804: Types of Quality Reviews of Research Team Files and Activities
Random Scheduled: This type of review is considered a full review. The focus of the review includes roles and responsibilities of research team members, regulatory and IRB compliance, consent form elements, recruitment, eligibility and consenting process, case review for protocol adherence, source documentation and data collection, adverse events, file security, and other suitable aspects of the study. It is unlikely this type of review would occur more than once in a twelve month period.
Directed (Emergency): This review is performed when concerns regarding compliance, protocol adherence, or subject safety are brought to the attention of the IRB or UNR RIO. This is considered a full review. This type of review may occur more than once in a twelve month period if concerns about the protocol were brought to the attention of the IRB on multiple occasions. Additional reviews or continued monitoring may result from a review in which corrective actions were prescribed by the IRB.
Informed Consent: This type of review is intended to support researchers in assuring that adequate informed consent is obtained from human subjects participating in their studies. They are performed at the request of the IRB and may be requested by researchers as an educational experience. This type of review includes observation of the consenting process; verification that the person consenting the subject is qualified and designated by PI; review of the consent form for valid version date, signatures and date signed; confirmation that a copy of the consent documents were given to subject, if applicable; review of the consent form for basic elements of consent according to the Common Rule, and observation and review of HIPAA consenting process. It is unlikely this type of review would occur more than once in a twelve month period unless continued monitoring was a corrective action prescribed by the IRB as the result of a Directed review.