Stanford University Office of the Dean of Research

Human Research Protection Program (HRPP)

DOMAIN I: ORGANIZATION

Chapter 2:  Resources Supporting the HRPP

STANFORD* assures the availability of resources sufficient to protect the rights and welfare of research participants, taking into consideration the research activities in which they are asked to participate. (AAHRPP Standard I-2)

rev 2/9/07

2.1  Sufficient Human and Fiscal Resources

STANFORD provides resources to the Human Research Protection Program (HRPP) sufficient for conducting the activities under its jurisdiction. (AAHRPP Element I.2.A)

Human Resources: Stanford University has demonstrated 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 and Graduate Policy (Dean of Research), pursuant to the authority delegated by the Office of the President (see Delegation of Authority to Institutional Officer).  The Dean of Research is supported by the Associate Dean of Research, who oversees the entire Research Compliance Office (RCO) (see Research Compliance Organization Chart).  A well-functioning and effective HRPP is a result.

Fiscal Resources: Stanford University has demonstrated a high level of institutional commitment to its HRPP in terms of fiscal resources.  Stanford University is committed to provide the RCO with adequate means to carry out its mission while keeping the protocols-to-staff-ratio within accepted boundaries.  

Resource Allocation in support of HRPP:  The RCO receives its annual budget through the Office of the Dean of Research.

The process by which the annual budget is established consists of 3 phases:

(1) In the fall, 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 Dean of Research and to the Associate Dean of Research during a meeting also attended by the RCO Director, the RCO Associate Director and the IRB Managers.  

(2) In the spring, the budget officers in the Office of the Dean of Research and the RCO Deputy Director 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. 

During the fiscal year, the RCO Associate Director and the budget officers in the Dean of Research office analyze and explain the 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 Dean of Research through the Associate Dean of Research. These needs are considered in light of their urgency and fiscal implications.

rev 2/9/07

2.2  Matching IRBs to Volume and Types of Human Research

STANFORD provides the appropriate number of IRBs for the volume and types of human research to be reviewed, so that reviews are accomplished in a thorough and timely manner. (AAHRPP Element I.2.B)  Each IRB meets at least once a month, with the exception of the non-medical IRB, which does not meet in August and IRB 6 which processes only expedited and exempt protocols and does 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 any protocols with physical interventions, e.g., MRI, venipuncture, or actions that involve the collection or analysis of protected health information.  Protocols involving stem cells, gene transfers, prisoners, HIV/AIDS with recruitment in San Mateo County for ACTG studies, or other special issues are usually assigned to medical IRB 1.

Procedure

The RCO assesses no less than once a year its level of activity in order to optimize its 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 Dean of Research.  When adjustments are necessary, their financial implications are considered during the budget process outlined above in Section 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 RCO website.  Submitted protocols are thoroughly assessed for completeness before their assignment to one of the IRBs (Intake Checklist).  The IRB review process starts as soon as the protocol is assigned to one of the IRBs.  It includes a detailed pre-meeting review phase that ensures that substantive issues and compliance requirements are addressed in a timely fashion.  

rev 2/9/07

2.3  Human Research Protection, Care of Participants, and Safety

STANFORD provides resources that are necessary for human research protection, care of research participants, and safety during the conduct of the research. (AAHRPP Element I.2.C) 

To approve research, the IRB must determine that, where appropriate, there are adequate resources to insure the care and safety of participants, from the screening and recruitment phases throughout the project.  The IRB assesses the information using the Protocol Checklist - Medical or Protocol Checklist - Nonmedical.  As necessary, the IRB will ask for additional details during its review.  If the protocol does not provide adequate protection, it will not be approved.

Procedure

Protocol Directors (PDs) are required to indicate in the New Protocol Application -Medical or New Protocol Application - Nonmedical 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 protocol applications are either unfunded or funded by gift or department funds, the PDs obtain from their department chairs or division chiefs a statement confirming the PDs have access to adequate resources to conduct the research. This attestation is generally provided to the IRB via email. When the PD is a student, this attestation may be sent by the Faculty Sponsor.

rev 3/19/07

2.4  Communication and Interaction

STANFORD provides for communication and interaction for its units that might be involved in the conduct of human research. (AAHRPP Element I.2.D)

Communication

The IRB ensures that the communications required by the New Protocol Application Form takes place.  The following situations require communication and interaction between various components of the HRPP:

• 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 cannot be approved, and must be tabled to a future convened meeting.  A copy of the protocol is given to Radiation Safety by the IRB, and communication from Radiation Safety is received in the form or a review sheet or an electronic approval of an eProtocol.

• Protocols employing biosafety materials and requiring review by the Biosafety Panel must be reviewed by this Panel and receive an approval letter prior to review by the IRB.  The RCO Director is an ex-officio member of this Panel.  A senior member of the IRB staff also attends the Biosafety Panel and receives communications directly from the Panel regarding submitted protocols.

• For human embryo or embryonic cell research that does not use federally approved embryonic cell line(s), a Human Embryonic Stem Cell Tracking Form (HESCRT form) is required to be completed by the investigator in order for a protocol to be approved.  The tracking form alerts other departments such as RMG that a stem cell protocol has been proposed.  There are procedures in place to share this information between various impacted University departments. 

• 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.  The protocol application provides a way for the investigator to explain what certifications have been received.  Protocols which do not meet Electrical Safety Committee requirements cannot be used in the OR and cannot be approved by the IRB.

• Investigator Conflict of Interest disclosures are dealt with at length in Chapters 3.7, 6.3, and 14.1. 

For research conducted by School of Medicine (SOM) faculty and SOM academic staff, investigator conflicting interest is managed via the Conflict of Interest Review Program (COIRP) and its associated Conflict of Interest Committee (COIC).  A SOM protocol with conflicting interests cannot be approved without the review and approval of the COIRP/COIC. 

For research conducted by Non-SOM faculty and Non-SOM academic staff, investigator conflicting interest is managed via the mechanism defined by the Dean of the School with which the investigator is associated. 

For all research, whether SOM or non-SOM, the HRPP will hereafter refer to conflict of interest resolution and management “by the appropriate School Dean’s office”.  The IRB will not issue an approval until conflict of interest resolution is reached.  When a management plan is proposed, the convened IRB must review the plan and may either accept the plan, reject the plan, or require additional protections.

Interaction

STANFORD provides for interaction for its units that might be involved in the conduct of human research. (AAHRPP Element I.2.D)  Several groups provide a vehicle for interaction among key individuals who are responsible for human research participant protection:

· Compliance Support Task Force (CSTF):  Meeting monthly, CSTF is composed of representatives from the Schools and Central administration.  The mission of the CSTF is to provide a forum to discuss University-wide compliance issues, to draw on the collective expertise available throughout the University and to act in an advisory capacity to the Dean of Research and to the Associate Vice President, Office of Research Administration.  Agendas are drafted with input from the members and distributed ahead of time. 

· Institutional Compliance Coordinating Committee (ICCC):  ICCC is part of the Stanford’s Institutional Compliance initiative and provides coordination and support to the offices at Stanford which have direct responsibility for complying with government regulations.

· VA/Stanford IRB Working Group: This group is comprised of the VA Compliance and Privacy Officers, PAIRE Executive Director, Stanford University Legal Counsel, Sr. IRB Staff and Sr. Research Compliance Staff.  The group meets monthly.

· HIPAA Council:  The HIPAA Council is convened by Stanford University Privacy Officer to explore issues related to the implementation and enforcement of the Privacy and Security rules under HIPAA.

· Stanford/Packard Center for Translational Research in Medicine (SPCTRM): SPCTRM 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 SPCTRM 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.

· SPCTRM 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 SPCTRM organization

- Give feedback regarding opportunities for synergy across the Stanford community.