When is an institution considered to be “engaged in research”?

OHRP clarifies this in a revision to the frequently asked question "Regarding Engagement in Research". The revised FAQ answer is found at http://www.hhs.gov/ohrp/FWAfaq.html#q4

Reminders about existing Just-in-Time requirements - IRB and IACUC

As noted in the revised policy on responsibilities for Just-in-Time submissions (NOT-OD-10-120), several pieces of a grant application are not required at the time the application. This is information will be requested later in the review cycle. Related to IRB and IACUC protocols:

IACUC Approval Date: If the proposed project involves research using live vertebrate animals, the verification date of IACUC approval along with any IACUC-imposed changes must be submitted. Pending or out-of-date approvals are not acceptable.

IRB Approval Date: If the proposed project involves human subjects research, the certification date of IRB review and approval must be submitted. Pending or out-of-date approvals are not acceptable.

Human Subjects Education: If the proposed project involves human subjects research, certification that any person identified as senior/key personnel involved in human subjects research has completed an education program in the protection of human subjects must be submitted.
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-10-120.html)

Grant related Vertebrate Animal Section (VAS) information

The NIH has just published further clarification on how the Vertebrate Animal Section (VAS) of applications for grants and cooperative agreements is evaluated as part of the peer review process and is considered as part of the overall scoring. An important detail to consider when designing and writing proposals for funding. See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-10-027.html for more information.

IRB application submissions for approval

Submit IRB applications early to allow time for review. Each category of review has time periods built in to allow the IRB the opportunity to provide guidance and approval for your study. GO to http://www.umbc.edu/research/HARPO/IRB/IRBprotdevelop.html#submit for the schedule.

HARPO Presentations

The Fall 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, contact HARPO at 5-2737 or HARPO@umbc.edu to schedule a time. The current schedule is found at: http://www.umbc.edu/research/HARPO/presentations.html

Comparison table for the 1996 vs. 2010 Guide for the Care and Use of Laboratory Animals

THe American Association for Laboratory Animal Science (AALAS) has created a comparison table for the 1996 vs. 2010 Guide for the Care and Use of Laboratory Animals. This compares text differences, section by section, between the 1996 and 2010 editions.

http://www.aalas.org/bookstore/downloads.aspx (go to Other downloads section)

Meetings dates for IRB and IACUC

The IRB and IACUC have set their schedule for meetings and for acceptance of protocols for the next academic year. Please review the below:

Institutional Review Board (IRB)

October 04, 2010; Full Board Review applications due by September 06, 2010
December 06, 2010; Full Board Review applications due by November 08, 2010
February 07, 2011; Full Board Review applications due by January 03, 2011
April 04, 2011; Full Board Review applications due by March 07, 2011
June 06, 2011; Full Board Review applications due by May 09, 2011

Institutional Animal Care and Use Committee (IACUC)

Protocols must be submitted to
The IACUC will meet in:  HARPO no later than:

October, 2010  August 15, 2010 
January, 2011  November 15, 2010
April, 2011  February 15, 2011
July, 2011  May 15, 2011