Attention all UMBC investigators a notice from the CITI website (www.citiprogram.org) from today:
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On Monday, February 16, 2009 at approximately 6 AM EST, the CITI web site will taken offline for site upgrades. We expect the downtime to be approximately six hours. To prevent loss of data, please complete your work and logoff prior to this time.
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Please be aware of this if you plan to log onto CITI on the 16th.
13 February 2009
11 February 2009
Updated IRB forms and applications
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 this 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 this 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.
05 February 2009
Copies of Training Certificates
Investigators who completed the UMBC IRB training on Blackboard can request a copy of their certificate from HARPO. We have electronic versions of certificates from January 1, 2005 through September 17, 2007). We also have copies of AALAS Animal Care and Use in Research and Education exam records for animal researchers who completed this training from February 1, 2006 through September 17, 2007).
After 09/17/2007, the Collaborative Institutional Training Initiative (CITI) web training program was put into place to satisfy the training requirement for UMBC researchers. Investigators may print copies of their own IRB or IACUC training certificates by logging into CITI (www.citiprogram.org), using your username and password, and clicking the "Print" link under the Completion Reports column in My Courses.
Please contact the HARPO staff at 5-2737 or HARPO@umbc.edu if you need additional assistance in retrieving a certificate copy.
After 09/17/2007, the Collaborative Institutional Training Initiative (CITI) web training program was put into place to satisfy the training requirement for UMBC researchers. Investigators may print copies of their own IRB or IACUC training certificates by logging into CITI (www.citiprogram.org), using your username and password, and clicking the "Print" link under the Completion Reports column in My Courses.
Please contact the HARPO staff at 5-2737 or HARPO@umbc.edu if you need additional assistance in retrieving a certificate copy.
03 February 2009
Updated application forms and documents on the HARPO web site
Looking for the link to access all forms used for human and animal research? Click on these links (and add to your shortcuts) to get to the most up to date versions:
IRB - http://www.umbc.edu/research/Resources/irb_forms.htm
IACUC - http://www.umbc.edu/research/Resources/iacuc_forms.htm
Biosafety - http://www.umbc.edu/research/HARPO/Biosafety/Biosafetyforms.html
IRB - http://www.umbc.edu/research/Resources/irb_forms.htm
IACUC - http://www.umbc.edu/research/Resources/iacuc_forms.htm
Biosafety - http://www.umbc.edu/research/HARPO/Biosafety/Biosafetyforms.html
Changes to the HARPO web site
As announced by Elliot Hirshman, Provost and Senior Vice President for Academic Affairs and Geoffrey Summers, Interim Vice President for Research on January 30, 2009, the web access to all UMBC research information has been redesigned. The link to the updated site is http://www.umbc.edu/research.
With the update of the UMBC Research site, access to all HARPO related web pages has changed as well. Please click on http://www.umbc.edu/research/HARPO/ to access pages for the IRB, IACUC, training as well as other research compliance information.
With the update of the UMBC Research site, access to all HARPO related web pages has changed as well. Please click on http://www.umbc.edu/research/HARPO/ to access pages for the IRB, IACUC, training as well as other research compliance information.
23 January 2009
Guidance on Engagement of Institutions in Human Subjects Research
When an institution is engaged in non-exempt human subjects research that is conducted or supported by HHS, it must satisfy HHS regulatory requirements related to holding an assurance of compliance and certifying institutional review board (IRB) review and approval.
Before engaging in human subjects research that is not exempt, an institution must hold or obtain an OHRP-approved Federalwide Assurance and certify to the HHS agency conducting or supporting the research that the research has been reviewed and approved by an IRB.
Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. A human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information. An institution is defined in 45 CFR 46.102(b) as any public or private entity or agency (including federal, state, and other agencies).
In other words, institutions are considered engaged in an HHS-conducted or -supported non-exempt (EXPEDITED OR FULL BOARD) human subjects research project when the involvement of their employees or agents in that project falls into various examples including:
Institutions whose employees or agents intervene for research purposes with any human subjects of the research by performing invasive or noninvasive procedures
Examples of invasive or noninvasive procedures include drawing blood; collecting buccal mucosa cells using a cotton swab; administering individual or group counseling or psychotherapy; administering drugs or other treatments; surgically implanting medical devices; utilizing physical sensors; and utilizing other measurement procedures.
Institutions whose employees or agents intervene for research purposes with any human subject of the research by manipulating the environment
Examples of manipulating the environment include controlling environmental light, sound, or temperature; presenting sensory stimuli; and orchestrating environmental events or social interactions.
Institutions whose employees or agents interact for research purposes with any human subject of the research
Examples of interacting include engaging in protocol dictated communication or interpersonal contact; asking someone to provide a specimen by voiding or spitting into a specimen container; and conducting research interviews or administering questionnaires.
For more information and other examples, go to http://www.hhs.gov/ohrp/humansubjects/guidance/engage08.html.
Before engaging in human subjects research that is not exempt, an institution must hold or obtain an OHRP-approved Federalwide Assurance and certify to the HHS agency conducting or supporting the research that the research has been reviewed and approved by an IRB.
Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. A human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information. An institution is defined in 45 CFR 46.102(b) as any public or private entity or agency (including federal, state, and other agencies).
In other words, institutions are considered engaged in an HHS-conducted or -supported non-exempt (EXPEDITED OR FULL BOARD) human subjects research project when the involvement of their employees or agents in that project falls into various examples including:
Institutions whose employees or agents intervene for research purposes with any human subjects of the research by performing invasive or noninvasive procedures
Examples of invasive or noninvasive procedures include drawing blood; collecting buccal mucosa cells using a cotton swab; administering individual or group counseling or psychotherapy; administering drugs or other treatments; surgically implanting medical devices; utilizing physical sensors; and utilizing other measurement procedures.
Institutions whose employees or agents intervene for research purposes with any human subject of the research by manipulating the environment
Examples of manipulating the environment include controlling environmental light, sound, or temperature; presenting sensory stimuli; and orchestrating environmental events or social interactions.
Institutions whose employees or agents interact for research purposes with any human subject of the research
Examples of interacting include engaging in protocol dictated communication or interpersonal contact; asking someone to provide a specimen by voiding or spitting into a specimen container; and conducting research interviews or administering questionnaires.
For more information and other examples, go to http://www.hhs.gov/ohrp/humansubjects/guidance/engage08.html.
IACUC review of federal grant funded animal research
PHS Policy regarding review and approval of animal studies state that "the IACUC shall conduct continuing review of activities covered by this policy at appropriate intervals as determined by the IACUC but not less than once every three (3) years". UMBC animal research protocols are approved for a three-year term. The investigator or instructor must resubmit a new application for Committee review in order to continue research activities.
What doe this mean if the proposed research, at the time of grant award, will not involve animal research until years 4 or 5 of an award?
The Office of Laboratory Animal Welfare (OLAW) recently issued guidance about this (http://grants.nih.gov/grants/olaw/faqs.htm#proto_20). If this occurs, the PHS awarding unit will not make an award unless the institution provides "..verification of approval by the IACUC of those components of the application or proposal related to the care and use of animals".
IACUC review must be performed prior to the conduct of any PHS-supported animal activity; this usually means approval must be obtained before an award is made and well before any animal research activity can begin. But, an IACUC can review activities if they will occur later in the life cycle of a grant. OLAW says that during these rare cases, the grant application must clearly explain when these activities will occur and that the PHS awarding component will issue a Notice of Award with a special term and condition indicating that no funds may be drawn from the grant or contract until a valid IACUC approval date has been issued by the IACUC.
Be sure to discuss any and all components with your OSP contact during the UMBC routing process or with the Human and Animal Research Protections Office.
What doe this mean if the proposed research, at the time of grant award, will not involve animal research until years 4 or 5 of an award?
The Office of Laboratory Animal Welfare (OLAW) recently issued guidance about this (http://grants.nih.gov/grants/olaw/faqs.htm#proto_20). If this occurs, the PHS awarding unit will not make an award unless the institution provides "..verification of approval by the IACUC of those components of the application or proposal related to the care and use of animals".
IACUC review must be performed prior to the conduct of any PHS-supported animal activity; this usually means approval must be obtained before an award is made and well before any animal research activity can begin. But, an IACUC can review activities if they will occur later in the life cycle of a grant. OLAW says that during these rare cases, the grant application must clearly explain when these activities will occur and that the PHS awarding component will issue a Notice of Award with a special term and condition indicating that no funds may be drawn from the grant or contract until a valid IACUC approval date has been issued by the IACUC.
Be sure to discuss any and all components with your OSP contact during the UMBC routing process or with the Human and Animal Research Protections Office.
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