New IRB members

Please welcome the following new members to the UMBC Institutional Review Board, beginning in the Fall of 2008:

Gina Fitzmaurice, Undergraduate student member, Health Administration & Policy Program

Satarupa Joardar, Graduate student member, Biological Sciences

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

Questions participants should ask before agreeing to participate in a research study

Investigators are always on the look out for participants to enroll in a study; without them, how could you collect valuable data?

When approaching/recruiting potential participants, provide lots of information about your study but also encourage them to ask questions. Full disclosure about the study and honest answers to questions will make life easy for you, the investigator, as well as your participants.

Some questions participants should ask (courtesy of OHRP - http://www.hhs.gov/ohrp/outreach/questions.html):

• Why is the research being done?

• What will be done to me as part of the research?

• How will I benefit from the research?

• Could the research hurt me?

• What will the researcher do with my information?

• Will the research cost me anything?

• Who pays if I�m unexpectedly injured in the study?

• How long will the study last?

• What happens if I decide to leave the study early?

• Who should I call if I have a question about the research?

Slide shows that explain CITI compliance training registration

Everyone likes a slide show, right? Except, maybe, for Uncle Harry's bonanza of 400 slides of his trip to the Grand Canyon.

Well, never fear. We at HARPO would rather not put you sleep, but make your introduction and registration with the compliance training programs with the Collaborative Institutional Training Initiative (CITI ) a bit easier.

Currently, there are several compliance training programs to take, including Human Participant Use, Animal Care and Use and Responsible Conduct of Research.

Click on the http://www.umbc.edu/HARPO/training.htm to view the program that interests you or are required to review before conducting research. Select the slide show to view; additional registration instructions are available for download.

Let us know at HARPO@umbc.edu or 410-455-2737 if you have any questions or need more information.

P.S. - we won't tell Uncle Harry you left the room!

Office of Laboratory Animal Welfare IACUC Staff Outreach

The Office of Laboratory Animal Welfare (OLAW) is hosting a series of free online seminar series to help Institutional Animal Care and Use (IACUC) staff understand their responsibilities in the oversight of PHS-funded research involving the use of animals. IACUC members, veterinarians, compliance personnel and animal care staff are also invited to attend the free seminars.

All you need a computer with internet access with Flash software installed.

For more details and registration for this free event (get the free message, right?), go to:
http://grants.nih.gov/grants/olaw/e-seminars.htm

who should a participant contact

The contact information (telephone, email, address) should be listed for the principal researcher/investigator and HARPO office.

First and foremost, state to the participant in the consent process and on the consent form how they can reach the researcher/investigator at the time of the study and after the study is completed in case they have any questions, concerns, or complaints. List the contact information for a faculty advisor if applicable.

The staff of the HARPO office, who represents the IRB, must also be listed as a contact point to provide assistance to participants to about the IRB review process or that person's rights as a research participant.

The consent form must clearly state who and how to contact both. Use the consent form examples on IRB web site to create this form.

Animal Welfare Matters fromthe NIH

Animal research news and notes from the NIH Office of Extramural Research
http://nexus.od.nih.gov/nexus/nexus.aspx?ID=44&Month=4&Year=2008

IRB applications and team members

The applications for IRB review now request that you list the principal investigator, faculty adviser as well as the research team members associated with the research project. The list of all pertinent individuals in the application does two things: 1) it shows the IRB who is associated with the research and that these individuals have completed the CITI training and 2) provides for the necessary documentation in who may be involved in the participant consenting process.

The later point is important for, when we in HARPO go and review protocol files, we find that only those associated with a research project are involved in the consent process and have the necessary knowledge to inform participants about the purposes and intent of a study. Plus, it's a good measure for primary investigators to maintain quality control over how the research is being conducted.

So, fill in all names you, as the primary investigator know will be associated with the study. If you don't know at the time of application (waiting for grad students to come on board or are waiting for those helpful undergrads to sign up for study), send an email to the HARPO office (HARPO@umbc.edu) with the names. We'll at the minimum verify these individuals have completed the CITI training.