Updated as of
PLEASE NOTE: The AA-IRB Office will be temporarily relocating
to the 6th Floor of the Bank of America Center on April 22, 2002,
until further notice. A memo has been sent out to departments regarding
this move. The telephone numbers and email addresses of the AA-IRB
Office WILL REMAIN THE SAME. The ADDRESS IS CHANGING to: CB# 3378,
6th FL, Bank of America Center.
All IRB submissions must now include documentation that all members
working on research projects have completed required ethics training.
Click on the following filename to read more information about this required
ethics training, under Human Subjects Protection: http://research.unc.edu/services/human_sub.html.
April 11, 2002 updates include: Most recent AA-IRB membership
roster, current dates and deadlines of the monthly meetings of the Board,
REVISED sample letters, and slightly revised Final Report/Annual Renewal Form
. NOTE that the PDF version of the Manual as been disabled due
to various problems and is no longer available online. Therefore, it
is recommended that the new forms be downloaded for use from the HTML version.
The entire manual is in the process of being revised. We will keep
you posted.
Regarding informed consent documents, the AA-IRB is no longer requiring
that researchers include the Chair's name and the entire address of the AA-IRB
for participants to contact should they have questions or concerns about
their rights as research participants. Effective immediately, it will
be acceptable to state that the project has been reviewed and approved by
the Academic Affairs Institutional Review Board (AA-IRB), and if anyone has
any questions or concerns about his or her rights as a research participant,
then he or she should contact the AA-IRB Office at (919) 962-7761 or via email
at aa-irb@unc.edu.
A. How to use this Manual
The Academic Affairs Institutional Review Board (hereafter called the AA-IRB)
has created this manual to aid investigators in preparing materials for review.
The manual you are reading reflects procedures and policies that were current
as of the date indicated at the top of this page. The topics listed
below are reviewed in separate, linked documents. Access to each document
is obtained by pointing your cursor at the name and clicking your mouse button.
Return to this table of contents page by using the BACK button on your browser.
If you have difficulties using the web-based manual or wish to comment, please
contact the AA-IRB Office (see below).
B. How to Contact the AA-IRB
Contact Joyce Hamlett, AA-IRB Administrator, or Barbara Davis Goldman, Chair,
1. by coming to Room 624, 6th FL, Bank of America Center, Franklin Street,
Chapel Hill, NC
2. by calling (919) 843-5018 or 962-7761
3. by mailing to AA-IRB Office, CB# 3378, 6th Floor, Bank of America Center,
UNC-Chapel Hilll,
4. by email: joyce_hamlett@unc.edu or aa-irb-chair@unc.edu
(note: a separate email alias has also been established for PARTICIPANT
CONTACTS: aa-irb@unc.edu )
Table of Contents
I. Introduction
A. Applicability and Jurisdiction
B. Judging If Review by the AA-IRB is Required
C. Goals, Principles, and Authorization
D. AA-IRB Membership, Scheduled Meetings, and Deadlines
II. Steps in the Application Process
A. Initial Application
1. Decisions to be made by Principal Investigator (PI) and Faculty Advisor
(FA), if the PI is a student
2. A Word of Caution for PI/FAs
3. Local Review
4. AA-IRB Review
5. Final Action
B. Protocol Change
1. Minor Protocol Change
2. Significant Protocol Change
C. Annual Review/ Progress Report
D. Completion of Project
V. Instructions for preparing application forms
A. Cover Sheet
B. Proposal Form
C. Final Report / Annual Renewal Form
1. Completed Projects
2. Projects never started
3. Work Still in Progress
D. Protocol Change
VI. Forms (These forms will open in Acrobat Reader. ).
A. Cover Sheet
B. Proposal Form
C. Final Report/Annual Renewal Form
D. Local Review Committee Working Form
VII. Principles of Informed Consent and Voluntariness
A. Active Consent
B. Pronoun forms and verb inflection
C. Who must consent?
D. Essential elements of the consent process
E. Implicit Consent
F. Oral Consent
G. Witnessed Consent
H. Oral Consent to Begin and Written Consent to Confirm Participation
I. Written Consent
VIII. Sample Consent Forms (These forms are in HTML format and may be downloaded
as starting points for investigators developing their own consent forms)
A. Minimal Risk
B. Mailed Anonymous Questionnaire
C. Parental Consent Letter
IX. Level of Review
A. Exempted From Further IRB Review (unless protocol changes)
1. Overview and Restrictions
2. Specific criteria for exemption
B. Expedited IRB Review
1. Overview and Restrictions
2. Specific Statement of Criteria for Expedited Review
C. Full IRB Review
D. Grant Proposals (GP) vs Specific Projects (SP)
E. Single Project Agreements for Off-Campus Research Sites
X. Special Groups of Participants
A. Minors as Research Participants
1. Specific Statement regarding Children
2. Consent by Parents or Guardians
3. Children's Assent
B. Prisoners
XI. Glossary of Terms Used in this Manual
XII. Additional Readings and Internet Links
XIII. American Psychological Association Standards
for Research with Human Participants