|
|
In This Issue (click
titles):
|
Don't forget President's Day -
Monday, February 17
It's an HRA
Holiday!
|
Period |
Timesheet |
Payday |
|
1/16-1/31 |
2/07 |
2/14 |
|
2/01-2/15 |
2/21 |
2/28 |
|
2/16-2/28
|
3/07 |
3/14 | |
IRB
Update
Research Coordinator
Meeting:
We are going to have another HIPAA
meeting. Our speaker will be Dr. Spicer, the IRB
Chair. Please note that we start at 1:00 pm for this
meeting.
| Subject: |
HIPAA
for
Researchers |
| Date: |
3/5/03
Wednesday |
| Time: |
1:00 -
2:00 pm |
| Place |
Hastings
Auditorium |
Contact:
Fumi Stark
tel: (323) 276-2226
e-mail: stark@usc.edu |
Position Announcement:
President & CEO,
Health Research
Association
Health Research Association (HRA)
is seeking a President and CEO. HRA is a private
non-profit organization founded in 1947 to conduct and
manage medical, health, and scientific research. More
than 80% of the research conducted by HRA is sponsored
by private industry, with nearly 200 pharmaceutical
company supported studies contracted annually.
The ideal candidate should have over ten years
of senior management experience, preferably in
non-profit and for-profit environments. Experience in a
clinical research environment is preferred. A master’s
degree or equivalent is desired.
A detailed
position profile is available. Inquiries and résumés
should be directed to:
Johnston and
Company
Attn: HRA
6167 Bristol Parkway,
Ste.140
Culver City, CA 90230.
Fax: 310-410-3906
E-mail johnstonco@earthlink.net
Additional information about Health Research Association
can be found at: www.health-research.org |
Thank You from Corazón de La
Familia
contributed by
Kathy Yutchishen, Corazón de La Familia Infant-Child
Intervention Program
The entire staff
at Corazón de La Familia Infant-Child Intervention
Program would like to take this opportunity to thank
everyone who donated toys, games and gifts for our
annual holiday food and gift baskets. The children were
very excited to receive their gifts and the parents most
appreciative. We were very fortunate to receive many
donations and were able to provide gifts for more than
250 children. A special thank you to HRA for letting us
use their reception area as our donation drop-off
site.
Thank you for your generosity. We wish you
all a healthy, happy and prosperous new
year!
|
Grants &
Contracts
Contributed by
Kathi Biem, HRA Grants &
Contracts
A few months ago, we
discussed the various steps of the clinical trial
contract process. In the second step, there are several
items that the HRA Grants & Contracts Office looks
for in the contract. The following areas are of specific
importance:
- Confidentiality
- Indemnification
- Intellectual Rights
- Publication
- Warranty
- Termination
- Budget and Payment Schedule
- Assignment
After reviewing the entire
agreement, we send our revisions to the Principal
Investigator for his or her approval prior to forwarding
to the Sponsor or CRO. The process then involves
negotiation (several follow-ups) to obtain the best
results for that particular study and to ensure mutual
satisfaction between the Sponsor or CRO and HRA, who
represents the PI.
For more information, please
contact:
Kathi Biem
Email: kbiem@health-research.org
or
phone (323) 223-4091
or Denise Deack
Email: ddeack@health-research.org
or
phone (323)
223-4091 |
|
Attention:
Principal Investigators & Research
Assistants
contributed by
Tom Lim, HRA Accounting Health Research
Association will be conducting its bi-annual fixed asset
inventory audit for FY 2002. This audit involves a
physical inventory audit of all equipment and leasehold
improvements purchased through projects at Health
Research Association. Our internal auditors require us
to send out inventory questionnaires to assess the
existence and condition of the fixed assets.
If
you receive the questionnaire, please fill out promptly
and return to Tom Lim at HRA no later than March 14,
2003. Business office personnel will also need to go to
certain locations to inspect sampled items. As a
courtesy, HRA representatives may call to aid you in
filling out the questionnaire.
Please direct
questions or concerns to:
Tom Lim, HRA
Accounting
Phone (323) 223-4091 ext 128
E-mail tlim@health-research.org |
Tech
Tips
Make the most of Microsoft Office
and its rivals with the help of the following five sites
(click title to link):
Woody's Office
Portal Home of busy message boards
and an opinionated Microsoft Office
newsletter.
David McRitchie's Excel
Pages Number crunchers rejoice! Meaty
articles and tutorials galore.
Office Update
Microsoft's official Office site backs the suite with
plentiful help and downloads (and relatively little
promotional hype).
WordPerfect
Universe An online community of
WordPerfect aficionados, plus links to other
resources.
About.com's Desktop
Publishing The name doesn't say it
all - this site covers word processing and
more. |
|
| February
2003 |
|
For best
printing results, visit this newsletter online -
CLICK HERE for
the best version of this newsletter!
You may now
link to the email addresses of HRA Administrative
Employees! Just click on the name of the employee
you wish to email. Scroll down to the list of names and
job titles at the bottom left corner of the
newsletter.
CLICK HERE to go
there now. |
HRA and USC sign Research
Agreement HRA is proud to announce that in
December 2002, a Memorandum of Agreement (MOA) was signed
between USC on behalf of the Keck School of Medicine and HRA.
The MOA is a contract between HRA and USC which names HRA as
the administrator of industry funded research agreements for
USC investigators. This Agreement, which was long in the
planning, was greeted with much anticipation and enthusiasm by
HRA’s management and employees.
In recent months,
HRA’s Grants & Contracts Office has experienced some
difficulties with pharmaceutical sponsors who did not
understand the relationship between USC and HRA. In some
cases, the absence of an official agreement between the two
parties was causing delays in the completion of clinical trial
agreements, thus delaying the onset of studies.
The
MOA clearly outlines the relationship between HRA and USC, and
defines goals and objectives for HRA that are synchronized
with USC’s strategic growth initiative. HRA’s management team
is excited to partner with USC in attaining these goals. HRA
is planning meetings with USC decision-makers and those
involved directly in clinical work to create the most
effective strategies to meet these goals.
Investigators: Join us for lunch We
welcome relevant parties to contact us with any feedback you
have on ways HRA can help you with your research goals. To
this end, HRA will be holding monthly lunch meetings with
interested investigators (PI's, sub-PIs) to gather direct
feedback. If you are interested in participating, contact
Jo Anne Mastrangelo at: jm@health-research.org, or
phone (323) 223-4091. Space at the lunch table is limited,
so please reserve early. Our first meeting will be held on
Tuesday, February 18, at noon at Michael J’s restaurant on the
first floor of the HRA building.
HIPAA Update
Excerpted from HSC Weekly The
University of Southern California, like academic medical
centers and health care providers nationwide, will soon be
required to obtain signed consent from patients
Need
more
information?
Access
online education
program, template documents,
and
policies and procedures
available on the USC Office
of
Compliance Web site:
www.usc.edu/compliance
Want to arrange
for a presentation
on HIPAA?
Contact the
Office of
Compliance at
(213) 740-8258 or
email complian@usc.edu | prior
to any use or release of personal medical information under a
new federal regulation aimed at protecting patients’
privacy.
Laura La Corte, executive director of compliance,
said that the privacy rule, a component of the Health
Insurance Portability and Accountability Act (HIPAA) of 1996,
went into effect in April 2001. USC must be in full compliance
with the privacy rule by April 14, 2003.
The new
regulations generally prohibit health care providers, such as
USC physicians, pharmacists, dentists and allied health
professionals, as well as USC's hospital partners and health
plans such as the USC Network from using or disclosing an
individual's "protected health information" without prior
written authorization from a patient.
"Protected
information includes information relating to the health of an
individual, the care provided or payment for that care in any
form or medium—from a paper medical record to a fax
authorization or referral to a conversation between colleagues
consulting on the care of a patient,” La Corte said. CLICK HERE for
continuation of story (below)...
HRA Co-Sponsors FREE FORUM:
"Maximizing the Impact of Rapid HIV Testing: Developing
Effective Linkages" A forum will be held on
February 14 to educate industry professionals on the topic of
rapid HIV testing.
Presenters will address the
following questions:
To register:
Call (310) 794-0448
or email kcoussey@mednet.ucla.edu
Date:
February 14
Time: 8:30 am - 5 pm
Place: St. Anne's
Conference Center
155 N. Occidental Blvd.
Los
Angeles, CA 90026
REGISTRATION and PARKING are
FREE!! |
- What is Rapid HIV testing?
- What are the challenges posed by rapid HIV testing for
community-based organizations?
- What have we learned from our initial experiences with
rapid HIV testing?
Presenters:
- Nellie De Augustine, Prevention Health Bureau, Long
Beach
- Charles L. Henry, LA County Office of AIDS, Programs and
Policy
- Tiffany Horton, LA Gay and Lesbian Center
- Peter Kerndt, MD, M.P.H., LA County STD Program
- Kevin Malotte, Ph.D., CA State University, Long
Beach
- Deanna Sykes, Ph.D., State Office of AIDS
- Moderator: Arleen Leibowitz, Ph.D., UCLA School
of Public Policy & Social Research
The event will
be held Friday, February, 14, 2003 from 8:30 am - 5:00 pm at
St. Anne's Conference Center. Registration is free, and
continental breakfast and lunch will be provided. Three
organizations have joined together to sponsor the event:
Center for HIV Identification, Prevention, and Treatment
Services (a co-operative venture of UCLA, Charles Drew
University and RAND), the California State Office of AIDS, and
Health Research Association. Please pre-register so that
organizers are able to provide enough seating and refreshments
for all attendees.
|
|
|
|
|
How to Hire an Employee through
HRA
Contributed by HRA's Human Resources
department When hiring a new HRA employee,
please follow this procedure:
Step 1 - Employee
Payroll Authorization Form:
Complete an Employee
Payroll Authorization Form. This form must be mailed or faxed
to the Human Resources Department two days prior to the new
employee’s start date. If you have any questions regarding
this form, please call the Human Resources Department and they
will walk you through the paperwork process. Newly hired
employees may not start working until this form has been
completed and given to the HRA Human Resources Department for
processing.
Step 2 - Job description:
All
new hires need a job description before they can start
working. If you do not have a job description, contact the Human Resources Department
and they will send you a generic version that allows
you to fill in the appropriate detail. The job description
will be retained in the employee’s personnel
file.
Step 3 - New Hire Orientation:
All new
employees must attend a New Hire Orientation. Orientations are
conducted twice a week at the HRA office: Wednesday mornings
at 9 a.m. and Thursday afternoons at 1 p.m. New employees may
make an appointment by calling 323-223-4091 x103, and will
need to bring the following to the orientation: the original
Payroll Authorization form, Job description, and one or more
pieces of ID for the I-9 form. The new hire will meet with a
representative from the Human Resources Department who will
present information on HRA, explain employee benefits and
polices, and assist new employees in completing all necessary
paperwork.
As a reminder for new projects, you must
secure funding before employees can start working.
If
you have any questions regarding HRA’s hiring process, please
call the Human Resources Department at (323) 223-4091 x103 or
email dheinsberg@health-research.org
Spotlight on Project
Employees:
"Smart Nurse" - Janet V. Johnson,
RN, BSN
Contributed by Kimberley
Mooney of HRA’s Human Resources department  We are pleased to kick off the “Spotlight on
Project Employees” campaign by honoring Janet Johnson for over
16 years of loyal service to HRA and LAC+USC. Janet started as
a research coordinator with Dr. Elkayam in 1987, and is now
the Senior Research Coordinator for The Heart Failure
Program in the Division of Cardiology. In addition, Janet
has worked on numerous studies with other esteemed
investigators such as Drs. Mehra, Akhtar, Shotan, Ostrzega,
and Sinjh.
Janet began her medical education at the
LAC + USC Medical Center School of Nursing, and then completed
a Bachelor of Science in Nursing at California State
University, Los Angeles. In addition to her vast research
experience, Janet has served as a Critical Care Registered
Nurse.
Janet has found success as a prolific writer
and lecturer as well, and has contributed to many research
articles in various Cardiology periodicals. Last year, she
presented at a conference in Beijing, China. In addition,
Janet’s career travels have taken her all across the United
States, and to Israel, Egypt, and Paris. Despite her busy
schedule, Janet strives for balance in her life and the
ability to share quality time and care with her husband, two
children, and patients.
After speaking to Janet for
five minutes, it becomes apparent why she is considered a
leader in her profession. She is dedicated to her patients
with a professional ferocity seen only in people who have
truly found their calling. Janet passionately discusses
remembrances of patients with whom she spent their last days.
She recalls an elderly patient who used to “dress to the
nines” before arriving for his appointment because it was the
only place he went. Annually, Janet sends Christmas cards to
all her patients; many of them have remarked that it was the
only card they received. Janet is a self-described “smart
nurse,” but even at a glance you can tell she is much more.
Janet Johnson is a compassionate caregiver, a devoted
professional, an authority in her field, a loyal employee, a
friendly ear, a shoulder to cry on, and a warm embrace in time
of need.
| Clinical Trial Opportunities from
HRA |
HRA has
pursued a very successful marketing effort that has resulted
in direct contacts being made with pharmaceutical companies
and CROs. Our goal is to make sponsors aware of the vast
number of researchers at LAC+USC, and the numerous specialties
of our investigators. As a result of these on-going efforts,
we continuously receive information notifying us of up-coming
or on-going studies in need of investigators. Below is a list
of those studies received by HRA in January, 2003. Please
contact HRA immediately if you are interested in any of these
opportunities.
We also have the ability to conduct a
personal study search for LAC+USC investigators. Contact us at
info@health-research.org for
further information on a specialty-targeted study (there is no
cost associated with this).
CRO:
Quintiles
Sponsor: Johnson & Johnson
Specialty:
Hematology
Title/Subject: Phase II, dose
ranging study for the treatment of anemia in patients
receiving chemotherapy
Note: Procrit, subjects: 18+
years of age, solid tumor cancers, hemoglobin levels 8-10
gm/dc. No placebo, must be receiving chemotherapy for at least
15 weeks after initial randomization.
Contact: info@health-research.org, or Jo Anne
at (323) 223-4091
Reference Number of Study: 03-12
(please provide this number when contacting
HRA)
CRO: Medpace, Inc.
Sponsor: Not
available
Specialty:
Cardiovascular - Lipid Study
Title/Subject: Lipid study in the Hispanic
population
Contact: info@health-research.org, or Jo Anne
at (323) 223-4091
Reference Number of Study: 03-01
(please provide this number when contacting
HRA)
CRO: Investigator Location Services
(ILS)
Sponsor: Not available
Specialty: Cardiology – Cath
Lab
Title/Subject: PTCA or stenting in
diseased saphenous vein coronary bypass graft
Note:
Randomized comparison of a balloon occlusion distal protection
device with an active debris removal system vs. standard of
care. Grant: $1500/patient up to $30,000
Contact: info@health-research.org, or Jo Anne
at (323) 223-4091
Reference Number of Study: 03-02
(please provide this number when contacting
HRA)
CRO: PharmaNet, Inc.
Sponsor: Not
available
Title/Subject:
Appendicitis
Contact: info@health-research.org, or Jo Anne
at (323) 223-4091
Reference Number of Study: 03-04
(please provide this number when contacting
HRA)
Sponsor: PRA International
Specialty: Pediatric
Nephrologist
Subject/Title: Hypertension
in children, ages 6-16
Contact: info@health-research.org, or Jo Anne
at (323) 223-4091
Reference Number of Study: 03-05
(please provide this number when contacting HRA)
CenterWatch: Seeking Investigators
Phase I/II
NOC WATCH
Kathryn E. Kelly,
Dr.P.H.
Email: kek@nocwatch.comDevice name:
NOC.watch
Specialty:
Experience with medical devices and injury prevention
preferred
Indication: Fall prevention
Notes:
More details at www.nocwatch.com
Phase
II
InClin, Inc.
Michele Sayre
Email: sayrewalla@attbi.com
Drug name: IV
antibiotic
Specialty:
Urologist, I.D.
Indication: Complicated Urinary
Tract Infection including Pyelonephritis
Note: This study
requires hospitalization for 7-14 days with administration of
q8h IV infusions.
Still,
she noted, “health care providers and practitioners can
continue to use protected health information to treat
patients, obtain payment for such treatment or for health care
operations such as teaching students and residents,
credentialing, quality assurance and compliance reviews, among
other things, without an authorization from a
patient.”
In those instances, USC must provide the
patient with a Notice of Privacy Practices, which summarizes
all of the possible ways that USC may use an individual's
health information. In addition, USC must make a good faith
effort to obtain the patient's acknowledgment of receipt of
the Notice of Privacy Practices, she said.
For most
other uses, such as fundraising and targeted marketing,
individuals must sign a specific authorization permitting USC
to use their health information for those purposes. An
authorization is a signed document that permits the release of
protected information for specific purposes over a specific
period of time, and is required before any such communication
may occur.
For research, the HIPAA privacy rule
authorization may be incorporated into the informed consent
document. The USC Institutional Review Boards (IRBs) have been
charged with enforcement of certain aspects of the privacy
rule as they relate to research, La Corte noted.
The
HIPAA privacy rule also gives individuals expanded rights to
access their medical and billing records, request amendments
to them and obtain an accounting of disclosures of protected
health information. USC also must not use more than the
"minimum necessary" amount of patient health information to
accomplish a particular task.
For example, La Corte
said, while a physician or resident may need to see all of a
patient's health information for treatment purposes, a
receptionist whose job responsibility is limited to checking
patients in to the clinic, should not need to see medical
records. Similarly, students do not necessarily need to
receive identifiable information about actual patients, such
as names, in a classroom setting.
The HIPAA privacy rule is
comprehensive and impacts USC and other academic medical
centers in far-reaching ways.
Two years ago, USC's
Office of Compliance was charged with implementation and
enforcement of a university-wide program to comply with the
privacy rule by the April 14 deadline.
Its implementation
efforts include the following:
- Designating LaCorte as the privacy officer for HIPAA
compliance purposes;
- Developing an online HIPAA education privacy program
that must be taken by faculty, staff and other USC
employees, as well as students, volunteers, agents and
certain other individuals who have access to patient health
information through USC providers;
- Working with numerous individuals and working groups to
develop policies, procedures and templates for the
university community. Such templates include notice of
privacy practices, authorizations for research, fundraising
and marketing purposes, and policies and procedures and
other guidance for complying with the privacy
rule—particularly as it impacts clinical practice, research,
fundraising, marketing, the USC health plans and
non-clinical health education.
University employees
who deal with patients and their health information will
receive additional information about the privacy rule in the
coming weeks from the USC Office of Compliance, from HRA, and
from the university's IRBs.
|
| | |
