IRB

ATTN: The IRB process has changed, and the information needs to be updated. (8/29/2015)

I. What needs to be reviewed?

All research that involves interacting or intervening with humans needs to undergo review. (Research
by undergraduates as part of a class does NOT generally need to be reviewed unless there is "High
Risk" involved).

II. Who reviews my human subjects materials?
Reviewed by Departmental Human Subjects Review Committee:

* Faculty research that is not funded by a grant
* Graduate student research (regardless of whether it is part of a course or is a dissertation or
thesis project) that is not funded by a grant
* Undergraduate Honors theses or class projects with High Risk

Reviewed by the University Institutional Review Board:

* Research done by faculty members that is funded
* Research done by graduate students that is grant funded
* Any research by faculty and graduate students that is High Risk must also attain University
IRB approval
* Please plan accordingly since IRB approval takes 4-6 weeks

III. What is the process for review?

Submit the following four items to Professor Castañeda (instructions and forms are available at
http://www.umass.edu/research/comply/IRBsubmission.htm):

* An abstract of the research design.
* Form 441, which asks you to detail the characteristics of the population you are studying, the
risks and benefits of their participation in the research, the necessity of the research, the
means by which you will protect their identities, and your short- and long-term projected
uses of the data.
* A highly detailed informed consent form, complete with elements required by the University.
* Registration Form for Unsponsored Human Subjects Research (forms are available at http://www.umass.edu/research/comply/LHSRBregistration.doc)

Within two weeks, the department level committee will send you a request for changes / revisions or
acknowledgment of approval via the Registration Form for Unsponsored Human Subjects Research.

If your research has an external funding source, you must also complete the online training for human
subjects research (http://www.umass.edu/research/comply/citi.html) – this will take approx 2 hours
(FYI – the shorter version of the online training will not count for external funding). If you have external
funding, you must print out your certificate when you are finished and submit a copy with the rest of
your materials. [If you have completed the online training training in the past, your certificate should
still be valid.]