Wednesday, November 12, 2014

Medical Futility Blog: "Lethal Malformations" and Language of "Futility"

Medical Futility Blog: "Lethal Malformations" and Language of "Futility": In the October 2014 Seminars in Neonatal and Fetal Medicine , Dominic Wilkinson and colleagues discuss the use of language surrounding severe congenital malformations.  This seminar brings up a very important issue that is important for everyone engaged in clinical research.  The terms that are used to describe various abnormalities may inadvertently confer some type of clinical judgement.  For example, calling a condition such as anencephaly "incompatible with life" infers that a baby with the condition will not survive, even though babies with the condition can survive for a period of time.  I highly recommend listening to this seminar and giving thought to how it may apply to your line of research. 

Tuesday, November 11, 2014

Top 10 Things Reviewers Should NOT Say in a Review

This list from the Center for Scientific Review made me chuckle.  The list provides advice to reviewers that includes 10 things they should not say when reviewing grants.  Unfortunately, I have seen several of these comments on summary statements.  The one I have seen the most is the "fishing expedition" comment.  Sometimes, though, reviewers have to call a spade a spade.  Some proposals (my own included) really do qualify to be called fishing expeditions.

Monday, November 10, 2014

Center for Scientific Review webinars

The Center for Scientific Review presented a series of webinars this month for potential applicants.  The webinars each include presentations by experts from NIH, as well as question and answer periods at the end.  If you missed your chance to view the webinars, don't worry.  They will all be posted at this link very soon.  I highly recommend the R01 webinar for those who are new to the application process or who have not successfully competed for an R01 grant in the past. 

OppNet helps behavioral and social sciences researchers find funding opportunities

If your research is applicable to the areas of behavioral or social sciences, you should familiarize yourself with OppNet.  Presented by NIH, OppNet's mission is "to pursue opportunities for strengthening basic behavioral and social science research (b-BSSR) at the NIH while innovating beyond existing investments".  OppNet is collectively managed and funded by all NIH institutes and centers.  Find out more about OppNet's current funding here.  There is also a regularly updated page of current NIH funding opportunities related to behavioral and social science research here.

Friday, November 7, 2014

Just what is a clinical trial, anyway?

In a recent notice, NIH revised its definition of "clinical trial".  This change was made in a effort to better distinguish between clinical research studies and clinical trials, to ensure that the appropriate level of oversight is provided to each type of project.  This new definition will apply to competing grant applications with deadlines of January 25, 2015 and beyond. 

The new NIH clinical trial definition is as follows:
A research study1 in which one or more human subjects2 are prospectively assigned3 to one or more interventions4 (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.5
1See Common Rule definition of research at 45 CFR 46.102(d).

2See Common Rule definition of human subject at 45 CFR 46.102(f).

3The term “prospectively assigned” refers to a pre-defined process (e.g., randomization) specified in an approved protocol that stipulates the assignment of research subjects (individually or in clusters) to one or more arms (e.g., intervention, placebo, or other control) of a clinical trial.

4An intervention is defined as a manipulation of the subject or subject’s environment for the purpose of modifying one or more health-related biomedical or behavioral processes and/or endpoints. Examples include: drugs/small molecules/compounds; biologics; devices; procedures (e.g., surgical techniques); delivery systems (e.g., telemedicine, face-to-face interviews); strategies to change health-related behavior (e.g., diet, cognitive therapy, exercise, development of new habits); treatment strategies; prevention strategies; and, diagnostic strategies.

5Health-related biomedical or behavioral outcome is defined as the pre-specified goal(s) or condition(s) that reflect the effect of one or more interventions on human subjects’ biomedical or behavioral status or quality of life. Examples include: positive or negative changes to physiological or biological parameters (e.g., improvement of lung capacity, gene expression); positive or negative changes to psychological or neurodevelopmental parameters (e.g., mood management intervention for smokers; reading comprehension and /or information retention); positive or negative changes to disease processes; positive or negative changes to health-related behaviors; and, positive or negative changes to quality of life.

Wednesday, November 5, 2014

Plan now for upcoming AHRQ opportunity

NIH released a notice this week describing a new request for U19 applications that will be released over the winter.  This funding opportunity, issued by the Agency for Healthcare Research and Quality (AHRQ), will promote the dissemination of patient-centered outcomes research findings through clinical decision support.  Applications are expected to be due in Spring 2015. 

Thursday, October 23, 2014

Calling all superstar doctoral students!

The RFA was just released for the NIH Director's Early Independence Awards (DP5).  This program is designed for people who are ready to launch independent research careers without completing postdoctoral fellowships.  Only 2 applications per institution will be accepted, and only 10 total grants will be awarded.  If you are close to the completion of your doctoral training and have a significant record of publication and promising research ideas, talk to your mentors and other senior researchers about applying for this opportunity.

Wednesday, October 22, 2014

Just in Time for the party?

Hooray!  It's time to celebrate!  My grant was reviewed and the JIT link popped up in the era commons.  This must mean my proposal is within funding range, right? 


In previous years, the JIT link only became active in the commons if scores fell within certain percentiles.  However, this has been changed, and JIT will appear in the commons after every proposal is reviewed.  The only way to know if it is really needed is if the PI receives an email request for information from NIH. 

For more information about how to access JIT in the era commons and how the requested information should be submitted, view this helpful video from NIH:

Tuesday, October 21, 2014

New NIH video provides top 10 electronic grant submission tips

The NIH eSub Top 10 video was created by NIH to offer tips to prevent commons errors in electronic grant submission.  Some of these tips are very basic, but overall the video provides a helpful primer for people who are new to electronic submission of grant proposals.