Initial Review: Submission and Review Policy
This document describes the policies and procedures UW-Madison IRBs use for conducting initial reviews of non-exempt research involving human participants.
- All human participants research must be reviewed and approved by an IRB, unless determined to be exempt in accordance with the Exempt Research policy, prior to the start of activities involving human participants.
- UW-Madison does not conduct classified research.
- All new studies that do not appear to constitute exempt human participants research or are determined to be ineligible for expedited review are reviewed by the convened IRB.
- To approve non-exempt federally-funded research involving human participants, UW-Madison IRBs must determine that the following criteria are satisfied as applicable:
- Risks to participants are minimized by using procedures which are consistent with sound research design, do not unnecessarily expose participants to risk and whenever appropriate using procedures already being performed on the participants for diagnostic or treatment purposes.
- Risks to participants are reasonable in relation to anticipated benefits, if any, to participants, and the importance of the knowledge that may reasonably be expected to result from the research.
- Selection of participants is equitable.
- Unless the IRB grants a waiver of consent or waiver of documentation of consent, informed consent will be sought from each prospective participant or the participant's legally authorized representative and documented in accordance with applicable regulations.
- When some or all of the participants are likely to be vulnerable to coercion or undue influence, such as children, prisoners, pregnant women, individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons, additional safeguards have been included in the study to protect the rights and welfare of these participants.
- When appropriate:
- The research plan makes adequate provision for monitoring the data collected to ensure the safety of participants.
- There are adequate measures to protect the privacy of participants and to maintain the confidentiality of data.
- In addition, for federally funded research involving pregnant women, fetuses or neonates; prisoners; or children, the IRB must determine that the research satisfies the requirements of subpart B, C, or D, respectively, of 45 CFR part 46.
- For any non-exempt research, the UW-Madison also will comply with any other applicable federal, state, local, or institutional laws and pertinent regulations, policies and guidelines.
- In the case of non-exempt human participants research which is not federally funded, the UW-Madison IRBs generally follow the requirements of the Common Rule and its subparts for IRB approval, but may also apply other protections if they are viewed as greater or equal to those outlined under the Common Rule and its subparts.
- The federal regulations allow for expedited review of a study in accordance with the requirements set forth in the 45 CFR 46.108 (b) and 21 CFR 56.110 (b). All other studies require review by the convened IRB.
- Expedited reviews are carried out by the IRB chair or by one or more experienced reviewers designated by the chair from among members of the IRB (expedited reviewers).
- Designees of the Chair must be experienced IRB members.
- The IRB Chair in consultation with the IRB Director determines who is qualified to serve as an expedited reviewer.
- The following criteria are considered when determining whether an IRB member is experienced: length of IRB service, training regarding expedited review procedures, research experience/expertise, and/or knowledge about the topic(s) and/or population(s) like that being studied.
- For training purposes, if a reviewer does not meet the criteria of an experienced IRB member, that individual is paired with an experienced IRB member for the expedited review.
- The expedited reviewer will be provided access to the entire study file and all materials study teams are required to submit for IRB review.
- In addition to the above criteria, to approve studies through the expedited process, UW-Madison IRBs must also determine that the study meets the federal regulations and guidance governing the expedited review of research, including one or more categories in the List of Categories of Research That May Be Eligible for Expedited Review published in the Federal Register by the DHHS and FDA.
- For categories 1-7, the research study must meet the definition of minimal risk research.
- Additions to, and extrapolation from, this list by the institution or the IRB are not allowed.
- For federally supported research, if an expedited reviewer determines under 45 CFR 46.110(b)(1)(i) that research appearing on the expedited review list described in 45 CFR 46.110(a) is more than minimal risk, the reviewer will provide his or her rationale for this determination.
- The UW-Madison IRBs have discretion to refer an eligible study to the convened IRB for review. For example, if additional expertise is needed or if it involves a potentially sensitive topic.
- While UW-Madison IRBs generally do not use expedited review procedures for the initial review of federally funded research in which it is known that prisoners will be included in the study population, if it is determined that expedited review is appropriate, a prisoner representative will serve as an expedited reviewer.
- On initial review of a study involving human participants that does not qualify for exemption, UW-Madison IRBs may make the below determinations as appropriate.
- The convened IRB may:
- Approve a study without modifications
- Approve the study with an administrative hold
- Administrative hold means that the approval is being held only for the resolution of an administrative issue, such as a finalized IND number or VA Research & Development Committee final approval.
- Approve a study pending resolution of required modifications (contingent approval)
- Contingent approval may be used when the requested modifications involve non-substantive changes or the IRB stipulates specific revisions requiring simple concurrence from the study team.
- If the convened IRB requests non-substantive changes in order for a research team to secure final IRB approval, the response will be reviewed by an IRB member designated to conduct expedited review to determine whether final IRB approval can be granted by applying the expedited review criteria for minor changes of study.
- If the convened IRB stipulates specific revisions requiring simple concurrence from the study team, an IRB staff member can verify that the IRB’s requests have been met and finalize the approval notice on behalf of the IRB.
- Defer a study must be used when more information is needed for the IRB to make the determinations required under the Common Rule (45 CFR 46.111, 21 CFR 56.111)
- Disapprove a study
- If the IRB decides to disapprove a research activity, it shall include in its written notification a statement of the reasons for its decision and give the investigator an opportunity to respond in person or in writing.
- Expedited reviewers may exercise all of the authorities of the IRB except that the reviewers may not disapprove the research.
- If necessary, the expedited reviewer may request revisions to the submission, including supporting materials, in order to secure approval.
- The study team may either revise the materials provided to the IRB for review as requested or provide a justification for not making the requested revisions, which will be reviewed by the expedited reviewer.
- If the reviewer cannot resolve the issue with the study team, the study may be referred to the convened IRB.
- If the expedited reviewer determines that the study is not eligible for expedited review, the study will be referred to the convened IRB for review.
- All IRB members will be provided with a list of research studies approved under expedited procedures, including resolution of modifications requested by the convened IRB that were subsequently granted final approval by expedited reviewer.
- IRB members shall be provided access to the IRB files for any research study in which they may have a concern.
- Study teams will be notified in writing of all IRB decisions and, if applicable, the expedited review category under which the research was approved.
- An application for initial review that has been disapproved, deferred, or for which modifications have been requested by an IRB cannot be resubmitted to a different IRB for review as an alternative to following the procedures as set forth in this policy unless the IRB to which the research was originally submitted refers the application to the other IRB.
Adopted By: All Campus IRB
Adoption Date: November 10, 2005
Revised: April 12, 2007
Revised: January 22, 2009
Revised: May 6, 2010
Revised: March 1, 2012 by HRPP Advisory Committee
Revised By: Cross-Campus Human Research Protection Program Committee
Revision Date: July 7, 2015
Revision Date: November 11, 2015
Revision Date: April 7, 2016
Revision Date: January 3, 2019
Copyright © 2016 University of Wisconsin System Board of Regents
- Emergency Use of Test Articles and of Humanitarian Use Devices Policy
- IRB Analysis of Risks and Benefits of Research Guidance
- Equitable Selection of Research Participants Guidance
- Obtaining and Documenting Informed Consent
- Review of Data and Safety Monitoring in Research
- Protecting Research Participants Privacy Interests and Confidentiality of Data
- Review of Research Involving Vulnerable Participants
- Exempt Research
- OHRP & FDA Expedited Review Guidance
- Additional Requirements When Conducting Human Subjects Research with Department of Defense (DOD) Support
- Additional Requirements When Conducting Human Subjects Research with Department of Justice (DOJ) Support
- Additional Requirements When Conducting Human Subjects Research with Department of Energy (DOE) Support
- Additional Requirements When Conducting Human Subjects Research with Department of Education (ED) Support
- Additional Requirements When Conducting Human Subjects Research with Environmental Protection Agency (EPA) Support