HARPO will be closed

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

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”?

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

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 Pending or out-of-date approvals are not acceptable.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 Pending or out-of-date approvals are not acceptable.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

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

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

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

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

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

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

OLAW Clarifies Use of Animals in NIH Grants | ALN

PubMed® Advanced Search Page Modified

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

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

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

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

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

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

Animals, Research, and Alternatives Conference

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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.