Resources Supporting the HRPP
In this chapter:
Section revised: 3/13/13
The provision of adequate human and fiscal resources facilitated through the budgeting process results in a well-functioning and effective HRPP.
Human Resources: Stanford University demonstrates a high level of institutional commitment to its HRPP in terms of human resources. The HRPP is led by the Vice Provost and Dean of Research, pursuant to the authority delegated by the Office of the President (see Delegation of Authority to Institutional Officer). The Vice Provost and Dean of Research oversees the Research Compliance Office (RCO).
Fiscal Resources: Stanford University demonstrates a high level of institutional commitment to its HRPP in terms of fiscal resources, and is committed to providing the RCO with adequate means to carry out its mission while keeping the protocols-to-staff-ratio within acceptable boundaries.
Resource Allocation in support of HRPP: The RCO receives its annual budget through the Office of the Vice Provost and Dean of Research.
The annual budget is established by a three-phase process:
1. IRB Chairs provide input regarding priorities and resources needed for the new academic year. This input is included in the Annual Report and communicated to the Vice Provost and Dean of Research during a meeting also attended by the RCO Director, the RCO Deputy Director, the HRPP Associate Director, and the IRB Managers.
2. The RCO Deputy Director and budget officers in the Office of the Vice Provost and Dean of Research prepare income and expense forecasts for the following year. Income forecast includes fees collected for the review of protocols on company-sponsored clinical research. Expenditure forecast takes into consideration:
· Adequate number of IRBs
· Adequate staffing
· Adequate technology support
· Adequate funds for educational opportunities for IRB members and IRB staff, including off-site conferences
· Adequate funds to provide on-going office and logistic support
· Adequate funds to carry out agreed-upon special projects.
3. These forecasts are converted into a budget ultimately reviewed and approved by the Provost. This budget is then integrated by the University Budget Office into the University’s consolidated budget forecast presented to the Board of Trustees for approval. It takes effect on September 1 of each year.
During the fiscal year, the RCO Deputy Director and the budget officers in the Office of the Vice Provost and Dean of Research analyze and explain any variance between actual income and expense (or projected income and expense) and the Consolidated Budget of the RCO, in accordance with the guidelines provided by the University Budget Office (Administrative Guide Memo 34.1 - University Funds). When unanticipated needs arise, they are communicated by the RCO Director to the Vice Provost and Dean of Research. These needs are considered in light of their urgency and fiscal implications.
Other components of the HRPP have similar budget and review processes.
Section revised: 3/13/13
Each IRB meets at least once a month, with the exception of:
· The non-medical IRB (IRB 2), which does not meet in August or in months when no presented protocols are included on the agenda, and
· Those IRBs which process only expedited and exempt protocols and do not meet routinely.
The non-medical IRB reviews research conducted in the field of human behavior, social sciences, education, anthropology, and other similar areas. This IRB generally will not review protocols with physical interventions, e.g., MRI, venipuncture, or actions that involve the collection or analysis of protected health information.
Human subject research protocols which also involve stem cells are usually assigned to IRB/SCRO; those involving gene transfers or prisoners are usually assigned to IRB 1.
The RCO assesses its level of activity at least annually in order to optimize the workflow and IRB load. It considers the ratio of protocols to staff, the number of transactions generated by each protocol, the type of protocols (regular, expedited or exempt), and any other appropriate elements. Input from the IRB Chairs regarding the level of activity and other IRB-related matters are gathered in the IRB annual report that is presented to the Vice Provost and Dean of Research. When adjustments are necessary, their financial implications are considered during the budget process outlined above in Chapter 2.1.
New IRBs or new staff positions are created to meet the demands of the workload. Meeting schedules and corresponding protocol submission deadlines are posted on the Human Subjects Research website. Submitted protocols are assessed for completeness before their assignment to an IRB. Once a protocol is assigned to an IRB, the review process can start. This includes a detailed pre-meeting review phase that ensures that substantive issues and compliance requirements are addressed in a timely fashion. See Chapter 7 for information on the review process.
Section revised: 3/13/13
To approve research, the IRB must determine that, where appropriate, there are adequate resources to ensure the care and safety of participants, from the screening and recruitment phases throughout the project. During review of the submitted protocol, the IRB assesses the information in the Protocol Application and as necessary asks for additional details. (See Chapter 7 for information about the review process.) If the protocol does not provide adequate protection, it will not be approved.
Protocol Directors (PDs) are required to indicate in the Protocol Application whether investigators: will have access to a population that will allow recruitment of the required number of participants; will have sufficient time to conduct and complete the research; will have adequate numbers of qualified staff; will have adequate facilities; will have a process to ensure that all persons assisting with the research are adequately informed about the protocol and their research related duties and functions; and will have medical or psychological resources available that participants might require as a consequence of the research when applicable.
When the protocol is not funded by a contract or a grant, the availability of resources is affirmed by the Academic Sponsor, the Division Chief, Department Chair, School Dean or their designee (as appropriate to the sponsorship/funding and administration of the study).
PDs should continually monitor the resources allocated for their research and notify the IRB if any change in the availability of resources may adversely impact the rights and welfare of participants.
Section revised: 6/1/13
The IRB ensures that the communications required by the information supplied in the Protocol Application takes place. The Intake Checklist and the Protocol Checklist are used when reviewing a protocol application to ensure that situations which require communication and interaction between various components of the HRPP are handled appropriately:
· The Radiation Safety Committee must certify that it has reviewed a protocol using radioisotopes or radiation machines and recommends it for approval. Without this approval, a study which employs these modalities will either be tabled to a future convened meeting, or will be approved contingent on Radiation Safety Committee recommendation for approval. If a modification involves review by Radiation Safety, the IRB will hold its approval until Radiation Safety forwards its approval to the IRB. Radiation Safety is given access to the protocol information by the IRB.
· Protocols involving biosafety materials and requiring review by the Biosafety Panel must be reviewed by this Panel and receive an approval letter in addition to review by the IRB. A new protocol generally will not be presented at an IRB convened meeting until the Biosafety Panel has approved it. If a modification or continuing review involves review by Biosafety, the IRB will hold its approval until Biosafety forwards its approval to the IRB. The HRPP Associate Director, and the Senior IRB Manager are ex-officio members of the Biosafety Panel. A senior member of the IRB staff attends the Biosafety Panel meetings and receives communications directly from the Panel regarding submitted protocols. The Biosafety Officer and Biosafety Specialist (from the Environmental Health & Safety department) are ex officio members of the medical IRBs and IRB/SCRO and attend medical IRB and IRB/SCRO Panel meetings.
· Protocols that also involve the use of human stem cells, human embryos, or their derivatives must be reviewed and approved by the IRB/SCRO (IRB/Stem Cell Research Oversight) Panel, in addition to having an IRB protocol reviewed and approved by IRB/SCRO, prior to activity commencement.
· Patient related equipment using electricity must meet the standards established by the Hospital Instrumentation and Electrical Safety Committee. For protocols using such equipment, the investigator is referred to Clinical Engineering.
· Investigator Conflict of Interest disclosures: All investigator conflicting interest is managed via the Conflict of Interest Review Program (COIRP) and its associated Conflict of Interest Committee (COIC). The IRB will not approve a protocol until any disclosed COI has been reviewed and resolved by the COIRP/COIC, and as appropriate, a plan or strategy to adequately eliminate, mitigate, or manage the conflict has been determined by the COIRP/COIC. See Chapters 3.7, 6.3, and 14.1.
· An FDA investigational drug or biologic that is not under the control of the hospital pharmacy (SHC or LPCH): The PD must have a Security and Controlled Access Plan for the drug or biologic on file with the applicable pharmacy. See Chapter 5.2.
· Blood, tissue, or data (slides, X-rays, etc.) that are being transferred in or out of the institution, and there is no contract in place: The PD must coordinate with the Office of Technology Licensing (OTL) about a Material Transfer Agreement (MTA).
Several groups provide a vehicle for interaction among key individuals who are responsible for human research participant protection:
· VA/Stanford Working Group: Comprised of representatives of the VAPAHCS, and the Stanford RCO, who report back to their respective senior management.
· HIPAA Council: Convened by Stanford University Privacy Officer to explore issues related to implementation and enforcement of Privacy and Security rules under HIPAA.
· Stanford/Packard Center for Translational Research in Medicine (Spectrum): Spectrum serves faculty and clinical research personnel at Stanford: in the School of Medicine, Stanford University Medical Center, Lucile Packard Children's Hospital (LPCH) and Veterans Affairs Palo Alto Health Care System (VAPAHCS). The Spectrum mission is to enhance the quality of clinical and translational research performed at Stanford by:
- Aligning organizational “service” based activities
- Providing education, training and mentoring to clinical research coordinators & staff
- Developing an integrated research infrastructure.
- Spectrum Research Personnel Advisory Committee (RPAC): Formed to:
- Represent SoM Research Personnel interests, concerns and opportunities
- Participate in identifying “areas of impact” for change and or advancement of clinical research activities
- Serve as Research Personnel sounding board for new and innovative program offerings by the Spectrum organization
- Give feedback on opportunities for synergy across the Stanford community.
- An IRB Manager is a regular attendee at the RPAC meetings.
Policies Available to all Parties to Research
The HRPP Policy Manual and other relevant policies and procedures are available to the STANFORD research community, including researchers, research staff, IRB staff, IRB members, employees, students and sponsors, as described in Chapter 3.1.