Clinical Trials Reporting Requirements, Our Shared commitment

What Researchers and Recipients Should Know about ClinicalTrials.gov

Discussing Not Discussed

 Using Review Critiques and Program Input on Applications

Application Preparation Timelines

Responsible Conduct of Research and Training 

Phase III Trials

Sex As a Biological Variable

Building Bridges

Inclusion Plans (Part 2): Peer Review and Post-Award

The Office of Extramural Research (OER) at the National Institutes of Health (NIH) presents conversations with NIH staff members. Designed for investigators, fellows, students, research administrators, and others, we provide insights on grant topics from those who live and breathe the information. In mp3 and updated monthly. 216139

Hope to have more

Very informative podcast about the NIH GRANTS Process.

Very helpful

All About Grants at NIH

Increase your knowledge about the roles of NIH extramural staff and who you should reach out to for help at different stages of the grants award and application process in this 4-part series, “Who Should I Contact at NIH?” In the second episode, “Finding a Funding Opportunity and Developing Your Application”, NIH experts talk about who to contact at NIH as you are identifying funding opportunities and developing your application. Sharing their expertise and perspectives on this topic are program officer Sue Brobst (Program Officer from the National Institute of Allergy and Infectious Diseases), Nick Gaiano (Scientific Review Officer from the Center for Scientific Review), Grace Olascoaga (Grants Management Officer with the National Institute of General Medical Sciences), and Dave Hunter (Lead Customer Support for Electronic Research Administration systems). Other episodes in this series include:  Roles of NIH staff and How They Work Together (Part 1), Application Submission through Review (Part 3), and Life After Peer Review (Part 4).

Who Should I Contact at NIH - Part 2 of 4: Finding a Funding Opportunity and Developing Your Application.

Dr. Michael S Lauer, Deputy Director for Extramural Research, NIH speaks to Megan Columbus and provides a brief introduction to NIH's new definition for clinical trials and what this means for individuals submitting applications on or after January 25, 2017.

Understanding the Definition Of a Clinical Trial and What That Means for You

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.

NIH’s Interest in Diversity and Supplement Programs 

Peter Cooper of the National Library of Medicine describes a tool for research administrators that allows them to monitor and report on NIH Public Access Policy compliance across their research institution. To learn more about NIH grants, visit http://www.grants.nih.gov.

Peter Cooper of the National Library of Medicine describes a tool for research administrators that allows them to monitor and report on NIH Public Access Policy compliance across their research institution. To learn more about NIH grants, visit <a href="http://www.grants.nih.gov" rel="nofollow" target="_blank">http://www.grants.nih.gov</a>.

Using the Public Access Compliance Monitor Tool

Increase your knowledge about the roles of NIH extramural staff and who you should reach out to for help at different stages of the grants award and application process in this 4-part series, “Who Should I Contact at NIH?” In the first episode, “Roles of NIH Staff and How They Work Together”, NIH experts describe their roles in grants administration and how they work as a team to support extramural research. We are joined by Sue Brobst (Program Official from the National Institute of Allergy and Infectious Diseases), Nick Gaiano ( Scientific Review Officer from the Center for Scientific Review). and Grace Olascoaga (Grants Management Officer with the National Institute of General Medical Sciences). Other episodes in this series include: Finding a Funding Opportunity and Developing Your Application (Part 2), Application Submission through Review (Part 3), and Life After Peer Review (Part 4).

Who Should I Contact at NIH - Part 1 of 4: Roles of NIH Staff and How They Work Together

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.

  Notices of Special Interest (NOSIs) 

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.

   Certificates of Confidentiality 

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.

 New “All About Grants” Podcast on Letters of Support

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.

 Increasing Diversity in NIH Small Business Programs

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.

 Rigor, Reproducibility, and Transparency  in Research

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.

NIH's Inclusion Across the Lifespan Policy 

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.

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 <a href="http://ClinicalTrials.gov" rel="nofollow" target="_blank">ClinicalTrials.gov</a> 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.

 Valid / Stratified Analyses

Ever wonder why a grant application must undergo a separate round of peer review, even after a panel of experts initially weigh in on its scientific merit and provide scores for NIH to consider when making funding decisions? During this podcast, we will explore the role and functions of these advisory councils across NIH. Dr. Sally Amero with the NIH Office of Extramural Research and Dr. Rebekah Rasooly with the National Institute of Nursing Research will join us to discuss who makes up these groups, what they are tasked with reviewing, and their general decision-making processes.

NIH Advisory Councils 

NIH takes the security and privacy of data of people supported by NIH grants seriously. Some of this information is made public if we make an award—such as name and contact information. That said, other sensitive data are protected from public release, such as your age, gender, and race/ethnicity. If you have ever wondered how NIH protects these data, then take a few minutes and listen to the discussion on a new All About Grants podcast (MP3 / Transcript).  You will hear about the federal Privacy Act; what NIH considers sensitive and non-sensitive data on grantees, applicants, investigators, and trainees; as well as what may be released publicly.Keywords: Privacy, Personally Identifiable Information, Administrative Data, Security

NIH takes the security and privacy of data of people supported by NIH grants seriously. Some of this information is made public if we make an award—such as name and contact information. That said, other sensitive data are protected from public release, such as your age, gender, and race/ethnicity. If you have ever wondered how NIH protects these data, then take a few minutes and listen to the discussion on a new All About Grants podcast (MP3 / Transcript).  You will hear about the federal Privacy Act; what NIH considers sensitive and non-sensitive data on grantees, applicants, investigators, and trainees; as well as what may be released publicly.<br>Keywords: Privacy, Personally Identifiable Information, Administrative Data, Security

How Does NIH Protect Your Privacy?  

Dr. Cathie Cooper, director of the NIH Division of Receipt and Referral (DRR) speaks to Megan Columbus about the cover letter file and in what it is used for in conjunction with NIH applications.

Cover Letters and their Appropriate Use

Dr. Cathie Cooper, director of the NIH Division of Receipt and Referral(DRR) speaks to Megan Columbus about the NIH appendix policy and new limits on what can be included as appendices.

A look at NIH's Appendix Policy

Dr. Sally Amero, NIH's Review Policy Officer speaks to Megan Columbus and provides a brief overview of NIH's post submission material policy.

NIH's Post Application Submission Policy

Dr. Pat Brown, director of the Office of Laboratory Animal Welfare, explains what must be included in this section of your grant application if you use vertebrate animals in your research. For more information, visit http://grants.nih.gov/grants/olaw/olaw.htm .

Dr. Pat Brown, director of the Office of Laboratory Animal Welfare, explains what must be included in this section of your grant application if you use vertebrate animals in your research. For more information, visit <a href="http://grants.nih.gov/grants/olaw/olaw.htm" rel="nofollow" target="_blank">http://grants.nih.gov/grants/olaw/olaw.htm</a> .

Writing Your Vertebrate Animal Section

OER’s Michelle Bulls, director of the Office of Policy for Extramural Research Administration, discusses the grants closeout process. To learn more about NIH grants, visit www.grants.nih.gov.

OER’s Michelle Bulls, director of the Office of Policy for Extramural Research Administration, discusses the grants closeout process. To learn more about NIH grants, visit <a href="http://www.grants.nih.gov" rel="nofollow" target="_blank">www.grants.nih.gov</a>.

What Administrators Need to Know About Financial Closeout of Grants

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