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Diving and Boating Safety Training for Southern Campuses
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We are pleased to report that the DOI-MOCC course is available for the southern campuses with the two-day training as follows:
Day 1 - March 12, FAU Boca Raton Campus
Day 2 - March 13, John Prince Park
Space is limited, register for these dates as soon as possible to secure your spot.
For other upcoming training dates, click
here
or contact the DBSO's.
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Certificates of Confidentiality
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As of Oct. 1, 2017, the National Institutes of Health will automatically issue Certificates of Confidentiality through the funding award to all research being funded by the NIH that is collecting or using identifiable, sensitive information. Additional certificates do not need to be requested from the Institutional Review Board if you are an NIH funded researcher. Learn more here.
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Regional IACUC Conference
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FAU will host the IACUC 101 Series Conference Nov. 7 - 9 at the Delray Beach Marriott on Ocean Boulevard. This affordable conference will provide comprehensive overviews of laws, regulations and policies that govern the humane care and use of research animals. Join us for one, two or all three days. We encourage you to share with your colleagues.
Registration is available
here
.
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AAALAC International Accreditation of FAU's Animal Care and Use Program
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 AAALAC International representatives completed their comprehensive review of the animal care and use program, including site visits throughout FAU where animals are used in research, teaching and testing activities. FAU will be working on mandatory as well as suggested improvements as a result of this recent visit.
IACUC, Comparative Medicine, Environmental Health and Safety, and Research Integrity will work together to develop and implement plans to address these items over the next couple of months. In May, the site visitors will present the program to the Council on Accreditation, which will then make a final decision regarding accreditation status. Stay tuned for more updates.
An enormous 'thank you' goes to all researchers and administrators who participated in the site visit and represented the animal care and use program.
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Clinical Trials Definition Clarification
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Randomized: According to the NIH's Glossary: "The process by which two more alternative treatments are assigned to volunteers by chance rather than by choice." A randomized study must, at minimum, have a control group and an in
tervention group.
Intervention:
A manipulation of the subject or subject's environment for the
purpo
se of
modifying one or more health-related biomedical or behavioral processes and/or endpoints.
- Examples include drugs, small molecules, compounds; biologics; devices; procedures (e.g. surgical techniques); delivery systems (e.g. telemedicine, face-to-face interviews); strategies to change health-related behavior (e.g. diet, cognitive therapy, exercise, development of new habits); treatment strategies; prevention strategies; and diagnostic strategies.
Health-related biomedical or behavioral outcome:
The pre-specified goal(s) or condition(s) that reflect the effect of one or more interventions on human subjects' biomedical or
behavioral status
or quality of life.
- Examples include positive or negative changes to physiological or biological parameters (e.g., improvement of lung capacity, gene expression); positive or negative changes to psychological or neurodevelopmental parameters (e.g., mood management intervention for smokers; reading comprehension and / or information retention); positive or negative changes to disease processes; positive or negative changes to health-related behaviors; and positive or negative changes to quality of life.
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Deciding Which IRB Forms to Use for Your Research Project
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All new study submissions require the following forms, available on IRBNet.org:
- Form 1 New IRB Application to Conduct Human Subjects Research (brief overview)
- Research Protocol
- (templates available: basic protocol, chart review protocol, clinical trials protocol, registry or repository protocol. Choose the protocol which describes your study and includes project summary, objectives, background and research plan.)
- Informed Consent Document
- (templates available: adult consent, paragraph low risk research for online or verbal consent, parental consent, child assent, cognitive impaired assent, clinical consent, and MRI consent. Choose the consent form/process which is appropriate for your study.)
- Request for Waiver of Signed Consent Form (if applicable)
- If you are conducting minimal risk research with an online survey or phone interviews, an informed consent without signature may be appropriate.
- Data Collection Instruments: Questionnaires / Surveys / Interview Questions (if applicable)
- CITI IRB Training Completion Reports (for principal investigator and all study personnel)
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| Determining When IRB Review is Necessary |
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 Did you know we have a Human Subjects Determination (HSR) Form? If you are uncertain whether your study is human subjects research which requires IRB review, you may find and complete it on our webpage
"Do I Need IRB?". There you can also read more about requirements in our policy or follow the HHS.gov flowchart for determining human research.
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Check Out The Beacon Online
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The archived editions of
The Beacon
can be found online
here
.
Please share with colleagues or use as references to our tips and hints!
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