IRB Tip Archive

When should we re-consent subjects?

The basic criterion is this: Does the new material represent information that might affect the decision of a reasonable person about whether to continue participation in the study? The decision of a reasonable person might be affected by considerations that impact his or her values, goals, or interests. For example, changes in sub-investigators or the addresses of investigators would be unlikely to impact on the values, goals, or interests of study participants. Similarly, a protocol revision to utilize part of blood already being drawn to investigate the value of a new, prognostic biomarker is also unlikely to bear on the values, goals, or interests of subjects. On the other hand, the addition of an important new risk of the study drug or the inclusion of new invasive procedures in the study are examples of changes that may affect a reasonable person's determination of whether continued participation accords with his or her values, goals, and interests. When in doubt, just call the IRB office!

Continuing Review and Total number of subjects enrolled/accrued

Federal regulations set the criteria for IRB approval of research undergoing continuing review. Under these regulations, the investigators and the IRB are responsible for fulfilling specific requirements associated with the continuing review. In particular, investigators are responsible for submitting sufficient materials and information regarding their project so that the IRB is able to meet its regulatory obligations prior to the expiration date of the current IRB approval. The investigator meets these obligations through the submission of a Form 3 (Continuing Review Submission Form) via iMedRIS, the IRB electronic system.

As part of the continuing review of a research project, the IRB evaluates the number of subjects who have been enrolled or accrued to the study. Therefore, investigators must supply to the IRB the total number of subjects who have been enrolled or accrued to the study. Enrollment in a research study occurs when the consent form is signed, not when the subject is randomized. The total number of subjects enrolled in a research study also includes the number of subjects who failed screening procedures, subjects who were lost to follow-up, or subjects whose participation was terminated by the investigator.

Consider the following when calculating the total number of subjects who were enrolled or accrued to a study:

Formula thumbnail image

(click equation to enlarge)

Quality Improvement (QI) Projects and IRB Review

QI activities oftentimes occupy an uncertain territory between clinical care and research.  Although most QI activities involve a systematic investigation of some question of interest, many do not involve research as defined in the federal regulations for the protection of human subjects (45 CFR 46).  In other cases, QI activities are designed to accomplish both a research purpose as well as a non-research purpose and IRB review is required.  The following chart formulates some criteria that may be helpful in determining whether a QI project involves a research component and must be reviewed under the regulations for the protection of human subjects:

QI projects may include a research component if:
QI projects do not include a research component if:
  • One purpose of the project is to develop generalizable results by testing a hypothesis OR by establishing a clinical practice standard where none exists
  • Study procedures involve applying a new intervention that is beyond current standard practice
  • Study procedures involve randomizing subjects into different intervention groups
  • The project imposes risks or burdens to patients beyond those associated with the standard of practice
  • One outcome sought is to generate an analysis that can be applied to other programs, processes or systems
  • The only purpose of the project is to assess or improve a process, program, or system OR improve performance as judged by established/accepted standards
  • The only procedures involve standard practices, interventions or treatments
  • The only study procedures involve observing or comparing interventions that are already being done
  • The project does not impose additional risks on patients, with the exception of privacy/confidentiality concerns
  • The only outcome sought is an improvement in a program, process, or system

Submission Routing

Don’t forget that before you submit an application or response to the IRB, you need to route the submission to the appropriate key study personnel so that he/she may apply his/her electronic signature. For additional assistance, consult the Routing, Signoff and Workflow Tracking Guide located under the iMedRIS Guides and Tips on the left side of your screen.

Type of Submission Required Signature(s)

Registrations
(converting an exempt paper study to an iMedRIS study)

Principal Investigator (PI) only

Response to recommendations/provisos for any submission form

PI or investigator

New Application

PI, all Co/Sub-Investigators, Hospital Service Chief (for Regional One Health studies), Dept. Chair if PI is a UT student/fellow/resident/employee/faculty member, & Faculty Advisor if PI is a student, fellow, or resident

Revisions (Form 2), Continuation (Form 3), Adverse Events (Form 4x), etc.

PI or Co/Sub-investigator