This document describes how UW-Madison manages IRB oversight of research studies.
A UW-Madison IRB may act as IRB of record (“Reviewing IRB”) for a non-UW-Madison research site (“Relying Institution”) or a collaborating investigator not acting as an employee of a federalwide assurance (FWA)-holding institution. A UW-Madison IRB may cede review of a research study to another institution’s IRB.
UW-Madison may act as a Reviewing IRB or cede review to another IRB when the institution determines that doing so is warranted or required as a condition of an award (e.g., NIH Single IRB Policy or other federally supported research) or regulation and ceding oversight complies with federal and institutional requirements and does not compromise the ability of the institution to adequately oversee its HRPP.
When an IRB Authorization Agreement (IAA) or written agreement is required by federal regulations, the responsibilities of both the designated and ceding institution are apportioned in the relevant IAA or other written agreement and corresponding institutional standard operating procedures.
The authority to make decisions regarding whether to serve as Reviewing IRB for another site or cede IRB review rests with the UW-Madison IRB office that will oversee the review of the research or would have been responsible for the review of the research study if IRB oversight were not ceded, except as described below.
In the case of requests for a UW-Madison IRB to act as Reviewing IRB for a non-UW-Madison research site or an individual engaged in human participants research, the applicable IRB will consider whether, by accepting this role, UW-Madison will need to encumber other significant institutional resources to oversee the study (e.g., Conflict of Interest Committee, Legal Counsel, Post-Approval Monitoring) and will consult with applicable institutional officials regarding the appropriateness of serving as a Reviewing IRB.
If a UW-Madison IRB determines that it cannot meet its regulatory requirements in serving as a Reviewing IRB or ceding IRB review to another institution, in order to preserve the regulatorily required independence of the IRBs, institutional officials cannot overturn this decision.
For non-exempt research, a UW-Madison IRB may act as Reviewing IRB for a non-UW-Madison research site or individual engaged in human participants research if the following conditions are met:
A formal request is submitted to the relevant UW-Madison IRB office.
Individuals engaged in human participants research activities from outside the UW-Madison will meet relevant UW-Madison requirements, which include:
Relying Institution study team members or individual/independent investigators must complete human participants protection training. The UW-Madison accepts the human participants protection training required by the relying institution. If the relying institution does not require human participants protection training, individuals engaged in human subjects research must still complete human participants protection training and can work with the relevant UW-Madison IRB office regarding an acceptable training.
Disclosure of applicable conflicts of interests (COIs) and management plans so that the UW-Madison IRB can assess them in relation to the ceded study.
If the Relying Institution does not have policies regarding the disclosure and management of research personnel conflicts of interest related to the research or processes in place to assess and manage potential conflicts of interest, the Relying Institution must disclose this information to the UW-Madison as part of the reliance request process.
In the case of Relying Institutions, they must agree, such as through an IRB authorization agreement, to:
Ensure faculty, staff, students, or agents engaged in the ceded research under their purview have adequate education, training, and qualifications to perform the research and safeguard the rights and welfare of research participants.
Require their research personnel to comply with the determinations and requirements of the UW-Madison IRB, applicable federal regulations, all applicable state and local laws, and local institutional requirements related to the ceded research.
Have a mechanism or access to a mechanism to conduct a for-cause audit of the ceded research when the UW-Madison IRB determines such infrastructure is necessary for it to serve as the Reviewing IRB for the ceded research.
Notify the UW-Madison promptly in writing of any suspension, restriction, termination, or expiration of its FWA.
Help ensure its study teams do not initiate any research or change of protocol (except where necessary to eliminate an apparent immediate hazard to subjects), without receiving prior approval from the UW-Madison IRB overseeing the ceded research.
Require its research personnel to provide any information about the conduct of the research at the Relying Institution that the UW-Madison Reviewing IRB requires for continuing review.
Communicate to the UW-Madison Reviewing IRB the requirements of any applicable state or local laws, regulations, institutional policies, standards, or other local factors (including local ancillary reviews) relevant to the ceded research that would affect the conduct or approval of the research at the Relying Institution.
Provide the UW-Madison Reviewing IRB with site-specific information permitted to be customized in the study consent form, when written consent is required, and require their study teams to not make any changes to the consent form(s) without obtaining prior approval of the revisions from the UW-Madison Reviewing IRB.
Ensure they have an institutional mechanism by which complaints about the ceded research can be made by local research participants or others to a local contact.
Require their study teams to promptly notify the UW-Madison Reviewing IRB, in accordance with UW-Madison policies and procedures, of any:
Unanticipated problems that may involve risks to participants or others;
Significant subject complaints that occurred at the Relying Institution;
Potential noncompliance with applicable human subjects protection regulations or with the requirements of the UW-Madison Reviewing IRB in connection with the ceded research at the Relying Institution.
Promptly notify the UW-Madison Reviewing IRB of any suspension or restriction by the Relying Institution or any third parties of any of its research personnel’s authority to conduct human subjects research.
Cooperate (and require its study team to cooperate) with any audit by the UW-Madison of the ceded research, which includes providing relevant research records, promptly communicating with the UW-Madison in regard to information requested, and assisting with the development and implementation of any applicable corrective action plan.
Promptly provide the UW-Madison with any comments on any draft report (e.g., findings of unanticipated problems, serious or continuing noncompliance) to external parties (e.g., OHRP, FDA) that will be made by the UW-Madison related to the ceded research and relevant to that Relying Institution
Individuals engaged in human participants research from outside UW-Madison who are not associated with a collaborating research site must be collaborating with a UW-Madison investigator, except when special arrangements are made.
The UW-Madison IRB serving as the Reviewing IRB satisfies the Office for Human Research Protections (OHRP) guidelines for knowledge of the local research context.
The UW-Madison IRB determines there is an acceptable plan in place for monitoring activities at and communications amongst other sites and ensuring compliance with applicable human participants regulations, as appropriate for the research study.
For federally funded, supported, or regulated research studies:
If a non-UW-Madison site has its own FWA, an IAA or other written agreement is required between the UW-Madison and the other site.
If a non-UW-Madison site is the primary awardee or engages in federally funded or supported research activities, the site must have its own, current FWA.
If UW-Madison is the primary awardee of the federal grant or coordinating center for the research study, then the institution must ensure that all of its subawardees engaged in such research operate under an appropriate FWA for the protection of human participants.
If a collaborating investigator is not acting as an employee of an FWA-holding institution, the collaborating investigator engaged in research activities will be required to enter into an individual investigator agreement (IIA).
If individuals are associated with a particular organization (e.g., employees at a community center) and will engage in human participants research as part of their association with that institution, the UW-Madison may require the study team to obtain a letter from an appropriate official from that organization acknowledging their employees’ engagement in human participants research.
For non-federally funded research studies:
If a non-UW-Madison site has its own FWA, an IAA or other written agreement is required between the UW-Madison and the other site.
If a non-UW-Madison site does not have an FWA, or the collaborating investigator is not acting as an employee of an FWA-holding institution, the UW-Madison may require a study team to obtain a letter from the appropriate official from that organization that documents that the organization is aware of and supports their employees’ engagement in human participants research.
If a non-UW-Madison site does not have an FWA, or the collaborating investigator is not acting as an employee of an FWA-holding institution, the UW-Madison study team must provide each person engaged in research with the Collaborating Investigator Responsibilities Summary, which is available from UW-Madison IRB offices.
UW-Madison may cede review of human participants research to another IRB or ethics committee of record if the following conditions are met:
A formal request is submitted to the UW-Madison IRB office that would oversee the human participants research if oversight were not ceded and the IRB office agrees to a ceded review.
For funding applications that require ceding review to an external IRB, the grant applicant must consult with the UW-Madison IRB office that would oversee the human participants research if oversight were not ceded prior to submission of the grant application before asserting in a funding application that such an arrangement can be entered into.
An IAA or other written agreement is required between the UW-Madison and the other site.
For federally funded or supported research studies, the non-UW-Madison site must have its own FWA if it receives federal funds or support for the research.
If the IRB to which UW-Madison cedes review is non-accredited, the Reviewing IRB must provide an assurance that it will conduct its review consistent with the applicable ethical standards and regulations, such as within the IAA or other written agreement between the institutions.
The UW-Madison may request the Reviewing IRB to attest that it has completed its own internal quality review process or require some other vetting process to assess the quality of Reviewing IRB and its compliance with applicable ethical standards and regulations.
When not contrary to law or a funding agency’s requirements, UW-Madison may terminate an IAA or other agreement for ceding review to another IRB when it determines termination is necessary to protect the integrity of UW-Madison’s HRPP (e.g., substantial breach by the other IRB of the IAA).
Although, in most cases, a UW-Madison IRB will agree to act as Reviewing IRB for another institution or cede review of a research study to another institution’s IRB only on a study-by-study basis, a UW-Madison IRB may enter into a “blanket” IAA or other written agreement under which it may review all studies or studies of a particular kind from another institution or may cede review of all studies of a particular kind to another institution.
When a “blanket” IAA or other “blanket” written agreement is in place with another institution, requests to cede IRB review must be made to the relevant IRB office for each individual study in order to allow the UW-Madison to ensure compliance with institutional requirements and to track and monitor human participants research conducted under its HRPP.
The UW-Madison IRB office must document when a “blanket” agreement is invoked to cover a study unless the written agreement specifies which studies it covers (e.g., the Memorandum of Understanding with the Madison VA Hospital).
In the case of exempt human participants research, regardless of funding source, a UW-Madison IRB generally will not act as the Reviewing IRB for a non-UW-Madison research site or cede review of a project to another institution’s IRB, except when special arrangements are made. Instead, the UW-Madison IRB must review and determine the human participants research to be exempt and the other institution will be required to follow its own policies and procedures related to exemption determinations.
Only UW-Madison employees, students or agents will be listed as study team personnel on the UW-Madison application.
For those non-UW-Madison sites that do not have an IRB, the UW-Madison IRB may require the investigator to obtain a letter of support for the conduct of the research at the site signed by an appropriate official.
X. When UW-Madison is serving as the IRB of record for research outside Wisconsin, UW-Madison takes into account applicable laws, regulations, and institutional policies where the research is occurring.