The American Academy of Clinical Toxicology (AACT) announces a call for submission of multicenter clinical toxicology research protocols. Up to $30,000 is available to fund one multicenter study. The goal of this grant program is to provide competitive funding for clinical research that encourages the development of new therapies and treatment and adds to the understanding of the principles and practice of clinical toxicology. The intended research should advance the mission of the AACT to unite "scientists and clinicians in the advancement of research, education, prevention and treatment of diseases caused by chemicals, drugs and toxins." Completed applications must be received by November 1. Questions about the process should be directed to the AACT administrative office at 717-558-7847 or jreisinger@pamedsoc.org.

Priority will be given to proposals that evaluate the treatment or diagnosis of clinical toxicity, clearly support the need and value of a multicenter trial, and effectively establish the feasibility of successful study completion. Proposals for new studies will take priority over proposals for continuation of ongoing studies.

Include blinded copies of information where indicated. This means that information should be on plain white paper with no identifying marks. (e.g., letterhead, institution name, applicant name, etc.)

The primary investigator and all site investigators must be members in good standing of AACT.

Applicants may not be members of the AACT Research Committee.

Up to $30,000 is available through this grant program. The funded project must be completed within two years of receipt of the grant award.

Funding can be used for costs associated with subject recruitment, laboratory analysis, data management, statistical analysis, and other similar activities. AACT will not fund requests for principal and/or site investigator salaries, institutional indirect costs, or capital equipment purchases.

Fifty percent (50%) of the awarded funds will be disbursed at study initiation and fifty percent (50%) will be disbursed upon completion of fifty percent (50%) of the study. (This is defined generally by the number of patients enrolled.)

Cover Letter
Applications must include a cover letter that contains a statement that the protocol is being submitted as the investigator's intellectual property. The investigators must provide justification that their requested funding will allow them to complete the protocol as submitted. The investigator must state whether or not the protocol is currently being considered for funding by any other organization. If the protocol is concurrently funded, or being considered for funding by any other organization, the investigator must state that they will not accept duplicate funding. A statement that the investigator will provide copies of all institutional review board approvals prior to disbursement of funds must also be included. The investigator must also state that they agree that the Journal of Toxicology - Clinical Toxicology, the official journal of the AACT, has the right of first refusal of all manuscripts resulting from the funded project. The investigator should also state that they will submit an abstract of the results of this project to the North American Congress of Clinical Toxicology (NACCT) in the year following completion of the research and that they expect to be able to attend the NACCT to receive the research award. The investigator must also state that all presentations and publications of the research will recognize the AACT as the source of study funding.

Protocol
The protocol should be limited to no more than 6 pages, single-spaced with one-inch margins, excluding a one-page coversheet. The protocol should be blinded as described previously. The following should be included within the protocol:

1. An introduction that clearly demonstrates the importance of the proposed study, its potential impact on clinical toxicology, and a discussion of relevant prior work. The introduction should clearly state the expected benefits of the proposed research;
2. A clear statement of the scientific hypothesis that will be tested and primary and secondary trial outcomes;
3. Sample size and power calculations; A discussion of the informed consent process that will be utilized; Detailed study methods;
4. Study timeline; and A description of the feasibility of successful completion of the proposed study. (This should include support for estimates of expected patient enrollment rates, availability of resources needed to complete the protocol, and any other evidence that supports the investigators' ability to successfully complete the study protocol in the time period described.)

The following supporting documents should also be included:

1. Letters of participation/agreement from each site investigator; Curricula vitae for all investigators;
2. A detailed budget that includes all in-kind or matching support from the investigator's institution or other sources must be provided. A justification for each component of the budget must also be included; and
3. Documentation from the host institution's Grants Management Office indicating the waiver of all indirect costs.
4. A copy of the institution's determination letter from the Internal Revenue Service that verifies Tax Exempt Status.

AACT Executive Office
777 E. Park Drive, PO Box 8820
Harrisburg, PA 17105-8820

Review will be blinded as to author and institution. Authors should avoid using any identifying references within the body of the paper. The Research Awards Committee will be asked to evaluate proposals based upon the following criteria:

• Clear statement of objectives/hypothesis to be tested.
• Logical statement of the rationale why this project needs to be completed. Summary of related work in the area.
• Understandable discussion of the methodology to be employed.
• Description of the statistical analysis as appropriate.
• Clear statement of the significance of the proposed project to the field of clinical toxicology.
• Feasibility of the project within the time and budget limitations.

A progress report should be submitted six months after disbursement of the award and at completion of the study. A copy of the article that emanates from this research should also be submitted upon publication.

Please contact Trevor Penning, Ph.D., Director of the Center of Excellence in Environmental Toxicology and Professor, Department of Pharmacology, Biochemistry & Biophysics and OB/GYN