Monday, January 28, 2019

"Just the Facts": 2 Months into the New eIRB

Many of you know, on November 29, 2018, the joint IRB system went live for research at both MedStar Health and Georgetown University. Thank you to everyone who has been a part of the process in implementing and launching this new system. Many of you saw the blog post last week from Amy Loveland, who shared here positive experience as a user of this new system. In response, some of you asked about the 'stats' or 'facts' of the new IRB system, so we thought it good to share it here.

MHRI has held three IRB meetings since go-live and the current turnaround time is less than 30 days for all IRB decisions. Over 100 items have been or are being submitted for review. This includes 57 new studies not previously reviewed and 66 items (new protocols, modifications and continuation requests) currently in review.  






All new submissions for IRB reviews, including modifications and continuing review of active projects must be submitted through the new platform at gumedstarirb.georgetown.edu/irb.  If you do not have a MedStar ID or Huron login, you must request one to obtain access to the system.  Please continue to provide us with your feedback and keep us aware of any trouble you may be experiencing.

To learn more information, including training material, policies, templates and quick reference guides, please visit here.

Should you have any questions, please contact the ORI helpdesk aMHRI-ORIHelpdesk@medstar.net.

These are great statistics for the launch of the new system and none of that would be possible without the dedicated teams at ORI, IT, research operations, collaboration with Georgetown, communications, regulatory coordinators, compliance and many, MANY volunteers from the research team -  THANK YOU ALL!!!

Wednesday, January 23, 2019

When an Upgrade Really Is an Upgrade

Guest Blogger:
Amy Loveland
Associate Director, MedStar Community Clinical  Research Center


As probably most everyone knows by now, there has recently been an upgrade to the Georgetown-MedStar IRB system.  Gone are InfoEd and eRIC, and the replacement is a system called Huron, which has been touted as a much more user-friendly and streamlined system.  And probably much like everyone else, I am usually somewhat skeptical of claims about how much better a new system will be than the old one.  Having been a user (and no fan) of both InfoEd and eRIC, and having played around in the system during user training, I was cautiously optimistic that this one might actually live up to the hype.  I had no idea.
On the first day of go-live, I had the opportunity to test it out with an annual continuation that was due for a large, long-term federal study.  This study has literally hundreds of documents that have to be submitted for re-approval every year.  As anyone who has used the old systems can attest, submitting numerous documents was a time-intensive and tedious process.  Submitting the annual continuation for this study in the old system could take several hours, assuming the site didn’t crash while I was doing it, and not counting the time it took to gather demographic information and signatures before I even started the submission.


In contrast, the total time for submission in Huron: 20 minutes.  I kept checking to see if I had missed something, but it truly was that easy.  In addition, the system visually shows you where your submission is in the process, so you can track the progress as it moves from submission to approval.  Everything truly is user-friendly, efficient, and the smart-forms make it easy to submit the correct information.

I’m not normally one to rave about new systems, but this is one I think people are going to really like.  The amount of time saved on each submission will have an immediate impact on the day-to-day workflow of anyone doing regulatory work.  And anything that saves time and makes life easier is definitely something to be excited about.           


Monday, January 21, 2019

Far More Than Mixed Emotions...


Approximately 20 years ago, on my first day of work at MedStar, I walked into a temporary housing unit (yes, a trailer!) behind the MedStar Washington Hospital Center to meet the Research Institute president and the head of Human Resources. Karen Wade greeted me with a big smile and a warm welcome to MedStar, just as she has greeted hundreds of others after me. 

Karen has been working with MHRI for almost 21 years, first leading the human resources department and then building her career within MHRI to become the VP of Administration.  She has touched virtually every MHRI employee at some point and has been my partner in many transformational improvements at MHRI over the years. She has also become a close, trusted professional friend.  It is therefore with far more than 'mixed emotions' that we bid her best wishes for her next steps beyond MHRI.

At UTC we celebrated Karen's journey at MHRI and
expressed our admiration and gratitude for all of her many efforts and dedication to her work and her colleagues. It was no suprise that the room was packed and we all got a little emotional.

MHRI would certainly not be the organization it is today without her contributions. THANK YOU Karen for all you've done! You will be greatly missed!





















Thursday, January 17, 2019

MHRI Managers Come Together for Design Thinking

With the help of Lizard Brain Solutions, the MHRI managers came together this week for 'design thinking' to solve issues and improve our organization.  The four domains addressed at this meeting included how to: 1) increase research growth through shared responsibility, 2) build a stronger management team, 3) develop a culture where people speak up and feel comfortable raising concerns/suggestions for improvement and 4) tackling 'real' problems that face managers everyday.  It was a great, highly engaged session where we walked away with action items and work groups that will carry forward these plans. Stay tuned as we continue to work on these new initiatives.

Here are some pictures from the session:











Indivumed-MedStar Collaboration Reaches Milestone Enrollment

Approximately one year ago we started a collaboration with Indivumed, GmbH, a Germany-based oncology research company, to advance the health of our cancer patients through unique biospecimen collection, preservation, and analysis.

In early 2018, we opened the Indivumed project at MWHC with Dr. Christopher Gallagher and our team of MHRI associates began working with the surgical and pathology departments to collect biospecimen from MWHC patients undergoing surgery as part of their cancer treatment. This effort has resulted in the creation of the “MedStar Health Biobank and Clinical Library” a resource for high quality, annotated blood, urine, and tissue samples available to MedStar researchers interested in advancing precision medicine for cancer prevention, detection, and treatment.

Within one year we enrolled over 100 participants (with over 300 samples collected)! This is a remarkable milestone for the partnership and a tribute to the excellent work of our MHRI - MWHC team. Thank you to everyone on the team who is making this happen!




Monday, January 7, 2019

New Year, New Mindset

Below is my monthly message for the January 2019 edition of the MHRI newsletter, Focus. You can view Focus online at MedStarResearch.org/FOCUS.


Dear Friends and Colleagues,
What was your New Years’ resolution this year? Or did you decide to be practical and recognize that the act of making a New Years’ resolution is futile (some say only 8% of people accomplish their stated goal)? One 2014 poll, conducted by researchers at the University of Scranton, found that while 77% adhered to their New Year's resolutions for the first week, that figure dips to less than half within months.

So I ask you: are you losing weight, exercising more and doing all those other self-improvement promises you made a week ago?

I am a very pragmatic person, so for the last few years, I have either skipped the ‘opportunity’ to make a resolution or taken it so lightly that it would not cause any guilt when I inevitably did not stick to it. This year, I’ve decided to do something entirely different. Rather than look inward for something to improve my physical well-being, I decided to look outward to be more of the person I want to be. Let me explain.

When people ask about my professional path, I share how lucky I have been to have had the chance to be so many different things within one career: a clinician, an educator, an investigator, and an administrative leader. However, when I look at what brings me the greatest satisfaction, it is the impact I can have on others. For example, a highlight of my early career was when I became the cardiology training program director and created a first-class cardiology fellowship across the MedStar hospitals in Washington. That combined my clinical and educational experiences and helped dozens to follow their aspirations in medicine. More recently, my work with the MedStar Physician Leadership Development Program (PLDP) has combined my clinical, educational and administrative leadership experiences. Today, several members of the PLDP are important leaders across MedStar Health.

There is a term mudita which is from an ancient language of India called Pali. Mudita is “the pleasure that comes from delighting in other people’s well-being and success. The traditional paradigmatic example of this mind-state is the attitude of a parent observing a growing child’s accomplishments and successes.”

When I reflect on these things throughout my career, I realize there is a wonderful, easy, and extraordinarily impactful New Year’s resolution I can embark on that pulls them all together. If I embrace mudita with every personal interaction I have at MedStar, it will accomplish so many great things at once:
  1. It allows me to apply my educational/personal growth mindset while leveraging my clinical, research, and administrative leadership experience.
  2. It will help create a learning environment for everyone, well beyond the traditional students or trainees. This is an essential component of creating a nationally acclaimed academic health system.
  3. It will support our goal to enhance professional development for every MHRI associate.
  4. It will make us a richer, more exciting and highly successful organization when each person is living to their highest potential.
  5. And, for the pragmatic within me, it will be easy to sustain this New Year’s resolution because I will get joy from seeing others thrive and thus making our organization thrive!

Happy New Year everyone. I hope you all had a wonderful (and restful) holiday season and I so much look forward to working with you in 2019 and seeing the things we accomplish together. Mudita!

Thank you!
Neil



Read Focus at MedStarResearch.org/FOCUS.