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

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

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.

Position Statements: OLAW Responds to Concerns Regarding Adoption of the Guide for the Care and Use of Laboratory Animals: Eighth Edition

OLAW has released information about their adoption of the new edition of the Guide for Use of Laboratory Animals. OLAW requests public comment on various position statements they plan to use as guidance for institutions to use for animal care and use programs.

Please go to this site (http://grants.nih.gov/grants/olaw/2011positionstatement.htm) to view these statements and for links to submit comments.

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!

Description of animal research in scientific publications

OLAW provides information guidance for the description of animal research in scientific publications - http://www.nap.edu/catalog.php?record_id=13241

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

President’s Bioethics Commission releases results of investigation of 1940s US Public Health (USPH) STD Studies in Guatemala

http://www.bioethics.gov/

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

Conflict of Interest Rules Finalized for NIH

The Department of Health and Human Services has issued an updated final rule on conflict of interest to use in identifying, managing, and avoiding investigators’ financial conflicts of interest. The regulations will be implemented after publication of the final rule in the Federal Register.

Major changes to the regulations include:

A requirement for investigators to disclose to their institutions all of their significant financial interests related to their institutional responsibilities.

Lowering the monetary threshold at which significant financial interests require disclosure, generally from $10,000 to $5,000.

Requiring institutions to report to the PHS awarding component additional information on identified financial conflicts of interest and how they are being managed.

Requiring institutions to make certain information accessible to the public concerning identified SFIs held by senior/key personnel.

Requiring investigators to complete training related to the regulations and their institution’s financial conflict of interest policy.

See this site, http://www.nih.gov/news/health/aug2011/od-23.htm, for more information and a full description of the major changes to the regulations.

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)

Update to NIH changes to conflicts of interest rules

The March 17, 2011 issue of "Report on Research Compliance ", published by the by National Council of University Research Administrators and Atlantic Information Services, says the Office of Management and Budget is reviewing NIH's final rule imposing new requirements for managing and reporting on financial conflicts of interest. Regulations are typically reviewed and released by the OMB within 90 days of this process, but stay tuned for further details.

The original Notice of Proposed Rulemaking from the NIH regarding these changes to financial conflict of interest rules and reporting may be found at http://grants.nih.gov/grants/policy/coi/

Temporary fax number for ORPC

The suite where ORPC is located will be going under renovations beginning next week which will affect our ability to accept faxed documents. Renovations that affect the ORPC should be complete by March 18, 2011.

We will still accept and review information electronically via our email submission addresses (irbsubmissions@umbc.edu and iacucsubmissions@umbc.edu) and will process applications and answer questions related to protocols.

We have a temporary fax number that investigators may use in the meantime. Please use 410-455-8750 to send signed application pages.

Thank you for your patience.

RCR instruction for NIH awards

The NIH has made a policy change regarding RCR instruction for Institutional Training Grant Applications (Ruth L. Kirschstein National Research Service Award (NRSA) Institutional Training grants and Non-NRSA Institutional Training grants). See link on the ORPC page for Regulations and Policy.

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

Updated IACUC forms and applications

Please use the most up to date forms and applications when submitting for IACUC 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 this forms is: http://www.umbc.edu/research/ORPC/iacuc_forms.html

Public Comment requested on the NIH adopting the updated Guide

The National Institute's of Health has issued a Federal Register Notice requesting public comments on:

1) NIH’s adoption of the eighth edition of the Guide for the Care and Use of Laboratory Animals, and

2) NIH’s proposed implementation that would require that institutions perform at least one semiannual program and facility evaluation using the eighth edition by March 31, 2012.

NIH encourages comments to be entered at: http://grants.nih.gov/grants/olaw/2011guidecomments/add.htm. Comments must be received on or before March 25, 2011. Comments will be made publicly available after March 25, 2011.

See the NIH Guide Notice: NOT-OD-11-042.

Full version of the interactive movie, The Lab, now available online

From the Office of Research Intergrity

The long awaited release of "The Lab: Avoiding Research Misconduct" is now available for viewing on the ORI web site. The video simulation allows users to assume the role of a graduate student, post-doc, research administrator, or PI and make decisions that affect the integrity of research.
http://ori.hhs.gov/TheLab

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/

HARPO is changing its name

Change is coming! The Human and Animal Research Protections Office will soon be known as the Office for Research Protections and Compliance (ORPC). All human and animal research compliance information will be moved to this site. Please bookmark http://www.umbc.edu/research/ORPC/.

Revised NIH Guidelines for Breeding of Transgenic Rodents

From the NIH Office of Biotechnology Activities (OBA) : http://oba.od.nih.gov/oba/index.html

NIH Guidelines Revised to Exempt Most Experiments Involving the Breeding of Transgenic Rodents Housed Under BL1 Conditions - Under the revisions to the NIH Guidelines for Research Involving Recombinant DNA Molecules effective January 19, the breeding of transgenic rodents that may be housed under BL1 containment conditions is exempt from the NIH Guidelines with the exception of:

Breeding experiments involving transgenic rodents that contain more than 50 percent of the genome of an exogenous eukaryotic virus from a single family, in order to prevent inadvertent reconstitution of an exogenous virus in the resultant transgenic rodent; and

Breeding experiments in which the transgenic rodent's transgene is under the control of a gammaretroviral long terminal repeat (LTR), in order to address the small risk of recombination with endogenous retroviruses which could potentially result in mobilization of the transgene via a replication-competent mouse retrovirus.

The above two types of experiments must still be registered with, and eventually approved by, an IBC under Section III-E of the NIH Guidelines.

A full description of these changes can be found in the January 19, 2011 Federal Register ( 76 FR 3150 )

Affiliate with UMBC in CITI

If you completed the CITI training at another institution, but want to affiliate with UMBC, no problem. The advantage of affiliation is that some institutions (like UMBC) may require the same modules that only need to be completed once. The software gives credit for completion.

Here's how to affiliate:

1) Log back into CITI (using your username and password). The site that appears will be your "Learner's" page or Main Menu - the one that shows the courses you're enrolled in.

2) Look for the link at the top of the page that says "Affiliate with another institution".

3) Choose the drop down box next to “Participating Institutions” and select University of Maryland, Baltimore County. Click “Submit”

4) Complete the “Member Information” section (similar to what was completed during the initial CITI registration phase) and click “Submit”

5) Choose the training module that you plan to take (or have already taken) on the “Select Curriculum” page and click “Continue”

6) You'll then be back at your "Learner's Menu" page. Look for the heading “University of Maryland, Baltimore County “. If the modules completed at your current institution say “Passed (with a date)”, under University of Maryland, Baltimore County heading, then no further action is required. If not, you’ll see a link(s) for modules under My Courses with a link that says "Not Started - Enter". Click on that link and you'll see a list of additional training modules to take. Continue with reviewing the training materials and take the quizzes. Once completed, you'll have a new certificate showing the completed modules.

Office of Research Integrity (ORI) to release a video simulation of research intergrity

A video simulation on research integrity, entitled "The Lab", will be released within the next month on the ORI web site and as a DVD. This simulation focuses on a hypothetical research misconduct case that causes lab to lose funding, create bad publicity for the university, and eventually causes the withdrawal of a multi-million dollar endowment.

Like the popular "Choose Your Own Adventures" stories, "The Lab" will allow viewers the opportunity to undo the damage by assuming the roles of a graduate student, post doc, principal investigator,
and a research integrity officer and make decisions to prevent misconduct from occurring unnoticed. The interactive video addresses the handling of misconduct, data management, authorship, mentoring, work-life balance, and other issues that today's researchers face. A fully-functional online version will be available on the ORI site in January, with a DVD version expected to ship PHS funded institutions before February 2011.

A trailer of the video can be viewed at http://ori.hhs.gov/TheLab

What is "Research Integrity"?

The NIH Office of Extramural Research has created a website that explains research integrity, gives a definition of research misconduct and what is expected from researchers. This a great teaching tool.

Go to http://grants.nih.gov/grants/research_integrity/

Final version of the updated Guide for the Care and Use of Laboratory Animals now available

It's here! The Institute for Laboratory Animal Research (ILAR) has announced the publication of the final version of the 8th Edition of the Guide for the Care and Use of Laboratory Animals. This is the primary reference used by institutions who are engaged in the humane treatment of animals in research, testing, and teaching. The 2010 edition replaces the Guide, which was last updated in 1996, and includes recently published data, scientific principles, and expert opinion to recommend practices for responsible laboratory animal use.

Go to http://www.nap.edu/catalog.php?record_id=12910 to view and/or purchase a copy.

Updates to the OHRP website

The Office for Human Research Protections (OHRP) has updated its website on January 2, 2011. The new site has the content from the original site but is now "revised and streamlined." Go to http://www.hhs.gov/ohrp.