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BIOMEDICAL GUIDANCE AND REGULATIONS
APPLICABILITY AND DEFINITIONS
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”.
FDA Definitions
“Human Subject” means an individual who is or becomes a participant in research, either as a recipient of the test article or as a control. A subject may be either a healthy individual or a patient.  In the case of research involving a medical device, a human subject also includes an individual on whose specimen a medical device is used.
“Research” means any experiment that involves a test article and one or more human subjects, and that either must meet the requirements for prior submission to the FDA...or the results of which are intended to be later submitted to, or held for inspection by, the FDA as part of an application for a research or marketing permit.
“Test Article” means any drug (including a biological product for human use), medical device for human use, human food additive, color additive, electronic product, or any other article subject to regulation under the Federal Food, Drug, and Cosmetic Act or under sections 351 and 354-360F of the Public Health Service Act (42 U.S.C. 262 and 263b-263n).

BIOMEDICAL GUIDANCE AND REGULATIONS

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.

TO WHAT DOES THIS INFORMATION APPLY?

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.

WHERE SHOULD THE RESEARCHER BEGIN?

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).

COLLABORATION WITH EXTERNAL INSTITUTIONS

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.

WHO CAN BE CONTACTED FOR ASSISTANCE?

UCSB HSC COORDINATOR (Tel: 805-893-3807; Email: hsc@research.ucsb.edu)

REVIEW PROCESS FOR FACULTY AND RESEARCHERS

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.

  1. If your proposed research does not meet the above criteria for review by UCSB’s HSC, please contact hsc@research.ucsb.edu.
  2. Research Integrity staff will collect some basic information about your proposed research and, if it is determined that the UCSB IRB can not review your research, assist with finding an appropriate IRB to review the research study.
  3. If the proposed research meets the FDA definition of human subjects research, or if you anticipate that any of your research data will be used to support the development of a clinical drug or device, then it is encouraged that you receive guidance from the FDA directly, or that you hire a clinical study consultant.
  4. Once an outside IRB is selected, you will need to write a protocol and submit it to that IRB
  5. Once approved, you may not begin any human subjects research until UCSB has signed an Inter-institutional Authorization Agreement (IAA) with the outside IRB, which states that UCSB will rely on their IRB.
  6. Once the IAA is executed, the UCSB human subjects coordinator will create a human subjects protocol in our electronic system (ORahs), which will allow Sponsored Projects to release your funding.

APPLICABILITY AND DEFINITIONS

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”.

FDA Definitions

Comparison of FDA and HHS Human Subject Protection Regulations

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.

BIOLOGICAL SPECIMENS

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.

OHRP Guidance on Research Involving Biological Specimens

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Updated: January 05, 2017.