Examples of Relying Institution in a sentence
Once any consent forms are approved for the Relying Institution’s/Site Investigator(s)’s/other Personnel’s use, the Relying Institution will not, and will require that its Site Investigator(s)/other Personnel not, make any changes to the forms without obtaining prior approval of the changes from the Reviewing IRB.
A Reviewing IRB/Reviewing IRB Institution is under no obligation to review the content of a HIPAA authorization form/language provided by a Relying Institution unless such HIPAA authorization form/language will be merged into the consent documents, and even in the circumstance of merged documents is under no obligation to ensure that a HIPAA authorization form/language provided by a Relying Institution meets the requirements of 45 CFR 164.508(b) and (c).
With respect to Research under Ceded Review, a Relying Institution will promptly notify the Reviewing IRB of any potential noncompliance with the Federal Policy, other applicable federal human subjects protection regulations or policies, and/or the FDA Clinical Investigation Regulations, as applicable, or with the requirements or determinations of the Reviewing IRB by the Relying Institution or its Personnel in connection with the Research.
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 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.
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.
To the extent not prohibited by law, a Relying Institution shall comply with and shall require its Personnel to comply with all corrective actions required by the Reviewing IRB/Reviewing IRB Institution, but nothing herein shall prevent the Relying Institution from adopting its own more stringent additional corrective actions.
A Relying Institution will notify the Reviewing IRB/Reviewing IRB Institution of any Local Considerations (defined below) that require a HIPAA authorization form/language to be separate from any consent documents for the Research; in the absence of any such Local Considerations, the Reviewing IRB/Reviewing IRB Institution may (but is not required to) merge the HIPAA authorization form/language into the consent documents.
If a Reviewing IRB/Reviewing IRB Institution identifies concerns about the content of a HIPAA authorization form/language provided by a Relying Institution as may affect the rights or welfare of Research participants, the Relying Institution will work with the Reviewing IRB/Reviewing IRB Institution to address such concerns.
With respect to Research requiring documentation of consent, a Relying Institution or its Site Investigator(s) or other Personnel will provide the Reviewing IRB with the site-specific customizations to the consent form(s) in accordance with Section 5.6, for review and approval by the Reviewing IRB.