NIAID Funding News -- July 29, 2005
 News
Articles
Opportunities and Resources
Advice Corner
New Initiatives
|
News Articles |
 |
R34 Clinical Trials Update
Few clinical investigators will be beyond the sweep of NIAID's new investigator-initiated Clinical Trial Planning Grant process, a.k.a. R34. Only those responding to requests for applications or requests for proposals are excluded.
Career and small business awards
In addition to standard research grants such as R01s, the new policy will affect applicants seeking career development or small business awards.
For career award applicants, we will not accept K-series applications proposing to conduct independent clinical trials. See the March 28, 2008, Guide notice for reference. However, you should participate in planning, designing, and implementing ongoing clinical trials conducted at your institution. For more information on career awards, call Dr. Milton Hernández at 301-496-3775 or email mh35c@nih.gov.
Our Guide notice for small business awards is in the works and should be published shortly. To adapt the R34 concept to Small Business Innovation Research and Small Business Technology Transfer awards, we are tweaking that application process. Stay tuned.
Prepare before calling
If you're thinking of applying for an R34, you must use a new online resource before you call a program officer to request permission to submit an application. Go to Requesting Permission to Submit an R34 to see what information to have on hand for that discussion.
We'd like to clarify the process and timing for NIAID approval. Here are the key steps; please see our Investigator-Initiated Clinical Trials (R34) questions and answers for more details:
- Before you do anything, review Requesting Permission to Submit an R34.
- Armed with that information, call or write the appropriate program officer listed in the NIAID Clinical Trial Planning (R34) Grants program announcement to find out how to request approval to apply.
- Following the program officer's instructions, submit a written request at least six weeks before the application receipt date.
- Submit a letter of intent 30 days before the receipt date; this is in addition to the written request in step 3. For timing information, see What is the timeframe for hearing back about staff approval and for sending in my letter of intent?
In case you missed previous news, here's a recap. NIAID is funding investigator-initiated clinical trials through a two-stage process: 1) a clinical trial planning grant (R34), which lays the foundation for 2) a clinical trial implementation cooperative agreement (U01).
We wrote about R34s in three of our last four newsletter issues:
|
 |
Saying Farewell to the PHS 398
As early as December 1, NIH will launch a two-year phase-in of the SF 424 Research and Related forms, which will ultimately replace the PHS 398.
NIH is part of a federal government-wide move toward a single,
electronic grant application through Grants.gov, which should simplify process for applicants. Parts of the 398 will remain to supplement the new forms.
As soon as we have more information about the transition, we'll let you know. |
Opportunities and Resources |
 |
Find New Reagents at the NIH Tetramer Facility
If you need to quantify T-cell responses and have used or are considering tetramers, you may want to check out new resources at the NIH Tetramer Facility. There are three new items: 1) human and mouse CD1d tetramers, 2) custom class II major histocompatibility complex (MHC) reagents for four HLA-DR alleles, and 3) tetramers with an expanded range of fluorophores.
Human and mouse CD1d tetramers. These reagents are loaded with PBS-57, an analogue of alpha-GalCer ligand that Dr. Paul B. Savage of Brigham Young University recently developed. The facility also provides lymphocyte staining with these tetramers; go to CD1d Tetramers.
Custom synthesis of class II MHC tetramers. In addition to a small number of pre-made class II tetramers, the Tetramer Facility is offering custom peptide-loaded tetramers of the following HLA-DR alleles, through a collaboration with Dr. Kai Wucherpfennig at the Dana Farber Cancer Institute:
- DRB1*0101/DRA1*0101
- DRB5*0101/DRA1*0101
- DRB1*1501/DRA1*0101
- DRB1*0401/DRA1*0101
You can expect more mouse, human, and non-human primate MHC class II alleles in the coming months. Find more details in NIH Tetramer Facility News.
Please help prioritize future products. Tetramer Facility staff are subcloning several class II genes for future production, including six mouse I-A alleles and human alleles. Indicate which alleles are most valuable for your research by filling out the Survey of the Desired MHC Class II Alleles and Epitopes.
Expanded range of fluorophores. In addition to the standard PE- and APC-labeled tetramers, you can now order tetramers with the following labels:
- Pacific Blue
- Fluorescein
- Alexa 488 (similar in fluorescence emission to fluorescein)
- Alexa 647 (similar in fluorescence emission to APC)
- Alexa 680
Why use tetramers
With their outstanding antigen specificity and sensitivity, tetramers can help you monitor immune responses of antigen-specific T cells in infectious organisms -- viruses, bacteria, and parasites -- as well as cancer and autoimmune disease states.
Created in 1999 by NIAID with NCI support, the NIH Tetramer Facility provides approved scientists with custom synthesis and distribution of soluble MHC peptide tetramer reagents at little cost.
How to apply
Use these forms to request tetramers:
- Form for Custom Synthesis of MHC Class II Tetramers
- Request Form for MHC Class II Only for premade reagents
- Request Form for MHC Class I Only
After you are approved, you can receive approximately 0.2 mg of MHC class I or II peptide tetrameric reagent. As a requestor, you supply the peptides and pay shipping costs, while the NIH Tetramer Facility covers tetramer production costs.
Find the General Guidelines and other information on the NIH Tetramer Core Facility home page. For comments or questions, email NIAID project officer Alison Deckhut Augustine at adeckhut@niaid.nih.gov. |
 |
International Workshop -- Free for Foreign Grant Administrators
If you work with grants in the international arena, you may wish to look into an upcoming seminar on administering NIH grants.
A full-day international workshop will give you information and tools that should help you on your job. It takes place on October 16 in Milwaukee, Wisconsin, as part of the annual meeting of the Society of Research Administrators.
Free to people from foreign countries, the workshop is also targeted to domestic grantees with international components. A panel of NIH staff and foreign grants administrators will discuss common issues and problems.
The Society is working with the NIH Fogarty International Center to recruit foreign grants administrators from the developing world and their U.S. counterparts to form a team for a discussion panel. If you're interested, call Fogarty's Bruce Butrum at 301-496-1670 or email butrumb@mail.nih.gov.
For information on this and other workshops, go to SRO International 2005 Annual Meeting -- Milwaukee Pre-Meeting Workshops. |
Advice Corner |
 |
Banish Those Unscored Application Blues
No one looks forward to an unscored application. After all, it means your application ended up in the bottom half of the review pile and didn't even get a full review. Is it an omen to mothball your lab coat? No! You've got lots of company -- please read on.
With streamlining, peer reviewers don't review applications the committee unanimously feels are in the lower half. But all kinds of application flaws can put you in that group.
Unscored applications can be, and often are, high quality and ultimately fundable. That's because some flaws, though fatal in review terms, can be easy to correct, e.g., not protecting the safety of lab workers or animals. Others are more serious, such as an unprovable hypothesis.
What to do? Stay objective, and spend time figuring out where the problems lie. Start by carefully reading the primary and secondary reviewers' critiques. Then get advice from your program officer and experts in your institution.
Our Research Funding site houses lots of practical advice and strategies based on the knowledge and experience of NIAID staff scientists. Go to Part 11b. Not Funded, Reapply in the NIH Grant Cycle: Application to Renewal and also visit Advice for Unfunded Applicants questions and answers.
Most importantly,if the problem is fixable, don't give up. Many applications do not succeed on the first try, including unscored applications. NIH gives you three tries to succeed: the initial application and two revisions.
Even if you don't succeed after three tries, you can keep your ideas alive. Place the best parts of your original application in a new one, so you can continue to pursue funding. Find out more in Part 11b. Not Funded, Reapply in the NIH Grant Cycle: Application to Renewal. |
 |
When Is a Human Sample "Human Subjects Research"?
Are you confused about whether human samples without identifiers are considered human subjects research? You're not alone -- it's confusing. Some people assume their research does not count as "human subjects" because their samples do not have identifiers. That assumption isn't always correct.
If you're using coded private information, data, or specimens, NIH will consider your research human subjects unless it meets two conditions: 1) you are not collecting samples by interacting or intervening with living people and 2)
you and your collaborators cannot identify the subjects.
Your research must meet both criteria. Generally, you would meet the first one by using samples only from previously conducted studies. You'd pass the second test by ensuring that the key to the code has been destroyed, having a binding agreement prohibiting your access to the key, or taking a similar measure.
Here are a couple of questions and answers that illustrate the concept:
I am proposing to work with an existing collection of coded specimens. My collaborators might be able to access the key to decipher the code. Is my research human subjects?
Yes. Although your samples are from previously conducted studies, if you or your collaborators can access the code you fail criterion number two.
I plan to collect specimens from living people and record the information
in a way that cannot be linked to them. Is this human subjects research?
Yes. Because of your direct involvement with living people, you do not meet the first criterion.
Even if you determine that your study is human subjects research, you could be exempt from some requirements. To find out, see Scenario C. Exempt Human Subjects Research in the PHS 398.
For further edification, go to OHRP's decision trees at Human Subjects Regulations Decision Charts, especially Is an Activity Research Involving Human Subjects Covered by 45 CFR Part 46?,
and the December 30, 2004, Guide notice. |
 New
Initiatives
|
|
|
Subscribe to Alerts
