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.

Meeting the Information Requirements of the Animal Welfare Act

The National Agricultural Library in Beltsville, Maryland if offering for principal investigators, members of IACUCs, information providers, administrators of animal use programs, and veterinarians a workshop about the responsibilites of meeting the requirements of the Animal Welfare Act (AWA).

The AWA require that investigators provide documentation with their applications demonstrating that alternatives to procedures that may cause more than momentary pain or distress to the animals have been considered and that the proposed activities do not unnecessarily duplicate previous experiments.

See the NAL website, http://www.nal.usda.gov/awic/awicworkshops/regform.htm, for registration information for this free workshop.

IRB Protocol audits (this is not the IRS)

Many faculty and students have received notices over the past several weeks regarding the post approval protocol monitoring (PAPM), or as it may be better known as a "protocol audit".

Because an investigator is chosen for an "audit" or PAPM, it doesn't mean he/she has done anything wrong. UMBC required by federal regulation to exercise "appropriate oversight mechanisms" to make sure the policies and procedures designed for protecting the rights and welfare of human participants are being followed and that participant's well being is safeguarded.

So, in addition to complying with procedures, the PAPM is used to educate researchers about human subject protection issues and improve the quality of research by finding potential errors or omissions as research is performed.

It's good for the researcher and good for the university.

If you get the email or phone call about a PAPM, don't fret; it's all done to make your research experience easier and hopefully less complicated.

Read more about Protocol Audits .

The IRB is looking for a few (student) volunteers

The Institutional Review Board (IRB) is currently accepting applications from undergraduate and graduate students to join the IRB. Student members are considered full members of the board, which meets five times a year from 10 am-12 pm on Mondays. The meetings are held during the months of October, December, February, April and June. In addition to meetings, student member review research protocols and vote on issues related to the protection of human subjects.

This is a terrific opportunity to learn about ethical issues related to research; and being a member of the IRB looks good on a CV or resume. Interested students should email Susan Sonnenschein, IRB Chair,
(sonnensc@umbc.edu) to apply. In addition to your CV or resume, describe in your email your research interests and experience.

Additional information about the IRB is found at http://www.umbc.edu/irb/.