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How do you define a “study” for the purposes of providing information on the PHS Human Subject and Clinical Trial form and registering in ClinicalTrials.gov?
How do you define a “study” for the purposes of providing information on the PHS Human Subject and Clinical Trial form and registering in ClinicalTrials.gov?
Our application instructions provide guidance to submit a study record for each protocol. When in doubt, NIH supports lumping several aims or hypotheses into a single study record, to the extent that makes sense for your research.
Have other questions related to the new PHS Human Subject and Clinical Trial form or NIH clinical trial policies? Find more FAQs and their answers at grants.nih.gov.
Last month, NIH announced a revision (NOT-OD-18-116) to a decades-old policy originally conceived in response to concerns that children were not appropriately included in clinical research. These changes broaden the policy to address inclusion of research participants of all ages, and as discussed at the last Advisory Committee to the NIH Director meeting, will apply beginning in 2019 to all NIH-supported research involving human subjects. Our goal is to ensure that the knowledge gained from NIH-funded research is applicable to all those affected by the conditions under study.
To get here, NIH solicited feedback from experts and the public through a Request for Information and a workshop held over the summer. We heard from many of you, from pediatricians, geriatricians, primary care providers, statisticians, publishers, bioethicists, and people from the general public. Among the concerns raised were that many trials include poorly-justified age-based exclusions (Cherubini 2011, Cruz-Jentoft 2013), and that older adults, who carry a disproportionate burden of disease, are often underrepresented in clinical trials. For example, while nearly a third of US cancer patients are 75 years or older, less than 10% of patients in cancer trials are in this age range (Hurria 2014).
After considering input and in accord with the 21st Century Cures Act, our policy now requires people of all ages, including children under 18 years and older adults, be included in clinical research studies unless there are scientific or ethical reasons not to include them. We outline when certain age groups may be excluded and note that grantees are now required to annually report on the age at enrollment of their participants along with sex/gender, race, and ethnicity.
So, for application due dates on or after January 25, 2019 (yes, one year from now), if you propose a study involving human subjects, you must have a plan describing how participants across the lifespan will be included and justify the proposed age range of participants. Reviewers will consider whether the proposed age range is appropriate in the context of the specific scientific aims. Should the study be funded, keep in mind that your progress reports will include de-identified individual-level participant data on sex/gender, race, ethnicity, and age at enrollment (in units ranging from hours to years). Ongoing NIH-funded research (type 5 awards) are exempt from this policy, but the policy will apply if you are submitting a competitive renewal application on or after January 25, 2019.
We understand that sometimes research should exclude certain participants. For example, if the disease does not occur in the excluded group, or the knowledge sought is already available on the excluded group, then this may be an appropriate justification to limit who is in your study. We also recognize that there are situations where participation of certain groups would be unethical, or laws or regulations bar the inclusion of a specific group in research. The Guide notice describes situations in which exclusion of individuals based on age may be justified. Keep in mind that the age distribution of participants should be appropriate in the context of the science.
We look forward to working with you in the implementation of these high priority inclusion policies, which are designed to assure that our funded research will better help us make informed health and health care choices going forward.
Uwe Reischl, a professor in the Department of Community and Environmental Health in the College of Health Sciences, recently conducted a project in Bukhaywa, Kenya, to evaluate a new architectural ventilation design concept developed at Boise State.
The design reduces harmful indoor smoke accumulation generated by open fires in rural kitchens. Kenya’s rural population relies primarily on indoor open fires for cooking. Fuels such as firewood, charcoal, agricultural waste products and animal dung create toxic smoke that lead to chronic respiratory health problems primarily for women and children. It is estimated that more than 600,000 women worldwide die prematurely each year from illnesses caused by such exposures. Past efforts to address this problem focused on the distribution of new stove technologies. However, this approach has had minimal impact because poor families cannot afford the stoves.
An interior photo of the kitchen concept.
Using a different approach altogether, a low-cost kitchen ventilation concept was developed that can now reduce smoke build-up in rural kitchens. The design feature allows families to continue using their traditional open fires while experiencing a reduction in smoke build-up by 80 percent. To evaluate the new application under actual conditions, Reischl built a full-scale prototype kitchen in Bukhaywa and evaluated the performance.
Use of the prototype kitchen by a rural family showed that healthful indoor air quality conditions can now be achieved without requiring new technologies. Reischl believes that the design application will not only be able to reduce the overall health burden imposed on poor rural women and their children in Kenya, but can also improve the indoor air quality conditions of families in other parts of the world.
The “Boise State kitchen” under construction in Kenya using local construction techniques.
Two New “All About Grants” Podcasts: 2018 Appendix Policy Changes, and Why We Encourage You to Submit Your Application Early
NIH’s Office of Extramural Research brings you two new “All About Grants” podcasts to ring in the new year. In “Why it’s so Important to Submit Applications Early” (mp3, transcript), Dr. Cathie Cooper, director of the Division of Receipt and Referral in the NIH’s Center for Scientific Review, talks about the importance of submitting application early due to changes in NIH’s policies and application forms for 2018.
All About Grants podcast episodes are produced by the NIH Office of Extramural Research, and designed for investigators, fellows, students, research administrators, and others just curious about the application and award process. The podcast features NIH staff members who talk about the ins and outs of NIH funding, and provide insights on grant topics from those who live and breathe the information. Listen to more episodes via the All About Grants podcast page, through iTunes, or by using our RSS feed in your podcast app of choice.
2017 Year in Review: Federal Grant Highlights
With 2017 in the rearview mirror, let’s pause to look back on what was a significant year for federal grants. With important developments and growth in the grants community in 2017, this post takes note of key points worth remembering and helpful resources, not just from us, from some of you in the grants community.
#1 – Get Your (DATA) Act Together
This would not be a real grants ‘year in review’ for 2017 without starting with the Digital Accountability and Transparency Act (DATA Act). Coordinating across all federal award-making agencies and the diverse applicant communities to standardize and improve the quality and transparency of federal financial data? That’s big.
If you are completely unfamiliar with the DATA Act, welcome to the party—start with this basic update. You should also do a web search for trainings and updates about the DATA Act to hear from a variety of stakeholders on what it means for the grant community.
To get you thinking about possibilities in the future, HHS’ Deputy Assistant Secretary of the Office of Grants and Acquisitions Policy and Accountability (OGAPA), Andrea Brandon, posed this question at the DATA Transparency conference in September this year, “Do we need [nonfederal entities] to actually complete an SF-424 or do we just need structured data sets that come through a particular portal?”
#2 – Not Taken for Granted
Over $700 billion in grants and cooperative agreements were awarded in FY 2017. The DATA Act gets another nod here, which led to the new beta USAspending.gov to improve the quality and transparency of federal spending data. If you are interested in more spending data, check out the USAspending.gov Agency Profiles and Spending Map.
As a note, that number does include Medicare and Medicaid funding in the form of formula grants, but there were thousands of discretionary funding opportunities posted on Grants.gov for which many of you applied for—and it is a competitive process.
Of course, we need to mention at least one grant-writing tip here—do not eliminate yourself from the competition by not checking that you have followed all the basic requirements.
#3 – Grants Community Growth with More Events and Training Resources
Anecdotally, 2017 certainly seemed like one of the most prolific with regard to grant events and training resources available to the community. If anyone out there would like to investigate this by the numbers, let us know what you find.
#GrantChat – Talk with fellow grant professionals on a range of topics relevant to your work. This is a great way to hear tips, share resources, and get to know your professional peers online.
Resources By You, For You – Here’s a sampling of grant resources for you to review: eCivis blog, Grant Professionals Association Resource Center, Grant Training Center, Grant Writer’s Blog, GrantSpace by Foundation Center, GrantStation Insights blog, Learn Peak Grantmaking, Management Concepts Applying for Federal Grants & Cooperative Agreements, National Grants Management Association Annual Grants Training, NIH Regional Seminar & Extramural Nexus blog, SmartGrants Blog, the bmtconsulting blog, The Grant Plant Resources, Thompson Grants Federal Grants Forum, or check out our Where to Find Free Online Resources for Federal Grant Applicants Part 1 and Part 2 for more.
#4 – Did the 2017 Grants.gov Plan Happen?
Last January, we shared high-level plans for 2017, and we are happy to say that we were able to stick to these plans. Admittedly, #1 and #3 from last year’s plan go hand-in-hand, but here’s a link to Grants.gov Workspace resources just in case you haven’t read about it yet.
We are proud to have received awards confirming the direction of the program. FedHealthIT 100 awarded John Enggren, the Grants.gov Program Manager, for developing Workspace and his efforts of “driving change and advancement in the Federal Health Information Technology and Consulting Market.” In June 2017, Enggren and the program also received recognition at the 2017 AFFIRM Leadership Awards Celebration for Workspace.
Now that we have looked back on 2017, be among the first to read about Grants.gov’s plans for 2018 by subscribing to the Grants.gov Community Blog.
Last September, and in January of this year, we wrote about a suite of initiatives aimed at improving the quality and transparency of the NIH-supported research that most directly engages human participants – clinical trials. These initiatives include dedicated Funding Opportunity Announcements for clinical trials, Good Clinical Practice training, enhanced registration and results reporting on ClinicalTrials.gov, and required use of single IRB’s for multi-site studies. We are now entering the final phases of implementation of these initiatives – so, if you are contemplating research involving human subjects, please read on.
We’ve received queries from members of the research community seeking clarity on whether their human subjects research will be affected by these new policies, and if so, how. So, we want to call your attention to four questions researchers involved in human s studies need to ask, and answer. These questions are:
- Does the study involve human participants?
- Are the participants prospectively assigned to an intervention?
- Is the study designed to evaluate the effect of the intervention on the participants?
- Is the effect that will be evaluated a health-related biomedical or behavioral outcome?
If the answer to all four questions is yes, then we consider your research a clinical trial.
The NIH definition of a clinical trial is “a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes”. The definition was published in 2014, after extensive public input, and affirmed, after even more public input, in our policypublished in September 2016. The clinical trial definition encompasses a wide variety of study types, as shown in figure 1. These range from mechanistic studies to behavioral studies, to pilot/feasibility studies, all the way to large-scale efficacy and effectiveness trials.
The breadth of the NIH definition is intentional, given the nature of the NIH portfolio and imperatives for maximal transparency. Transparency shows respect for the participants who put their trust in us, in the face of unknown outcomes, to help advance science. Our concerns about transparency stem in part from the issues surrounding the reporting of clinical trials data. For both NIH-funded and non-NIH funded trials, unreported data and untimely dissemination of results has been documented over and over again. Others have expressed concern that the NIH has not collected needed trans-NIH data to enable it to function as proper stewards of clinical trials.
Some have argued that we should not expect trial registration and reporting for small or exploratory trials, for trials that focus on safety, or for trials that fail to meet enrollment targets. As we stated last September, NIH chose to emphasize the value of transparency for these kinds of trials as well, as “the benefits of transparency and the need to fulfill the ethical obligation to participants is as relevant to these types of trials as to any other type.” We have an ethical obligation to report results, and this is especially true when volunteers contribute their time as study participants in prospective experiments, whether large or small. And, to be effective stewards of precious and constrained taxpayer monies, we need to collect a minimum of standardized data.
This transparency complements existing efforts to promote data sharing, public access to NIH-funded research results, and scientifically rigorous research design, all of which ultimately benefit the research community directly, as well. By developing and sharing robust data, we maximize the value of NIH’s investment in research by allowing scientists to build upon solid results. The definition, and our clinical trial policies, are an integral part of our efforts to enhance scientific stewardship, dissemination of information, transparency, and to excel as a federal science agency that manages for results.
Why is it important to know whether you are proposing to conduct a clinical trial? Correctly identifying whether your study is a clinical trial is crucial to complying with NIH policies, many of which are now in effect, such as registering and reporting all NIH supported clinical trials in ClinicalTrials.gov and good clinical practice training. Very soon, your answer will be crucial to picking the appropriate NIH funding opportunity for your application, writing your research plan correctly (since some information will be captured in the new human subjects and clinical trials form), and ensuring that your application includes all the information required for peer review.
If you are having difficulty answering the four questions that determine whether a study meets the NIH definition of a clinical trial, we encourage you to consult the case studies and FAQs that are available on our webpage on clinical trial requirements for grants and contracts. We’ll be following up with additional blogs and NIH Extramural Nexus articles that provide more depth on the various initiatives. We strongly encourage you to look at these materials, and share them with your colleagues, to ensure that as an awardee conducting clinical trial research, you are aware of the need to register your trial and report its results.
Recent policy changes requiring clinical trial applications to be submitted to FOAs that specifically allow clinical trials, first announced in fall of 2016, impact how all NIH applicants choose a FOA, whether you are submitting a clinical trial or not.
Over the last year, each NIH Institute and Center has been carefully evaluating its research funding priorities and strategic goals and using that information to articulate their funding priorities for clinical trials. They are communicating their priorities through the funding opportunity announcements they issue.
The requirement to respond to clinical trial specific FOAs begins for applications submitted for due dates on or after January 25, 2018. NIH is reissuing any FOA that will accept clinical trial applications after that date. Many of these FOAs have already been issued, others will be published at least 60 days before the first due date for which they will accept applications. How can you tell which FOAs will allow clinical trials? Reissued clinical trial FOAs make clinical trial allowability clear in both the title and in section 2, and they include clinical trial review criteria.
Responding to the correct type of FOA ensures that you know what information you are expected to include in your application and that you can develop an application that is responsive to the review criteria. It also ensures that reviewers apply the correct criteria and give your application the best review possible.
Before beginning your search for an FOA, if you are doing human subject research you should use our clinical trial tool to determine whether NIH considers any of your studies a clinical trial.
If any study (or component) of your application meets the NIH definition of a clinical trial (even if your application includes other studies that are not clinical trials), you must respond to a FOA that allows for clinical trials.
If none of your specific aims include studies that meet the NIH definition of a clinical trial, be sure to respond to an FOA that does not require clinical trials. Check section II of the FOA; there will be a row entitled “Clinical Trial?” that should say either “Clinical trials not allowed” or “Clinical trials optional”.
We are re-issuing existing parent announcements as “clinical trial not allowed” for due dates on or after January 25, 2018. Our most recent reminder notice provides a list of all the parent announcements (old and new) and when they will be reissued. .) . The participating organizations may vary between the “clinical trial not allowed” parent FOA and the “clinical trial required” parent FOA for the same activity code. Read the details of each FOA carefully. Note that some institutes that participate on a “Clinical Trial Required” parent may limit their participation to mechanistic studies. Check the Related Notices section of the FOA for any restrictions.
Some IC’s are using different FOAs for different kinds of trials. We encourage you to visit individual IC’s web pages for guidance.
Note that even for resubmissions, revisions or renewals, you may need to find a new FOA to apply to with the appropriate clinical trial allowability that reflects the research in the application you are submitting.
The upshot of all this? The FOA landscape is changing. It is important to pick your FOA carefully. We will be reissuing all parent FOAs and all FOAs that will allow clinical trials at least 60 days before the first due date. Before you are ready to apply, check back to be sure you are responding to the latest version of the FOA, and to read any related notices that have been issued since you first looked at the FOA. Learn more about understanding funding opportunities and NIH clinical trial requirements on the NIH Grants and Funding website. And be on the lookout for a new video we will be putting out in the next few weeks on finding and understanding funding opportunities.
If you are new to working with the NIH grants application and awards process….you need to read on! With only one NIH Regional Seminar on Program Funding and Grants Administration scheduled for 2018, you will not want to miss out on this unique opportunity in Washington, DC, from May 2-4, 2018.
Why Attend? The NIH Regional Seminar involves approximately 65 NIH and HHS staff who are brought to a central location in order to educate, share, and hear your questions over the course of two days, plus pre-seminar workshops. There are over 45 different topic areas and 6 optional workshops covering human subjects, electronic research administration, a “boot camp” for beginners, and intellectual property. See the two day seminar & pre-seminar workshop agendas for more details.
This seminar is your opportunity to make direct contact with NIH policy officials, grants management, program and review staff, and representatives from the Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP), HHS Office of the Inspector General (OIG), and others. Plus, you’ll be able to take advantage of discussions involving more than 600 fellow attendees from around the world.
Unique Opportunity to Meet NIH Face-to-Face: In addition to learning more about the NIH grants processes and policies through the optional workshops and two days of sessions, there are opportunities throughout the seminar to Meet the Experts 1:1. These 15 minute chats are a great way to get more specific questions answered by NIH & HHS experts. You’ll have the opportunity to sign up in advance or on-site to speak with the expert(s) of your choice while participating in the seminar. With the Washington, DC location located close to NIH, expect even more NIH & HHS experts to join us.
Registration rates increase on Saturday, December 16. Space is limited and these seminars traditionally reach capacity prior to the event, so register now and save your spot!
From Anna Reineke, Regional Coordinating Director, GMaP REgion 6, Huntsman Cancer Institute, University of Utah
Dear Colleagues and Students,
I have been asked by our NCI and NIA intramural scientists to identify a stellar post-baccalaureate candidate who would be interested in joining a research project at Imaging facility at NIH main campus in Bethesda, MD. Please send me your top-notch post-bac students name, resume and contact information who would be forwarded to the hiring senior investigators at NIH for potential 1 to 2 years of appointment.
NCI would greatly appreciate receiving your nominations of potential candidates on or before December 1, 2017. Sorry for the short turnaround time for this request as this position needs to be urgently filled for this joint collaborative project between NCI and NIA investigators at NIH.
Additional details below
- The position start date is flexible anytime in early/spring 2018.
- The student will work in the NCI High-throughput imaging facility on a joint project with the National Institute on Aging.
- The student will be trained in high-throughput imaging assays including fluorescence microscopy methods.
- Candidates with some experience in standard cell and molecular biology skills, ideally including cell culture of mammalian cells and imaging, can be trained for this project.
Please contact Anna Reineke with potential Candidates:
GMaP Region 6 includes: ID, MT, NV, ND, SD, UT & WY
Posted: November 19, 2017
Deadline: February 1, 2018
Grants of up to $250,000 over two years will be awarded to projects that encourage active integration of patients, caregivers, clinicians, and other healthcare stakeholders as integral members of the patient-centered outcomes research….