Revised Common Rule
On January 21, 2019, all new federally funded human subjects research studies must comply with the revisions to the U.S. Department of Health and Human Services (DHHS) human subjects research regulations. Where research studies are also Food and Drug Administration (FDA) regulated “clinical investigations,” they must also comply with those regulations. The FDA is working on harmonizing its regulations with the revised version of the DHHS regulations. In addition, all research conducted in Maryland must continue to follow the Common Rule.
Study applications submitted after 2019 should refer to the revised consent documents below.
Complete Information can be found on the Revised Common Rule webpage. For documents about The Common Rule, please visit that webpage.
Application Materials
Exempt Applications
Studies involving certain types of minimal risk research may qualify as exempt from full HIRB review. Studies that may qualify for exempt status may not be undertaken until HIRB verifies the exemption. Exempt applications must be submitted through eHIRB. All faculty, staff, and students who are listed on the IRB application must complete the CITI Training.
Most new applications can be reviewed within two to six weeks after receipt of the complete application. Studies involving special populations, research at international sites, and/or multiple sites often require additional review time to ensure compliance with Federal regulations. If you are unsure if your study needs to be reviewed by the HIRB, please go to eHIRB and create a new application. In Section 1, Question 3.0 of the new application, select “Unsure if Review Required”. Answer the questions and if you are then still unsure, please contact the HIRB.
Expedited and Full Board Applications
Some studies involving human research participants may qualify for expedited review. The application form for expedited and full board review is the same, but studies qualifying for expedited status may be reviewed by only one or two HIRB members rather than by the full board. All faculty, staff, and students who are listed on the IRB application must complete the CITI Training.
Most new applications can be reviewed within two to six weeks after receipt of the complete application. Studies involving special populations (e.g., children), research at international sites, and/or multiple sites often require additional review time to ensure compliance with Federal regulations. If you are unsure if your study needs to be reviewed by the HIRB, please go to eHIRB and create a new application. In Section 1, Question 3.0 of the new application, select “Unsure if Review Required”. Answer the questions and if you are then still unsure, please contact the HIRB.
Getting Started
Primer on the eHIRB system.
How to Submit a New Application
To provide the user with step-by-step instructions on how to complete/submit a new protocol application.
Further Study Action (FSA) Documents
Amendments and Changes
Investigators must submit a request for changes to the approved application before implementation. This includes changes to their research team, research protocol, recruitment materials, measures, or consent documents. According to federal regulations, investigators may not implement changes without prior HIRB review and approval, unless necessary to eliminate immediate to participants.
Continuing Reviews
Federal regulations require that all non-exempt studies approved by institutional review boards undergo continuing review at least once a year. Applications for continuing review must be submitted six weeks prior to the expiration of a study’s approval date to allow adequate time for review. Please note that failure to submit a continuing review application by the deadline requires that all research activities be stopped. A new application will then need to be submitted and approved by HIRB before study activities may resume.
Reportable Events
Investigators must submit a report to HIRB when an unanticipated problem or adverse event occurs that poses risk to participants or others and is reasonably related to the conduct of the study.
Study Closures
The PI should submit a study closure request once data analysis is complete and no further contact with participants is expected. Closing a study eliminates the need for HIRB approval and continuing review.
Consent Forms
Certificate of Translation
When some or all of the targeted population is not fluent in English, informed consent documents must be translated, typically after the HIRB has approved the English version, and the translation must be certified as accurate by a non-investigator using this form. The form and the translated consent documents should be uploaded in the Consent section of the application.
Key Information Guidance
The revised federal rule governing human subjects research (the “Common Rule”) requires changes to the format of informed consent documents. This includes the new element of “key information,” which must be presented at the beginning of the consent form.
Revised Consent Form Checklist
Please use this form to ensure that all of the required elements and applicable additional elements of informed consent are present in the consent document(s).
Revised Parental Permission Template
Also can be used jointly for assent of older children. You will need to complete this for your study then upload as a Word document into eHIRB.
Revised Written Consent Form Template
For adults. Oral scripts can be based on this document. You will need to complete this for your study then upload as a Word document into eHIRB.