These FAQs apply to the following notice of funding opportunity (NOFO):
Senator Paul D. Wellstone Muscular Dystrophy Specialized Research Centers (MDSRC) (P50 Clinical Trial Optional)
Frequently Asked Questions
What does it mean to be “new to the field”?
“New to the Field” is being interpreted as an NIH experienced investigator who is new to muscular dystrophy research as demonstrated by funding history. This includes, but is not limited to, having been a PI or mPI, primary recipient or subcontract, on a muscular dystrophy grant as determined by Research, Condition, and Disease Categories (RCDC) coding and/or PI or Co-PI of a muscular dystrophy grant supported by private funding, primary recipient or subcontract, research project or training/career development award.
Can the NI/New to the field be an MPI for a Scientific Project?
Yes, the leadership of the scientific project can be a multiple leadership team including the NIH-defined New Investigator and an experienced MD researcher. This would fulfill the requirement of having an NI or New to the field PI.
Can the NI/New to the field be a PI or MPI to the Training Core, the Resource Core or the Administrative Core?
The Training and or Resource Core PI may be an NIH-defined NI or new to the field, but this does not fulfill the requirement of having an NI or New to the field PI. It is not advised to have an NIH-defined NI or an experienced but new to the field PI as PI or MPI of the Administrative Core, in addition this would not fulfill the requirement of having an NI or New to the field PI.
If I am an NIH-defined ESI or NI will I lose my ESI or NI status as MPI of the scientific project?
No, you do not lose your ESI or NI status as MPI of a scientific project.
What information is required in section 2.5 the "Recruitment and Retention " attachment, in addition to that described in the standard instructions for this attachment?
- Describe how the proposed recruitment and retention plan is designed to overcome obstacles to study participation. Recommended strategies to overcome obstacles to study participation and promote greater diversity are described on the website of the Muscular Dystrophy Coordinating Committee.
- In addition to the primary plan for recruiting sex/gender, racial, and ethnic group members, provide alternative/back-up strategies to be used if enrollment significantly deviates (more than 20% of any category for each annual milestone) from the planned numbers according to sex/gender, race or ethnicity. Back-up plans may, for example, propose to add research sites with access to additional individuals that are underrepresented in the enrollment.
- Describe what other research studies may be competing for recruitment of the same patient population at the same clinic sites that are proposed in the application. Describe plans for communicating to potential study participants the options available to them.
- For renewal applications, describe the actual enrollment (total and by sex/gender, race and ethnicity) from the previous grant term relative to the planned enrollment at the beginning of that term. Describe any obstacles encountered in recruiting and retaining appropriately diverse cohort(s) of participants in the previous grant term and how the plans moving forward benefit from previous lessons learned.
What information is required in section 2.4 the "Inclusion of Women and Minorities" attachment, in addition to that described in the standard instructions for this attachment?
- Provide data if available on the demographics of individuals affected by the condition under study in the catchment area for the clinic sites proposed in the application.
- Provide annual milestones for enrollment including numbers by sex/gender, race and ethnicity.
- Identify the person/people in the research team that will carry out the proposed outreach and their qualifications or relevant abilities such as fluency in languages other than English.
- Please refer to Strategies to Promote Diversity in Muscular Dystrophy Research Participation