Chief Operating Officer, Programme Heads, accountants, communication staff, administrative support) and research personnel (e.g., clinical trial coordinators, biostatisticians, research nurses, data managers, etc.);
Costs of database and maintenance of information holdings directly related to the Network;
Costs of regional, national and international networking activities, including collaboration, planning, and knowledge exchange activities, directly related to Network activities;
Support of research trainees. At minimum, trainees must be paid at the rate specified by CIHR for trainees paid from research grants but may be paid at the rate for CIHR Training Awards. The Network is expected to provide a superior training environment;
Release time payments to enable employees of community partners to participate in the research program, limited to 50% of salary costs, and an overall maximum of $100,000 per year;
A maximum of $40,000 annually for a release time stipend for the network leader and $20,000 for release time stipends for other members of the leadership team (i.e., Principal Applicants);
Costs involved in communications, linkage with and dissemination of research findings to those engaged in the Network and those who use the results, as appropriate (including other researchers, HIV/AIDS community, the public, practitioner and policy communities, and the private sector);
Purchase of equipment and maintenance contracts for common services and shared facilities;
Costs involved with feasibility testing and pilot projects, including seed funding for establishment of satellite sites in low- and middle-income countries; and
Costs involving website development and maintenance; and office management.

The following expenditures will be considered eligible for funding received through this funding opportunity:

Benefits (federal, provincial and institutional) and training and professional development costs for Network staff;
Honoraria for committee chairs and members, investigators, and external referees for participation in teleconferences and meetings, excluding Principal Applicants and Co-Applicants, limited to a total of $45,000 per year;
Legal and audit costs;
Insurance including liability insurance for committee members, network leaders and administrators and office insurance (i.e., theft/damage to office and data management equipment);
Office and data management equipment and supplies; and
Telecommunication costs including purchase/lease of telephones and cell phones required for Network operations; local and long-distance costs for the National Centre; and teleconferences.

Funding cannot be used to support:

The direct conduct of research beyond pilot or feasibility studies; or
The full operation of satellite sites in low- and middle-income countries.

Conditions of Funding

All conditions specified in CIHR General Grants and Awards Policies shall apply to applications funded through this Funding opportunity. Conditions cover areas such as Applicant and Institutional Responsibilities, Ethics, Official languages policy, Access to Information and Privacy Acts, and Acknowledgement of CIHR's Support. Successful applicants will be informed of any special financial conditions prior to the release of funds or when they receive CIHR's Authorization for Funding (AFF) document.

In addition to CIHR standard guidelines and requirements, the following special conditions shall apply:

Within three months after the end of a fiscal year, the Nominated Principal Applicant is required to submit a performance report, summarizing the Network's progress and achievements and describing how the grant funds were used. CIHR may cancel the grant if the progress is unacceptable or if it does not receive a report. Further details regarding the reporting requirements will be provided by CIHR.
Within six months after the end of the grant's term, the Nominated Principal Applicant is required to submit a final performance report, summarizing the results and describing how the grant funds were used. Further details regarding the reporting requirements will be provided by CIHR.

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.

Communication Requirements

In addition to following the policies relating to the Public Communication and Acknowledgment of CIHR's Support, the grant recipient will also be required to adhere to special branding requirements as a condition of receiving a CIHR network grant. "CIHR" must be included as the first 'word' in the title of the Network. The network name must be used in all communication and promotion relating to the CIHR grant. A network name must be proposed as part of the application. The successful applicants and their host institutions will be required to agree in writing to proper use of the network name as well as the CIHR logo(s) on appropriate communications materials such as brochures, letterhead, publications and media materials. Recognition guidelines, including instructions on logo use, will be provided to successful applicants as part of the approval package.

Performance Measurement

CIHR is committed to demonstrating results to Canadians for the money invested in health research. Therefore, processes for monitoring progress and appropriate use of funds, as well as for performance measurement and program evaluation are in place. As a result, funding recipients must:

Adhere to CIHR's reporting requirements and provide required information in a timely fashion. A performance report will be required following years 1, 2, 3 and 4. The Nominated Principal Investigator is required to submit the report, summarizing the Network's progress and achievements and describing how the grant funds were used. CIHR may cancel the grant if the progress is unacceptable or if it does not receive a report;
Submit a final performance report summarizing the results and describing how the grant funds were used;
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; and
Encourage their associates, trainees and administration to participate in the monitoring, review and evaluation of CIHR's programs, policies and processes as required.

Review Process and Evaluation Criteria

Peer Review

The CIHR Clinical Network in HIV/AIDS application will be evaluated by a specifically-constituted peer review committee. The committee will include individuals from within and outside Canada with expertise in HIV/AIDS and randomized controlled trials.

Evaluation Criteria

The CTN will be evaluated on its achievements to date, with a focus on the last four and half year period (2003-04 to 2007-08), as well as the Network's visions, plans and ability to make significant contributions in the next funding period (2008-09 to 2012-13). Reviewers will use the questions listed below to assess the application.

Importance and Relevance

Evaluation of Progress

Has the CTN enabled Canada to make a significant contribution to clinical HIV/AIDS research and the conduct of clinical trials? Is there evidence that the CTN infrastructure has added value in terms of the quality, quantity and efficiency of trials conducted?
Have the CTN's activities been relevant to community needs and those of the research community?