26 May 2010

Updates to IRB protocol continuation forms

To help with the management of protocols approved via expedited or full board review, two documents are now available for use by investigators.

Click to download the Annual Continuation Report for Expedited Review protocols

Click to download the Annual Continuation Report for Full Board Review protocols

Details about the procedures involving these forms are found at http://www.umbc.edu/research/HARPO/IRB/IRBpostapproval.html

17 May 2010

Public Health Service (PHS) Policy for information submitted in applications to the NIH that involve live vertebrate animals

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.

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
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From: Christina Stanger, CRA
Assistant Director
Office of Sponsored Programs
University of Maryland Baltimore County