The IRB application has a section that requires investigators to address data collection and how these data will be protected and stored. Encrypting electronic data may not be enough, as The Research Ethics Blog advises.
IRB applications need to address where are the data being stored and how are the data being stored.
The investigator's strategy and protection plan have to be stated for the IRB to evaluate. Also, the consent process has to include this as well.
See http://www.researchethics.ca/blog/2010/01/privacy-of-data-is-ongoing-concern.html for more details and contact HARPO with any questions.
25 January 2010
15 January 2010
NIH Releases Report on Researcher Conflict of Interest
The National Institutes of Health released a report related to financial conflicts of interest reported in 2006, containing data from 41 grant recipient institutions. A majority (111 out of 165 researchers) of conflicts were due to stock or other equity ownership in companies which could affect researcher's ability to be impartial.
See more information on the Social Science Research News blog
See more information on the Social Science Research News blog
Animal Welfare Information Center 2010 Workshop
The Animal Welfare Information Center (AWIC) teaches a one and a half day workshop (Meeting the Information Requirements of the Animal Welfare Act) at the National Agricultural Library (NAL) in Beltsville, Maryland for individuals who are responsible for providing information to meet the requirements of the Animal Welfare Act (AWA).
The 2010 workshop dates are:
March 17-18, 2010
May 5-6, 2010
October 20-21, 2010
For more information go to AWIC Workshops.
The 2010 workshop dates are:
March 17-18, 2010
May 5-6, 2010
October 20-21, 2010
For more information go to AWIC Workshops.
PRIM&R Webinar for animal users
Top Tips for IACUCs: Perspectives in Animal Care
Join Public Responsibility in Medicine and Research (PRIM&R) for a Webinar – “Top Tips for IACUCs: Perspectives in Animal Care” – February 9, 2010, from 1:00 until 2:30 PM ET.
Program Agenda:
+ A review of top reportable issues to OLAW
+ An OLAW perspective on crisis preparation and management
+ Selection and training of new IACUC chairs and committee members
+ The fundamentals of program review and inspections
Presenters: Patricia A. Brown, VMD, MS, Diplomate ACLAM, Director of the Office of Laboratory Animal Welfare (OLAW) at the National Institutes of Health (NIH) and Monte Matthews, BA, CPIA, Director of the Office of Veterinary Services & Animal Care Officer at the University of Oregon.
For more information, visit http://www.primr.org/Conferences.aspx?id=7887.
Join Public Responsibility in Medicine and Research (PRIM&R) for a Webinar – “Top Tips for IACUCs: Perspectives in Animal Care” – February 9, 2010, from 1:00 until 2:30 PM ET.
Program Agenda:
+ A review of top reportable issues to OLAW
+ An OLAW perspective on crisis preparation and management
+ Selection and training of new IACUC chairs and committee members
+ The fundamentals of program review and inspections
Presenters: Patricia A. Brown, VMD, MS, Diplomate ACLAM, Director of the Office of Laboratory Animal Welfare (OLAW) at the National Institutes of Health (NIH) and Monte Matthews, BA, CPIA, Director of the Office of Veterinary Services & Animal Care Officer at the University of Oregon.
For more information, visit http://www.primr.org/Conferences.aspx?id=7887.
08 January 2010
Updated IRB forms and applications
As a reminder, please use the most up to date forms and applications when submitting for IRB review and approval. Using older forms may delay the processing of your application (and causing minor headaches for the HARPO staff!).
The direct link to these forms is: http://www.umbc.edu/research/Resources/irb_forms.htm.
As usual, contact the HARPO office at 5-2737 or HARPO@umbc.edu if there are any questions.
The direct link to these forms is: http://www.umbc.edu/research/Resources/irb_forms.htm.
As usual, contact the HARPO office at 5-2737 or HARPO@umbc.edu if there are any questions.
News from Ofiice for Human Research Protections (OHRP)- January 5, 2010
Information relayed from OHRP-L@LIST.NIH.GOV:
OHRP has moved two guidance documents to its archive of guidance documents no longer in effect. The two documents are “Local IRB Review of Multicenter Clinical Trials” and “Local Institutional Review Board (IRB) Review of Multicenter Clinical Trials Sponsored by the Division of Aids (DAIDS) National Institute of Allergy and Infectious Diseases (NIAID).”
These documents have been archived because OHRP’s policy regarding local IRB review has changed and they no longer represent OHRP’s policy. OHRP policy continues to be that a reviewing IRB should have knowledge of the local context for studies it reviews, but that review by a local IRB is not favored over review by a non-local IRB.
All archived OHRP documents may be accessed on the OHRP Web site at:
http://www.hhs.gov/ohrp/policy/archive.html.
OHRP has moved two guidance documents to its archive of guidance documents no longer in effect. The two documents are “Local IRB Review of Multicenter Clinical Trials” and “Local Institutional Review Board (IRB) Review of Multicenter Clinical Trials Sponsored by the Division of Aids (DAIDS) National Institute of Allergy and Infectious Diseases (NIAID).”
These documents have been archived because OHRP’s policy regarding local IRB review has changed and they no longer represent OHRP’s policy. OHRP policy continues to be that a reviewing IRB should have knowledge of the local context for studies it reviews, but that review by a local IRB is not favored over review by a non-local IRB.
All archived OHRP documents may be accessed on the OHRP Web site at:
http://www.hhs.gov/ohrp/policy/archive.html.
05 January 2010
HARPO Presentations
The Spring semester is nearly upon us and HARPO is getting ready to make presentations to classes to review the Institutional Review Board's (IRB) requirements for submission, review and approval. We can also answer questions students may have about research compliance in general or about any planned student research projects.
Look for emails soon to our request to visit. Or, please contact HARPO at 5-2737 or HARPO@umbc.edu to schedule a time.
Look for emails soon to our request to visit. Or, please contact HARPO at 5-2737 or HARPO@umbc.edu to schedule a time.
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