Answer:
For this case the answer would be exampt. Since this is the only level that require a determination by the irb or an irb designee.
Explanation:
Previous concepts
We have 3 levels of the IRB review from the lowest to the highest:
Exempt. For thi slevel we have less than the minimal risk. And we have some examples like a survey with anonymous participants. And not classifed info. Other examples are: (Education research, Surveys, interviews, educational tests,
public observations (that do not involve children)
,Benign behavioral interventions
,Analysis of previously-collected, identifiable info/specimens
,Federal research/demonstration projects
,Taste and food evaluation studies).
Expedited. For this level we have more risk than th exempt level. An example would be analyze some info for non reasearch pruposes, but we can identify the subjects of the study. Other examples are :(Clinical studies of drugs and medical devices only when certain conditions are met
, Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture in certain populations and within certain amounts
, Prospective collection of biological specimens for research purposes by noninvasive means
, Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for non-research purposes
, Collection of data from voice, video, digital, or image recordings made for research purposes
)
Full board. That's the level with the maximum risk. Have included the identification of the subjects and the desire variable analyzed.
For our question:
Which type of irb review does not require an irb approval but does require a determination by the irb or an irb designee?
For this case the answer would be exampt. Since this is the only level that require a determination by the irb or an irb designee.
