Ancillary & Institutional Reviews

IBC Website
Contact: Submit a ticket to EH&S

When is this review required? IBC approval is needed in addition to IRB approval for protocols that include the following:

1. Experiments involving the deliberate transfer of Recombinant or Synthetic Nucleic Acid molecules, or DNA or RNA derived from Recombinant or Synthetic Nucleic Acid molecules, into one or more human research participants;
2. use of Biological/Infectious Agent;
3. use of samples from participants that are known or likely to be infected with a Biological/Infectious Agent in a research lab.

How does this affect IRB review? For research involving Recombinant DNA, RNA or synthetic Nucleic Acid molecules in humans, a new IRB protocol generally will not be presented at a convened meeting until IBC approval has been received. If a modification or continuing review requires IBC review, the IRB will hold its approval until IBC forwards its approval to the IRB.
How do I submit to this ancillary committee? Submit a separate IBC application in eProtocol.

Cancer Clinical Trials Office Website - SRC Website
Contact: SRC-Office@stanford.edu

When is this review required? Review by the Stanford Cancer Institute (SCI) SRC is required for all hypothesis-driven cancer-related clinical research.
How does this affect IRB review? SRC review must be completed prior to IRB submission if no other review of Scientific and Scholarly Validity (SSV) will be done for the study.
How do I submit to this ancillary committee? Researchers should submit through the Stanford Cancer Institute Clinical Trials Office (SCI-CTO) Intake form.

CRSCo Website
Contact: Marshall Wen mwen@stanford.edu

When is this review required? If a human research study involves any radioisotopes or radiation-producing machines, CRSCo must certify that it has reviewed the protocol and recommends approval of the research.
How does this affect IRB review? The IRB will hold its approval until CRSCo approval is received.
How do I submit to this ancillary committee? The IRB will facilitate Radiation Safety review via the IRB protocol application in eProtocol.

COI Website
Contact: Contacts List by School

When is this review required? Any potential conflict of commitment or conflict of interest related to a human subjects research study must be disclosed and reviewed by the school COI manager. If necessary, this review will be escalted to the COI Committee.
How does this affect IRB review? Before a protocol application can be submitted to the IRB, the Protocol Director (PD), faculty listed on the protocol, and any others identified by the PD as presenting a potential COI must answer screening questions to identify any potential COI. 
When appropriate, a plan or strategy to adequately eliminate, mitigate, or manage the conflict must be determined by the COI Office and accepted by the IRB. The IRB will not approve a protocol until any disclosed COI has been reviewed and resolved by the COI Committee.
How do I submit to this ancillary committee? Submit a disclosure in the OPACS system.

Medical Education Research Policy
Contact: mededresearch@stanford.edu.

When is this review required? All medical education and research projects involving medical students and/or the required MD program curriculum must be reviewed and approved by the Medical Education leadership group.
How does this affect IRB review? It is recommended to submit to the Medical Education Research Policy for protocol review prior to IRB submission.
How do I submit to this ancillary committee? Please see the Medical Education Research Policy’s website for instructions on how to submit protocols for review.

Contact: Research Management Group (RMG) Clinical Trials Contract Officer

When is this review required? The RAC evaluates human subject research protocols for financial or administrative risks, or when a request is made to waive a policy related to clinical trial operations and administration.
How does this affect IRB review? If RAC review is required, it must be completed before IRB approval can be released.
How do I submit to this ancillary committee? A protocol is referred for RAC review by RMG during contract negotiations. RMG or RAC notifies the IRB when this review is needed.

SDU Website
Contact: SDU Intake Form or Submit an SDU Inquiry

When is this review required? This group reviews the social, ethical, and reputation aspects of sharing Stanford health data with external collaborators.
How does this affect IRB review? Updates to the IRB protocol may be required as a result of SDU Review.
How do I submit to this ancillary committee? The Contract Officer reviews draft agreements against the SDU Guiding Principles to determine if they are aligned with current guidelines and refers to the SDU Review Committee, as needed.

SCRO Website
Contact: scrostaff@lists.stanford.edu

When is this review required? SCRO approval is needed for protocols that involve the use of human stem cells, human embryos, or their derivatives.
How does this affect IRB review? SCRO and IRB review are done in parallel. Research must be reviewed and approved by the IRB/SCRO Panel prior to activity commencement.
How do I submit to this ancillary committee? Submit a SCRO application in eProtocol.

SaROC Website
Contact: stanford_saroc@stanford.edu

When is this review required? Human subjects research that includes Stanford student athletes must be reviewed by the SaROC.
How does this affect IRB review? It is recommended to submit to SaROC for protocol review as early as possible (prior to IRB submission, when possible) so that methods of recruitment, risks and benefits to Stanford student athletes, and other logistics can be reviewed by SaROC for appropriateness and feasibility when working with this specific population. SaROC requires proof of IRB approval once obtained.
How do I submit to this ancillary committee? Please see SaROC’s website for instructions on how to submit protocols for review.

Contact: sdoc_review@lists.stanford.edu

When is this review required? Human subjects research targeting students as participants specifically because of their status as a Stanford University student must be reviewed by SDOC. (This excludes research conducted in the GSB Behavioral Lab or research that recruits from student or departmental subject pools.)
How does this affect IRB review? If Stanford students are selected as a participant population in the IRB protocol application, either SDOC approval or a determination that SDOC review is not required is needed before the IRB protocol can be submitted for review.
How do I submit to this ancillary committee? Researchers should send their IRB protocol to SDOC prior to IRB submission.

Contact: Karamjeet Kaur Karamjeet.Kaur@va.gov

When is this review required? VA research must have PO & ISO approval before it can be initiated.
How does this affect IRB review? The IRB will hold its approval until VA PO & ISO approval is received.
How do I submit to the VA? The IRB will facilitate VA PO & ISO review via eProtocol.

Contact: Karamjeet Kaur Karamjeet.Kaur@va.gov.

When is this review required? VA research must have Research and Development (R&D) Committee approval before it can be initiated.
How does this affect IRB review? VAR&D Scientific review should be completed prior to IRB submission if no other review of Scientific and Scholarly Validity (SSV) will be done for the study.
How do I submit to the VA? Contact the VA to initiate the review process.

DPA Website
Contact: privacy@stanford.edu

When is this review required? The Stanford Research Repository, or STARR, is Stanford Medicine’s approved resource for use of clinical data for research purposes.  To obtain data from STARR, researchers must complete a Data Privacy Attestation (DPA).
How does this affect IRB review? To use STARR data for research, the DPA should be completed and approved prior to IRB submission.
How do I submit to this department? The STARR DPA can be accessed from the Confidentiality section of the IRB application.

DRA Website
Contact: dra_review@lists.stanford.edu

When is this review required?  A DRA is a review of whether a proposed transfer to a non-Stanford entity is consistent with Stanford’s Minimum Security Standards and Minimum Privacy Standards.
How does this affect IRB review? The IRB may need DRA review to ensure the privacy of participants and confidentiality of data is maintained. DRA may be required before IRB approval can be released.
How do I submit to this department? A DRA can be submitted to the University Privacy Office and Information Security Office via One Trust

ICO Website
• Data Use Agreement (DUA)
• Material Transfer Agreement (MTA)
• Human Tissue Agreement (HTA) 

Contact: ico@stanford.edu

When is this review required? ICO is responsible for reviewing, negotiating and signing research-related agreements on behalf of Stanford with industry and some non-profit collaborators.
How does this affect IRB review? Agreements should be initiated and reviewed in parallel with IRB submission.
How do I submit to this department? Submit an Intake Form to ICO

OSR Website
Contact: osr_intake@stanford.edu

When is this review required? OSR is responsible for reviewing, negotiating, and signing research-related agreements with federal and other non-profit entities.
How does this affect IRB review? IRB approval may be needed prior to the release of federal funding.
How do I submit to this department? Contact OSR to initiate the review process.

Administrative Guide 1.5.1: Political, Campaign and Lobbying Activities
Contact: irbnonmed@stanford.edu

When is this review required? This requirement applies to any experimental research involving current or future elections or political campaigns.
How does this affect IRB review? Review by the Vice Provost and Dean of Research (VPDoR) - who will consult with the General Counsel's Office for any legal restrictions - will be needed before the IRB can proceed with their review of the research. The IRB only applies the federal Criteria for IRB Approval, including assessment of risks to participants and the informed consent process. The VPDoR and Office of General Counsel may ask for additional information and changes in order to meet legal requirements for political campaign and lobbying activities.
How do I submit for VPDoR Review? The IRB will notify the VPDoR when these protocols are submitted to initiate this review. If possible, the VPDoR and IRB review will proceed in parallel to not delay decisions. VPDoR questions or requests for information from the Protocol Director will be communicated via the IRB staff to keep the process centralized and to aid with efficiencies in review. Please email the Stanford IRB for a consultation if you plan to conduct research involving political campaigns. Note that all necessary reviews can take up to 2 to 3 months.
 

RMG Website
Contact: Via Dept. RMG Clinical Trials Contract Officer

When is this review required? RMG provides support and oversight of sponsored projects for the School of Medicine.
How does this affect IRB review? Contract reviews should be initiated and reviewed in parallel with IRB submission.
How do I submit to this department? Contact RMG to initiate the review process.

CRQ Website
Contact: clinicalresearchquality@stanford.edu

When is this review required? Research involving an investigational drug or biologic that will not be stored and dispensed by a licensed pharmacy or hospital department will need an approved SCAP.
How does this affect IRB review? The SCAP should be approved before the project is submitted to the IRB, and documentation of the approved SCAP should be provided with your protocol submission in eProtocol.
How do I submit to this department? Complete the Security and Controlled Access Plan (SCAP) Intake Form. You should hear back on your SCAP application within 7 business days.

Cancer Clinical Trials Office Website
Contact: DSMC-Office@stanford.edu 

What Resources Are Provided? The Stanford Cancer Institute (SCI) DSMC provides ongoing monitoring to ensure data integrity and safety of participants in all cancer clinical trials. Clinical Trial monitoring is done throughout the life of an IRB approved study.  Monitoring reports that include reportable findings should be provided to the IRB according to IRB reporting guidelines.

CRQ Website
• Clinicaltrials.gov support
• IND/IDE and Regulatory Affairs Services
• Regulatory Knowledge and Support (RKS)

Contact: clinicalresearchquality@stanford.edu
Submit a request to CRQ Clinical Trials Support Services

What Resources Are Provided? CRQ facilitates clinical research regulatory compliance and contributes to school-wide quality and compliance-improvement initiatives. CRQ provides support with ClinicalTrials.gov registration, IND/IDE submission, GCP consultation, and Stanford policies and procedures. CRQ also conducts internal audits (quality reviews) upon request and supports external audits and regulatory inspections.

Data De-Identification Service Website
Contact: deid-support@lists.stanford.edu

What Resources are Provided? This service helps researchers remove or mask Personally Identifiable Information (PII) and Protected Health Information (PHI) in datasets, either before public sharing or during analysis.

EH&S Website
Contact: https://ehs.stanford.edu/contact

What Resources Are Provided? EH&S provides a wide variety of services including injury/illness prevention, protocol review for basic and clinical research, research animal safety, biosafety and biosecurity, hazardous waste management, radiation safety, laser safety, and occupational health and travel medicine.

Compliance FAQ
Contact: ComplianceOfficer@stanfordhealthcare.org
PrivacyOfficer@stanfordhealthcare.org

What Resources Are Provided? Stanford Health Care (SHC) & Stanford Medicine Children’s Health (SMHC) have established a compliance program under the leadership of the Chief Compliance and Privacy Officer. Contact the OCP for questions pertaining to research billing compliance, patient privacy matters (e.g., medical record/patient data sharing), and general hospital compliance matters (e.g., STARK, Anti-Kickback, False Claims Act).

OTL Website
Contact: info@otlmail.stanford.edu

What Resources Are Provided? OTL evaluates, markets, and licenses technology owned by the University, including the disclosure of new inventions, obtaining patents, licenses, and other requirements related to the creation of new technology.

PEP Website
Contact: EngageParticipants@stanford.edu

What Resources Are Provided? PEP helps Stanford researchersmeet their participant recruitment and retention goals, with a focus on engaging participants as partners in research. Services include one-on-one consultations and technology-driven networks for enlisting study participants and collaborators both inside and outside of Stanford Medicine. The team manages the PEP Platform consisting of honest broker Direct Email, Epic MyChart/MyHealth, and Postal Mail study invitations, as well as other recruitment services, including the Stanford Research Registry (a database of individuals interested in being contacted for research), and social media. Additionally, a partnership with StudyPages enables study teams to create participant-friendly sign-up webpages and access online participant management and communication tools. These services are available for engaging both healthy volunteers and patients with different conditions, from all ages and backgrounds. 

SCBE Website
Contact: biomedicalethics@stanford.edu

What Resources Are Provided? SCBE provides ethics consultations for Stanford clinical researchers that include analyzing the impacts of a particular policy, identifying ethical or social impacts of research, or suggestions for minimizing risks and maximizing benefits.

STARR Website
Contact: Submit a request to RIC

What Resources Are Provided? STARR is Stanford Medicine’s approved resource for working with clinical data for research purposes. STARR services include cohort discovery and chart review tools.

SUOHC Website
Contact: stanfordohc@stanford.edu

What Resources Are Provided? SUOCH provides clinical care to faculty, staff, and post-docs, including medical evaluation and treatment for work-related illnesses, and health surveillance and screening.

UPO Website
Contact: Submit a service now ticket

What Resources Are Provided? The UPO enforces privacy policies and standards related to HIPAA, FERPA, GDPR, data sharing, data storage and retention, and other such policies.  UPO is also responsible for investigating potential privacy breaches or related incidents.