ࡱ > & bjbj i x x
y / / / / / C C C 8 { 4 T C , q q q y { { { { { { ! \ { / 9 O O " 9 9 { / / 6 1 1 1 9 L / / 1 9 y 1 1 1 pί[ C 1 0 1 " + " 1 " / 1 q q 1 q q q q q { { 1 q q q q & " p " q q q q q q q q q : New Study Expedited: Reviewer Checklist and Action Determination
(Last revised: 8/3/11)
Principal Investigator: _______________________________
Study Title:_____________________________________________________________________
DocumentsYESNON/ACommentApplication FormAre strategies to protect participant privacy and minimize risk adequate? (Sec. V, question 1)*Are all risks to participants adequately articulated, addressed, & justifiable? (Sec. V)Are any vulnerable populations adequately protected and any exclusion of populations justifiable? (Section VI) Any other regulations?**Are consent procedures included? (VI, VII)Is any request to waive or alter consent form or process justified? (Section VII)Have one or more expedited categories been appropriately requested? (Section VIII)Are all required questions answered and answered adequately?Research ProtocolAre purposes adequately described?Are procedures clear? Are samples adequately described?Are measures clearly described?Are procedures for recruiting participants ethical and free of coercion?Consent Forms and Minor Assents (If not applicable is checked, waiver form is required) Effective explanation of study (goals, procedures) and a statement that it is researchEffective description of what participants are likely to do and expected length of participationEffective description of any likely risks or discomforts. Any potential harm is in language participants can understandStatement of benefits to participant limited to those directly linked to participation in studyDiscloses any alternative treatments that might be advantageous to the participantsClear and complete statement of level of privacy and how it is securedCorrect statement of whom and how to contact for questions about the researchCorrect statement of how Alverno IRB chair may be contacted about concerns over participant privacy or rightsAlverno IRB sanctioned statement of voluntary withdrawal at any time without penaltyClear and appropriate lines for participant signatures and dateOverall consent form is readable & supports consent processGeneral JudgmentsAre all needed supplemental materials attached (e.g., instruments, consent form)?Is this study minimal risk?
MonthsComment36912Based on risk/benefit ratio how frequently should this study, if approved, be reviewed by the IRB?
REVIEWER ACTION DETERMINATION
(Check one)
___ Approved with no revisions
___ Approved with revisions/conditions (specify at bottom of form)
___ Request for additional reviewer (specify needed expertise/perspective at bottom of form)
___ Request for study to go to full board (specify concerns at bottom of form)
Reviewer Signature
__________________________________ Date:_____________________
__________________________________
(print name)
Explanations and Specifications for any action other than approved with no revisions
Submit completed review to Alverno College IRB Chair (then filed by IRB Administrator). IRB Chair notifies researcher in writing of determination.
* Section numbers refer to the New Study Application for IRB Review form.
** Note especially Federal funding may entail additional regulations. For example, NIH (but not NSF) has required Parts BD of 45 CFR Part 46 which provide additional protection for vulnerable populations.
(GR)\Word\ FILENAME \* Caps \p U:\IRB\FORMS CURRENT\Expedited New Study Reviewer Form 2.Doc\12/7/07
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