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
There were previously six of these, now there are eight.
What are exempt categories?
100
This new term includes electronic formats.
What is "written" or "in writing"?
100
The final rule does not extend coverage to these trials.
What are non-federally funded trials?
100
We need to provide this up front, and most reasonable people would agree.
What is key information?
200
We're no longer required to conduct these for certain studies, but many institutions have alternative plans.
What is continuing review?
200

Research using this is not eligible for exemption unless the subjects prospectively agree that they will be unaware of or misled regarding the nature and purpose of the research.

What is research using deception?
200
Information most likely to assist in understanding why to participate (or not) in research. It should be presented first in the consent discussion.
What is key information?
200

Approved research prior to the effective date of the final ruling will be ______ (i.e., will not be required to comply with the changes).

What is "grandfathered"?
200
These come in many formats, and are now allowable on consent documents.
What are electronic signatures?
300
The effective date for when single IRBs will be mandated for all Cooperative research.
What is 1/20/20?
300

Under some of the new exempt categories, exempt research would require this to ensure that there are adequate privacy safeguards for identifiable private information and identifiable biospecimens.

What is limited IRB review?


300
Children, prisoners, impaired decision-making and economically or educationally challenged individuals.
Who are vulnerable subjects?
300

This agency has everyone holding their breath and wondering when they will harmonize.

What is the FDA?
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

This will now only apply to research that is federally conducted or supported. Institutions may still voluntarily extend the regulations to all research, but this extension will no longer be part of the assurance process and, importantly, such research will not be subject to federal oversight even if the institution uses federal policy for its approval and conduct.

What is Federalwide Assurance (FWA)?
400

If these previously vulnerable participants are now incidentally included, the research can still meet the exemption criteria.

Who are prisoners/incarcerated individuals?
400

The re-use of identifiable information and identifiable biospecimens collected for some other "primary" or "initial" activity.


What is secondary research?


400

A third category was added to allow this if the subjects are members of a distinct cultural group or community in which signing forms is not the norm.


What is waiver of requirement to obtain signature?


400

The IRB would be prohibited from waiving informed consent for the storage, maintenance or secondary research use of biospecimens and information in this case.

What is “if an individual was asked to consent to the storage or maintenance for secondary research use of identifiable private information or identifiable biospecimens in accordance with the proposed broad consent provisions and such individual refused to consent?"

500
Someone at your institution must be responsible for this. It has 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

Defined as "brief in duration, harmless, painless, not physically invasive, not likely to have a significant adverse lasting impact on the subjects, and the investigator has no reason to think the subjects will find the interventions offensive or embarrassing".

What are benign behavioral interventions?
500

Applies only to select exempt categories, must be conducted by an IRB member, and does not require continuing review.

What is limited IRB review?
500

Documentation of this type of agreement between institutions and external IRBs is now required to be maintained as part of the IRB records.

What are reliance agreements?
500
These are three additional consent elements.

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

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