Institutional Review Board (IRB)
Changes in the Federal Policy for the Protection of Human Subjects
Health and Human Services and other federal departments have issued final revisions to the Federal Policy for the Protection of Human Subjects (the Common Rule) to become effective on Jan. 21, 2019.
The revisions were made to better protect human subjects while facilitating research and reducing burden and ambiguity for investigators. Research begun before July 19 will be regulated under the pre-2018 Common Rule. Research begun after July 19 will be regulated under the revised rule.
Here are the key revisions:
- For minimal risk (expedited) studies, continuing review has been eliminated
- For low risk (exempt) studies, five of the six categories of review have been expanded or revised and two new categories have been added
- Informed consent information must be presented in sufficient detail and organized in a way that is more understandable to subjects
This overview guides you through the revisions. In addition, the Winona State IRB has revised the protocol request form (PDF) consent form templates (PDF) along with other forms and documents to comply with the revised Common Rule.
These updated forms will be available in IRBNet Forms & Templates on Dec. 1. Investigators may use only the new forms beginning on Jan. 21, 2019.
The Winona State Institutional Review Board (IRB) facilitates research involving human subjects conducted by WSU faculty, staff, and students, while protecting subjects’ rights and welfare during their participation.
Faculty members from various disciplines, plus a community representative and prisoner advocate, make up the WSU IRB. The IRB process is based on federal, state, local, and university regulations and policies.
Does My Study Need IRB Approval?
If your study involves human subjects and meets the definition of research, you must complete the IRB review process. The IRB conducts reviews to uphold two broad standards: Human subjects are not placed at undue risk, and they give un-coerced and informed consent to their participation.
- Does your study involve human subjects? Human subjects are living individuals about whom an investigator obtains data through intervention, interaction, or identifiable private information.
- Does your study meet the definition of research? Research is defined as “systematic investigations, including development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.”
- Is there an intent to publish or disseminate results outside the classroom – now, or in the future?
The Review Process
All human subjects research must obtain IRB approval (PDF) before the study may begin. Research protocols will fall into one of three review categories, depending on risk and subject demographic:
- Exempt – review by one IRB member; declared low risk and involves human subjects as outlined in 45 CFR 46.101(b)
- Expedited – review by the IRB chair or his or her designee; involves minimal risk and does not include deception, does not involve sensitive populations or topics, and includes appropriate informed consent as outlined in 45 CFR 46.110
- Full board review – review by the full IRB; involves more than minimal risk, protected populations, intentional deception, or personally intrusive, stressful, or potentially traumatic procedures
Learn how to get started (PDF):
- Complete the Human Subjects Education Module (HSEM) (PDF) – all faculty members, staff, co-investigators, faculty sponsors, students, and individuals responsible for design and conduct of the study must include documentation of successful completion.
- Determine the type of review required for your study.
- Complete the protocol package – Winona State uses IRBNet to manage package submission and review; all instructions, forms, and a package checklist (PDF) are available in the IRBNet Forms & Templates library.
- Submit your package – the Human Protections Administrator will look over your package and forward it for review when it is complete.
- Follow the recommendations of the reviewer – you will be notified that the review is complete via an email through IRBNet. Turnaround time for exempt and expedited reviews is typically five days. Turnaround time may be longer during heavy submission times (typically around weeks 3-7 of the fall and spring semesters).
- Make required reports – for non-exempt studies longer than one year in duration, a continuing review/progress report (PDF) must be submitted prior to the anniversary of the study’s approval date. During the conduct of the project, it is the principal investigator’s responsibility to notify the IRB of any modifications in the protocol, changes in the treatment of human subjects, unanticipated problems, or any unexpected harm to human subjects.