Frequently Asked Questions
Is my project subject to review by the IRB?
The IRB reviews research that involves human subjects. This may include but is not limited to clinical trials, behavioral research, educational research or psychological research.
You may refer to the decision tree on this web site to determine if your study is subject to IRB review. If you have further questions, please contact the office of the IRB at (605) 322-4755.
My project is research. Now what should I do?
In order to conduct human sujects research at Avera facilitiesm you need to have IRB approval. This entails completing the application process and receiving approval. The researcher provides the IRB with all the necessary materials to conduct their review, including a full description of the proposed project, materials the subjects will use (surveys, questionnaires, tests, etc.), a description of the manner in which subjects will be recruited and provide consent to participate in the project (including a consent form), and how the subjects' confidentiality will be maintained. The IRB examines all these materials to determine if the research participants are adequately protected. Items required with your application include the following: IRB request for approval of human subjects research, proposal template, informed consent (please use the Avera template), Documentation of Human Subjects training (CITI training is acceptable or at a minimum access the on-line training from the Office for Human Research Protections (OHRP) at www.hhs.gov/ohrp/), and current Curriculum Vitae (CV).
To submit a new IRB application, ammendment, continuing review or problem report, visit the IRB website. As you work on your application, make sure to check the forms page on the IRB website, which contains downloadable versions of most of the forms you will need for your IRB application.
Are handwritten applications acceptable?
No. All pages must be typed or prepared on the computer by the applicant following the designated format. Handwritten applications will be returned to the researcher or faculty advisor without being reviewed.
How long will it take for my new protocol submission to be approved?
The IRB sets a deadline date each month prior to the IRB meeting. Deadlines occur approximately ten (10) working days prior to the scheduled meeting. Studies submitted prior to the deadline date will be placed on the agenda for that month’s scheduled meeting.
Once reviewed by the full board, you should receive a letter from the IRB (approval, or further action needed) within five (5) working days of the scheduled meeting.
Do research activities previously approved by the IRB require continued review?
Yes. Research activities will continue to be reviewed at least once a year and possibly more often, if the degree of risk to human subjects warrants it.
What do I have to report to the IRB?
You must report all serious adverse events, all changes to ongoing research protocols, any protocol violations or deviations, and any emergency use of an Investigational Drug.
When should Adverse Events be reported to the IRB?
Adverse events should be reported to the IRB within five (5) working days of the event, or upon learning of the event.
What does the IRB stamp mean on the Informed Consent Document?
The approval date corresponds with the date that the full IRB gave approval (IRB Meeting date). The approval expiration date is the date that the approval of the IRB expires (typically one year from the approval date). If a consent is modified during the approval period, the stamp would have the approval date of the revision, but would retain the expiration date for the study.
When should a final report or notice of study completion be submitted to the IRB?
The final report should be submitted to the IRB as soon as follow-up is complete (no more interaction with subjects), unless your study sponsor wishes the study to remain open.
Do I need approval from the IRB before I can advertise for research subjects?
Yes. Direct advertising for research subjects (e.g. newspaper, radio, flyer, TV) is considered by the FDA to be the start of the informed consent and subject selection process. Advertisements should be given to the IRB as part of the initial package for review and approval. If advertisement is proposed for an ongoing project, the advertising may be considered as an amendment to the project and may be eligible for expedited IRB review.