Exemption Determination definition
Examples of Exemption Determination in a sentence
With respect to Research for which an Exemption Determination has been provided by the Reviewing IRB/Reviewing IRB Institution, a Relying Institution will notify the Reviewing IRB/Reviewing IRB Institution of proposed changes to such Research so that the Reviewing IRB/Reviewing IRB Institution can determine whether the proposed changes render the Research non-exempt and/or whether a new Limited IRB Review (if applicable) is required.
Unless a Relying Institution provides documentation that it has reviewed or obtained third-party review of a request for a HIPAA waiver/alteration of authorization, and subject to Section 4.4.3, a Reviewing IRB performing Ceded Review or an Exemption Determination on behalf of a Relying Institution that is a HIPAA Covered Entity will review in accordance with 45 CFR 164.512(i)(1)(i) and (i)(2) a request for a HIPAA waiver/alteration of authorization in connection with the Research.
A Relying Institution and its Personnel will not initiate any Research or initiate any change to the Research (except where necessary to eliminate apparent immediate hazards to Research participants), without first receiving prior approval from the Reviewing IRB or an Exemption Determination, as applicable, from the Reviewing IRB/Reviewing IRB Institution.
Unless a Relying Institution provides its own HIPAA authorization form/language, and subject to Section 4.4.3, a Reviewing IRB/Reviewing IRB Institution performing Ceded Review or an Exemption Determination on behalf of a Relying Institution that is a HIPAA Covered Entity will provide a HIPAA authorization form/language meeting the requirements of 45 CFR 164.508(b) and (c) as necessary to permit the use and disclosure of Protected Health Information (“PHI”) (defined in Exhibit A) for the Research.
With respect to Research submitted for an Exemption Determination, a Reviewing IRB/Reviewing IRB Institution will perform the Exemption Determination (including, as applicable, any Limited IRB Review) in accordance with the requirements of the Federal Policy.
With respect to Research that is the subject of an Exemption Determination, such notification will be limited to a determination that a Report is required of serious and/or continuing noncompliance with the Federal Policy or with the terms of the Exemption Determination that disqualifies the Research from the relevant exemption.
The Overall PI (defined in Exhibit A) may, within the Participating Institution where the Overall PI is primarily employed or affiliated, make a request for Ceded Review (or for an Exemption Determination, as applicable) with respect to an instance or multiple instances of Research (“Reliance Request”).
With respect to Research that is the subject of an Exemption Determination, such notifications will be limited to decisions, findings and actions regarding serious and/or continuing noncompliance or apparent serious and/or continuing noncompliance with the Federal Policy or with the terms of the Exemption Determination that disqualifies the Research from the relevant exemption.
If there is no Overall PI or if the Overall PI is not making but does not object to a Reliance Request, other Participating Institutions may still participate in a Ceded Review or Exemption Determination, as applicable; in that case, a Site Investigator (defined in Exhibit A) may make a Reliance Request within the Participating Institution where the Site Investigator is primarily employed or affiliated.
If the Participating Institution of the Overall PI (or of the Site Investigator, as applicable) does not wish to serve as Reviewing IRB/Reviewing IRB Institution, then the determination of the appropriate Reviewing IRB/Reviewing IRB Institution should be made by and among the Participating Institutions involved in the Ceded Review or Exemption Determination, as applicable.