Activities

Description

IRB Review Required?

Clinical Investigation

Experiments using a test article (e.g., investigational drug or biologic, or device) on one or more human subjects, or on the specimen of a human subject, that are regulated by the Food and Drug Administration (FDA) or support applications for research or marketing permits for products regulated by the FDA.Products regulated include foods, including dietary supplements that bear a nutrient content claim or a health claim, infant formulas, food and color additives, drugs for human use, medical devices for human use, biological products for human use, and electronic products that aid in diagnosis or treatment of injury or illness.

YES

Medical Practice

Standard practice, innovative care, or off-label use of FDA-approved drugs, biologics, devices and other articles or substances that are used in the normal course of medical practice, provided the activity does not involve systematic collection of safety or efficacy data, and is limited to prevention, diagnosis, mitigation, treatment, or cure of disease in affected individuals.

NO

Standard Diagnostic or Therapeutic Procedures

The collection of data about a series of established and accepted diagnostic or therapeutic procedures, or instructional methods for dissemination or contribution to generalizable knowledge.

YES

An alteration in patient care or assignment for research purposes.

YES

A diagnostic procedure added to a standard treatment for the purpose of research.

YES

An established and accepted diagnostic, therapeutic procedure or instructional method, performed only for the benefit of a patient or student but not for the purposes of research. (See Case Studies.)

NO

Standard Public Health Surveillance Activities

Public health surveillance activities, including the collection and testing of information or biospecimens, conducted, supported, requested, ordered, required, or authorized by a public health authority (e.g. CDC, DPH). Such activities are limited to those necessary to allow a public health authority to identify, monitor, assess, or investigate potential public health signals, onsets of disease outbreaks, or conditions of public health importance (including trends, signals, risk factors, patterns in diseases, or increases in injuries from using consumer products).  Such activities include those associated with providing timely situational awareness and priority setting during the course of an event or crisis that threatens public health (including natural or man-made disasters). See our Public Health Surveillance vs. Research page for detailed guidance. 

Must be submitted to the IRB for a determination about whether review is needed. 

Case Studies - Clinical

Report about up to three clinical experiences or observations identified in the course of clinical care, provided that FDA regulations requiring IRB approval do not apply such as use of: articles (e.g., drugs, devices, biologics) that have not been approved for use in humans; articles requiring exemption from FDA oversight; articles under an IND/IDE.

NO

Case Studies - Other

Report about experiences or observations associated with up to three individuals.

NO

Innovative Procedures, Treatment or Instructional Methods

Systematic investigation of innovations in diagnostic, therapeutic procedure or instructional method in multiple participants in order to compare to standard procedure. The investigation is designed to test a hypothesis, permit conclusions to be drawn, and thereby develop or contribute to generalizable knowledge.

YES

The use of innovative interventions that are designed solely to enhance the well being of an individual patient or client and have a reasonable expectation of success. The intent of the intervention is to provide diagnosis, preventive treatment, or therapy to the particular individual. (Also see Case Studies.)

NO

Repositories
(e.g., data, specimen, etc.)

A storage site or mechanism by which identifiable human tissue, blood, genetic material or data are stored or archived for future research by multiple investigators or multiple research projects.

YES

Chart reviews
(review of identifiable medical information)

Review of identifiable medical data intended only to assess the feasibility of future research (i.e., activity preparatory for research). The IRB and Privacy Office recommend using the Clinical Data Research Consultations (CDRC) for any preparatory to research activities. CDRC may provide aggregate data on the availability of specific study populations at UCSF. Note, contacting prospective participants for prep to research activities (feasibility) is not permitted.

YES (Privacy Rule only)

The collection of individually identifiable data about a series of patients for dissemination or contribution to generalizable knowledge, or for potential recruitment into current or future research.

YES

UCSF Functioning as the Coordinating Center for a Multi-Center Research Project

UCSF is not an enrolling site and the UCSF PI has agreed to serve as the coordinating center for a multi-center project, which may include activities such as data collection, data analysis, reporting of adverse events to regulatory authorities, and/or oversight of the research at participating sites.

YES

UCSF is an enrolling site and the UCSF PI has agreed to serve as the coordinating center for the multi-center project, which may include activities such as data collection, data analysis, reporting of adverse events to regulatory authorities, and/or oversight of the research at participating sites.

YES

Emergency Use of an Investigational Drug or Device

Institutional Policies do not permit research activities to be started, even in an emergency, without prior IRB acknowledgement.

1. This does not limit the physician's ability to deliver emergency care. The physician may deliver such care, but the data derived from such care without prior IRB acknowledgement (such activities must be reported to the IRB within five working days), but the data derived from such care may not be used in any prospectively conceived research.

2. Emergency care involving investigational drugs, devices or biologics must meet the Food and Drug Administration (FDA) requirements and data from such use may not be used in any manner of research.

For more information, please review Emergency Use and Compassionate Use of Experimental Drugs and Devices.

YES

Classroom Assignments/ Research Methods Classes

Activities designed for both educational purposes and to contribute to generalizable knowledge.

YES

Activities designed strictly for educational purposes that teach research methods or demonstrate course concepts. The activities are not intended to create new knowledge.

NO
(but instructors have an obligation to protect students and others)

Research Using Publicly Available Data Sets

Use of publicly available data sets that do not include information that can be used to identify individuals. "Publicly available" is defined as information shared without conditions on use. This may include data sets that require payment of a fee to gain access to the data.

NO

Research on Organizations

Information gathering about organizations, including information about operations, budgets, etc. from organizational spokespersons or data sources. Does not include identifiable private information about individual members, employees, or staff of the organization.

NO

Oral History

Interviews that collect, preserve and interpret the voices and memories of people, communities, and participants in past events as a method of historical documentation. The intent is to document a particular past or unique event in history.

NO
(but exercise of professional ethics is expected)

Journalism

Activities focused on the collection, verification, reporting, and analysis of information or facts on current events, trends, newsworthy issues or stories about people or events. There is no intent to test a hypothesis.

NO
(but exercise of professional ethics is expected)

Quality Assurance and Quality Improvement Activities -Clinical

Systematic, data-guided activities designed to implement promising ways to improve clinical care, patient safety and health care operations. The activity is designed to bring about immediate positive changes in the delivery of health care, programs, or business practices in the local setting. The activity is not funded by a research grant.

See the Quality Improvement (QI) and Quality Assurance (QA) for more info.

NO
(but PHI must be handled with appropriate care)

Quality Assurance and Quality Improvement Activities - Non-Clinical

Data collected with the limited intent of evaluating and improving existing services and programs or for developing new services or programs. Examples include teaching evaluations or customer service surveys.

See the Quality Improvement (QI) and Quality Assurance (QA) for more info.

NO

Research Involving Only Decedents

Research involving only de-identified data or tissue obtained from individuals who are deceased prior to the conduct of the research. There must not be any interaction or intervention with living individuals, or collection of private data or specimens associated with individuals.

NO

NOTE: Research involving identifiable data or specimens from individuals who are deceased requires IRB review in order to obtain a HIPAA authorization waiver for review of identifiable protected health information (PHI).

YES