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URGENT
NEW ANNOUNCEMENTS !!!! |
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Announcing New Financial
Disclosure Form Dear Investigators:
The financial disclosure form
has been revised with content approved by General Counsel and
consistent with requirements for CRADAs. The new form (7/11/08
version) will be required for submissions for the 8/18/08 IRB
meeting. The submission deadline for that meeting is 8/1/08. The
form may be obtained through the VANJHCS Research website (on the
VBRI website). Thanks,.
Orval Gautier, M.Ed., CIP, Research Compliance Officer
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YOUR PROTOCOL
HISTORIES AVAILABLE FOR SELF EVALUATION OF STUDY RECORDS
Dear Human Research
Investigators and Study Staff:
One of the primary references used in the local Research Compliance
review of investigators’ records is the
“Protocol History”. All of
the submissions to the IRB and approvals are listed and each of the
items must be part of the investigator’s study records.
The R&D
Committee suggested that the Protocol Histories be made available to
investigators so that in advance of any audits you can check to
confirm that all the listed items are present in your study files.
You are encouraged to request a copy of the protocol history for
each of your studies through me or directly from the IRB Intake
Staff Person: Ms. Cheryl Dillard at extension 1794. It can be
provided in hard copy or as a pdf file e-mail attachment.
The Protocol
History does not reflect all the documents to be maintained in study
files. The data collection tool lists other items that are part of
the review:
Investigator’s Human
Research Records:
Accountability and Safe Guard
Checklist
Oversight
agencies such as the VHA Office of Research Oversight (ORO), VHA
Office of the Inspector General (OIG), the DHHS Office for Human
Research Protection (OHRP) and the FDA may conduct inspections and
investigations that could involve review of your study records. You
need to be able to demonstrate that you are maintaining adequate
study files and readily produce required documents during a
regulatory site visit.
It is suggested that you obtain protocol histories and establish a
process for review of your own study records (with correction and
reorganization as necessary).
posted 3/20/2008 |
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Questions, Concerns and
Suggestions are Welcome from Investigators and Members of the
Research Community regarding the Human Research Protection Program
and other Research issues
The following individuals
are available to respond to your research Questions, Concerns and
Suggestions:
ACOS/ R&D: Richard P. Wedeen MD x 7877
Research Compliance Officer: Orval Gautier, CIP x 2024
Administrative Officer: Heather Middleton x 1340
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- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
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2008 Quarterly Research Meetings
2:00 PM to 3:30 PM
East Orange Campus, 3rd Floor Auditorium
Thursday,
March 13, 2008
Wednesday, June 11, 2008
Thursday, September 11, 2008Wednesday, December 10, 2008
posted 1/11/2008
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A Research RE-CONSENT
CPRS progress note template is now available for documenting
re-consent! This re-consent progress note template will NOT post
a clinical warning on the CPRS medical record cover sheet! The
re-consent template will prompt you to enter required information.
If you have new information for providers and want a progress note
documenting re-consent to be listed in the clinical warning
postings, use the Research Consent & Contact template (which will
post a clinical warning).
When preparing to enter re-consent progress notes, select the “Research
Re-Consent” progress note title in CPRS and the template will
appear.
Questions about use of the new Research Re-Consent progress note
template may be referred to Orval Gautier, M.Ed., CIP, Research
Compliance Officer at ext 2024.
posted 6/4/07 |
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Starting immediately,
Please begin using the HIPAA
Authorization form posted on the research website
(version 5-3-07 or later).
The HIPAA Authorization
form has been revised to include a new item required by the VHA
Privacy Handbook.
“Your treatment, payment, enrollment, or eligibility for benefits,
outside research, is not dependent upon your signing this
authorization.”
posted 5/3/07 |
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Privacy Training
(click on link)
PHI Disclosure
Reporting (see forms
page)
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Dear Research
Community:
Here is the schedule of
Quarterly Research Meetings for
2007
EO 3rd
floor Auditorium from 2 PM to 3:30 PM
Thursday
March 15
Thursday
June 14
Wednesday
September 19
Wednesday
December 12
PLEASE NOTE: The
date for the September meeting has been changed to the 19th.
This is a change from the date provided at the Quarterly Research
Meeting on December 13, 2006.
Please place on your
calendars and plan to attend.
We hope to see you at
these sessions.......
Orval
Dec 14,
2006 |
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New IRB training begins Jan 1,
2007. Must be completed before end of June, 2007. Please fax
completion certificate to Research Office
See
Training Webpage
Dec 12, 2006 |
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New Consent Form Template
for SURROGATE CONSENT
Investigators desiring to
include subjects with impaired decision making capacity (IDMC) will
need to submit a Surrogate Consent Form for approval along with
their application materials. The new surrogate consent form is
available through the "Forms" link on this web page. Please see IDMC
SOP for instructions.
posted Dec 7,
2006 |
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Please note changes:
Consent Form
DMC Form
Continuing Review Form
Application to do Research Form
Financial Disclosure Form
New forms:
Unexpected Event Reporting Form
Investigational Device Application
New Policies:
Nearly All!!!
posted 10/20/06 |
Please note changes:
- Use note title "Research
Consent and Contact" to
initiate a study and document consent
- Use note title "Research
Completed" to designate end
of a study
- Use note title "Research
Note" if you do not have a
clinical note title to use for your study, otherwise use your
usual clinical note title and enter "Research" in the "subject"
box.
Coming soon, the consent form
will have attached 2 additional pages at the end- one page to tell
the subject to reply if interested in receiving further information
about Research Activities in the future and a second page is a survey
for the research subject to be completed and returned.
posted 7-6-06
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Questions, Concerns and
Suggestions are Welcome from Investigators and Members of the
Research Community
The following individuals are
available to respond to your research Questions, Concerns and
Suggestions:
ACOS/ R&D: Richard P. Wedeen MD
x 7877
Research Compliance Officer: Orval Gautier, CIP x 2024
Administrative Officer: Heather Middleton x 1340
IRB
IRB Coordinator: Stephanie Bell x3879
IRB Chairperson: Robert Eng, MD (thru IRB Coordinator) x 3879
IRB Support: Julia Kogut x1989
IRB Support: Brenda Mosby x3880 /1338
IRB Support: Jessica Capeci x1794
Credentialing
WOC Support MaryAnn Dixon x3897
Animal Research
Animal/Safety Support: Tia Harris x1957
IACUC Chairperson: Ambrose Dunn-Meynell, PhD, (thru Animal/Safety
Support) x 1957
ARF Lead Animal Technician: Gloria Browning x1221/1466
Subcommittee On
Research Safety
Animal/Safety Support: Tia Harris x1957
Subcommittee On Research Safety Chairperson: John D’Ambrosio (thru
Animal/Safety Support) x 1957
Research and
Development Committee (R&D)
R&D Coordinator: Sean Johnson x 1824
R&D Committee Chairperson Michael Condon, PhD (thru R&D Coordinator)
x 1824
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Budget Analyst:
Netra Saigal x 7182
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Research Service Telephone (973) 676-1000,
ext. 3880, 1269; Fax: 973 395 7184
April 3, 2006 |
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Announcement:
New Accrediting Organization for
Human Subjects Protection Program
AAHRPP (Association for the
Accreditation of Human Research Protection Programs, Inc.) has been
awarded the contract to conduct accreditation of all VHA Human
Research Protection Programs. The VA NJ Health Care System will be
preparing for AAHRPP accreditation.
The AAHRPP Accreditation
standards include 5 Dimensions: I. Organization; II. Research Review
Unit, including IRB’s; III. Investigator; IV. Sponsored Research and
V. Participant Outreach. The accreditation process and standards are
very different from that followed by NCQA.
More information regarding
AAHRPP’s accreditation process can be found at their website:
http://www.aahrpp.org/www.aspx?PageID=95
NCQA will not be conducting our
accreditation survey.
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Annual Training of all Staff involved
in Human Research Projects
As a reminder, all staff involved
in human research are required to take training courses in human
research ethics and good clinical practice annually as per the VHA
Office of Research and Development training requirement. Our
training cycle is concurrent with the Fiscal Year (October 1 2005 –
September 30, 2006). Please refer to the Standard Operating
Procedure entitled, “ Human Studies Educational Requirements” for
details and resources for meeting this training requirement.
This training is also apart of the
Medical Center’s Mandatory 2006 Service Education Plan.
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The latest Informed Consent
version is dated 5/3/06 |
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Office Staff:
- ACOS/ R&D: Richard P. Wedeen MD
x 7877
- Administrative Officer:
Heather Middleton x 1340
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IRB Coordinator: Stephanie Bell x3879
- IRB Support: Julia Kogut x1989
- IRB Support: Brenda Mosby x3880
/1338
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IRB Support: x1794
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R&D
Support: Sean Johnson x 1824
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Animal/Safety Support: Tia
Harris
x1957
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WOC
Support: Sabina
Rendall x3897
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Budget Analyst: Netra Saigal x 7182
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ARF Lead Animal Technician: Gloria
Browning x1221/1466
Research Office Telephone (973) 676-1000, ext.
3880, 1269; Fax: 973 395 7184
- Research
Compliance Officer: Orval Gautier CIP x2024
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