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Employees Site |
| URGENT NEW ANNOUNCEMENTS !!!! |
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SAFETY TRAINING
From:
Johnson, Sean L. [mailto:Sean.Johnson2@va.gov] Attention: The Safety / Biohazard Committee has posted a Research laboratory training module for researchers and their staff whose projects have been approved for the use of biohazards. The training module can be found on the VBRI Required Training webpage as well as at the follow link: http://www.vbri.org/Research/forms.htm which is located in the research form section next to the Safety Committee annual review form. The training module is very large 8mb PowerPoint slide which can be save to your desktop. The training module is required for any investigators whose projects has been approved by the Safety Committee for use of biohazards in the projects. Investigators are to submit an annual training information form which is part of the Safety annual review form once a year. A copy of the training information form is available on both the Required Training webpage and the Forms webpage. This training will be a requirement on a annual basis for researchers and staff involved with biohazards in research. If you have any questions feel free to contact my office. Thanks
Sean L. Johnson
R&D Committee Coordinator
Sean.Johnson2@va.gov |
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From:
Wedeen, Richard
Dear Investigators and Study Staff: This is to remind you that all research staff must visit the Research Service Office and see Stephanie Bell, Administrative Officer, as part of the clearance process when leaving the VA New Jersey Health Care System. This applies to employees that are ending their employment and for WOCs and contractors. The requirement comes from the Medical Center Director. PI’s are responsible to assure that their research staff clear through the Research Service Office. Staff at the Lyons campus may call the research office (extension 1340 or 1269) to arrange for the clearance process. Thank you, Richard P. Wedeen, M.D., ACOS, R&D
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VANJHCS SCOPE OF WORK/PRACTICE There is a new Research Scope of Practice Form. The form accommodates: · Animal Research · Science-Only Research · Human Research. This new form will replace the previous form that was used exclusively for human research staff. The new form is available on the Forms page and the Animal Research page of the VBRI website All those working in Animal, Laboratory and Science-Only research will need to have a research scope of practice. PIs are no longer exempt from the requirement that they have a Research Scope of Practice. Those with an existing Research Scope of Practice will not need to submit a new research scope of practice on the new form unless there are changes to their scopes of practice. Clinicians with Clinical Privileges that cover the work that they do in research do not have to have a Research Scope of Practice. Please submit research scopes of practice to:
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Submission Time Requirements for *** New Requirement *** Data Safety Monitoring Board (DSMB) and Data Monitoring Committee (DMC) reports (where no immediate action is being recommended for the protection of subjects) must be submitted to the IRB by the PI within 30 (calendar) days of receipt by the PI. For cases where the DSMB or DMC is recommending immediate action for the protection of subjects, the DSMB or DMC report is to be submitted to the IRB within 5 work days of receipt by the PI. 3/16/2010 |
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RESEARCH OUTREACH PROGRAM Dear Human Research Investigators and Study Staff: Please remember to obtain and maintain a supply of the VA brochure: “Volunteering in Research – Here are some things you need to know” · Make them available in your workplace ‘traffic’ area · Distribute them to prospective research subjects. · The brochure must be given to every prospective participant, when the individual is approached to take part in a project. (All consented subjects) Brochures are available from the IRB Coordinator, extension 3879 This is part of the VA research outreach program that began February 28, 2009 (VHA Dir 2008-079). ~~~~~~~~~~~ posted 7/12/09 |
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Electronic Computer Access Request: ECAR
Use the web based ECAR program to request authorization to transport/utilize sensitive information outside VANJHCS protected environment and to request for IRM provided equipment. Here is the ECAR web site address: https://ecar.v03.med.va.gov/do/main/logon A user guide is available on the ECAR website. A link to the ECAR website is also available on the forms page in the SECURITY section of this VBRI website. January 26, 2009 |
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Guidance for Organization of Human Research Regulatory Records Guidance for maintaining study records is available on this VBRI website. The guidance is on the Procedures page. [See: Guidance for Organization of Human Research Regulatory Records] Not all the sections are applicable to all studies. Sample forms and explanations are provided. The forms are intended to serve as examples that may be adapted for your use. The contents include: ESSENTIAL DOCUMENTSProtocol & Amendments Operations Manual - Approved Case Report Forms IRB Approved Consent Forms / Information Provided to Subjects Subject Log / Clinic Lists in CPRS IRB Submissions / Notifications / Approvals Serious Adverse Events / Safety Reports Notes-to-File Investigator Agreements (with Sponsor, Institution, FDA, etc.) Study Site Personnel (Signatures, Qualifications, Training) Site-Sponsor Correspondence - Conference call minutes (section tab provided) - Newsletters (section tab provided) Investigator Brochure (DIR) / VA Form 10-9012 Investigational Products (Accountability, Handling, Pharmacy) Laboratory Subject Files Visitor Log (Site Visitor Log would be a more accurate term for this form)
More information: Forms and Tools may be obtained from the SMART Website https://vaww.csp.research.med.va.gov/smart.cfm Posted Dec 5th,2008 |
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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 - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - |
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Privacy Training (click on link) PHI Disclosure Reporting (see forms page)
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Office Staff:
Research Office Telephone (973) 676-1000, ext. 3880, 1269; Fax: 973 395 7184
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