PROSPR Frequently Asked Questions

As defined in the RFAs, a healthcare system is “…a collection of primary and specialty care clinicians and support staff, medical facilities, and organizational structures which together provide the environment for the comprehensive delivery of healthcare services related to the cancer screening process, from determination of screening eligibility through treatment of benign precursor or malignant disease diagnosed as a result of screening.” For the purposes of these RFAs, this definition can be interpreted broadly (i.e., a system does not necessarily need to represent a distinct corporate entity). However, a “system” should have common organizational characteristics and unifying features that can be compared and contrasted with the other systems in the PRC, as part of the PROSPR research program.

Yes. There is unlikely to be a set of participating health systems that can achieve a perfect balance of heterogeneity in health care environments and diversity of patient populations. You should, however, select your health systems so that you can address the most important research gaps for screening for the cancer of interest, and include different types of healthcare environments and diverse patient populations. Inclusion of racial/ethnic minority and/or other medically underserved populations, as well as a variety of environments in which care is delivered (e.g., managed care, safety-net settings, primary care networks) are factors which will impact how your application is scored.

Yes, for the cervical- and colorectal-focused PRCs. A minimum number of eligible patients was required to increase the types of research that could be conducted as part of PROSPR 2. For the lung cancer-focused PRC, the 50,000 patient minimum applies to those who are age-eligible for screening; many of these individuals may not be eligible to be screened for lung cancer based on their smoking history. See also NOT-CA-17-004.

There is not a restriction against health systems affiliated with cancer centers, medical schools, or other academic settings participating in PROSPR 2. However, you would need to make the case in your application that your choices of systems do include patients seen in community settings, and that the 3 or more healthcare systems were well-chosen to address the most important research gaps regarding the cancer screening process in community settings.

Yes, as opposed to appendiceal materials, reviewers are required to examine the information you provide in your other attachments.

No. Some PROSPR 1 data may become part of PROSPR 2, if participating health systems were also part of PROSPR 1. However, it is not the responsibility of the PCC to coordinate the data sharing process if a research collaboration only involves PROSPR 1 data.

Yes, as stated in the terms and conditions section of the PCC RFA, the PCC is responsible for coordinating both the twice-yearly in-person meetings and twice-monthly teleconferences. It is anticipated that additional working groups focused on specific tasks (e.g., screening quality, system factors) will also form, and the PCC will be responsible for providing administrative support to these groups as well.

There is no specific requirement to have a central data repository housed at the PCC in PROSPR 2. The PCC is responsible for data analysis for research projects that include more than one PRC. How this analysis is conducted (i.e. centrally versus distributed) is to be negotiated between the PRCs and the PCC, and different approaches may be taken for different projects depending on the needs of the analysis.

Yes, there is no restriction against this. However, healthcare systems may not participate as data-contributing sites in more than one PRC application focused on the same cancer type (e.g., could not be data contributing sites for 2 distinct cervical applications).

No. As stated in the RFAs, foreign institutions are not eligible to apply. Furthermore, because the intent is to study cancer screening delivery in the U.S., all participating health systems must be providing care to patients in the U.S.. Foreign investigators may participate as co-investigators in PROSPR applications, as permitted by NIH grants policy.

Generally, responsibility for the conduct of single cancer type projects will lie with the relevant PRC. If, however, an external collaborator is working on a single cancer type research project, the PCC may become involved in their role as overseers of PROSPR 2 data sharing policies and procedures; the PCC is tasked with developing, implementing, and overseeing these policies.

Per the PRC RFA, interventions are meant to be focused on one cancer type, and developed and pilot-tested within individual PRCs. However, as part of their trans-PROSPR research program, should multiple PRCs and the PCC wish to collaborate with one another in developing an intervention focused on more than one cancer type, there would be no restriction against this.

Both the PRCs and the PCC are expected to reserve funds in their budgets to conduct Trans-PROSPR research projects; the PRCs should additionally reserve funds for intervention development and pilot-testing. Note that the structures dictated by both the PRC and PCC RFAs include a required Trans-PROSPR research section where the funds for Trans-PROSPR research should be budgeted; intervention development and pilot-testing is a subsection of the PRC Research Program. You should plan to include investigator time and other expenses needed to participate in trans-PROSPR research in these sections of your application. Because the nature of this research is such that the specific projects to be conducted are unknown at the time of the application, there may be a need for some rebudgeting during the course of the funding period, in order to meet the needs of specific trans-PROSPR projects and intervention(s).

You should provide one budget with a breakout justification as to what is being spent on each of the subsections. In your budget justification section, you should include both: (1) a table that summarizes the direct and indirect costs for each structural/functional unit by year of the grant; and (2) a narrative description of how investigator time and other expenses break down by core, e.g., "Dr. _____ will spend X calendar months for admin core functions, including…, Y calendar months for data acquisition unit functions, including…", etc. This breakdown is needed based on the fact that both the UM1 and U24 mechanisms are officially considered “single component” applications, but we wanted reviewers and NCI staff to better understand how investigator time and other resources would be allocated for different PRC functions, to inform the review.

The intent of having budget breakouts is to have you provide information about what proportion of the entire budget would be spent on the various cores/activities associated with your center’s work. As such, this information should be provided for both the prime site and the subcontracts.

As stated in the RFAs, “…there is an expectation that PROSPR investigators make data and scientific resources available to external investigators for research purposes.” However, there is no prescribed approach by which data sharing will be accomplished. In fact, one of the tasks of the PCC is to lead the development, implementation, and oversight of a data sharing process, to ensure that external investigators can propose research ideas that would be considered and approved (or not) by the PROSPR Steering Committee. This process will be developed with the active involvement of both the PRCs and the NCI. Applicants should be aware that NIH data sharing policies are evolving rapidly, in order to promote increased sharing. Funding decisions will be dependent on the ability and continued willingness of all participating organizations of the PROSPR center to comply with NIH data sharing policies.

There will be one single panel, with appropriate expertise to cover screening for all 3 cancer types.