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Possible sources of funding for my grant (July 6, 2006). Category: Adverse events in clinical trials

The NIH has a Request for Application (RFA) titled Research on Research Integrity (R01). The full text of this announcement is on the web at

The goal of this RFA is

to foster empirical research on research integrity. The sponsoring programs are particularly interested in research that will provide clear evidence (rates of occurrence and impacts) of potential problems areas as well as societal, organizational, group, and individual factors that affect, both positively and negatively, integrity in research. Applications must have clear relevance to biomedical, behavioral health sciences, and health services research.

I have written on my weblog about some research that I want to get grant funding for:

and this RFA might be a place where I could apply for funding. This RFA seems to be focused predominantly on research misconduct, and that might be a problem. Accrual problems may actually represent sloppy planning rather than misconduct.

Another source of funding that might fit this project well is a Program Announcement (PA) cited by this RFA is Research On Ethical Issues In Human Subjects Research (R03). This PA can be found at

Similar announcements using the R01 and R21 grant mechanisms are

respectively. The distinction among R01, R03, and R21 grants is important to remember.

Applications for R21 awards should describe projects distinct from those supported through the traditional R01 mechanism. For example, long-term projects, or projects designed to increase knowledge in a well-established area will not be considered for R21 awards. Applications submitted under this mechanism should be exploratory and novel. These studies should break new ground or extend previous discoveries toward new directions or applications. Projects of limited cost or scope that use widely accepted approaches and methods are better suited for the R03 small grant mechanism (see R03 announcement citation). grants.nih.gov/grants/funding/r21.htm

The goal of these PAs is to

solicit research addressing the ethical challenges of human subjects research in order to optimize the protection of human subjects and enhance the ethical conduct of human subjects research.

There are seven broad areas for this PA. The fifth one, Research Oversight: IRBs, DSMBs, and COI Committees, is perhaps the most relevant to my work. These PAs want to

"Identify and evaluate strategies to improve the oversight of protections for human subjects by IRBs"

and mention as one example

"Development of appropriate outcomes measures and quality indicators for the IRB review process for measurement of adequate protection of human subjects. Development and testing of a framework for assessing IRB review quality; determination of when variability in IRB outcomes would be acceptable and when such variation would indicate inconsistent quality."

Any grant that I submit to NIH should acknowledge the priorities that NIH has set for itself. In particular, I should cite the NIH Roadmap.

The NIH Roadmap is an innovative approach to accelerate fundamental discovery and translation of that knowledge into effective prevention strategies and new treatments. The strategic initiatives to be funded under the NIH Roadmap will address critical roadblocks and knowledge gaps that currently constrain rapid progress in biomedical research. They will synergize the work of many NIH Institutes and Centers, and collectively represent a unique effort that no single or group of Institutes or Centers other entity can do, but are the responsibility of the NIH as a whole. Three broad initiatives will be stimulated with these funds: 1) New Pathways to Discovery, which includes a comprehensive understanding of building blocks of the body's cells and tissues and how complex biological systems operate; structural biology; molecular libraries and imaging; nanotechnology; bioinformatics and computational biology; 2) Research Teams of the Future, including interdisciplinary research, high-risk research, and public-private partnerships; and 3) Re-engineering the Clinical Research Enterprise. Through these efforts, NIH will boost the resources and technologies needed for 21st century biomedical science.

Details about the NIH Roadmap can be found at

Before I go to the NIH for a big grant, I will possibly look at funding from a local group, the Kansas City Area Life Sciences Institute (KCALSI). Their main web page is at

and the RFP for the 2006 Research Development Grant Program is available in Microsoft Word format. The research grant

should address a critical question(s) in the life sciences and clearly identify how the institutions intend to generate critical preliminary data needed for future proposal submissions to external agencies. While applicable life sciences research may include a wide range of topics, the proposal must be focused in one of the five target research areas or three crosscutting enabling technologies as noted in the BACKGROUND section herein.

The critical research question we hope to address is "How can an IRB properly monitor the accrual rate in a clinical trial and decide when the rate is so slow as to jeopardizes the scientific integrity of the research?" and that this fits in well among the crosscutting enabling technologies, in particular, the development of information technology/bioinformatics tools.

(Note: the original title of this weblog entry was "Research on research integrity.")

07/08/2008.

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