It may be surprising, but not all research requires subjects to sign a consent form. Many types of research can be reasonably conducted without written consent documentation. Depending on the level of risk, and if the consent form would be…

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…

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…

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…

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.…

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…

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…