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 grants.gov forms.

Tuesday, January 23, 2018

The shutdown is over!

Yesterday, President Trump signed a temporary funding bill that ended the shutdown.  It will keep our government open for approximately another 2 weeks, at which point hopefully an agreement can be made that prevents another shutdown.  For now at least, government employees are back at work and systems are up and running.

Sunday, January 21, 2018

How will the government shutdown affect NIH grants?

The government shutdown has everyone in the scientific community on edge.  How long will it last?  Will important projects be set behind due to temporary delays? Unfortunately, there is no way to predict how long this will last or how bad things will get.  A recently published news article in Nature describes many of the potential impacts of a prolonged shutdown.  For now, we do know that currently-funded research projects can continue to conduct business as usual.  However, no new grants will be awarded.  If federal workers are furloughed, it will delay questions and conversations with NIH program staff.  We can only hope that all sides come to a resolution that will keep our government going.  I am very disappointed in the Democrats who seemed to want this to happen to score political points.  The operations of the US government are not a game.

Sunday, January 7, 2018

Single IRB policy for multi-site trials

By Metropolitan Transportation Authority of the State of New York (Blizzard of 2015: Empty Grand Central Terminal) [CC BY 2.0 (http://creativecommons.org/licenses/by/2.0)], via Wikimedia Commons
The new policy requiring a single IRB for multi-site clinical trials goes into effect on January 25th, 2018.  All of your IRB approvals will now need to be routed through one IRB that will serve as a central hub.  For details, including links to the many previous NIH notices regarding this change, visit this page.

Friday, January 5, 2018

New changes to human subjects mean updated review criteria

NIH has released updated review criteria that will be used to evaluate grant applications proposing clinical trials.  According to NIH, the purpose of the expanded criteria is "to ensure that key pieces of clinical trial-specific information are submitted with each application and that reviewers appropriately consider this clinical trial-related information. Implementing new and more rigorous review criteria for evaluating clinical trial applications will ensure the highest likelihood of translating research results into knowledge that will improve human health."
The full description of the updated clinical trial-specific review criteria and rationale can be accessed here. 

Thursday, December 7, 2017

Is my grant a clinical trial?

It can be very confusing to determine whether your project meets the NIH definition of a clinical trial.  Given the new Forms-E that will be effective starting with January submission deadlines, it is now more important than ever to correctly characterize your project. 
NIH has provided investigators with a useful tool in order to make this determination.  This series of questions will help you to ascertain whether your proposed project meets the NIH definition of a clinical trial, which will help to guide you as you complete all of the newly required Human Subjects attachments.

Monday, November 27, 2017

Your final report will now be public

In a recently-released notice, NIH announced that all Project Outcomes sections from interim and final RPPR reports will be made public.  This applies to all submissions starting October 1, 2017.  The reports will be available in the NIH RePORTER.  This is an important step toward showing transparency in publicly-funded research.  It will be interesting to see how it is received by the public.  There has been considerable outcry in the past over NIH-funded research, including studies of sexy goldfish, origami condoms, and poop-throwing monkeys. Although this new policy is based on good intentions, I can't help but wonder if it will hurt scientists whose potential research impact is not obvious to those without particular scientific knowledge.  To help prevent this type of scrutiny, it is important to write your Project Outcomes section in clear language that can be easily understood by the public.