Friday, March 16, 2018

What does it mean when your NIH grant application is "Not Discussed"?

Although it is a few years old, this helpful article from NIAID provides an overview of the proposal review process that explains what it means for a proposal to be classified as Not Discussed.  This designation is also referred to by some of the old-school folks as "unscored" or "bottom-halved".  Interestingly, the article advises that, in some circumstances, it is a good idea to resubmit a Not Discussed proposal.  This is contrary to a common notion that proposals that are not scored should be significantly revamped and submitted as new.  As the article advises, it is important to contact the appropriate staff member from the relevant Institute/Center to discuss the application and your next steps.

Monday, March 12, 2018

Avoiding Grant Scams

Avoid Grant Scams: No legitimate federal government employee would ever call you and tell you that you qualify or have been approved for a grant for which you never applied. This helpful page from NIH helps you to spot and avoid a grant scam.

Thursday, March 1, 2018

Preliminary data: the perpetual problem of the chicken or the egg

NIAID recently published a helpful article about the importance of preliminary data in strengthening your grant application.  Although this article is somewhat specific to NIAID applicants, the overall message is relevant to everyone: preliminary data is important, and may be your key to getting funded.  Even R21 applications, which by definition do not technically require preliminary data, are strengthened by the addition of relevant preliminary data. 

Wednesday, February 28, 2018

Rare Disease Day- February 28th

Today marks the 11th anniversary of Rare Disease Day.  This day is observed internationally in an effort to bring more attention to rare, understudied diseases.  Here are some events happening today that may be of interest to the academic community:

Want to know more about which diseases are classified as rare?  A full list is located here.

What does the fiscal year 2019 budget mean for NIH funding?

The budget for the 2019 fiscal year proposed by President Trump on February 12th included some modifications to NIH funding.  Importantly, though, the budget would remain at a similar level to the ones in recent years.  This would mean no major cuts or caps on indirects.  However, the new budget does propose the creation of  the National Institute for Research on Safety and Quality, which would replace the Agency for Healthcare Research and Quality (AHRQ), and moving both the National Institute of Disability, Independent Living, and Rehabilitation Research and the National Institute of Occupational Safety and Health (NIOSH) under the NIH umbrella.  The proposed budget also seeks to reduce the amount of salary an investigator can receive from NIH grants and cap the amount of salary each can receive at 90%.  For more information about how the proposed budget impacts the NIH, CDC, and FDA, click here.

Tuesday, February 27, 2018

New NIH human subjects requirements will encourage you to befriend statisticians

As if data science experts couldn't get any more valuable, NIH has given us one more reason to bestow chocolate, baked goods, lunches, and other gifts upon our statistician colleagues in order to remain at the top of their long lists of priorities. The new Statistical Design and Power attachment is required for NIH applications that propose a clinical trial.  In this section, you must include statistical power calculations and analysis plans for each Outcome Measure listed in the fields in section 4.3 of the human subjects form.

The Statistical Design and Power attachment must include the following for each outcome measure:

  • number of subjects you expect to enroll
  • expected effect size
  • power
  • statistical methods to be used
As you can imagine, it is virtually impossible to write this section well without the full involvement of a qualified statistician. Yes, much of this information will duplication what is included in the Approach section of your Research Strategy, but the attachment requires a more in-depth level of detailed explanation than is often included in the text due to space constraints. 

Tuesday, February 13, 2018

NIH’s New Rules Governing Human Research Go Into Effect

NIH’s New Rules Governing Human Research Go Into Effect: More than 3,500 scientists had signed an open letter to NIH Director Francis Collins opposing the rules change.

With some backtracking, the new rules are here to stay, at least for the time being. 

Monday, February 5, 2018

NIH forms E Human Subjects and Clinical Trials Information Form- Try this video before you bang your head against the wall

This video will show you all of the required fields on the new Human Subjects and Clinical Trials Information Form that is required of all Forms E applications as of January 25, 2018.  That's right- not only are there an obscene number of new attachments, but there are also required form fields that must be completed.  Some of this is repetitive of information provided elsewhere in the application, but some is not.  For example, be prepared to provide the date of enrollment of your first subject.
Eventually we will all get used to this, but right now it is a steep learning curve and the February R21 deadline is proving to be quite painful for many of us.  Hopefully by the time the next cycle rolls around, NIH will provide us with examples to help decipher what is needed in each section of the application.

Tuesday, January 30, 2018

Training grant human subjects requirements are incorrect in Forms E instructions

According to a recently-released NIH notice, the Forms E instructions incorrectly advise that a human subjects section attachment is required for institutional training (T series) grant proposals.  The correction states that no human subjects attachments are required, even if the box to select "yes" to human subjects is checked on the forms.