Human Subjects & Approval

What is the HSC?

The Human Subjects Committee (HSC) is an independent administrative committee mandated by the Department of Health and Human Services and responsible to the Office of Protection from Research Risks. The HSC is composed of a variety of professional and lay people knowledgeable in the fields that commonly use humans in research. The HSC is coordinated by a staff member in the Office of Research. This Coordinator, a voting member of the HSC, acts as liaison between the HSC, various governmental agencies, and the University community.

While acting independently, the HSC interacts with and plays an important role in both the Sponsored Projects and Research Development aspects of the Office of Research. In the development stage of any research project, the HSC Coordinator is available to the investigator for advice and assistance in planning the use of human subjects within Federal, State and University regulations. The exchange of information between the HSC Coordinator and the Sponsored Projects Office ensures that extramural funding is not released for the conduct of research without proper review and approval of the use of human subjects.

Who Needs HSC Approval?

All research involving human subjects conducted by OR using students, staff or faculty of UCSB must be reviewed and approved by the UCSB HSC.

This includes:

• Pilot studies (yes, even *just* one subject).
• Funded or unfunded research.
• Research on yourself, your staff, your students, your lab staff, your friends, your enemies.

Where to Begin?

Okay. . .you've figured out what we do AND that you probably need Human Subjects approval. . .so what do you do next? If you haven't already, review the Information Sheets. This has replaced the HS packet that used to be distributed by the HSC and campus departments. It contains everything you ever wanted to know about Human Subjects regulations including a "Federalese" to English translation of many regulations. You can now find the full protocol form (112f) and the exemption form (112e) located here.

Peruse the Exemption and Expedited review requirements. Quite often you may find that your project doesn't "exactly" fit into these guidelines. If you are in doubt about what type of form to fill out or what type of approval to request, contact Kathy Graham at 805.893.3807 or graham@research.ucsb.edu. Discussing your project with Committee staff during the planning stages can simplify and shorten the approval process.

You've determined the type of form you need to fill out, you know what type of approval to ask for. . .what next, you ask? If you have a project that is complicated, involves more than minimal risk or you're just not sure you've got everything together. . .bring it in for a test drive before you make all those copies. (See Kathy Graham, Office of Research, 3227 Cheadle Hall.)

Exemption

Please see "Applicability and Exemptions " section for details of exemptible procedures.

A 112x form should be completed and submitted to your department Chair or ORU Director for signature. The form is then forwarded to the Human Subjects Committee Coordinator for approval.

NO SUBJECTS MAY BE USED BEFORE AN APPROVAL FROM THE HSC IS RECEIVED.

Expedited Review

Please see the "Criteria for Expedited Review of Research" section for details of expeditable procedures.

A full protocol (112d) must be completed for an expedited review request. The original and three (3) copies must be submitted. A copy of all consent documents and instruments to be used must be attached to EACH protocol.

The face page must be completed as is. However, sections 1–9 on the protocol can be done in a word processor with each section numbered and titled.

The protocol must be signed by the Principal Investigator or, in the case of a student researcher, the faculty advisor.

FACULTY ADVISORS NOTE: By signing your student's protocol, you are assuming responsibility for the conduct of this research project. This includes, but is not limited to, assuring and insuring that the student is qualified to conduct described research, and that you are providing appropriate supervision and guidance.

Please allow two weeks for approval if no modifications are necessary. Incomplete forms or proposed procedures requiring modification will delay approval.

*DEADLINES*

NO SUBJECTS MAY BE USED BEFORE AN APPROVAL FROM THE HSC IS RECEIVED .

Full Board Review

A full protocol (112d) must be completed. The original and 12 copies must be submitted. A copy of all consent documents and instruments to be used must be attached to EACH protocol.

The face page must be completed as is. However, sections 1–9 on the protocol can be done in a word processor with each section numbered and titled.

The protocol must be signed by the Principal Investigator or, in the case of a student researcher, the faculty advisor.

FACULTY ADVISORS NOTE: By signing your student's protocol, you are assuming responsibility for the conduct of this research project. This includes, but is not limited to, assuring and insuring that the student is qualified to conduct described research, and that you are providing appropriate supervision and guidance.

Please allow four to six weeks for approval when NO modifications are required. Incomplete forms or proposed procedures needing modification will delay approval.

*DEADLINES*

NO SUBJECTS MAY BE USED BEFORE AN APPROVAL FROM THE HSC IS RECEIVED .