IRB Member Education December 2020 Major versus Minor Contingencies IRB Policy 91 recaps all of the decisions the IRB can make Full Board has the option to send back either major or minor contingencies ID: 919984
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Slide1
Major or Minor?Plus some reminders
IRB Member Education
December 2020
Slide2Major versus Minor Contingencies
IRB Policy 9.1 recaps all of the decisions the IRB can make.
Full Board has the option to send back either major or minor contingencies.
Major Contingencies
Major contingencies request substantive clarifications or modifications directly relevant to the determinations the convened IRB must make.
When the IRB is unable to make a determination regarding one of the criteria for approval, it sends back major contingencies. The convened board needs to consider the contingency response to make the required determination.
Examp
Examples: “Describe why Arm 2 is required” (risks to subjects are minimized by using procedures consistent with sound research design) or “The IRB has the following concerns about the consent process” (to the extent required, informed consent will be sought..)
Major contingencies are the larger, big-picture contingencies. PIs determine the response to them.
Major contingency responses
must be reviewed by the convened board
, because the convened board is required to make the determinations required for approval
.
Slide3Major v Minor Contingencies, cont.
Minor contingencies address items that do not directly affect the IRB’s ability to make the determinations required for approval.
Minor contingencies are
very specific
and allow the IRB chair or other expedited reviewer to verify whether the contingencies are met.
They give specific instruction: Please rewrite the consent form’s description of risks to use lay language only, as subjects will not understand terms like “
pruritis
” and “In the recruitment flyer, make the compensation description the same font size as the rest of the text, to avoid creating an undue influence regarding the decision whether or not to participate.”
Minor contingency responses are reviewed by
an expedited reviewer
.
Note that for
expedited status studies
, the office reviewer only sends minor contingencies, since the office staffer is the one who makes the determinations required for approval.
Slide4Speaking of Criteria, and Categories…
The criteria for approval for all research are in IRB policy 7.1.
There are additional criteria for studies involving children, prisoners, or pregnant women/fetuses. These are all in IRB policy section 17.
Expedited and exempt status studies must fall into certain clearly defined categories.
Expedited: IRB Policy 7.5
Exempt: IRB policy 7.3
Cannot use expedited or exempt procedures to review research just because a study “feels”
expeditable
or
exemptable
. (Heaven knows we’d like to.)
Find all of our policies at irb.uams.edu. Occasional review of them is
strongly recommended.