Checklist for
Investigators
Incomplete applications will be returned.
(1)
This application includes a lay abstract stating the purpose of
the study.
(2)
The application describes the study population,
inclusion/exclusion criteria, process of identifying subjects,
etc.
(3)
The abstract includes a description of tasks the subjects will be
asked to complete.
(4)
The application includes a full description of anticipated risks
and benefits of study participation.
(5)
Provisions have been made to minimize risks and those procedures
are outlined on the form.
(6)
Provisions have been made and documented to care for subjects in
case of accident or injury.
(7)
Procedures to maintain confidentiality have been fully
described.
(8)
Provisions have been made to obtain informed consent from all
individuals related to the study. (e.g., parents, subjects,
cooperating institutions, etc.)
(9)
All questions on the form have been completed.
(10)
All supporting documents have been attached, including protocol,
survey instruments, interview schedules, solicitation letters,
advertisements, consent forms, etc. Supporting documents must
be in final form as you intend to distribute them. Your
application will be returned if these documents are in outline or
first draft form.
(11)
If this study requires approval of another committee or
cooperating agency, documentation of approval or notice of
application has been attached.
(12)
Appropriate departmental signatures and signature of academic
advisor for student research have been obtained on Page
1.
(13)
A copy of this application has been made for the investigator's
records.
(14)
I request blind review. I have omitted all identifiers from copies
submitted. (Original copy contains all names for IRB
file.)
(15)
The application is in the same page format as shown in this
electronic word processing file. The location of questions and
pagination is the same as in the original.
(16) Any unanticipated problem involving risk to subjects or
noncompliance with regulations regarding subjects must be reported
immediately to the IRB.
(17) If the research period is longer than 11 months, the IRB must review the research project again.
(18) Some projects which are either complicated procedurally or
are of a long duration may require verification that no material
changes have occurred since the IRB review.
(19) Any changes in approved research protocols must be reported
promptly to the IRB and may not be initiated until IRB approval except
when necessary to address immediate hazards to subjects.
(20) Please print
and submit your application double-sided to save paper. Do not submit
the instructions with your application--only the actual application
needs to be submitted to the committee.
(21) Please submit your complete mailing address and e-mail so that the IRB can communicate with you.
(22)
I have attached 11 copies for full review applications or two
copies for expedited applications or two copies for exempt
applications, including any attached instruments and
materials.
You must make a preliminary
judgment about the level of review required for your application.
The chair will then determine the level of review after submission
and contact you if additional copies are required.
Completed, typed forms
should be returned to:
Augsburg College Institutional Review Board
c/o Norma Noonan, Ph.D., chair
2211 Riverside Avenue, Campus Box 107
Minneapolis MN 55454-1351
Telephone: 612-330-1198
Hand-delivered applications should be brought to Memorial 111.
Applications may
not be sent by electronic mail or facsimile because the IRB
original application requires original signatures of the
applicant, advisor, and/or department chair and because email is
not a confidential communications medium, HOWEVER, an electronic copy
of the application, consent form and other documents must be sent to
the IRB chair at the same time.
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