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FAQs & Resources for Researchers
On this page:
• Education archive of IRB presentations to investigators
• Stanford Education Resources
• Other Education Resources - FDA and OHRP FAQs, PRIM&R, SRA
• Required Tutorial - information about CITI training, links to the CITI course
• FAQs
eProtocol Help and FAQs
• Getting started, working with protocols, troubleshooting >>
Getting started
• Do I have to submit an application to the IRB? >>
• What qualifies as a pilot study? >>
• I have to submit a protocol for IRB review. Where do I start? >>
• This is my first application - got any tips? >>
• Should I submit a Medical or Nonmedical application? >>
• Review Type: What is it, and why do I need to know? >>
• Who should be listed on the eProtocol application? >>
• What is the status of my application? >>
• My research involves the VA; is there any additional information needed? >>
Closing protocols, expiration, and final reports
• My protocol expired. Can I still continue my research? >>
• My research is finished. Do I need to submit a Final Report? >>
Stanford students conducting or participating in human subjects research
• I need information about Stanford students for my study - how do I get this? >>
• Can Stanford students conduct HS research? >>
• Who oversees student research? >>
Consent
• What if there are non-English speaking participants? >>
• Where can I get a consent form translated? >>
• Short Fom: When can I use the short form consent process? >>
• Are there sample translated short form consent documents? >>
• Can consent requriements be waived? >>
• Does my research require an assent form? >>
Training
• What training do I need? >>
• What is "CITI"? >>
Other topics
• What does "STANFORD" (all caps) signify? >>
Getting started |
Answer |
More info? |
Do I have to submit an application to the IRB? |
Studies that meet the definition of Human Subject Research must be submitted to the IRB, and must receive IRB approval before any study activities take place. | |
| What qualifies as a pilot study? | A pilot study is a preliminary investigation of the feasibility of the study which would not contribute to generalizable knowledge and therefore is not considered research. However, if the researcher plans to use the pilot data for research purposes, IRB review is required. |
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| I have to submit a protocol for IRB review. Where do I start? | See instructions for protocol submission via eProtocol. | |
| This is my first application - got any tips? | Hints for students and others new to the IRB submission process. | |
| Should I submit a Medical or Nonmedical application? | Medical Protocols: Protocols conducted by personnel within, or conducted through, the School of Medicine (SOM), the Veterans Affairs Palo Alto Health Care System (VAPAHCS), the Palo Alto Institute for Research and Education (PAIRE), or otherwise involving any medical procedure or use of personally identifiable health information are submitted on the Medical protocol application. Nonmedical Protocols: Protocols for research not being conducted by personnel within, or conducted through, the School of Medicine or the hospitals (e.g., protocols from the Schools of Education, Engineering, Earth Sciences, Humanities and Sciences, Law and Business) are submitted on the Nonmedical protocol application. |
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Review Type: What is it, and why do I need to know?
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Before starting an eProtocol application, investigators must identify the appropriate Review Type. This determines which questions are prompted for on the application. | |
| Who should be listed on the eProtocol application? | The Protocol Director decides whom to list in the personnel section of the eProtocol application. [The Human Subjects training requirement is not limited to those personnel listed on the eProtocol application, but extends to all research staff.] |
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What is the status of my application? |
The eProtocol system is the system of record, and should be accessed for information on current protocols. | |
My research involves the VA; is there any additional information needed? |
An additional set of questions is required for VA research. These must be completed and 'attached ' to the eProtocol application (Section 16). | |
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Closing protocols, expiration, and final reports |
Answer |
More info? |
| My protocol expired. Can I still continue my research? | Research that continues after the approval period expires is considered research conducted without IRB approval. Research activities must stop, unless the IRB determines that continued involvement is in the best interest of enrolled subjects who are still receiving study-related interventions; see HRPP Policy Manual Chapter 7.7, paragraph 'Approval Period and Determination of Expiration Date'. |
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My research is finished. Do I need to submit a Final Report? |
Final Reports are required on all projects that were subjected to regular review and that enrolled participants. |
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Students: Conducting or Participating in HS Research |
Answer |
More info? |
| I need information about Stanford students for my study - how do I get this? | If you plan to request email addresses, or biographic, demographic or academic data on Stanford students from the Registrar's Office as part of your research, contact the Director of Institutional Research regarding the process to obtain these data before you submit your application to the IRB. | |
| Can Stanford students conduct HS research? | Stanford University supports a wide range of both undergraduate and graduate student research projects using human subjects - from course-related research exercises to Ph.D. dissertation studies. | |
| Who oversees student research? | Student protocols must have a Faculty Sponsor for review of scientific and scholarly validity, and oversight. | |
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Consent |
Answer |
More info? |
What if there are non-English speaking participants?
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Investigators are encouraged to recruit and include all segments of the community in research, including individuals whose primary language is not English. A general requirement for informed consent is that the 'information that is given to the subject or the representative shall be in a language understandable to the subject or the representative' [45 CFR 46.116 21; CFR 50.20]. | |
Where can I get a consent form translated? |
It is important that consent forms be translated accurately. Procedures for ensuring accurate translation should be described in the protocol application. For more information, contact Translation Services (Stanford Hospital and Clinics) at (650) 724-8735. | |
Short Form: |
When all of the participants in a study (i.e., the target population) are anticipated to be non-English speaking, a full translated consent is strongly encouraged. Use of the short form consent process and documents requires prior IRB approval. |
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| Are there sample translated short form consent documents? | There are short form templates in Chinese, Farsi, Japanese, Korean, Russian, Spanish and Vietnamese. | |
Can consent requirements be waived?
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FDA-regulated research: FDA regulations do not provide for a waiver or alteration of the informed consent process; the only exceptions to the informed consent requirements are for clearly defined circumstances of emergency use of a test article, and waivers granted for planned emergency research. Non-FDA-regulated research: The IRB may approve a • Waiver/Alteration of consent, or a • Waiver of Documentation (signature requirement) if the research meets regulatory criteria. |
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| Does my research require an assent form? | Generally, a child 7 - 17 years old should sign an assent form. | |
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Training |
Answer |
More info? |
What training do I need?
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Completion of human subject research training by all staff working on a research project (all investigators and other study personnel, including all persons who are responsible for the design, conduct, data analysis or reporting) is one of the requirements for protocol approval by the IRB. | |
What is "CITI"?
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Stanford provides access to the required training through the interactive online Collaborative IRB Training Initiative (CITI) Course: The Protection of Human Research Subjects. | |
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Other |
Answer |
More info? |
What does STANFORD (all caps) signify?
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This denotes the five STANFORD affiliated organizations: |
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topStanford Education Resources
- Education archive of presentations to investigators
- STANFORD HRPP Presentations, Classes, and Programs addressing Human Subject Research Protections: To request classes and presentations geared towards your needs, or to request individual appointments contact IRB Education.
- Stanford University
is a proud member of CISCRP's Circle of Supporters. CISCRP The Center for
Information and Study on Clinical Research Participation is a nonprofit group
dedicated to educating and informing the public, patients, medical/research communities,
the media, and policy makers about clinical research participation.
- SPCTRM Stanford/Packard Center for Translational Research in Medicine
- Stanford School of Medicine Dean's Newsletters
- Legal issues, news, and information
- Research
and Laboratory Safety
Other Education Resources
- Belmont report
- FDA
- FAQs: Frequently Asked Questions IRB organization, membership, procedures and records; informed consent process and document content; clinical investigations; general questions
- FAQs: Frequently Asked Questions IRB organization, membership, procedures and records; informed consent process and document content; clinical investigations; general questions
- OHRP Office of Human Research Protections
- Educational Materials
- FAQs: Frequently Asked Questions Assurance process, IRB registration process, 45 CFR 46, research with children, investigator reponsibilities, prisoner research, informed consent, quality improvement activities
- Institutional Review Board Registry Domestic and international listings
- Policy Guidance
- Public Outreach Page The Office for Human Research Protections information for the general public about research participation
- ORI Newsletters: The Office of Research Integrity (ORI) publishes articles of interest to laboratory directors, investigators, department heads, researchers, mentors, postdocs, and graduate students.
- PRIM&R Public Responsiblity in Medicine & Research
- SRA Society of Research Administrators
Human Subjects Federalwide Assurance Number: FWA00000935, 8/14/2001 - 3/5/2012
Medical IRB Nos. 01, 03, 04, 05, 06, 07 & 08 Nonmedical IRB No. 02
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Last modified: Thursday, 17-Sep-2009 16:32:54 PDT