UNIVERSITY OF MARYLAND, COLLEGE PARK
Institutional Review Board
Initial Application for Research Involving Human Subjects
Principal Investigator/
Project Faculty Advisor
(NOT a student or fellow)
Email
Address
Telephone
Number
Co-Investigator
Email
Address
Telephone
Number
Student Investigator
Email
Address
Telephone
Number
Last Rev 09/8/2010
Project Title
Department/ Unit
Administering the Project
Where to send Approval
Documents
Student master’s thesis
Check if this is
OR
Dissertation research project
Funding Agency(s)
ORAA Proposal ID Number
Target Population: The study population will include (Check all that apply):
pregnant women
minors/children
human fetuses
neonates
prisoners
students
individuals with mental disabilities
individuals with physical disabilities
Exempt (Optional): You may suggest this protocol meets the requirements for Exempt Review by checking the box below
and listing the Exempt category(s) that may apply. Please refer to the Exempt Category document for additional
information.
Exemption Category(s):
Rationale:
Date
Signature of Principal Investigator [REQUIRED]
Date
Signature of Co-Principal Investigator
Date
Signature of Student Investigator
Date
Signature of IRB Liaison/Department Chair [REQUIRED]
Print Name ______________________________________ Title_______________________________
(Please print name of IRB Liaison/Department Chair)
UNIVERSITY OF MARYLAND, COLLEGE PARK
Institutional Review Board
Initial Application for Research Involving Human Subjects
1.
Abstract:
2.
Subject Selection:
a.
b.
c.
d.
3.
Procedures:
Last Rev 09/8/2010
UNIVERSITY OF MARYLAND, COLLEGE PARK
Institutional Review Board
Initial Application for Research Involving Human Subjects
4.
Risks:
5.
Benefits:
6.
Confidentiality:
7.
Consent Process:
Last Rev 09/8/2010
UNIVERSITY OF MARYLAND, COLLEGE PARK
Institutional Review Board
Initial Application for Research Involving Human Subjects
8.
Conflict of Interest:
9.
HIPAA Compliance:
10. Research Outside of the United States:
Last Rev 09/8/2010
UNIVERSITY OF MARYLAND, COLLEGE PARK
Institutional Review Board
Initial Application for Research Involving Human Subjects
Last Rev 09/8/2010
11. Research Involving Prisoners:
SUPPORTING DOCUMENTS
Each copy of the application must include the IRB application cover sheet, the information required in
items 1-11 above, and all relevant supporting documents including: consent forms, letters sent to recruit
participants, questionnaires completed by participants, and any other material that will be presented,
viewed or read to human subject participants.
For funded research, a copy of the Awarded Grant Application (minus the budgetary information) must
be included. If the Grant has not been awarded at the time of submission of this Initial Application, a
statement must be added to the Abstract Section stating that an Addendum will be submitted to include
the Grant Application once it has been awarded.
NUMBER OF COPIES
Please send 1 original application including the signed cover sheet to:
IRB Office
1204 Marie Mount
College Park, MD 20742-5125