Routine for Institutional Review Board (IRB) ethical review of research at Stockholm University
The aim of this routine is to clarify the review process and how responsibility is distributed. The Routine complements Stockholms University’s Procedure for USA-funded research projects1. The Routine has been established by the Office for Research, Engagement and Innovation Services.
This is a translation of a supporting document. In case of a discrepancy between the Swedish and the English versions, the Swedish version will prevail.
Responsible unit: Office for Research, Engagement and Innovation Services
Contact: Sara Belfrage
(The document has been reviewed in 2024. In need of revision.)
1. Introduction
Special requirements apply to research on human subjects that is funded by US Department of Health and Human Services (HHS), and research funded by other federal US agencies that have adopted the Federal Policy for the Protection of Human Subjects (often referred to as “The Common Rule”). For example (with
some exceptions) it is required for the research principal within whose operations the research is conducted to register a Federal Wide Assurance (FWA) with HHS.
This requires that the research principal has access to and designates an ethical review body, a so-called Institutional Review Board (IRB), which meets the criteria put forward in the HHS Protection of Human Subjects regulations, 45 CFR part 46.
Research projects of the kinds described above that have been granted funding need to be reviewed by this IRB.
Stockholm University (SU) has registered an FWA4, and reached an agreement with Karolinska Institutet (KI) setting forth that research projects at SU are to be reviewed by the Kommittén för etisk värdering av medicinsk humanforskning med
amerikansk federal finansiering (hereinafter referred to as "the Committee"), which is the IRB established at KI.
The review carried out by the Committee does not replace review of research in accordance with the Act on ethical review of research involving humans (lag (2003:460) om etikprövning av forskning som avser människor, the Ethical Review Act). It is the responsible researcher's task to ensure that the requirements of the Ethical Review Act are also complied with, while the head of
department/equivalent is responsible for taking measures to prevent research being conducted in violation of the Ethical Review Act. The Office for Research, Engagement and Innovation Services provides support regarding this if need be.
In the following, the process for and division of responsibilities regarding the review carried out by the Committee are described.
2. The review process
Before the start of the project, an initial review must be carried out. Thereafter, the project must be reviewed annually.
2.1 Initial review
1. Before the start of the project, the responsible researcher contacts the ethics support function at the Office for Research, Engagement and Innovation Services via etik@fs.su.se. From there, the researcher receives a form for initial review by the Committee. The researcher sends back the completed
form together with:
a. the complete application for ethical review sent to the Swedish
Ethical Review Authority as well as the decision on approval and any amendments
b. a copy of the research application (the parts of the application that specifically describe the work to be carried out at SU and in Sweden as well as an abstract for the entire application) or most recent version of the Statement of Work (SoW)
2. The ethics support function forwards the form and attachments to the Committee via compliance@ki.se.
3. The Committee reviews the documentation and, if necessary, requests additional information from the responsible researcher with copy sent to etik@fs.su.se.
4. The Committee decides on the outcome of the review, i.e. whether the project is approved or not, and records the decision in a protocol in English signed by the Chairman of the Committee and its administrator/secretary. The decision is conveyed to the responsible researcher with a copy to etik@fs.su.se.
2.2 Annual review
1. Before the annual review, which usually takes place in connection with the annual agreements with the funder or the main applicant, the responsible researcher submits a completed and signed form for annual review to the ethics support function at the Office for Research, Engagement and Innovation Services via etik@fs.su.se, attaching any amendment applications as well as a copy of SU's part of the annual Research Performance Progress
Report (RPPR)/Progress Report submitted via eRA Commons – the submission system used by the National Institutes of Health (NIH).
2. The ethics support function forwards the documentation to the Committee via compliance@ki.se.
3. The Committee reviews the documentation and, if necessary, requests additional information from the responsible researcher with copy sent to etik@fs.su.se.
4. The Committee decides on the outcome of the annual review, i.e. whether the project is approved or not, and records the decision in a protocol in English signed by the Chairman of the Committee and its administrator/secretary. The decision is conveyed to the responsible researcher with a copy to etik@fs.su.se.
3. Reports
The responsible researcher is responsible for reporting the Committee's decision to the funder or the main applicant in connection with standard reporting.
4. Responsibilities
The responsible researcher is responsible for submitting complete documentation to the Committee before the start of the project via the ethics support function at the Office for Research, Engagement and Innovation Services. Deviations from the
project plan and/or ethical review approval must be reported to the Committee via the ethics support function at the Office for Research, Engagement and Innovation Services.
The Committee's protocols are archived at KI, and are made available upon request to a US authority or funder, or the main applicant.
The Office for Research, Engagement and Innovation Services, through the ethics support function, is responsible for contacts with the Committee, as well as for the agreement with KI on the use of the Committee. The ethics support function is also responsible for keeping SU's FWA active.