Does your research or project qualify for a Full review?
A full review is indicated if the study involves more than minimal risk to participants or if there is the likelihood of substantial stress or discomfort to participants. A full review is also often required if any of the participants or potential participants belong to a protected population. Protected populations include but are not limited to pregnant women, prisoners, people with mental illnesses and fetuses.
A full review may also required for interviews or surveys in which participants are identified and are asked about sensitive matters such as sexual behavior, alcohol use, or drug use or if participants may be placed at risk for criminal or civil penalties or would otherwise suffer embarrassment of humiliation if the participants' responses were to become known outside the research.
If your study involves any of the following you may need to complete an application for full IRB review:
- Studies involving more than minimal risk for the participant, which is defined more than would encountered in everyday life.
- Likelihood of risk or substantial stress or discomfort to the participant.
- Identification of the participants and/or their responses would reasonably place them at risk of criminal or civil liability or be damaging to the participants financial standing, employability, insurability, reputation, or be stigmatizing, unless reasonable and appropriate protections will be implemented so that risks related to invasion of privacy and breach of confidentiality are no greater than minimal.
- Exposure to electromagnetic radiation (X-rays, microwaves), lasers, high frequency sound waves.
- Deception or procedures that are not known to the participant (e.g., the participant will not be fully informed).
- Involves special populations (prisoners, pregnant women, fetuses, or individuals who are mentally or psychologically ill or incompetent).
- Collection of blood samples of greater than 50 ml (or 3 ml per kg weight) in an 8 week period and collection of blood samples more than twice a week.
Please keep in mind this is not an exhaustive list. Any study that causes greater than minimal risk to subjects requires a full review.
To apply for a full review, the Principal Investigator must submit a complete application to the IRB. This includes all supporting documentation such as:
- Consent forms
- Surveys or interview questions
- Test forms
- Subject screening forms
- Recruitment materials (posters, phone scripts, etc.)
- Letters of agreement, or other supporting documentation to assure the IRB that appropriate coordination has been done with outside organizations or institutions (clearances to perform research or distribute surveys, etc., at any facility or institution where the research will be conducted).
E-mail all documents to firstname.lastname@example.org, with a copy to your faculty advisor(s). The attachments must be complete and consistent; the receiver must be able to open, print and edit every document in an electronic submission.1 Then, deliver one complete paper application, with all required signatures and appendices, to the IRB office. The application must be signed by the PI, faculty advisor (if student PI), and the department chair. Any needed Letters of Agreement should also be signed at this point. Then wait for written IRB approval before beginning data collection.
Submission Date: These materials should be submitted to the IRB 10 working days before the next IRB meeting, as shown on the calendar. The IRB is not able to perform full reviews over the summer, since many of the IRB members are on leave during this time period. Protocols should be submitted to the IRB office. If you have questions, please call the IRB Administrator or the current Chair of the IRB.
Sponsorship: For student research applications, the Full Review Application must have a faculty sponsor. The IRB will review the application for appropriateness as an exempt review and rely on the sponsoring faculty member for subject matter expertise and design issues. The IRB will not accept student research applications without the signature of the faculty sponsor.
1 Supporting documents such as brochures or cited papers, which are not available to the PI in electronic form, may be sent as an appendix with the paper submission and omitted from the electronic submission. In that case, the application must clearly refer to the paper appendices.