A institutional review board classifies biomedical research protocols into three oversight… — GMAT

A institutional review board classifies biomedical research protocols into three oversight streams based on two parameters: Participant Risk Level (High, Medium, or Low) and Data Integrity Score ( $S$ , where $0 \le S \le 100$ ). The classification is governed by the following strict hierarchy of rules:

1. Full Board Audit: Assigned if the protocol has a High Participant Risk Level OR a Data Integrity Score of $S < 60$ .
2. Expedited Committee Review: Assigned if the protocol does not require a Full Board Audit AND meets at least one of the following conditions: Medium Participant Risk Level OR a Data Integrity Score in the range $60 \le S \le 80$ .
3. Administrative Exemption: Assigned to any protocol that does not meet the criteria for either Full Board Audit or Expedited Committee Review (i.e., Low Participant Risk Level AND $S > 80$ ).

Four trial protocols are currently under review:
- Protocol 101: Medium Participant Risk; $S = 55$
- Protocol 102: High Participant Risk; $S = 85$
- Protocol 103: Low Participant Risk; $S = 75$
- Protocol 104: Low Participant Risk; $S = 90$

Match each research protocol to its specific oversight stream classification.

Protocol 101 (Medium Risk; $S = 55$ )Full Board Audit (triggered primarily by $S < 60$ )
Protocol 102 (High Risk; $S = 85$ )Full Board Audit (triggered primarily by High Participant Risk)
Protocol 103 (Low Risk; $S = 75$ )Expedited Committee Review (triggered by $60 \le S \le 80$ )
Protocol 104 (Low Risk; $S = 90$ )Administrative Exemption (triggered by Low Risk and $S > 80$ )

Answer

Protocol 101 matches Full Board Audit triggered by

S < 60

; Protocol 102 matches Full Board Audit triggered by High Risk; Protocol 103 matches Expedited Committee Review; Protocol 104 matches Administrative Exemption.

Each protocol must be evaluated strictly sequentially according to the rule hierarchy: Full Board Audit criteria first, then Expedited Committee Review criteria, and finally Administrative Exemption criteria.

Step-by-Step Solution

Evaluate Rule 1 (Full Board Audit criteria) for all protocols

Protocol 101 meets

S < 60

(

S = 55

). Protocol 102 meets High Participant Risk. Both are assigned to Full Board Audit.

Rule 1 is evaluated first in the hierarchy. Any protocol meeting either High Risk or

S < 60

is classified under Full Board Audit.

Evaluate Rule 2 (Expedited Committee Review criteria) for remaining protocols

Protocol 103 has Low Risk and

S = 75

, which satisfies

60 \le S \le 80

. It is assigned to Expedited Committee Review.

Protocol 103 did not meet Rule 1 criteria, so Rule 2 is evaluated next.

Evaluate Rule 3 (Administrative Exemption criteria) for remaining protocols

Protocol 104 has Low Risk and

S = 90 > 80

, satisfying Administrative Exemption.

Protocol 104 does not meet Rule 1 or Rule 2 criteria, defaulting to Rule 3.

Key Concept

Multi-attribute categorical classification governed by strict hierarchical decision rules.

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