An alteration of consent is when the [IRB [. . . approves] a consent procedure that omits some or alters some or all of the elements of informed consent]. The IRB may grant alterations to your informed consent form if…
Who are Prisoners in Research?
Prisoners are classified as a vulnerable population per CFR 46 Subpart C. A question an IRB sometimes faces is exactly who are prisoners? While the answer seems clear, some grey areas do exist with this vulnerable population. The prisoner definition…
Waiver of Consent
The IRB may grant a waiver of informed consent in certain instances. (Not to be confused with a waiver of consent documentation, where consent other than written consent is obtained, please see our article Waiver of Documentation of Consent if…
General Elements of Consent
Welcome to the start of our Informed consent article series! Solutions IRB is excited to bring you weekly articles covering the different types of consent, informed consent, waiver of consent documentation, waiver or consent, alteration of consent and broad consent.…
Spring 2022 Letter from the IRB Chair
Welcome to Letter from the IRB Chair, we hope each and every one of you is emerging from the demands and stresses of the past two years successfully and healthfully. As chair, I will be communicating with you on a…
Minimizing Risk
It is the responsibility of IRB members to thoroughly review a research plan and decide whether to approve a protocol. When reviewing research Solutions IRB’s guidelines address three ethical principles that are fundamental to human subject protection, these being: respect…
Protocol Deviations
While protocol deviations are not defined by the Code of Federal Regulations (45CFR46 or 21CFR50), for Solutions IRB, a protocol deviation occurs when the activities occurring within a study stray from the Institutional Review Board-approved protocol. Deviations may be minor…
Tips to Effectively Submit Revisions with Solutions IRB
Once your study has been pre-reviewed or reviewed by a Solutions IRB reviewer, the designated research team members will receive an email with any required revisions. There are some important steps that now need to be taken to effectively submit…
Change may be good, but it needs to be reported to the IRB
Recognizing when to submit an amendment is crucial. An amendment is viewed as ANY change to what was previously approved to an existing approved Institutional Review Board (IRB) protocol. Some examples for when to submit an amendment are, but not…
If it’s exempt why do I need an IRB review?
There is often confusion about “exempt review” among researchers, and this is entirely understandable. Sometimes we are asked: “well, I’ve already determined that this is an exempt study—so why do I need an IRB to do a review?” Projects that…
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