Do I Need IRB Review?
Research involving human subjects must be conducted in accordance with federal regulations, state laws, local policies, and established ethical principles. An Institutional Review Board (IRB) is a committee established to protect the rights and welfare of human subjects participating in research by ensuring applicable regulations, policies and ethical standards are met. The Stanford IRB is responsible for all human subjects research projects conducted by Stanford-affiliated researchers.
Projects that meet the regulatory definitions of ‘research’ or ‘clinical investigation, and ‘human subject’ must be submitted to the IRB for review and approval. Review the information for what type of application should be submitted before submitting your application in eProtocol. Additional definitions related to human subjects research can be found here.
Throughout history, there have been many examples of unethical human experimentation such as the Nuremburg Trials (1945-1946) involving German leaders of the Nazi Party and the Tuskegee Untreated Syphilis Study (1932-1972) involving under-privileged African-American men. These events led to the development of federal regulations and ethical principles for conducting human subjects research. The basic ethical principles identified in the Belmont Report include respect for persons, beneficence, and justice.
Research – a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.
Human Subject – a living individual about whom an investigator 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
FDA regulations also require IRB approval for projects that meet the FDA definitions of a clinical investigation involving a human subject.
Clinical Investigation – any research experiment that involves a drug, device, or biologic and one or more human subjects and is subject to requirements for prior submission to the FDA (e.g., a change in labeling) or the results of the research (e.g., safety and efficacy) are intended to be submitted to the FDA as part of an application for a research or marketing permit. Such research requires both IRB and FDA reviews. The terms research, clinical research, clinical study, study, and clinical investigation are deemed to be synonymous for this definition.
Human Subject – an individual who is or becomes a participant in research, either as a recipient of a test article or as a control. A subject may be either a healthy individual or a patient.
If you are unsure whether IRB review is needed, please review the Human Subjects Research (HSR) Determination Form. This form can be submitted to the IRB with an HSR application in eProtocol for a formal determination about whether a project needs IRB review.
IRB Education is also available to discuss your project with you.
For additional information on certain student projects, pilot studies, oral history projects, or quality assessment/quality improvement projects, see:
Summary of Activities That May Require IRB Review
The following table outlines when IRB review is required for some common activities that may be conducted.
Medical
| Activity | Description | Is IRB Review Required? |
|---|---|---|
| Clinical Investigation | Experiment using a test article (e.g., investigational drug, biologic, and/or device) on one or more human subjects, or as a control, or on the specimen of a human subject, that are regulated by the Food and Drug Administration (FDA) or supports an application for research or marketing permit for an FDA-regulated product. | Yes |
Standard Medical Practice | Standard of care treatment, diagnostic activity or intervention used in normal medical practice. This includes off-label use of FDA approved drugs or biologics to prevent, diagnose, or mitigate disease, when the use does not involve a systematic collection of safety or efficacy data. ----------------------------------------------------------------------------------- Normal patient care is altered, added to, assigned or randomized for research purposes. |
No
Yes |
| Public Health Surveillance | Public health surveillance activities, including the collection and testing of information or biospecimens, conducted, supported, requested, 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). 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). | No |
| Case Report/Series | Report of up to 3-5 clinical experiences or observations identified in the course of clinical care, provided that the project is not a clinical investigation, as noted above, requiring IRB approval (e.g. investigational use of drugs, devices, biologics). Note – Contact Hospital Privacy & Compliance (PrivacyOfficer@stanfordhealthcare.org) to ascertain any additional requirements for conducting case report/series at Stanford Medicine Health Care. | No |
Innovative Care/Treatment | Medical care which departs in a significant way from standard or accepted practice. The primary purpose of innovative care is to benefit a patient(s), not to collect information to support a hypothesis or theory. It is a non‐standard procedure or treatment that is employed solely to enhance the well being of a patient, but for which there is limited prospective evidence of safety and efficacy. See additional information on Innovative Care Guidelines at Stanford. ----------------------------------------------------------------------------------- If the primary purpose is to seek new knowledge, to reorder existing knowledge or to apply existing knowledge to a new situation; the intervention is offered to a larger number of patients; or if the intervention meets the definition of a clinical investigation as noted above. |
No
Yes |
Innovative Medical Education Practices | Systematic investigation of an instructional method in multiple participants designed for both educational purposes and to contribute to generalizable knowledge. ----------------------------------------------------------------------------------- Activities designed strictly for educational purposes that teach research methods or demonstrate course concepts. The activities are not intended to create new knowledge. Note – All medical education and research projects in a required MD program curriculum must be reviewed and approved per the Medical Education Research Policy. For questions related to this review, please email mededresearch@stanford.edu. |
Yes
No |
| Repositories (biospecimens/medical information) | A storage site or mechanism by which identifiable biospecimens (e.g., human tissue, blood, genetic material, etc.) or information are stored or archived for future research by multiple investigators or multiple research projects. | Yes |
Medical Chart Reviews | 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. ----------------------------------------------------------------------------------- Review of aggregate de-identified medical information intended only to assess the feasibility of future research (i.e. activities preparatory to research). |
Yes
No |
| Stanford Serving as Coordinating Center for a Multi-Site/Cooperative Trial | The Stanford Investigator 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. Stanford may or may not be an enrolling site. | Yes |
| Emergency Use of an Investigational Drug/Device | The use of a test article on a human subject in a life-threatening situation in which no standard acceptable treatment is available and where there is not sufficient time to obtain IRB approval. | No (when conditions are met) |
| Research Using Publicly Available Information | Use of publicly available information that have been anonymized or de-identified to protect privacy. "Publicly available" is defined as information shared without conditions on use. This may include information that require payment of a fee to gain access to the information. | No |
| Quality Assurance/Quality Improvement (QA/QI) Activities | 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. Note – For QA/QI activities conducted at the below referenced sites, contact the following to ascertain any additional requirements:
| No |
| Pilot Studies | Preliminary investigation of the feasibility of a study, usually done on a small scale (approximately 10 or fewer participants) and exploratory in nature. The purpose is to refine data collection procedures and instruments or prepare a better, more precise research design, rather than contribute to generalizable knowledge. Data collected should not be included as research data. ----------------------------------------------------------------------------------- Pilot study, regardless of the sample size, that:
| No
Yes
|
| Research involving Decedents | Research involving information and/or biospecimens obtained from individuals who are deceased prior to the conduct of the research. There must not be any interaction or intervention with living individuals. Note – If the information and/or biospecimens include Protected Health Information (PHI) contact the University Privacy Office to determine how best to obtain authorization to use and disclose the information. | No
|
| Use of a Community Advisory Board (CAB) or Steering Committee | Creation of or consultation with a Community Advisory Board (CAB) or Steering Committee to help inform the study design and/or to help interpret the research findings. | No |
Non-Medical
| Activity | Description | IRB Review Required? |
|---|---|---|
| Social/Behavioral Case Report/Series | Report about experiences or observations associated with up to 3-5 individuals. | No |
Innovative Education Practices | Systematic investigation of an instructional method in multiple participants designed for both educational purposes and to contribute to generalizable knowledge. --------------------------------------------------------------------------------------- Activities designed strictly for educational purposes that teach research methods or demonstrate course concepts. The activities are not intended to create new knowledge. |
Yes
No |
| Repositories (data) | A storage site or mechanism by which identifiable data are stored or archived for future research by multiple investigators or multiple research projects. | Yes |
| Stanford Serving as Coordinating Center for a Cooperative Study | The Stanford Investigator 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. Stanford may or may not be an enrolling site. | Yes |
| Research Using Publicly Available Information | Use of publicly available information that has been anonymized or de-identified to protect privacy. "Publicly available" is defined as information shared without conditions on use. This may include information that requires payment of a fee to gain access to the information. | 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. ---------------------------------------------------------------------------------------- Interviews that collect, preserve and interpret the voices and memories of people, communities, and participants in past events as a method of information gathering for a research project. The intent is to create generalizeable knowledge. |
No
Yes |
| 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 |
| Quality Assurance/Quality Improvement (QA/QI) Activities | Information 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. | No |
| Pilot Studies | Preliminary investigation of the feasibility of a study, usually done on a small scale (approximately 10 or fewer participants) and exploratory in nature. The purpose is to refine data collection procedures and instruments or prepare a better, more precise research design, rather than contribute to generalizable knowledge. Data collected should not be included as research data. ----------------------------------------------------------------------------------- Pilot study, regardless of the sample size, that:
| No
Yes
|
| Use of a Community Advisory Board (CAB) or Steering Committee | Creation of or consultation with a Community Advisory Board (CAB) or Steering Committee to help inform the study design and/or to help interpret the research findings. | No |
| Research Practicum Projects | Projects done for the purpose of fulfilling specific course requirements. Note - projects that begin as research practica may need IRB approval if additional data is collected outside of the context of the course project. Thesis, dissertation, and capstone projects do NOT fall into this category and may need IRB review. | No |
| Creative Work | Activities with a goal of producing creative work such as a novel, creative nonfiction writing, photography, or other art exhibition. | No |
Page updated June, 2025