4. The Role of Non-w88 casino games, Reno (External) IRBs, Single IRB and Independent Investigator Agreements

Updated Feb. 4, 2025

The University considers an external w88 casino games to be any w88 casino games that is not the University w88 casino games (i.e., thelocal w88 casino games) including:

• Independent w88 casino games: a review board that is not owned or operated by the research organization for which it provides review services; an independent w88 casino games may or may not charge for these services.
• Central w88 casino games: an w88 casino games that provides review services for multiple sites participating in a clinical trial.

The University strongly supports the notion that resources devoted to the evaluation and management of research – whether internally or externally reviewed – should be calibrated appropriately according to the risks posed by the research. This extends to the content, assessment, and implementation of reliance agreements, including Master Agreements or reliance agreements. Examples of when the use of specific external IRBs may be required include: (1) Use of the Central Institutional Review Board for the National Cancer Institute (NCI CIRB). (2) The funding entity requires use of an external w88 casino games when the organization is a participating site in multi-site research. (3) Federal regulations, state laws, or local policies require use of a specific w88 casino games. (4) The principal investigator(s) (PI), or a research consortium is mandating use of a single w88 casino games.

The University may enter into an w88 casino games Authorization Agreement (IAA) with other entities to delegate w88 casino games review or to conduct the review. Reliance relationships include reliance on an external w88 casino games for review of multiple projects meeting defined criteria, reliance on a central w88 casino games, and review by local w88 casino games for a single project. Federal regulations require written agreements between/among institutions when w88 casino games review and oversight of non-exempt research is not provided by the investigator's home institution.

Research Integrity& Securitysenior staff review and determine if it is appropriate to proceed with execution of a Reliance Agreement. The Director or senior staff will inquire if the external w88 casino games's policies and procedures are compliant with AAHRPP standards. The external institution must provide copies or share web access if the w88 casino games policies/procedures are not a public resource. Research Integrity& Securitystaff will verify the FWA.

The decision to enter into an agreement with another institution for reliance of both institutions on one of the IRBs is made, depending on the risks of the study, after consideration of one or more of the following:

• evaluation of the external institution’s w88 casino games policies and procedures;
• whether regulatory compliance and University standards may be upheld through the relationship;
• analysis of whether an efficient process may be implemented to conduct the reviews;
• discussions between w88 casino games administrators from each institution;
• the level of risk from study procedures

Definitions

Single w88 casino games (sIRB): One w88 casino games of record (or Reviewing w88 casino games), selected on a study-by-study basis, provides the ethical review for all sites participating in a specific multi-site study.

Relying w88 casino games: The w88 casino games that relies on the reviewing w88 casino games for the regulatory reviews. The relying w88 casino games is still responsible for institutional reviews (Conflict of Interest, Radiation, Biosafety, Privacy, and others).

Reviewing w88 casino games: The selected w88 casino games of record that conducts the ethical review for participating sites of the multi-site study, including initial reviews, modifications, continuing reviews, and reportable events.

Lead PI: Responsible for the communication and overall conduct of the study and regulatory compliance. The Lead PI will be submitting the regulatory w88 casino games submissions on behalf of all the sites relying on the reviewing w88 casino games. (Note: The Lead PI may not always be associated with the reviewing w88 casino games, but the Lead PI’s responsibilities nevertheless remain the same).

Relying PI: Responsible for providing the Lead PI with necessary information according to the reviewing w88 casino games’s policies and procedures so the reviewing w88 casino games can conduct an w88 casino games review. The relying PI must know what is also required from their local relying w88 casino games.

Commercial w88 casino games: Commercial or independent IRBs are contracted agencies that are not affiliated with specific institutions and are paid to conduct reviews of research with human participants.

Independent Investigator Agreements: When an investigator is not engaged with the University as an employee or student for the purpose of conducting a research project involving human participants, that project will be considered external and will require an agreement to utilize the University w88 casino games.

External w88 casino games: A review board that is not the University w88 casino games.

Commercial w88 casino games

The University has a Master Agreement with WCG w88 casino games (formerly WIRB) to utilize regulatory review services when the research involves a multi-center, industry sponsored, non-federally funded clinical study, excluding the VA. (The VA permits use of a commercial w88 casino games as an w88 casino games of Record for VA facilities only if it has been specifically designated by ORD as a commercial w88 casino games that may serve as an w88 casino games for cooperative research.) These include pediatric, as well as adult studies and drug, device, or observational studies. The commercial w88 casino games will review HIPAA Authorization language in consent documents. The PI will have all WCG w88 casino games submissions in the IRBNet archive. PIs planning to conduct research that is under 21 CFR 56.104 (for FDA-regulated research) at WCG w88 casino games must complete the steps outlined below:

• Create a New Project in IRBNet; go to Select Library, click on WCG w88 casino games (formerly WIRB), Puyallup WA-documents for Researchers.
• Add a Part I Cover Sheet.
• Obtain PI signature electronically through IRBNet.
• Submit the project for Administrative Review.

Research Integrity& Securitystaff will forward to WCG w88 casino games. WCG w88 casino games accepts the transmission via IRBNet as local policy review and approval.

SMART w88 casino games Portal

The University has joined Streamlined, Multisite, and Accelerated Resources for Trials known as SMART w88 casino games. Through a SMART w88 casino games Master Common Reciprocal Authorization Agreement, reliance arrangements between collaborating institutions can be determined and documented, paving the way for easier collaboration and adherence to the National Institutes of Health (NIH) Policy on the Use of a Single Institutional Review Board for Multi-Site Research. Access to SMART w88 casino games allows research investigators or their designee to submit requests for w88 casino games reliance. Typically, the SMART w88 casino games request is initiated by the researchers whose "Home Institution" w88 casino games will be requested as the Reviewing w88 casino games (the w88 casino games accepting the reliance of other IRBs). If you have never used the SMART w88 casino games online reliance system, you must first Request Investigator Access through SMART w88 casino games. Please review SMART w88 casino games's Checklist for Initiating a Request in the Online System for instructions on how to submit a request for reliance.

Reliance Agreements

A reliance agreement, also called an w88 casino games Authorization Agreement (IAA), is a document signed by two or more institutions engaged in human research that permit one or more institutions to cede review to another w88 casino games. This is generally initiated and provided by the relying w88 casino games. If the research project is NOT using SMART w88 casino games or another partner for which we already have an existing agreement, then a Reliance Agreement is needed. The Human Research Protection Program will route the Reliance Agreement to the appropriate person for signature when a request is submitted for review. Templates are available in the Forms and Templates section of IRBNet. Research Integrity& Securitywill assist the investigator in preparing an IAA and obtaining the requisite signatures of the two Institutional Signatories. The University templates specify responsibilities for the participating sites (including the University) that are relevant to the protection of human participants. Therefore, the University w88 casino games prefers investigators use its templates, but may allow use of the external site's IAA or the investigator's agreement form only on a case-by-case basis. w88 casino games agreements may apply to one or more specific projects; to select aspects of a project; or to all projects conducted by a single investigator or overseen by a specific w88 casino games. The agreement should specify the research to which it applies.

Written agreement must describe whether the organization conducting the w88 casino games review, or the relying organization, is responsible for the following:

• Education to researchers and research staff;
• Identifying which organization’s process is used to decide whether each incident of noncompliance is serious or continuing;
• Obtaining management plans for researcher and research staff conflicts of interest;
• Ensuring that, should termination of a reliance agreement occur, one of the parties is clearly responsible for continued oversight of active studies until closure or a mutually agreed upon transfer of the studies.

When local University serves as the Reviewing w88 casino games

For local University principal investigator (PI) requests that the local University w88 casino games serve as the reviewing w88 casino games for an external research site, the PI submits a protocol for review and approval prior to or concurrent with the addition of external sites. The w88 casino games determines on a case by-case basis whether to review the site additions as separate protocols or as modifications to the previously approved research. If a site is added through a modification, the w88 casino games decides whether to handle such a modification using expedited review procedures or the convened w88 casino games for review.

The relying site provides the local University w88 casino games with general information (e.g., FWA, Point of Contact/Signatory Authority, ancillary reviews, local consent language, local laws, investigator qualifications, local resources, recruitment materials, and communication plan). When relying upon an w88 casino games that is not AAHRPP-accredited, policies and procedures must also define: (1) The process ensuring research is being reviewed appropriately and complies with applicable law and (2) Criteria describing the extent of the review to confirm compliance with the organization’s ethical standards and with applicable laws and regulations. The extent of the review of the non-accredited w88 casino games can vary, depending upon the level of risk to participants in the research.

The relying site must have policies and procedures that describe the roles of the reviewing w88 casino games, including:

• Ensuring the structure and composition of the w88 casino games is appropriate to the research reviewed and complies with applicable laws and is properly constituted;
• Conducting review of research to determine that research is ethically justifiable, according to all applicable regulations and laws;
• Conducting review of the addition of investigative sites to previously approved protocols;
• Ensuring the w88 casino games has the final authority to decide whether researcher or research staff has any conflict of interest and its management;
• Making available relevant w88 casino games documentation, including but not limited to minutes, approved protocols, consent documents, and other records that document the w88 casino games’s determinations to the relying organization upon request;
• Making relevant w88 casino games policies readily available to the relying organization, including HRPP staff, and researchers and research staff, and having a mechanism for communicating to the organization when policies are updated;
• Specifying the contact person and providing contact information for the reviewing w88 casino games for researchers and research staff to obtain answers to questions, express concerns, and convey suggestions regarding the w88 casino games.

The local University w88 casino games considers this information when conducting its review. Each relying site complies with its own institution’s HIPAA policies and procedures.

Open communication between relying sites and the local University w88 casino games is encouraged. The relying institution staff members may reach out via phone or email using the contact information provided in the reliance agreement.

When local University relies on an External w88 casino games

The determination to defer review is made on a case-by-case basis based on criteria outlined in the Request to Use an External w88 casino games form. The w88 casino games does not sign reliance agreements for exempt activities or activities deemed to be not human subject research (exceptions may be made on a case-by-case basis for exempt activities).

The University w88 casino games may voluntarily decide to rely on an external w88 casino games in certain situations. Examples of voluntary reliance include:

• Using another w88 casino games because it has expertise for reviewing the research;
• Identifying an external w88 casino games to act as the w88 casino games on behalf of the organization when the organization has determined due to resources, legal, organizational conflicts of interest, or other concerns that conducting its own review or serving as the w88 casino games for a multi-site project is not feasible;
• Relying upon an external w88 casino games to facilitate collaborations among researchers and organizations.

The local University may agree to cede/defer responsibility for w88 casino games review to an institution not accredited by AAHRPP for research that is not greater than minimal risk. The local University investigator complies with the reviewing w88 casino games’s policies and procedures for initial and continuing review, record keeping, and reporting requirements, and ensures that all information requested by the reviewing w88 casino games is provided in a timely manner. The relying organization’s policies and procedures must:

• Describe the roles of the organization and researchers when relying upon another organization’s w88 casino games;
• Specify which studies are eligible for review by another organization’s w88 casino games;
• Ensure that researchers are knowledgeable about the need to obtain any approvals from their own organization prior to seeking review by another w88 casino games;
• Providing the reviewing w88 casino games with requested information about local requirements or local research context issues relevant to the w88 casino games’s determination, prior to w88 casino games review;
• Ensure that officials of the relying organization may not approve the research subject to the reliance agreement if it has not been approved by the reviewing w88 casino games;
• Acknowledge that researchers must cooperate in the reviewing w88 casino games’s responsibility for initial and continuing review, record keeping, and reporting, and that all information requested by the reviewing w88 casino games must be provided in a timely manner;
• Ensure that researchers, when responsible for enrolling participants, will obtain, document, and maintain records of consent for each participant;
• Report promptly to the reviewing w88 casino games any unanticipated problems involving risks to participants or others;
• Ensure researchers and research staff have appropriate qualifications and expertise to conduct the research.

Research Integrity& Securitystaff maintain electronic versions of all fully executed Reliance Agreements for three years after project closure. When an agreement applies to a project/package in IRBNet, Research Integrity& Securitystaff add the fully executed agreement to the project/package as a Board Document.

UNR Medical Students Join A Research Study Approved by an External w88 casino games

UNR Medical students may be asked by a Community Physician to join a research study that was reviewed and approved by an external w88 casino games. Documentation of the approved study should be uploaded as an IRBNet submission, as follows:

• Create a New Project in IRBNet.
• Add a Part I Cover Sheet.
• Add completed UNR Med External Research form.
• Upload the Approval letter from the external w88 casino games.
• Upload the documentation to external w88 casino games adding the UNR medical student as study personnel.
• Upload the approved consent form.
• Obtain PI signature electronically through IRBNet (alternatively, UNR Med Research Director or designee).
• Submit the project for Administrative Review ceding regulatory review to external w88 casino games.

Determination that Dual or Joint Review by an External and the local University w88 casino games Is Required

Review by both an external and the local University w88 casino games may be required when research activities take place at both an external institution and a University/Affiliate site; University/Affiliate faculty, students, or staff will be enrolled as participants in multi-site research; the sponsor requests use of a central/independent w88 casino games for multi-site research, but the local University w88 casino games determines local oversight is warranted (e.g., participant risk is extreme, the research involves highly regulated or toxic substances, local context issues are significant); or limited review by the local University w88 casino games is necessary to assess/monitor local context issues or concerns directly affecting the local community.

Submission Requirements when Research Integrity& SecurityDetermines Review by an External w88 casino games Is Acceptable

After Research Integrity& Securityconfirms review by an external w88 casino games is acceptable, the PI must complete the following steps:

• Determine if an existing IAA applies or if a new IAA is required (see policy for w88 casino games agreements).
• Use the Consent Form Checklist and revise the sponsor/external w88 casino games-prepared consent templates to include University/AAHRPP-required elements for informed consent, including local contacts for research participants’ questions or compensation for injuries, where applicable.
• Comply with University training requirements.
• Comply with University or the Affiliate institution's conflict of interest disclosure requirements.
• Comply with applicable University/Affiliate-site requirements for review by local, ancillary committees (e.g., biosafety, radiation safety, pharmacy). Documentation of ancillary committee approval should be added to the project in IRBNet.
• Create a New Project in IRBNet.
• Add Part I, Cover Sheet.
• Complete the Request to Use an External w88 casino games form.
• Add the proposed consent document, protocol, data collection tools, and recruitment materials.
• Obtain the PI's signature electronically through IRBNet.
• Submit the project to IRBNet for Administrative Review. (NOTE: The Research Integrity& SecurityDirector may determine a request to use an external w88 casino games requires Expedited or Full Committee Review.)
• Research Integrity& Securitystaff will instruct the PI on obtaining an IAA or use of SMART w88 casino games.

Submission of External w88 casino games Approval

The PI should submit the external w88 casino games approval correspondence and approved informed consent form (and any revised documents) within sixty days of the initial submission of a Request to Use an External w88 casino games form in IRBNet.

• Open the existing project in IRBNet.
• Create a New Package for the existing project, selecting Submission Type "Other."
• Add the external w88 casino games of Record approval letter and approved consent document (including any revised documents).
• Obtain the PI's signature electronically through IRBNet.
• Submit the project to IRBNet for Administrative Review.

As noted previously, the preferred sequence of events is for the local University w88 casino games to (1) confirm the proposed consent document complies with University requirements and acknowledge the external w88 casino games as the w88 casino games of Record BEFORE the project is submitted for review by the external w88 casino games; and (2) after the external w88 casino games approves the project, acknowledge the external approval, again by administrative review. If this order is reversed, the PI should attach the external w88 casino games of Record approval letter and approved consent form when submitting the Request to Use External w88 casino games form. Under these circumstances, the University w88 casino games may require changes to consent documents approved by the external w88 casino games if the documents do not comply with University requirements.

Requirements for Post-Approval Notifications to the local University w88 casino games

To enable the local University w88 casino games to ensure requirements for post-approval monitoring are met, University PIs conducting research reviewed by an external w88 casino games must promptly notify the local University w88 casino games of:

• the w88 casino games of Record's determinations of serious or continuing noncompliance, unanticipated problems, and suspension or termination of the w88 casino games approval or investigator's involvement in the research;
• study closures.

Notifying the local University w88 casino games of the External w88 casino games's Determinations of Serious/Continuing Noncompliance, Unanticipated Problems, or Suspension/Termination of w88 casino games Approval or Investigator's Involvement in the Research

For the duration of the research, University PIs must promptly provide the University w88 casino games with documentation of each determination of Serious/Continuing Noncompliance, Unanticipated Problems, or Suspension/Termination of w88 casino games Approval from the external w88 casino games of Record.

• Open the existing project in IRBNet.
• Create a New Package for the existing project, selecting Submission Type "Other."
• Add documentation of the w88 casino games of Record's determination (including w88 casino games of Record's Reporting form and w88 casino games correspondence).

Notifying the local University w88 casino games of Closure of Projects Overseen by External w88 casino games of Record

University PIs must promptly notify the University w88 casino games of closures of research projects that are overseen by an external w88 casino games of Record.

• Open the existing project in IRBNet.
• Create a New Package for the existing project, selecting Submission Type “Closure/Final Report.”
• Add documentation of the w88 casino games of Record’s closure of the study and submit a Closure Request form.

Single w88 casino games (sIRB) Criteria

Single w88 casino games means that the local University w88 casino games either assumes (reviewing w88 casino games) or gives up (relying w88 casino games) its oversight of the research activity to another equally qualified w88 casino games. sIRB is designed to reduce duplication and increase efficiency by designating a sIRB review when more than one site is involved in a research project. The basis for the Single w88 casino games Model is to allow multiple institutions that are conducting the same protocol to use a single w88 casino games for review, instead of using multiple IRBs to review the research at the sites individually. The University w88 casino games also bears responsibility for the local conduct of sIRB studies, including managing noncompliance and unanticipated problems, ensuring training, study monitoring, local ancillary requirements, managing reliance agreements, and handling study-specific issues.

The University will decline to serve as the single w88 casino games of record for greater than minimal risk research unless there are extenuating circumstances, such as University faculty being the lead PI for the multi-site study.

The University may allow for single w88 casino games review when:

• The local University investigator is a collaborator on human research primarily conducted at another organization where the PI of the organization will have direct oversight of the University investigator, or the organization agrees to take responsibility for the University investigator;
• The other organization is AAHRPP accredited. (Note: For organizations that are not AAHRPP accredited, decisions are made on a per-protocol basis to ensure that the organization can maintain equivalent standards to AAHRPP accreditation);
• The lead PI or the research consortium is mandating use of single w88 casino games;
• The funding entity requires use of an external w88 casino games when the organization is a participating site in multi-site research. (For example, the Final NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research requires all multi-site research to use a single w88 casino games with a few exceptions);
• Federal regulations, state laws, or local policies require use of a specific w88 casino games. For example, the revised Common Rule requires review by a single w88 casino games for any cooperative research conducted in the United States.

The University maynotallow for single w88 casino games review when:

• The project involves prisoners or vulnerable populations that require special considerations;
• The proposed w88 casino games of record does not have sufficient knowledge of local context or a robust human research program (as required by federal guidelines and AAHRPP accreditation) to assume w88 casino games oversight for sites that fall under University purview;
• A study team member has a conflict of interest that requires a management plan, and the management plan prohibits or limits activities that the individual can engage in related to human research;
• A team member has a history of noncompliance with w88 casino games policies or processes;
• The proposed w88 casino games of record or participating research sites are located outside the United States.

Documentation Required

Before a project can participate in a sIRB agreement, the University must verify that all institutional approvals are in place prior to issuing the approval to allow another w88 casino games to review the project.

A request for sIRB submitted to IRBNet must include at least the following documentation:

• Request to Use an External w88 casino games form.
• Current sIRB approved study protocol.
• Training Certificates for study team members.
• Reliance Agreement.
• Approved Consent Template, data collection tools and recruitment materials.
• Approval letter from the w88 casino games of Record (Relying/Lead w88 casino games).
• Any additional supporting materials related to enrollment at the University.

Reporting Requirements for Multi-Site Research

When a University investigator is involved in the conduct of a multi-center study, reporting requirements vary as follows:

• For problems that occur locally (i.e., at the investigator’s institution), the PI must inform the Universityw88 casino gamesof complaints from participants or other local situations or events that involve possible noncompliance, and unanticipated problems involving risks to participants or others.
• PIs must inform thesponsorof complaints, local problems and adverse events as described in the clinical protocol or contract.
• The investigator must inform the Universityw88 casino gamesand sponsor of their decision to suspend or terminate a research project at the local site.
• PIs are required to report sponsor assessments or notifications, or safety reports involving external adverse events that may be unanticipated problems involving risks to participants or others; and all notifications of suspension or termination of a research project.
• If a University investigator is the lead PI or managing investigator for a multi-center study, they must inform the University w88 casino games ofexternal(i.e., occurring at other sites) complaints from participants or others, possible noncompliance, and unanticipated problems involving risks to participants or others. If the University investigator is not the lead PI or managing investigator, and w88 casino games, Reno is in the position as a relying institution, they will promptly notify Overall PI, Site Investigator(s), and Relying Institution(s) of any findings of serious and/or continuing noncompliance. The Reviewing IRB will also notify the Overall PI, Site Investigator(s), and Relying Institution(s) of any suspension or termination of IRB approval and any remediation actions pertaining to findings of serious and/or continuing noncompliance at any other institution if such finding or actions relate to or may affect the conduct of the Research or the safety, rights, or welfare of human participants participating in the Research at the Relying Institution(s). The Reviewing IRB shall inform the Relying Institution of any corrective actions in connection with the audit, investigation, or resolution of any matter that are required by the Reviewing IRB but shall not prevent the Relying Institution from adopting its own more stringent additional corrective actions.

Independent Investigator Agreements

An Independent Investigator Agreement is required when an individual wishes to conduct human research at or on behalf of an external entity that does not have an w88 casino games, and the individual wants the University w88 casino games to be the w88 casino games of Record. The Research Integrity& SecurityDirector determines on a case by-case basis whether to proceed with an Independent Investigator Agreement. Generally, the research study and/or investigator must have a direct relationship to the University.
The w88 casino games will only conduct external reviews of proposals for which it is qualified in terms of adequate experience and subject expertise. The infrastructure that supports the w88 casino games is funded by the indirect (F&A) return on expenditures. That cost is not captured when the funding is run outside of the University. The fees are charged to help offset the costs of such operations, including expertise-based protocol reviews, administrative support, technological infrastructure (electronic-based submission systems), educational and training requirements, and other activities of the Human Research Protection Program (HRPP).