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IRB Home > FAQs and Resources

  Frequently Asked Questions and Resources

Basics

 

See below for Other/Special Circumstances:

 

Human Subjects Training

Before Submitting a Protocol

Submitting a Protocol (questions the PD should consider)

After Submitting a Protocol

After a Protocol is Approved

Closing a protocol

 

Other/Special Circumstances

Expanded Access, Emergency Use, Humanitarian Use (HUD)

Genomic Data Sharing

  • How do I obtain Institutional Certification so I can submit data to an NIH-supported genomic data repository (e.g., dbGaP)?
  • What should I do if the initial consent forms are not consistent with submission of data to the NIH Repository, or if there was no informed consent obtained?

Working with Central and External IRBs (CIRB)

 

Other Education Resources


 

Basics

What is the eProtocol system?
eProtocol is an online application used at Stanford to submit, review and approve research.

How do I use the eProtocol system?
See the webpage about how to get started and eProtocol FAQs.

What is a protocol?
A protocol is a detailed plan for conducting research.

What does STANFORD (all caps) signify? 
This denotes the five STANFORD affiliated organizations:

  • Stanford University (SU)
  • Stanford Hospital and Clinics (SHC)
  • Lucile Packard Children’s Hospital at Stanford (LPCH)
  • Veterans Affairs Palo Alto Health Care System (VAPAHCS)
  • Palo Alto Veterans Institute for Research (PAVIR)

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Human Subjects Training

What training do I need? 
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.
See CITI (Tutorial) for more information.

What is CITI? 
Stanford provides access to the required training through the interactive online Collaborative IRB Training Initiative (CITI) Course: The Protection of Human Research Subjects.

How do I transfer training from another institution?

  • Transfer CITI training completed at another institution:
    • Click on the link 'Associate With Another Institution' and choose Stanford
    • Your completed modules will be recorded in Stanford's database.  

  • Transfer non-CITI training completed at another institution:
    • Contact IRB Education (650-724-7141) to see if your past training can be transferred. Generally, Stanford University will accept comparable Humans Subjects training from other institutions. You will need to provide the IRB your most recent training completion report.
    • When your training expires, register at CITI with Stanford University as your affiliate institution to take the Refresher course.

  • See CITI (Tutorial) for more information.

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Before Submitting a Protocol

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. This chart may assist you in determining whether your study meets the definition.
 
For additional information on certain student projects, pilot studies, oral history projects, or quality assessement/quality improvement projects, see:

You may also complete this form and email it to the IRB Coordinator if you want the IRB to determine whether your activity constitutes human subject research. For help, contact the Research Compliance Office.


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. More information on pilot studies is found here.

Can Stanford students conduct Human Subject 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. More information is found here.

How do I get information about Stanford students for my study? 
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, email the Director of Institutional Research regarding the process to obtain these data before you submit your protocol to the IRB.

Who oversees student research? 
Student protocols must have the Academic Sponsor review and fill out the form for scientific and scholarly validity, and oversight

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Submitting a Protocol (questions the PD should consider)

Should I submit a medical or non-medical protocol? 

Medical 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 Veterans Institute for Research (PAVIR), or otherwise involving any medical procedure or use of personally identifiable health information are submitted on the Medical protocol application

Nonmedical 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.  

 

Review Type: What is it and why do I need to know? 
Before starting an eProtocol application, investigators must identify the appropriate Review Type. This determines which questions are prompted for on the application.  There are four types of form type:  Regular, Expedited, Exempt, and a streamlined Chart Review form.

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Chart review

 

Use for chart review studies that only involve the use of materials (data, documents, records) that have been collected for research or non-research purposes, or will be collected for non-research purposes.  
Do not use if a study involves interaction/intervention with participants, evaluating safety and effectiveness of a drug or device, or obtaining/analyzing specimens: This must be submitted on an Expedited or Regular form (see below).

Exempt review

Studies meeting specific criteria (pdf). These studies are exempted from IRB continuing review - not from initial review. The IRB determines whether the claim for exemption is appropriate and whether it will be granted. Exemption from IRB continuing review continues unless the protocol is to be modified such that it no longer will meet the criteria for exemption.  

Expedited review

Minimal risk studies meeting specific criteria (pdf). Protocols are generally reviewed by one primary IRB reviewer.  Protocols approved under Expedited review are subject to IRB continuing review.

Regular review

Protocols that involve more than minimal risk or do not meet the criteria for Exempt or Expedited. They are reviewed at a convened IRB meeting. Examples of protocols requiring initial regular review are studies using FDA investigational test articles, randomized double-blind placebo-controlled studies, Phase I, II, III and IV clinical trials, and studies using x-rays.

 

Is there a guide to help me through the eProtocol system?
On the right side of your eProtocol homepage, there is a help section. Following are sections which may be useful to you:

Getting Started

A Summary for New Users

eProtocol Training

eProtocol Basics Video and Information on Group Training

eProtocol FAQs

Getting Started, Managing Protocols, Troubleshooting

HELPSU and Contact Us

For eProtocol Assistance

 

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Consent

Documenting Consent

Can consent requirements be waived? 

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.

What if there are non-English speaking participants? 
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.

When can I use the short form consent process? 
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.

Does the IRB provide translated short form consent documents? 
There are short form templates in many languages.

Does my research require an assent form? 
Generally, a child 7 - 17 years old should sign an assent form.

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Is any additional information needed for research involving the VA? 
An additional set of questions is required for VA research. The Required Questions - VA Research must be completed and attached in eProtocol.

 

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After Submitting a Protocol

What happens after I submit my protocol?
Be sure to watch for IRB comments. IRB staff may contact you by email or phone to obtain further information or to inform you of IRB questions/comments that require you to submit a response.

List where you can be contacted by email, phone or fax. Please check your email daily for IRB comments during the month your protocol is being reviewed. Approval of your project may be delayed if responses to comments are not received promptly.

What is the status of my application? 
The eProtocol system is the system of record and should be accessed for information on current protocols. 

Can I begin working on my protocol before I receive IRB approval? 
NO.  WAIT for IRB Approval. You may not begin your project until you have been notified of the IRB's approval. The IRB process takes about a month to review a new protocol, depending on the review type. Be sure to allow time for the IRB to review and approve your protocol before you begin your research.

Under no circumstances should you interpret a lack of communication from the IRB as an approval. You can view your protocol status in the eProtocol home page.

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After a Protocol is Approved

Protocol Directors must maintain appropriate study oversight, as described in HRPP Policy Ch. 15.3 Research Oversight.

Changes to approved protocols
All proposed changes to approved research must be prospectively reviewed and approved by the IRB, (except where necessary to eliminate apparent immediate hazards to subjects – see Events and Information that Require Prompt Reporting to the IRB.)

Events that must be reported to the IRB
Certain events and circumstances (for non-Exempt human subject research) must be promptly reported to the IRB. See Events and Information that Require Prompt Reporting to the IRB.

Continuing IRB Approval
The Protocol Director is responsible for ensuring that (non-Exempt) protocols continuing with human subjects are submitted for continuing review and approval by the IRB before the expiration date of the protocols, and in sufficient time to ensure the non-interruption of studies. 

What happens when a protocol approaches its expiration date?
The expiration date is the last day that the protocol is approved (that is, the investigator may conduct research on the expiration date itself, but may not on the next day unless the IRB has approved renewal of the protocol following continuing review).

Researchers are alerted about an expiring protocol two months in advance by an eProtocol-generated notice, with a second reminder approximately one month later.  

If no continuing review application has been received, an expiration notice is sent out within three business days of the protocol expiration; to keep the protocol active, a continuing review application must be submitted immediately.

If a protocol expires
Expired protocols appear in red type on the investigator’s eProtocol Home Page under “Non-Active Protocols”. They are not automatically closed due to non-response by the Protocol Director; once expired, the PD may ask the IRB staff to perform an ‘administrative close’, or may contact the IRB to discuss options available.

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Closing a protocol

When and how to close a protocol
Protocols should be closed in eProtocol when the study has been completed, or when the only remaining activity is analysis of unidentifiable data.  The Protocol director is responsible for reporting the completion of the protocol to the IRB within 30 days.

A protocol is completed when all participants have been enrolled; all participants have completed all research-related interventions, including any protocol required follow-up; all analysis of identifiable data is completed; and all funding and contracting issues have been completed/cleared.

Protocols are closed via eProtocol, either by submitting a Final Report to the IRB (required for certain protocols – see below), or by changing the protocol status in eProtocol (see eProtocol instructions.)

When is a Final Report required?
A Final Report must be submitted to the IRB for:

  • Protocols that have undergone regular review and have enrolled participants,
  • All FDA-regulated protocols.

The Final Report should be submitted to the IRB within 30 days of the study completion.

Record retention
All data, including all signed consent form documents, must be retained for a minimum of three years past the completion of this research. Additional requirements may be imposed by the funding agency, Stanford department, or other entities.
Researchers should refer to RPH 1.9 - Retention of and Access to Research Data.

 

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Expanded Access, Emergency Use, Humanitarian Use (HUD)

What is Expanded Access?

Expanded Access is when investigational drugs, biologics, or devices are made available, under certain circumstances, to treat patient(s) with a serious disease or condition who cannot participate in a clinical trial. Expanded Access can be permitted by the FDA for individuals, intermediate size groups or widespread treatment, each under specific criteria. [21 CFR 312.300 (Subpart I)]

See: Expanded Access Brochure ; HRPP Policy Manual Chapter 5.8

Get more info

What is Compassionate Use?

“Compassionate Use” has commonly been used to refer to expanded access. The term ‘Compassionate Use’ is used in the FDA guidance for Single Patient/Small Group Access to a device.

Get more info

Does Expanded Access require IRB approval?

All Expanded Access, except Emergency Use (see GUI-6), requires prior IRB review and approval.

Get more info

Does Expanded Access require FDA approval?

DRUGS
Prior approval from the FDA is required (either a new IND or a protocol amendment to an existing IND). 

DEVICES
The sponsor should submit an IDE supplement to the FDA requesting approval for a protocol deviation.

Get more info

What are Expanded Access reporting requirements to the FDA?

DRUGS
Submit IND safety reports promptly, and annual reports if the protocol continues for one year or longer.

DEVICES
Sponsor must submit semi-annual progress reports to the FDA until the filing of a marketing application.  After filing, progress reports must be submitted annually [21 CFR 812.150(b)(5)].

Get more info

What is Emergency Use?

Use of an investigational article on a human subject in a life-threatening situation in which no standard acceptable treatment is available, and in which there is not sufficient time to obtain IRB approval [21 CFR 56.102(d)].

Get more info

Is permission needed for Emergency Use?

Contact sponsor to obtain permission to use and obtain test article.

Contact FDA for DRUGS – Emergency use may be requested by telephone, facsimile, or other means of electronic communications.

DEVICES – No prior approval from FDA is required for shipment or emergency use of investigational devices.

IRB: Emergency Use is exempt from prior IRB review and approval, provided it is reported to the IRB within 5 working days after the use. Contact IRB if you have any questions.

Get more info

What are Emergency Use reporting requirements?

IRB:
Must be reported to the IRB within 5 working days after the use:
Emergency Use of a Test Article – Notification to the IRB [APP-11m]

FDA:
Drugs: Physician or sponsor must submit a new IND, or amendment to an existing IND, within 15 working days of FDA’s authorization of the use.  Clearly mark “Emergency IND” on top of  Form 1571. 

Devices with IDE: Sponsor is responsible to report the use after receiving sufficient information from the physician.
Devices with no IDE: Physician must report the use within 5 working days.

See also HRPP Policy Manual Chapter 5.9

Get more info

What is a Humanitarian Use Device (HUD)?

A device intended to benefit patients by treating or diagnosing a disease or condition affecting fewer than 4,000 individuals in the United States per year.

See also HRPP Policy Manual Chapter 5.10

Get more info

 

 

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Genomic Data Sharing

See:

How do I obtain Institutional Certification so I can submit data to an NIH-supported genomic data repository (e.g., dbGaP)?  

Complete and sign an Institutional Certification form and submit by email to the IRB, along with the following:

    • Your eProtocol ID number, or 
    • A copy of the consent form used to collect the data or specimens, if the data was not collected under a Stanford IRB approved protocol.

 

What should I do if the initial consent forms are not consistent with submission of data to the NIH Repository, or if there was no informed consent obtained?

  • For data from specimens collected before 1/25/2015, the IRB will assess whether the data submission is consistent with the informed consent given by the participant.  NIH will accept data derived from de-identified cell lines or clinical specimens lacking consent for research that were created or collected before 1/25/15.

  • For studies initiated after 1/25/15, NIH expects researchers to obtain participants’ consent for their data to be shared broadly for future research.

  • For studies that prohibit sharing by using statements such as “Your data will never be shared outside of Stanford,” re-consenting may be possible.  Any plan to re-consent should be submitted to the IRB as a modification to the protocol along with the modified consent form prior to implementation.

  • See Related Non-Stanford Sites for additional NIH resources.

 

 

Other Education Resources

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