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 before 2019 should refer to the revised consent documents below.
Complete Information can be found on the Revised Common Rule webpage. For documents about The Revised Common Rule, please visit that webpage.
Application Materials
Sample eHIRB Applicaton
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.
Consent Forms
Assent Template
Can be used for oral or written assent of children. You will need to complete this for your study then upload as a Word document into eHIRB.
Note: a request for the Use of Oral Consent (Waive Consent Documentation) for waiver of signed consent documentation and Waiver/Alteration for waiver or alteration of informed consent process must take place through eHIRB.
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.
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).
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.
Written Informed Consent 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.
Related Documents and Resources
All faculty, staff, and students who conduct human subjects research must complete the CITI training. In addition, Homewood IRB members must also complete CITI Training. Please read the instructions so you take the correct CITI training.