University Park
Institutional Review Board
TITLE OF
PROJECT
PRINCIPAL
INVESTIGATOR
/CO-PI
FUNDING
SOURCE
FUNDING
AMOUNT
PROPOSAL
INSTRUCTIONS FOR SECTION I
Must be completed for all proposals,
full board, expedited and exempt.
Grace Ford Salvatori Hall
Room 226
Los Angeles, CA 90089-1695
Phone: 213/821-5272
Fax: 213/821-5276
Use a fully descriptive title. If the study is funded, please include the grant title, unless
the sponsor’s protocol uses the identical title in your IRB submission. Include the
sponsor’s protocol number, version and version date, if applicable.
The Principal Investigator is the Principal Investigator (Faculty Advisor) at USC. The CoPI is generally the other faculty member at USC and/or the student investigator.
Indicate the funding source and include a copy of the grant application, award letter,
and/or funding source proposal.
Indicate the amount of funding requested.
Training Grant: Submit a copy of the grant application and an assurance in a letter of
transmittal that no funds will be disbursed to individuals proposing to do research
involving human subjects until the proposed project has been reviewed and approved by
the IRB.
Program Project: Submit a copy of the grant application and a list of those projects
proposed/developed under the grant. In addition, principal investigators applying for IRB
approval for Program Project/Multiple Project Grants will need to submit, at the same
time, all individual components of the grant which propose to involve human subjects
each of which is assigned a separate IRB number and reviewed separately.
Center Grants: For a Center Grant that includes sub-projects, submit a copy of the grant
application and an assurance in a letter of transmittal that no funds will be made available
to individuals proposing to do research involving human subjects until individual projects
have been reviewed and approved by the IRB.
Expedited Review: Research activities that (1) present no more than minimal risk to
human subjects, and (2) involve only procedures listed in the expedited review categories,
may be reviewed by the IRB through the expedited review procedure authorized by 45
CFR 46.110. The activities listed should not be deemed to be of minimal risk simply
because they are included on this list. Inclusion on this list merely means that the activity
is eligible for review through the expedited review procedure when the specific
circumstances of the proposed research involve no more than minimal risk to human
subjects. The categories in this list apply regardless of the age of subjects, except as
noted. The expedited review procedure may not be used where identification of the
subjects and/or their responses would reasonably place them at risk of criminal or civil
liability or be damaging to the subject’s financial standing, employability, insurability,
reputation, or be stigmatizing, unless reasonable and appropriate protections will be
implemented so that risks related to invasion of privacy and breach of confidentiality are
no greater than minimal. The standard requirements for informed consent (or its waiver,
alteration, or exception) apply regardless of the type of review--expedited or convened-utilized by the IRB.
Exempt: There are certain categories of research specified in 45 CFR 46.101 (b)(1-6)
that are exempt from IRB review. To request a claim of exemption, please submit a
Claim of Exemption Form to the UPIRB. Exemption categories are listed on the
exemption form. Section II need not be completed.
IRB Application – Instructions for Section I (Rev.
4/03)
Page 1 of 3
NATURE OF
RESEARCH
Interviews/Focus Groups/Survey/Questionnaire: If you propose to conduct interviews,
focus groups, and/or distribute surveys/questionnaires, provide a set of the
interview/focus group questions or survey/questionnaire instrument.
Internet Research: Provide documentation as to how the research will be conducted
through the internet, including security information and any third-party entities (ISP) to
assist in housing the website and maintaining security.
Deception: If the research involves deception, provide a debriefing statement that
includes the name of the study, an explanation of the deception, contact information, and
any referrals, if necessary.
Study of Existing Data: Indicate in Section II, Research Design and Methods, the source
of the data, whether it is publicly available, how the data was collected, and whether the
links of the identities of subjects exist and with whom.
Genetic Research: Indicate in Section II, Research Design and Methods and in Data
Storage and Confidentiality, what genetic data is being collected, how confidentiality is
being maintained, and use the Informed Consent Form Template for Genetic Research.
Identifiable Health Information: If you need to access or use patient/subject identifiable
health information (e.g. medical records, mental health information, lab reports, x-rays,
tissue samples) for your research, all the PIs, Co-PIs, Co-Investigators, and individuals
authorized to obtain informed consent must take the HIPAA education program and
provide PI’s, Co-PI’s and Co-investigators’ certificates of completion of the HIPAA
education program with this application. To take USC’s online HIPAA education program,
visit www.usc.edu/admin/compliance/. Individuals employed by another entity (e.g., L.A.
County) may submit proof of completion of their employer’s HIPAA education program. If
you have not taken the HIPAA education program, your study will not be reviewed until all
of the requested information has been provided and your application may be returned to
you for completion.
HIPAA Authorization & Waiver of HIPAA Authorization:
a. Recruitment/Screening only:
Are you recruiting/screening subjects? If you are going to recruit subjects at the
LAC+USC Healthcare Network facilities, USC University Hospital, or USC Norris
Hospital in order to review medical records information to learn whether a subject has
the condition of interest, you must request a waiver of HIPAA authorization for this
activity. This is a request for a limited waiver to review medical records information to
assess potential eligibility before approaching the subject to enter the study. You
must provide justification by specifically documenting the following:
(1) The use or disclosure of protected health information involves no more than
minimal risk to the privacy of individuals, based on, at least, the presence of the
following elements: (a) An adequate plan to protect the identifiers from improper
use and disclosure; (b) An adequate plan to destroy the identifiers at the earliest
opportunity consistent with conduct of the research, unless there is a health or
research justification for retaining the identifiers or such retention is otherwise
required by law; and (c) Adequate written assurances that the protected health
information will not be reused or disclosed to any other person or entity, except
as required by law, for authorized oversight of the research project, or for other
research for which the use or disclosure of protected health information would be
permitted by this subpart.
(2) The research could not practicably be conducted without the waiver or alteration;
and
(3) The research could not practicably be conducted without access to and use of the
protected health information.
b. Research Subject:
Are you accessing, using, or obtaining a research subject/patient’s identifiable health
information (e.g., medical records, mental health information, lab reports, x-rays,
IRB Application – Instructions for Section I
(Rev. 4/03)
Page 2 of 3
tissue samples) from a:
 Healthcare provider (e.g., physician or other healthcare practitioner, hospital,
clinic, nursing home) (in some cases, the researcher may also be the healthcare
provider),
 Health plan (e.g., group health plan, insurance company, HMO), or
 Health care clearinghouse (e.g., billing service)
That is governed by the HIPAA privacy federal regulations?
If yes, you will need either:
a. A HIPAA compliant authorization from the subject/patient in order for the
healthcare provider, health plan, or clearinghouse to release identifiable health
information to you.
(Template authorization can be downloaded from:
www.usc.edu/admin/compliance/), or
b. An IRB-approved waiver of HIPAA authorization. In order for the UPIRB to
approve the waiver of the HIPAA authorization, the investigator needs to provide
justification by specifically documenting the following:
(1) The use or disclosure of protected health information involves no more than
minimal risk to the privacy of individuals, based on, at least, the presence of
the following elements:
(a) An adequate plan to protect the identifiers from improper use and
disclosure;
(b) An adequate plan to destroy the identifiers at the earliest opportunity
consistent with conduct of the research, unless there is a health or
research justification for retaining the identifiers or such retention is
otherwise required by law; and
INFORMED
CONSENT
LOCATION
SUBJECTS
(c) Adequate written assurances that the protected health information will not
be reused or disclosed to any other person or entity, except as required by
law, for authorized oversight of the research project, or for other research
for which the use or disclosure of protected health information would be
permitted by this subpart.
(2) The research could not practicably be conducted without the waiver or
alteration; and
(3) The research could not practicably be conducted without access to and use
of the protected health information.
Indicate the type of informed consent that will be utilized in the study. The Informed
Consent Form templates are labeled according to the type of research involved. The
Information Sheet template contains all the required elements of the informed consent
form; however, this is only used when administering surveys via mail, internet, or
distributed to mass numbers of subjects. You will need to contact the IRB Administrator
to determine whether your study qualifies for the use of the Information Sheet. If the study
involves children over the age of 7 years, both a Parental Permission Form and Child’s
Assent Form should be included. The form for the child should be written to the
appropriate developmental level or age. If a waiver of written informed consent is
requested, a script of the proposed verbal informed consent should be provided.
Generally, the UPIRB will require a copy of this script to be given to the study subject. If
a waiver of informed consent is requested, please make certain the protocol detail
(Section II) justifies this request.
Indicate the location where the research procedures will occur. If the location is off the
University Park Campus, then indicate the location appropriately.
Carefully indicate the characteristics of the human subjects that will be involved in the
project. When special populations are included or when some or all of the subjects are
likely to be vulnerable to coercion or undue influence, indicate what additional safeguards
have been included in the study to protect the rights and welfare of these subjects.
IRB Application – Instructions for Section I
(Rev. 4/03)
Page 3 of 3