For Researchers

SCRO Review Categories Flow Chart [1] ( ): This flow chart shows the type of review necessary for different types of human stem cell research. Stem Cell Matrix [2] ( ): A list of hESC approved for use at Stanford University. Somatic Cell Informed Consent for use in Human Stem Cell Research [3] ( ): A template informed consent that meets requirements for developing human therapies from stem cell sources. SCRO eProtocol Application [4] ( ): A Word version of the questions in SCRO?s eProtocol application to use for training or for gathering your information prior to submission.


Training
"Let the IRB Staff Come to You!" [8]: Researchers can arrange for 1-on-1 or group sessions For research participants, patients, and others interested in medical practice research -a new resource on the Spectrum website: Research on Medical Practices (ROMP) [9] and ROMP Videos [10].

Do I need an IRB Submission?
Does My Project Need IRB Review? [11] ( ) [12]Determination of Human Subject Research Application [12] ( ) This form should be submitted in eProtocol as a Human Subjects Research (HSR) Determination.
To submit a 'Determination of Human Subject Research' form in eProtocol [13], select 'Create a Protocol' on the 'My Dashboard' webpage. After completing the requested information, select 'Human Subject Research (HSR)' as your type of review. Complete the application and attach the Human Subject Research (HSR) Determination Form [12] for review (there is also a link to this form in the attachments section of the protocol application). After the IRB has made its determination, the IRB will "Keep" or "Withdraw" the HSR application. Withdrawn applications DO meet the definition of human subjects research, and require that an IRB protocol be submitted and approved prior to any research activities being conducted, including recruiting or consenting prospective participants.
To view the IRB's determination in eProtocol: Go to 'My Dashboard' and select 'Non-Active Protocols'. Open the protocol number in question. Click the bottom left red tab, "Print View" for a PDF of the HSR application --the HSR determination will be on page 2.
IRB Review Type: What is it and why do I need to know? [14]

Medical Research
Medical Application Process [19] Filling out the Medical Protocol Application [20] Sample Medical eProtocol applications [21] Clinical trial documents: The following checklists are from the FDA E6 Consolidated Guidance for Good Clinical Practice

NIH Funded Studies
NIH policy [28] on the Use of a Single Institutional Review Board for Multi-Site Research (effective January 25, 2018).
All sites participating in multi-site studies involving non-exempt human subjects research funded by the NIH must use a single IRB (sIRB). Applicants must include a plan for the use of a sIRB in their applications/proposals submitted to the NIH on or after January 25, 2018.
Costs associated with the sIRB review may be included as direct costs in the application budget. Work with your Research Process Manager [29] prior to submitting your proposal to NIH. NIH FAQs on sIRB costs [ [36]) that all institutions located in the United States that are engaged in cooperative research conducted or supported by a Common Rule department or agency [35] rely upon approval by a single IRB for the portion of the research that is conducted in the United States The Single IRB plan should be identified and included by the applicant within the grant application or the contract proposal. The proposed budget in the grant application/contract proposal should reflect all necessary Single IRB costs without an approved ?other exception?. Applicants should not assume that an exception will be granted when considering what Single IRB costs to include in the budget.
Will the single IRB that is identified in the NIH application/proposal be evaluated during peer review?(NIH FAQs [44]) No. The proposed single IRB will not be evaluated as part of the peer review process and will not affect the overall assigned score of an application/proposal or the overall rating of the acceptability of the Protection of Human Subjects section. Peer reviewers may note if the plan to comply with the NIH single IRB policy is not included in the application/proposal but this will not impact the score.

Relying on a Single IRB (sIRB)
Stanford's IRB may agree to rely on a single IRB (sIRB) for multisite studies to provide initial and ongoing regulatory reviews. The reliance terms are outlined in an IRB Authorization Agreement (IAA). Stanford has signed on to SMART IRB [45], which supports IRB reliance across the nation. The sIRB is responsible for reviews required by federal regulations at 45 CFR 46, and 21 CFR 50 and 56 (initial review, continuing review, modifications, reportable events). When Stanford?s IRB relies on a sIRB, it retains responsibility to: ensure investigator compliance with the protocol, oversee the sIRB's determinations, ensure applicable federal and state regulations, and ensure Stanford policy.
Stanford's IRB also bears responsibility for the local conduct of sIRB studies, including managing noncompliance and unanticipated problems, ensuring training, study monitoring, local ancillary requirements, managing reliance agreements, and handling study specific issues.
Reliance on a sIRB is considered on a case-by-case basis for high risk studies when not mandated by NIH Single IRB policy or required by the Revised Common Rule's Cooperative Research Provision (45 CFR 46.114). Some examples might include first-in-human drug or device studies, certain biological agents or Recombinant DNA Vector studies, or studies that involve stem cells or hESC. Stanford?s IRB will not rely on a sIRB when Stanford is the sole site.
The Protocol Director (PD) is required to submit a sIRB eProtocol [46] application to request reliance on a sIRB. When the (1) sIRB eProtocol application and the (2) reliance IAA are complete, a Reliance Letter will be issued through eProtocol. Please see the sIRB SOP [47] for more detailed information. See here [48] for additional Relying PI responsibilities. [49] NCI CIRB -the NCI Central IRB Initiative