Application Instructions These instructions should be followed carefully. Only after all the requested information has been received, will an application be considered complete and eligible for evaluation by the AACT Grant Review Panel. Grant Program Description Eligibility Funding Information Grant Recipient Responsibilities Application Process/Selection Criteria Itemized Instructions for Grant Application

Instructions Application

APPLICATIONS THAT DO NOT STRICTLY COMPLY WITH THE APPLICATION INSTRUCTIONS WILL BE RETURNED WITHOUT REVIEW

I. GRANT PROGRAM DESCRIPTION

The AACT is offering a research grant program that supports clinical toxicology research and the development of new investigators & research skills.

Applications for this research grant program should emphasize study objectives that focus on clinical toxicology research, sound research methods that support the study objectives, interdisciplinary collaborations, the potential for the project to be replicated, and prudent use of grant funds. The mentoring of new researchers by more experienced senior investigators is also a priority of this program.

II. ELIGIBILITY

• The research must focus on clinical toxicology research.
• The junior and senior investigator must be members of the American Academy of Clinical Toxicology.
• The principal investigator must be a new researcher within 5 years of completion of his/her terminal degree or postgraduate training or have professional experience greater than 5 years and no more than two externally funded research projects as a principal investigator. Also, the principal investigator must have a senior investigator participate on the research team as a mentor/advisor. In the application process and grant progress reports, evidence must be included regarding the support and involvement of the senior investigator. Multidisciplinary research teams are encouraged.

• The proposed research must be submitted to an institutional review board (IRB) for approval. Evidence of IRB approval must be provided to the AACTupon acceptance of the grant award. Grant funds will not be disbursed until evidence of IRB approval or evidence of exemption from IRB review has been received.

• The research must comply with the NIH Policy and Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research that was amended in October, 2001.
• The research must comply with theNIH Policy and Guidelines On the Inclusion of Children As Participants in Research Involving Human Subjects.
• The study timeline should not exceed 24 months from project initiation.

III. FUNDING INFORMATION

One $30,000 grant will be awarded. Grants are awarded to provide funding for specific projects conducted by junior investigator and senior investigator research teams that address clinical toxicology research and are not intended for long-term support of research programs. Fifty percent of the total grant will be provided upon execution of the award letter and submission of evidence of IRB or animal research approval or evidence of exemption from IRB review. The remaining fifty percent will be provided upon receipt of a final research report that is due within 60 days of project completion.

Funds may not be applied to:

• Ongoing general operating expenses or existing deficits
• Purchase of permanent equipment, facilities, or software, or other capital costs
• Endowment contributions
• Stipends or loans
• Facilities and administrative costs

Funding is generally available for:

• Salary support for study personnel
• Consumable supplies and services
• Travel essential to the conduct of the proposed project
• Subject expenses/reimbursement
• Travel to present project findings in the range of $1,000 to $1,500 per project

Grants will be awarded to individuals and the funds will be disbursed directly to the sponsoring institution for administration.

IV. GRANT RECIPIENT RESPONSIBILITIES

• The grant period will begin upon grant award by the AACT and will expire no later than 24 months after the initial disbursement.
• Following initial disbursement of funds, the grantees must submit quarterly Research Reports to the AACT that address:

  Progress toward completion of activities included on the study timeline for the quarter in question;

  Any protocol modifications and documentation of IRB review and approval of such modifications; and

  A summary of all adverse events associated with execution of the study during the quarter in question and documentation of IRB review of such adverse events.

• Within 60 days of study completion, the grantees must submit a Final Research Report to the AACT. This report must include:

  A summary of the study results including statistical analysis if applicable;

  Preliminary conclusions;

  A summary of all adverse events associated with execution of the study and documentation of IRB or animal research review of such adverse events;

  A summary of all protocol modifications and documentation of IRB or animal research review and approval of such modifications; and

  Specific plans for presentation and publication of the study findings.

• Following receipt and acceptance of the Final Research Report, the AACT will disburse the final grant payment. Within 60 days of disbursement of the final grant payment, the grantees must submit a Final Financial Report. This report must include a complete and full accounting of the expenditure of AACT funds related to the execution of the study.

• Any unused funds must be returned to the AACT by the grantees.
• If, for any reason, the grantee does not complete the project, the investigator must inform the AACT in writing within 30 days of study termination. Within 60 days of study termination, the grantees are required to complete the Final Research Report and Final Financial Report and return any unused funds to the AACT as described above.
• The grantees may request a grant extension. Only one extension will be granted for any study. The project must be completed and all other requirements of the grant fulfilled by the end of the extension period.
• The AACT requires that the findings of the funded study be submitted for presentation at a national or international scientific meeting. The North American Congress of Clinical Toxicology retains the right of first refusal for presentation of all findings that emanate from this AACT-sponsored research.
• Within 6 months of submission of the Final Research Report, the findings of the study must be submitted to a peer-reviewed journal for publication. Clinical Toxicology retains the right of first refusal for publication of all findings that emanate from this AACT-sponsored research.
• A reprint of all articles that emanate from this study should be submitted to the AACT.
• All presentations, publications, and other communications regarding this study must include the following acknowledgement: “This study was funded (or partially funded) by a research grant from the American Academy of Clinical Toxicology.” This must be stated in the body (i.e., in the author identification page) of all manuscripts submitted for publication.
• By accepting this award, the grantee will undertake all reasonable efforts to complete the study and take responsibility for fulfilling the terms described within the award letter.

V. APPLICATION PROCESS/SELECTION CRITERIA

Grant application reviewers will use the following criteria in evaluating applications:

Objectives - 20 points maximum
Do the study objectives appropriately address research related to the specific grant program focus and the mission and vision of the AACT? Are the objectives original and innovative?

Rationale - 10 points maximum
Does the proposal clearly explain why this study should be undertaken? Does it reflect an adequate review of the literature? Does the study challenge existing paradigms or propose new methods or techniques? If the study is not innovative but is essential to move the field forward, the applicant should mention and discuss this aspect in the proposal.

Significance - 10 points maximum
Does this study address an important problem? Will the outcome(s) of the study make a positive contribution to the clinical toxicology evidence base? Can the proposed study methods be replicated and generalized?

Study Methods - 40 points maximum
Does the proposal describe with sufficient clarity and detail the study methods to be used? Are the described methods logical and appropriate for the stated objectives? Do the procedures to be followed include, where applicable, information on sampling techniques, controls, data to be gathered, subjects and/or facilities to be used, and statistical and other analyses to be made? Are there plans for recruitment and retention of study subjects?

Scope and Timeline - 5 points maximum
Is the proposed timeline realistic? Is it probable that the study can be completed in the proposed time period (maximum 2 years)? Can the study be completed according to the methods described? Is the study feasible?

Personnel and Facilities - 15 points maximum
Are the professional competencies and experiences of the investigators appropriate to execute the work required? Is there evidence of a commitment to collaboration between the research team? Are the facilities appropriate and adequate for the proposed project? Is there evidence of institutional support?

Completed applications should be mailed to:

American Academyof Clinical Toxicology
AACT Executive Office
6728 Old McLean Village Drive
McLean, VA 22101

If additional space is needed for any item(s), append additional page(s) and reference with item numbers. Letters of support should be appended in this fashion. Ten (10) copies (original plus nine) of the completed six-page application form, with all attachments, must be submitted. Each copy must be collated in the order in which the items appear in the grant application:

1. Completed application form (6 pages)
2. Any attached pages required to complete Items 1-9
3. Project plan (Item 10(a) parts 1-10)
4. Curricula vitae for all investigators (Item 10(b))

VI. ITEMIZED INSTRUCTIONS FOR GRANT APPLICATION

1. Self-explanatory.
2. Funds may be requested for a maximum period of two years.
3. Total amount requested may not exceed $30,000 for a two-year period.
4. (a,b) The Junior Investigator must be an AACT member in good standing. Consider this entry carefully, as no changes will be accepted once a grant has been awarded.
   (c,d) Institution and the department or division in which the Junior Investigator is currently employed.
   (e-i) Self-explanatory.
5. (a,b) The Senior Investigator must be an AACT member in good standing. Consider this entry carefully, as no changes will be accepted once a grant has been awarded.
   (c,d) Institution and the department or division in which the senior investigator is currently employed.
   (e-i) Self-explanatory.
6. (a) The sponsoring institution is that location at which the research will be conducted. Grant checks will be made payable to the institution name listed.
   (b) Self-explanatory.
   (c-f) Grant officer at sponsoring institution to whom checks will be mailed.
7. (a) All personnel for whom salary support is requested must be named in this section. Salary support is available only for study personnel (i.e. Junior Investigator, Senior Investigator, technical personnel, clerical personnel, and other professional personnel.) In the personnel budget justification section, provide a detailed justification that describes each individual & role. The budget justification should correspond directly to the project plan.
   (b) All consumable supplies must be itemized as to description, number, cost per unit, and total cost. If exact costs are not known, estimates must be provided. Provide a detailed justification for each budget item. The budget justification should correspond directly to the project plan.
   (c) Only travel costs essential to the conduct of the project are eligible for funding. Travel to present project findings is acceptable in the range of $1,000 to $1,500 per project. In the travel budget justification, provide a detailed justification for each budget item. Estimated costs for meeting registration
   fees, airfare, lodging, meals, and ground transportation must be provided.
   (d) All other expenses not already specified must be itemized and justified in relation to the project. Requests for permanent equipment, facility construction or renovation, or software are not eligible for funding. Provide a detailed justification for each budget item. The budget justification should correspond directly to the project plan. Facilities and administrative costs rates are not allowed. TOTAL budget should be the same as Item 3.
8. (a) All other professionals engaged in the study for whom salary support is not being requested must be named here with their official title, institution, e-mail address and the number of hours per week they will devote to the project.
9. This "certification" must be signed by the Junior Investigator, the Senior Investigator, and the financial officer.
10. (a) Each of the ten headings must appear in the stipulated order. The abstract should summarize the proposal and is limited to one page. In developing the proposal, the applicant should provide sufficient detail in the methods section including a power analysis, if applicable, and plans for data management and analysis. A detailed description of the subject recruitment process, including the informed consent process, should be provided. The application must address the ability to recruit a sufficient number of subjects to successfully complete the study. Under Role of the Junior Investigator and Senior Investigator, describe the types of mentoring activities that are planned and include information on regular communications between the Junior and Senior investigator. Describe the qualifications of the each researcher according to the eligibility requirements described above. Including the abstract, the narrative of the project plan may not exceed ten (10) pages (using 11 point font or larger, 8.5 by 11 inch paper, 1 inch margins, single spacing and single sided pages). Applicants should strictly comply with font size, paper size, spacing and page limit requirements. Letters of recommendation should be appended to the application. Applications that do not strictly comply with the application instructions will be returned without review.
    (b) Curricula vitae should be limited to 4 pages and should be submitted in the format provided in the U.S. Department of Health and Human Services PHS 398 form.

APPLICATIONS THAT DO NOT STRICTLY COMPLY WITH THE APPLICATION INSTRUCTIONS WILL BE RETURNED WITHOUT REVIEW