28 February 2008

IACUC application details

To get your IACUC application reviewed in a timely fashion, and to make life simple for us, follow these steps:

1) Complete the CITI training program. There's no need to send us a copy of your training certificate as we'll have that electronically. But check off the box on the application that you, your advisor and members of your research team, have completed the training.

2) Fax and/or scan the front page of your application. Please only send the signature page by fax or email a scanned copy only. Electronically submit the rest of your application, via email, to iacucsubmissions@umbc.edu. Of course, if there are any parts of your application that cannot be sent electronically to fax or mail to the HARPO office.

3) Check your spelling and grammar. There have been far too many times applications have been submitted with these types of errors. It's best to present to the IACUC a well presented application that not only fully describes your research but also shows you have the adequate know-how and expertise in the areas of animal care and use.

4) Allow yourself sufficient time for review of the research. The review cycle has been created to make sure the folks on the IACUC have adequate time to review, ponder and make any recommendations about your research study. Remember, the IACUC's mission is to ensure that animal use is necessary and that high standards of humane care are observed. They need the time in the review cycle to do this. So, submit as early as you can. The review cycle guidelines are found in the IACUC's Protocol Policy Procedures.

Where in the world is HARPO?

In case you were wondering and would like to visit or drop off any paperwork, the staff of HARPO are located in the UMBC Research Park (bwtech@UMBC) at 5523 Research Park Drive, Suite 310, Baltimore, Maryland 21228.

A map showing our location may be found at http://www.bwtechumbc.com/pdf/bwtech_umbc.pdf.

Give us a call at 410-455-2737 or send an email to HARPO@umbc.edu to let us know you're coming.

IRB application details

To get your IRB application reviewed in a timely fashion, and to make life simple for us, follow these steps:

1) Complete the CITI training program. There's no need to send us a copy of your training certificate as we'll have that electronically. But check off the box on the application that you, your advisor and members of your research team, have completed the training.

2) Fax and/or scan the front page of your application. Please only send the signature page by fax or email a scanned copy only. Electronically submit the rest of your application, via email, to irbsubmissions@umbc.edu. Of course, if there are any parts of your application that cannot be sent electronically to fax or mail to the HARPO office.

3) Check your spelling and grammar. There have been far too many times applications have been submitted with these types of errors. It's best to present to the IRB a well presented application that not only fully describes your research but also shows you'll be ready to interact with and adequately inform subjects about participation in a research study.

4) Allow yourself sufficient time for review of the research. The review cycle has been created to make sure the folks on the IRB have adequate time to review, ponder and make any recommendations about your research study. Remember, the IRB's mission is to provide oversight on all human participant research, with a focus on protecting individuals from risk and safeguarding their well-being. They need the time in the review cycle to do this. So, submit as early as you can to make sure you won't run into participant scheduling problems or not completing your project before the semester ends. The review cycle guidelines are found in the IRB's Researcher's Guide.

18 February 2008

CITI training (part 2)

How would you figure out which is the best human participant training for you? First, think about the level of risk your project entails.

Research protocols that would present a low amount or risk or less than minimal risk to participants most likely will be reviewed by the IRB in any of the six "exempt" review categories. As such, choose the Researchers conducting less than minimal risk research module or the Data or Specimens Only Research module in the CITI training program.

Conversely, research that presents a a minimal risk or higher level of risk will be reviewed in the "expedited" or "full board" review cycles. The module entitled " Social & Behavioral Minimal Risk Research" must be completed by all investigators performing this type of work.

Examples of the type of research in the above review categories can by found on the IRB web site.

If you are unsure of which group to select, or feel your research falls within two of these learner areas, please contact Tim Sparklin in the Human and Animal Research Protections Office at 410-455-2737, email sparklin@umbc.edu or send an IM message to HARPO246.

14 February 2008

HARPO Compliance Console Newsletter

View the latest issue of the Compliance Console - Volume 1, Issue 2, January 2008

HARPO presentations

The staff from the Human and Animal Research Protections office are available to meet with faculty at departmental meetings or speak to students in informal or formal (research methodology classes) to better educate and inform about research compliance issues. Contact the HARPO office at HARPO@umbc.edu or 410-455-2737 for more information or to schedule a time for your group or class. The current schedule of presentations may be found at this link.

CITI training

Unsure of which learner group to select for the Collaborative Institutional Training Initiative (CITI) web-based courses? Review the below list to determine which best fits your training needs;contact Tim Sparklin if you have any questions. Note that links will open into a new page.

Human Research

Social & Behavioral Minimal Risk Research
This module is designed for faculty, staff, graduate students, and undergraduate students involved in minimal risk research, who plan to submit for expedited review and who have not previously completed the UMBC IRB training program.

Data or Specimens Only Research
This module is designed for faculty, staff, graduate students, and undergraduate students involved in less than minimal risk research that uses pre-existing data, records and/or specimens and when such data may fall within the exempt (
subcategory 4) or expedited categories of review (Category 5).

Researchers conducting less than minimal risk research
This module is designed for faculty, staff, graduate students, and undergraduate students involved in less than minimal risk research, which entails no known physical, emotional, psychological, or economic risk, to nonvulnerable subjects. Students who are enrolled in PSYC 332 or related undergraduate research methods courses will take this module for training.

IRB Investigator Refresher Module
These modules are designed for faculty, staff, graduate students, and undergraduate students whose UMBC IRB training certification has expired and are contemplating continuing research with human participants. Investigators will have received a notice from HARPO regarding re-certification and be instructed on the appropriate module to take.

Animal Care and Use

Working with the IACUC – the basic course required for investigators and research staff who plan to use laboratory animals or plan to supervise such work at UMBC. Investigators and research staff are also required to choose appropriate species-specific module.