To jump to a topic, click on your choice in the menu below:
A-B , C-D , E-F , G-H , I-J , K-L , M-N , O-P , Q-R , S-T , U-V , W-X , Y-Z
A-B
- Accreditation Training
- Administrative Regulations
- Advertising (see also Recruitment)
- AIDS
- Approval (see Submission Process)
- Assurance Information
- Bioethics and Patients' Rights Program
- Biological Specimens (see also Coded Private Information)
- Brochures
C-D
- Case Studies (for Human Research Accreditation Training)
- Certificate of Confidentiality
- Children in Research
- Checklists (see also Reviewer Checklists)
- CITI - Human Research Training (see also Online Training)
- Clinical Trials
- Coded Private Information (see also Biological Specimens)
- Common Rule (see also Federal Regulations)
- Community Member
- Compliance (see also Noncompliance)
- Confidentiality
- Conflict of Interest
- Consent (see Informed Consent)
- Criteria for IRB Approval
- Data and Safety Monitoring
- Decision Charts (OHRP)
E-F
- Education Options
- Emergency Research
- Emergency Response Plan
- Engagement in Research (see also Off-site Research)
- Ethical Principles
- Exempt Review
- Expedited Review
- Federal Regulations (see also Common Rule)
- Federal Wide Assurance (see also Assurance Information)
- Finder's fees
- Full Board Review
G-H
- Genetic Research
- HIPAA Educational Module (see also Online Training)
- HIV/AIDS (see also AIDS)
I-J
- Informed Consent
- International Research
- Internet Research
- Investigational New Drugs/Devices (see also IRB Policies)
- Investigator Responsibilities
- IRB Policies (see also Finder's Fees)
- IRB Reporting to Federal Agencies
- IRB Student Mentor
K-L
M-N
O-P
- Off-site Research
- Online Training
- Other Human Research Protection Sites
- Policies and Procedures (HSPP)
- Privacy
Q-R
- Recruitment (see also Advertising)
- Reviewer Checklists (see also Checklists)
- Risk Assessment
S-T
- Significant New Findings Requiring IB Documentation
- Student Mentor
- Study Personnel (see also Key Personnel)
- Submission Process
- Tissue/Specimen Repositories
U-V
W-X
Y-Z
Advertising (see also Recruitment)
When creating advertisements, certain guidelines must be followed to prevent coercion of potential subjects and to ensure their being properly informed:
- Criteria for Advertisements/Recruitment Documents [PDF]
The OHRP site gives helpful guidance on AIDS research:
Approval (see Submission Process)
Bioethics and Patients' Rights Program
Biological Speciments (see also Coded Private Information)
- Is Your Project Human Subjects Research Brochure: This brochure discusses biological specimens and coded data under #12.
The HSPP developed and printed a wealth of human subjects brochures available to users online or hard copy by request. To request a brochure, contact the IRB Office or the OPRS. To access the brochures click here.
These IRB application templates are provided to assist investigators in completing IRB iStar applications. Model IRB Applications Page
University Park IRB Applications
Certificate of Confidentiality
Certificates of Confidentiality protect the privacy of the research subject by preventing researchers and institutions from being compelled to disclose information that would identify research subjects. For more information visit the Certificate of Confidentiality Page.
Checklists (see also Reviewer Checklists)
Checklists, or Reviewer Guidelines are used in the reviews of research protocols in order to assure the presence of required elements. The checklists also serve as a mental diving board off of which reviewers jump when thinking about the ethical considerations in the protocols. These guidelines/checklists can be found: here.
CITI - Human Subjects Research Training (see also Online Training)
- CITI FAQs
- CITI Program: This is the CITI main website.
Definition: A controlled study involving human subjects, designed to determine the safety and effectiveness of a drug, biologic, device or other treatment or behavioral intervention.
Coded Private Information (see also Biological Specimens)
Common Rule (see also Federal Regulations)
Compliance (see also Noncompliance)
- Office of Compliance website
Confidentiality pertains to the treatment of information that an individual has disclosed in a relationship of trust and with the expectation that it will not be divulged to others in ways that are inconsistent with the understanding of the original disclosure, without permission.
Consent (see Informed Consent)
Check out the Reviewer Checklists/Guidelines to see what required elements the reviewers are looking for in the application.
Data Safety Monitoring Plan is now requested (27.4) on the iStar application. The iStar Memo describing these changes can be accessed here.
Engagement in Research (see also Off-site Research)
When it is determined that the study is in one of the six exempt categories listed in the Regulation (46 CFR 46.101(b)), it is exempt.
Federal Regulations (see also Common Rule)
In section 11.4 of University of Southern California Human Subjects Protection Program (HSPP) Policies and Procedures it is stated that "payments for referrals (Finder's Fees) are not permitted.
The HIPAA Page links to the Office of Compliance's HIPAA education program.
HIV/AIDS (see also AIDS)
The International Research Page discusses the many cultural and ethical issues that arise when doing research internationally. Procedures normally followed outside the United States for research involving human subjects often differ from those set forth in federal and University policies.
A rapidly increasing volume of research is being done via the Internet. This location presents its own set of ethical issues regarding human subjects protection including data security, ability to verify participant's age, as well as others. These unique issues should be considered in your application. For more information about these issues, click the link below:
Investigational New Drugs/Devices (see also IRB Policies)
Chapter 18 of the HSPP Policies and Procedures deals with Investigational New Drugs and Devices
- IRB Liason Manual (see page 5)
IRB Policies (see also Finder's Fees)
IRB Reporting to Federal Agencies
IRB Student Mentor (see Student Mentor)
"Key Personnel" is defined in the Form 398 as individuals who are involved in the design and conduct of the study, including investigators and co-investigators on the respective project.
All “key personnel” listed on an iStar application must have completed CITI, the online education requirement or similar program, for the application to get IRB approval.
Lay Terms (see also Informed Consent)
For guidance on the levels of review, go to the Brochures page.
These IRB application templates are provided to assist investigators in completing IRB iStar applications: Model IRB Applications.
University Park IRB Applications
See chapter 21 of the HSPP Policies and Procedures.
The PI must obtain permission for off-site locations for collecting data.
See CITI the online Human Subjects Certification Course
Other Human Research Protection Sites
- U.S. Department of Health and Human Services (DHHS) [HTML]
- Office for Good Clinical Practice (previously the Office of Human Research Trials) [HTML]
- Office for Human Research Protections (OHRP) [HTML]
- DHHS Office of Research Integrity (ORI) [HTML]
- U.S. Food and Drug Administration (FDA) [HTML]
- Radioactive Drug Research Committee (RDRC) Program [HTML]
- U.S. Department of Energy U.S. Department of Education [HTML]
- National Archives and Records Administration Code of Federal Regulations [HTML]
- National Institutes of Health (NIH) [HTML]
- NIH Certificate of Confidentiality Information [HTML]
- NIH Guidelines for Research Involving Recombinant DNA Molecules [HTML]
- National Bioethics and Advisory Commission [HTML]
- International Conference on Harmonisation (ICH) [HTML]
- Public Responsibility in Medicine and Research (PRIM&R) [HTML]
- NIH 398 Application Section e (series of guidelines for completing) [HTML]
Policies and Procedures (HSPP)
Definition: Control over the extent, timing and circumstances of sharing oneself (physically, behaviorally, or intellectually) with others.
Recruitment (see also Advertising)
Recruitment documents must adhere to certain criteria in order to protect human subjects from coercion and to ensure subjects' being properly informed about the research. Below is a link to the criteria for recruitment documents:
- Criteria for Advertisements/Recruitment Documents [PDF]
Reviewer Checklists (see also Checklists)
The IRB Reviewer Guidelines/Reviewer Checklists are used by IRB members and staff to aid in the review of applications. 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.
- 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
When submitting a protocol, one must determine whether or not the study is greater than minimal risk, minimal risk, or less than minimal risk. The IRB makes the final determination of risk level. "No more than minimal risk" means that "the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests."
Significant New Findings Requiring IRB Documentation
The IRB Student Mentor is a peer mentor who counsels USC student investigators on issues related to human subjects protection and to the IRB application process, through individual advisement and group workshops. For the Student Mentor Page click here.
Study Personnel (see Key Personnel)
For explanations of the submission process, click below:
- How To Submit a New Proposal...
- How To Submit a Claim of Exemption...
- How To Submit a Continuing Review...
- How to Submit an Amendment to a Previously Approved Protocol...
- How To Submit a Not Human Subjects Determination Application
- Why is IRB Submission Required?
- iStar Application at a Glance...
- IRB Application Templates/Examples
- HHS - Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research
- HHS - Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects
- HHS - Additional Protections for Children Involved as Subjects in Research
- Vulnerable Populations - Education Slides (see slides 26-27)
Waiver of Informed Consent Requirements (see also Informed Consent)