This section of the Reliance Manual describes additional cede considerations, including: types of external IRBs, HIPAA Privacy Board considerations, fee and budget considerations, and institutional requirements.
Types of External IRBs
UW-Madison has experience working with various external IRBs. Depending on the nature of your study and sponsor, more than one type of external IRB may be appropriate for your study. RELIANT can assist you in identifying the best external IRB option for the study. External IRB options include:
- Commercial IRBs – Contracted: UW-Madison has contracted with the two largest commercial IRBs – Advarra and WCG. Studies funded by industry sponsors will typically be reviewed by either of these IRBs.
- Commercial IRBs – Not Contracted: UW-Madison can cede IRB review to qualified commercial IRBs with which it is not contracted. These decisions are made on a case-by-case basis and require a separate reliance agreement.
- National Cancer Institute Central IRB (NCI CIRB): Studies sponsored by the NCI are reviewed by the NCI CIRB.
- Academic Institutions: UW-Madison cedes IRB review to other academic institutions, with an accredited or similarly robust Human Research Protection Program (HRPP).
- Other institutions: UW-Madison may cede IRB review to other institutions such as community hospitals (e.g., UPH Meriter) or healthcare systems (e.g., Advocate Aurora Healthcare), if they have an accredited or similarly robust Human Research Protection Program (HRPP).
HIPAA Privacy Board Considerations
The UW-Madison IRB serves as the institution’s HIPAA privacy board. This means the IRB is responsible for reviewing and granting requests for waivers or alterations of HIPAA authorization. When ceding IRB review, we will also cede privacy board review when the reviewing IRB agrees to assume that responsibility. In some cases, however, the reviewing IRB will not agree to serve as the privacy board and UW-Madison is then required to retain that responsibility. If this occurs and your study requires a HIPAA waiver, you will need to provide additional information with your cede application to ensure we can provide appropriate privacy board review. RELIANT will advise you when this is required and when you will need to complete HRP-810-FORM-Applications for HIPAA Waiver for Ceded Studies. If required, the completed form should be uploaded in the supplemental information page of the cede application.
Please note that a HIPAA privacy board is not responsible for reviewing authorization forms and this remains an institutional responsibility. If your study requires use of an authorization form, RELIANT will review that form to ensure the required elements are included during its review of your cede request. For more information, see HRP 834-WORKSHEET-Institutional Requirement for Ceded Studies and HRP-502c -TEMPLATE- Institutional Consent Language. For criteria used by the IRB to grant a waiver or alteration of authorization, see HRP 441 – CHECKLIST – HIPAA Waiver of Authorization.
Fee and Budget Considerations
Study teams should be aware that IRB fees may apply to studies reviewed by an external IRB and budget accordingly. (UW-Madison does not charge a fee for reviewing a cede application except as described below.) IRB fees may be charged in the following cases:
- Commercial (independent) IRBs charge for their services.
- Industry sponsors typically cover these fees.
- UW-Madison charges a one-time fee ($3000) for review of industry-sponsored cede applications to cover administrative costs. Again, industry sponsors willbtypically cover this fee.
- To obtain a fee schedule for a commercial IRB, you will need to contact them directly.
- Other academic institutions may charge for their services.
- The lead study team is responsible for consulting with the reviewing IRB to determine what, if any, fees it charges and communicating this information to relying sites.
- If the reviewing IRB charges fees that apply to your role in the study, you are responsible for working with the lead study team to determine how these costs will be covered.
Human research studies require exemption or IRB approval, but additional institutional requirements also need to be met before your study can begin. The most common of these are conflict of interest reporting and human research training requirements (including Good Clinical Practice, if applicable). Requirements like these are folded into the cede application review process, but others are not, such as radiation safety and joint security and privacy review (JSPR). You are responsible for obtaining those approvals or signoffs.
To assist researchers in navigating these institutional requirements and understanding when they might apply to their study, we have developed HRP 309-WORKSHEET-Ancillary Review Matrix. We encourage you to review this prior to submitting your cede requests and to reach out to us with any questions.