Among the fruits of LLU research and scholarship are possible new products to benefit society in the realms of healthcare and science.  The path to make this happen is through commercial and private partnerships managed by our Technology Transfer Office (TTO).  Come hear Eric Gosink, PhD, new Director of the TTO explain patents and intellectual property, licensing, material transfer agreements, and confidentiality agreements. Also, learn what kinds of assistance may be available to develop and support business derived from great ideas spawned right here.

The seminar will be held in the Research Affairs main conference room from 12-1pm. Physicians attending this session will earn CME. 

You must register to receive credit and a healthy lunch. Seating is limited.

 Please click link   Register

Did you know that well-qualified volunteers with a passion for research are looking for investigators like you?

If you have ancillary tasks that need to get done to keep your research on-track, a  volunteer can do some of those for free.  And, they will likely be enthusiastic about it even if the tasks are very basic, just for the opportunities to be in a research environment, make contacts, and to contribute to projects of value.  

Some volunteers also have more advanced skills for you to employ. 

That is our situation at the moment (and is not always the case).   We have a Loma Linda graduate from our School of Public health who just received his Masters in Public Health (MPH) with a concentration in biostatistics  He has completed all the  prerequisites with Volunteer Services, which means he is background-checked, badged, and ready-to-go to support your research.  His resume is attached, where you will find diverse research experiences.   

If you have a need for someone like this, do call quickly so you are not disappointed.

Contact information: 

Majed Ramadan

1905 Orange ave, apt #704                         

Redlands CA 92373                        

(909) 379-4779, mramada1979@gmail.com

“Scientific and technological breakthroughs that have arisen from NIH-supported research account for many of the gains that the United States has seen in health and longevity,” said NIH Director Francis S. Collins, M.D., Ph.D. “But much remains to be done. This strategic plan will guide our efforts to turn scientific discoveries into better health, while upholding our responsibility to be wise stewards of the resources provided by the American people.”

The plan focuses on four essential, interdependent objectives that will help guide NIH’s priorities over the next five years as it pursues its mission of seeking fundamental knowledge about the nature and behavior of living systems and applying that knowledge to enhance health, lengthen life, and reduce illness and disability. The objectives are to:

1. advance opportunities in biomedical research in fundamental science, treatment and cures, and health promotion and disease prevention;
2. foster innovation by setting NIH priorities to enhance nimbleness, consider burden of disease and value of permanently eradicating a disease, and advance research opportunities presented by rare diseases;
3. enhance scientific stewardship by recruiting and retaining an outstanding biomedical research workforce, enhancing workforce diversity and impact through partnerships, ensuring rigor and reproducibility, optimizing approaches to inform funding decisions, encouraging innovation, and engaging in proactive risk management practices; and
4. excel as a federal science agency by managing for results by developing the “science of science,” balancing outputs with outcomes, conducting workforce analyses, continually reviewing peer review, evaluating steps to enhance rigor and reproducibility, reducing administrative burden, and tracking effectiveness of risk management in decision making.

“We are faced with extraordinary opportunities that demand exceptional attention if their promise is to be fully realized. Implementing these objectives will enable the more than 300,000 researchers supported by NIH across the nation and around the world to drive science further and deliver cures faster,” said NIH Principal Deputy Director Lawrence A. Tabak, D.D.S., Ph.D.

To inform development of the strategic plan, Dr. Tabak said NIH solicited input from a wide range of stakeholders through a Request for Information, which generated more than 450 responses; a series of interactive webinars, which attracted more than 750 participants; and meetings with 21 NIH advisory councils, including the Advisory Committee to the NIH Director.

The plan concludes with a bold vision for NIH, listing some specific achievements and advances that the agency will strive to deliver over the next five years. These aspirations include:

• Many thousands of cancer patients will experience enhanced survival from application of precision medicine.
• A candidate vaccine that induces a broad antibody-binding response to multiple strains of the influenza virus will be in clinical trials — a critical step toward a universal flu vaccine.
• NIH-supported research will develop effective, tailored behavioral and social interventions to promote health and prevent illness in populations that experience health disparities.
• Application of pharmacogenomics in real-world clinical settings will lead to improved outcomes in the use of several drugs.
• A pivotal efficacy trial of a novel HIV vaccine, expected to begin in the Republic of South African in 2016, will confer at least 50% protection against the acquisition of HIV.
• NIH-supported clinical trials will show that at least a half-dozen interventions thought to be clinically beneficial actually have no value.
• Radical new methods for structural biology will revolutionize drug screening and optimization.
• NIH-supported research will directly contribute to FDA-approved therapies for at least a dozen rare diseases.
• Application of certain mobile health (mHealth) technologies will provide rigorous evidence for their use in enhancing health promotion and disease prevention.
• A wearable biosensor for monitoring blood-alcohol levels in real time will be developed and show efficacy for preventing alcohol-related injury and disease.
• Technologies to reverse paralysis and restore some normal functions will be available to spinal cord injury patients.
• Vaccines against respiratory syncytial virus will be field tested for efficacy, promising a solution for this leading cause of childhood pneumonias.
• Research on the artificial pancreas will lead to advanced trials showing significantly better management of diabetes, without dangers of hypoglycemia.
• NIH will be known as the model agency for applying the scientific method to itself — for learning and implementing in a rigorous way, how best to support biomedical research.

Over the next five years, NIH leadership will evaluate the agency’s progress in meeting the objectives laid out in the strategic plan, which will be a living document that will be open to refinements throughout its life-cycle.

The NIH-Wide Strategic Plan, Fiscal Years 2016–2020: Turning Discovery Into Health can be found at: http:///www.nih.gov/sites/default/files/about-nih/strategic-plan-fy2016-2020-508.pdf

About the National Institutes of Health (NIH): NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.

Original story can be found at: http://www.nih.gov/news-events/news-releases/nih-unveils-fy2016-2020-strategic-plan

NIH has recently announced that Rigor and Transparency must also be addressed in all progress reports (RPPRs) that are due on or after January 25, 2016. Specifically:

"By January 25, 2016, the Research Performance Progress Report (RPPR) instructions will be updated to include the following additional guidance for 6.2 Section B - Accomplishments, in addition to the existing instructions.  Progress reports submitted on or after January 25, 2016 that are initiated prior to the instruction updates may use the current forms while following these additional instructions.  The instructions that will address rigor are listed below for your convenience.

B.2 What was accomplished under these goals?

Include the approaches taken to ensure robust and unbiased results.

B.6 What do you plan to do for the next reporting period to accomplish these goals?

Discuss efforts to ensure that the approach is scientifically rigorous and results are robust and unbiased."

More information and background can be found in NOT-OD-16-031.

It is hard to believe 2016 is just around the corner. With the new year comes new forms and new grant policies (NOT-OD-16-004, NOT-OD-16-005).

Our updated application forms (we’ll be calling FORMS-D) must be used for applications for due dates on or after (but not before) May 25, 2016 and you’ll start seeing the updated forms and instructions showing up in funding opportunity announcements by March 25, 2016. You’ll be hearing a lot from me about FORMS-D between now and then.

Some of our policy changes couldn’t wait (or didn’t need to wait) for our FORMS-D forms and will take effect for applications for due dates on or after January 25, 2016. We have new instructions for research and career development applications that specify what we want to see in terms of rigor to enhance the reproducibility of NIH funded research. We redefined the age of a child for the purposes of NIH's inclusion policy to individuals under 18 years old instead of under 21 years old. We also updated guidance for the vertebrate animal and training program plan sections of applications – including a reduction in data collection. Wow – reduction in data collection – that’s a rare and wonderful concept!  

We strive to have revised guidance available to you at least 60 days prior to the first due dates for which the changes apply. For January changes, that means by November 25, 2015 we’ll post an updated FORMS-C application guide. By that date, you will also see a link to revised review language in our active research and career development funding opportunity announcements.

There are certainly a lot of changes ahead, but it was the same last year and the year before that. We are constantly in a state of change and somehow it always seems to work out just fine.

Eyeballs Catch Stuff Systems Don’t

People have eyeballs. Systems typically don’t have eyeballs. People interpret situations and circumstances to make decisions. Systems take actions based on clearly defined rules. Why is this important? When checking application compliance against documented business rules, some checks can be easily automated and others are best left to actual people with eyeballs and cognition.

We talk a lot about showstopper errors identified by eRA systems that can prevent your application from moving on to our division of receipt and referral for NIH processing. We don’t often talk about the manual checks done by our staff once your application gets to them.

Here is some of the stuff our staff look for…

• Does the topic of the application fit NIH’s mission?
• Is the applicant eligible to apply? 

For example, if applying to the AREA (R15) program do the applicant organization and PI meet the eligibility requirements specific to that program?

• Does the application include all critical sections?

Our systems can tell if you attached a pdf document in a certain spot in the application, but can’t assess the content of that attachment. We’ve received all sorts of “unintended” attachments over the years from our own application guide instructions to a great recipe for cranberry margaritas (true story). To be fair, the recipe makes excellent margaritas (I’ll be making them again this holiday season), but it was a poor substitute for a research strategy.

• Does the application include information in inappropriate places to get around page limits?

We refer to the use of appendices and other non-page limited application sections to augment information in page limited sections as “overstuffing” your application (NOT-OD-11-080, NOT-OD-07-018). Your specific aims, research strategy, abstract, biosketches and other application attachments have page limits for a reason – to provide a fair and level playing field to convey information. We take that “fairness” thing pretty seriously around here.

• Was the application submitted on-time?

Unlike many agencies, NIH does not shut down the ability to submit to a funding opportunity announcement at 5:01 pm on a due date. We keep the submission door open and assess the circumstances of “late” submissions on a case-by-case basis. Staff check your cover letter submitted with your application for documented circumstances allowed under our late policy. They check to see if the application falls under our continuous submission policy. They also check to see if you ran into any system issues along the way and appropriately notified the eRA service desk to document them.

• Do you already have an application with essentially the same content under review?

Even under our latest submission rules which allow you to submit the same application again, you can’t have overlapping applications under review at the same time (NOT-OD-14-074).

• Does your application adhere to FOA-specific instructions in Section IV – Application and Submission Information?

Instructions in this section are often not systematically enforced, since they are exceptions from our general guidance. So, don’t rely on system checks to catch page limits and missing attachments documented in this section.

• If reference letters apply, were the correct number of reference letters received by the due date?
• Did you follow font and margin guidelines documented in the application guide when preparing all your attachments?
• If requesting over $500K in direct costs in any budget period, did you have institute permission to submit?
• If human embryonic stem cells are indicated, were all restrictions for their use met?

Although you may not have seen this particular list of checks before, I doubt there are a lot of surprises. The real takeaway here is that system checks are great (begin shameless plug – The Validate Application feature in ASSIST is awesome!  – end shameless plug), but they are not the whole story when it comes to assessing whether an application meets all the conditions to be accepted for review and funding consideration.

When submitting your application, don’t just think about getting through our systems. Stop to think how your application will hold up to the scrutiny of someone with eyeballs.

Mistakes Are Meant for Learning, Not Repeating – Biosketch Compliance

On November 5, NIH started sending email notifications to applicants indicating reviewers found one or more biosketches that did not comply with our current biosketch format (NOT-OD-15-032). Hundreds of letters have already gone out. If you’ve received one of these notifications, don’t panic. These letters are currently just warnings and require no action on your part. However, they do demonstrate NIH’s commitment to enforcing compliance with our biosketch policy.

What does it mean to have a compliant biosketch?

eRA systems ensure some biosketch rules are met by flagging errors upon submission. Applications that violate these rules won’t even move forward to NIH for consideration.

• A biosketch is attached for each and every Sr/Key person listed in the application
• Each biosketch is less than or equal to 5 pages
• Each biosketch attachment is in PDF format

But, there are additional rules you must follow to be compliant that aren’t systematically caught by eRA systems.

• Include each section (A - Personal Statement; B – Positions and Honors; C – Contributions to Science; D – Research Support or Scholastic Performance)
• Include no more than 5 contributions to science with no more than 4 citations per contribution
• Ensure that if you include the optional link to a full list of your published work in a site like My Bibliography that the URL is public, accessible without providing any login or personal information, and doesn’t link to websites that may violate page limit rules
  • Note: We will restrict this link to federal (.gov) sites beginning with applications to due dates on/after May 25, 2016 (NOT-OD-16-004)
  • Refrain from including information, such as preliminary data, that belongs elsewhere in the application
  • Follow NIH guidance on font type, font size, paper size, and margins (See section 2.6 of application guide)

Did you catch the part where I said “reviewers found” the non-compliant biosketches? We have provided instructions to our reviewers to flag any applications with biosketches that don’t follow current guidelines. Don’t make extra work for your reviewer – give them a clean application without the distraction of non-compliant formatting they have to write up.

Having trouble keeping up with NIH’s biosketch rules and getting your key personnel to follow them? Encourage people participating on your application to use SciENcv. Not only does SciENcv help manage biosketch information, it also creates perfectly compliant biosketches.

If you’ve received a warning letter, learn from your mistakes and don’t repeat them. Eventually, these warning letters will be replaced with notifications that applications have been removed from consideration. You’ve been warned (queue foreboding music in your head).

Thought for the Day

Gratitude can transform common days into thanksgiving,

turn routine jobs into joy,

and change ordinary opportunities into blessings.

–William Arthur Ward, writer

Sheri Cummins

Communications & Outreach

NIH Office of Extramural Research

cumminss@mail.nih.gov