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Home » Grants and Funding » Participating Clinics in Multicenter Clinical Trials

Participating Clinics in Multicenter Clinical Trials

Policy and General Information

The National Eye Institute (NEI) supports investigator-initiated multicenter clinical trials using cooperative agreement awards. This mechanism of support is used because NEI staff will be substantially involved with the investigators during the conduct of the clinical trial. Therefore, the organizers of a proposed clinical trial should contact NEI as soon as possible when contemplating submission of an application. Investigators at potential participating clinics should contact the Chairperson of the proposed trial for the submission schedule, logistical arrangements, and for trial-specific information and guidance. The following sections provide generic information regarding the preparation, submission, peer review, and award of applications from potential participating clinics.

Application Procedures

Submit applications using form PHS 398 (Rev. 5/2001) which is available in an interactive electronic format at http://grants.nih.gov/grants/funding/phs398/phs398.html. Follow the instructions supplied with this form, and the specific instructions given below. An investigator submitting an application for support for a participating clinic should check with the study Chairperson and/or NEI staff regarding submission procedures. The study Chairperson will usually collect all applications associated with the study and send them to NIH in a single package. Whether submitted by the study Chairperson or the participating clinic investigator, the original application and FOUR exact copies of the application must be sent to:

Center for Scientific Review
National Institutes of Health
Suite 1040
6701 Rockledge Drive MSC 7710
Bethesda, MD 20892-7710
Bethesda, MD 20817-7710 (for express mail or courier service)

In order to expedite the review of the application, at the same time, please mail or deliver ONE additional complete copy of the application to:

Samuel C. Rawlings, Ph.D.
Chief, Scientific Review Branch
National Eye Institute
Division of Extramural Research
Suite 1300
5635 Fishers Lane, MSC 9300
Bethesda, MD 20892-9300

Peer Review

Applications assigned to the NEI will be reviewed for scientific merit by an initial review group convened by staff of the Scientific Review Branch, NEI. Second level program and policy review for applications assigned to NEI will be conducted by the National Advisory Eye Council.

Review Criteria

All applications will be reviewed using the general NIH review criteria, with special emphasis on the following:

Specific Instructions

Enter the code U10 in item 2 on the face page of the application.

Applications should be written with the principal purpose of demonstrating that the clinic will be able to deliver sufficient high-quality data to make its participation desirable and cost-effective. An application should include information that, at a minimum, addresses the peer review criteria, and the NIH policies on the welfare of human subjects, the inclusion of children, and the inclusion of women and minorities in study populations.

Specific information that is pertinent includes the following:

Personnel.

Resources and Facilities. The specific information presented should demonstrate access to patients and physical facilities such that the clinic will be able to recruit, examine/test, treat, and follow a sufficient number of patients who meet all study eligibility criteria and who would be willing to participate. Thus, the specific information presented should include:

Budget. This section should fully explain and justify all requested items, especially:

Experimental Design. The specific information that should be provided in the Research Plan section of Form 398 should not repeat the Manual of Procedures for the overall study. But, it should make clear that the investigators at the participating clinic understand the study design and that sufficient thought has been given to how the protocol will be carried out on a day-to-day basis at the clinic. Thus, the following should be addressed:

Human Subjects. As part of the peer review process, the peer review group carefully considers protections from research risk. The reviewers will assess the adequacy of safeguards of the rights and welfare of research participants based on the information in the application. NIH no longer requires IRB approval and certification of the proposed research prior to NIH peer review of an application. If the application is to be funded, NEI grants management staff will contact the institution for the certification of IRB approval. Please refer to the PHS 398 application kit for further information and guidance on human subject issues.

Inclusion of Children and of Women and Minorities in Study Populations. NIH-funded projects that involve human subjects are required to include children, minorities and both genders in study populations so that research findings can be of benefit to all persons at risk of the disease, disorder, or condition under study. Special emphasis should be placed on the need for inclusion of children, women and minorities in studies of the diseases, disorders, and conditions that affect them disproportionately. Further information on this policy appears in the Form 398 application kit. Peer reviewers will address specifically whether the research plan conforms to these policies. If the representation of children, women or minorities is inadequate to answer the scientific question(s) addressed and the justification for the selected study population is inadequate, it will be considered a scientific weakness or deficiency in the study design and will be reflected in the recommendation to further consider the application and in the priority score assigned to the application. NIH funding components will not award grants or cooperative agreements that do not comply with this policy.

For multicenter clinical trials, the Chairperson's application must discuss these issues for the study as a whole. Applications from participating clinics, as indicated in Resources above, should address the age, gender and racial/ethnic composition of their referral base, eligible patient pool, and likely enrollment of patients.

Inquiries

Written and telephone inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcomed.

For further information regarding the initial scientific review, prospective applicants should contact Dr. Rawlings at (301) 451-2020.

For inquiries about the programmatic aspects of this announcement, applicants should contact: Eleanor B. Schron, Ph.D., Maryann Redford, D.D.S., M.P.H., Natalie Kurinij, Ph.D., or Donald Everett, M.A., Collaborative Clinical Research, NEI, at:

National Eye Institute
Division of Extramural Research
Suite 1300
5635 Fishers Lane, MSC 9300
Bethesda, MD 20892-9300
Telephone: (301) 451-2020

For grants administration information, applicants should contact:

William W. Darby
National Eye Institute
Division of Extramural Research
Suite 1300
5635 Fishers Lane, MSC 9300
Bethesda, MD 20892-9300
Telephone: (301) 451-2020
Fax: (301) 496-9997
Email: wwd@nei.nih.gov

Authority and Regulations

This program is described in the Catalogue of Federal Domestic Assistance No. 93.867, Vision Research. Awards made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review.



Department of Health and Human Services NIH, the National Institutes of Health USA.gov