New Project (Initial IRB Review)
Some types of research must be reviewed at a convened IRB meeting. These projects may include:
- Studies where subjects may be identified and their responses would reasonably place them at risk of criminal or civil liability or be damaging to the subjects financial standing, employability, insurability, reputation, or be stigmatizing.
- Studies that request sensitive information such as drug use, illegal/criminal activity, sexual practices or beliefs, abuse, etc.
- Studies asking employees for his/her perspective on working conditions or supervisory conditions where the supervisor may access the information.
- Studies that place the subject at greater than minimal risk.
- Studies involving vulnerable populations where a convened IRB must make required determinations.
- Research not meeting the specific categories for exempt and/or expedited review of research.
- Research involving PRISONERS must be reviewed at a Full Board convened meeting except if certain conditions apply. Please contact the Human Research Compliance Manager for guidance.
A proposal classified as “Expedited” must meet all of the following criteria:
(1) The project must be minimal risk. Minimal risk is defined as nothing imposing more risk on the subjects than would be experienced during everyday life as a healthy volunteer or when completing standard evaluations and assessments about standard of care;
(2) Where identification of the subjects and/or their responses would NOT reasonably place them at risk of criminal or civil liability or be damaging to the subjects financial standing, employability, insurability, reputation, or be stigmatizing. However some research may be reviewed if the following evidence is provided: description of reasonable and appropriate protections to be implemented so that risks related to the invasion of privacy and breach of confidentiality are not greater than minimal risk;
(3) Fall specifically within one of the categories specified by the federal regulations as permissible research under an expedited review process.
Please note that “expedited” does NOT constitute a “fast” review. Qualifying expedited reviews are reviewed internally by IRB Members and not at a convened IRB meeting.
Completion of education in human research protection is required before submitting to the IRB.
Documents to be submitted for both types of review:
- Completed Full/Expedited Review-New Project Application;
- Research Protocol/Description of Methods and Procedures as requested in the application or appended. The description must include specific details on how you are going to conduct all research activities, protection and storage of research data/files, recruitment processes, data analysis, follow-up procedures, if applicable and initiatives to protect the privacy and confidentiality of the subject;
- Informed Consent Document(s) with page numbers (if applicable);
- Assent Form with page numbers (if applicable. This is necessary for research with children and other vulnerable subjects);
- Recruitment Materials: Flyers, poster, Radio/TV ad scripts, other advertisements, Pamphlets, etc.;
- Instruments: Surveys, Questionnaires, Assessments, etc.;
- For students, copy of the Dissertation,Thesis or proposal approved by your committee and /or mentor;
- A signed Dissertation or Thesis Committee Review Form, if applicable;
- Copy of the grant application for any private or federally funded/government funded study;
- Letter of permission, letter of collaboration and/or IRB review determination/approval or equivalent from the Institution if subjects are being recruited at another site or data is being acquired from another site;
- Principal Investigator Agreement (Must be an electronic or original signature. Cannot be typed in);
- Faculty Mentor Agreement (Must be an electronic or original signature. Cannot be typed in);
- Any additional material that will be given or read to subjects for the participation of this study.
If you have any questions, please contact the IRB Administrative office. Please be prepared to answer detailed questions regarding methods/procedures, aims, intent of your project, subject population, recruitment practices, etc. We are happy to help guide you through the submission and review processes.