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Clinical Research Center Grant [P50]

Update 2008

A Clinical Research Center Grant (P50) supports a research program in which a team of investigators works on a clearly defined central theme of mutual scientific interest. The NIDCD believes this mechanism facilitates economy of effort, space, and equipment, and accelerates the acquisition of knowledge by stimulating cooperation among clinical investigators whose projects are directed toward a common goal.

  • Overview
  • Program Characteristics/Description
  • Preparing a P50 Application
  • Submission and Review of Applications
  • Staff Consultation
  • Preparing a Revision Clinical Research Center Grant Application
  • Award Administration
  • Required Federal Citations

I. Overview


These guidelines supersede all prior guidelines for the NIDCD Clinical Research Center Grants (P50). Additional information may be obtained from NIDCD staff NIDCD staff listed under Staff Consultation. or may be found on the NIDCD grants homepage.

The National Institute on Deafness and Other Communication Disorders (NIDCD) invites applications for Clinical Research Center Grants designed to advance the diagnosis, prevention, treatment, and amelioration of human communication disorders. The NIDCD believes that most research within its mission areas can be best accomplished via the investigator-initiated individual research grant (R01) and the research core center grant (P30) mechanisms. There are special circumstances in clinical research however, that warrant use of the P50 mechanism to support clinical research. Clinical Research is defined as research involving individuals with communication disorders or data/tissues from individuals with a communication disorder. Examples of such research include but are not limited to, studies of the prevention, pathogenesis, pathophysiology, diagnosis, treatment, management or epidemiology of a disease or disorder of hearing, balance, smell, taste, voice, speech, or language.

Potential applicants for Clinical Research Center Grants (P50) should consult with NIDCD program staff during the early planning stages of preparing an application. This will help potential applicants determine whether the planned project is appropriate for the P50 mechanism and gather other advice that may be useful during the application and review process.

Applicants planning to submit an investigator-initiated new (type 1), renewal (type 2/competing continuation), revision (type 3), or any resubmission (amended/revised version) of the preceding grant application types requesting $500,000 or more in direct costs for any year must obtain prior approval from NIDCD at least 6 weeks prior to date of submission. Applicants must identify the staff member who agreed to accept assignment of the application, in a cover letter sent with the application. Refer to Program contacts are listed by program area at the end of this document under Staff Consultation. For general P50 information, please contact Dr. Lana Shekim at

II. Program Characteristics/Description

A. General Description
The Clinical Research Center Grant (P50) supports an investigator-initiated research program in which a team of investigators works in a clearly defined central theme of mutual scientific interest. The NIDCD believes this mechanism facilitates economy of effort, space, and equipment, and accelerates the acquisition of knowledge by stimulating cooperation among clinical investigators whose projects are directed toward a common goal.

B. Essential Criteria
The essential criteria for Clinical Research Center Grant (P50) eligibility are listed below. All four of the criteria must be met for an application to be considered appropriate for the P50 mechanism.

  1. The research to be conducted must be clinical as defined above.
  2. The P50 must have a well-defined central unifying theme consisting of three or more subprojects with supporting cores as appropriate.
  3. Each subproject must be unambiguously related to the central unifying theme. Synergistic and substantial interactions among the subprojects must be evident.
  4. The overall P50 must provide multidisciplinary approaches to the central theme, defined as having subprojects representing different disciplines, approaches and expertise.

C. Additional Instructions
Studies with normal human subjects (e.g., those without a communication disorder) may be included in the research only when data from normal controls are essential for interpretation of the results.

Non-human research will be allowed on a NIDCD P50 grant only if translational or serves as a platform for translational research. Prior approval from the designated NIDCD Program Director and the NIDCD P50 Coordinator must be obtained and documented in the cover letter.

Core support can be requested as part of a P50 application to provide essential resources required by multiple subprojects. Requests must be carefully justified and not be used to acquire additional support for existing cores already at the institution.

III. Preparing a P50 Application

A.Submit grant applications on form PHS 398
P50 grant applications must be submitted on form PHS 398 using the application standard receipt dates. Please see i.e. January 25, May 25 and September 25 for new, renewal or resubmission.

These application guidelines are designed to supplement and be used in conjunction with the Instructions for PHS 398. Since the Form PHS 398 is designed primarily for the traditional research project grant (R01) application, several sections have to be expanded, so that the form can be used to provide the additional information needed for the P50 grant application. Page limitations stipulated in the Instructions for PHS 398 apply to each of the component subprojects within a Clinical Research Center Grant application.

Submit a signed original of the application, including the checklist and three signed photocopies in one package to:

Center for Scientific Review (CSR)
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

In addition to the copies submitted to CSR, send two copies and all appendix CDs, in one package, to:

Chief, Scientific Review Branch, NIDCD
6120 Executive Blvd, EPS – 400C, MSC 7180
Bethesda, MD 20892-7180 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20852 (for express/courier service; non-USPS service)

Instructions for completing PHS 398 (Revised 11/2007)

The PHS 398 application kit is available at in an interactive format.

B. References
Published manuscripts and/or abstracts that are publicly available in a free, online format may be referenced in the application. These publications may not be included in the appendix. URLs or NIH PubMed Central (PMC) submission identification numbers may be included along with the full reference in the Literature Cited section, the Progress Report Publication List section and/or the Biographical Sketch section. While there is no limit to the number of URLs or PMC submission identification numbers that can be cited, applicants should be both judicious and concise. The PD/PI is responsible for making sure that any links are functional.

C. Appendix
All paper PHS 398 applications submitted for May 25, 2008 and subsequent due dates must provide appendix material on CD only. Include five identical CDs in the same package sent with the application under separate cover to the Chief of Scientific Review at NIDCD. See

Do not use the appendix to circumvent the page limitations of the research plan component. An application that does not observe the required page limitations may be delayed in the review process

D. Letter of Intent
Not Applicable

E. Research Grant Table of Contents (Form Page 3 PHS 398)
Prepare a detailed table of contents that will enable reviewers to find specific information readily. Present the subprojects first and the cores last. Identify each subproject by title, assign each subproject a number and each core a capital letter that reflects the order in which the subprojects and cores are presented in the application, and provide the name of the responsible investigator for each component. Number the pages consecutively. Indicate the beginning page numbers for each subproject, core, and their respective budgets.

F. Budget (Form Pages 4 and 5 PHS 398)
P50 grants are not one of the mechanisms included in NIH's Modular Grants initiative. A detailed budget must be provided.

Reproduce the standard budget forms, pages 4 and 5, as necessary to allow preparation of both a "Detailed Budget for First 12-Month Budget Period" and a "Budget for Entire Proposed Project Period" for a composite budget, each subproject, and each core. All budgets (composite, subproject, core, and consortium/contractual) will be in this one section, placed in the same order that the subproject and cores are listed in the table of contents, and paginated accordingly. The complete budget section should include the following:

Composite budget for first 12-month budget period. Refer to Section VIII, Illustration 1 of this document for a sample composite budget for the first 12-month period. The composite budget is presented on Form Page 4, PHS 398. For each of the applicable budget categories (PERSONNEL, CONSULTANT COSTS, EQUIPMENT, SUPPLIES, TRAVEL, PATIENT CARE COSTS, CONSORTIUM/CONTRACTUAL COSTS, AND OTHER EXPENSES), give the amount requested for each subproject and core and provide subtotals where appropriate, as illustrated. If contractual arrangements or "purchased services" involving other institutions or organizations are anticipated, as in Project 5 and Core B in the sample budget shown in Illustration 1, include both direct and indirect costs associated with such participation in the CONSORTIUM/CONTRACTUAL COSTS category, as shown.

Composite estimates for all years of support requested. Refer to Section VIII, Illustration 2 of this document for a sample future-years composite budget, and use Form Page 5, PHS 398. Use the example format to present these composite budget estimates by category for all years of support requested.

Person months distribution among subprojects: As an aid to reviewers, the information on the person month of personnel should be presented in tabular format, such as shown in Section VIII. Illustration 3.

Individual first and future years’ budget estimates. Use the standard budget forms contained on Form Pages 4 and 5 of the PHS 398 to present the first budget period and future years’ budgets for each subproject and core. Place these after the aforementioned pages (the two pages of composite budgets and the page that illustrates the person month distribution among subprojects and cores) in the order the subprojects and cores are presented in the table of contents and in the application. Where appropriate, provide subtotal costs for calculations that are not obvious, such as: 2 blood samples x 40 patients x 2 outpatient visits @ $20/sample = $3,200. Explain non-inflationary cost increases added in future years. Provide explicit explanations to justify individual personnel and each major item requested in each of the other categories. Include budget justifications on the appropriate budget page (Form Page 5 PHS 398) even though explanatory information may be provided, or seems apparent, in the text of the research subproject or core.

Beginning with the May 2008 submission, budgets for new P50 applications are limited to $1,500,000/year direct cost (DC), including consortium direct costs but excluding facilities and administrative consortium costs. Competing renewals (type 2) P50 grant applications may request budgets (DC) that are no greater than 10% above the budget (DC) of the last year of the existing grant. Annual budget increases should not exceed more than NIH allowances at the time of submission of the application. Salary levels in all years are limited to the NIH maximum rate, currently at $191,300 per year. See

G. Biographical Sketches (Form Page 6 PHS 398)
Prepare biographical sketches as described in PHS 398 application guidelines and place them, in alphabetical order, in one section immediately after the budget section. Biographical sketches are required for all professional personnel (including consultants) who participate in the research subprojects and cores. If the pertinent publications listed constitute only a portion of an investigator's published works, please indicate the total number of full-length refereed publications.

H. Research Support
To aid in the review of your application, a tabular presentation of research support (current and pending) for all named investigators presented, such as that shown in Section VIII. Illustration 4 is requested.

I. Resources and Environment (Form Page 8 PHS 398)
If necessary, use continuation pages to describe multiple facilities and to explain geographic relationships.

J.  Research Plan
The research plan should begin with a statement that provides an overview of the entire program and describes the central theme and goals of the Clinical Research Center (P50). Provide the rationale for the proposed research program. Explain the strategy for achieving the objective(s) of the overall program and how each subproject and core relate to that strategy.

The beginning of the research plan is the appropriate place to: indicate any prior collaborative arrangements between investigators in the group; emphasize the events that led to the current application; predict the anticipated advantages that would be gained by including the research in the proposed program; describe the overall theme of the center and how the subprojects are related to that theme; and, describe the multidisciplinary nature of the proposed research.

K. Organizational and Administrative Structure
Describe in detail the chain of responsibility for decision-making and administration, beginning with the principal investigator and including the investigators (key personnel) responsible for the research subprojects and cores. Indicate where, in the chain of responsibility, advisory groups of internal and (or) external consultants would be used, and describe their function. (Letters of agreement from consultants should be included in the application).

Specific managerial responsibilities: Indicate who would be responsible for assisting the Principal Investigator with the day-to-day administrative detail, research patient care, program coordination, and the planning and evaluation of the program.

Relation of the Clinical Research Center organization and administration to the applicant institution: Describe the relation between the proposed Clinical Research Center and other existing research, academic, and administrative units of the applicant institution, such as centers, institutes, departments, and central administration.

Consortium/contractual arrangements: If the proposed program includes requests for funds for research activities that involve institutions other than the applicant organization, the program is considered a consortium effort. Such cooperative activities may be included in a P50 application, but it is imperative that a consortium application be prepared so that the programmatic, fiscal, and administrative considerations are explained fully. Where pertinent, include a letter from each of the cooperating organizations that signifies their intent to participate and to provide the necessary resources proposed in the application.

Applications with Multiple PIs: When multiple PD/PIs are proposed, use the Face Page-Continued page to provide items 3a – 3h for all PD/PIs. NIH requires one PD/PI be designated as the “contact PD/PI” for all communications between the PD/PIs and the agency. The contact PD/PI must meet all eligibility requirements for PD/PI status in the same way as other PD/PIs, but has no special roles or responsibilities within the project team beyond those mentioned above. The contact PD/PI may be changed during the project period. The contact PD/PI should be listed in block 3 of Form Page 1 (the Face Page), with all additional PD/PIs listed on Form Page 1-Continued. When inserting the name of the PD/PI in the header of each application page, use the name of the “Contact PD/PI, et al.” The contact PD/PI must be from the applicant organization if PD/PIs are from more than one institution.

All individuals designated as PD/PI must be registered in the eRA Commons and must be assigned the PD/PI role in that system (other roles will not give the PD/PI the appropriate access to the application records). Each PD/PI must include their respective eRA Commons ID in the eRA Commons User Name field.

All projects proposing Multiple PDs/PIs will be required to include a new section describing the leadership plan approach for the proposed project. See the Multiple Principal Investigator webpage for further information:

Multiple PD/PI Leadership Plan: For applications designating multiple PDs/PIs, a new section of the research plan, entitled “Multiple PD/PI Leadership Plan” must be included. A rationale for choosing a multiple PD/PI approach should be described. The governance and organizational structure of the leadership team and the research project should be described, and should include communication plans, process for making decisions on scientific direction, and procedures for resolving conflicts. The roles and administrative, technical, and scientific responsibilities for the project or program should be delineated for the PDs/PIs and other collaborators.

If budget allocation is planned, the distribution of resources to specific components of the project or the individual PDs/PIs should be delineated in the Leadership Plan. In the event of an award, the requested allocations may be reflected in a footnote on the Notice of Award.

L. Summary Report of Progress
Renewal (formerly competing continuation) applications must include a progress report that highlights achievements of the overall Clinical Research Center since the last competitive review. A specific progress report is required for each subproject and core unit in its respective section of the application. The progress report must include the following information:

  • a brief summary of major accomplishments that can be attributed to the grant and a brief explanation of how these accomplishments have contributed to further the stated objective(s) of the grant;
  • a list of all publications and manuscripts accepted for publication that have resulted from the grant (do not list manuscripts submitted or in preparation);
  • a list of any changes in the professional staffing since the last competitive review;
  • a tabular list of subprojects and cores that have been discontinued, completed, or modified since the last competitive review, identified by number and title, with a brief explanation of the reasons for the changes; and
  • a list of subprojects and cores in the ongoing program, with the amount of current funding for each and the requested funding for the first budget period of each subproject and core that would be continued.

M. Format for the Presentation of a Component Research Subproject
Describe each subproject in the same detail required for the traditional, individual research grant (R01) application so that the scientific merit can be judged on the basis of the written application alone. Keep in mind that the application will be reviewed by experts who will judge, collectively, all areas represented in the application but who may not be familiar, individually, with each area of research proposed. Therefore, the description of a subproject should be explicit enough to enable experts in related areas to understand the main thrust of the subproject and how the subproject relates to the main theme of the program.

Each component research subproject must begin with the standard printed Form Page 2 PHS 398, DESCRIPTION.

Title of project: Title and number each subproject so that it can be readily distinguished from other subprojects.

Names and titles of investigators: Provide the name, academic title, and department or organization of the principal investigators and all key personnel.

Research plan: Follow the instructions for "Section 2. RESEARCH PLAN" (Instructions PHS 398), for presentation of each research subproject.

N. Format for the Presentation of a Component Core
A "core" is defined as a resource for the program that provides centralized services to more than one research subproject. Actual research is not conducted in a core. The following information must be provided whether the proposed core is new or existing [e.g., as in the case of an institution with an existing Core Center (P30) grant that is appropriate to the P50 application].

Title of core: Title and assign an alphabetic designation to each core so that it can be readily distinguished from the subprojects.

Names and titles of investigators: Provide the name, academic title, and department or organization of the core leader and each participating investigator.

Description of core: Explain the function of the core as a resource for the P50. Describe the facilities, techniques, and professional skills that the core would provide. As justification for the core, indicate how and which specific subprojects would utilize the resources of the core. Estimate the percent time and effort that core personnel would allocate to individual subprojects.

Progress report: For a renewal or revisional application, summarize the utilization and value of each core during the preceding period of support.

O. Resubmission Application

When submitting a resubmission application, an Introduction section is required and should summarize any substantial additions, deletions, and changes made. Include responses to criticisms in the previous summary statement. Do not exceed 3 pages for the Introduction to the resubmission application; each subproject or core of a resubmission may also include an Introduction not to exceed three pages. Changes within the text of the research plan should be highlighted by vertical lines in the margin, bracketing, indenting, or changing of typeface. Incorporate in the progress report any work done since the prior version was submitted. A resubmission application will be returned if substantial changes are not clearly apparent.

IV. Submission and Review of Applications

A. Submission of Applications
The receipt dates are the same for all new (Type 1), renewal (competing continuation/Type 2), resubmission (revised or amended) and revision (Type 3) P50 applications.

Application Receipt Dates: January 25th, May 25th, September 25th
Initial Review Dates: June/July, October/November, February/March
National Advisory Council Dates: September, January, May
Earliest Possible Start Dates: December 1, April 1, July 1

The original and three copies of the completed application must be mailed to the NIH Center for Scientific Review; the CSR address label is included in the application kit (PHS 398).

In addition to the copies submitted to CSR, send two copies and all appendix CDs, in one package, to:

Chief, Scientific Review Branch, NIDCD
6120 Executive Blvd, EPS – 400C, MSC 7180
Bethesda, MD 20892-7180 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20852 (for express/courier service; non-USPS service)

1. Appendix
All appendices for the P50 shall be submitted to the NIDCD, not to the CSR. If such materials are submitted, they should be mailed to the Chief, Scientific Review Branch, NIDCD.  All appendix material must be clearly identified with one subproject or core. The appendix for each subproject has a limit of 3 publications, which are not publicly available, that will be considered in the initial peer review.  See the formal application instructions for more details at:

Five identical CDs of Appendix material must be received by the NIDCD Scientific Review Branch at the time of submission of the P50 application. If Appendix materials are being submitted, this should be indicated on the Table of Contents page, by checking the appropriate box at the bottom of the page.

2. Late Material
A P50 application submitted for a specific receipt date is considered complete and in final form as received. As emphasized in the Instructions for PHS 398: "Submit a complete application. An application will be returned if it is illegible, if it fails to follow the instructions, or if the material presented is insufficient to permit an adequate review. Unless specifically required by these instructions (e.g., human subjects certification, changes in other support, appendix), do not send supplementary or corrective material after the receipt date unless the scientific review officer of the initial review group (IRG) solicits or agrees to accept this information. Because there is no guarantee that late material will be considered, the application must be complete and accurate at the time of submission." Unsolicited late material, including proposal revisions, addenda, and budget modifications may not be accepted or may result in deferral of the application.

B. Review of Application
Upon receipt, applications will be reviewed for completeness and responsiveness. NIDCD staff will review for responsiveness to the P50 funding mechanism, based on the essential criteria listed in Section II.B. of this document.  Incomplete and/or non-responsive applications will be returned to the applicant without further consideration. Applications that are complete and responsive will be evaluated for scientific and technical merit by an appropriate peer review group (Initial Review Group or IRG) convened by the NIDCD in accordance with the review criteria stated below.  As part of the initial review, all applications will be discussed and receive a written critique. Applications receive a second level of review by the National Deafness and Other Communication Disorders Advisory Council.

1. Review Criteria
Only the review criteria described below will be considered in the review process.

2.  Review and Selection Process
Applications that are complete and responsive to the FOA will be evaluated for scientific and technical merit by an appropriate peer review group convened by NIDCD and in accordance with NIH peer review procedures (, using the review criteria stated below.

As part of the scientific peer review, all applications will:

  • Undergo a selection process in which only those applications deemed to have the highest scientific and technical merit, generally the top half of applications under review, will be discussed and assigned a priority score.
  • Receive a written critique.
  • Received a second level of by review by the National Deafness and Other Communication Disorders Advisory Council.

The following will be considered in making funding decisions:

  • Scientific and technical merit of the proposed project as determined by peer review
  • Availability of funds
  • Relevance of the proposed project to program priorities

The goals of NIH supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health.  In their written critiques, reviewer will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals.  Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application.  Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a meritorious priority score.  For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward.

Review Criteria for Individual Research Subprojects

  • Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced?  What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?
  • Approach: Are the conceptual framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics?  For applications designating multiple PDs/PIs, is the leadership approach, including the designated roles and responsibilities, governance, and organizational structure, consistent with and justified by the aims of the project and the expertise of each of the PDs/PIs?
  • Innovation: Is the project original and innovative?  For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field?  Does the project develop or employ novel concepts, approaches, methodologies, tools or technologies for this area? Are the aims original and innovative?
  • Investigators: Are the PD/PI(s) and other key personnel appropriately trained and well suited to carry out this work? Is the work proposed appropriate for the experience level of the principal investigator and other researchers? Does the PD/PI(s) and investigative team bring complementary and integrated expertise to the project (if applicable)? Are the commitment of the investigators, and their ability to devote the required time and effort to the subproject appropriate?
  • Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there adequate evidence of institutional support?
  • Appropriateness for the mechanism: Is the proposed research clinical? To what level is this subproject related to other subprojects and to the overall theme of the center? How well does this subproject contribute to the multidisciplinary nature and overall theme of the center?

NIH considers the following in evaluating Center grant applications:

  • The scientific and technical merit of the proposed program;
  • The qualifications and experience of the center director and other key personnel;
  • The statutory and program purposes to be accomplished;
  • The extent to which the various components of the proposed program would be coordinated into one multi-disciplinary effort within the center;
  • The extent to which the center’s activities would be coordinated with similar efforts by other organizations;
  • The administrative and managerial capability of the applicant; and
  • Other factors which the awarding IC considers appropriate in light of its particular statutory mission.

Additional Review Criteria: In addition to the above criteria, the following items will continue to be considered in the determination of scientific merit and the rating:

Resubmission Application (formerly “revised/amended” applications): Are the responses to comments from the previous scientific review group adequate?  Are the improvements in the resubmission application appropriate? 

Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed (see the Research Plan section on Human Subjects in the PHS 398 instructions).

Inclusion of Women, Minorities and Children in Research: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed.  Plans for the recruitment and retention of subjects will also be evaluated (see the Research Plan section on Human Subjects in the PHS 398 instructions).

Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five points described in the Vertebrate Animals section of the Research Plan will be assessed.

Biohazards: If materials or procedures are proposed that are potentially hazardous to research personnel and/or the environment, determine if the proposed protection is adequate.

Additional Review Considerations:

Budget: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research.  The priority score should not be affected by the evaluation of the budget.

Applications from Foreign Organizations: Whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions in other countries that are not readily available in the United States or that augment existing U.S. resources will be assessed.

In the case of a competing renewal (continuation) application, the progress made during the past period of funding is also an important consideration in the review of subprojects.

It should be noted that each meritorious subproject will receive a priority score and that these scores will appear in the summary statement.  Individual subprojects judged as "less meritorious" (because the proposed research is less significant and substantial when judged against the above criteria, or there are other significant concerns) will be deleted from the overall P50.  Inclusion of a 'weak' or 'non-essential' subproject will reflect poorly on the overall program (see overall center criteria).  In addition, the NIDCD retains the right to delete individual subprojects when making final funding decisions.

Review Criteria for Individual Cores

  • Utility of the core to the Clinical Research Center: Does each core provide essential facilities or service for two or more subprojects judged to have substantial scientific merit?
  • Facilities and services: What is the quality of the facilities and services provided by this core (including procedures, techniques, quality control, and criteria for user priority)?
  • Personnel: Are the qualifications, experience, and commitment of the personnel involved in the core appropriate and adequate?

In the case of a renewal (competing continuation) application, the progress made during the past period of funding is also an important consideration in the review of cores.

Overall Clinical Research Center Review Criteria
Each P50 must have a well-defined central unifying theme with three or more meritorious subprojects for the duration of the project period and may contain appropriately justified cores that support two or more subprojects. Whereas subprojects are scored individually, the overall P50 score is an overall evaluation, and not an average of the individual subprojects’ scores.  Program staff may consider deletion of a weak subproject when recommending award of the remaining reduced scope yet strong P50. The IRG will evaluate the relationship and contributions of the combined subprojects and cores to the overall theme of the Clinical Research Center. Additional factors include overall scientific considerations, leadership, and administration, as detailed below. However, the most important consideration will be the scientific merit of the research plans, as judged in the individual subprojects.

Scientific Considerations

  • Significance of the overall center goals.
  • Level of scientific gain from combining the individual subprojects/cores into a center.
  • Level of cohesiveness of the center's component parts, including the interrelationships and coordination.
  • Past accomplishments of the center or the demonstrated ability of the core personnel in conducting similar programs.

Scientific Considerations for Renewal (Competing Continuation) Applications

  • Progress and achievements specific to this center since the previous competitive review, with consideration for the level of collaboration, integration and use of multidisciplinary approaches (e.g., publications, conferences).
  • Evidence that the previous specific aims have been accomplished, that new research goals are logical extensions, and that the basic requirements for a clinical research center still apply.
  • Evidence that previously funded cores, if any, were well utilized and contributed significantly to the center's performance.
  • Justification for adding new subprojects or cores, and for deleting previously supported components.

Leadership and Administration

  • The ability of the principal investigator to manage the overall scientific effort and budget. Evidence of established leadership in scientific research and demonstrated capabilities in program administration.
  • The utilization of internal and/or external advisory committees to assist in making scientific/administrative decisions and evaluating progress and direction.
  • Planned meetings or other methods to facilitate the interaction of participating investigators and assure a cohesive program (sharing and evaluate results, new ideas).
  • Academic environment and resources in which the research will be conducted, including availability of space, equipment, human subjects, or other resources as required, and the potential for interaction with scientists from other departments/disciplines.
  • Institutional commitment to the requirements of the program, including fiscal responsibility and management capability of the institution to assist the principal investigator and his or her staff in following DHHS and NIH policy.
  • Administrative planning and leadership capability to provide for internal quality control of ongoing research, allocation of funds, enhancement of internal communication and cooperation among the investigators involved in the program, and replacement of the principal investigator if required on an interim or permanent basis.
  • This overall leadership and administration also should be demonstrated in the considerations for human subject protection; inclusion of women, minorities, and children, and biohazard issues as reviewed in the individual components.

3. Review by the National Advisory Council
The recommendations of the initial review group are reviewed by the National Deafness and Other Communication Disorders Advisory Council. Items considered in this review include:

  • scientific merit (as determined by peer review)
  • availability of funds
  • programmatic priorities

V. Staff Consultation

Inquiries about P50 applications should be directed to the appropriate Program Director listed below. Consultation regarding renewal (competing continuation) grant applications should be sought from the NIDCD Program Director responsible for the existing P50.

Division of Scientific Programs, NIDCD
6120 Executive Blvd, EPS, MSC 7180
Bethesda, Maryland 20892-7180
Phone: (301) 496-5061
Fax: (301) 402-6251

Dr. Amy Donahue

Dr. Nancy Freeman

Dr. Bracie Watson

Dr. Christopher Platt

Neural Prosthesis:
Dr. Roger Miller

Dr. Barry Davis

Dr. Lana Shekim

Dr. Judith Cooper

Inquiries regarding review procedures may be addressed to:
Melissa J. Stick, Ph.D., MPH
Chief, Scientific Review Branch
Division of Extramural Activities, NIDCD
6120 Executive Blvd., Rm 400C
Bethesda, Maryland, 20892-7180
(For Express Mail/Courier please use
Rockville, Maryland 20852)
Phone: 301-496-8683
Fax: 301-402-6250

Inquiries regarding fiscal and administrative matters may be addressed to:
Christopher Myers
Chief, Grants Management Branch
Division of Extramural Activities, NIDCD
6120 Executive Boulevard, EPS 400-C, MSC 7180
Bethesda, MD 20892-7180
Phone: (301) 435-0713
Fax: (301) 402-1758

VI. Preparing a Revision Clinical Research Center Grant Application

A revision application may be submitted only to request support for the continuation of subprojects originally recommended for a period shorter than the parent grant. Requested project periods may not exceed the time remaining on the parent grant.

Potential applicants for a revision to a Clinical Research Center grant (P50) are urged to consult with NIDCD program staff before beginning an application. NIDCD staff will determine whether the planned project appears to be appropriate as a revision to an existing P50. NIDCD staff will offer advice and suggestions to the principal investigator during the application and review process. Program staff are listed by program area in this document under Section V, Staff Consultation

Preparing an Application for a Revision
Since the grant application upon which the revision request is developed is available only as a resource document during the merit review, the existing parent program must be described in sufficient detail to allow adequate evaluation of the revision application. The overall format and content of the revision application must conform to the instructions provided in the applicable preceding sections of these Guidelines. The same review criteria described above will be applied to applications for revisions.

Face Page
In preparing a revision application, type "CLINICAL RESEARCH CENTER GRANT (P50) REVISION" in the top left-hand corner of the face page immediately above the words "Department of Health and Human Services." Line 1 should be the title of the parent grant, and line 3 should be the name of the Principal Investigator of the parent grant.

On page 2 of the Application Form PHS 398, provide a brief description of the entire program in addition to a summary of the revision request.

Refer to the section on the preparation of the budget that is presented in the main section of these Guidelines. For each subproject or core unit in the revision request, prepare the standard "Detailed Budget for First 12-Month Budget Period" and the "Budget for Entire Proposed Project Period." Update the originally submitted "Person Month Distribution among Projects and Core Units" (Section VIII, Illustration 3), to include the revision component(s) requested. Budget periods must conform to the parent grant and the duration of the revision cannot extend beyond the parent grant.

When appropriate, provide brief explanations, in tabular form, of any changes in the budgets of the subprojects and core units since the last competitive review. In particular, note and explain any rebudgeting of funds between subprojects and core units.

Personnel - Position
Johnson - CoPI
Campbell - Tech
Gutierrez - PI
Smith - Lab Asst
Lerner - M.D.
Martin - PI
Patient Coord.
Research Tech II

VII. Award Administration Information

After the peer review of the application is completed; the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General.

Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NOA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs. See also NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NOA) will be provided to the applicant organization. The NOA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the Notice of Award will be generated via email notification from the awarding component to the grantee business official (designated in item 14 on the Application Face Page). If a grantee is not email enabled, a hard copy of the Notice of Award will be mailed to the business official.

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.

A final progress report, invention statement, and Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.

VIII. Required Federal Citations

This program is described in the Catalog of Federal Domestic Assistance No. 93.866 and No. 93.865. Awards are made under authorization of sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and administered under NIH grants policies and Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review.

The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

Use of Animals in Research
Recipients of PHS support for activities involving live, vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory Animals ( as mandated by the Health Research Extension Act of 1985 (, and the USDA Animal Welfare Regulations ( as applicable.

Human Subjects Protection
Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (

Data and Safety Monitoring Plan
Data and safety monitoring is required for all types of clinical trials, including physiologic toxicity and dose-finding studies (phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative trials (Phase III). Monitoring should be commensurate with risk. The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risks to the participants (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts,

Sharing Research Data
Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible (

Investigators should seek guidance from their institutions, on issues related to institutional policies and local IRB rules, as well as local, State and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score.

Policy for Genome-Wide Association Studies (GWAS)
NIH is interested in advancing genome-wide association studies (GWAS) to identify common genetic factors that influence health and disease through a centralized GWAS data repository. For the purposes of this policy, a genome-wide association study is defined as any study of genetic variation across the entire human genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight), or the presence or absence of a disease or condition. All applications, regardless of the amount requested, proposing a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. Data repository management (submission and access) is governed by the Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088. For additional information, see

Sharing of Model Organisms
NIH is committed to support efforts that encourage sharing of important research resources including the sharing of model organisms for biomedical research (see At the same time the NIH recognizes the rights of grantees and contractors to elect and retain title to subject inventions developed with Federal funding pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement All investigators submitting an NIH application or contract proposal, beginning with the October 1, 2004 receipt date, are expected to include in the application/proposal a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit other researchers to benefit from the resources developed with public funding. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated.

Access to Research Data through the Freedom of Information Act
The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at Applicants may wish to place data collected under this funding opportunity in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award.

Inclusion of Women and Minorities in Clinical Research
It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research (; a complete copy of the updated Guidelines is available at The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.

Inclusion of Children as Participants in Clinical Research
The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects (

Required Education on the Protection of Human Subject Participants
NIH policy requires education on the protection of human subject participants for all investigators submitting NIH applications for research involving human subjects and individuals designated as key personnel. The policy is available at

Human Embryonic Stem Cells (hESC)
Criteria for federal funding of research on hESCs can be found at and at Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding ( It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s) to be used in the proposed research. Applications that do not provide this information will be returned without review.

NIH Public Access Policy Requirement
In accordance with the NIH Public Access Policy (, investigators must submit or have submitted for them their final, peer-reviewed manuscripts that arise from NIH funds and are accepted for publication as of April 7, 2008 to PubMed Central (, to be made publicly available no later than 12 months after publication. As of May 27, 2008, investigators must include the PubMed Central reference number when citing an article in NIH applications, proposals, and progress reports that fall under the policy, and was authored or co-authored by the investigator or arose from the investigator’s NIH award.  For more information, see the Public Access webpage at

Standards for Privacy of Individually Identifiable Health Information
The Department of Health and Human Services (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule", on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR).

Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website ( provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at

URLs in NIH Grant Applications or Appendices
All applications and proposals for NIH funding must be self-contained within specified page limitations. For publications listed in the appendix and/or Progress report, internet addresses (URLs) must be used for publicly accessible on-line journal articles. Unless otherwise specified in this solicitation, Internet addresses (URLs) should not be used to provide any other information necessary for the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site.

Healthy People 2010
The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This PA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at

Authority and Regulations
This program is described in the Catalog of Federal Domestic Assistance No. 93.866 and No. 93.865. Awards are made under authorization of sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and administered under NIH grants policies and Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review.

The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

The NIH Grants Policy Statement can be found at

The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

Loan Repayment Programs
NIH encourages applications for educational loan repayment from qualified health professionals who have made a commitment to pursue a research career involving clinical, pediatric, contraception, infertility, and health disparities related areas. The LRP is an important component of NIH's efforts to recruit and retain the next generation of researchers by providing the means for developing a research career unfettered by the burden of student loan debt. Note that an NIH grant is not required for eligibility and concurrent career award and LRP applications are encouraged. The periods of career award and LRP award may overlap providing the LRP recipient with the required commitment of time and effort, as LRP awardees must commit at least 50% of their time (at least 20 hours per week based on a 40 hour week) for two years to the research. For further information, please see:

Illustration 1

Program Director/Principal Investigator
(Last, First, Middle):

(Applicant Organization Only)
Months Devoted to Project INST. BASE SALARY DOLLAR AMOUNT REQUESTED (Omit Cents)
NAME ROLE ON PROJECT Cal. Months Acad. Months Summer Months
PROJECT 1 Principal Investigator        
PROJECT 2          
PROJECT 3          
PROJECT 4          
PROJECT 5          
CORE A (ADMIN)          
CORE B (CLINICAL)          
Core A: 5,500 Core B: 6,400
Proj 3: 27,000 Proj 5: 9,100 Core B: 6,400

SUPPLIES (Itemize by category)
Proj 1: 46,200
Proj 2: 47,800
Proj 3: 16,700
Proj 4: 28,980
Proj 5: 18,400
Core A: $7,000
Core B: 21,000

1trip per project at 2,200 each
OUTPATIENT Proj 3: 5,000 Proj 5: 10,600
OTHER EXPENSES (Itemize by Category)
Proj 2: $22,300 Proj 3: $19,200 Core A:$8.847 Core B: $10,850
$    1,500,000

Illustration 2

Program Director/Principal Investigator
(Last, First, Middle):

(From Form Page 4)
PERSONNEL: Salary and fringe benefits. Applicant organization only. 911,334 953,834 953,834 953,834 953,834
CONSULTANT COSTS 8,900 8,900 8,900 8,900 8,900
EQUIPMENT 42,500        
SUPPLIES 186,160 186,160 186,160 186,160 186,160
TRAVEL 11,000 11,000 11,000 11,000 11,000
OUTPATIENT 15,600 15,600 15,600 15,600 15,600
OTHER EXPENSES 61,197 61,197 61,197 61,197 61,197
DIRECT 263,309 263,309 263,309 263,309 263,309
(Sum = Item 8a, Face Page)
1,500,000 1,500,000 1,500,000 1,500,000 1,500,000
F&A 167,998 167,998 167,998 167,998 167,998
TOTAL DIRECT COSTS 1,667,998 1,667,998 1,667,998 1,667,998 1,667,998

JUSTIFICATION. Follow the budget justification instructions exactly.
Use continuation page as needed.







Illustration 3

Personnel - Position
Johnson - CoPI
Campbell - Tech
Gutierrez - PI
Smith - Lab Asst
Lerner - M.D.
Martin - PI
Patient Coord.
Research Tech II

Illustration 4

Other Support
Federal Support Title Number Total Project Period Current Effort (months)
Johnson ABR Infants Pending 12/05-11/10
Guitierrez Mol. Genetics HG00723 05/06-04/11
Smith Presbycusis AG19056 03/03-02/08
Lerner Otitis Media HD21672 12/04-11/08
Martin Presbycusis AG19056 05/06-04/11
Non-Federal Support  
Johnson Infant Hearing DRF-1616 05/06-04/09
Smith Anatomy AHS-404 02/07-01/12
Smith New Investigator UNIV0027 02/07-01/09

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