Any proposed use of live vertebrate animals for experimental research, including the use of tissues, is considered research by the Office for Laboratory Animal Welfare.
Investigators who plan use vertebrate animals in research and will apply for funding from NIH (using the PHS398 and SF424 forms)are required to complete the Vertebrate Animal Section (VAS) of the application.
Federal policy requires that the following five points are addressed in all applications:
1) Detailed description of the proposed use of the animals, including species, strains, ages, sex and number to be used
2) Justification for the use of animals, choice of species, and numbers to be used
3) Information on the veterinary care of the animals
4) Description of procedures for minimizing discomfort, distress, pain, and injury
5)Method of euthanasia and the reasons for its selection
A complete description of the animals and proposed procedures must be provided within the VAS as this will allow peer reviewers and NIH staff to evaluate the application.
As principal investigators work on the research plan, they are encouraged to use the Worksheet for the Review of the Vertebrate Animal Section to help develop their responses. This information may be used, in turn, to answer questions on the UMBC IACUC protocol application form. That way, the IACUC may be assured that what investigators are proposing for funding are consistent in description. It will also help avoid having to make substantive changes later once funding is awarded.
Additional details and information about this requirement are found at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-10-027.html
Give HARPO a call at 5-2737 or HARPO@umbc.edu with any questions.
17 May 2010
New NIH SNAP Policy that relates to IRB and IACUC approvals
Beginning with SNAP progress reports due on/after August 1, 2010, paper progress reports will not be accepted.
All progress reports for awards subject to SNAP must be submitted electronically using the eRA Commons eSNAP module. The purpose of this firm implementation date is to electronically capture all SNAP Progress Reports eligible for funding in FY2011. Paper submissions will be considered noncompliant and will not be accepted or used for consideration for funding and will not become part of the official grant file. Grantees who incorrectly submit a paper progress report will be required to resubmit the progress report electronically using eSNAP.
Note that late progress reports may delay a noncompeting award.
New SNAP Provisions
The SNAP provisions are hereby expanded to include the following:
1.SNAP Progress reports will be due 45 days prior to the next budget start date instead of 60 days.
2.IRB and IACUC approval dates will not be required as part of each progress report submission. However, it remains an institutional responsibility to ensure that these reviews are conducted in accordance with all Federal requirements. The Federal-wide (human subjects) and Animal Welfare Assurance numbers will continue to be maintained in the Institutional profile section of the eRA Commons. Approval dates must
be submitted to the NIH upon request.
3.The grantee may delegate authority to the PD/PI to submit the progress report directly to NIH. This is an optional delegation authority available in the eRA Commons eSNAP tool.
For more information visit:
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-10-093.html
----------------
From: Christina Stanger, CRA
Assistant Director
Office of Sponsored Programs
University of Maryland Baltimore County
All progress reports for awards subject to SNAP must be submitted electronically using the eRA Commons eSNAP module. The purpose of this firm implementation date is to electronically capture all SNAP Progress Reports eligible for funding in FY2011. Paper submissions will be considered noncompliant and will not be accepted or used for consideration for funding and will not become part of the official grant file. Grantees who incorrectly submit a paper progress report will be required to resubmit the progress report electronically using eSNAP.
Note that late progress reports may delay a noncompeting award.
New SNAP Provisions
The SNAP provisions are hereby expanded to include the following:
1.SNAP Progress reports will be due 45 days prior to the next budget start date instead of 60 days.
2.IRB and IACUC approval dates will not be required as part of each progress report submission. However, it remains an institutional responsibility to ensure that these reviews are conducted in accordance with all Federal requirements. The Federal-wide (human subjects) and Animal Welfare Assurance numbers will continue to be maintained in the Institutional profile section of the eRA Commons. Approval dates must
be submitted to the NIH upon request.
3.The grantee may delegate authority to the PD/PI to submit the progress report directly to NIH. This is an optional delegation authority available in the eRA Commons eSNAP tool.
For more information visit:
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-10-093.html
----------------
From: Christina Stanger, CRA
Assistant Director
Office of Sponsored Programs
University of Maryland Baltimore County
28 April 2010
New date for the next IRB meeting
Due to a scheduling conflict, the next UMBC IRB meeting will be held on Tuesday, May 25, 2010.
26 April 2010
Animals, Research, and Alternatives Conference
The Physicians Committee for Responsible Medicine, George Washington University Medical Center, the Johns Hopkins University Center for Alternatives to Animal Testing, the Institute for In Vitro Sciences, and the Kennedy Institute of Ethics at Georgetown University are sponsoring a conference entitled "The Animals, Research, and Alternatives: Measuring Progress 50 Years Later" on Aug. 26 and 27, 2010, at the Washington Marriott in Washington, D.C.
Topics covered include animal experimentation, changing cultural perspectives about the status of animals in society, and new alternatives to animal research.
To the view the agenda and register for the event, go to http://www.pcrm.org/resch/ara/overview.html
Topics covered include animal experimentation, changing cultural perspectives about the status of animals in society, and new alternatives to animal research.
To the view the agenda and register for the event, go to http://www.pcrm.org/resch/ara/overview.html
24 March 2010
OHRP Releases Human Subjects in Research Videos
The Office for Human Research Protections (OHRP) has announced the availability of educational videos on topics regarding federal regulations for the protection of human subjects.
Currently available videos are "Research Use of Human Biological Specimens and Other Private Information" (http://videocast.nih.gov/ram/ohrp_kaneshiro.ram) and "Reviewing and Reporting Unanticipated Problems and Adverse Events" (http://videocast.nih.gov/ram/ohrp_carome.ram)
Each video is approximately 20-25 minutes in length. Real® Media player installed on your computer to view the training modules
Go to http://www.hhs.gov/ohrp/education/#materials for more information
Currently available videos are "Research Use of Human Biological Specimens and Other Private Information" (http://videocast.nih.gov/ram/ohrp_kaneshiro.ram) and "Reviewing and Reporting Unanticipated Problems and Adverse Events" (http://videocast.nih.gov/ram/ohrp_carome.ram)
Each video is approximately 20-25 minutes in length. Real® Media player installed on your computer to view the training modules
Go to http://www.hhs.gov/ohrp/education/#materials for more information
12 March 2010
Applying for IRB review
Unsure which review category to apply to apply for? Confused whether or not you really need IRB review?
Click on the below two sources to use from the IRB website:
Does my project require IRB review? Examples of research that generally does not require IRB review.
How do you identify human subejct research? Use this handy list to determine if IRB review is required.
Remember, the IRB has the final say in what research must be reviewed.
Click on the below two sources to use from the IRB website:
Does my project require IRB review? Examples of research that generally does not require IRB review.
How do you identify human subejct research? Use this handy list to determine if IRB review is required.
Remember, the IRB has the final say in what research must be reviewed.
08 March 2010
HARPO will be closed
The Human and Animal Research Protections Office will be closed during UMBC’s spring break (including the furlough period), from Monday, March 15, 2010 through Friday, March 19, 2010, and will reopen on March 22, 2008.
We will review any protocol applications submitted during this period but submit for the appropriate review upon our return to campus on March 22. Please be sure to review the protocol review timelines for exempt, expedited or full board review to include this additional week the campus is closed and plan your project activities accordingly.
We will review any protocol applications submitted during this period but submit for the appropriate review upon our return to campus on March 22. Please be sure to review the protocol review timelines for exempt, expedited or full board review to include this additional week the campus is closed and plan your project activities accordingly.
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