Request for Applications

Institute of Genetics &
Institute of Health Services and Policy Research

Summary

The purpose of this Request for Applications (RFA) is to provide development funds in support of initiatives likely to lead to longer term research proposals or programs of inquiry to address the most important, emerging issues facing the Canadian health care system in response to new understandings about human genetics, and the burgeoning of genetic information, technologies, products and services.

Table of Contents

Introduction
Background
Partners
Specific Objectives and Eligible Research Areas
Who is Eligible to Apply?
Specific Eligibility Requirements
Mechanism of Support
Funds Available
Allowable Costs
How to Apply
Evaluation Process and Criteria For Peer Review
General CIHR Guidelines and Conditions of Funding
Performance Measurement and Evaluation
Address for Submitting Application and Contact Information

Introduction

The mandate of the Canadian Institutes of Health Research's (CIHR) Institute of Health Services and Policy Research (IHSPR) is to support outstanding research, capacity-building and knowledge translation initiatives designed to improve the way health care services are organized, regulated, managed, financed, paid for, used and delivered in the interest of improving the health and quality of life of all Canadians.

The mandate of CIHR's Institute of Genetics (IG) is to support excellent research on the genetic and biochemical basis of health and disease, including the interaction of genes with the physical and social environments, to facilitate the translation of research findings into health policy and practice, and to examine the ethical, legal and social implications of genetic discoveries.

The purpose of this Request for Applications (RFA) is to provide development funds in support of initiatives likely to lead to longer term research proposals or programs of inquiry to address the most important, emerging issues facing the Canadian health care system in response to new understandings about human genetics, and the burgeoning of genetic information, technologies, products and services.

Background

"The multitude of recent and anticipated research developments in the fields of genetic information and genetic technologies hold out the potential to fundamentally re-define medicine within the lifetime of many Canadians . the research breakthroughs in human genetics will come to play an increasingly important role, a role, which if appropriately managed, promises much for both healthcare and society in general" (Ontario Report to the Premiers, 2002). Canadian genetics researchers have played, and will continue to play, a significant role in international efforts to understand the human genome and develop new genetic technologies. Similarly, Canadian health services and policy researchers have played, and will continue to play, an important role in helping health services administrators, managers and policy makers 'appropriately manage' health care and address important ethical, regulatory, financial and organizational issues facing the health care system.

The demand for genetic services is expected to increase substantially; 60% of Canadians, by some estimates, will experience a disease with some form of genetic link during their lifetime. For diseases in which we know there are genetic underpinnings, however, there may be little that health care can currently offer by way of curative or preventive intervention. Nevertheless, there are growing pressures, from the demand and supply sides, for the implementation and utilization of genetic services. There is a significant risk that the establishment of genetic services will be driven by the technological ability to conduct testing, whether or not health care can provide services other than counseling. At the moment, genetic testing and counseling services are already well established within Canadian health care without good evidence of the impact on individuals, populations, and the broader health care system. As advised by the Saskatchewan Health Services Utilization and Research Commission in their report on genetic testing and gene patenting, "We have a window of opportunity in which to act while things are still in a manageable scale" (HSURC, 2001). Unfortunately, many health policy decisions relevant to genetic services are being made, and will continue to be made despite limited understanding of these larger impacts, in part because of a dearth of health services and systems research in this emerging field.

These current and emerging genetic understandings and innovations raise profound issues for Canadians. The potential impact on our understanding of human health and on health care services and health systems is unquestionably immense. Topics for which research is timely span the entire 'discovery' life-cycle, from new genetic discoveries where ownership, intellectual property and patenting issues surface, to genetic testing where information control and human rights become issues, to gene-based counseling and therapies where quality of care (including access, comprehensiveness, coordinated delivery, etc.), cost-effectiveness, and health human resource issues arise, to health system and policy impacts where service organization, regulation, financing, ethical, social and legal issues are germane. This Request for Applications (RFA) is intended to provide development funds to support initiatives that are likely to lead to the development of research proposals or programs of inquiry to "ensure that the inevitable growth in genetic health services is in accordance with scientific evidence and in a way that enables us to reap its full benefit" (HSURC, 2001).

In September 2001, CIHR sponsored a Health Services for Genetic Disease workshop where individuals were invited to address specific questions or problems important to genetics health services and policy research in Canada. The purpose of the workshop was to reach a consensus on recommendations or conclusions on priority research issues. A summary of workshop proceedings is available at the CIHR Institute of Genetics website

Because of the emerging importance of health services and genetics research in Canada, IG and IHSPR recently funded investigators to conduct an environmental scan to provide background information regarding past and current research on the subject of genetic health services and related matters. The scan was designed to capture relevant policy and research material regarding the social, legal, ethical and health service/policy implications related to the use of genetic technologies in health care (mainly genetic testing). The Environmental Scan report [ HTML | PDF ] is now available on the CIHR website.

In May 2002 the two Institutes partnered on an RFA to support Interdisciplinary Capacity Enhancement Teams in strategic areas including "genetics and health services". The purpose of this strategic initiative is to bring genetics and health services and policy researchers together to build capacity among teams of investigators to conduct research and translate new knowledge in this increasingly important area. In early fall 2002 the Institutes established a relationship with the Federal/ Provincial/ Territorial Coordinating Committee on Genetics and Health to begin joint discussions regarding research and knowledge translation areas of mutual interest.

The present RFA is intended to build on those prior developmental activities and funding opportunities, to help groups of researchers prepare themselves to launch more substantial programs of research in this important area.

CIHR also has a number of other funding programs (e.g., investigator-initiated or open competition, equipment and maintenance grants for infrastructure support such as databases, group grants, partnerships program) to which researchers can also apply to obtain longer term funding to support research projects, programs of inquiry and knowledge translation initiatives relevant to genetic health services and policy.

Partners

The partners supporting this initiative include CIHR's IG and IHSPR. In 2001 these two Institutes created a working group composed of leading researchers to undertake to identify the most compelling research questions and knowledge translation opportunities in the area of genetic health services and public policy, and to contribute to the development of appropriate CIHR strategic funding initiatives.

CIHR's IG and IHSPR have established relationships with health policy makers to identify research priorities and facilitate knowledge translation. For example, formal linkages have been made between IG, IHSPR, and the Federal/Provincial/Territorial Coordinating Committee on Genetics and Health. This FPT Coordinating Committee has wide representation from the provinces, territories and federal government, and is actively working on a range of policy issues pertaining to the current and future role of genomic medicine in healthcare. For the purposes of assisting applicants who seek linkages with policy makers for the purposes of developing their research proposals, IG and IHSPR are committed to facilitating linkages between applicants and policy makers via the Federal/Provincial/Territorial Coordinating Committee on Genetics and Health.

IG and IHSPR are dedicated to identifying and developing partnership relationships with other funding organizations to enhance the availability of funding for this and future strategic initiatives in this area.

Specific Objectives and Eligible Research Areas

It is not intended or expected that any single applicant or team responding to this request will address all of the objectives. The overall objectives of this initiative are to develop capacity and longer-term programs of research that will address:

• The organization, financing, delivery, regulation, use, impact, quality of, and payment for, genetic services in Canada.
• Health care and health policy implications of current and emerging genetic products and services, and alternative approaches to the area of gene patenting.
• Health human resources issues in the provision of genetic services, and the role of different types of providers in providing information on genetic services.
• Social, legal, and ethical issues related to genetic health services that affect health services and policy research and public policy.

The application of health services and policy research to issues inherent in genetic discoveries, products and services is relatively new. Therefore, research in this area might benefit from the development or modification of conceptual theories or frameworks for understanding unique issues in this applied area. While developmental proposals of this nature are eligible under the terms of this RFA, interested potential applicants should first make themselves familiar with the concurrent strategic RFA entitled "Advancing Theories, Frameworks, Methods and Measurement in Health Services and Policy Research". This latter RFA provides 3-year funds in support of research likely to lead to new "basic science" breakthroughs in health services and policy research, and may be more applicable.

Projects should be designed for a period of up to twelve months. The following represent examples of eligible preparatory/developmental areas. This list is not intended to be exhaustive, nor is there any intention to imply that applications focusing on these examples would be more successful than others:

• Analysis of evidence base for, or decision framework/criteria used for guiding development of, genetic services.
• Systematic review(s) of a specific aspect of research on health services for genetic disease in any/all areas described above (See overall objectives). It is expected that reviews generate new knowledge relative to that already funded and described above as one of the precursor activities of the two Institutes, and help in clarifying the design of future projects and programs of research in this area.
• Validation of the application of an existing, or development of new, conceptual theory or framework to guide health services and policy research in the area of genetic services and/or public policies (See also: November 2002 RFA entitled "Advancing Theories, Frameworks, Methods and Measurement in Health Services and Policy Research") (See end of this section **)
• Development of protocol(s) and methods for conducting effectiveness, efficiency or equity evaluations of genetic health services.
• Descriptions of the organization, financing, delivery, use and quality of genetic services in Canada. It is expected that these descriptions generate new knowledge relative to that already funded and described above as one of the precursor activities of the two Institutes, and help in clarifying the design of future projects and programs of research in this area. (See end of this section**)
• Development of models for organizing, financing and delivering genetic services in an efficient and high quality manner, that could be piloted and evaluated in future work.
• Development of methods/protocols for assessing the population-level impact of genetic service availability (as distinct from the impact of those with, e.g., familial history)
• Description and/or evaluation of the volume and type of genetic counseling and testing in Canada, with population stratification where possible.
• Documentation of the current human health resources capacity for delivery of genetic services in Canada.
• Health human resources modeling for delivery of genetic services in Canada, or development work towards such a project.
• Development of a template for surveillance systems for genetic testing services and their outcomes.
• Review of the genetic testing quality assurance and/or technology assessment procedures in place across Canada.
• Analysis of current understandings of the implications of globalization, such as trade legislation, on genetic testing and treatment for Canadians and genetic testing and treatment services in Canada. (** See end of this section)
• Development of research protocol(s) for new research on the implications of globalization or built on a comprehensive review of what is currently known in this area. (** See end of this section)
• Evaluation of the public policy and service delivery implications of ethical and legal issues inherent in the use of genetic databases; variations in anti-discrimination law, malpractice law, privacy legislation, and/or regulation of genetic services (** See end of this section)

** It is expected that applications for funding will build on or complement other work currently underway or recently completed across the country. For example, applicants are expected to build on work initiated by government or other committees or working groups, who are already undertaking research in the general area of health services and genetics. Seminal reports from these efforts are just now emerging in published documents, such as the report of the Provincial Advisory Committee on New Predictive Genetic Technologies, entitled "Genetic Services in Ontario: Mapping the Future"

Also, as mentioned, CIHR's IG and IHSPR have recently funded and published an environmental scan to provide background information regarding past and current research on the subject of genetic health services and related matters. The Environmental Scan report [ HTML | PDF ] is now available on the IG and IHSPR's websites.

Who is Eligible to Apply?

Eligibility criteria for all CIHR research funding (grant) programs apply. Please refer to Eligibility for Research Funding Programs on the CIHR website.
The business office of the institution of an eligible Principal Applicant generally administers CIHR funds. The eligibility requirements for Institutions are found on the CIHR website in the Financial Administration of Funds Guide.

Specific Eligibility Requirements

This RFA is designed to foster collaborative research among genetics and health services and policy researchers where appropriate. To that end, groups are encouraged, but not required, to form research teams comprised of researchers from different disciplines (e.g. bioethicists, geneticists, legal scholars, health services administrators, patent lawyers, policy-makers, social scientists).

Mechanism of Support

Funded as a strategic initiative, this RFA is designed to solicit grant applications for projects that last up to one year.

Funds Available

• The maximum amount awarded for a single grant is $75,000 (including equipment; see below) for the duration of twelve months.

• The total amount available for this initiative is $500,000 plus other partnership funds that IG and IHSPR, or applicants, identify.

Allowable costs

Allowable costs include:

• Operating support for specific research activities undertaken by the members of the team
• Purchase and maintenance of equipment and other research tools, maintenance funding for common services and shared facilities (up-to $5,000)
• Costs of data collection and maintenance of information holdings
• Costs of regional, national and international networking activities, including collaboration, planning and research exchange activities directly related to the research project
• The salary of a professional coordinator and/or research assistants (as appropriate)
• Costs involved in dissemination of the results of the work funded under this RFA to target audiences
• Consulting fees (as appropriate)

Applicants should review CIHR's guidelines on Eligible Expenditures for Research Funding Programs for a complete listing and description of allowable costs and activities.

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

How to Apply

• To access CIHR application forms, including CVs, all applicants and co-applicants must acquire Personal Identification Numbers (PIN). There will be a delay of approximately one working day to receive confirmation of a PIN. More than one working day may be required in peak periods - late January and early August.

• There is one step to applying for this RFA. Applicants are encouraged to use the Webforms.

  1. Registration Stage. Register your application to apply, using the CIHR Operating Grants registration package, which consists of pages from the CIHR Research Module, in addition to pages one and two of the CIHR CV Module or Common CV for each applicant and co-applicant participating in the research project. If you are using the Webforms, after entering your PIN and password, create a new application, and then complete the "Operating" section under the Research Funding Programs heading. Once you have completed this section, Save and Exit, then choose the print option for "Registration Pages Only." Send the original plus one copy of the registration pages plus the CV pages to CIHR by courier by the registration deadline indicated in this document, which may be different from the Operating Grants registration deadline.

  2. "Linkage with Policy Makers" Stage. IG and IHSPR are committed to facilitating linkages between applicants and policy makers prior to development of full proposals, for researchers who seek assistance in this area. Applicants who are interested in having the Institutes try to identify potential policy makers on their behalf must submit a covering memo indicating their intent and consent using, at a minimum, the following wording: "I (name of Principal Applicant) consent for the release of information contained within the registration package (including the summary of the research proposal) to members of the Federal/Provincial/ Territorial Committee on Genetics and Health for the purposes of identifying policy makers who would be interested in collaborating on the research proposal and project". For applicants specifically expressing their interest in this, information contained within the registration package will be forwarded to the Federal/Provincial/Territorial Coordinating Committee on Genetics and Health. Members on this committee would identify contact information for policy makers who would be interested in collaborating with researchers. This information will be forwarded to the applicants, who are not bound to use such information or establish linkages with the individuals in the development of their full proposals. The peer review panel will be blind to this process.

  3. Full Application Stage. Complete the full application using the CIHR Operating Grants application package, which consists of the CIHR Research Module, the CIHR Operating Budget Module and a CIHR CV Module or Common CV for each applicant and co-applicant participating in the research project. Courier the original, plus eight copies of the full application by the application deadline indicated in the text of this document.

• Applicants are advised to refer to the "Guidelines for Completion" specific to each application module, and the instructions on 'How to Apply,' including the applicable Grants and Awards Guides. Note that the proposals must address the criteria described under the "Evaluation Process and Criteria for Peer Review" section in the text of this RFA.

• The following special instructions apply to this RFA:

To ensure that your registration and application are forwarded to the appropriate CIHR staff, indicate 'Staying Ahead of the Wave: Genetics, Health Services and Health Policy, Institute of Genetics and Institute of Health Services and Policy Research" under the heading "Name of Industrial Partner(s) OR Partnership Program OR Special Program (if applicable)" in the General Information section of the Research Module (page 7 of the PDF form).

Evaluation Process and Criteria for Peer Review

Applications deemed relevant will be evaluated by a CIHR peer-review committee. The committee may be drawn from one of CIHR's pre-existing committees or may be created specifically for this Initiative. Committee members are selected based on suggestions from many sources including the Institute(s) and partner(s). Names of committee members are published on the CIHR website. The committee will follow the CIHR peer review process for grants .

Evaluation Criteria for Peer Review

The peer review committee shall consider the following general and specific evaluation criteria to determine how each project proposal will meet the relevant objectives of this initiative. It is understood that referees and committees may weigh questions such as these differently from one application to another.

General criteria:

The Research Proposed: Bearing in mind that this RFA is intended to fund developmental work:

• How important and/or original are the hypotheses, questions or issues to be addressed, and how clearly are they formulated?
• How important and original are the contributions expected from the research proposed? What is the potential for important new observations or knowledge?
• How well will the proposed project(s) address the compelling issues?
• How appropriate are the methods to be applied and the proposed analyses? How well will the applicant implement new methods that are to be introduced and/or explored? How well have the applicants anticipated difficulties in their approach and considered alternatives?
• How critically is the relevant literature appraised and evaluated?

The Applicant's Productivity, Experience and Training

• How appropriate to the research proposed is the training or track record of the applicant(s)? How important and original is the recent productivity of the applicant(s)? How much confidence do you have that the applicant(s) can do the work proposed? (The proposed time commitment to the research may influence this judgment.)

• If applicable, does the proposed team bring together the necessary expertise and mix of skills to accomplish the work proposed? For example, depending on the topic of investigation it may be appropriate for teams to include individuals from disciplines such as bioethics, genetics, law, health services administration, patent law, policy-making, social sciences.

Specific Evaluation Criteria:

In addition to these general criteria, the peer review committee shall consider the criteria below:

• Relevance and responsiveness of the proposal to the purpose and objectives as stated in this Request for Application
• Potential for significant advance in understanding important, emerging issues facing the Canadian health care system in the genetics area
• Extent to which the application is likely to involve a variety of relevant perspectives, expertise and disciplines germane to the topic
• Potential that the project will lead to the establishment of a longer term program of research by the team of investigators and other collaborators

On completion of the review, the Institute(s) and partner(s) will receive the ranking lists, merit scores (ratings) and recommendation of the Committee for the applications submitted. Based on the total funds available for the initiative, applications will be funded from the top-ranked down as far as budget will allow. Applications receiving a score less than 3.0 will not be considered for funding.

General CIHR Guidelines and Conditions of Funding

All conditions, as specified in CIHR's Grants and Awards Guides , shall apply to those funded through this initiative. Conditions cover areas such as Applicant and Institutional Responsibilities, Ethics, Official Language Policy, Access to Information and Privacy Acts, Acknowledgement of CIHR support etc. Successful recipients will be informed of any special financial conditions when they receive CIHR's Authorisation for Funding Form (AFF). The principal applicant (with funding responsibilities) will be required to submit a final report to CIHR summarising the results and describing how the grant funds were used.

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

Communication Requirement

Recipients who receive funding are required to acknowledge the CIHR Institute(s) and partner(s) in any communication or publication related to the grant as follows: CIHR-Institute of Genetics and Institute of Health Services and Policy Research.

Proposal Requirement

Successful applicants whose research aims to address a subset of the questions outlined in one of the identified eligible research areas are expected to successfully pursue appropriate peer-reviewed publication of their research, and such other knowledge translation activities as may be relevant to the particular project. CIHR will make every effort to facilitate all forms of knowledge translation stemming from the research funded under this RFA. In cases where the 'products' of the research are not intended for peer-reviewed publication, the applicants are expected to submit a final report, length dependent on the product (e.g. a systematic review would be expected to be much longer than a report on a proposed new evaluation protocol), to CIHR within one year after the funding end date. An electronic copy of such report must be submitted in a format to be determined by the Institutes. It is the Institutes' intention to compile and release publicly all reports arising from this RFA, in one comprehensive document.

Performance Measurement and Evaluation

The CIHR Institute of Genetics and Health Services and Policy Research have made plans to assess this initiative through ongoing monitoring and periodic evaluation. We are committed to informing Canadians about the outcomes from, and impact of, all of our initiatives.

The following table is intended to further clarify objectives by linking them to expected outcomes and measures. All funded applicants will be expected to participate in the evaluation strategy, contributing advice, data and reports as required for assessment purposes.

Address for Submitting Application and Contact Information

Send Application by Courier to:

RE: "Staying Ahead of the Wave: Genetics, Health Services and Policy Research"
Canadian Institutes of Health Research
Research Portfolio
410 Laurier Avenue W., 9th Floor
Address Locator 4209A
Ottawa, ON K1A 0W9

Contacts for Further Information:

For questions regarding the review process, application forms, eligibility and submission requirements, applicants should contact the following person in CIHR's "Knowledge Creation Programs":

Tina Lawton
Program Delivery Coordinator
Canadian Institutes of Health Research
410 Laurier Avenue West, 9th floor, Address Locator 4209A,
Ottawa, ON K1A 0W9
Telephone: (613) 941-1068; Fax: (613) 954-1800; Email: mailto:tlawton@cihr-irsc.gc.ca%20

For questions about this initiative and the research objectives contact:

Stephanie Robertson, MA
Assistant Director, Special Projects
Institute of Genetics
Telephone: 613-954-0533
Fax: 613-954-1800
Email: mailto:srobertson@cihr-irsc.gc.ca%20

Diane Watson PhD, MBA
Assistant Director
Institute of Health Services and Policy Research
Telephone: 604-822-3136
Fax: 604-822-5690
E-mail: dwatson@chspr.ubc.ca