Completing the Vertebrate Animal Section of NIH applications

OLAW has developed a new factsheet to assist grant applicants in completing the Vertebrate Animal Section of grant applications, contract proposals and cooperative agreements for submission to the NIH. See http://my.umbc.edu/groups/compliance/news/11773

Submission of applications for review

Please be sure to use the correct email address for submitting protocol applications for review. That way, we at ORPC can respond to your requests in a timely manner and forward your application to the appropriate compliance committee.

Send all IRB applications and requests to irbsubmissions@umbc.edu. Protocol submission information may be found at: http://www.umbc.edu/research/ORPC/irb_forms.html.

Send all IACUC applications and requests to iacucsubmissions@umbc.edu. Protocol submission information may be found at: http://www.umbc.edu/research/ORPC/iacuc_forms.html.

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 Pending or out-of-date approvals are not acceptable.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 Pending or out-of-date approvals are not acceptable.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)

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.

OLAW Clarifies Use of Animals in NIH Grants | ALN

OLAW Clarifies Use of Animals in NIH Grants | ALN

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.

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.

Electronic Data and Security

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.

The exemption applicaiton form has been updated

Check it out - http://www.umbc.edu/research/HARPO/IRB/exemptapplication.html

A greener HARPO

In our effort to be "green", help our environment and to help with the timely review of your project, please be sure to review the submission requirements for sending in any IRB or IACUC protocols.

We ask that you electronically submit the protocol along with any accompanying documents to either irbsubmissions@umbc.edu (for human research applications) or iacucsubmissions@umbc.edu (for animal research applications).

Submission information and documents may be found at:

http://www.umbc.edu/research/Resources/irb_forms.htm (IRB)
http://www.umbc.edu/research/Resources/iacuc_forms.htm (IACUC)

Please be sure to include the applicable pages with the signature of the investigators. We prefer this page be submitted electronically (a scanned version as a PDF document will do). If that's not possible, fax that page (and that page only) to the Human and Animal Protections Research Office at (410) 455-3868. Protocol applications will not be processed until this face page is received.

The UMBC IACUC meets four (4) times a year. In order to allow for sufficient review and placement on the meeting agenda, new or renewal protocol applications must be submitted at least 45 days before the scheduled meeting. Applications not received by that deadline date will be automatically placed on the agenda for the next scheduled meeting. The next meetings are listed below. Animal research applications must be submitted to HARPO no later than 45 days before the scheduled meetings.

- October, 2009 - August 15, 2009
- December, 2009 - November 15, 2009
- April, 2010 - February 15, 2010
- July 2010 - May 15, 2010

Application forms and instructions may be found on the IACUC protocol development page.

Updated application forms and documents on the HARPO web site

Please use the most up to date forms and applications when submitting for compliance committee review and approval. Using older forms may delay the processing of your application (and causing minor headaches for the HARPO staff!).

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

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.

Updated IRB forms and applications

Always remember to keep checking back on the IRB web site for the latest forms and applications that are used by the IRB. The most recent updates include revisions to the Expedited and Full Board Review forms, updates to wording on the Informed Consent form and a new form - a short descriptive form for theses, master's and doctoral dissertation research. This form tracks master's or dissertation students own lines of inquiry that was developed under a faculty mentor’s IRB approved protocol. A seperate, full blown application is not required, but the IRB will want to keep track of any and all research that occurs.

See those updates and new forms at http://www.umbc.edu/irb/irbforms.htm

How long does the IRB take to review and approve a protocol?

CHECK IT OUT! http://www.umbc.edu/irb/howtosubmitaprotocol.htm