This webpage provides guidance for faculty members conducting clinical or biomedical human subjects research. This type of research may require specialized review and/or consulting from off-campus resources. The information discussed here may be printed in its entirety for reference by clicking on the PRINT VERSION link at the top right of the webpage.
The information provided below applies to research and development of investigational medical devices, drugs, and/or biologics. Discussion also includes how the use of a previously approved device for a new application as well as research and development of research software/algorithms also must meet specific regulatory requirements.
It's important for the researcher to be familiar with the applicable regulatory requirements. Common links for research with investigational drugs, devices, and/or biologics under the regulatory oversight of the FDA are found on the Resources webpage. Additional resources are available on the FDA website. The conduct of human subjects research outside of the United States must comply with the regulatory and ethical review boards of the country in which the research will take place.
For proposed research in international settings, view applicable regulatory requirements at The International Compilation of Human Subjects Standards (a list of over 1,000 laws, regulations, and guidances for the protection of human subjects in research for more than 100 countries around the world).
UCSB - SBCH COLLABORATION
UCSB - OTHER UC CAMPUS COLLABORATION
UCSB - OTHER EXTERNAL COLLABORATION
FDA Science and Research IDE/IND Contacts: The FDA provides extensive discussion and direction for newly proposed research with investigational drugs, devices, and biologics. Search Investigational Device Exemptions (IDE) resources for specific instruction.
UCSB HSC COORDINATOR (Tel: 805-893-3807; Email: firstname.lastname@example.org)
The FDA has a specific definition of human subjects research, and studies that meet that definition will require review by an external IRB. Some studies that do no meet the FDA definition may also require external review. In general, the focus of your research question will determine if UCSB’s IRB can review your study. If the focus of your research is biomedical, it is likely that external review will be necessary.
The Office of Research will assist in finding an outside IRB that is qualified to review your human subjects research protocol. Several UCSB faculty members collaborate with UC Medical Center campus researchers and use the UC Reliance Registry to facilitate human subjects approval. Others work with Cottage Health System’s IRB or utilize a commercial IRB. In all of the above cases, it is very important that you communicate with UCSB staff prior to initiating an approval process outside of the UCSB campus. Additional consulting may be required if you are conducting a clinical trial. External review and consultation should be budgeted for at the proposal stage and we encourage you to discuss this with our staff.
REVIEW BY UCSB HSC ONLY/WHEN EXTERNAL IRB REVIEW IS NOT REQUIRED
Some studies that utilize medical equipment or human biological material may be eligible for UCSB Human Subjects Committee (HSC) review only. The UCSB HSC may review studies that include the collection and use of some biological specimens (e.g. blood, saliva, hair) and/or the collection of data via non-invasive methods (e.g. magnetic resonance imaging, electrocardiography, moderate exercise) that are normally considered clinical in nature. Such research may be reviewable by the UCSB HSC if: 1) the goal of the research is to develop or contribute to generalizable knowledge that is primarily social/behavioral in nature; and 2) the physiological interventions are sufficiently benign as to involve no more than minimal risk to the subjects.
Human subjects research may not be conducted until Human Subjects Committee (HSC) approval has been granted. All research involving human subjects, regardless of the source of funding or whether the research is funded, in which USCB is engaged, requires HSC review.
UCSB has committed to uphold regulatory and ethical standards through a Federal-Wide Assurance, issued by the federal Office for Human Research Protections (OHRP). Under this FWA, UCSB’s HSC is authorized to review human subjects research as defined in the “Common Rule”. However, the UCSB HSC is not certified to review clinical studies that are regulated by the FDA. An authorized outside Institutional Review Board (IRB) must review research falling under the FDA definition. See the review process section for more details.
In order to receive HSC review, a study must meet the definition of human subjects research. The Department of Health and Human Services (DHHS) and the Food and Drug Administration (FDA) each has their own definition of “human subjects” and “research”.
Off-label use of a FDA regulated device or drug for research requires HSC review. Collecting safety and efficacy data will require outside IRB review.
There is often confusion regarding when research utilizing human biological specimens is considered human subjects research. When the HSC makes this evaluation, the first step is to determine if the activity meets the definition of human subjects research. If biological specimens are obtained through intervention or interaction with a living person or identifiable private information, then the research activity involves human subjects. The use of commercially available biological tissue is typically exempt under DHHS regulations because the material is publicly available. Commercial sources undergo their own IRB review prior to collecting this material and ensure that proper consent has been obtained for use in research.