Research Compliance notes

Bioethics Commission Releases Report on Human Subjects Protection

2011-12-15T08:02:00.003-05:00

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

2011-12-09T10:11:00.001-05:00

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

2011-12-05T12:12:00.000-05:00

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

2011-12-01T22:45:00.001-05:00

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

2011-10-05T10:12:00.000-04:00

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

2011-09-29T08:41:00.002-04:00

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

2011-09-28T11:45:00.000-04:00

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

2011-09-13T12:39:00.000-04:00

http://www.bioethics.gov/

UMBC's FWA has been renewed

2011-09-13T10:46:00.000-04:00

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

2011-09-09T09:24:00.001-04:00

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

2011-09-09T09:20:00.001-04:00

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

2011-04-04T12:43:00.002-04:00

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

2011-03-11T10:28:00.000-05:00

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

2011-03-02T12:43:00.000-05:00

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

2011-02-28T13:30:00.001-05:00

Updated IACUC forms and applications

2011-02-28T13:29:00.000-05:00

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

2011-02-24T16:13:00.000-05:00

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

2011-02-08T15:34:00.000-05:00

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

2011-02-03T09:07:00.000-05:00

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

2011-01-28T14:03:00.001-05:00

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

2011-01-21T11:55:00.000-05:00

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

2011-01-20T09:56:00.000-05:00

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

2011-01-11T12:57:00.000-05:00

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"?

2011-01-04T13:10:00.000-05:00

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

2011-01-04T12:15:00.000-05:00

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

2011-01-04T11:59:00.000-05:00

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.

HARPO will be closed

2010-12-22T13:39:00.001-05:00

The Human and Animal Research Protections Office will be closed during UMBC’s winter break from December 23, 2010 through January 2, 2011, and will reopen on January 3, 2011.

Internet Research Ethics

2010-12-17T12:47:00.000-05:00

The Internet Research Ethics site hosts a library, research center, and common area for many things related to Internet research.

The mission of this project is to "push the boundaries of traditional research ethics issues, allowing transformative models for managing internet research. It exists to provide sound resources, a solidified research base, and expert advice as more researchers and more IRBs/ethics boards struggle with the complexities of Internet research ethics."

See more at:http://internetresearchethics.org/

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

2010-10-20T11:23:00.000-04:00

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

2010-09-20T10:05:00.000-04:00

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

2010-09-09T11:22:00.000-04:00

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

2010-08-23T16:41:00.000-04:00

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

2010-08-23T16:38:00.001-04:00

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

2010-08-11T08:56:00.001-04:00

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

2010-07-21T10:41:00.003-04:00

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

OHRP educational videos on YouTube

2010-07-20T13:15:00.004-04:00

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)."

OLAW Clarifies Use of Animals in NIH Grants | ALN

2010-07-08T10:03:00.001-04:00

OLAW Clarifies Use of Animals in NIH Grants | ALN

PubMed® Advanced Search Page Modified

2010-06-25T15:34:00.003-04:00

As reported on the Animal Welfare Information Center (AWIC)website (http://weblogs.nal.usda.gov/awic/archives/007674.html), the PubMed Search Builder section of the Advanced Search page will soon be modified to provide users with a more cohesive method to build searches. This will be very useful to animal researchers when creating protocol application and addressing the 3 R's. See: http://www.nlm.nih.gov/pubs/techbull/mj10/mj10_pm_adv_search_page.html

June 15th NCURA Telecast - Non-Financial Research Compliance

2010-06-01T09:18:00.002-04:00

The UMBC Office of Sponsored Programs, Office of Contract & Grant Accounting and UB's Office of Sponsored Research will be co-hosting a NCURA Telecast on June 15, 2010 from 11:30 am to 3:30pm. The topic will be Non-Financial Research Compliance.

The telecast's learning objectives will focus on gaining a better understanding of:

Research and scientific integrity
Responsible conduct of research
Care and use of laboratory animals
Human subjects protection
Use of hazardous materials, including rDNA
Conflict of interest oversight update

RSVP to Joanne Williams (joannew@umbc.edu) in the UMBC Office of Sponsored Programs.

Updates to IRB protocol continuation forms

2010-05-26T11:47:00.002-04:00

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

Public Health Service (PHS) Policy for information submitted in applications to the NIH that involve live vertebrate animals

2010-05-17T11:00:00.007-04:00

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.

New NIH SNAP Policy that relates to IRB and IACUC approvals

2010-05-17T10:56:00.001-04:00

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

New date for the next IRB meeting

2010-04-28T13:47:00.001-04:00

Due to a scheduling conflict, the next UMBC IRB meeting will be held on Tuesday, May 25, 2010.

Animals, Research, and Alternatives Conference

2010-04-26T14:37:00.003-04:00

The Physicians Committee for Responsible Medicine, George Washington University Medical Center, the Johns Hopkins University Center for Alternatives to Animal Testing, the Institute for In Vitro Sciences, and the Kennedy Institute of Ethics at Georgetown University are sponsoring a conference entitled "The Animals, Research, and Alternatives: Measuring Progress 50 Years Later" on Aug. 26 and 27, 2010, at the Washington Marriott in Washington, D.C.

Topics covered include animal experimentation, changing cultural perspectives about the status of animals in society, and new alternatives to animal research.

To the view the agenda and register for the event, go to http://www.pcrm.org/resch/ara/overview.html

OHRP Releases Human Subjects in Research Videos

2010-03-24T12:33:00.003-04:00

The Office for Human Research Protections (OHRP) has announced the availability of educational videos on topics regarding federal regulations for the protection of human subjects.

Currently available videos are "Research Use of Human Biological Specimens and Other Private Information" (http://videocast.nih.gov/ram/ohrp_kaneshiro.ram) and "Reviewing and Reporting Unanticipated Problems and Adverse Events" (http://videocast.nih.gov/ram/ohrp_carome.ram)

Each video is approximately 20-25 minutes in length. Real® Media player installed on your computer to view the training modules

Go to http://www.hhs.gov/ohrp/education/#materials for more information

Applying for IRB review

2010-03-12T14:01:00.002-05:00

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.

HARPO will be closed

2010-03-08T13:11:00.002-05:00

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.

Updates to adding or changing training modules on CITI

2010-02-18T10:07:00.002-05:00

So, you've taken the CITI training - thank you! But, your mentor/supervisor has suggested that you take additional training to supplement the work you'll perform the lab or continue with, say, your dissertation research. To change the CITI course registration that will fit your training requirements, you will have to switch "learner groups". All it takes is going through a couple of steps.

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 that says "Add a course or update your learner groups for University of Maryland, Baltimore County".

3) You are now on the course enrollment page. Scroll down the page that lists the CITI Course Enrollment Questions. Move down page and select the radio button next to "Research with pre-existing data, records data or laboratory specimen" OR "Researchers conducting less than minimal risk research" OR "Social/Behavioral Research Course", then continue scrolling to the bottom of the page and click the Continue button.

4) You'll then be back at your "Learner's Menu" page. You’ll see a link that shows the selected module 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 taking the quizzes. Once completed, you'll have a new certificate showing the completed modules.

Of course, if you have any questions about these steps, contact ORPC at 5-2737 or compliance@umbc.edu.

Descriptions of CITI training modules

2010-02-16T17:50:00.002-05:00

To assist investigators in choosing the most appropriate training module, we've updated the descriptions in our training page. Please visit http://www.umbc.edu/research/HARPO/Training/Training.html and click on the training module links.

Use of Existing and Archival Data

2010-02-16T10:16:00.001-05:00

The IRB's list of pre-approved data holders whose archives include publicly available, de-identified data has been updated. Go to http://www.umbc.edu/research/HARPO/IRB/IRBspecialtopics.html#archival on the IRB's web page to see why this is important.

Compliance document processing and campus closing

2010-02-08T18:54:00.002-05:00

As UMBC is closed for the inclement weather, we in HARPO know that investigators will want their protocols review and approval documents processed as soon as possible. We can access documents sent to irbsubmissions@umbc.edu and iacucsubmissions@umbc.edu and will perform the initial reviews of the protocols as they come in. Please allow a little patience with our reviewers as they may have limited access to documents and may not be able to complete their reviews in a timely fashion.

We will process all protocols as soon as we can in order to provide the approval to continue your research. Please contact us at HARPO@umbc.edu if you have any questions.

Electronic Data and Security

2010-01-25T08:47:00.000-05:00

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.

NIH Releases Report on Researcher Conflict of Interest

2010-01-15T13:27:00.000-05:00

The National Institutes of Health released a report related to financial conflicts of interest reported in 2006, containing data from 41 grant recipient institutions. A majority (111 out of 165 researchers) of conflicts were due to stock or other equity ownership in companies which could affect researcher's ability to be impartial.

See more information on the Social Science Research News blog

Animal Welfare Information Center 2010 Workshop

2010-01-15T13:19:00.002-05:00

The Animal Welfare Information Center (AWIC) teaches a one and a half day workshop (Meeting the Information Requirements of the Animal Welfare Act) at the National Agricultural Library (NAL) in Beltsville, Maryland for individuals who are responsible for providing information to meet the requirements of the Animal Welfare Act (AWA).

The 2010 workshop dates are:

March 17-18, 2010

May 5-6, 2010

October 20-21, 2010

For more information go to AWIC Workshops.

PRIM&R Webinar for animal users

2010-01-15T13:13:00.000-05:00

Top Tips for IACUCs: Perspectives in Animal Care

Join Public Responsibility in Medicine and Research (PRIM&R) for a Webinar – “Top Tips for IACUCs: Perspectives in Animal Care” – February 9, 2010, from 1:00 until 2:30 PM ET.

Program Agenda:
+ A review of top reportable issues to OLAW
+ An OLAW perspective on crisis preparation and management
+ Selection and training of new IACUC chairs and committee members
+ The fundamentals of program review and inspections

Presenters: Patricia A. Brown, VMD, MS, Diplomate ACLAM, Director of the Office of Laboratory Animal Welfare (OLAW) at the National Institutes of Health (NIH) and Monte Matthews, BA, CPIA, Director of the Office of Veterinary Services & Animal Care Officer at the University of Oregon.

For more information, visit http://www.primr.org/Conferences.aspx?id=7887.

Updated IRB forms and applications

2010-01-08T13:15:00.001-05:00

As a reminder, 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 these 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.

News from Ofiice for Human Research Protections (OHRP)- January 5, 2010

2010-01-08T10:58:00.001-05:00

Information relayed from OHRP-L@LIST.NIH.GOV:

OHRP has moved two guidance documents to its archive of guidance documents no longer in effect. The two documents are “Local IRB Review of Multicenter Clinical Trials” and “Local Institutional Review Board (IRB) Review of Multicenter Clinical Trials Sponsored by the Division of Aids (DAIDS) National Institute of Allergy and Infectious Diseases (NIAID).”

These documents have been archived because OHRP’s policy regarding local IRB review has changed and they no longer represent OHRP’s policy. OHRP policy continues to be that a reviewing IRB should have knowledge of the local context for studies it reviews, but that review by a local IRB is not favored over review by a non-local IRB.

All archived OHRP documents may be accessed on the OHRP Web site at:
http://www.hhs.gov/ohrp/policy/archive.html.

HARPO Presentations

2010-01-05T09:21:00.002-05:00

The Spring 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, please contact HARPO at 5-2737 or HARPO@umbc.edu to schedule a time.

2009-12-20T16:08:00.002-05:00

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.

International Compilation of Human Subject Protections

2009-12-09T09:09:00.005-05:00

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.

The exemption applicaiton form has been updated

2009-10-05T16:08:00.001-04:00

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

CITI Training in multiple languages

2009-09-02T10:34:00.002-04:00

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.

Reminder - Next IACUC meetings for 2009

2009-08-24T12:34:00.003-04:00

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

2009-08-24T12:33:00.003-04:00

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.

Updated IACUC forms and applications

2009-08-13T10:38:00.000-04:00

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

2009-08-13T10:37:00.001-04:00

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.

A greener HARPO

2009-08-12T11:44:00.005-04:00

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.

Office of Laboratory Animal Welfare Topic Index

2009-07-23T11:37:00.002-04:00

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.

IMPORTANT ANNOUNCEMENT - Maintenance on CITI Training Program Servers

2009-07-20T09:37:00.006-04:00

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.

New Resource for Recognizing and Alleviating Pain in Animals

2009-06-17T10:49:00.000-04:00

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

2009-06-17T10:43:00.003-04:00

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

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

2009-06-16T14:46:00.004-04:00

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.

2009-06-15T16:06:00.004-04:00

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

2009-06-15T16:02:00.005-04:00

Updated application forms and documents on the HARPO web site

2009-06-12T10:33:00.001-04:00

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

Protocol modifications

2009-06-11T14:45:00.002-04:00

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.

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

2009-05-27T16:02:00.001-04:00

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

2009-05-27T15:57:00.002-04:00

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

HARPO will be closed

2009-05-21T16:15:00.001-04:00

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

IACUC correspondence and guidance

2009-04-15T13:14:00.003-04:00

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.

Updates regarding the use of Existing and Archival Data

2009-03-25T11:01:00.005-04:00

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.

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

2009-03-18T13:26:00.002-04:00

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.

HARPO will be closed

2009-03-13T15:16:00.001-04:00

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

HARPO will be closed

2009-03-09T13:15:00.005-04:00

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.

CITI Training

2009-02-13T15:02:00.003-05:00

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.

Updated IRB forms and applications

2009-02-11T15:15:00.004-05:00

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.

Copies of Training Certificates

2009-02-05T10:23:00.004-05:00

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.

Updated application forms and documents on the HARPO web site

2009-02-03T10:45:00.003-05:00

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

2009-02-03T09:06:00.003-05:00

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.

Guidance on Engagement of Institutions in Human Subjects Research

2009-01-23T14:40:00.003-05:00

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

2009-01-23T09:57:00.005-05:00

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.

Join OHRP's and OLAW's News Distribution Lists

2008-12-19T12:55:00.004-05:00

The Office for Human Research Protections (OHRP)and the Office of Laboratory Animal Welfare (OLAW) invites all researchers to sign up for their news distribution lists. These act a primary source of news, regulatory changes and updates from the federal perspective.

Go to http://grants1.nih.gov/grants/olaw/references/list.htm to sign up for the OLAW LISTSERV or http://www.hhs.gov/ohrp/news/distributionlist.html for the OHRP distribution list.

HARPO will be closed

2008-12-19T12:52:00.002-05:00

The office will be closed for winter break, beginning December 24, 2008 through January 2, 2009. We'll reopen on January 5, 2009.

Reminder - Next IACUC meetings for 2009

2008-12-19T12:45:00.004-05:00

Student Research Within a Faculty Advisor’s Approved Protocol

2008-12-16T09:49:00.004-05:00

Student researchers will, at times, develop ideas for research projects as part of a senior thesis, master’s project or doctoral dissertation. that involve using data collected on a faculty advisor’s IRB approved protocol. The IRB will allow this provided the level of risk does not change, no additional benefits are realized by participants, and the scope of the student’s research project does not significantly differ from the parent protocol.

Rather than burden a student researcher with completing a full application for review and approval, the IRB has developed a Thesis, Masters or Dissertation Research Notification form. This form will assist the IRB in monitoring if the planned activities of the project are already part of a previously IRB approved protocol and/or if there will be any modifications (to risks, consent processes, use of identifiers, etc.) during the course of the research project that will change the provisions of the approved protocol.

If you have a project that falls within this category, download this form (http://www.umbc.edu/irb/tmdr_application.doc) and follow the directions.

Contact HARPO at 5-2737 or HARPO@umbc.edu with any questions.

International laws, regulations, and guidelines on human subject protections

2008-12-02T14:30:00.002-05:00

The Office for Human Research Protections has just released a compendium of human subject protections laws, regulations, and guidelines (almost 1,100 in all) from 92 countries. The list includes web addresses to link directly to the law, regulation, or guideline of interest.

Go to http://www.hhs.gov/ohrp/international/HSPCompilation.pdf for more information.

So, if you're planning an international-based research study, it would behoove you (I like that word!) to investigate whether or not additional research protections are required.

HARPO will be closed

2008-11-24T16:30:00.002-05:00

The office will be closed for Thanksgiving, November 27 and 28, 2008. We'll reopen on December 1, 2008.

Updated IRB forms and applications

2008-11-14T15:39:00.002-05:00

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

Keep your data (and computer) safe

2008-11-04T12:08:00.003-05:00

Words of advice from the Office of Information Technology

Securing Your Laptop Against Physical Theft

Theft of laptops, desktop computers, computer parts and peripherals is a growing problem. According to insurance company figures, there is a 1 in 14 chance of a PC owner being victimized. If you lose your computer, or any part of its system, you've lost more than the cost of the laptop. You have lost your data. The hardware can be replaced, but the loss of work in progress could be devastating.

Click on this link for more information.

People who volunteer to participate in research do so with the understanding that investigators will protect their identity and their information from inadvertent and inappropriate disclosure.

So treat collected data just like your laptop to keep safe and secure. A few helpful tips:

1) train research staff on the proper methods of keeping data secure.

2) de-identify data when saved on the laptop - this means stripping all personal identifiers from the saved data.

3) if the research requires that identifiers be kept, save your data to a removable medium (i.e. external hard drive) and secure that drive under lock and key. You may wish to use an identity key to match various data sets; if so, secure that key as well.

4) sensitive data may be secured using data encryption - the algorithmic transformation of data into an unrecognizable format that can only be recovered using a secret decryption key.

New IRB members (part 2)

2008-11-04T11:01:00.002-05:00

Please welcome additional new members to the UMBC Institutional Review Board who began in the Fall of 2008:

Sarah Chard, Assistant Professor, Anthropology/Sociology

Joseph Clift, Managing Associate/Project Manager, Association for the Study and Development of Community

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