(Originally posted 1/22/2019) Most changes are designed to reduce burden on investigators and take advantage of the new flexibility offered whenever possible. In the coming weeks and months you may notice some revised application questions, new/revised guidance, and new templates offered. Please contact the SBS IRB office (firstname.lastname@example.org) with any questions.
Some changes include:
- New and expanded exempt categories: some sensitive, identifiable research (e.g., interviews, surveys, etc.) as well as some research involving benign behavioral interventions can now qualify for exempt review or limited IRB review
- Removal of continuing review requirements for almost all research that qualifies for expedited IRB review
- Informed consent is required to begin with a concise and focused presentation of the key information that is most likely to assist a prospective subject or legally authorized representative in understanding the reasons why one might or might not want to participate in the research, and presented in a way that facilitates comprehension. For most SBS research with consent forms less than four pages, no separate summary section will be necessary—longer forms may now require a summary.
- New elements of informed consent must be included (when applicable)
- A statement that identifiers might be removed from the identifiable private information or identifiable biospecimens and that, after such removal, the information or biospecimens could be used for future research studies or distributed to other investigators for future research use without additional informed consent
- Unless it is known that clinically relevant research results, including individual research results, will be disclosed to the subject in all circumstances, a statement that such results may not be disclosed to the subject
- For research involving biospecimens: whether the research will involve whole genome sequencing, and whether specimens may be used for commercial profit (and whether the subject will or will not share in this commercial profit)
- New requirements for federally-funded clinical trials