Maternal-Fetal Medicine Units (MFMU) Network and Neonatal Research Network (NRN) Frequently Asked Questions (FAQs)

Requests for Applications (RFAs)

MFMU

• RFA-HD-23-016: NICHD MFMU Network: Clinical Centers (UG1 Clinical Trial Optional)
• RFA-HD-23-017: NICHD MFMU Network: Data Coordinating Center (U24 Clinical Trial Optional)

NRN

• RFA-HD-23-001: NICHD NRN: Data Coordinating Center (U24 Clinical Trial Optional)
• RFA-HD-23-002: NICHD NRN: Clinical Centers (UG1 Clinical Trial Optional)

If you have additional questions that are not addressed on this page, please email MFMUNRNFOA@nichd.nih.gov.

FAQs

For Both Clinical Center (CC) and Data Coordinating Center (DCC) RFAs

• Will the government supply a recording of the Notice of Pre-Application Webinars for the MFMU Network and NRN Funding Opportunity Announcements (FOA) (NOT-HD-22-023) presentation for those who were unable to attend on June 8, 2022?
   
  • Unfortunately, we are unable to provide a recording of the webinar; however, the questions and answers from that call are included in this list of FAQs.
     
• How will the protocol concepts be submitted and reviewed?
   
  • NICHD will implement a protocol review process with the goal to further enhance rigor and reproducibility in line with the guiding principles of NICHD-supported multi-site clinical research.
     
  • Proposals from both network investigators and those outside of the networks will undergo NIH scientific review.
     
  • Dr. Robert Tamburro presented a protocol FOA concept to the National Advisory Child Health & Human Development Council on June 15, 2022. View the NIH VideoCast recording at https://videocast.nih.gov/watch=45662.
     
  • On July 27, 2022 NICHD issued a Notice of Intent to Publish (NOT-HD-22-028) with additional details about this process.
     
• Can you give us any additional details on how proposals for future studies will be evaluated?
   
  • This is still under development.
     
• Will the protocols go to an existing study section for review? Will they have a separate study budget to work with?
   
  • The protocols will go to NIH peer review, but we are still developing and working out the details.
     
  • We anticipate that any incoming studies will come in under the upcoming protocol FOA, which will cover study costs.
     
• Will the steering committees have a say in deciding which protocols to approve, especially from outside investigators?
   
  • The steering committee and/or relevant subcommittees will work with the outside investigators, giving input and developing the full study protocols. Once developed, the protocols will then be submitted via the upcoming protocol FOA for NIH peer review and funding decisions.
     
• Will the NRN and MFMU protocol review subcommittees continue to exist in addition to review from outside the networks? If so, will these network subcommittees conduct reviews before or after NIH peer review?
   
  • We anticipate that the protocol development/review subcommittees will continue to provide valuable guidance in assisting both internal and external investigators with development of protocols and budgets. Protocol development/review subcommittee feedback would likely be obtained prior to submission for NIH peer review.
     
• Are animal studies eligible for funding under these RFAs?
   
  • No, these networks are for clinical trials and observational studies in humans.
     
• For the MFMU incumbent CCs and DCCs with current awards under the Limited Competition RFAs (RFA-HD-21-028 and RFA-HD-21-029), should applications for the new RFAs come in as renewals or as new applications? Will the Limited Competition awards continue if a site successfully recompetes for these RFAs?
   
  • Incumbent network awardees should submit their applications as renewals as they are renewals of the last full-cycle RFAs (starting in 2016).
  • Institutions that do not have current network awards should submit their applications as new.
  • If an incumbent site (CC or DCC) receives an award under these RFAs, its award from the Limited Competition will end, to ensure the infrastructure for the old and new awards are not duplicative. The site may request approval to carry over any remaining funds to the new award.
  • If an incumbent site does not receive an award under these RFAs, its Limited Competition award will continue to completion.
     
• Can an institution apply for both a DCC and a CC grant? Can an individual principal investigator (PI) apply as part of both a DCC and CC proposal?
   
  • An institution can apply to be both a DCC and a CC, but it should submit only one application per RFA.
     
  • If one institution does apply for both a DCC and a CC grant for the same network, it will need to do the following:
     
    • Have separate PIs and co-PIs for the two grants.
       
    • Provide details in the management section on how a “firewall” will be maintained between the two, so that the CC team does not become unblinded or have access to study data, Data Safety Monitoring Board reports, etc., during a study and/or prior to when other study investigators gain access.
       
• Can a department chair be an alternate PI? Also, would it be better to have a different multi-PI and alternate PI, or for the same person to serve in both roles? Does this apply to the DCC and CC PIs?
   
  • The alternate PI can be a department chair.
     
  • For multi-PI applications, the alternate PI can be both a multi-PI from the application and a department chair.
     
  • This requirement applies to both the DCC and CC PIs.
     
• Should applications be submitted as “delayed onset” and include a delayed onset studies justification (for multiple studies)?
   
  • Yes, do the following in eRA Commons under “Clinical Trial Optional”:
     
    • Select “Delayed Onset”
       
    • Use an appropriate title
      • For the NRN: “Clinical Trials in Neonates”
      • For the MFMU Network: “Clinical Trials in People of Child-Bearing Age”
         
    • Include a justification
      • Per the RFA, “There is no requirement to submit a protocol.” We, the investigators, acknowledge that ongoing network clinical trials will continue and that new trials may be added. We acknowledge our intent to participate in such trials and to prioritize NRN or MFMU studies over other investigations.
         
  • Note: Once the application is designated as delayed onset, you will not be asked to enter human subject inclusion reporting data.
     
• Should we submit human subject forms for the ongoing studies?
   
  • Only include a form for the previously mentioned "delayed onset" study.
  • For the DCCs, forms for the ongoing studies (and, eventually, new studies) can be added after new awards are issued.
     
• Please confirm that the RFA review criteria noted specifically for clinical trials are not a requirement and that reviewers will be so instructed. For example, are we supposed to include a timeline in the application (a requirement for applications designated as clinical trials required)?
   
  • The FOA is designated as "clinical trial optional," so the clinical trial text insert (including the timeline) that was included is not a requirement unless you were to propose a clinical trial.
     
• Would an otherwise eligible candidate qualify as an early-stage investigator for an R01 award if they are selected as a PI for a Network UG1 award?
   
  • No, a PI for a Network UG1 award would not qualify as an early-stage investigator for other NIH awards (https://grants.nih.gov/policy/early-stage/index.htm).
     
• “Co-PI” and “Alternate PI” are used separately in the RFAs but are listed on the same bullet in the “R&R Budget” section. Could this be two separate individuals; for example, could there be an alternate PI at the main institutions and a co-PI at a satellite site?
   
  • Yes, you could potentially propose separate people. The important thing is to have an alternate PI that can fill in for the main PI, when needed.
     
• For the RFA section on “Experience in Conducting Clinical Trials,” are we only supposed to highlight completed studies, or can we include ongoing studies and studies that have finished the intervention phase and are waiting for follow-up to complete work? Do all studies/trials including those conducted by fellows, for example, need to be included? Do we only include clinical trials? What about observations studies? Biospecimen collection or translational studies?
   
  • Included studies do not need to have been completed between 2016 to 2022 (they can be ongoing) or have publications available. You may also include studies from fellows, but you do not have to include every study. Select what is pertinent for highlighting institution/PI expertise that is relevant to the objective of the application.
     
  • The attachment may include interventional trials, observational studies, biospecimen collection, and/or translational studies that highlight your institution’s clinical research experience in relation to the purpose and objectives of the network.
     
  • For the ongoing concurrent research attachment required for CCs, this should include all studies that will recruit subjects from the “Populations Available for Research” you identified in Attachment 1, including interventional trials and any observational studies that collect biospecimens and/or have more than minimal risk.
     
• For the “Clinical Research Experience” attachment, how will the dates of institutional review board (IRB) approval and first enrollment in studies be used in the evaluation? Many of the trials get IRB approval way before being ready to start.
   
  • If the time from IRB approval to first enrollment for a particular study is long, you may explain in the attachment why this happened.
     
• As for the publication list we are providing, is this related to the trials in the “Clinical Research Experience” table or should the list include all studies that involved pregnant people and/or their infants over that 5-year period?
   
  • The publication list should include any publications related to the studies listed in the “Clinical Research Experience” table, and may also include other publications that show the applicant’s experience in clinical research, particularly related to the purpose and objectives of the network.
     
• Will the NRN’s generic database (GDB) and follow-up studies be funded in the future?
   
  • We anticipate that the GDB and follow-up studies will continue in the next network cycle.
     
• The RFA states that these networks will follow the NIH policy on requiring use of a single IRB. Does our IRB need to supply a letter of support? Are there any recommended letters from hospital/institutional leadership?
   
  • No, you do not need to include a letter of support from an IRB.
     
  • These networks must comply with the NIH requirement for a single IRB (NOT-OD-21-174).
     
  • The PI may choose to have discussions with their site IRB director prior to application to ensure they are familiar with the single IRB requirements.
     
  • For other letters of support, you may want to include letters from:
    • CC maternal-fetal medicine and neonatology departments (required)
    • Satellite site institutions (required if applicable)
    • Clinical and translational science awards grant PI (required if applicable)
    • Other relevant institution departments (pediatric pharmacology, lactation support, etc.) that may provide special support (not required)
       
• How many centers in total will be selected?
   
  • That will depend on how many applications are receive and how many score well, as well as on funding availability.
     
• How will the representation on the steering committee be managed in cases where there are multi-PI applications?
   
  • Per the RFA, each CC and DCC will get one vote on the steering committee per award. If a CC proposes multiple PIs, it will need to designate which PI will be the main attending and voting member on the steering committee; the other PIs on the multi-PI award can fill in when the designated PI is unable to attend.
     
• Would NIH accept cost sharing in the application? Also, would reviewers rate the inclusion of additional staff favorably?
   
  • Cost sharing is not a requirement for the application. We cannot address how reviewers might evaluate added positions or increased time. From our perspective, it would be acceptable.
     
• Should we submit our applications as "new" or "renewal"?
   
  • All CCs and DCCs with current network awards should submit applications as renewals.
  • All institutions that do not have current network awards should submit applications as new.

CC RFAs

Staffing and Budgeting for Personnel

• For the coordinator position, can the full-time role be filled by two people? Can the coordinator and data entry clerk effort (12+6 person-months) be combined and divided between two individuals at different sites in the same center, if both are research coordinators/data entry clerks?
   
  • The main issue is to be sure that the duties of the research coordinator and/or the data entry clerk are covered at all proposed sites. Usually, centers propose one coordinator, but if there are clear management strategies as to what work will be covered by each person, then the level of effort (LOE) can be split.
     
• Can any additional personnel, such as a Bayley Scales of Infant and Toddler Development examiner, have effort on the grant or is it limited to the PI, co-PI, coordinator, and data entry personnel?
   
  • You may include effort for additional personnel as long you do not go over the direct cost budget cap.
     
• For the NRN RFA, can the alternate PI and follow-up roles be filled by one person?
   
  • Yes, these positions can be filled by the same person.
     
• Is the budget for the alternate/co-PI supposed to be 10% each, or 10% total effort (i.e., 5% each)? If we can fit 10% each for follow-up investigator and alternate PI without exceeding the budget cap, is this allowed? Could you clarify if/how the allowed effort for the PI (e.g., multi-PI), additional investigators, research coordinator, and data entry clerk may be split. If awarded, would the PI be able to redirect funding to support another co-investigator associated with the center, so long as committed effort for the PI remains the same (e.g., committed 10% full-time equivalent remains constant, but monies are used to support a different investigator on the team)?
   
  • The RFA states that the “alternate/co-PI, additional investigator, or additional PI support” be up to 1.2 person-months (10%) effort. This is 10% total, but may go up to the budget cap.
     
  • The main issue is to have all duties and responsibilities outlined in the RFAs covered by staff with appropriate qualifications. The LOE listed in the RFAs is what we believe is needed to successfully do this. If applicants change the LOEs proposed from those previously listed, they need to show in their staffing proposal and management plan that these duties and responsibilities are covered by staff with appropriate qualifications.
     
  • After award, the funding received must be used to support the network, as needed. That said, the PI is expected to play an active role in the network and at their site(s) for study development, recruitment, implementation, management, results analysis, and publications. The research coordinator(s) also play a major role in making this happen, as is apparent from the LOE listed.
     
• Which staff positions in the RFA require submission of a biosketch? Is it just the key personnel (PI and alternate/co-PI), or also others?
   
  • Please include biosketches for the following positions:
     
    • PI
    • Co-PIs/alternate PI
    • Follow-up PI (for the NRN RFA)
    • Research coordinator
       
  • You are welcome to include additional biosketches for other team members (e.g., additional specialists or other significant contributors), but it is not required. These may be uploaded in the Senior/Key Personnel profile section.
     

Satellite Sites

• If a proposal includes a satellite recruitment site, do we need to replicate the same hiring at the satellite? For example, would each satellite site need to include a research coordinator and data entry personnel?
   
  • No, you do not have to replicate the same hiring structure at a satellite site. You do need to describe in the management plan how the staff you do propose will provide recruitment, study implementation, data entry, follow-up, and other coverage needed at the satellite site.
     
• Does data from a satellite site need to be submitted from the satellite site or from the primary site, or is it flexible for the sites to decide?
   
  • This can be flexible, with either the satellite or primary site submitting the data. However, the primary site is responsible for ensuring data quality and timeliness of data entry. It may need to set up regular checks of data entry, and train satellite site staff in data entry and protocol implementation. The primary site also is responsible for ensuring that all data queries or requests from the DCC are addressed in a timely manner.
     
• If we want to add a satellite site, what types of contracts or agreements need to be in place at the time of grant submission?
   
  • You do not need to have a formal agreement in place at the time of grant submission, but you will need to include a Letter of Support from the satellite site indicating their commitment to join the grant (view the “Research Plan” section of the RFA for details on what to include in the Letters of Support).
     
• In the past, there was some limit on distance between the main CC and any satellite sites. Are there any geographic requirements? For example, would it be acceptable if the sites are not in the same state?
   
  • There is no geographic location requirement for satellite sites.
     
  • Provide justification for the site(s) chosen.
     
  • The main concern is whether the CC can effectively manage and oversee the proposed satellite sites.
     
• We have enough patients and an appropriate research track record to submit an application, but I am looking for guidance on the potential benefits or risks of adding an ancillary site, particularly one that does not have a track record of NIH-funded neonatal research.
   
  • Applicants can include such satellite sites. In the application, you can provide justification for adding the site(s), such as increased access to relevant populations, enhanced participant diversity, broader geographic catchment area, and so forth. In the management strategy section, you will need to describe how the main center will provide the adequate training, assistance, quality assurance monitoring, and oversight for the ancillary site(s), particularly regarding each site’s current capabilities.
     
• How will geographic diversity be assessed in terms of nearness to existing CCs?
   
  • This will be assessed more at the network-wide level, than at the individual application level, looking at the well-scoring applications to ensure that the CCs awarded provide geographic spread across the United States, as well as racial and ethnic diversity in the “Populations Available for Research.”
     

Attachments

• For Attachment 1, “Populations Available for Network Studies,” the name for this attachment exceeds the 50-character limit. What should we do?
   
  • You can abbreviate the titles for the attachments to fit within the system limits, but please try to make the contents clear with your abbreviations.
     
• The MFMU Network CC RFA instructions indicate that “Centers are required to have a minimum of 3,000 deliveries per year, at least 30% of which must be high-risk pregnancies. A large majority of patients with obstetric complications must also receive prenatal care at the sites.” Should the 30% high-risk patients be of the total deliveries or of those receiving prenatal care from the site? How do you define “high-risk” pregnancies?
   
  • The requirement is to have a minimum of 3,000 deliveries per year, at least 30% of which must be high-risk deliveries. Please list the percentage for each hospital. You may also note the percentage for the center as a whole.
     
  • The RFA does not provide a specific definition for high-risk pregnancies, as it does not require a specific number or percentage of every possible category of “high-risk.” This could include patients with pre-existing conditions (e.g., cardiac conditions), those with pregnancy complications that endanger the pregnant person and/or fetus, either during gestation or during labor and delivery, or post-partum.
     
• Can you clarify how to define people with disabilities when reporting on our population?
   
  • Per NOT-OD-20-031, individuals with disabilities are defined as “those with a physical or mental impairment that substantially limits one or more major life activities, as described in the Americans with Disabilities Act of 1990, as amended.”
     
• For the MFMU RFA, the “Populations Available for Research” requests the number of ultrasounds performed. Does this include obstetric and gynecology sonograms or just obstetric ultrasounds?
   
  • Because the MFMU Network is focused on obstetrics, please include only obstetric sonograms/ultrasounds.
     
• For the MFMU and NRN RFAs, the “Populations Available for Research” asks for antepartum admissions versus obstetrical admissions. Are antepartum admissions only those admitted and not delivered during that admission? What about those women who are admitted for days or weeks before a preterm delivery? These may ultimately deliver during that stay, but it could be some length of time.
   
  • Antepartum admissions should count patients who are admitted for pregnancy issues, but who did not delivery during that admission.
     
  • Obstetrical admissions are those that result in delivery.
     
• The NRN CC RFA states an expectation of at least 500 Neonatal Intensive Care Unit (NICU) admissions yearly at each CC, with more than 70% inborn. Is 70% a firm number?
   
  • NICHD has issued a notice of correction for this statement (NOT-HD-22-024).
     
  • CCs are expected to have the following:
     
    • A minimum of 500 NICU admissions per year with a minimum of 350 of those NICU admissions being inborn
       
    • For CCs with more than 500 NICU admissions per year, having 70% of them inborn is preferred, but not required
       
• For the NRN CC RFA, are the last three rows of the "Populations Available for Study" table ("neonatal deaths per 1,000 births," "follow-up clinic visits at 24 months corrected age," and "follow-up clinic visits at 5-7 years of age") only for inborn infants < 29 weeks? Our follow-up clinic sees all infants < 32 weeks plus term babies with hypoxic-ischemic encephalopathy, seizures, gastrostomy tubes, and so forth. Should we only put the numbers for infants < 29 weeks in the table? In addition, we only follow children to 5-7 years in our NICU follow-up clinic when they are in trials. Should we include the research visits in that number?
   
  • The last three rows of this table should include all infants. This can include research visits.
     
• For the NRN CC RFA “Populations Available for Study” table, how are you defining “symptomatic patent ductus arteriosus (PDA)”? The NRN’s ongoing PDA trial is using oxygen support, but we typically do not use that in the first week or so, as 99% of our babies are on oxygen at this elevation. We use physical symptoms such as bounding pulses, pulmonary hemorrhage, and unstable blood pressure. Later, we may look at inability to wean oxygen support. Should we use the PDA study’s definition? Also, how are you defining bronchopulmonary dysplasia (BPD)?
   
  • We recognize that different hospitals may categorize PDA and BPD differently. For these numbers, please include any infants diagnosed with these conditions based on your institution’s local protocols.
     
• For the “Special Strengths” attachment, can you please add more specific information regarding the mentioned “Pediatric Pharmacology Resources,” “Lactation Support,” and “Clinical and Translational Science Awards (CTSA) Support”? Is CTSA support required for MFMU studies or just pediatric studies? What exactly are you looking for?
   
  • If an applicant has any special resources related to pediatric pharmacology, lactation, or other relevant available resource, please describe these in your application. This might include any investigational pharmacy special resources or pharmacokinetic/ pharmacodynamic experience. Also, if your institution has conducted any lactation studies and/or has a lactation support research group, you may describe this in your application.
     
  • If an institution has a CTSA, these grants may provide support for adult trials (including pregnancy). They also have a special provision to provide support for pediatric trials. The network RFAs ask what support those grants will provide to network studies.
     
• For Attachment 4, “Clinical Research Experience,” should incumbent MFMU centers include studies since submission of their Limited Competition awards in 2020 or since 2016?
   
  • Because these RFAs are renewals of the 2016 RFAs, the information should go back to 2016. This also will ensure that both incumbent and new centers are submitting the similar sets of information for peer review.
     
• Attachment 5, "Clinical Center Facilities," includes a bullet point for "Level III medical and surgical subspecialties." Does this refer to total hospital subspecialties (for example, neurology, neurosurgury, trauma, oncology, etc.), or is it specific to NICU specialties?
   
  • Yes, this refers to the NICU and its specialties. For this attachment, however, you may include other hospital specialists relevant to the purpose and objective of the network.
     
• For the NRN CC RFA Attachment 5, "Clinical Center Facilities," what types of facilities or capabilities would be related to "intrapartum diagnosis and laboratory testing"?
   
  • "Intrapartum diagnosis and laboratory testing" refers to diagnostic capabilities to help manage pregnant people and infants with complications during labor and delivery, such as rapid testing for chorioamnionitis, respiratory failure, sepsis, preeclampsia, etc.

Research Plan

• For programs applying for the first time, it would be advantageous to understand the goalposts for follow-up completion, but this isn’t spelled out in the FOA. Can you please clarify?
   
  • We expect high follow-up rates, particularly for intervention trials, as neurodevelopmental follow-up is often a primary or key secondary outcome. We understand that for sites with more rural catchments this can be challenging. We also understand that during the pandemic, it has been difficult to bring infants back for non-clinical visits.
     
  • In your application, we suggest you describe the challenges your institution has faced in recent years and how you will work to improve your follow-up rates (e.g., conduct home visits, provide extra reimbursement for extensive travel costs, do more frequent and innovative patient tracking).
     
• The RFA instructions for the “Multiple Program Director/PI Leadership Plan” are the same as for the “Management Plan.” Please clarify.
   
  • Generally, multiple PIs are proposed from different institutions. A leadership plan should lay out how roles and responsibilities will be divided between the team members.
     
  • The management plan needs to detail how oversight will be conducted for any satellite sites.
     
• For the RFA’s "Enrollment of Diverse Populations" portion of the research plan, it's unclear what the second sentence means: “Without duplicating information requested in 'Population Available for Studies,' please describe how the CC will recruit participants from various racial and ethnic groups. For the ongoing network studies mentioned in Section 1, applicants must provide a breakdown of eligible populations."
  
  Attachment 1, Table 2 requires applicants to provide a breakdown of total number of NICU inborn admissions <29 weeks GA for 2021 by race and ethnicity, which is what it seems like the RFA is asking to be put in the research plan, but it also says not to duplicate Attachment 1. What other information should we include? The overall racial/ethnic breakdown of our catchment area?
   
  • These two sentences in the RFA are requesting two different pieces of information:
    • For “describe how the CC will recruit participants from various racial and ethnic groups,” this should be a narrative about your institution’s strategies to reach and recruit from different racial and ethnic groups.
       
    • Related to the second sentence, “For the ongoing network studies mentioned in Section 1, applicants must provide a breakdown of eligible populations,” for each of the network’s ongoing studies listed in the RFA’s Section I, Ongoing Studies in the Neonatal Research Network, please include information on your institution’s estimated annual eligible participants.

Review Criteria

• Are the standard project review criteria for “Significance,” “Investigator(s),” “Innovation,” “Approach,” and “Environment” not applicable and superseded by the RFA-specific criteria?
   
  • View Section V of the RFAs. The standard review criteria for these sections still apply, including specific criteria for these FOAs.
     
• The RFA states the following: “When developing applications for this FOA, please follow the headings and subheadings outlined in this section to ensure that all requested information is included and to streamline the study section review process.” Under what section should these headings and subheadings go?
   
  • We suggest that applications are structured according to the standard review criteria in Section V and that the subheadings in Section IV (“Staffing and Management,” “Management Plan,” etc.) be incorporated under the relevant standard review criteria sections.

DCC RFAs

• Will DCC costs be included in the protocol FOA grants? What needs to be budgeted for in this RFA’s applications?
   
  • DCC infrastructure budgets need to cover the staffing needed to complete the ongoing trials listed Section I of the RFAs and implement new ones. During the next project period, NICHD expects both the MFMU Network and the NRN to conduct approximately 5 to 10 trials.
     
  • The DCCs also will need to provide support for general network operations, protocol concept development, and manuscript preparation. DCCs should be staffed accordingly.
     
  • The protocol FOA under development is intended to cover study costs only. Budgets submitted in response to the protocol FOA will be reviewed on a case-by-case basis as part of the rigorous pre-application process.
     
• Does the DCC PI need to have a Ph.D.?
   
  • A Ph.D. is not required. The proposed individual must have “the skills, knowledge, and resources necessary to carry out the proposed research.”
     
• Can the effort for the PI and alternate PI be split up differently?
   
  • The PI and a co-PI may split the combined minimum of 11.4 to 15.6 person months effort required for the DCC activities.
     
  • If a different split than previously listed is proposed, please describe in the management plan how the roles and responsibilities will be split between the two.
     
  • The PI is still expected to play an active role in DCC management and network activities.
     
• Is the amount listed for the DCCs under “Funds Available and Anticipated Number of Awards” for total estimated costs or direct costs only?
   
  • The amounts listed are for total estimated costs.
     
• The DCC RFA states, “If the applicant’s institution is also submitting an application for the NICHD Maternal Fetal Medicine Units (MFMU) Network: Data Coordinating Center RFA (RFA-HD-23-017), the applicant must describe how the MFMU and NRN Network programs will streamline processes and promote interdisciplinary teamwork.” Does this mean that NICHD wants institutions to apply for both DCCs?
   
  • Institutions do not need to apply to both the MFMU and the NRN DCC RFAs.
     
  • If they choose to do so, then we ask that they describe how the institution would streamline and synergize their processes as a DCC for both networks, should they be awarded both grants.
     
• Which DCC staff positions in the RFA require submission of a biosketch? Is it just the key personnel (PI and alternate/co-PI), or also the biostatisticians and others?
   
  • Please include biosketches for the following positions:
    • PI
    • Co-PI
    • Biostatisticians
    • Programmers
       
  • You are welcome to include biosketches for other team members, but it is not required. These may be uploaded in the Senior/Key Personnel profile section.
     
• This is regarding the “Are Human Subjects Involved?” question on the R&R Other Project Information form and subsequent PHS Human Subjects and Clinical Trials Information form. Given that the DCC provides protocol development, study design, data management, statistical analysis, and other related services but has no direct contact with study participants, please confirm that NICHD agrees that DCC offerors can select "no" in regard to human subjects not being involved in this work.
   
  • DCC applicants should respond "yes" to "Are Human Subjects Involved?" While the DCC will not have direct contact with the study participants, it may need to set up single IRBs for studies, and it will need to report network-wide enrollment data for NIH-required inclusion reports.
     
• The third paragraph of the R&R Budget: Protocol Costs section states "applicants should not include specific study expenses, such as capitation, IRB setup and management, etc., in this budget; they will be included in separate protocol budgets requested at a future date."
  
  Can NICHD please clarify whether it considers the following types of costs to be "specific study expenses" and thus not included in this base budget: data management/electronic data capture system costs; interactive response technology system/randomization system costs; language translation costs for study materials (e.g., protocol, informed consent form (ICF), etc.)?
   
  • For DCC budgeting purposes, the data management system and randomization system costs should be included in this base budget for the assumed 5-10 studies anticipated. If a study will require special data management systems (e.g., for the U.S. Food and Drug Administration's investigational new drug applications), these may be included in the upcoming protocol RFA applications. Language translation costs for study materials (e.g., protocol, ICF, etc.) would be consider part of the protocol budgets, not part of the base budget.