Common Forms
IRB
Protocol Application: This form is to be used
for all new submissions.
The protocol application can them be emailed with all necessary
supplements to the Institutional
Review Board (IRB).
TRAINING REQUIREMENT: Final IRB approval will be withheld until required research team members complete the IRB-approved course in human subject protections (CITI).
Certified
Instructor Application: This form is designed to use
for research methodology classes in which graduates or undergraduates
will be expected to actually conduct "research activities" beyond
the classroom activities.
Modification
Request: This form must be used for all proposed
changes to an approved IRB Protocol. Email the completed
form and your modified IRB Protocol to the Institutional
Review Board (IRB). NOTE: Requests to add personnel to an approved IRB Protocol will not be granted until the indvidual(s) complete the required training.
Continuing
Review: All IRB Protocols must undergo continuing
review at least every 365 days; they automatically become
inactive on day 366. Principal investigators are responsible
for ensuring that a signed continuing review form is received
by the IRB in time to be reviewed at the meeting preceding
the date it becomes invalid (this date is identified on
your most recent approval letter). This
form may also be used to close an IRB Protocol.
Adverse
Event Report - this form must be submitted by the Principal
Investigator whenever an adverse event related to an approved
IRB Protocol occurs. Individuals other than the Principal
Investigator may report questions or concerns about human
subjects research on the Quality Improvement Reports (below).
Quality Improvement
Program
Quality
Improvement Report - this form may be submitted
by anyone with concerns about human subjects research conducted
at UAF or by UAF personnel at other locations.
Sample Document
These are intended to serve as examples, they
may or may not be a reasonable starting point for your study
depending on the type of research you plan to do.
The most common problem with consent/assent
documents submitted to the IRB is that the text is written
at too high of a grade level (you should strive for a 6-8 grade
reading level for adult consent forms and an age appropriate
level for minor assent forms). If you need help writing your
consent documents contact the Research
Integrity Administrator.
IRB Member Materials
Human
Subject Regulations Decision Making Charts: These are
issued by the Office of Human Research Protections (OHRP)
and are intended as guidance for IRB Administrators and Members.
IRB
Checklist: This is a worksheet to assist IRB members
as they review IRB Protocols.
Federal Certificate of Confidentiality
Certificates
of Confidentiality designed to protect researchers from
having to turn their research and sources over to law-enforcement
agencies. If the research has any component which may give
the researcher access to illegal activities as a valid part
of the research design a certificate of confidentiality is
recommended.
OHRP Sample Agreements
IRB
Authorization Agreement - This agreement allows one
institution with a Federalwide Assurance (FWA) to rely
on the IRB of another FWA institution for review and oversight
of a specific project(s). Authorization Agreements must
be executed by the UAF Institutional Official. Contact
ORI for more information.
Individual
Investigator Agreement - This agreement between a FWA
holding institution and an unaffiliated individual researcher
allows the institution to extend its FWA to include the unaffiliated
individual. Individual Investigator Agreements must be executed
by the UAF Institutional Official. Contact ORI for more information.
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