Pre-registration is required and a continental breakfast will be provided.

To register, go to http://www.surveymonkey.com/s/DataCommunication.

For more information download a flyer or contact Crystal Evans at cevans20@jhmi.edu or call 410-550-2281.

• traditional ecological (air, soil and water)
• vector-born or zoonotic diseases
• human flora and built (home, hospital and community)

Johns Hopkins faculty are eligible to apply. The application deadline is Thursday, November 15, 2012.

Applications may be submitted using ICTR Connection Request. For more information click here or call Yvonne Higgins at 410-614-0440.

Click here to download a flyer with information about all of the sessions. To register for these free workshops, email Julie Simon.

I am very pleased to make you aware of a change in the research participant parking program that I have negotiated with the JH Parking office!

The documents below (one for Adult OPD and one for PCRU), describe a MUCH reduced rate for purchasing parking stamps, how to get this rate, and a parking map to each of the CRU units.

Aimed at scientists, clinicians, and support personnel fully engaged in clinical investigation or its regulation, this five course award program is designed to support translational clinical research by teaching the necessary skills to design, analyze, and interpret clinical investigations and implement studies in compliance with ethical and regulatory norms.

Click here for a flyer with more information about this innovative program.

Click here to download a flyer with information about all of the sessions. To register for these free workshops, email Julie Simon.

This grant is designed to support research projects conducted by JHU investigators that are aligned with JHHC strategic priorities, including the design of health care models that reduce costs and improve health, and translational research that leads to improved patient care. After receiving multiple promising applications, JHHC, which funds the program, and ICTR, which administrates it, plan to collaborate again to make this an annual grant.

“This is just the first example of a greater partnership between Johns Hopkins HealthCare and the ICTR,” says Director Dan Ford. “We are all deeply interested in population health, and we are excited about the potential of Dr. Cheng’s work to improve infant outcomes through more integrated maternal care.”

This community health-focused research effort will also include the School of Medicine, the School of Public Health, and Johns Hopkins Community Physicians.

The Johns Hopkins Institute for Clinical and Translational Research (ICTR) cordially invites you to attend The Third Annual Henrietta Lacks Memorial Lecture on Saturday, October 6, 2012, from 10:00 am to 1:00 pm in Turner Auditorium on the East Baltimore (Medical) Campus. Continental breakfast and check-in begin at 9:00 am. The program will begin at 10:00 am, and will feature a talk by David Ewing Duncan, author of Experimental Man: What One Man's Body Reveals about His Future, Your Health, and Our Toxic World and Masterminds: Genius, DNA, and the Quest to Rewrite Life. The program will be followed by a lunch reception and book signing, with book copies available for purchase.

The goal of this event is to describe the reach and complexity, both biomedically and ethically, of the story of Henrietta Lacks and HeLa cells as well as to provide some insight into the past, present, and future of the conduct of clinical research. By honoring Mrs. Lacks and the positive global impact of HeLa cells through this lecture series, ICTR also hopes to draw attention to the thanks and honor due to everyone who participates in the clinical research process.

This event is free and open to the public. Advance registration is required. View and download an event flyer here.

Read the full article here.

This week, NCATS announced five new industry collaborators in this initiative, along with new funding opportunity information and the 58 compounds the companies are making available. Abbott, Bristol-Myers Squibb Company, GlaxoSmithKline, Janssen Pharmaceutical Research & Development, L.L.C., and Sanofi now have joined Pfizer, AstraZeneca, and Eli Lilly and Company in this innovative approach to research.

NCATS created the Therapeutics Discovery program to re-engineer the research pipeline. By crowdsourcing compounds that already have cleared several key steps in the development process, including safety testing in humans, scientists nationwide, and NIH intramural researchers have the opportunity to contribute their expertise to advancing these resources for new disease therapies.

For more information, please see the NCATS news release at http://www.nih.gov/news/health/jun2012/ncats-12.htm.

If you are interested in participating in clinical research projects, then the Johns Hopkins Clinical Research Network (JHCRN) would like to know about you.

The JHCRN is an integrated network of academic and community-based clinical researchers in Maryland, Washington DC, and Northern Virginia which includes Johns Hopkins Medicine, Anne Arundel Medical Center (AAMC), Greater Baltimore Medical Center (GBMC), INOVA Health System, and Peninsula Regional Medical Center (PRMC).

• "This publication was made possible by Grant Number UL1 RR 025005 from the National Center for Advancing Translational Sciences (NCATS) a component of the National Institutes of Health (NIH), and NIH Roadmap for Medical Research. Its contents are solely the responsibility of the authors and do not necessarily represent the official view of NCATS or NIH."

• "The project described was supported by Grant Number UL1 RR 025005 from the National Center for Advancing Translational Sciences (NCATS) a component of the National Institutes of Health (NIH), and NIH Roadmap for Medical Research, and its contents are solely the responsibility of the authors and do not necessarily represent the official view of NCATS or NIH."

Thank you for your cooperation in acknowledging the ICTR's support in your publicaitons.

To view the newsletter, visit:

http://ncats.nih.gov/ncats/newsletter/E-newsletter.html

Faculty, students, researchers and others involved with scientific research can access this platform and share information. To begin using this system, visit http://jhu.researchaccelerator.org.

Dr. Flexner is both ICTR Deputy Director for Clinical Research Resources and Facilities and Program Director for the ICTR Clinical Research Units.

If you would like your clinical trial to be considered for these publications, please send an IRB-approved brief summary to Brittany Garcia in Marketing and Communications at brittany.garcia@jhmi.edu.

NCATS will study the steps in diagnostics and therapeutics development, testing, and implementation into patient care; identify bottlenecks amenable to re-engineering; and experiment with innovative methods to streamline the process. NCATS will complement--not compete with-- translational research being carried out by the private sector. By focusing on the development of innovative new ways of conducting therapeutic and diagnostic discovery, as opposed to developing therapeutics themselves, NCATS can enable others to bring safer and more effective treatments to patients.

For more information about this important transition, click here for the full NIH press release.

This service is free and available to Johns Hopkins faculty, staff, and students, as well as service providers and community leaders from organizations throughout Greater Baltimore. While a main focus of the ICTR is on research conducted throughout Greater Baltimore, consultations can take place for projects conducted with communities outside of Greater Baltimore.

To learn more, go to http://ictr.johnshopkins.edu/communityconsult.

To apply for this service, if you have a JHED ID you can select "ICTR Connection Request" from the side menu or go directly to http://ictr.johnshopkins.edu/connection. If you do not have a JHED ID, you can request a consultation by sending an email to Shardai Thomas at Sthoma81@jhmi.edu or calling her at 410-550-9026.

Last March, the Johns Hopkins Medicine Human Research Protection Program implemented new compliance training recertification requirements for principal investigators (PIs) engaged in human subjects research (HSR). PIs must complete recertification within five years of initial certification and every five years thereafter. Although our original deadline for completion was January 1, 2012, we are extending the deadline until March 15, 2012. After March 15, the JHM IRB will not accept new applications from PIs who have HSR training more than 5 years old and have not completed recertification.

I am concerned that many PIs have not started or completed their recertification. More than 1000 PIs need to recertify this year. To date, less than 110 have completed recertification, 340 have started but not completed, and more than 590 have not started.

The morning session featured the announcement of the first recipient of the Urban Health Institute’s Henrietta Lacks Memorial Award. This $15,000 award, previously known as the Henrietta Lacks Award for Community-University Collaboration, was given to Newborn Holistic Ministries to support their work with the underserved in the Sandtown-Winchester and Upton communities.

Here is one review of his role in advancing the principles of clinical research.

Thanks to all those who attended the event. For a summary of the day, click here.

The Johns Hopkins Institute for Clinical and Translational Research (ICTR) cordially invites you to attend the Henrietta Lacks Memorial Lecture: HeLa Reflected on Saturday, October 1, 2011, from 9:30 am to 3:00 pm, in Turner Auditorium on the East Baltimore (Medical) Campus.

The program will feature a talk by Medical Apartheid and Deadly Monopolies author Harriet Washington, other special guests, and presentations on the scientific and social relevance of HeLa cells. As this year marks the 60th anniversary of both the world-changing discovery of HeLa cells and of the passing of Mrs. Henrietta Lacks, in addition to the lecture we will be holding a number of breakout sessions, panels, and associated educational activities throughout the day. The program will include a lunch reception and book signing, with book copies available for purchase.

This event is free and open to the public. Advance registration is required.

The goal of this event is to describe the reach and complexity, both biomedically and ethically, of the story of Henrietta Lacks and HeLa cells as well as to provide some insight into the past, present, and future of the conduct of clinical research. By honoring Mrs. Lacks and the positive global impact of HeLa cells through this lecture series, ICTR also hopes to draw attention to the thanks and honor due to everyone who participates in the clinical research process.

The DDRS is composed of a free repository of regulatory knowledge, guidance and reporting documents, and useful templates. In addition, the DDRS offers a Project-Specific Consultation Service for those investigators seeking guidance and assistance with the preparation of FDA IND and IDE submissions and/or management of investigational products post application submission to the FDA. The Project-Specific Consultation Service includes a complimentary eight-hour consultation, with additional support available on a fee-for-service basis.

So, if you or your principal investigator are working with an investigational drug or device and are in need of guidance with regard to navigation of FDA regulations and required submissions, please visit the ICTR DDRS website at http://ictr.johnshopkins.edu/DDRS. If you have questions for the DDRS, please submit a Connection Request to the new service via the ICTR Connection Request system.

The Office of Human Research Protections (OHRP) in the Department of Health and Human Services is proposing some substantial changes to the Common Rule governing human subjects research in the United States. The proposed changes range from reducing need for IRB review for low-risk studies to require consent for use of all biospecimens, even those previously categorized as de-identified. It is early in the process, and OHRP is asking for feedback from the research community.

Aimed at scientists, clinicians, and support personnel fully engaged in clinical investigation or its regulation, this five-course certificate series is designed to support translational clinical research by teaching the necessary skills to design, analyze, and interpret clinical investigations and implement studies in compliance with ethical and regulatory norms.

Click here to download a flyer with more information about this innovative program.

This is a reminder that all principal investigators who completed the Human Subjects Research course more than five years ago must complete recertification by Jan. 1, 2012. After that date, you will not be able to submit new eIRB applications until recertification is complete.

• A variety of recertification learning activities are available.
• PIs must obtain 100 points to complete recertification.
• Course registration and points are tracked through myLearning.

The JHCRN was established by Johns Hopkins Medicine (JHM) in early 2009 and includes Anne Arundel Medical Center, Greater Baltimore Medical Center and Inova Health System, plus the medical centers that comprise Johns Hopkins Medicine. JHCRN creates a bridge for research between Hopkins and community-based medical centers by linking physician-scientists and staff from the Johns Hopkins Medical Institutions with community-based medical centers in the region, and makes clinical trials available to patients who may not ordinarily have access to them.

Network Increases Research Opportunities for Patients Throughout the Region

The JHCRN, which was established by Johns Hopkins Medicine (JHM) in early 2009, included Anne Arundel Medical Center and Greater Baltimore Medical Center as the first non-JHM members, creates a bridge for research between Hopkins and community-based medical centers by linking physician-scientists and staff from the Johns Hopkins Medical Institutions with community-based medical centers in the region. It serves several purposes, the most important of which is to make clinical trials available to patients who may not ordinarily have access to them.

Click here to register.

If you are currently considering or addressing any ethical issues that are related to the development, conduct, or analysis of a research study at Johns Hopkins, we hope you will consider this service. To access the expert assistance and support of the ICTR RECS consultants, go to ictr.johnshopkins.edu/researchethicsconsult.

The main focus group of this webinar is informatics-oriented, but the workflow sharing may be of interest to the larger research community. For more description and dial-in information, visit the CVRG homepage.

The Johns Hopkins Medicine Human Subjects Protection Program has not had any requirements for recertification for principal investigators engaged in human subjects research. We are now joining with many of our peer institutions to institute a new recertification program for principal investigators.

At this point, regulatory agencies are giving IRBs the freedom to institute recertification programs that are tailored to be relevant and useful to our research teams. Recertification should be viewed as an opportunity for continuing education in ethical research practices.

Designed to facilitate faculty research and project collaboration, the information in SciVal Experts is based on published output indexed in the PubMed database. It can help research personnel:

• put together multidisciplinary teams to tackle translational and big-science research projects;
• help keep up with the constant influx of new faculty and post-docs who might be working in a related area;
• find a potential mentor;
• know if there is a JHMI investigator who focuses on similar work in a complementary translational phase.

ICTR Retreat Presentations

You can find the article online at http://articles.baltimoresun.com/2010-12-15/news/bs-ed-michael-fox-research-20101215_1_biomarkers-alzheimer-s-disease-neuroimaging-initiative-disease-research.

Housed in the Department of Epidemiology in the Bloomberg School of Public Health, the interschool CCT is dedicated to the promotion of clinical trials as a method of evaluation of preventive and therapeutic approaches to health problems. Directed by Milo Puhan, MD, PhD, the consulting program offers a thorough discussion and framing of research questions that can be addressed through a clinical study.

Specific types of support offered are:

In speaking with research volunteers about barriers to research participation and inconveniences of participating in research at the Johns Hopkins Medical Campus, many volunteers brought up the issue of parking--specifically, the inconvenience of parking, and for some volunteers the expense of parking. So in an effort to increase research participant satisfaction, we arranged with the Rutland Garage to accept clinical research participants to this facility.

Overall this arrangement has worked well for the last two years. However, because of recent security issues, there have been some "glitches" with entering the garage and problems getting in to the building at the Rutland/Carnegie overpass to the hospital. The following updated parking instructions will tell you how to direct your patients so they can avoid these inconveniences.

Among his many other contributions to health care, education, and research, Dr. Saudek served as program director of the Johns Hopkins General Clinical Research Center (GCRC) for more than 20 years. When the GCRC was integrated into the Johns Hopkins Institute for Clinical and Translational Research (ICTR) in 2006, Dr. Saudek facilitated this transition by becoming one of the ICTR’s founding deputy directors.

“Chris was always excited by the research his colleagues were doing and was committed to helping them succeed,” says Gerald Stacy, ICTR’s administrative director. “He deeply cared about research at Hopkins and never lost his enthusiasm for listening to investigators and connecting them to the resources that would help them the most.”

We join the Hopkins community in mourning the loss of this colleague, mentor, and friend and extend our deepest condolences to his family.

Learn more about Dr. Saudek's life and career.

The occasion marked the inauguration of the Henrietta Lacks Memorial Lecture Series, which was announced by Daniel E. Ford, MD, MPH, ICTR director and vice dean of clinical investigation at Hopkins. Also announced were the Henrietta Lacks East Baltimore Health Sciences Scholarship, sponsored by the Johns Hopkins Health System, which provides up to $10,000/year to support promising graduates of Paul Laurence Dunbar High School; and the Henrietta Lacks Award for Community-University Collaboration, sponsored by the Johns Hopkins Urban Health Institute, which provides a $15,000 annual award to recognize outstanding, pre-existing community-university collaborations in Baltimore.

ICTR would like to acknowledge all of the individuals and organizations who contributed to this program.

Anne Arundel and GBMC Join Forces with Hopkins to Increase Research Opportunities for Patients Throughout the Region

The JHCRN creates a bridge for research between Hopkins and community-based medical centers by linking physician-scientists and staff from the Johns Hopkins Medical Institutions with community-based medical centers in the region. The network, which will ultimately have additional member institutions, will serve several purposes, the most important of which is to make clinical trials available to patients who may not ordinarily have access to them.

Effective Aug. 1, the Johns Hopkins Medicine institutional review boards (JHM IRB) will implement new compliance training requirements for participation in human subjects research. Our intent is to make it easier for investigators and study team members to determine which courses they are required to take, register for the courses, and have access to their course completion information. The compliance training will be tracked using the Hopkins myLearning website at www.hopkinsmedicine.org/interactive_learning/my_learning.

Following are the significant changes in our compliance training requirements:

The AHA, which has been compiling an annual list of top advances in heart disease and stroke research since 1996, is recognizing the circulating TGF-β study (originally in Circulation 2009;120;526-532) as one of the year's top ten research achievements in heart disease and stroke. The study indicates that circulating TGF-β may be a useful biomarker for monitoring treatment in patients with Marfan syndrome, a connective tissue disorder inherited by nearly one in every five thousand people. Marfan syndrome negatively affects many parts of the body, including the aorta. To learn more about this study and the AHA "Year's Best" list, click here.

Last fall I initiated the Clinical Research Management Database to help me understand what factors are making it easier or harder for us to conduct clinical and translational research within the Johns Hopkins SOM and SON. As part of this process, we systematically selected a sample of recent IRB-approved protocols for more in-depth assessment. We have had nearly 300 responses to the survey (nearly a 75% response rate), and I appreciate the many comments from faculty. I thought you might be interested in some of the main findings from the survey:

• The Institutional Review Board (IRB): Faculty do not see the IRB as a substantial barrier. 86% of the faculty are extremely satisfied or satisfied with both the quality and efficiency of their IRB reviews. Only 12% were not satisfied with the eIRB application process.