The Department of Medicine is pleased to be hosting a free research course from the National Institutes of Health (NIH), open to anyone interested in learning more about research:

“Introduction to the Principles and Practice of Clinical Research (IPPCR)” http://clinicalcenter.nih.gov/training/training/ippcr.html

The Introduction to the Principles and Practice of Clinical Research (IPPCR) is a supplemental course to train you on how to effectively conduct clinical research. The course focuses on the spectrum of clinical research and the research process by highlighting epidemiologic methods, study design, protocol preparation, patient monitoring, quality assurance, and Food and Drug Administration (FDA) issues. Other areas covered include data management and ethical issues, including protection of human subjects, building a budget, plus many special topics.

All are welcome to enroll. There is no fee for the course. You may view the course live, or via web-broadcast on your personal computer and at your own convenience. An optional, open-note exam from NIH will be given at the end of the course. All registered participants are eligible to take the exam to be awarded a Certificate of Completion from the NIH for the course.

The first session will be launched:

Tuesday, October 13, 2015

1:30 PM – 3:30 PM

LLU Medical Center A-Level Amphitheater

Thereafter, the live transmissions will take place twice weekly, on Mondays and Tuesdays from 2:00 – 3:30 PM at LLU Medical Center Room 1584.  See attached syllabus for more information. A syllabus will be provided to registered students, indicating meeting locations.

You must register to gain access to the IPPCR course and materials, whether you plan to view the course remotely or in person during the live stream.

To register, please go to: http://ippcr.nihtraining.com/register.php?remote_site=true

Select Loma Linda University, Department of Medicine from the “Name of Remote Site” drop-down menu, and fill in all required fields (indicated with red asterisks)

Registration closes on October 12, 2015 so please enroll prior to this date. 

 For more information, please email Courtney Bushey at cbushey@llu.edu

Learn how to appropriately and efficiently gain access to electronic medical records for research purposes.  Knowing the difference between clinical access and research access can make research easier and help you avoid the perils of privacy non-compliance.     See the attached flyer for more information about this timely and useful program, presented by Lila Dalton, Director of the Clinical Trials Center.

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 so we can have lunch ready for you. Seating is limited.

Click here to Register

Also, attendees who submit an evaluation form after the program will be entered into a drawing for a $25 gift card.  Congratulations to Tami Terry for winning the drawing for a $25 gift card at the last seminar.  

Thank you for your attention. We look forward to seeing you there.

Issued by
Center for Scientific Review (CSR)

Purpose

The purpose of this Notice is to inform new NIH applicants, their mentors, and grant administrators at their institution about two upcoming webinars the NIH Center for Scientific Review (CSR) is hosting in November 2015.  These webinars are designed to give participants useful insights into our application submission and peer review processes.  CSR is the portal for NIH grant applications and their review for scientific and technical merit.

Each Webinar Will Have a Different Focus

All of the webinars will run from 2:00 to 4:00 p.m. EST, including a 30 minute Q&A period.

Viewers Will See Presentations by Five CSR/NIH Experts

• The Review of Your NIH Grant Application Begins Here
• What You Need to Know about Application Receipt and Referral
• How Your Application Is Reviewed
• Key Things to Know About the NIH Grants Program  
• Jumpstart Your Career with CSR’s Early Career Reviewer Program (R01 webinar only)

How to Participate in the Webinar

• Go to www.csr.nih.gov/webinar to register for the webinar you wish to join by Monday, October 29.  You will not need to download special software.  You will just need a reliable Internet connection and browser.
• Submit questions for the Q&A session before or during the webinar by sending them to the moderator at AskExperts@csr.nih.gov. 

• Go to www.csr.nih.gov/webinar on the day/time your webinar is scheduled.  Click on the link that will be provided there to view it.

View Archived Webinars  

• View archived webinars and PowerPoint slides now: Our 2014 Meet the Experts in NIH Peer Review webinars for R01, R15, Small Business and Fellowship grants are available via our webinar webpage. 
• View our 2015 Webinars and PowerPoints about a month after broadcast: They will be posted on our webinar webpage.     

If you have general questions about the NIH application and review processes at other times, please visit the CSR or the NIH Grants and Funding websites. The NIH Information Service can address specific questions.  

Inquiries

Please direct all inquiries to:

Don Luckett    
Center for Scientific Review
Telephone: 301-435-1111
Email: AskExperts@csr.nih.gov

Notice Number: NOT-HD-15-028

Key Dates
Release Date:   August 20, 2015

Issued by
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)  

Purpose

This Notice serves to announce the launch of the NICHD Data and Specimen Hub (DASH), a centralized resource for researchers to store and access de-identified data from NICHD-funded research studies for the purposes of secondary research use.

NICHD DASH is available for NICHD-funded extramural and intramural investigators to house research data from studies when such data are ready for sharing as per the NIH Data Sharing Policy and the NIH Genomic Data Sharing Policy or in accordance with some other policy or interest.

NICHD DASH is a publicly accessible website. All users may browse and view information about studies and data archived in NICHD DASH. Users who are interested in submitting or requesting study data must register for a free account.

The Resources section of the website includes the NICHD DASH Policy, the NICHD DASH Data Use Agreement, a tutorial, answers to frequently asked questions, and other supplemental materials to orient new users.

By supporting data sharing through NICHD DASH, NICHD aims to accelerate scientific findings and improve human health.

Inquiries

Please direct all inquiries to:

Rohan Hazra, M.D.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6868
Email: hazrar@mail.nih.gov

Issued by
National Institutes of Health (NIH)

Purpose

The National Institutes of Health (NIH) is informing the research community that it will not fund research in which human pluripotent cells are introduced into non-human vertebrate animal pre-gastrulation stage embryos while the Agency considers a possible policy revision in this area.

Background

The field of regenerative medicine, largely through the use of human pluripotent cells, has progressed to the stage in which some scientists are considering employing early stage animal embryos to grow human tissue and organs. Currently, the NIH Guidelines for Human Stem Cell Research (http://stemcells.nih.gov/policy/pages/2009guidelines.aspx) include the following section that pertains to this type of research:

“Section IV. Research Using hESCs and/or Human Induced Pluripotent Stem Cells That, Although the Cells May Come from Eligible Sources, is Nevertheless Ineligible for NIH Funding”

This section governs research using hESCs and human induced pluripotent stem cells, i.e., human cells that are capable of dividing without differentiating for a prolonged period in culture and are known to develop into cells and tissues of the three primary germ layers. Although the cells may come from eligible sources, the following uses of these cells are nevertheless ineligible for NIH funding, as follows:

• Research in which hESCs (even if derived from embryos donated in accordance with these Guidelines) or human induced pluripotent stem cells are introduced into non-human primate blastocysts.
• Research involving the breeding of animals where the introduction of hESCs (even if derived from embryos donated in accordance with these Guidelines) or human induced pluripotent stem cells may contribute to the germ line.”

Given the rapid expansion of potential research models employed beyond the scope described above, NIH would like to undertake a deliberative process to evaluate the state of the science in this area, the ethical issues that should be considered, and the relevant animal welfare concerns associated with these types of studies.

Implementation

Effective with the date of this Notice, NIH will not fund any new or competing grant applications or contract proposals for research in which human pluripotent cells are introduced into non-human vertebrate animal pre-gastrulation stage embryos. This policy will be in place until NIH issues a subsequent policy notification.

• Current research funding: NIH will not consider requests for administrative supplements or revisions to any grants or modification to R&D contracts that include costs for or involve research introducing human pluripotent cells into non-human vertebrate animal pre-gastrulation stage embryos. Ongoing NIH awards will be addressed with the awardees on a case-by-case basis.
• Peer reviewed competing applications:  Any grant applications previously submitted to the NIH and already reviewed (through both the initial and Council levels of review) which propose to introduce human pluripotent cells into non-human vertebrate animal pre-gastrulation stage embryos will be held for funding decisions until NIH has issued a policy notification.  At that time, highly ranked applications can be modified, as necessary, to comply with the policy notification to receive full consideration for funding.
• Competing applications/contract proposals pending submission and/or peer review:  NIH will not review applications or contract proposals for research proposing to introduce human pluripotent cells into non-human vertebrate animal pre-gastrulation stage embryos until NIH has issued a policy notification. 
• Once the policy notification is released, applicants for grants that have not completed initial peer review will have the opportunity to submit additional post-submission material to comply with the policy notification.  Provided that the additional material can be sent 30 days before the initial peer review meeting, those grant applications will be reviewed and considered for funding.  See NOT-OD-10-115 for instructions and details.
• Once the policy notification is released, offerors for R&D contract proposals shall not submit additional material or information addressing the issue related to this notice after the cutoff date for receipt of proposals, unless directed to do so by the Contracting Officer.
• Applications that completed initial peer review before issuance of this Notice will not proceed to Council review at this time.  R&D contracts that have completed peer review and have been determined to be in the competitive range before issuance of this Notice may proceed to negotiations.
• Alternatively, applicants may withdraw the application and submit again at the next available due date. 
• No contracts proposing research in which human pluripotent cells are introduced into non-human vertebrate animal pre-gastrulation stage embryos will be awarded until further notice.

Inquiries

For questions regarding a specific application, please contact the assigned NIH program officer.

For questions regarding a specific contract proposal, please contact the assigned NIH contracting officer.

General inquires about this change may be directed to:

Division of Receipt and Referral
NIH Center for Scientific Review
csrdrr@mail.nih.gov
301-435-0715

Or

NIH Review Policy Officer
Office of Extramural Research
ReviewPolicyOfficer@mail.nih.gov