Thanks to a suggestion from a listener, in this NIH All About Grants episode a duo of NIH program officers, Drs. Lillian Kuo from the National Cancer Institute and Kentner Singleton from the National Institute of Allergy and Infectious Diseases, share their advice and experience on developing a research plan for a grant application. They discuss the relationship between the specific aims and research strategy, provide suggestions for when you sit down to start writing, and share common pitfalls. More helpful advice on writing your application is available from the NIH Grants and Funding site. Have an idea for a future podcast? Email ExtramuralNexus@mail.nih.gov and tell us all about it. We appreciate the feedback!

So you have confirmed that you are doing human subjects’ research after listening to the first podcast in our human subject mini-series.And you have a clear human subjects’ protection and monitoring plan developed for your application after tuning in to the second episode in the series.Now, what should you keep in mind after the award is made? The latest NIH All About Grantspodcast episode delves into just this issue. Lyndi Lahl, an NIH Human Subjects’ Officer, joins us (and her dog too!) in this final episode of this human subjects’ researchmini-series. Tune in for tips about important post-award requirements, what’s needed for annual progress reporting, engaging your IRB and NIH when a protocol change is needed, the difference between adverse events and unanticipated problems, and much more.

Your experimental designs are coming into focus. Sample sizes…power analyses…and treatment conditions, oh my! And, all throughout, perhaps laboratory animals are needed. But, are they? Can you actually replace them and still rigorously test the hypothesis? If not, maybe the protocol can be refined in such a way to reduce their overall numbers, while still ensuring their humane care and use? Considering alternatives to animals in your application is the topic of our next NIH All About Grants podcast. Drs. Neera Gopee with the NIH Office of Laboratory Animal Welfare and Christine Livingston with the National Center for Advancing Translational Sciences join us for this conversation. We will go into the 3Rs (replace, refine, and reduce), helpful resources for relevant policies, what’s needed for the vertebrate animal section, role for IACUCs and peer review, as well as organoids, in silico models, and other alternatives…oh my again! On a related note, keep an eye out for recommendations coming from the Advisory Committee to the NIH Director working group on Enhancing Rigor, Transparency, and Translatability in Animal Research this December. Part of their charge is validating alternative models to animal research as well as considering benefits and burdens of registering animal studies. Their recommendations will also encompass public feedback in response to a Request for Information (NOT-OD-20-130) released this summer (see this NIH Open Mike blog post for more).

You have done your homework. Read the requisite materials on human subjects. Spoken with program staff at NIH. Even listened to Part 1 of this podcast mini-series for some insights on how you know if you are doing human subjects research. And, now you are ready for the next step: explaining in the application how research participants will be protected and monitored. Dawn Corbett, NIH’s Inclusion Policy Officer, shares why human subjects’ protection and monitoring plans are important in this next NIH’s All About Grants podcast. We will discuss what should be included in these plans, what should be left out, what are risks and what are benefits to study participants, how reviewers assess it all, and so much more.

That’s a bit…odd. That gel image looks photoshopped. The data looks to good to be true. And, wait a second, that figure appeared in another paper! These are examples of research misconduct. What do you do if you suspect research misconduct? Join us for this next installment of NIH’s All About Grants podcast with Dr. Christine Ring on addressing research misconduct. As an NIH Research Integrity Officer, she will share with us what is meant by fabrication, falsification, and plagiarism, how it affects the integrity of our supported research, what to do if you suspect research misconduct, how we work with the HHS Office of Research Integrity when responding to an allegation, and much more.

You have a promising research idea that may involve human participants to carry out the study. Do you know what to do next? Join us for the next NIH’s All About Grants podcast conversation about how you know you are doing human subjects’ research. Lyndi Lahl, R.N., a Human Subjects’ Officer with the NIH’s Office of Extramural Research, will help you understand what exactly is meant by “human subjects’ research,” its relation to the recently revised Common Rule, what research may be exempted, what institutions need to have in place, where to find important resources to help you going forward, and so much more.

So your supported research led to a nifty new invention, one that is patentable. What do you do next? Does NIH need to know about the invention resulting from the awarded grant? What patent protections and rights do you have? Ever heard of Bayh Dole or iEdison? In this next installment of the NIH’s All About Grants podcast series, we will get into the nuts and bolts of what NIH grantees should know about intellectual property, invention reporting, and patent protections. Scott Cooper, J.D., an Assistant Extramural Inventions Policy Officer with the NIH Office of Extramural Research, joins us to discuss these topics in more detail, provide some handy tips and best practices to keep in mind, shares resources available on our intellectual property webpage and iEdison FAQs, and reiterates that we are here to help you along the way.

Yes, we are talking about contracts in this next installment of the NIH’s All About Grants podcast series. Our guests will be George Kennedy and Brian O’Laughlin, who are acquisition staff from the National Institute of Allergy and Infectious Diseases and National Institute of Drug Abuse, respectively. The conversation will introduce you to the world of contracts at NIH, what they are, how they differ from grants, where to find them, what types of research are solicited, tidbits to focus on when developing a proposal, and more. Check out the System for Awards Management (SAM) to find more information on contract solicitations.

Avid NIH Open Mike blog readers will recall a post from a couple months ago contextualizing why NIH revised its definition of the economically disadvantaged category as a way to be more inclusive and diversify the biomedical workforce. In our next installment of the NIH’s All About Grants podcast series, we sit down with the Director of the National Institute of General Medical Sciences, Dr. Jon Lorsch, to chat about diversity. The conversation weaves between NIH’s interest in diversifying the research workforce, to how this interest manifests in funding opportunities, who is eligible to apply, how diversity supplements can help someone’s career, and sheds light on the review process.

When dutifully scanning the weekly Table of Contents email for the NIH Guide for Grants and Contracts every Friday afternoon, have you found yourself wondering where all the Notices of Special Interest (NOSI) came from? And, what is a NOSI anyways? Dr. Jodi Black, Deputy Director of NIH’s Office of Extramural Research, joins us in this next installment of the NIH’s All About Grants podcast series to break down NOSIs. We discuss what they are and why NIH is using them, what you should know about them when putting together an application, who you should go to for questions, and why it is so important to include that NOSI number in Box 4B of your application. Need a refresher on the alphabet soup of funding opportunity types touched on in the discussion? Check out our Understand Funding Opportunities page or listen to this classic 2011 All About Grants podcast to learn the difference between PAs, PARs, PASs, RFAs and parent announcements.

The people who volunteer to participate in NIH-funded research trust that the sensitive information they provide will be protected. To help ensure this protection, NIH issues certificates of confidentiality for awarded studies. Certificates of Confidentiality protect the privacy of research subjects by prohibiting disclosure of identifiable, sensitive research information to anyone not connected to the research except when the subject consents or in a few other specific situations. In this next installment of the NIH’s All About Grants podcast series, we delve into what you should know about certificates. Lyndi Lahl, a Human Subjects Officer within the NIH’s Office of Extramural Research, explains exactly what are certificates, when is disclosure of participant data allowed and when it is not, how to know if your study should have a certificate to protect participants, where to find a certificate associated with your study, and much more.

Thousands of researchers serve as peer reviewers each year at NIH. As part of their service, they assess the scientific and technical merit of numerous applications. Sometimes, during their review, they recognize a possible conflict of interest with an application that should be disclosed to NIH.In this next installment of the NIH’s All About Grants podcast series, we talk about how NIH manages conflicts of interest to ensure that we maintain integrity throughout the peer review process. Sally Amero, Ph.D., NIH’s Review Policy Officer, joins us and explains why it is important to manage these conflicts, what is and is not a potential conflict, how to disclose conflicts, and who is involved throughout the peer review process.

Letters of support are a valuable part of your grant application. They provide an opportunity for you to document the commitment and support of your institution and collaborators, the availability of required resources, and more. In this next installment of the NIH’s All About Grants podcast series, Cathleen Cooper, Ph.D., who directs the NIH’s Center for Scientific Review’s Division of Receipt and Referral, joins us to talk all about letters of support. Hear what information should be included in these letters, what should not, how they differ from other letters submitted as part of an application, and more.

Confidentiality is at the core of ensuring research ideas submitted in grant applications are protected. In this next installment of the NIH’s All About Grants podcast series, Sally Amero, Ph.D., NIH’s Review Policy Officer, discusses how NIH strives to maintain the highest levels of confidentiality and integrity in the peer review process. She highlights the core values of peer review, what reviewers agree to when serving on study sections, what may be discussed regarding study section meetings, and how applicants can learn more about the review of their application. Further, we delve into actions NIH may take when breaches in confidentiality occur.

You probably know the NIH RePORT suite of tools as a useful hub of information where you can find reports, data, and analyses of NIH-funded research and answers to the most commonly asked questions on the NIH budget and extramural research programs. But do you know RePORT can be a helpful tool as you are developing your grant application? In this next installment of the NIH’s All About Grants podcast series, Dr. Brian Haugen and Dr. Cindy Danielson from the NIH Office of Extramural Research join us to share their advice on applying these tools to help you throughout the grants process. We touch on areas such as figuring out who to contact at NIH to discuss your research ideas, seeing what research projects NIH has funded, and how to apply these tools to strengthen your grant application. RePORT attracts over 120,000 unique visitors each month, so tune in to see what the excitement is all about and learn how you too can strategically use its tools.

In this next installment of the “All About Grants” podcast series, small business innovators can learn more about programs geared towards women-owned companies or those led by socially or economically disadvantaged groups. Dr. Kory Hallett, a Program Director with the National Cancer Institute, and Ms. Stephanie Fertig, a Director of Small Business Programs with the National Institute of Neurological Disorders and Stroke, will highlight how NIH is taking steps towards diversifying the NIH small business programs. You will hear about who qualifies, tips for strengthening your application, and what goes on behind-the-scenes in a study section reviewing the merit of your application. They also share some good general food-for-thought that many other applicants may find helpful when trying to turn research ideas into words.

This podcast aims to help the extramural research community better understand the NIH’s Rigor and Transparency policy. Dr. Patricia Valdez, NIH’s Extramural Research Integrity Officer, describes how to address the key policy elements, including rigor of the prior research, rigorous experimental design, consideration of key biological variables, and authentication of key biological and/or chemical resources, in an application, how they are considered during peer review, and annual progress reporting following award.

Wondering how to knock that investor pitch out of the park? In this next installment of the “All About Grants” podcast series, small business innovators will get a front row seat to hear how to prepare for private investment. Dr. Ethel Ruben, NIH’s Entrepreneur-In-Residence, steps up to the plate and shares insights on who these investors are, how they decide on what innovations to invest in the biomedical commercial space, and some valuable tips and tricks to improve the accuracy of your investor pitch. Tune in to learn the ins and outs of private equity and how it can help you continue developing biomedical innovations post-NIH award and bring it home to the marketplace.

For decades, NIH has required so called valid analysis, also known as stratified analysis, to explore how well interventions work across sex/gender and race/ethnicity for all applicable clinical trials. Last year, we amended this existing policy to require the findings from such stratified analyses on these variables be reported on ClinicalTrials.gov after an applicable NIH-Defined Phase III clinical trial has completed. Ms. Dawn Corbit, NIH's Inclusion Policy Officer, joins us on this podcast to discuss the revised policy and what it means for the extramural research community. By taking this step, we are encouraging findings from stratified analyses to be more readily available to the public as a means to better understand the effect that sex and race may have on health outcomes and physiologic conditions.

In 2017, as part of our on-going implementation of the 21st Century Cures Act, NIH announced the Inclusion Across the Lifespan policy. Effective January 29, 2019, NIH will begin considering age, along with sex/gender and race/ethnicity, in applications seeking NIH support that involve human participants. Ms. Dawn Corbit, NIH's Inclusion Policy Officer, discusses the policy in this podcast and how it affects how applicants and awardees may design their study. Through this policy, we can help ensure that the knowledge gained from NIH supported research will be applicable to the broad range of those affected by the condition under study, and have that knowledge be used to help make better informed medical decisions going forward.