Mechanism Principal/Co-Investigators Concept Protocol Budget Cooperative Agreement Roles and Responsibilities Review
A U10 is a Cooperative Clinical Research award. Unlike clinical research supported by investigator-initiated R01 grants, these research protocols are designed and executed in a cooperative manner amongst several different institutions. There is also substantial involvement of NIH Program Staff in the research. Usually, the site Principal Investigators and NIH Program Staff participate in an oversight Steering Committee that is responsible for prioritizing the research and designing protocols. U10 grants cannot be submitted without a specific solicitation, so there must be a Request for Applications published in the NIH Guide asking for the proposals.
Applicants should address these aspects in the Research Plan section of the PHS 398. It is suggested that the research plan be structured as outlined in the RFA and not by using the headings designed for basic research projects (e.g., Specific Aims, Background and Significance, etc…).
There is no specified page limit for the proposal; however brevity and clarity of language are always appreciated. The applicant must address the elements outlined in the RFA.
While the RFA does not specify that the co-investigator hold an MD degree, they must be able to demonstrate clinical expertise in reproductive medicine. NIH’s interpretation is that the co-investigator must therefore evaluate and treat patients, either currently or in the recent past. The intent is to bring the clinical perspectives of reproductive diseases and disorders of both genders into the Network.
Only if that individual possesses clinical experience and expertise as described above. We are not looking for those individuals with Ph.D.s whose only clinical experience is the evaluation of semen and embryos derived from IVF treatments.
Yes—the RFA only stipulates that this co-investigator be doctoral level and does not specify the particular degree. The key thing is to be able to demonstrate that the proposed co-investigator possesses the appropriate statistical/epidemiological expertise.
Yes, in general. While we would prefer experience in cooperative, multi-site RCTs, industry-sponsored trials could provide the Principal Investigators with the appropriate expertise to demonstrate their ability to be a part of the RMN. The specific roles of the PI and the presentations/publications that resulted from the study should be adequately described to give the review committee an idea of the PI’s clinical research experience and be able to evaluate them appropriately.
Yes, there may be co-Investigators for the DCC. The application should clearly spell out the roles and responsibilities of each co-Investigator, if different, and how the lines of communication will be established and maintained during the project so that each co-I is continually up-to-date on what is happening in the Network.
If he/she can be considered key personnel or a significant contributor, then he/she must provide a biosketch for the application. For the definition of key personnel/significant contributor, please refer to the PHS 398 instructions found at: http://grants.nih.gov/grants/funding/phs398/phs398.html.
Within the 10-page limit, the applicants must address Human Subjects and Vertebrate Animals (if applicable) as described in the PHS 398 instructions. The bibliography will not be counted towards the 10 pages.
Yes. Please address the proposed patient population and all points articulated in the PHS 398 instructions for Human Subjects.
It depends. NIH can only support research that does not conflict with the proscriptions described in the Dickey-Wicker amendment to NIH’s appropriations. Generally, the proposed research must not involve any invasive assessments of human embryos, cannot involve eggs that have been previously exposed to sperm, and cannot harm or destroy human embryos. You may propose research on eggs that have not been exposed to sperm, noninvasive studies on discarded culture medium, and noninvasive microscopy and assessments of human embryos. While outcome studies are not a priori excluded, each protocol will need to be evaluated on an individual basis to ensure that the proposed research adheres to the current guidelines.
No, please do not include a budget for the concept protocol. The purpose of the concept protocol is to provide the reviewers a means to evaluate your ability to design a clinical research project.
Yes, as long as the study necessitates a large subject population and a multi-site approach.
Possibly. The protocols that are initiated by the RMN are agreed upon by the entire Steering Committee and approved by the Data and Safety Monitoring Committee (DSMC). During the initial Steering Committee meetings, concept protocols will be discussed and prioritized. If sufficient members of the Steering Committee agree that the concept warrants a full protocol, then the Principal Investigator will expand the protocol for full consideration by the Advisory Board and DSMC.
Yes, the concept protocol must be a new study. For competing continuation applicants, the study must not be one that has been previously considered by the current Network. For new applicants, it cannot be a study that has previously been considered by NIH or other public or private funding agencies.
The RMN’s protocol costs will be managed under a capitated system. In this scheme, each clinical site will receive a base budget, covering primarily personnel costs, each budget year. Once protocols have been approved and initiated, the RMN Steering Committee will establish a “cost per subject” for particular protocols. Each site will inform NIH and the Data Coordinating Center (DCC) of their expected protocol enrollment for the coming budget year and they will be awarded monies for each subject based on the cost per subject. If the site exceeds their enrollment, more funds will be disbursed mid-budget year. The funds will be disbursed through the DCC to the sites. Monies are only awarded for randomized subjects.
For budget purposes, the Principal Investigator and the other clinical co-Investigator must attend the Steering Committee meetings. You should also budget for the nurse coordinator to attend as well, although his/her attendance is not required.
Yes, this is possible and, perhaps, preferred for some clinical sites that need to expand their available patient pool. However, there can only be a single named applicant institution on the face page—the collaborating institutions will need to be considered sub-contracts to the applicant institution.
All applicants should prepare a non-modular budget.
Yes, for purposes of calculating the total direct costs of the grant. However, if the total directs exceed $200,000 for clinical sites and $500,000 for the data coordinating center only by the amount of the sub-contract indirects, then the application is still acceptable. More details on this policy can be found at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-05-004.html.
Applicants should budget for at least 4 meetings in Bethesda each year for at least two persons—the Principal Investigator and the co-Investigator with expertise in the opposite gender. Additionally, it has been common practice for the nurse coordinators to attend at least two of these meetings with the PI, so it would be a good idea to budget for 3 persons for at least two of the annual meetings.
No, those costs will be borne by the NICHD.
The NIH Project Scientist is the individual at NIH that will have substantial involvement in the design and prioritization of the research. This person participates as a voting member of the Steering Committee and may have his/her name on Network publications. The NIH Program Officer is the individual who performs the usual stewardship role associated with a grant award. They receive and review the annual progress reports to ensure that government resources are being used to support the approved project. They do not participate in the Steering Committee as a voting member, but do generally attend the meetings to stay abreast of the Network’s progress.
The applications that are submitted in response to this RFA will be reviewed by a Special Emphasis Panel convened by the NICHD. The applications will not be reviewed in any currently standing study section. The applications will be reviewed as a group and each application will receive a priority score. The applications will not be percentiled.