HRPP POLICIES & PROCEDURES
Pace University Research Review System (PURRS)
Meet the IRB Team
Structure of the HRPP
The HRPP is a function of the Office of Research at Pace University. The Office of Research provides support, resources and assistance for research-related activities at Pace University, helping faculty, staff, and students who are seeking grants and external funding for their research, scholarship, and creative activities. The Office of Research houses the Institutional Review Board (IRB) and IACUC committees, and administers research compliance and integrity programs for funded projects and the university community.
The three components of the HRPP are the Pace Institutional Review Board (IRB), the HRPP communication program that provides education and training to investigators and others, and the HRPP auditing program.
Assurances and Certifications
Pace University maintains an active Federal-Wide Assurance (FWA) FWA00023526 in compliance with all Federal requirements. Pace University IRB #1 is linked to this assurance as OHRP IRB#00004707.
For research involving human subjects that is supported by a Federal department or agency, Pace University provides a certification that the research has been determined to be exempt, determined to be exempt with limited IRB review, or reviewed and approved by the IRB according to these policies. No human subjects may be involved in any project supported by a Federal department or agency until the project has been determined to be exempt, determined to be exempt with limited IRB review, or reviewed and approved by the IRB, and until Pace University has provided certification to the Federal department or agency component supporting the research.
Written Plan for the HRPP
The Human Research Protection Program (HRPP) written plan consists of the ‘HRPP Policies and Procedures’ document, including all referenced supporting materials. The written plan constitutes Pace University policy that applies to all Pace investigators, and not following the policy is considered noncompliance. Exceptions to these policies and procedures are permitted if consistent with applicable Federal, State, and local requirements and if the IRB chairs (for IRB policies) or the HRPP Director (for other HRPP policies) approves the exception and documents the rationale in writing.
The current, approved version of the ‘HRPP Policies and Procedures’ document is maintained on this Office of Research website and is available to sponsors, investigators, research staff, other members of the research community, IRB members, and research participants. For access to the ‘HRPP Policies and Procedures’ document, go to the ‘HRPP Operations’ tab, or click on the links below for the .html and .pdf formats:
Click here to view the webpage version of the ‘HRPP Policies and Procedures.’
Click here to download a .pdf of the ‘HRPP Policies and Procedures.’
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HRPP Auditing Program
The HRPP auditing program encompasses for-cause and not-for-cause audits.
For-cause audits are initiated when the IRB or the Institutional Official provides a written request specifying the reason that an audit is needed. Not-for-cause audits are initiated by the HRPP according to the Quality Assurance plan. The IRB process for responding to compliance concerns is described in Section 6.9.7 of the ‘HRPP Policies and Procedures’ document.
Allegations of research misconduct (fabrication, falsification, or plagiarism) are investigated by the Office of the University Counsel. The HRPP notifies the Office of the University Counsel of any information indicating possible research misconduct, and works with the Office of the University Counsel to the extent possible in coordinating investigations.
Managing Conflicts of Interest in the Conduct of Research
Investigators must disclose to the IRB whether any member of the study team has a significant financial interest at the time of initial application and if a new significant financial interest arises during the course of the project.
For NIH and NSF externally sponsored projects, investigators must also disclose significant financial interests to the Office of Sponsored Research. For projects without NIH or NSF funding, the University Reviewing Official follows the same process for financial conflicts of interest that are disclosed to the IRB or for institutional conflicts of interest disclosed to the Office of Research.
Reliance Relationships for Human Subjects Research
Use of a single IRB is required for research that is funded by the NIH or NSF and involves more than one institution and that requires IRB approval or limited IRB review. The reviewing IRB is identified by the funding agency or proposed by the lead institution subject to the acceptance of the funding agency.
The Pace IRB acts as the single IRB when Pace is the lead institution if the project is low risk and if the Institutional Official determines that appropriate IRB resources are available, based on information about the project provided by the Pace Principal Investigator as described in Section 126.96.36.199.3.
When the Pace IRB agrees to act as a single IRB for the involvement of one or more external investigators who are affiliated with an institution with an FWA, Pace University enters into a written IRB Authorization Agreement with the relying institution(s) that specifies the allocation of responsibilities between the Pace IRB and the external institution(s).
For external investigators who are not affiliated with an institution with an FWA, the Pace IRB will extend oversight if the IRB determines that the investigator is sufficiently qualified and that the Pace Principal Investigator has the training, experience, and resources to oversee the conduct of the external investigator. External investigators with no institutional affiliation must complete an Individual Investigator Agreement and external investigators with an affiliation with an institution that does not have an FWA must complete a Collaborating Institutional Investigator Agreement. These agreements confirm the training and experience of the investigator in conducting research with human subjects and the investigator’s responsibility to protect the rights and welfare of human subjects and to comply with all relevant requirements.
A Pace Principal Investigator who wishes to use an external IRB must submit an application as described in Section 188.8.131.52.4 which is reviewed as described in Section 6.2.4. The Pace Principal Investigator for a study with an external IRB of record is responsible for complying with all requirements of the IRB of record, and in addition, for notifying the Pace IRB about Unanticipated Problems that occur during the study, for submitting study personnel changes for approval prior to submitting them to the IRB of record, and for submitting check-in/closure reports.
When Pace University relies on an external IRB, Pace University enters into a written IRB Authorization Agreement with the institution of the IRB of record that specifies the allocation of responsibilities between Pace University and the external IRB.
HUMAN RESEARCH PRINCIPLES
Respect for Persons
requires potential subjects to be treated as autonomous individuals capable of making an informed decision about whether or not to participate in research, and includes safeguards for those groups with less autonomy, such as children, prisoners, and adults with diminished capacity to consent.
requires that any risks to subjects are reasonable in relation to the benefits to subjects and to society at large from the knowledge to be gained by the research.
requires that the risks and benefits of the research be distributed fairly.