Show:
IRB Operations
Exemptions
Definitions
Miscellaneous
To Consent
(Or Not to Be)
100
The less, the merrier: Soon, we'll all need to find the one and only for cooperative research review.
What is s-IRB?
100
This exemption at §___.104(d)(3)(i) applies only to adult subjects.
What is benign behavioral intervention?
100
“a living individual about whom an investigator, whether professional or student conducting research: (i) obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or (ii) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.”
What is a human subject?
100
If these previously vulnerable participants are now incidentally included, the research can still meet the exemption criteria.
Who are prisoners/incarcerated individuals?
100
We need to provide this, and most reasonable people would agree.
What is key information?
200
Many, like Susan Rose, USC, have been wanting more of this for some time, and the Preamble says the new rule provides for this.
What is flexibility/flex coalition?
200
You can still have your cake and sensory test it too.
What is exemption 6?
200
“A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.”
What is a clinical trial?
200
This is one source of guidance, and it's helpful!
What is The Secretary's Advisory Committee to OHRP with recommendations on broad consent, benign behavioral interventions, and others.
200
These come in many formats, and are now allowable on consent documents.
What are electronic signatures?
300
To switch or not to switch is a major question about these studies.
What are existing non-exempt studies?
300
The feds (or someone) will be reviewing this at least every four years.
What is identifiable private information or identifiable biospecimens?
300
"... a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge...."
What is research?
300
We're no longer required to conduct these, but many institutions have alternative plans.
What is "continuing review?"
300
This is an option for institutions. It can be used for the storage and secondary research uses of identifiable private information or identifiable biospecimens in lieu of obtaining study specific informed consent.
What is broad consent?
400
Your offices of sponsored programs should take note. These no longer need to undergo review and approval for the purpose of certification.
What are “grant applications?" (section 46.102.)
400
It's not broad, and it can only apply to select exemption categories.
What is Limited IRB review?
400
This individual can be recognized by institutional policy as acceptable for providing consent in the nonresearch context on behalf of the prospective subject to the subject’s participation in the procedure(s) involved in the research.
What is legally authorized representative?
400
This agency has everyone holding their breath and wondering, "when doth thou harmonize??
What is the FDA?
400
In the Final Rule, this section's goal is to facilitate a prospective subject’s or legally authorized representative’s understanding of the reasons why an individual might or might not want to participate in the research.
What is 46.116 and 46.117?
500
Someone at your institution must be responsible for this, to occur when a trial is closed to recruitment & within 60 days of last study visit by any subject.
What is post informed consent to Clinicaltrials.gov (or some other yet to be named site)?
500
Storage, maintenance and secondary research of private identifiable information are allowed if these are applied. Many have no idea what to do with these!
What are exemptions 7 and 8?
500
Its Latin roots are per scripturam, and now, we have expanded options.
What is "written or in writing?"
500
This list of research categories hasn't changed.
What is the list of research categories that can be approved under expedited review?
500
According to .116c, these are three additional elements to include:
What is: 1. Discussion of commercial profit and whether the subject will share in such profit 2. Whether clinically relevant results will be returned to the subject & if so what conditions 3. For research involving Biospecimens whether the research will or might include whole genome sequencing