The Forsyth Institute possesses its own Federal Wide Assurance (FWA), with a single Institutional Review Board (IRB) registered to it. This board consists of generous volunteers from within Forsyth and the outside world - from biology, clinical dentistry, humanities and from the lay community. In addition, there are two non-voting observer/members, one a research subject advocate and one a part-time administrative manager.
The Forsyth IRB reviews all research proposals and protocols involving human subjects. The IRB provides oversight and assurance of the protection of the rights and welfare of human subjects participating in clinical research.
If you are designing a protocol that will involve using samples or information from human beings, you will probably need IRB approval to do your research.
All personnel named in an IRB-approved protocol or informed consent form must complete the online training in Human Research Participant Protections (HRPP)
through Collaborative Institutional Training Initiative (CITI). Proof of successful completion of the training program is mandatory prior to approval of any new or continuing research projects.
Your protocol may turn out to be exempt from IRB oversight, or it may be simple enough to get expedited approval, or it may have to go before the full, convened board.
Please submit your materials anytime to either the IRB Administrator or the IRB Chair, for a preliminary review. Keep in mind that the full IRB meets monthly,
however, and there is a deadline for submitting study documentation for full review, in case you have a feeling that this will be called for.
Here are the schedules for IRB meetings and submission deadlines for calendar year 2012.
All research subjects have the right to:
Be informed of the nature and purpose of the experiment/study.
Be given an explanation of the procedures to be followed in the study, and any drug or device to be utilized.
Be given a description of any discomforts and risks reasonably to be expected from the experiment/study.
Be given an explanation of any benefits to the subject reasonably to be expected from the experiment/study, if applicable.
Be given a disclosure of any appropriate alternative procedures, drugs or devices that might be advantageous to the subject, and their relative risks and benefits.
Be informed of the avenues of treatment, if any, available to the subject after the experiment/study if complications should arise.
Be given an opportunity to ask any questions concerning the experiment or the procedures involved.
Be instructed that consent to participate in the experiment/study may be withdrawn at any time and the subject may discontinue participation in the medical experiment without prejudice.
Be given a copy of the signed and dated written consent form.
