What types of research require IRB approval?

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Who Needs IRB Approval
Principal Investigator (PI) and Co-PI Eligibility

Studies that fit any of the categories below typically do not need IRB review.

Data collection for internal departmental, school, or other University administrative purposes. Examples: teaching evaluations, customer service surveys.
Service surveys issued or completed by University personnel for the intent and purposes of improving services and programs of the University or for developing new services or programs for students, employees, or alumni, as long as the privacy of the subjects is protected, the confidentiality of individual responses are maintained, and survey participation is voluntary. This would include surveys by professional societies or University consortia. Note: If at a future date, an opportunity arose to contribute previously collected identifiable or coded survey data to a new study producing generalizable knowledge; IRB review may be required before the data could be released to the new project.
Information-gathering interviews where questions focus on things, products, or policies rather than people or their thoughts regarding themselves. Examples: canvassing librarians about their libraries’ inter-library loan policies or periodical purchases or interviews with company engineers or managers about how a product is made.
Course-related activities4 designed specifically for educational or teaching purposes, where data are collected as part of a class exercise or course requirement, but are not intended for use outside of the classroom. Note: Review the Guide for Human Subjects Research under Chapter 9, Course Related Student Projects for the seven criteria that must be met for this condition to be applicable. If you have any question as to whether or not your project meets this definition, contact the HSO at prior to beginning the project.
Biography research involving a living individual that is not generalizable beyond that individual.
Research involving cadavers, autopsy material or biospecimens from now deceased individuals. Note: Some research in this category, such as genetic studies providing private or medical information about live relatives, may need IRB review. Please contact the IRB for further information.
Innovative therapies except when they involve "research" as defined by the above criteria. (An innovative clinical practice is an intervention designed solely to enhance the well being of an individual patient or client. The purpose of an innovative clinical practice is to provide diagnosis, preventative treatment, or therapy to particular individuals, or when the innovative therapy is investigational.) Note: When innovative therapies differ significantly from routine practice it should be viewed and treated as such with appropriate safeguards in place to protect the rights and welfare of the patients.
Quality improvement projects are generally not considered research unless there is a clear intent to contribute to generalizable knowledge and use the data derived from the project to improve or alter the quality of care or the efficiency of an institutional practice. Any individual who is unsure whether or not a proposed quality improvement project should be classified as research should contact the IRB for guidance. If the data are re-examined or re-analyzed and new information surfaces that would contribute to generalizable knowledge, an application must be submitted to the IRB.
9. Case history or Case Study which are published and/or presented at national or regional meetings are not considered research if the case is limited to a description of the clinical features and/or outcome of a three or fewer patients and do not contribute to generalizable knowledge. Note: Investigators should contact the IRB if they are uncertain as to whether or not they are contributing to generalizable knowledge.
Publicly available data do not require IRB review. Examples: census data, labor statistics. Note: Investigators should contact the IRB if they are uncertain as to whether the data qualifies as “publicly available.”
Coded private information or biological specimens that were not collected for the currently proposed projects do not need IRB review as long as the investigator cannot link the coded data/specimens back to individual subjects. If the data/specimen provider has access to the identity of the subjects (e.g. subjects’ names, addresses, etc.), the investigator must enter into an agreement with the data/specimen provider that states under no circumstances will the identity of the subjects be released to the investigator. Note: Investigators can not independently make this determination. These projects require verification from the IRB Chair or their designee. (http://www.hhs.gov/ohrp/policy/checklists/decisioncharts.html#c1)
Some examples of Non-Engagement in Research include: when an institution’s employees or agents act as consultants on research but at no time obtain, receive, or possess identifiable private information, perform commercial services for the investigators, or inform prospective subjects about the availability of research. Note: the examples above are not an all inclusive listing.(http://www.hhs.gov/ohrp/policy/cdebio.pdf)

Course work as part of a Master’s Theses, Dissertation, or other Honor’s Program would not fall under this category.

Research involving the secondary analysis of existing data must be reviewed by the IRB to ensure that the original data were properly and ethically obtained and to ensure that the objectives of the secondary analysis are in keeping with those for which consent was obtained.

In order for the committee to evaluate research which includes secondary analysis, the researcher will need to provide:

A complete protocol for the secondary study;
The details of primary data collection (which may include the original protocol, consent and approval, if research), or the source of publicly available data; and
If the data are not publicly available, a letter from the source authorizing access to the data or, if the data were purchased commercially, a copy of the contract authorizing the use of the data.

After these documents are submitted, the committee will be able to decide if the research is exempt, non-exempt, requires a new consent, or does not need to be reviewed further.

Terms useful in discussing Secondary Analysis of Existing Data:

Existing data are data that exist at the time the research is proposed.

Existing samples must already be "on the shelf" (meaning, they must have already been gathered) at the time the research is proposed. For example, existing blood samples, existing tissue samples, completed surveys, existing interview notes, and existing audio- and video-tapes.

De-identified data are data from which all identifiers have been removed. Identifiers include obvious information such as name, address, social security or medical record numbers, photographs, address, telephone number, etc. as well as things such as biometric identifiers (voice and finger prints) and even zip code, if there are less than 20,000 people in the geographic area. A birth date coupled with a diagnosis may be sufficient to identify an individual in many research populations.

Non-exempt review
Existing data containing identifiers may need to be reviewed as non-exempt research.

Exempt review
Existing data that are publicly available or are recorded by the researcher in such a manner that the participants cannot be identified (de-identified data, or data for which the key to identities will not be provided the secondary researcher) may qualify for exempt review.

When New Consent is required
If the purpose of the secondary data analysis is found to differ significantly from the purpose of the original study, the IRB may require that informed consent for secondary data analysis is obtained from the participants.

Some research may not have to be reviewed by the IRB because the data are so anonymous that they no longer implicate human subjects. For example, some public health data, amalgamations of median income and average longevity, statistics from the U.S. Census Bureau are pooled such that anonymity is ensured.

The IRB must review all research that involves human subjects performed by UCSF faculty, staff or students or researchers at UCSF-affiliated institutions, as described below.

DHHS Regulations define research as a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge according to 45 CFR 46.102[1] Common Rule.

For purposes of IRB review, we further defines the following terms:

A “systematic investigation” as an activity involving a prospective plan that incorporates:

The organized collection of quantitative and/or qualitative data, or biological specimens
Analysis (or anticipation of analysis) of those data or specimens to answer a question or questions

“Generalizable knowledge” is information based on results or findings that are expected:

To be reproducible
Applied broadly with the expectation of predictable outcomes

The following activities are deemed not to be research:

Scholarly and journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal research, and historical scholarship), including the collection and use of information, that focus directly on the specific individual(s) about whom the information is collected.
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. 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).
Collection and analysis of information, biospecimens, or records by or for a criminal justice agency for activities authorized by law or court order solely for criminal justice or criminal investigative purposes.
Authorized operational activities (as determined by each agency) in support of intelligence, homeland security, defense, or other national security missions.

FDA Regulations defines clinical investigation as 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 n under section 505(i) or 520(g) of the act, or need not meet the requirements for prior submission to the Food and Drug Administration under these sections of the act, but the results of which are intended to be later submitted to, or held for inspection by, the Food and Drug Administration as part of an application for a research or marketing permit. (21 CFR 50.3(c), 21 CFR 56.103(c), 21 CFR 312.3(b), and 21 CFR 812.3(h)).

DHHS Regulations define human subject as a living individual about whom an investigator (whether professional or student) conducting research: (i) Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies or analyzes the information or biospecimens; or (ii) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens. (45 CFR 46.102(e)(1).

We further define the following:

Intervention includes both physical procedures by which information or biospecimens are gathered (e.g. venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes.

Interaction includes communication or interpersonal contact between an investigator and a subject.

Private information includes 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 that the individual can reasonably expect will not be made public (e.g., a medical record).

Identifiable private information is private information (see above) for which the identity of the subject is or may readily be determined by the investigator or linked (directly or indirectly) with the information.

An identifiable biospecimen is a biospecimen is a biospecimen for which the identity of the subject is or may readily be determined by the investigator or is (directly or indirectly) with the biospecimen.

See the Not Human Subjects Research guidance if your research involves only unidentifiable/de-identified or coded private information or biospecimens.

FDA Regulations define a human subject as an individual who becomes a participant in research, either as a recipient of the test article (drug, device or biologic) or as a control. (21 CFR 50.3(g), 21 CFR 56.103(e), 21 CFR 312.3(b), and 21 CFR 812.3(p))

A subject may be either a healthy individual or a patient
If the research involves a medical device, individuals are considered “subjects” when they participate in an investigation, either as an individual on whom an investigational device is used or as a control. Further, individuals are considered "subjects" when they participate in an investigation, in which their specimen(s) is used or as a control.

Note: Under limited circumstances, research involving only unidentifiable or coded private information or specimens is not human subjects research. Also review the Quality Improvement (QI) and Quality Assurance guidance, as well as the Quick Guide: Activities Needing IRB Approval, to learn more about what activities need IRB review and approval.

Who Needs IRB Approval

UCSF faculty, staff, or students or researchers at UCSF-affiliated institutions conducting human subjects research require IRB approval before initiating the study. IRB approval is required regardless of the site of the study or the source of funding (if there is funding).

UCSF-affiliated researchers involving human subjects must receive prior approval from the IRB if any of the following circumstances apply:

Researchers Paid > 50% Time by UCSF

All faculty and staff paid by UCSF for greater than 50% of their effort must have IRB approval before they begin research involving human subjects. This requirement applies regardless of the source of funding and even when no funds are involved, and regardless of the site of the study activities.

Researchers Paid < 50% Time by UCSF

If researchers are paid by UCSF for less than 50% of their effort, they need not obtain IRB approval for human research, unless one of the following conditions applies:

The funding is granted to or applied for through UCSF, or
Subjects will be recruited at UCSF, ZSFG (formerly SFGH) or the SFVAHCS, or
The research will take place at a UCSF, ZSFG or SFVAHCS facility.
A UCSF-affiliated institution holds an FWA that identifies the UCSF IRB as the IRB of record for all its human research.

Per UCSF PI eligibility requirements or the PI eligibility requirements of the various affiliates: If the above conditions apply, researchers must arrange for an eligible faculty member to serve as the PI for the study, or they may obtain a waiver from the Department Chair. This is because researchers paid less than 50% time are not typically eligible to serve as PI at UCSF nor are they eligible to have research reviewed by the IRB.

Important Note: Even if IRB review is not required, any investigator holding a UCSF appointment must obtain approval from another IRB before conducting human research. Anyone accepting the privilege of a UCSF faculty title must also assume the duty of obtaining prior approval from a duly-constituted IRB in order to conduct human research.

If the human research is supported either by extramural funds granted to (or applied for through) the Regents of the University of California or by University funds, IRB review is required.

If UCSF is the primary recipient of a grant, then the UCSF PI must obtain IRB approval, even if the research is being conducted elsewhere only for the scope of work. If multiple sites are involved, the IRB will require evidence of the various and relevant IRB approvals at all subcontracted sites.

If UCSF has been awarded a subcontract and is not the prime recipient of the grant, then the IRB need review only the subcontracted portion of the study that will be completed by the UCSF researcher.

For more information, please review Just in Time guidance.

Postdoctoral fellows, clinical fellows and residents are allowed to serve as PIs on IRB applications if certain conditions are met.

Students are not eligible to serve as PIs, as described below.

Students who are doing research at sites that are not affiliated with UCSF may not need individual approval from the UCSF IRB if:

their mentor (PI) is not a UCSF faculty member
they already have an IRB approval from the other institution
they are not supported by extramural funds granted to (or applied for through) the Regents of the University of California or by University funds
they are not accessing UCSF facilities, medical records, patients or personnel

If they are accessing any of these, they will need individual UCSF IRB approval with a qualified UCSF faculty member to serve as the PI.

Several institutions have signed agreements and Federalwide Assurances designating the UCSF IRB as the institution’s IRB (e.g., SFGH, SFDPH, SFVAHCS, Gladstone Institutes, Gallo Institutes). Researchers working under the auspices of those institutions must obtain IRB approval for human research as required by individual institutional policies, and are eligible to obtain IRB review as determined by UCSF institutional policies.

IMPORTANT NOTE: Investigators who wish to use facilities, involve patients or employees, or recruit subjects from any UCSF-affiliated institution must contact each institution to see what if any their additional requirements are. For example, the SF VAMC has its own set of requirements.

All human subjects research conducted at UCSF facilities or involving UCSF patients or employees (including students, faculty and staff) must either identify a UCSF faculty member.

Emeritus Professors may ask that the UCSF IRB review their studies, provided any funding is brought through UCSF, if there is funding.

Principal Investigator (PI) and Co-PI Eligibility

The PI must be a UCSF faculty member who meets the eligibility requirements for PI status on grant applications. The PI is ultimately responsible for all aspects of conducting the research study.

For studies conducted under the auspices of an affiliated institution (e.g., SFVAHCS, UCSF-Fresno, etc.), the PI must meet eligibility criteria defined by that institution.

If you are not eligible for PI status based on your appointment, you must be approved for PI status to submit an application to the IRB. Attach a signed PI Status Waiver Form to your IRB Application.

Postdoctoral fellows, clinical fellows and residents are now allowed to serve as PIs on IRB applications if the following two conditions are met:

A UCSF faculty member who would otherwise qualify as a PI is identified as the Co-PI on the application, and
A cover letter from the Co-PI faculty member is attached to the application stating that he or she agrees to serve as faculty support and/or a mentor to the fellow or resident listed as PI in the IRB Application.

Students cannot serve as PIs. They are required to seek the sponsorship of a UCSF faculty member, who will serve as the PI on the study. These studies are often smaller scale unfunded studies.

The Co-PI must be eligible to be a UCSF PI (see PI eligibility above). This means that study team members who do not meet the eligibility requirements (do not meet criteria for grant status noted above, are fellows, residents, specialists, etc) cannot serve as Co-PI. The Co-PI must be prepared to assume the responsibilities of the PI when the PI is unavailable.

FAQs

The health information of deceased individuals is protected under federal and state regulations. IRB review is determined by the level of Protected Health Information (PHI) associated with the data.

Records With No PHI: If the decedent study will not have direct access to PHI, IRB review and approval is not required because the deceased individuals cannot be identified.
Records With PHI: Decedent research that will have direct access to medical records or PHI, even if identifiers will not be recorded, must be submitted for IRB review and approval.

Death Data Files: California law requires local IRBs to review research using State of California-produced death data files that contain personal identifying information (i.e., state issued death certificates and indices). Submit an application to the IRB. The law specifies that the research can be approved only if the researcher has a "valid scientific interest" in the information. You may also need to obtain approvals from the CA Department of Public Health Vital Statistics Advisory Committee and the CA Health and Human Services Agency's Committee for the Protection of Human Subjects.

IRB Review Level Required for Decedent Research

Access to or Use of Medical Records	Use of PHI from State, County, Local Death Data Files	Level of IRB Review	IRB Consent and HIPAA Authorization Requirements
No	No	None	None
No	Yes	Expedited*	IRB Waiver of Consent and Authorization
Yes	Either Yes or No	Expedited*	IRB Waiver of Consent and Authorization

* Expedited review is required unless other parts of the study require full committee review.

To ensure that your JIT IRB application is handled expeditiously, email the UCSF IRB Expedited and Exempt Coordinator Manager ([email protected]) with JIT in the subject line as soon as NIH issues a JIT notice. In the e-mail text, provide

the study number
summarize the JIT request including the due date
indicate whether this is a single site protocol (i.e., data collection solely at UCSF sites) or whether UCSF is also serving as a coordinating center or data center for a study that includes two or more data collection sites.

When preparing your iRIS submission, fill out item 1.9 of the Initial Review Submission Packet noting “NIH JIT” and the due date.

Yes. It isn't the number of subjects that determines if review is needed; the determining factor is whether or not human subjects are involved. Make sure the aims of study are clear in the Purpose and Background section of the protocol.

IRB review is not needed if the materials do not contain personal identifiers (PHI). However, if personal identifying information is linked to the materials, then expedited review is required.