InstitutionalReview Board.

Certain studies are exempt from the regulatory requirements and IRB oversight outlined in the Code of Federal Regulations. However, this does not eliminate the need for IRB review. While exempt studies are not subject to ongoing IRB oversight, investigators or institutions often request an initial exemption determination by the IRB, rather than relying on self-exemption policies, to ensure accuracy and avoid potential conflicts of interest.

If you think your research qualifies, email IRB_Support@Unison-re.org and an IRB expert will confirm the category with you.

IRB oversight is required if you answer ‘Yes’ to either of the following:

• Are you considered ‘engaged in research’ under Federal Regulations?
• Does your research involve human subjects?

You are considered engaged in research if you participate in a systematic investigation, including research development, testing, or evaluation, intended to develop or contribute to generalizable knowledge.

“Human subject” is defined differently by DHHS and the FDA. DHHS defines a human subject as a living individual about whom an investigator conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information.

The FDA, however, defines a human subject as an individual who is or becomes a participant in research, either as a recipient of the test article or as a control. A subject may be either a healthy individual or a patient.

If you are uncertain whether you are engaged in research, or whether it involves human subjects, contact IRB_Support@Unison-re.org and we can help you make the determination.

To qualify for expedited review, research must meet the federally defined criteria outlined in 45 CFR 46.110. These categories typically involve the collection of samples or data in a manner that poses no more than minimal risk to participants (45 CFR 46.405) and is not anonymous.

Expedited review permits the IRB chairperson, or a qualified reviewer designated by the chair, to evaluate and approve these types of research. Reviewers conducting an expedited review may exercise the full authority of the IRB, except they cannot disapprove a study. If a reviewer is unable to approve the research under expedited review, the study must be referred to the full board for consideration.

A full board review is required for any proposed human subjects research that does not qualify for either exempt or expedited review categories. Such research is considered to present greater than minimal risk.

Required documentation for both pathways:

• Curriculum vitae and licenses for the principal investigator
• Study protocol
• Informed consent form
• Recruitment materials
• Investigator submission form and agreement to terms
• Sponsor submission form and agreement to terms

Advertising used for the recruitment of research subjects is regarded as the initial step in the informed consent process. Consequently, the recruitment of study participants constitutes a research activity, and all related materials must be reviewed and approved by an IRB before being presented to prospective or current subjects.

Recruitment materials include, but are not limited to, newsletters, media advertisements, subject or patient letters, online recruitment content, phone-screening scripts, website advertisements, social media postings, pre-screening scripts, and generic pre-screening informed consent documents.

The FDA sets out what recruitment material may say in its guidance on recruiting study subjects.

Any modification to an IRB-approved document or procedure must receive IRB review and approval before implementation. The only exception is when a change is necessary to protect subject safety. In such cases, the modification must still be reported to the IRB as soon as possible for approval of the updated protocol and consent form.

Many modifications involve minimal-risk adjustments and may be processed on an expedited or annual basis by the IRB chair, or by a qualified reviewer the chair designates. Examples include formatting updates, spelling corrections, adding key personnel, minor questionnaire changes, and revisions to recruitment materials. More significant changes, particularly those that could affect the risk-benefit ratio, require full board review and approval.

These requirements also apply to projects classified as exempt. Any change to an exempt-approved project must be reviewed in advance by Unison IRB staff.

Current clients submit documents for revision through the study portal. If you do not yet have a contract with Unison IRB, start on the contact page — ask about bundle discounts and customized packages for frequent research users.

Exempt protocols are not required to submit annual continuing reviews. For studies extending beyond one year, all protocols reviewed by a full board and certain expedited approvals must undergo an annual continuing review.

Current clients submit these reports through Key Solutions, our study management portal. For questions about the continuing review process, email IRB_Support@Unison-re.org.