Human Subjects
IRB Research
What research needs to be submitted to the IRB for approval?
- All research involving human subjects conducted at or sponsored by UCSC, regardless of the source of funding. Further details about what constitutes human subjects research are provided below.
- All research involving Private Health Information obtained from a covered entity (health plans, health care clearinghouses, and health care providers who electronically transmit any health information).
- Research involving State of California death data files that contain information that can be used to identify individual subjects.
If your research involves any of the above,
you must submit a Human Subjects Protocol
or a
Request for Exemption to the UCSC IRB before the research begins.
Are you are conducting human subjects research?
See the decision tree: Is an Activity Research Involving Human Subjects?
Human subjects research is research that involves either:
- Interaction or intervention with living individuals.
- Obtaining identifiable private information about living individuals
Definitions:
"Research"is defined as a systematic investigation
designed to develop or contribute to generalizable knowledge.
Generally, research does not include:
Student course work or undergraduate honors theses,
unless they are to be made available to the public, used by other researchers, or there is a possibility that the research may lead to a formal presentaion or publication. However, even
when
student work involving human subjects does not constitute research,
the faculty members who assign or supervise the work are responsible
for educating their students to safeguard the well being of the
subjects. If an instructor determines that there is a possibility
that a student's proposed research project may result in a formal presentation or
publication, he/she should recommend that the student submit the project
for IRB review.
- Oral History Projects are considered research
only when they are intended to contribute to generalizable knowledge or there is a
possibility that the resulting data will be used to contribute
to generalizable knowledge.
- Program Evaluation, Quality Assurance and
Quality Improvement Activities are considered research only
when they
are intended to contribute to generalizable knowledge or there is a
possibility
that the resulting data will be used to contribute to generalizable
knowledge. When the purpose of an activity is to assess
the success of an established program in achieving its
objectives and the information will be used to provide feedback to
improve that program, the activity is not human subjects research.
When the evaluation is undertaken to test a new, modified, or
previously untested intervention, service, or program to determine
whether it is effective and can be used elsewhere,
the activity is research.
"Human subject" is defined as a living person
about whom a researcher obtains:
- data through "intervention" (for example,
venipuncture or cognitive tests) or "interaction" (for
example, interviews) with the person, or
- identifiable private
information (for example, observations or private records). A
person may be a "human
subject" when a researcher obtains data about the person
from a third party as well as from the person directly.
"Intervention" includes both physical procedures
by which data are gathered (for example, venipuncture) and manipulations
of the subject or the subject's environment that are performed for
research purposes.
"Interaction" includes communication or interpersonal
contact between investigator and subject.
"Identifiable" in this context
implies that the identity of the subject is or may readily be ascertained
by the investigator or associated with the information obtained as
part of the research.
"Private Information" There are two kinds of private information included in the federal definition:
- information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and
- information that has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public, such as a medical or school record.
"Conducted at" or "sponsored by" the UCSC campus
means:
- using the facilities of the UCSC campus; or
- paid for by the campus or with funds administered
by the campus; or
- conducted as part of a researcher's progress
toward a campus degree; or
- conducted by a campus faculty member or employee
in the course of employment by the UCSC campus; or
- using UCSC students as subjects.
If you are doing Human Subjects Research:
If the proposed research will involve human subjects,
you must submit a Human Subjects Protocol or a
Request for Exemption. The protocol must be reviewed
and approved by the UCSC IRB before the research begins.
Failure to comply with these rules may have serious
consequences, including the suspension or termination of research,
allegations of research misconduct, and personal civil and criminal
liability.
PLEASE NOTE THERE ARE NO PROVISIONS FOR RETROACTIVE
APPROVAL OF RESEARCH PROTOCOLS. If research is begun without UCSC
IRB approval, upon discovery of the error, the researcher should stop
the research and notify the UCSC IRB immediately. The researcher
must then submit a protocol to the UCSC IRB along with an
explanation as to why the protocol was not submitted at the appropriate
time. If the researcher is a student, a detailed letter from his
or her faculty advisor must accompany the materials submitted to
the UCSC IRB. NOTE: If the above situation occurs,
conducting further research, spending research funds, using data
already collected,
or filing a thesis may be disallowed.