If you are conducting NIH-funded research that involves human subjects, or are considering applying to NIH for support of such research, we want to call your attention to important changes that may affect how you:

• select the right NIH funding opportunity announcement
• write the research strategy and human subjects sections of your application
• comply with appropriate policies and regulations

First, familiarize yourself with the new PHS Human Subject and Clinical Trial Information form. For application due dates of January 25, 2022, and beyond, you will be required to use an updated application forms package (FORMS-G), which includes the new human subject and clinical trial form. This form requests human subject and clinical trials information at the study level using discrete form fields, which is a change from current practice. Contract proposals will also require this information. Learn about the new form here.

Second, take a moment to answer these four questions about your current or proposed research:
1) Does the study involve human participants?
2) Are the participants prospectively assigned to an intervention?
3) Is the study designed to evaluate the effect of the intervention on the participants?
4) Is the effect that will be evaluated a health-related biomedical or behavioral outcome?

If the answer to all four questions is yes, then your proposed research meets the NIH definition of a clinical trial. Clarified and broadened in 2014, the definition encompasses a wide range of trial types: mechanistic, exploratory/developmental, pilot/feasibility, behavioral, and more. NIH expanded the clinical trial definition in response to widespread calls from diverse stakeholders for improved reporting of research milestones and outcomes, and for assuring maximal transparency. Need help determining whether your study would be considered by NIH to be a clinical trial? See our webpage on the definition that includes case studies, FAQs and other resources that can help. Still unsure? Contact your NIH program official or the scientific point of contact listed on the funding opportunity announcement to which you are applying.

Third, familiarize yourself with NIH policy changes related to enhancing stewardship of clinical trials. NIH made a number of policy changes to improve the stewardship of clinical trials across the life cycle of the trial. We encourage you to familiarize yourself with all that is changing, including:
• the requirement to apply to an FOA that specifically allows for the submission of clinical trial applications for due dates beginning January 25, 2018.
• Good Clinical Practice training expectations for NIH staff, grantees, and contractors that went into effect January 2017.
• updated peer review criteria that will be included in FOAs for clinical trial applications and solicitations for due dates on/after January 25, 2018.
• new Human Subject Information form requirements for clinical trials that will be included in updated application forms (FORMS-G) for due dates on/after January 25, 2018, and contract solicitations published as of January 25, 2022.
• use of a single IRB for non-exempt, multi-site clinical trials for application due dates on/after January 25, 2018.
• expanded ClinicalTrials.gov registration and reporting to include all NIH supported clinical trials.

Improving the design, efficiency, and transparency of clinical trials is important because it:
• respects our ethical obligation to participants to maximize the use of the knowledge from the trials in which they participate
• facilitates design of clinical trials while reducing unnecessary duplication
• promotes broad, timely, and responsible dissemination of research information and results
• fosters responsible stewardship of the public’s investment in biomedical research

We have developed a new Clinical Trial Requirements for NIH Grantees and Contractors web page to bring together all the information you need to know. Please review this information carefully. Your attention to detail will be critical to ensuring successful funding of your clinical trial awards. We will be putting out a series of reminder policy notices, training opportunities, and other resources in the NIH Guide to Grants and Contracts, in the NIH Extramural Nexus, and on this blog. The success of clinical trials relies on the public trust in scientific rigor and ethical oversight. We all play a critical role in this process. We are most grateful to you for your help and support.

Q: What types of feedback does the CFAR Developmental Review Committee give to applicants?
A: There are definitely themes that we frequently see across applications, disciplines, and years.  Common positive feedback includes:

Project is signifigant, scientifically interesting

The proposal includes strong mentors

The hypothesis is plausible and novel

Common negative feedback includes:

The proposal and intervention are too ambitious

PI needs guidance with methods

The analysis plan was lacking

The sample size is too small

No power calculations were discussed

The intervention may be too diffuse

No clear path to follow-up NIH funding

Much of the negative feedback could be avoided by active engagement with the PI’s mentor during the application process.  In addition, both the CFAR Biostatistics Core and Sonia Napravnik of the CFAR Clinical Core are willing to assist applicants with their methodology and/or analysis plans.  The Social and Behavioral Science Core is also willing to help by looking at intervention ideas and social/behavioral methodology.  We strongly recommend applicants utilize these resources before submitting their proposals – applications that have been through these steps prior to final submission tend to be more competitive.

Q: A mentor sounds useful.  How do I get one of those?

A: If you have one or more already, feel free to use them.  We understand the value of a mentoring team that may include a senior investigator who specializes in the science or methodology utilized by your proposal, another who knows your population or topic area, and perhaps another who has your dream career and can help you plan how to achieve one just like it.  If, however, you have not yet found a mentor that is a good fit for you and your research goals, don’t worry – we can help!  We could probably make some recommendations based on a conversation with you, but it would be even better if you had some ideas already.  We suggest that you go to the NIH RePORTER and search for investigators based on location (ideally UNC, FHI, or RTI), topic area (e.g., HCV and HIV, medication adherence and HIV, or whatever you are interested in), and NIH Institute that you think is the best fit for you.  After all, wouldn’t it be great to have a mentor that already knows the project officers, interests, quirks, etc., of your favorite Institute?  If they have already figured out how to succeed in your area and Institute, they might be a good person to seek out for advice.  Find a few people that fit those criteria if you can, and then email us with those names.  We’ll facilitate your interactions with them and see if we can’t help get you one of those useful mentors.

Tips on choosing a mentor from NIH: https://www.niaid.nih.gov/grants-contracts/tips-choosing-mentor

Q: Are overhead/indirect costs or PI salary support allowed in the Developmental proposal budget? [THIS POLICY HAS CHANGED]

A: It is our policy not to provide indirect costs at research-based colleges or universities. The UNC SOM similarly donates their share of the indirect costs back into the Award funds to maximize their reach.

However, PI salary support is now allowed for ALL ESI applicants. The amount should be carefully considered and thoroughly justified, and fall within the total budget limitations. As the application and amount of time that the applicant needs to be devoted to the proposed project is being developed, keep in mind that 10% LOE equals one half day a week, and 20% LOE equals one full day a week, and prepare the budget justification accordingly. Applicants are not required to request salary support and all justifications including salary support will be thoroughly reviewed.

Q: What’s a SWG?

A: The UNC CFAR is committed to fostering interdisciplinary collaboration among research investigators, and provides the support and resources necessary for investigators to work together in pursuit of unique research topics. UNC CFAR’s Scientific Working Groups (SWGs) are comprised of investigators who share common research interests and goals, and participate in competitively funded research.

One of the CFAR’s missions is to support the work of our SWGs, so we like to see new interdisciplinary research come out of these groups and encourage that by offering them money.  Currently, our CFAR has one SWG:

Carolinas United to End HIV, or CUE-HIV (Lauren Brinkley-Rubinstein and Kimberly Powers, co-Chairs)

If you like the idea of a Developmental Award and share their research interests, the SWGs are always open to new members!

If you like the idea of a Developmental Award and share their research interests, the SWGs are always open to new members!

Q: I’m a post-doc/fellow and really need some money for a great HIV-related project.  May I apply?

A: We appreciate post-docs/fellows and would love to help all of you but unfortunately our funds are limited.  Since the CFAR’s continued funding depends in part on how successful our Developmental Awardees are at getting R and K level awards, and federal research funds are becoming harder to come by, we have to give preference to applications that will lead to an R or K level award and also ultimately lead to publication of Developmental data.  In other words, while we are not currently completely ruling out post-doc applications at this time, strong preference is given to ESI faculty.

Q: I’m not a early stage researcher, but I haven’t worked in HIV before.  Don’t you want to help me?

A: Of course we do!  In fact, we love to lure in senior investigators from other fields… I mean, help them expand their research interests.  The application process is the same as for early stage investigators, as are the required documentation and outcomes.  If you have already been PI on an R01 for a project in HIV, however, you are already one of us and we cannot lure, ahem, fund you.

Q: My research interests align with NIH’s priorities and will lead to an R01, I’m sure of it.  Is that all I need to say about that?

A: No, of course not!  Tell us more – we want to hear all about it.  To which institute will you be applying?  Convince us that you and the NIH are soulmates, destined to come together in the relatively near future.  We want a very specific funding path, a plan outlining how the proposed work will lead to NIH funding, a timeline for seeking such funding, the NIH institute or center from which you anticipate seeking funding, and the type of grant you plan to pursue (one page maximum, and not part of four page grant text limit).  With which of NIH’s priorities does your project align?  Your application must also include a separate document explaining how the proposed work is aligned with the NIH priorities. This document does not count toward the four-page grant text limit either.

Q: Talk to me about CFAR Administrative Supplements.  

A: About once a year, NIH announces opportunities for CFAR Administrative Supplements.  The RFA targets a short list of specific areas of HIV research that are generally up to about $100,000-$150,000 for one year.  Each CFAR may submit one application per topic area to the NIH, so if more than one researcher is interested in a particular topic, we will do an internal review of letters of intent and choose one that can then move forward into a full application.

Q: That’s a lot more money than a CFAR Developmental Award.  Can I apply for a CFAR Administrative Supplement?

A: Only if your research idea is in an area of interest for this year’s Administrative Supplement RFA and you get the go-ahead from the CFAR leadership.  Eligible applicants should also keep in mind that Supplement proposals must clear three hurdles at NIH – 1) they have to be strong enough in their science and methodology to be selected for funding; 2) the UNC CFAR must not have a significant anticipated amount of carryover into the next fiscal year, or else NIH will tell us to go fund it ourselves – which, since carryover is always spoken for, we generally cannot do (which is why we are constantly reminding our funded ESIs to spend their money as fast as they reasonably can!); and 3) pay attention here – they have to be about HIV/AIDS!  NIH will no longer fund non-AIDS projects with AIDS money.  So if it is going through the Office of AIDS Research (as CFAR Administrative Supplements must), it had better have HIV or AIDS in its title.  There are many STIs and IDs that are important in the world of HIV, but they are no longer going to be funded through the OAR.  So if you want a CFAR Administrative Supplement, be sure you state clearly in the application and title that it is going to be HIV/AIDS research.

Q: What are the PI requirements for an Administrative Supplements?

A: They are similar to those of the Developmental Awards, i.e., you must be eligible to serve as a PI on an R level NIH grant, and you must be associated in some way with the CFAR through which you are applying (hence the requirement of the CFAR PI’s approval).  The primary desired Supplement outcome is a larger, directly related NIH grant.  The gold standard is an R01.  The primary difference between Developmental funding applicants and Supplement applicants is that the latter are not required to be ESIs, although we are still quite partial to ESIs. Regardless, we will be closely watching – and reporting on – Administrative Supplement PIs’ success(es), so that the NIH and Congress will see how important it is that they continue to provide CFAR and Supplemental funding.

Q: OK, so let’s say I get funding from a CFAR Developmental Award or a CFAR Administrative Supplement.  What do YOU get out of it?

A: Well, if you can cure AIDS, that’d be good.  But even if you can’t (yet), what we want is for you to succeed.  Our goal is to help early stage investigators build their HIV research careers and make a difference in this epidemic.  As Charlie always said, we are training our replacements.  As Kate says, we can see the light at the end of the tunnel now but the next generation of researchers is going to get to actually walk out into that light.

Of course, to justify our CFAR’s continued funding from NIH, we have to provide evidence that we are on the right track.  As mentioned above, the primary desired outcome is always a larger, directly related NIH grant.  The gold standard is an NIH R01 (or a less common “R01 equivalent”, i.e., R23, R29, or R37) grant, and that is what all of our Awardees and Administrative Supplement PIs should strive for.  However, any post-Award funding that is directly related to your CFAR award is positive achievement and should be reported proudly back to the Developmental Core so that we can effectively brag about it to NIH and anyone else who will listen.  An R21, for example, can be an intermediate step toward an R01 and may be easier to attain first.  Funding from CDC or other sources is also nice, although less desirable as far as our needed outcomes as funding from NIH.  In summary, smaller follow up funding is great, but keep your eye on the R01 as your ultimate goal.

We also need for you to share your CFAR research results with the scientific community.  We are all partners in the fight against AIDS and sharing information makes us all stronger.  Therefore, our other desired outcome for all CFAR-funded research is dissemination of results.  The gold standard in this outcome category is publication in a peer review journal (citing the CFAR, linking it to our grant, and obtaining a PMCID are all required), but as an intermediate step, we accept the presentation of research at national and/or international conferences.  Again, keep your eye on the prize – plan to publish.

Your mentor can play a key role in helping you achieve each of these outcomes.  We can help as well.  You have the support of an incredible HIV research community behind you – utilize us!  In fact, even if you are not a Developmental Awardee or Administrative Supplement PI, if you are a early stage investigator in the CFAR, we want to help you succeed.

Remember, we will be closely watching – and reporting on – your success(es), so that the NIH and Congress will see how important it is that they continue to provide CFAR and Supplemental funding.

Q: Is there any guidance on-line about writing an NIH grant proposal?

Yes, in fact, there is!  NIAID has great detailed information on-line.

Q. I want to do an RCT but I’m not sure whether it’s actually considered to be “clinical trial” per se. Does that really matter?

A. Projects involving clinical research (e.g., observational studies or sub-studies using existing data from an ongoing clinical trial) may be funded by the CFAR.However, CFARs are not allowed to fund clinical trials. The NIH definition of a clinical trial is very broad. Some investigators conducting human subjects research may not be aware that NIH considers their study to be a clinical trial. To find out for sure, click here. Applicants considering submission of proposals that might be considered clinical trials are strongly encouraged to seek advice from CFAR Developmental Core Director Dr. Kate MacQueenbefore submitting a proposal.

Q. What happens next, after I find out that my [Developmental or Supplement] application is going to be funded? Other than celebrations on both sides, of course.

A. A whole lot of paperwork. I’m not gonna lie, there are a ton of documents that you will be required to complete before we are allowed to release your funds, most having to do with human subjects

Obviously, you must forward a copy of all current Institutional Biohazard, Animal Care, and IRB approvals to the CFAR Developmental Core. All projects must be approved by the UNC-Chapel Hill IRB, even if the Awardee/PI is elsewhere. If there are two domestic IRBs that should be involved, Tonia Hossain and her team will help you put together an IAA form for one of them, authorizing the other to be the one to make a judgement on the project.

You and your mentor(s) will need to sign a mentor-mentee contract to be sure that everyone involved understands what we require your relationship to look like. And for sure we want your photograph to put on our website to show everyone how cool our newly funded folks are!

If your research involves human subjects and the UNC and/or international IRB/Ethics Committee has deemed the study “more than minimal risk”, projects must receive NIH Clinical Clearance before funding is released. If your project is international, you will also need NIH International Clearance. Don’t worry, though – it takes a while to complete, but the Dev Core will guide you through every step of the process. For example, we will give you an example of a detailed SOP that the NIH loved to serve as a template for yours. The Human Subjects Study form is likewise very detailed and time-consuming to put together, but we will give you a guidance document to explain every question on the form. You will be required to send us documentation that all of your research team has completed research ethics training (e.g., CITI training). Etc. But again, I promise we will help you through that painful process (and believe me, it is painful for all of us!).

The NIH requirements for Developmental Awards and Supplements are far more demanding than for other NIH-funded awards simply because the applications don’t go through peer review at NIH before they are funded. Therefore, in order to fulfill their responsibility to ensure that all NIH-funded projects are conducted ethically, they must require a lot more documentation – that they seriously go through extremely carefully! – after the funding decisions are made but before the start of the research. In other words, after your Award notification but before we are allowed to release your funds. They are very strict about receiving and reviewing all of the documentation before the research starts – if we start a project without getting all of the necessary approvals, the NIH has the power to shut down the CFAR as a whole. Please let’s not do that. As the mother of a child might say, that’s the wrong kind of attention to seek.

 

Microgrant Application

Reviewer Guidance on Rigor and Transparency

NIH Scoring Table for Research Grants

Additional scoring guidance for research applications

Visit our 2022-2023 CFAR Developmental Core Traditional RFP page for more information.

UNC CFAR 2023 RFA cover page

Visit our UNC CFAR Secondary Data Analysis NOSI page for more information.