Showing posts with label irb. Show all posts
Showing posts with label irb. Show all posts
07 March 2012
Updates to IRB consent templates
To continue our outreach and providing the most up to date templates for our investigators to use, please click on the ORPC Consent Template page to download the most current versions. Please contact us if you have any questions.
31 January 2012
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.
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.
15 December 2011
Bioethics Commission Releases Report on Human Subjects Protection
The Commission recommended changes to current practices to
better protect research subjects and to improve its tracking of research programs supported with taxpayer dollars.
See more at bioethics.gov/cms/node/559
The report that discusses these recommendations may be viewed at http://bioethics.gov/cms/sites/default/files/PCSBI-IRP_Research-Across-Borders.pdf
better protect research subjects and to improve its tracking of research programs supported with taxpayer dollars.
See more at bioethics.gov/cms/node/559
The report that discusses these recommendations may be viewed at http://bioethics.gov/cms/sites/default/files/PCSBI-IRP_Research-Across-Borders.pdf
09 December 2011
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 Office for Research Protections and Compliance staff!).
The direct link to these forms is: http://www.umbc.edu/research/ORPC/irb_forms.html
The direct link to these forms is: http://www.umbc.edu/research/ORPC/irb_forms.html
05 December 2011
2012 Edition of OHRP International Compilation
OHRP has released the 2012 edition of the International Compilation of Human Research Standards which lists over 1,000 laws, regulations, and guidelines on human subjects protections in over 100 countries and from several international organizations. Two new countries are included in the 2012 Edition: Barbados and Haiti.
Go to this link for more information.
Go to this link for more information.
05 October 2011
Searching for ORPC topics
Ever wonder where to find compliance topics, such as training? Use your favorite search engine to find it! For example, finding IRB training is as simple as typing "UMBC IRB training" in the search bar and you'll immediately gain access to the URL with all training information. Give it a try!
28 September 2011
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 03, 2011; Full Board Review applications due by September 06, 2011
December 05, 2011; Full Board Review applications due by November 07, 2011
February 06, 2012; Full Board Review applications due by January 07, 2012
April 02, 2012; Full Board Review applications due by March 07, 2012
June 04, 2012; Full Board Review applications due by May 07, 2012
Institutional Animal Care and Use Committee (IACUC)
Protocols must be submitted to
The IACUC will meet in: ORPC no later than:
October, 2011 August 15, 2011
January, 2012 November 15, 2011
April, 2012 February 15, 2012
July, 2012 May 15, 2012
Institutional Review Board (IRB)
October 03, 2011; Full Board Review applications due by September 06, 2011
December 05, 2011; Full Board Review applications due by November 07, 2011
February 06, 2012; Full Board Review applications due by January 07, 2012
April 02, 2012; Full Board Review applications due by March 07, 2012
June 04, 2012; Full Board Review applications due by May 07, 2012
Institutional Animal Care and Use Committee (IACUC)
Protocols must be submitted to
The IACUC will meet in: ORPC no later than:
October, 2011 August 15, 2011
January, 2012 November 15, 2011
April, 2012 February 15, 2012
July, 2012 May 15, 2012
13 September 2011
UMBC's FWA has been renewed
The University of Maryland, Baltimore County has a Federalwide Assurance (FWA00000069, approved through 09/13/2016) from the Office for Human Research Protections.
See this as well as other IRB related policies and procedures at http://www.umbc.edu/research/ORPC/IRBpolicyregs.html
See this as well as other IRB related policies and procedures at http://www.umbc.edu/research/ORPC/IRBpolicyregs.html
09 September 2011
Comment period on proposal to improve rules changes
The comment period for the advance notice of proposed rulemaking (ANPRM) on how current regulations for protecting human subjects has changed and will end on October 26, 2011. See the September 1, 2011 Federal Register (http://www.ofr.gov/OFRUpload/OFRData/2011-22341_PI.pdf)
28 February 2011
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 Office for Research Protections and Compliance staff!).
The direct link to these forms is: http://www.umbc.edu/research/ORPC/irb_forms.html
The direct link to these forms is: http://www.umbc.edu/research/ORPC/irb_forms.html
03 February 2011
IMPORTANT MESSAGE FROM THE CITI TRAINING PAGE
On Saturday, February 5, 2011 between 1:00 and 3:00 AM EST, the CITI Program web site will be taken offline for maintenance. Please complete the module you are working on and log off prior to this time. You will not lose credit for any module that you have completed already. You may resume where you left off when the site is brought back on line. For more information, go to https://www.citiprogram.org/
20 October 2010
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
20 September 2010
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)
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)
21 July 2010
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
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
20 July 2010
OHRP educational videos on YouTube
OHRP has created and published educational videos on the HHS YouTube channel (http://www.youtube.com/user/USGOVHHS#g/c/5965CB14C2506914).
Topics covered include "Research Use of Human Biological Specimens and Other Private Information", "Reviewing and Reporting Unanticipated Problems and Adverse Events," "Institutional Review Board (IRB) Membership" and "General Informed Consent Requirements Parts I (Research Investigator)and II (Research Subject)."
Topics covered include "Research Use of Human Biological Specimens and Other Private Information", "Reviewing and Reporting Unanticipated Problems and Adverse Events," "Institutional Review Board (IRB) Membership" and "General Informed Consent Requirements Parts I (Research Investigator)and II (Research Subject)."
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
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
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.
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.
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