20 December 2009

The Human and Animal Research Protections Office will be closed during UMBC’s winter break, from Friday, December 24, 2009 through Friday, January 1, 2010, and will reopen on January 4, 2010.

Please call the Office telephone number at 410-455-2737 if you have any research compliance questions and follow the instructions on the recorded message.

09 December 2009

International Compilation of Human Subject Protections

The 2010 edition of the International Compilation of Human Subject Protections has just been released by the Office of Human Research Protections. The 2010 version details over 1,100 laws, regulations, and guidelines on human subject protections from 96 countries, including five new countries: Dominica, Guatemala, Honduras, Kyrgyzstan, and Qatar.

View thus document at:
http://www.hhs.gov/ohrp/international/HSPCompilation.pdf.

02 September 2009

CITI Training in multiple languages

The Collaborative Institutional Training Initiative (CITI) training program for human and animal researchers if offered in a variety of languages to meet a researcher's need.

Investigators whose primary language is Chinese, Japanese, Korean, Portuguese, Russian, Spanish or Thai may take the training modules.

Contact Tim Sparklin at 5-2737 or sparklin@umbc.edu in HARPO for more information.

24 August 2009

Reminder - Next IACUC meetings for 2009

The UMBC IACUC meets four (4) times a year. This allows the committee time for sufficient review of new or renewal protocol applications. The next meetings are scheduled for April, 2009 and July, 2009. Therefore, animal research applications must be submitted to HARPO no later than February 15, 2009 for the April meeting and May 15, 2009 for the July meeting.

Application forms and instructions may be found at http://www.umbc.edu/iacuc/iacucforms.htm.

Reminder - IRB meeting dates for 2009 - 2010

The IRB meets every sixty (60) days during the academic year to review human subjects protocols. Full committee reviews of protocols are performed at each of the scheduled meetings; exempt and expedited review applications may be submitted at any time.

The meeting schedule for the 2009-10 academic year is as follows:

- October 05, 2009; Full Board Review applications due by September 07, 2009
- December 07, 2009; Full Board Review applications due by November 02, 2009
- February 01, 2010; Full Board Review applications due by January 04, 2010
- April 05, 2010; Full Board Review applications due by March 02, 2010
- June 07, 2010; Full Board Review applications due by May 03, 2010

Please visit the IRB's protocol development page for further information.

13 August 2009

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 HARPO staff!).

The direct link to this forms is: http://www.umbc.edu/research/Resources/iacuc_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

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.

12 August 2009

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.

23 July 2009

Office of Laboratory Animal Welfare Topic Index

The Office of Laboratory Animal Welfare (OLAW) has created a Topic Index – a new online resource to OLAW Guidance by subject matter. Investigator can now browse and search OLAW responses to Frequently Asked Questions, Commentaries and Articles written by OLAW staff, plus Policy Notices published in the NIH Guide for Grants and Contracts.

Go to http://grants.nih.gov/grants/olaw/olaw_topic_index.htm for more information.

20 July 2009

IMPORTANT ANNOUNCEMENT - Maintenance on CITI Training Program Servers

On Monday, August 3, 2009 at approximately 8 AM EST, the CITI Program web site will be taken offline for a major system upgrade. The CITI programming folks expect the downtime to be approximately five days (at least through August 9, 2009).

If you or anyone in your labs or teaching sections is working on a training module, please instruct them to complete the module and log off prior to August 3.

Updates will be posted to the HARPO training page at http://www.umbc.edu/research/HARPO/Training/Training.html.

17 June 2009

New Resource for Recognizing and Alleviating Pain in Animals

A new online resource available from the National Academy of Sciences to help those who care for and use laboratory animals, farm animals, and pets to prevent, recognize, and alleviate pain in different types of animals is available at http://nas.edu/pain.

New Animal Model Resource

The National Center for Research Resources (NCRR) reports that scientists who work with animal models will soon be able to use a new web site and database designed to increase research efficiency, improve collaboration and quickly find the best animal models for their research studies.

The Linking Animal Models to Human Disease Initiative (LAMHDI) will integrate data and information about animal models and make them available to researchers throughout the world.

Go to http://www.ncrr.nih.gov/comparative_medicine/linking_animal_models_to_human_disease.asp for more information

16 June 2009

Welcome to new IRB members; thank you to those leaving.

The IRB will welcome three new members this fall. New members include:

John Borrero, Assistant Professor, Psychology

Leigh Dalton, graduate student, Public Policy

Kelley Gurley, graduate student, Human-Centered Computing

The IRB also wishes to thank student members Gina Fitzmaurice and Satarupa Joardar for their service this past academic year.

The updated roster of Board membership is available on the IRB website.

15 June 2009

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.

Reminder - IRB meeting dates for 2009 - 2010

The IRB meets every sixty (60) days during the academic year to review human subjects protocols. Full committee reviews of protocols are performed at each of the scheduled meetings; exempt and expedited review applications may be submitted at any time.

The meeting schedule for the 2009-10 academic year is as follows:

- October 05, 2009; Full Board Review applications due by September 07, 2009
- December 07, 2009; Full Board Review applications due by November 02, 2009
- February 01, 2010; Full Board Review applications due by January 04, 2010
- April 05, 2010; Full Board Review applications due by March 02, 2010
- June 07, 2010; Full Board Review applications due by May 03, 2010

Please visit the IRB's protocol development page for further information.

12 June 2009

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

11 June 2009

Protocol modifications

As you may well know, any proposed change to an already approved human subject research protocol, measures, or informed consent document during the period of IRB approval must be submitted to the IRB for review and approval before that change commences.

We in HARPO, on the behalf of our reviewers, ask that you highlight any proposed wording changes in the application form, consent documents, recruitment fliers, etc. in yellow and underline and attach those changed documents to this form. This will assist the reviewer with understanding the changes investigators are planning to make.

See http://www.umbc.edu/research/HARPO/IRB/IRBpostapproval.html#modifications for more information.

27 May 2009

How can institutions and their IACUCs best prepare for a pandemic?

OLAW posted a reminder on its website to grantee institutions that the Guide for the Care and Use of Laboratory Animals requires PHS Assured institutions to “have a disaster plan that takes into account both personnel and animals.”

Look at the OLAW website in the Frequently Asked Questions section, question 9, under Institutional Responsibilities or see more information about the H1N1 Influenza at http://www.cdc.gov/h1n1flu/.

Public Responsibility in Medicine and Research webinar

Registration for the June 4, 2009 webinar at at 1:00 PM ET - If It's Not Broken, Improve It: New Strategies in Laboratory Animal Care - is still open, but closes on Tuesday, June 2.

This 90-minute intermediate/advanced-level webinar for animal program directors, facility/program operations managers, vice presidents of research/research policymakers, institutional animal care and use committee (IACUC) office directors, and veterinarians will provide information about:

Enabling Change in Laboratory Animal Management – Learn new operational strategies that incorporate continuous improvement and workforce empowerment adapted from Toyota's Production Systems (TPS) that can significantly improve efficiency, cost, and quality within any animal program.

and

Expanding the Concept of Medicine in Laboratory Animal Care – Explore opportunities for lab animal medicine to grow beyond its historical emphasis on preventive medicine and more recent practice of palliative medicine, by considering applications in restorative medicine without compromising protocol endpoints.

Register now at http://www.primr.org/Conferences.aspx?id=6653

21 May 2009

HARPO will be closed

The office will be closed for Memorial Day (and furlough days), May 22 and 25, 2009. We'll reopen on May 26, 2009.

15 April 2009

IACUC correspondence and guidance

Investigators are reminded to share any IACUC correspondence/guidance with all individuals (from technicians to students) working on protocols. The IACUC distributes information to Principal Investigators but it is the investigator's responsibility to ensure that all staff are aware of any issues raised by the IACUC.

(Thanks Dr. Rabin!)


Any questions or comments? Please contact HARPO at 5-2737 or HARPO@umbc.edu.

25 March 2009

Updates regarding the use of Existing and Archival Data

In many areas of the social sciences, one of the most commonly used methods of research is the secondary analysis of publicly available files of data.

The IRB is acquainted with the fact that the federal government as well as large data consolidation bureaus and consortiums provide public access to many data sets. Additionally, many federal funding programs as well as social science professional organizations and journals now require that researchers make the data they collect publicly available to encourage scholarly replication of research. Data may also available from previously IRB approved protocols where the data sets do not contain information that could be used to identify individual research participants

Under the federal regulations for human subjects (45 CFR Part 46), research involving publicly available data sets are exempt from IRB review:

* as long as the data come from sources that are publicly available
* and the data is deidentified and uncoded and stripped of identifiers.

Therefore, the IRB has determined that investigators who plan to use these publicly available, de-identified sources do not require prior IRB review. These means no application is required.

The IRB has created a list of pre-approved data holders whose archives include publicly available, de-identified data. Review this list and follow the respective links below to learn more about the access and download procedures each data source.

Go to the IRB website (http://www.umbc.edu/research/HARPO/IRB/IRBspecialtopics.html#archival) for more information about this process and to obtain the list of pre-approved data holders.

Cautionary note # 1: If you are designing a research project that merges more than one public data set and you recognize that this may increase the risk of identification of individual research participants, please contact the Human and Animal Research Protections Office at 5-2737 or HARPO@umbc.edu.

Cautionary note #2: Data holders whose archives are available on a restricted basis will require the submission of an application for Expedited or full board review.

18 March 2009

American Recovery and Reinvestment Act stimulus money and review of human subject or animal use protocols

The recently approved American Recovery and Reinvestment Act (ARRA) will provide opportunities for universities and other institutions to apply for research related monies from the stimulus funds. Federal agencies distributing these funds have or will be providing guidance to respond and submit applications with possible very tight turnaround times.

Unless the grant announcements say otherwise, the Just-in-time principles should apply. These procedures allow an applicant to defer certification of IRB approval of the project’s proposed use of human subjects or verification of IACUC approval of the project’s proposed use of live vertebrate animals.

I have asked the folks in Sponsored Programs to keep me informed in the event the funding agencies have requirements for a quick turn-around of compliance committee review as the distribution and the spending of funds may have to occur within a limited amount of time.

13 March 2009

HARPO will be closed

The office will be closed for Spring Break (and furlough day), March 16 and 17, 2009. We'll reopen on March 18, 2009.

09 March 2009

HARPO will be closed

The Human and Animal Research Protections Office will be closed March 11 and 12, 2009. The staff of HARPO will be attending a workshop at the Animal Welfare Information Center on both days. Please leave an email at HARPO@umbc.edu or a voice mail at 410-455-2737 and someone will get back to you shortly.

13 February 2009

CITI Training

Attention all UMBC investigators a notice from the CITI website (www.citiprogram.org) from today:

---------------------------------
On Monday, February 16, 2009 at approximately 6 AM EST, the CITI web site will taken offline for site upgrades. We expect the downtime to be approximately six hours. To prevent loss of data, please complete your work and logoff prior to this time.
---------------------------------

Please be aware of this if you plan to log onto CITI on the 16th.

11 February 2009

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.

05 February 2009

Copies of Training Certificates

Investigators who completed the UMBC IRB training on Blackboard can request a copy of their certificate from HARPO. We have electronic versions of certificates from January 1, 2005 through September 17, 2007). We also have copies of AALAS Animal Care and Use in Research and Education exam records for animal researchers who completed this training from February 1, 2006 through September 17, 2007).

After 09/17/2007, the Collaborative Institutional Training Initiative (CITI) web training program was put into place to satisfy the training requirement for UMBC researchers. Investigators may print copies of their own IRB or IACUC training certificates by logging into CITI (www.citiprogram.org), using your username and password, and clicking the "Print" link under the Completion Reports column in My Courses.

Please contact the HARPO staff at 5-2737 or HARPO@umbc.edu if you need additional assistance in retrieving a certificate copy.

03 February 2009

Updated application forms and documents on the HARPO web site

Looking for the link to access all forms used for human and animal research? 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

Changes to the HARPO web site

As announced by Elliot Hirshman, Provost and Senior Vice President for Academic Affairs and Geoffrey Summers, Interim Vice President for Research on January 30, 2009, the web access to all UMBC research information has been redesigned. The link to the updated site is http://www.umbc.edu/research.

With the update of the UMBC Research site, access to all HARPO related web pages has changed as well. Please click on http://www.umbc.edu/research/HARPO/ to access pages for the IRB, IACUC, training as well as other research compliance information.

23 January 2009

Guidance on Engagement of Institutions in Human Subjects Research

When an institution is engaged in non-exempt human subjects research that is conducted or supported by HHS, it must satisfy HHS regulatory requirements related to holding an assurance of compliance and certifying institutional review board (IRB) review and approval.

Before engaging in human subjects research that is not exempt, an institution must hold or obtain an OHRP-approved Federalwide Assurance and certify to the HHS agency conducting or supporting the research that the research has been reviewed and approved by an IRB.

Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. A human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information. An institution is defined in 45 CFR 46.102(b) as any public or private entity or agency (including federal, state, and other agencies).

In other words, institutions are considered engaged in an HHS-conducted or -supported non-exempt (EXPEDITED OR FULL BOARD) human subjects research project when the involvement of their employees or agents in that project falls into various examples including:

Institutions whose employees or agents intervene for research purposes with any human subjects of the research by performing invasive or noninvasive procedures

Examples of invasive or noninvasive procedures include drawing blood; collecting buccal mucosa cells using a cotton swab; administering individual or group counseling or psychotherapy; administering drugs or other treatments; surgically implanting medical devices; utilizing physical sensors; and utilizing other measurement procedures.

Institutions whose employees or agents intervene for research purposes with any human subject of the research by manipulating the environment

Examples of manipulating the environment include controlling environmental light, sound, or temperature; presenting sensory stimuli; and orchestrating environmental events or social interactions.

Institutions whose employees or agents interact for research purposes with any human subject of the research

Examples of interacting include engaging in protocol dictated communication or interpersonal contact; asking someone to provide a specimen by voiding or spitting into a specimen container; and conducting research interviews or administering questionnaires.

For more information and other examples, go to http://www.hhs.gov/ohrp/humansubjects/guidance/engage08.html.

IACUC review of federal grant funded animal research

PHS Policy regarding review and approval of animal studies state that "the IACUC shall conduct continuing review of activities covered by this policy at appropriate intervals as determined by the IACUC but not less than once every three (3) years". UMBC animal research protocols are approved for a three-year term. The investigator or instructor must resubmit a new application for Committee review in order to continue research activities.

What doe this mean if the proposed research, at the time of grant award, will not involve animal research until years 4 or 5 of an award?

The Office of Laboratory Animal Welfare (OLAW) recently issued guidance about this (http://grants.nih.gov/grants/olaw/faqs.htm#proto_20). If this occurs, the PHS awarding unit will not make an award unless the institution provides "..verification of approval by the IACUC of those components of the application or proposal related to the care and use of animals".

IACUC review must be performed prior to the conduct of any PHS-supported animal activity; this usually means approval must be obtained before an award is made and well before any animal research activity can begin. But, an IACUC can review activities if they will occur later in the life cycle of a grant. OLAW says that during these rare cases, the grant application must clearly explain when these activities will occur and that the PHS awarding component will issue a Notice of Award with a special term and condition indicating that no funds may be drawn from the grant or contract until a valid IACUC approval date has been issued by the IACUC.

Be sure to discuss any and all components with your OSP contact during the UMBC routing process or with the Human and Animal Research Protections Office.