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Meriter's Clinical Research
- IRB
Human Subject Protection
Training Requirement
Meriter's
Institutional Review Board requires all research staff to complete ongoing
education in human subject protection.
Why
Meriter IRB requires current and ongoing human subject protection training for
researchers and IRB members. This is in compliance with our Federal Wide
Assurance and is in keeping with our institutional mission for providing a Best
Practice Environment.
Timeline
- For New
Protocol Applications, you and your research staff must complete human
subject protection training before your protocol can be reviewed.
- When your
protocol is due for Continuing (Annual) Review you will have to show
proof of human subject protection training in the last three years.
What
- If you have
taken a human subject protection training course in the past three years,
then you will provide Meriter IRB with a dated completion certificate.
Qualifying courses include:
- University of
Wisconsin's online Human Subject Protection Training
- NIH human
subject protection training modules
- VA training
modules
- Other
- For
researchers' convenience, Meriter has subscribed to an on-line web based human
subject protection training program from the University of Miami called
CITI course. You can take training modules here to fulfill your training
requirement if you are not required to take another institution's training
modules.
Which CITI course Modules should I take?
- If you have
never taken a human subject protection training course - take the basic
modules (biomedical or social behavioral). Annual refresher modules are
required after this.
- If it has been
more than three years since your last human subject protection training -
take the basic modules (biomedical or social behavioral). Annual refresher
modules are required after this.
- If your
current human subject protection training is about to expire (three years old) –
take refresher modules 101 (biomedical or social behavioral)
- Should I take
the biomedical or social behavioral modules?
These terms refer to the type of research that you are involved in.
- Biomedical
modules – Research that focuses on physical disease processes, the treatment
and diagnosis of physical disease which may include the use of drugs and
devices.
- Social
Behavioral modules – Research that focuses on human behavior, how people act,
think, interact with others, make decisions, etc.
- If you are
still doing research at Meriter a year from now you will be required to take
further human subject protection training before your protocol receives
continuing review. Your choices are:
- Annual
refresher modules (1-2 hours) from the CITI course
- Other
equivalent qualifying course
- If you have
questions about the human subject protection training requirement, please
contact the Meriter IRB office (267-6411) for clarification.
How
- Log on to
http://www.citiprogram.org/.
- Register
yourself.
- Choose
Meriter as your institution. You do not need an employee number.
- Most
researchers will choose the biomedical modules although some
researchers may qualify for the behavioral modules. If you are not sure
contact the Meriter IRB Office.
- Each module
has test questions at the end. You can take the modules at your own pace,
stopping whenever you want. You can log back on to continue working.
- Once you have
finished all the modules, an electronic report is automatically sent to the
Meriter IRB office.
- Print your own
copy of your completion report and keep for your records.
Who
All research staff must have active training records before your protocol
receives Initial or Annual review.
Questions
Contact the Meriter IRB Office at (608) 417-6411 or
lmichaels@meriter.com.
Back to Researcher Main Page
3/21/2008
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