Cancer-Related Research

It can be challenging for UW researchers to identify which IRB should review cancer-related research. This is because:

• Cancer-related research and clinical care in the region have a long rich history of collaboration.
• The research often occurs in physical locations that involve multiple regional institutions.
• Federal funding agencies, consortia, and national network groups have specific IRB requirements.

What is Cancer-Related Research?

UW is a member of the Fred Hutch/UW/Seattle Children’s Cancer Consortium, a regional effort funded by the National Cancer Institute (NCI) to coordinate cancer-related research across UW, Fred Hutch, and Seattle Children’s. Cancer Consortium leadership defines what research conducted by those institutions is considered cancer-related.

Cancer-related research is research that meets any of the following criteria:

• Directly involves cancer patient research, or
• Funded by the National Cancer Institute (NCI), or
• The primary site of a multi-site trial has classified the study as cancer or cancer-related, or
• The trial cohort will include both patients with a cancer diagnosis and others without a cancer diagnosis and includes a primary or secondary analysis of the portion of the cohort with a cancer diagnosis, or
• Research of secondary conditions related to cancer treatment in patients with a cancer diagnosis who have received that treatment, or
• Cancer prevention studies that specifically include a primary outcome of cancer diagnosis, or
• Research on bone marrow transplant (BMT) that is not related to cancer treatment.

If the research meets any of the criteria above, it is considered cancer-related regardless of the departmental affiliation or academic discipline of the Principal Investigator (PI).

Which IRB should do the review for UW led cancer-related research?

The UW IRB does not have sufficient oncology expertise to review most interventional cancer research. In addition, there may be standing agreements by which another IRB should review the research. See below to identify the IRB that should review UW led, non-exempt cancer-related research. For exempt research, each institution involved in the research makes its own exemption determination.

Single Patient Emergency (Drug, Biologic, Device) or Compassionate Use (Device)
These activities are not considered research; however an IRB must be involved in this process due to FDA requirements. UW and Fred Hutch physicians may use this process to report these uses to the UW IRB.

Expanded Access Treatment (non-emergency) or HUD Protocols
These activities are not considered research, however an IRB must review the activity due to FDA requirements. These protocols should be reviewed by the IRB that would review the activities if they were research. This is usually either Advarra or WCG IRB if there is funding for the review fees, or Fred Hutch IRB if there is no funding. If reviewed by Fred Hutch IRB, the UW Office of Research will pay for the review of the UW activities. Visit the page Expanded Access Guidance for more information.

Industry-initiated-and-sponsored research
These studies are not required to have a single IRB of record. The UW portion of the research must be reviewed by Advarra, Fred Hutch, or WCG IRB at the sponsor’s expense. HSD charges a one-time administrative fee for this research. Visit the page Industry Sponsored Research for more information.

Investigator-initiated, industry-funded research
These studies are not required to have a single IRB of record.

If the research is greater than minimal risk and/or the UW IRB does not have appropriate membership expertise to review the research, and UW is the Primary Appointment of the PI as listed in the Cancer Consortium membership directory, the UW activities must be reviewed by Fred Hutch or another IRB that has agreed to be the single IRB. Review is at the expense of the funding sponsor or study team.

If the research is minimal risk, and UW is the Primary Appointment of the PI as listed in the Cancer Consortium membership directory the UW IRB will review the UW and Fred Hutch activities, but will not review for sites outside the consortium (e.g. Memorial Sloan Kettering Cancer Center (MSKCC)).

CITN studies
Cancer Immunotherapy Network (CITN) studies must be reviewed by the National Cancer Institute’s Central IRB.

NMDP and CIBMTR studies
Bone marrow donation or transplantation research involving the National Marrow Donor Program (NMDP) or the Center for International Blood and Marrow Transplant Research (CIBMTR) must be reviewed by the NMDP IRB.

NCTN and cooperative intervention studies
National Clinical Trials Network and cooperative group intervention studies must be reviewed by the National Cancer Institute’s Central IRB. Researchers must work with the Cancer Consortium’s Clinical Research Support office to obtain the IRB review.

Pediatric cancer-related trials
These studies may or may not be required to have a single IRB of record depending on funding. These must be reviewed by the Seattle Children’s IRB (if Seattle Children’s is involved) or the Fred Hutch IRB unless another IRB has agreed to be the single IRB.

Participating site in a federally funded multi-site study not listed above
These studies are required to have a single IRB of record. The IRB is typically chosen by the lead site or coordinating center and should not be the UW IRB. Visit the page UW is a Participating Site for more information.

Lead site in a federally funded multi-site study not listed above
These studies are required to have a single IRB of record. The IRB is typically chosen by the UW investigators in consultation with HSD. The IRB that will do the review depends on (1) the level of risk to research participants; and (2) which other institutions are involved in the research. For example:

If the research is greater than minimal risk, and UW is the Primary Appointment of the PI as listed in the Cancer Consortium membership directory, Fred Hutch may agree to be the single IRB if most of the sites are within the Cancer Consortium. Researchers should consult with the Fred Hutch IRO when preparing funding proposals in order to confirm this and to obtain information about Fred Hutch review fees.

If the research is minimal risk, and UW is the Primary Appointment of the PI as listed in the Cancer Consortium membership directory, UW IRB may agree to be the IRB according to its policy on serving as the single IRB. Researchers must consult with HSD when preparing funding proposals in order to obtain confirmation.

For some research, for example large clinical trials, neither Fred Hutch nor UW may be able to serve as the single IRB. Researchers may need to obtain review from a commercial IRB for this research. The costs of this review will be the responsibility of the study team.

All other UW-led cancer-related studies not described above
The IRB that does the review depends on (1) the nature of the UW’s participation; (2) which other institutions are involved in the research; and (3) the level of risk to the research participants. Consult with HSD at hsdrely@uw.edu if you are not sure which IRB is appropriate.

If the research is more than minimal risk, and UW is the Primary Appointment of the PI as listed in the Cancer Consortium membership directory, the Fred Hutch IRB does the review for the UW and any institutions within the Cancer Consortium, even if Fred Hutch is not otherwise involved in the research. Costs of review for UW are covered by the UW Office of Research.

If the research is minimal risk, and UW is the Primary Appointment of the PI as listed in the Cancer Consortium membership directory, the UW IRB will review for the UW activities and for Fred Hutch but not for sites outside of the Cancer Consortium (e.g. MSKCC).

What to do if Fred Hutch or another IRB will do the review

Follow the instructions for How to Ask for a Non-UW IRB. Be sure to identify all institutions (regional or otherwise) that are working with the UW researcher. HSD will issue an authorization letter for the study to be reviewed by the non-UW IRB. For studies led by a UW PI, the Fred Hutch IRB will not begin its review until it has received this letter from the study team.

What to do if UW will do the review

Submit an application in the UW’s Zipline e-IRB system. If there are any other institutions engaged in the research who will be relying on the UW IRB’s review (including Fred Hutch or Seattle Children’s), make sure to follow the UW Reviewing for Other Institution(s) pathway in Zipline.

If Fred Hutch is engaged in the research, request authorization for Fred Hutch to rely on UW’s review by completing the External IRB Cover Sheet and submitting in Hutch IRB. Once its review is complete, the Fred Hutch Institutional Review Office (IRO) will send an endorsement letter to proceed with external IRB review. This letter must be delivered to HSD for UW to complete the review on behalf of Fred Hutch.

What about fees?

When Fred Hutch IRB reviews the research
Fred Hutch IRB charges fees for IRB review of UW-led cancer-related research. Some of these fees may be charged to the UW Office of Research, some will be charged to the UW study team. Visit the Fred Hutch IRB fee webpage for more information.

HSD does not charge an administrative fee to rely on the Fred Hutch IRB unless the research is industry-sponsored-and-initiated. Visit the page Industry Sponsored Research for more information.

When UW IRB reviews the research
Except in rare circumstances, UW IRB does not charge fees for IRB review of UW-led cancer-related research, including review on behalf of non-UW institutions.

Other institutions may or may not charge administrative fees to rely on the UW IRB. Study teams are responsible for identifying these fees and budgeting appropriately.

When another IRB reviews the research
Other IRBs vary significantly regarding whether or not they charge fees and how this fee is structured. HSD will not cover the cost of these fees. The fees must be paid for out of the study budget or other resources.

HSD does not charge an administrative fee to rely on other IRBs unless the research is an industry-sponsored-and-initiated clinical trial. Visit the page Industry Sponsored Research for more information.

What about research led by a non-UW institution?

Research led by another institution can often engage the UW. This usually happens when UW employees do things such as obtain consent, perform protocol required procedures or collect study data under the direction of a non-UW PI. This most frequently happens when research is led by a Fred Hutch PI and takes place in UW facilities, but there can be other situations as well.

Cancer-related research led by a non-UW institution such as Fred Hutch is almost always reviewed by that institution’s IRB, or another IRB such as Advarra, WCG IRB, or the NCI cIRB. UW’s engagement must be accounted for in these circumstances, even if the Fred Hutch IRO has authorized review of the research by another IRB. This accounting for engagement is almost always accomplished by UW relying on the reviewing IRB rather than conducting its own review.

For the purpose of its relationship with Fred Hutch, UW considers the research to be Fred Hutch led when Fred Hutch is the Primary Appointment of the PI as listed in the Cancer Consortium membership directory.

Use the brief WORKSHEET UW Engagement for Fred Hutch-led Research to determine if UW is engaged in research led by Fred Hutch. For research led by other institutions, contact hsdrely@uw.edu for a consultation.

If UW is engaged, follow the instructions for How to Ask for a Non-UW IRB. Be sure to identify all institutions (regional or otherwise) that are working with the non-UW institution. Use the Quick Reference Guide for additional support when preparing submissions.

Other Considerations for Cancer-Related Research

Due to UW’s membership in the Cancer Consortium, there are additional requirements that may apply to cancer-related research, for example obtaining scientific review from the Cancer Consortium Scientific Review Committee before the external IRB reviews the research and registration in the OnCore Clinical Trial Management System (CTMS). Researchers are responsible for identifying whether these requirements apply to their research.