Available online— http://www.usc.edu/admin/provost/oprs/news/archives/index.html
VOLUME 3, ISSUE 1
USC HUMAN SUBJECTS NEWSLETTER
J AN U AR Y 2 3 , 2 0 0 7
HEADLINES
Human Subjects Newsletter—Headline Edition
Published by the Office for the Protection of Research Subjects (OPRS)
Susan L. Rose, Ph.D., Executive Director
Headlines:

Preparation for AAHRPP Site Visit In High Gear

Technical Difficulties Plague CITI (Human Subjects Education Program)

CITI-Lite Offered to Investigators Conducting “Low/No Risk” Research

New Reviewer Guidelines Offer Investigators an Inside Look at the IRB

iStar and CITI Help Desks Available

New HSPP Policies and Procedures Provide “One-stop” Resource
Preparation for AAHRPP Site Visit In High Gear
All individuals involved with Human Subjects Research are potential interviewees during the AAHRPP site
visit. This includes administrators, faculty, staff, and students. The site visit is the final step in the USC HSPP
(Human Subjects Protection Program) formally applying for AAHRPP accreditation. Everyone’s cooperation
and preparation are needed during and prior to the site visit.
The site visit is a major component in AAHRPP’s accreditation decision. It provides site reviewers with a
candid and critical look at human subjects protection programs. The interviews are used to assess
knowledge and commitment to human subjects protection, and are conducted in a very professional and
serious manner.
In preparation for the site visit and the interviews, the OPRS will host a number of education sessions to
provide information, answer questions, and prepare. Also, the interview guides listed below have been
created to aid interviewees in the preparation for the site visit.
For more information about AAHRPP, the site visit, the education sessions, and to download interview
guides, visit the USC—AAHRPP webpage http://www.usc.edu/admin/provost/oprs/aahrpp.
AAHRPP Interview Guides to help prepare for site visit:
 Human Subjects Administration Interview Guide
 IRB Members Interview Guide
 IRB Staff Interview Guide
 Human Subjects Researchers Interview Guide
*AAHRPP—Association for the Accreditation of Human Research Protection Programs
Technical Difficulties Plague CITI (Human Subjects Edu. Program)
CITI (the online Human Subjects education program) has moved forward with the implementation of CITI
(II). This promises to provide improved multi-course presentation, additional flexibility, foreign language
modules, a new “alert” system as well as user friendly utilities.
Due to the implementation of the new program, and heavy usage, the CITI website has been experiencing
technical difficulties during the past several weeks. The development team and programmers are aware of
these problems and are confident that the majority of them will be resolved soon. The OPRS and CITI
apologize for any inconvenience this may have caused.
1
USC HUMAN SUBJECTS NEWSLETTER
HEADLINES
CITI-Lite Offered to Investigators Conducting “Low/No Risk” Research
Several new user-groups have been added to the USC CITI program to accommodate investigators and
key personnel that conduct only “low/no risk” research. Typically this is research that qualifies for one of the
federally defined exempt categories and does not involve vulnerable populations. An additional usergroup has been created for Faculty Advisors who are not conducting human subjects research themselves,
but serve as the advisor on a student project. These new user-groups require fewer modules than the other
courses but still cover the basics of Human Subjects Research.
The new user-groups are listed below. Specific descriptions of each can be found on the OPRS website.
OPRS website: http://www.usc.edu/admin/provost/oprs/citi#13
 University Park Investigators Conducting Very Low/No Risk Research
 Health Sciences Investigators Conducting Very Low/No Risk Research
 Faculty Advisors on University Park Student Research Projects
New Reviewer Guidelines Offer Investigators an Inside Look at the IRB
IRB Reviewer Guidelines used by IRB members and staff to aid in the review of applications are available
online. These guidelines serve as excellent resources when completing your IRB application. The guidelines
provide guidance on issues/questions that the IRB considers when reviewing a study.
IRB Reviewer Guidelines: http://www.usc.edu/admin/provost/oprs/upirb/forms/
Reviewer Guidelines for New IRB Applications
Reviewer Guidelines for Continuing Review Applications
Reviewer Guidelines for Informed Consent
Reviewer Guidelines for Research Involving Pregnant Women, Human Fetuses, and Neonates
Reviewer Guidelines for Research Involving Prisoners
Reviewer Guidelines for Research Involving Children
iStar and CITI Help Desks Available
Help with iStar and CITI is available by contacting the iStar Help Desk manager, Yana Gorelik or the CITI
Help Desk manager, Melissa Venegas. Ms. Gorelik and Ms. Venegas are available by email or phone.
iStar Help Desk
Yana Gorelik
istar@usc.edu
(323) 276-2238
CITI Help Desk
Melissa Venegas
citi@usc.edu
(213) 821-5272
New HSPP Policy and Procedures Provide “One-stop” Resource
After a 3 year collaborative effort among the entire Human Subjects Protection Program (HSPP), the HSPP
Policies and Procedures (P&Ps) are completed and accessible online. The P&Ps provide regulatory and
ethical guidance for all USC human subjects research stakeholders including: faculty, staff, students, and
even research participants. They contain policies and procedures for the Health Sciences IRB (HSIRB), the
University Park IRB (UPIRB), and the Office for the Protection of Research Subjects (OPRS). All are
encouraged to refer to these Policies and Procedures when preparing, conducting, or participating in
human subjects research.
For user convenience, the online P&Ps can be downloaded as individual chapters or as one
comprehensive document, and the entire document is word searchable. The online P&Ps will be updated
as changes occur so the most recent version will always be available.
For the upcoming accreditation site visit in March 2007, we recommended human subjects stakeholders
familiarize themselves with the P&Ps by knowing where to find them and how to access them.
USC HSPP Policies and Procedures Webpage:
http://www.usc.edu/admin/provost/oprs/policies/hspp.html
2