About
The Solutions Institutional Review Board is registered with the United States Department of Health and Human Services Office of Human Subjects Protection and is accredited by the Association for the Accreditation of Human Research Protection Programs (AAHRPP). The IRB performs prospective and continuing review of protocols, the informed consent process, and the procedures used to enroll subjects in order to ensure that the human subject research is conducted ethically and in compliance with the code of federal regulation.
If you have any questions about the process of IRB review, please call (855)226-4472, email reviews@solutionsirb.com, or book a time here. We will be glad to assist you. In addition, you can find a variety of documents related to the IRB process, including a link to the code of federal regulations, our Investigator Handbook, and other documents regarding the protection of human subjects in the "Templates" tab under "Help" at the top of your screen.
How to Determine What Category of Research Your Study Is
As you start your application, you will answer a series of questions that will direct you to the appropriate category of review for your study.
Informed Consent
The federal regulations outline the elements of informed consent here: General requirements for informed consent under CFR 46.116. Not all protocols require a consent form and some protocols may only need a very truncated consent form (see below).
Waiver or Modification of Informed Consent
Under special circumstances the IRB may permit a modification of the requirements for informed consent or a complete waiver of informed consent. When indicated, this is built into the online study submission process where you will be asked about waiver of consent.
The IRB may, if appropriate and requested as part of your study, waive the requirement for documentation of informed consent, ergo, obtaining a signed consent form from each participant. The criteria for informed consent is available here: Guidance & Faqs.
Certificates of Confidentiality
When research involves particularly sensitive information (e.g., drug use, genetic information, etc.) that is linked to subject identifiers, the IRB may require that the investigator secure a "Certificate of Confidentiality" from the NIH click on this link: https://grants.nih.gov/policy/humansubjects/coc.htm
After Study Approval Reporting Requirements and Modifications
Amendments/Modifications
Any changes to existing protocols should first be reviewed by the IRB as they may impact the risk/benefit ratio of the protocol. To submit an amendment, go to the view protocol page and click on the "Amendments" tab at the bottom. You will find a button there to upload your amendment. Include in your amendment a summary of the changes. If your changes require modification of your consent form, include your consent form along with the summary and use track changes to highlight the changes you are making.
Annual Reports/Continuing Review
Exempt protocols are not required to file continuing reviews on an annual basis but all protocols approved by expedited or full board review procedures are required to submit a continuing review report or termination. This can be done in your application for the study you wish to continue or terminate. You will begin receiving reminders of upcoming annual reports 8 weeks in advance. If you have questions specific to annual reports, please follow this link to schedule a time with us.
Adverse Events
In the event that a human subject is harmed as a result of participation in your project, it is necessary that you immediately inform the IRB. Go to the view protocol page and click on the Adverse Events tab. There is a button there to upload a description of the event. You should include in your summary your judgment of whether the harm to the subject was a result of their participation in the project or incidental to it. You should also indicate if you think that the event warrants any changes to your protocol or consent form. If so, you should then submit an protocol amendment. It is best to talk with the IRB chair before submitting your amendment.
