What research needs to be submitted to the IRB for approval?

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 Acitivity 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.