Informed Consent Overview - Module 1s Sec 5


Module 1 Objectives
The Process
Basic Principles
A Brief History

What Research Must Be Reviewed
IRB Review Criteria

What Research Must Be Reviewed

All research at California State University, Los Angeles that involves humans,
human tissue, or records gathered on human subjects requires IRB review.
This is true regardless of its funding source or area of research.

Research that requires IRB review includes any research on human subjects

  • is conducted by University faculty, staff, or students;
  • involves University students, staff, or faculty as subjects;
  • is performed on the premises of the University;
  • is performed with, or involves the use of, facilities or equipment
    belonging to the University;
  • satisfies a requirement imposed by the University for the award of a
    degree or for the completion of a course of study; or
  • is certified by a dean or department head to satisfy an obligation of
    a faculty appointment at the University.

In addition, the following circumstances will require IRB review.

Research conducted at another institution

Research projects conducted at other sites should be reviewed by the Cal
State L.A. IRB as well as by the other institution's IRB.

Research that is part of multicenter clinical trials

Approval of a document at the national level is not sufficient to bypass approval at the local level. Therefore, documents must also be submitted for IRB review.

Research in foreign countries

conducted by University researchers in foreign countries
falls under University guidelines. Although they cannot be imposed on
other cultures, the standards for ethical conduct cannot be lowered.
Human subjects in foreign countries deserve the same level of protection
as subjects in the United States.

Research conducted in courses

Courses in research methods and class assignments involving research with human subjects require IRB approval.

Faculty-supervised student research

Faculty must take an active role in ensuring that research projects are conducted in accordance with the IRB's requirements.

Research at a pilot or feasibility stage

Pilot and feasibility studies, even those with only one human
subject, require the same review as full-scale research projects.
Applications to the IRB for pilot studies should be identified as such,
and subjects must be told during the consent process that the study is a pilot.

Research involving secondary use of data

Projects that use data on human subjects gathered in earlier projects and in which individual identifiers are present require IRB review.

If, however, the data is gathered by someone who has legitimate access to
the records and who gives the investigator only "blinded" data (meaning
the investigator is unable to identify the subjects), the research project
may qualify for an exemption from full review.

Research using "waste" and "extra" material

Research conducted on "waste" or "extra" human
tissue or fluids must be submitted for review.

  • "Waste" material is defined as material that is collected
    originally for clinical or diagnostic purposes but is no longer needed.
  • "Extra" material is defined as material that is collected
    above and beyond what is needed for a clinical or diagnostic procedure but
    for investigational purposes.

If the original consent for the clinical procedure contains permission
for the use of "waste" material for research, the IRB may not
require another consent form. Collection and use of "extra"
material will need IRB review.

Research projects in which the researcher is a
consultant under contract with the University

IRB review is not required if the researcher has a strict consulting relationship in which:

  • the researcher is hired on his or her own time,
  • the researcher holds no rights in the work, and
  • neither the researcher nor the University retains any data.

All three of these criteria must be met, or the IRB will need to
review the project.