Relying Institution definition

Relying Institution. A Participating Institution that cedes IRB review to a Reviewing IRB for an instance of Research under the Agreement.
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Relying Institution. A Participating Institution that cedes IRB review to a Reviewing IRB for an instance of Research under this Agreement. Research: Human subject research within the meaning of the Federal Policy or within the meaning of any other federal human subjects research regulations or policies; clinical investigations within the meaning of the FDA IRB regulations; and any other research, for which any Participating Institution(s) seek or are required to rely on a Reviewing IRB. As used in this Agreement, Research may reference a specific study or protocol in which there will be a reviewing and relying party operating pursuant to the terms of this Agreement, or collectively the studies subject to Ceded Review under the Agreement. Research Personnel: Members of the research team (including the Overall PI and Site Investigator(s)) engaged or involved in an instance of Research. These individuals may include, as applicable, physicians, research nurses, coordinators, data managers, lab technicians, postdoctoral fellows, students, volunteers and/or other personnel.
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Relying Institution the institution that has assigned an external Institutional Review Board (IRB) to serve as the Reviewing IRB under an IRB Authorization Agreement. Note the use of relying institution and not relying IRB, as the reliance agreement is between institutions. Cooperative (multi-site) research conducted at Woman’s As of January 20, 2020, under 45CFR46, most federally-funded multi-site research must have a single Institutional Review Board (IRB) of record. The requirement for single IRB review applies to awardees in the United States and participating research sites in the United States. The requirement for single IRB review does not apply to organizations outside the United States. The awardee institutions are responsible for ensuring that authorization agreements are in place and that documentation is maintained. Woman’s IRB recognizes that for these studies a single IRB as chosen by the study sponsor or federal agency will be the IRB of record; however, all studies that are conducted at Woman’s will be reviewed by the Research and Development Committee (R&D) for feasibility, scientific merit, and adherence to the mission of the hospital. The R&D Committee may also request local institutional IRB review by the full board or certain board members or consultants at the discretion of the R&D Chair in order to ensure protection of human subjects in research. This R&D review and possible subsequent local IRB review may not have regulatory implications but will be required in order for any study to be conducted at Woman’s. According to §46.114(b)(1):
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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.


More Definitions of Relying Institution

Relying Institution. The institution that relies on another institution’s IRB for review of human research or independent investigator for a specific study, group of studies, or for all human research conducted by the other institution/investigator.
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Relying Institution. A term used in Reliance Agreements to identify the party to the agreement that will rely on an IRB outside of its own entity. These are also referred to as the Relying Institution, Relying Site or Participating Site.
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Related to Relying Institution

  • Training Institution means the Grantee.

  • Lending institution Any insurance company, federally insured commercial or savings bank, national banking association, savings and loan association, credit union, employees’ welfare, pension or retirement fund or system, corporate profit sharing or pension trust, college or university, endowment fund, real estate investment trust, or other institutional lender or financial enterprise, including, without limitation, any corporation qualified to be treated for federal tax purposes as a real estate investment trust, having a net worth of at least $50,000,000 acting on its own behalf or as agent on behalf of other Lending Institutions.

  • Custodial Institution means any Entity that holds, as a substantial portion of its business, financial assets for the account of others. An entity holds financial assets for the account of others as a substantial portion of its business if the entity’s gross income attributable to the holding of financial assets and related financial services equals or exceeds 20 percent of the entity’s gross income during the shorter of: (i) the three-year period that ends on December 31 (or the final day of a non-calendar year accounting period) prior to the year in which the determination is being made; or (ii) the period during which the entity has been in existence.

  • Participating institution means an "institution" as defined in KRS 164.001 that actively participates in the federal Pell Grant program, executes a contract with the authority on terms the authority deems necessary or appropriate for the administration of its programs, and:

  • Financial institution means a Bank, Development Finance Institution, Non Banking Finance Company, Modaraba or an institution registered under relevant laws to provide financial services within or outside Pakistan.

  • credit institution means a credit institution as defined in point (1) of Article 4(1) of Regulation (EU) No 575/2013;

  • Depository Institution Any depository institution or trust company, including the Trustee, that (a) is incorporated under the laws of the United States of America or any State thereof, (b) is subject to supervision and examination by federal or state banking authorities and (c) has outstanding unsecured commercial paper or other short-term unsecured debt obligations that are rated P-1 by Moody's, F1+ by Fitch and A-1 by Standard & Poor's.

  • Qualified Institution means a depository institution organized under the laws of the United States of America or any state thereof or incorporated under the laws of a foreign jurisdiction with a branch or agency located in the United States of America or any state thereof and subject to supervision and examination by federal or state banking authorities that at all times has the Required Rating and, in the case of any such institution organized under the laws of the United States of America, whose deposits are insured by the FDIC.

  • private institution (“sefydliad preifat”) means an institution which is not publicly funded;

  • Special Servicer means the special servicer appointed to act in such capacity with respect to the Mortgage Loan as provided in the Lead Securitization Servicing Agreement.

  • Eligible Institution Any of the following: