DATA POINTS
News You Can Use From the MGH General Clinical Research Center
March/April, 2008
DATA POINTS provides a forum to share GCRC departmental updates, unit news, and staff profiles. We
invite readers to submit items of interest for future publications! Send your news, announcements and
ideas to asaltzman@partners.org.
Bionutrition’s DXA: Nearing 1,000 Scans
In less than one year, the MGH GCRC’s Dual Energy Xray Absorptiometry (DXA) machine has proven to be a
valuable scientific resource to many studies. DXA scans
measure bone mineral density (BMD) and body
composition for determination of bone status and body
compartments. Four GCRC Bionutrition staff members
are certified by the DXA manufacturer, Hologic, to
perform scans. Jane Hubbard MS, RD, and Leigh
Keating MS, RD will also be completing a bone
densitometry course this summer, sponsored by the
International Society for Clinical Densitometry (ISCD).
DXA hours of operation are: Monday through Friday
from 7:00 am to 4:00 pm, two Saturdays per month
from 7:00 am to 3:00 pm, with additional availability
by special request.
Magnetize!
Magnet Hospital Designation is the highest recognition that the American Nurses Credentialing Center grants to
healthcare organizations for excellence in nursing practice. This designation was established in the early 1980's in
an effort to combat a severe U.S. nursing shortage. Nationwide research was conducted to identify hospital
characteristics that enabled institutions to attract and retain nurses. These hospitals were designated as “Magnet
Hospitals.”
As of January 2008, approximately 265 Magnet Hospitals have been identified representing 5% of U.S. hospitals.
In 2003, MGH was the first hospital in Massachusetts to attain Magnet status, and is currently in the process of
obtaining Magnet redesignation, which is required every 4 years. During the week of Feb 20-22, five appraisers
from the American Credentialing Center conducted an MGH site visit. This is the last step in the process.
Preliminary feedback during a debriefing was favorable and we are all awaiting the formal response.
Research Participant Perception of Care Study
In collaboration with 14 research institutions across the country, the MGH RSA Program has begun work on a
study that will develop, validate, and implement a Clinical Research Participant Perception of Care Survey. The
study’s goal is to assess research participants’ perceptions of clinical research in order to identify best practices
and ways to optimize human subject protection. While previous studies have assessed participant recall of
informed consent information, and hospital performance surveys quantify satisfaction with inpatient care, neither
provides comprehensive measurement of the research subject’s experience. Information gathered in the
Research Participant Perception of Care Project will serve to guide future education of researchers, and of
research hospitals, in improving and enhancing the research volunteer’s experience. Additional advantages
include the ability to benchmark among various centers, and to identify and share best practices. An expedited
application to the Partners IRB for this study will be submitted in March.
SPOTLIGHT ON…
Darlene Pulley, GCRC Study Coordinator since 2005
I have a BA in Communications with an emphasis in Health Science from
Seattle Pacific University. I started my clinical research experience in 1997 at
the University of Washington. Initially I was a laboratory supervisor then
transitioned into working with study participants in Cardiology. I moved to
Boston in 2005 where I have been working for Dr. Merit Cudkowicz in the
Neurology Clinical Trials Unit focusing on amyotrophic lateral sclerosis clinical
trials. Additionally, I am in my last semester of nursing school. While it is
challenging, I am truly enjoying the education and looking forward to entering
the nursing profession. Something you didn’t know about Darlene: Prior
to her work in medical research, Darlene began her career in Forensics.
Kathleen Egan, RN, GCRC Nurse since 1993
Kathleen graduated from the Boston City Hospital Nursing program in 1966,
and first came to MGH in 1976. During her 32-year tenure at the hospital,
she has served as head nurse on both a General Medicine private unit and a
25-bed urology floor. Following five years of experience in the MGH blood
bank, Kathleen joined the GCRC in 1993, working with then Nurse Manager,
Jean Nardini, RN. She currently oversees the GCRC outpatient area, and is
responsible for monitoring study visits, managing supplies, and ensuring
subject safety. Something you didn’t know about Kathleen: As a child,
she enjoyed figure skating –and demonstrated tremendous talent. Ask her
about her death-defying triple axel!
New GCRC Staff
The GCRC welcomes the following new staff members:
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Jamie Doherty, Diet Technician
MaryEllen Foley, Diet Technician
Amelia Henley, Lead Scheduler
Danielle Hannigan, RN, Staff Nurse
Kathy Hall, RNCS, NP-BC, MS, Nursing Director
Good News! Continuing Review Submissions to GCRC No Longer Required
Continuing Review submissions are no longer required by the MGH or MIT GCRCs.
Please note, this GCRC change does not affect IRB reporting requirements at MGH or MIT. Continuing Review
documentation and review remains a requirement for the Partners HRC and the MIT COUHES. This means you
must continue to submit Continuing Review applications to the IRBs, as you have been doing and in accordance
with institutional guidelines.
Again, this new policy applies to GCRC Continuing Review only. Both GCRCs continue to require real-time
submission of the following documents:
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Protocol Amendments, including supporting documentation (updated consent forms and protocols,
IRB Amendment Forms). Submit to GCRC Administration office.
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Adverse Event Reports. Submit to RSA office.
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Correspondence between the PI and IRB/FDA/Sponsor regarding potential safety issues. Submit to
RSA office.
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Data and Safety Monitoring Board Meeting (DSMB) Minutes, if applicable. Submit to RSA office.
In order to ensure that GCRC research is conducted as written in the most recently IRB-approved protocol, we
continue to require prompt submission of amendments to the GCRC Administration offices.
We hope in the near future to further streamline requirements for document submissions to the GCRC. For
example, when Partners IRB applications become fully electronic and the MGH GCRC is linked, you will be able to
submit GCRC-specific information as part of the HRC application. We will keep you posted.
Check It Out!
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THANK YOU – Thanks to Dr. Matthew Smith, Director of Research in the MGH Genitourinary Unit of
Oncology, who recently provided a presentation to the GCRC staff about his study, “Lifestyle Intervention
to Improve Insulin Sensitivity and Markers of Cardiovascular Disease Risk in Prostate Cancer Survivors.”
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SER VOLUNTARIO EN ESTUDIOS CLINICOS: ES SU DECISION! - The Office of Human Research
Protections recently published a new Spanish version of its informational brochure, “Becoming a Research
Volunteer: It’s Your Decision.” The brochure provides a definition of clinical research, outlines its value,
and suggests questions to consider prior to study enrollment. Both English and Spanish versions are
available at the GCRC registration desk.
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CONGRATULATIONS to GCRC diabetes researcher, and RSA Director, Dr. Enrico Cagliero. Dr. Cagliero
was awarded a 2008 MGH Clinical Innovation Award, for his project evaluating the efficacy of an
electronic set of insulin orders for improving glycemic control in MGH inpatients.
Next Issue:
Look for the next issue of Data Points in May, 2008. Again, please send news and announcements to
asaltzman@partners.org. We look forward to hearing from you!