Relying Institution definition

Relying Institution. A Participating Institution that cedes IRB review to a Reviewing IRB for an instance of Research under the Agreement.

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.

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.

Examples of Relying Institution in a sentence

• Relying Institution is solely responsible for identifying all ancillary reviews required by applicable regulation or policy in the Reliance Application and must notify Reviewing IRB of the outcome of such reviews prior to final protocol approval.

• It is the responsibility of the Relying Institution, to inform the Reviewing IRB of any changes to the state or local laws that could affect a research protocol or informed consent document.

• If the Relying Institution is asked by the Reviewing IRB/Reviewing IRB Institution to conduct its own audit/investigation, or to work cooperatively with the Reviewing IRB/Reviewing IRB Institution to conduct an audit/investigation, then the Relying Institution will do so and will report its findings of fact to the Reviewing IRB/Reviewing IRB Institution within a reasonable timeframe.

• For clarity, it is not a requirement for participation as a Relying Institution in this Agreement for an institution to have an IRB.

• Should a Participating Institution decide to participate as a Reviewing IRB Institution or a Relying Institution with regard to any particular Research, no additional individual authorization or reliance agreements need to be completed to effectuate the Ceded Review.

• If the Relying Institution elects to make its own additional report, it will provide a copy of such report to the Reviewing IRB/Reviewing IRB Institution.

• No Participating Institution shall be obligated to participate as a Reviewing IRB Institution or a Relying Institution with regard to any particular Research.

• Promptly notify the Reviewing IRB of any specific local requirements and restrictions on use and disclosure of PHI that could prevent the Reviewing IRB from approving a request for waiver of HIPAA authorization with respect to the Relying Institution.

• Require its Research Personnel to provide any information about conduct of the Research at the Relying Institution that the Reviewing IRB requires for continuing review.

• The Relying Institution will also promptly notify the Reviewing IRB/Reviewing IRB Institution of communications received by the Relying Institution or between the Relying Institution and FDA, OHRP, and/or other regulatory agencies, regarding unanticipated problems, noncompliance, or other compliance concerns regarding the Research, and will require the Overall PI and Site Investigator(s) to do the same with respect to such communications between the Overall PI or Site Investigator(s) and such agencies.

More Definitions of Relying Institution

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. 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):

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.