HRPP Policy Manual

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*STANFORD refers to the five organizations covered by the HRPP.

*STANFORD refers to the five organizations covered by the HRPP.

Stanford University Office of the Dean of Research

Human Research Protection Program (HRPP)DOMAIN I: ORGANIZATION

Chapter 1: The Human Research Protection Program

The organizations (together referred to as STANFORD) covered by the HumanResearch Protection Program (HRPP) have a systematic and comprehensive programwith appropriate leadership. (AAHRPP Standard I-1)

STANFORD* has a written plan for its HRPP appropriate for the volume and nature ofthe research involving human participants conducted under its auspices. (AAHRPPElement I.1.A)

The Stanford University Research Policy Handbook (RPH) 7.0 provides informationabout the organization, scope, authority and responsibilities associated with theStanford University HRPP for the research community at Stanford University and itsaffiliates, and explains how the HRPP has been incorporated into one core document.

1.1 Organizations Covered by the HRPP

The five STANFORD affiliated organizations are:

Stanford University

Stanford Hospital and Clinics (SHC)

Lucile Packard Childrens Hospital at Stanford (LPCH)

Veterans Affairs Palo Alto Health Care System (VAPAHCS)

Palo Alto Institute for Research and Education (PAIRE).

Any components of these organizations as listed in theirFederalwide Assurances

(FWAs) are considered part of that organization for purposes of the HRPP and arecovered by this HRPP Manual.

SHC and LPCH are California non-profit corporations whose sole member is theBoard of Trustees of Stanford University. They provide hospital, clinic and physicianservices in affiliation with the Stanford University School of Medicine. They eachmaintain a memorandum of understanding with Stanford University that retains andrequires Stanford University to carry out the HRPP on their behalf. This documentalso requires that they agree to cooperate with Stanford University and take allnecessary actions to allow Stanford University to carry out the HRPP. Both SHC andLPCH file a FWA appointing the Stanford University IRBs to review their humansubject research.

VAPAHCS is operated by the US Department of Veterans Affairs to provide hospital,clinic and physician services in the region of Palo Alto and Stanford, California. It isaffiliated with Stanford University and its School of Medicine. Many of its physiciansand investigators are also faculty at the School of Medicine who conduct research atVAPAHCS facilities. PAIRE is a non-profit corporation established and controlled byVAPAHCS pursuant to 38 USC 7361 and 7368. Its purpose is to provide a flexiblefunding mechanism for the conduct of approved research (i.e., externally sponsoredresearch) at VAPAHCS facilities and through VAPAHCS physicians and investigators.Both VAPAHCS and PAIRE file a FWA appointing the Stanford University IRBs to
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review their human subject research. VAPAHCS and PAIRE also maintain amemorandum of understanding with Stanford University relating to the HRPP. Thisdocument is similar to the agreement with SHC and LPCH, but provides thatVAPAHCS remains ultimately responsible for the maintenance of its overallinstitutional system to protect human subjects. This occurs through the VAPAHCSResearch and Development Committee. Additionally, the memorandum ofunderstanding between VAPAHCS and Stanford University formally establishes the

Stanford University IRBs as the Research Privacy Board for VAPAHCS and PAIRE.

1.2 Goal and Objectives of the HRPP The goal of the HRPP is to protect human research participants by ensuring that in allSTANFORD research:

The rights and welfare of human research participants are adequately

protected.

Such research is guided by the ethical principles of respect for persons,

beneficence, and justice as set forth in the Belmont Report, and is conducted

with the highest level of expertise and integrity.

Such research complies with applicable laws.

Objectives of the HRPP

The HRPP includes mechanisms to:

Establish a formal process to monitor, evaluate, and continually improve the

protection of human research participants and dedicate resources sufficient to

do so

Exercise oversight of research protection

Educate investigators and research staff about their ethical responsibility to

protect research participants

When appropriate, intervene in research and respond directly to concerns of

research participants.

Written Plan for the HRPPThe written plan for the HRPP is comprised of policies, guidances, and supportingdocuments governing human subject research and the protection of participants. TheHRPP is approved by the Vice Provost and Dean of Research. The HRPP Manual isorganized in 20 chapters, around the standards and elements of the Association forthe Accreditation of Human Research Protection Programs (AAHRPP), with eachchapter corresponding to one of the twenty standards of AAHRPP, as follows:

Organization Chapters 1 5

Research Review Unit, Including IRBs Chapters 6 13

Investigator Chapters 14 15

Sponsored Research Chapters 16 18

Participant Outreach Chapters 19 20
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1.3 Delegation of the Responsibility for HRPP Implementation to Stan

UniversitySTANFORD delegates responsibility for the HRPP to the Vice Provost and Dean ofResearch, Stanford University, who is an official with sufficient standing, authority, andindependence to ensure implementation and maintenance of the program. (AAHRPPElement I.1.C)For the organizations covered by the HRPP, the President of Stanford Universitydelegates the primary responsibility to the Vice Provost and Dean of Research toestablish, maintain, and oversee the HRPP. (SeeDelegation of Authority toInstitutional Officerand Research Policy Handbook 7.0).

STANFORD considers the HRPP Manual to be a dynamic document, because thescientific developments, ethical issues, and regulatory circumstances that shape it arecontinuously evolving and improving. The Research Compliance Office (RCO)maintains policies and procedures reflecting the current practices of the IRB inconducting reviews and approvals of human research. As part of the RCO

Continuous Quality Improvement (CQI) program, the RCO Director, in consultationwith the HRPP Associate Director and the CQI Associate Director regularly reviews(i.e., at least annually) and refines the HRPP Manual and makes recommendations formodifications, or develops new policies and procedures as appropriate. The ViceProvost and Dean of Research may approve a modification of any portion of theHRPP Manual. The RCO Director may approve modifications to the HRPP Manualthat relate to the day-to-day review and operational functions of the IRB; othermodifications of the HRPP Manual must be approved by the Vice Provost and Dean ofResearch.

The RCO is responsible for disseminating all modifications to the HRPP Manual andincorporating them into the relevant educational programs (discussed in Chapter 4).

1.4 Research Covered by the HRPP

Types of human subject research at STANFORDSTANFORD conducts or oversees biomedical, social science and behavioralresearch. Human subject research is covered as stated in theFederalwide Assurancefor each STANFORD affiliated organization. All research engaged in at STANFORDthat involves human participants is covered by the HRPP.

An activity is covered by the HRPP when: It is considered human subject researchas defined in any one of the

following:

- FDA regulations

- DHHS regulations or other Common Rule regulations

- VA regulations (VHA Handbook 1200.05), or

- Any other applicable state or local regulations, e.g. California State

regulations

and STANFORD (or its employees or agents) is engagedin the research as

defined by being involved in one or more of the following activities:
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- Receiving an HHS award for research- Intervening with participants for research purposes (invasive or

noninvasive)- Manipulating the environment- Interacting with participants for research purposes- Obtaining identifiable private information or identifiable biological

specimens from any source for research purposes,

according to the OHRP guidance Engagement of Institutions in Research.

Agents include all individuals performing institutionally designated activities or

exercising institutionally delegated authority or responsibility, includingstudents, faculty, staff, employees, visiting scholars.

See Chapter 3.3 for HRPP Manual policies and procedures for determining whenstudies meet the regulatory definitions of human subject research.

Approvals Required Before Human Subject Research Commences

IRB approval is required before research activities may commence.In addition to approval from the IRB, depending on the funding source, either contractfinalization or departmental approval is required before research involving humanparticipants can commence, as follows:

Externally funded research (industry-sponsored clinical trials andother clinical research) undergoes a parallel review process by acombination of the following, depending on the funding source:

- Research Management Group (RMG), who: develop and negotiatebudget and payment schedules, route/ensure approvals,

- Office of Sponsored Research (OSR), who: negotiate terms andconditions, sign contracts, issue notices of award (NOA) for industry-

sponsored clinical trials- Industrial Contracts Office (ICO), who: handle Industry Research

Agreements and Material Transfer Agreements (MTAs)

Other research (see Chapter 1.7) requires approval by a Division Chief,Department Chair, School Dean or designee, or a faculty sponsor asappropriate, confirming:

- Scientific and scholarly validity- Adequacy of resources.

Some protocol-specific situations require additional review and approval by otherorganizational components, or must meet their standards (see Chapter 2.4).

1.4.1 International Research

STANFORD international (transnational) research activities are consistent with theethical principles set forth in its Human Research Protection Program and meetequivalent levels of participant protection as research conducted in the STANFORDprincipal location while complying with local laws and taking into account culturalcontext. (AAHRPP Standard I-3 as of 10/1/2009)

Researchers should ensure that participants outside the US have the equivalentprotections that participants would be afforded in the US. OHRP provides a
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compilation of regulations and guidelines that govern human subjects research inother countries, as well as standards from a number of international and regionalorganizations. [See OHRP International Compilation of Human Subject Protections]

Researcher Responsibilities

When studies are conducted in other countries (i.e. outside the USA) researchersshould be knowledgeable about the local laws and customs which apply to theresearch, and the cultural context in which they will be working. They should ensurethat participants in international research are afforded equivalent protections to thoseparticipating in the US.

IRB Responsibilities

Stanford IRB review of international research adheres to the same policies applied todomestic (US) research, when appropriate. Additional legal or cultural expertise maybe consulted by the IRB during its review.

Considerations for Informed Consent

In some circumstances it may be inappropriate to document consent by using thestandard written and signed consent document, and there might be different rules ondetermining e.g., who may serve as a legally authorized representative (LAR). Referto HRPP Chapter 12 for information on waivers and alteration of consent, etc.

Federally Funded Research additional considerations

For federally funded research, the regulations of that sponsoring agency apply and the

required federal protections must be provided; it is not sufficient to provideequivalent protections.

DoD-funded:

If foreign laws or regulations which apply to the research afford additionalprotections to participants, these additional protections should be provided.

If foreign procedures provide protections that are at least equivalent tothose provided for in the DoD regulations, the (federal) department oragency head may approve the substitution of the foreign procedures. [See32 CFR 219.101 (g, h)]

Dept. of Navy: Research involving human subjects who are not U.S.citizens or DoD personnel, conducted outside the United States, and itsterritories and possessions, requires permission of the host country. Thelaws, customs, and practices of the host country will be followed, in additionto the regulations of the (federal) funding agency. An ethics review by thehost country, or by a local Naval IRB with host country representation, isrequired. [See SECNAVINST 3900.39D]

1.5 Primary Officials, Administrative Units and Individuals of the HRPP
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STANFORD Domain I: Officials Responsible for the HRPPThe primary responsibility for the HRPP lies with Stanford University through the ViceProvost and Dean of Research. See Research Policy HandbookRPH 7.0. The Presidentof Stanford University delegates this responsibility to the Vice Provost and Dean ofResearch. The Board of Trustees of Stanford University, the governing body of StanfordUniversity (as established by Jane and Leland Stanford in the 1885 Founding Grant),appoints the President.

Ann Arvin, M.D.: In 2006 President John Hennessy appointedAnn Arvin, LucileSalter Packard Professor of Pediatrics and Professor of Microbiology/Immunology, tothe position of Vice Provost and Dean of Research. In this position she serves on theUniversity's Executive Cabinet. Dr. Arvins responsibilities and organization chart aregiven in Administrative Guide Memo 12.11.

As Stanford Universitys Institutional Official, the Vice Provost and Dean of Researchsigns the Federalwide Assurance of Compliance (FWA) on behalf of the institution andis ultimately responsible for:

Creating, establishing and maintaining the policies and procedures for the

HRPP and related research policies and procedures on behalf of StanfordUniversity

Overseeing the protection of human participants, regulatory compliance, andthe implementation of the HRPP for STANFORD

Ensuring that open channels of communication are maintained between thecomponents of the HRPP

Overseeing research investigators and staff, and research management Ensuring the independence of the IRB, including the authority to act without

undue influence Requiring periodic reviews of the HRPP Ensuring that the HRPP is functional, adequately staffed and funded, involving:

i). Annual review of the resources allocated to the HRPPii). Participation in the annual budget preparation for the HRPP and

incorporation of the HRPP budget into the budget of Stanford University.The day-to-day operational and oversight responsibility for the HRPP is delegatedtothe Research Compliance Director, a non-faculty, full-time administrator. TheResearch Compliance Director reports to the Vice Provost and Dean of Research.

Kathy McClelland: The Research Compliance Office (RCO) Director, KathyMcClelland, has day-to-day operational responsibility for the HRPP through the RCO.She has over 25 years experience at Stanford dealing with aspects of researchintegrity and compliance. She has served as Director for the last twelve years.Before joining the Office of the Dean of Research, she held positions in the School ofMedicine as an IRB manager; in the Office of Sponsored Research (OSR) asnonmedical IRB manager and Institutional Animal Care and Use Committee (IACUC)manager; and as Assistant Director of OSR in charge of compliance, as it pertained toresearch participants and animal welfare. Among other functions as the RCODirector, she is administratively responsible for the operations of the IRBs, theInstitutional Animal Care and Use Committee (IACUC), the Stem Cell ResearchOversight (SCRO) Panel, and in conjunction with Environmental Health and Safety,assists the Biosafety and Radiological Safety Committees.
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VAPAHCS Research and Development Committee: This committee is ultimatelyresponsible for all human subject research which occurs at VAPAHCS. Itsmembership, functions and responsibilities are described in the VAPAHCS HealthCare System Memorandum No. 151-05-08, Research and Development Committeeand Associated Subcommittees.

STANFORD Domain II: Research Review Unit, including IRBsIRBs: The Administrative Panels on Human Subjects in Medical Research and theAdministrative Panel on Human Subjects in Non-Medical Research are theInstitutional Review Boards (IRBs) and perform many of the core functions of theHRPP. The Vice Provost and Dean of Research appoints the chairs and themembers of the IRBs and assigns their authority and responsibility in the charge tothe Chairs and members. See Charge to theAdministrative Panel on HumanSubjects in Medical Research by the Vice Provost and Dean of Research, and Chargeto the Administrative Panel on Human Subjects in Non-Medical Research by the ViceProvost and Dean of Research. The charge emphasizes that the IRBs arefunctionally independent (e.g., of the individuals who are conducting the research) and

have ready access to the highest officials of the covered organizations, if needed, toensure protection for human research participants.

There are seven medical IRBs and one nonmedical IRB. Their authority, membershiprequirements, and responsibilities are described in Chapter 6. IRBs are responsiblefor the initial and continuing review, review of modifications, approval of all researchsubject to the HRPP, determining serious or continuing noncompliance, requiringmodification (to secure approval), disapproving research, and applying applicableethical standards.

Stanford University also participates in the Central Institutional Review Board (CIRB)Initiative of the National Cancer Institute (NCI). A facilitated review process for localIRB review of adult and pediatric national multi-center cooperative oncology groupcancer treatment trials is employed for selected protocols.

IRB Staff in the Research Compliance Office: The HRPP Associate Director isresponsible for supporting the daily operations of the IRBs. The IRB staff (Managersand Associates) review protocol applications for accuracy and completeness and actas liaisons between the Protocol Directors (PDs) and the IRB members. The IRBTraining Specialist and the HRPP Education Specialist are responsible for the trainingof all individuals who are affected by the Human Research Protection Program. TheContinuous Quality Improvement (CQI) Associate Director is responsible for the CQIplan and its implementation. This plan ensures periodic evaluation and strengtheningof the HRPP.

Upon request, the RCO has responsibility for review and comment on proposedexternal regulations dealing with human research. When appropriate, the RCOformulates and recommends draft policies and procedures for approval by theappropriate Stanford University bodies and promulgation by the Vice Provost andDean of Research.

See Research Compliance Organization Chart.

STANFORD Domain III: InvestigatorPrincipal Investigator/Protocol Director: The STANFORD individual ultimatelyresponsible for a protocol is the Protocol Director (PD). Most (but not all PDs) have
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faculty appointments at Stanford University. PD responsibilities are specified in theHRPP Manual and include ensuring that:

All STANFORD human subject research has received initial prospectivereview and approval by the IRB.

Continuing review and approval of the research has been accomplishedwithin the time frame stipulated by the IRB.

The research is conducted at all times in compliance with all applicable

regulatory requirements and the determinations of the IRB.

Other Members of the Research Team: Every member of the research team is

responsible for protecting human participants. Co-investigators, study coordinators,

nurses, research assistants, faculty sponsors, student/staff investigators, and all other

research staff have the following strict obligations to: Comply with all IRB determinations and procedures Adhere rigorously to all protocol requirements Inform the PD, and thus IRB, of unanticipated problems Ensure the adequacy of the informed consent process Take necessary measures to ensure adequate protection for study

participants.

Responsibilities and duties under the HRPP are described in more detail inChapter 14 and Chapter 15.

STANFORD Domain IV: Sponsored ResearchSponsors can be a company, institution, individual donor or organization responsiblefor the initiation, management, or financing of a research study. Both the sponsor andSTANFORD have obligations to protect research participants.

STANFORD Domain V: Participant OutreachParticipants in a research project also have responsibilities. These include telling the

truth, asking for clarification, following the protocol, notifying study personnel of their

non-compliance, and telling investigators if they wish to withdraw from the study.

HRPP Organizational ComponentsIn addition to the Vice Provost and Dean of Research and the Research ComplianceOffice, human research protection responsibilities are shared by these StanfordUniversity HRPP components:Cancer Clinical Trials Office (CCTO): TheCCTO provides administrative, research,and educational services to Cancer Center investigators conducting clinical trials.Programs serve to increase awareness and accrual to clinical trials as well as toimprove the quality and efficiencies of conducting clinical trials in compliance withregulatory, documentation, and oversight requirements. Its goals are to:

Facilitate clinical trials and translational research by providing administrativesupport to all Cancer Center investigators

Enhance and facilitate data collection and reporting of clinical cancer research

Provide programs to contribute to quality assurance and the ongoing educationof Cancer Center Clinical Research Personnel
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Coordinate outreach efforts in the community to increase clinical trials

awareness and accrual, and

Promote interdisciplinary collaborations and translational medical research.

All cancer-related studies are reviewed by the CCTO Scientific Review Committee(SRC), (except observational studies, retrospective chart reviews, compassionate usestudies, and multiple program projects (MPPs)). The Data Safety Monitoring

Committee of the CCTO reviews adverse event reports and requires them, asappropriate, to be submitted to the IRB. (See Chapter 3.10).Conflict of Interest Committee (COIC): The COIC of the School of Medicine (SOM)reviews CoI disclosures from all protocols (SOM and non-SOM) submitted to the IRB.The COIC considers the conflicting interests, determines or assesses any mitigationor management plan, and determines whether the conflict can be managed or needsto be eliminated. If further review is appropriate, the case is examined by the ViceProvost and Dean of Research. The decisions and actions of the COIC are reportedto the IRB staff, and considered at an IRB convened meeting. See Chapter 3.7 formore information.

Environmental Health and Safety(EH&S): EH&Sprovides and coordinatesprograms and services that minimize risks to safety and health, and environmentaland regulatory risks to the Stanford University community in a manner consistent withresponsible fiscal and environmental stewardship. EH&S works with investigators topromote safe and healthful laboratory environments that support the University'sscience and research mission.The Administrative Panel on Biosafety (APB)andHealth Physics Radiation Safety are under the auspices of EH&S. As appropriate:

Human subject research must have APB approval before research activitiesmay commence;

The Protocol Application contains questions about radioisotopes and radiation

machines the Radiation Safety Committee must certify that it has revieweda protocol using radioisotopes or radiation machines and recommends it forapproval. Without this approval, a study which employs these modalitiescannot be approved by the IRB, and must be tabled to a future convenedmeeting;

The Protocol Application instructs that patient related equipment, if used,must meet standards established by the Hospital Instrumentation andElectrical Safety Committee.

General Clinic Research Center (GCRC): The GCRC is a major clinical researchresource forStanford University School of Medicine. Its goals are to provide an

optimal facility for the conduct of patient-oriented research, to translate basic scientificknowledge into better understanding and treatment of human diseases, and to trainhealth professionals in clinical research.HIPAA Council: The HIPAA Councilis convened by the Stanford University PrivacyOfficer to explore issues related to the implementation and enforcement of the Privacyand Security rules under HIPAA for the Stanford Affiliated Covered Entity.Internal Audit and Institutional Compliance: The Internal Audit Departmentperiodically performs assessments of University operating units, such as the Research
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Compliance Office. Additionally, the Director of Internal Audit and InstitutionalCompliance has oversight over:

Institutional Compliance Coordinating Committee (ICCC): ICCC is part ofthe Stanfords Institutional Compliance initiative and provides coordination andsupport to the offices at Stanford which have direct responsibility for complyingwith government regulations.

Office of the General Counsel (OGC): The OGC is responsible for addressing all ofthe legal issues arising out of the activities of Stanford University, Stanford Hospitaland Clinics and Lucile Salter Packard Children's Hospital at Stanford. A representativeof the OGC serves as an ex-officio IRB member, and is available for consultation onissues regarding human subject research and participant protection.Office of Research Administration (ORA): The ORA manages the administrativeprocesses related to Stanfords sponsored research. Within ORA:

Office of Sponsored Research (OSR): The OSR negotiates contract termsand conditions for industry-sponsored clinical trials, and provides pre-awardand post-award administrative services for sponsored projects to ensure that

Stanford is fully compliant with sponsor terms and conditions, Universitypolicies, and federal regulations. IRB approval is a prerequisite for OSR to signa contract.

Compliance Support Task Force (CSTF): The CSTF is facilitated by ORA,and draws membership from the: School of Earth Sciences, Internal Audit,School of Engineering, Office of Research Administration, School ofHumanities and Science, School of Medicine, Controllers Office, Vice Provostand Dean of Research, and Environmental Health and Safety. Its mission is toprovide a forum to discuss University-wide research compliance issues, drawon the collective expertise available throughout the University, encouragedissemination of best practices, act in an advisory capacity to the Vice Provost

and Dean of Research and to the Associate Vice President of the Office ofResearch Administration.

Office of Technology Licensing (OTL): OTL is responsible for managing theintellectual property assets of Stanford University. The OTL charter is to help turnscientific progress into tangible products, while returning income to the inventor and tothe University to support further research. OTL has signature authority on behalf of theUniversity for license agreements, material transfer agreements, industrial contractsand other agreements that pertain to intellectual property. Of particular relevance tohuman subject research protections are:

Clinical Technology Assessment Agreements (CTAAs) - created when a

sponsor provides an investigational drug or device for research; the protocolmust have IRB approval, and, as appropriate an IND or IDE.

Material Transfer Agreements (MTAs) - these govern the use of tangibleresearch materials distributed to other institutions. The Protocol Applicationasks whether tissues are to be distributed as part of such an agreement.

Research Management Group (RMG): For School of Medicine research - Providesoversight and management of sponsored projects and ensures compliance withsponsor and University expectations for managing sponsored funds. RMG performs a
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parallel review to the IRB, and confirms IRB approval before routing sponsored projectinformation to the Office of Sponsored Research (OSR) contracts office (see above).Stanford Center for Biomedical Ethics (SCBE): The SCBE is dedicated tointerdisciplinary research and education in biomedical ethics, and provides clinical andresearch ethics consultation. SCBE serves as a scholarly resource on emergingethical issues raised by medicine and biomedical research, and is called upon for

consultation by the IRB when needed.Stanford/Packard Center for Translational Research in Medicine (SPCTRM):SPCTRM serves STANFORD faculty and clinical research personnel in the School ofMedicine (SOM), Stanford University Medical Center, Lucile Packard Children'sHospital (LPCH) and Veterans Affairs Palo Alto Health Care System (VAPAHCS). Itsmission is to enhance the quality of clinical and translational research by:

Aligning organizational service based activities Providing education, training and mentoring to clinical research coordinators

and staff Developing an integrated research infrastructure

IRB staff and SPCTRM collaborate to provide education to the research community,disseminate information about the HRPP, and to facilitate quality improvementactivities such as compliance reviews.Stanford UniversitySchools: Although human subject research (includingundergraduate research programs) takes place within any of the seven Schools, mosthuman subject research is performed by the Schools of Medicine, Education, andHumanities & Sciences, which includes the Department of Psychology. All suchresearch must receive IRB approval before research activities can commence.

1.6 Ethical and Legal Principles Governing Human Subject ResearchSTANFORD has the following written policies forworking with research participants,sponsors, investigators, and the RCO, including IRBs, to uphold legal and ethicalstandards and practices in research involving human subjects.(AAHRPP Element I.1.D)

Ethical Principles

The primary ethical principles applied to research covered by the HRPP, including

protocols exempt under federal regulations pertaining to human subject research,

are those set forth in The Belmont Report: Ethical Principles and Guidelines for the

Protection of Human Subjects of Research of the National Commission for theProtection of Human Subjects of Biomedical and Behavioral Research (Belmont

Report).

The three main principles are:

1. Respect for persons (e.g., applied by obtaining informed consent,

giving consideration to privacy and confidentiality, and adding

protections for vulnerable populations)

2. Beneficence (e.g., applied by weighing risks and benefits)

3. Justice (e.g., applied by the equitable selection of subjects)
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All parties involved in the conduct of research are expected to also adhere to theprinciples of expertise (competent to do the work) and integrity (faithfully adhere toprofessional principles). Ethical principles from other sources (e.g., InternationalConference on Harmonization) may also be applied to research covered by theHRPP, for example:

To an individual protocol because its particular circumstances raise a type of

ethical issue that most other protocols do not When they are recognized by the federal or other funding source or the state or

country where the research will occur

When they have been developed for specific areas or types of subjects (e.g.,

embryos and fetal tissue, illiterate subjects).

Investigator training on the ethical principles governing human subject researchand investigator responsibilities is provided by the tutorial Principal InvestigatorResponsibilities at Stanford University. These principles are also covered in theCITI required tutorial for investigators, IRB Members, and IRB Staff, and in theorientation given to new IRB members.

With respect to sponsored research, Stanford University and PAIRE address theprotection of research participants by including in their standard contract templatesa provision that the sponsor acknowledges and understands that the STANFORDHRPP is applicable to all human participant research. See Chapter 16.

Legal Principles

The basic legal principles governing human subject research, covered by the HRPP

and applicable to individual protocols are:

Federal Policy for Protection of Human Subjects (Common Rule) in 45 CFR

Part 46

Food and Drug Administration Regulations for the Protection of HumanSubjects in 21 CFR Parts 50 and 56

Standards for Privacy of Individually Identifiable Health Information (HIPAA

Privacy Rule) in 45 CFR Parts 160 and 164.

Department of Veterans Affairs regulations in 38 CFR Part 16 and VHA

Handbook 1200.5

Applicable California law.

(These and other legal principles are addressed when applicable in the individualchapters of the HRPP Manual.)

1.7 Scientific and Scholarly Validity Review and Ethics Review

STANFORD has the following written policies and procedures for reviewing the

scientific or scholarly validity of a proposed research study. Such procedures are

coordinated with the ethics review process. (AAHRPP Element I.1.B)

Scientific and Scholarly Validity Review

The IRB relies on the scientific and scholarly validity review provided by different

entities, as follows:
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For federally sponsored research, including VA-funded research, the

respective peer review process (e.g., NIH, NCI, DOD) provides scientificand scholarly review.

For research subject to FDA review, the FDA conducts a rigorous scientificdesign review during IND or IDE evaluation. Most industry-sponsoredresearch falls within this category. An important exception is Non-

Significant Risk device research. For research occurring at VAPAHCS, the VA Research and Development

Committee performs scientific review of all activities prior to initiation, inorder to evaluate the quality, design, desirability and feasibility of each newR&D proposal/application for funding, to assure maintenance of highscientific standards, protection of human research participants includingprivacy and confidentiality, and adequate safety measures. The process isdescribed in VAPAHCS Health Care System Memorandum No. 151-05-08,Research and Development Committee and Associated Subcommittees.

For research occurring in the General Clinical Research Center (GCRC) atSHC and LPCH, an internal review board provides scientific and ethicalevaluation. See the GCRC website pageResearch Protocol Approval andContinuing Scientific Review System.

The Cancer Center Scientific Review Committee (SRC) provides a peerreview of local and national research protocols involving cancer patientstreated at Stanford University Clinical Cancer Center and Lucile PackardChildren's Hospital. The review primarily focuses on the scientific merit ofthe study and applies to all phases of clinical therapeutic intervention,behavioral clinical trials, tissue and body fluid research, and diagnostictrials, which impact medical decision making for the treatment of cancerpatients. The process is described in its Stanford University Clinical Cancer

Center, Scientific Review Committee, Policies and Procedures. SRC isnot required for all cancer studies. For a list of types of research for whichSRC review is required, refer to the above Cancer Center website.

For research that has not otherwise gone through a scientific review asdescribed above , for example:

- research conducted by faculty without external sponsorship, or

- for all research conducted by students, including student research thatmay undergo scientific review by an awarding entity,

then:- In the School of Medicine: the Division Chief or Department Chair of the

PDs department, (or the School Dean or his designee when the DivisionChief or Department Chair has a conflicting interest), or

- In other schools: the School Dean or designee,is responsible forconfirming to the IRB that scientific review of the protocol has occurred.

- For research occurring at VAPAHCS: the VA Research andDevelopment Committee performs scientific review of the study and theoutcome of this review must be communicated to the IRB at the time theVA protocol is submitted to the IRB for review and approval.

When the PD is a student, this confirmation may be provided by the FacultySponsor who is responsible for the scientific review (the Faculty Sponsor
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submits a Review of Scientific and Scholarly Validity, and Oversight [APP-9]to the IRB). When the protocol application indicates that the research hasdepartmental funding, gift funding or no funding, the IRB requests that thePD have the Division Chief or Department Chair of the PDs department inthe School of Medicine (or the dean of other schools as appropriate),respond to the IRB, on the following (Review of Scientific and ScholarlyValidity [APP-10]):

a. Are the research procedures the least risky procedures that can be

performed consistent with sound research design?

b. Is the research likely to achieve its aims?

c. Is the proposed research of sufficient scientific importance to justify the

risks entailed?

d. Are there adequate resources (e.g. facilities, qualified staff, access to

participant population that will allow recruitment of the required number

of participants) to complete the study?

For regular review protocols, the PD must answer the questions in the ScientificReview Protocol for Human Subjects Research [NOT-13].

Forallresearch, the IRB evaluates, in accordance with federal research

regulations [45 CFR 46.111(a) and 21 CFR 56.111(a)] whether the following

requirements are satisfied:

a. Risks to participants (physical, psychological, social, legal and economic) are

minimized (i) by using procedures which are consistent with sound research

design and which do not unnecessarily expose participants to risk; and (ii)

whenever appropriate, by using procedures already being performed on the

subjects for diagnostic or treatment purposes.

b. Risks to participants are reasonable in relation to anticipated benefits, if any, toparticipants, and the importance of the knowledge that may be expected to

result.

If the requirements noted above are not satisfied, the protocol may notbe approved

as written. The IRB reviewer(s) may consider prior scientific reviews (e.g., NIH peer

review, GCRC internal review board, SRC review) in their evaluation. For protocols

where the protocol design is unusual or novel, in addition to the protocol being

assigned to primary reviewer(s) with relevant expertise, input from ad hoc consultants

may also be obtained. For further information, refer toguidance Evaluating Sound

Study Design.

Ethics Review

The IRB review of the study procedures, risks and benefits includes the identification,

evaluation and resolution of the ethics issues presented in the study in accordance

with the ethical principles outlined in Chapter 1.4. If necessary, the IRB may seek ad

hoc assistance from ethical consultants, both internal and external (e.g., members of

the hospital ethics committees of SHC, LPCH, or VAPAHCS, or members of Stanford

Universitys Center for Biomedical Ethics).
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An ethics review (in addition to the scientific review) is also conducted by the internal

review committees for research done in the General Clinical Research Center at SHC

and LPCH, and in the Cancer Center at SHC and LPCH.


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Stanford University Office of the Dean of ResearchHuman Research Protection Program (HRPP)

DOMAIN I: ORGANIZATION

Chapter 2: Resources Supporting the HRPP

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

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)

The provision of adequate human and fiscal resources facilitated through thebudgeting 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 ofhuman resources. The HRPP is led by the ViceProvost and Dean of Research, pursuant to the authority delegated by the Office ofthe President (see Delegation of Authority to Institutional Officer). The Vice Provostand Dean of Research oversees the Research Compliance Office (RCO) (seeResearch Compliance Organization Chart).

Fiscal Resources: Stanford University demonstrates a high level of institutionalcommitment to its HRPP in terms offiscalresources, and is committed to providingthe 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 Dean of Research.The annual budget is established by a three-phase process:

(1) In the fall, IRB Chairs provide input regarding priorities and resources neededfor the new academic year. This input is included in the Annual Report andcommunicated to the Vice Provost and Dean of Research during a meetingalso attended by the RCO Director, the RCO Deputy Director, the HRPPAssociate Director, and the IRB Managers.

(2) In the spring, the RCO Deputy Director and budget officers in the Office of theDean of Research prepare income and expense forecasts for the followingyear. Income forecast includes fees collected for the review of protocols on

company-sponsored clinical research. Expenditure forecast takes intoconsideration:

Adequate number of IRBs

Adequate staffing

Adequate technology support

Adequate funds for educational opportunities for IRB members andIRB staff, including off-site conferences

Adequate funds to provide on-going office and logistic support

Adequate funds to carry out agreed-upon special projects.
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2.3 Human Research Protection, Care of Participants, and SafetySTANFORD 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 areadequate resources to ensure the care and safety of participants, from the screeningand recruitment phases throughout the project. During review of the submittedprotocol, the IRB assesses the information in the Protocol Application and asnecessary asks for additional details. (See Chapter 7 for information about the reviewprocess.) If the protocol does not provide adequate protection, it will not be approved.

Protocol Directors (PDs) are required to indicate in the Protocol Application whetherinvestigators: will have access to a population that will allow recruitment of therequired number of participants; will have sufficient time to conduct and complete theresearch; 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 andfunctions; and will have medical or psychological resources available that participantsmight require as a consequence of the research when applicable.Human participant research cannot begin, including recruitment and enrollment, until(as appropriate to the sponsorship/funding and administration of the study), either theFaculty Sponsor has affirmed the availability of resources, the contract has beenfinalized (industry sponsored projects) or the grant award has been accepted(federally sponsored projects). For externally funded projects (industry or federalfunding) the Research Management Group prepares budgets supporting researchactivities. Additionally, the availability of adequate resources for a research study is

addressed through the scientific and scholarly review provided by different entitiesdepending on sponsorship/funding and administration of the study; for all researchconducted by students, this is accomplished by the oversight required from a FacultySponsor. See Chapter 1.7 for a full description of this process.

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.2.4 Communication and Interaction

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

Communication

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 the following situations

which require communication and interaction between various components of the

HRPP are handled appropriately:

The Radiation SafetyCommittee must certify that it has reviewed a protocolusing radioisotopes or radiation machines and recommends it for approval.Without this approval, a study which employs these modalities will either be
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tabled to a future convened meeting, or will be approved contingent onRadiation Safety Committee recommendation for approval. If a modificationinvolves review by Radiation Safety, the IRB will hold its approval untilRadiation Safety forwards its approval to the IRB. Radiation Safety is givenaccess to the protocol information by the IRB.

Protocols involving biosafety materials and requiring review by theBiosafety Panel must be reviewed by this Panel and receive an approval letterin addition to review by the IRB. A new protocol generally will not be presentedat an IRB convened meeting until the Biosafety Panel has approved it. If amodification or continuing review involves review by Biosafety, the IRB will holdits approval until Biosafety forwards its approval to the IRB. The HRPPAssociate Director, and the Senior IRB Manager are ex-officio members of theBiosafety Panel. A senior member of the IRB staff attends the Biosafety Paneland receives communications directly from the Panel regarding submittedprotocols. The Biosafety Officer (from the Environmental Health & Safetydepartment) is an ex officio member of all the medical IRBs.

Protocols that also involve the use of human stem cells, human embryos,or their derivatives must be reviewed and approved by the Stem CellResearch Oversight (SCRO) Panel, in addition to having IRB review andapproval, priorto activity commencement.

Patient related equipment using electricitymust meet the standardsestablished by the Hospital Instrumentation and Electrical Safety Committee.For protocols using such equipment, the investigator is referred to ClinicalEngineering.

Investigator Conflict of Interest disclosures:All investigator conflictinginterest is managed via the Conflict of Interest Review Program (COIRP) andits associated Conflict of Interest Committee (COIC). The IRB will not approve

a protocol until any disclosed COI has been reviewed and resolved by theCOIRP/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 ofthe hospital pharmacy (SHC or LPCH): The PD must have a Security andControlled Access Plan for the drug or biologic on file with the applicablepharmacy. See Chapter 5.2.

Blood, tissue, or data (slides, X-rays, etc.) that are being transferred in orout of the institution, and there is no contract in place: The PD must

coordinate with the Office of Technology Licensing (OTL) about a MaterialTransfer Agreement (MTA).

Funding status:Enquiries may be made of the Research Management Group(RMG)/Office of Research Administration (ORA) system, SPIDERS, to verifywhether there is active funding.

InteractionSeveral groups provide a vehicle for interaction among key individuals who areresponsible for human research participant protection:
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Institutional Compliance Coordinating Committee (ICCC): ICCC is part of

Stanfords Institutional Compliance initiative and provides coordination andsupport to the offices at Stanford which have direct responsibility for complyingwith government regulations.

VA/Stanford Working Group: This group is comprised of the VA Compliance

and Privacy Officers, PAIRE Executive Director, Stanford University LegalCounsel, Sr. IRB Staff and Sr. Research Compliance Staff.

HIPAA Council: The HIPAA Council is convened by Stanford UniversityPrivacy Officer to explore issues related to the implementation andenforcement 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 theSchool of Medicine, Stanford University Medical Center, Lucile PackardChildren's Hospital (LPCH) and Veterans Affairs Palo Alto Health Care System(VAPAHCS). The SPCTRM mission is to enhance the quality of clinical andtranslational 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 on opportunities for synergy across the Stanford community.

Stanford Association of Research Professionals (SARP): This group

provides a forum for communication, education and networking amongresearch professionals with the goal of achieving excellence in clinicalresearch. The HRPP Education Specialist is a regular attendee at SARPmeetings.
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Stanford UniversityOffice of the Dean of Research

Human Research Protection Program (HRPP)DOMAIN I: ORGANIZATION

Chapter 3: Compliance Monitoring

STANFORD* monitors compliance of all those involved in the research process. (AAHRPP Standard I-3)

3.1 Policies, Procedures, and Resources Available to Investigators andResearch Staff

STANFORD has the following written policies and procedures governing research withresearch participants that are available to investigators and research staff affiliatedwith STANFORD. (AAHRPP Element I.3.A)

The Research Compliance Office (RCO) has primary responsibility for ensuring theHRPP Manual and related materials are available to the entire STANFORD research

community, including: Investigators

Research staff

IRB staff

IRB members

Employees

StudentsThe RCO maintains the Human Subjects Research website which provides access to:

The HRPP Manual

Links to pertinent governmental regulations and guidelines

Links to STANFORD policies (Research Policy Handbook, Hospital and ClinicPolicies, Lucile Packard Childrens Hospital Policies and the VHA Handbook)

Guidance on various topics, such as sponsor-investigator research, children inresearch, use of test articles and reportable events

IRB forms, including checklists, consent form and HIPAA authorizationtemplates

Protocol Application instructions and information

Frequently Asked Questions and Practice Tips for investigators regardinghuman subjectresearch protections and the IRB review process

Human subject determination information and forms to assist investigators in

identifying which protocols involve human subject research requiring IRBreview. For example, the following might not be research under 45 CFR 46, or21 CFR 50, 56: QA/QI, pilot projects, research practicum, case studies(approximately 3 to 5), and oral histories. SeeDoes My Project Need IRBReview?

New alerts highlighting the posting of new information or changes in existingpolicies and procedures

IRB education presentations
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The IRB staff is readily available by telephone and in-person meetings to assistinvestigators and research staff on human subjectresearch matters, particularly IRBapplications and review questions.

IRB member and staff education is provided at each convened IRB meeting. At thebeginning of each meeting the IRB Training Specialist provides an educational

presentation on a specific policy or procedures governing human subject research.Each monthly education presentation is also emailed to all IRB members, whether ornot they attended the meeting.

The HRPP Education Specialist and other IRB staff regularly give presentations, oftento large research groups, and accept invitations to attend classes and departmentalmeetings to provide information and guidance to the STANFORD research communityon IRB policies and procedures governing human subject research.

Within the RCO, the HRPP Education Specialist and the IRB Training Specialist areresponsible for identifying new information involving human research participantprotection such as new organizational policies, or emerging ethical and scientific

issues. Information about new or modified laws might also be identified by legalcounsel. New information is posted on theHuman Subjects Research website and isdisseminated to the IRB staff, IRB members and the STANFORD research communityvia other distribution sources as noted above.

3.2 Independence of IRBs

STANFORD has the following written organizational structure, policies andprocedures that allow the STANFORD HRPP to function independently of other

organizational entities in its role in protecting research participants. (AAHRPPElement I.3.B)

Organizational Structure that Provides IndependenceThe President of Stanford University has delegated the authority and responsibility toestablish, maintain and oversee the HRPP to the Vice Provost and Dean of Researchas specified in the Presidents Delegation of Authority letter.

The Vice Provost and Dean of Research, the Office of the Dean of Research, and theRCO, which includes the IRBs and reports to the Vice Provost and Dean of Research,are separate from, independent of, and have no direct reporting relationship to anypart of STANFORD that carries out research or to any of the other organizations

covered by the HRPP. The duties of the Vice Provost and Dean of Research and theOffice of the Dean of Research relate to establishing policy for research and oversightof research compliance, particularly as it relates to human participant research.

Delegation to the IRBThe Vice Provost and Dean of Research delegates independence and authority to theIRBs through this Chapter 3.2 and the Charge to each IRB Chair (medical andnonmedical) and member at the time of their appointment. The IRBs have authorityto:

Review, approve, disapprove, or require changes in research involving humanparticipants
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Suspend or terminate research involving human participants or an

investigators privilege to conduct such research (e.g., in situations whereresearch is not being conducted in accordance with IRB requirements, or

where the research has been associated with unexpected serious harm toparticipants)

Observe, or have a third party observe the consent process

Observe, or have a third party observe the conduct of research.Prohibition against Others Usurping IRB Approval Authority or Using UndueInfluenceThe Vice Provost and Dean of Research prohibits STANFORD officials, investigators,and employees, and sponsors contracting with STANFORD for research from:

Maintaining or claiming IRB approval of research that has been disapproved ornot yet been reviewed by the IRB

Attempting to use or using undue influence with the IRB, any of its members orstaff, a PD or any other member of the research team to obtain a particularresult, decision or action.

Undue influence means attempting to interfere with the normal functioning anddecision-making of the IRB or to influence an IRB member or staff, a PD or any othermember of the research team outside of established processes or normal andaccepted methods, in order to obtain a particular result, decision or action by the IRBor one of its members or staff.

To help forestall undue influence of IRB members, the IRB preserves the anonymity ofmembers assigned as reviewers to specific protocols or protocol events.

An individual who believes he or she has been subjected to such undue influenceshould make a report of non-compliance underChapter 3.9 (e.g., to the Research

Compliance Director or Vice Provost and Dean of Research). Such reports will bereviewed in the same manner as possible non-compliance by an IRB Chair or memberby the Vice Provost and Dean of Research as described in Chapter 3.9. The types ofresponse to attempts to unduly influence the IRB are determined as appropriate to thesituation, by either the Research Compliance Director or Vice Provost and Dean ofResearch.

3.3 Regulatory Definition of Human Subject Research

STANFORD has written policies and procedures in the HRPP Manual for determiningwhen studies meet the regulatory definitions of human subject research. (AAHRPPElement I.3.C)

Human subject research is defined under 45 CFR 46.102(d) and (f), 21 CFR 50.3 (c)and (j), 45 CFR 46.102(f), 21 CFR 50.3(e). See also VHA Handbook 1200.5 athttp://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=1727 .

See Chapter 1.4 for a description of the types of human subject research conducted atSTANFORD.
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All protocols involving both "research" and"human subjects" (other than thosedetermined to be exempt) must be reviewed and approved by the IRB beforerecruitment and data collection may start.See:

Human Subjects Research website topic Human Subject Research

Does My Project need IRB Review?

Determination of Human Subject Research Application

Is My Project Research?

Does My Project involve Human Subjects?

Definitions

Regulations

The IRB retains ultimate authority to determine whether an activity meets the definitionof human subject research. Upon receipt of aDetermination of Human SubjectResearch Application IRB staff make this determination in a timely manner, andcommunicate to the PD via a Notice of Determination of Human Subject Research

their decision on whether the activity does ordoes not meet the definitions as definedin the HRPP Manual.

3.4 Exempt Research Determinations

STANFORD has written policies and procedures for determining when studies areexempt under applicable federal, state, and local regulations. Such policies andprocedures indicate that exemption determinations are not to be made byinvestigators or others who might have a conflicting interest regarding the studies.(AAHRPP Element I.3.D)

Categories of exempt research are stipulated in the Common Rule, Subpart A of45 CFR 46. See 45 CFR 46.101(b), and 21 CFR 56.104 (FDA), and for VA research

38 CFR 16.101(b)).

IRB staff refer to guidance Exempt Review Categories and use the Exemption

Eligibility Checklist to verify that the PD has requested an appropriate exemption

under the appropriate category. Except for VA research, confirmation of exempt status

is made by IRB staff or IRB members who have the knowledge and authority to

confirm exemption.

For VA research and in accordance with VHA policy, an IRB Chair or an IRB member

designated by the Chair must review and document that exempt status for a project isappropriate.

Emergency use of a test article is exempt from prospective IRB review under

21 CFR56.104. See Chapter 5.8 for more information on this topic.

Conditions under which Exemption cannot be granted

Exempt status shall not be granted when: Categories (1) through (5) apply and research is subject to FDA regulations
http://humansubjects.stanford.edu/research/medical/medical.html#hsrschhttp://humansubjects.stanford.edu/research/documents/HSresearch_if_IRB_review_neededFLW03H04.pdfhttp://humansubjects.stanford.edu/research/documents/HSresearch_applicationAPP03H08.dochttp://humansubjects.stanford.edu/research/documents/HSresearch%20is_it_research_AID03H08.pdfhttp://humansubjects.stanford.edu/research/documents/HSresearch%20is_it_HS_AID03H12.pdfhttp://humansubjects.stanford.edu/research/documents/HSresearch_definitionsAID03H11.pdfhttp://humansubjects.stanford.edu/research/documents/HSresearch_reg_definitionsAID03H13.pdfhttp://humansubjects.stanford.edu/research/documents/HSresearch_applicationAPP03H08.dochttp://humansubjects.stanford.edu/research/documents/HSresearch_applicationAPP03H08.dochttp://humansubjects.stanford.edu/research/documents/HSresearch_determination_does_NOT03H06.dochttp://humansubjects.stanford.edu/research/documents/HSresearch_determination_does_not_NOT03H02.dochttp://humansubjects.stanford.edu/research/documents/expeditedEXEMPTcategories_pg2_GUI03004.pdfhttp://humansubjects.stanford.edu/research/documents/ExemptionEligibilityChecklist_CHK03008.dochttp://humansubjects.stanford.edu/research/documents/ExemptionEligibilityChecklist_CHK03008.dochttp://humansubjects.stanford.edu/hrpp/Chapter5.html#ch5_8http://humansubjects.stanford.edu/hrpp/Chapter5.html#ch5_8http://humansubjects.stanford.edu/research/documents/ExemptionEligibilityChecklist_CHK03008.dochttp://humansubjects.stanford.edu/research/documents/ExemptionEligibilityChecklist_CHK03008.dochttp://humansubjects.stanford.edu/research/documents/expeditedEXEMPTcategories_pg2_GUI03004.pdfhttp://humansubjects.stanford.edu/research/documents/HSresearch_determination_does_not_NOT03H02.dochttp://humansubjects.stanford.edu/research/documents/HSresearch_determination_does_NOT03H06.dochttp://humansubjects.stanford.edu/research/documents/HSresearch_applicationAPP03H08.dochttp://humansubjects.stanford.edu/research/documents/HSresearch_applicationAPP03H08.dochttp://humansubjects.stanford.edu/research/documents/HSresearch_reg_definitionsAID03H13.pdfhttp://humansubjects.stanford.edu/research/documents/HSresearch_definitionsAID03H11.pdfhttp://humansubjects.stanford.edu/research/documents/HSresearch%20is_it_HS_AID03H12.pdfhttp://humansubjects.stanford.edu/research/documents/HSresearch%20is_it_research_AID03H08.pdfhttp://humansubjects.stanford.edu/research/documents/HSresearch_applicationAPP03H08.dochttp://humansubjects.stanford.edu/research/documents/HSresearch_if_IRB_review_neededFLW03H04.pdfhttp://humansubjects.stanford.edu/research/medical/medical.html#hsrsch


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Category (2)(b) applies and research involves children as participants, except

for research involving observations of public behavior when the investigator(s)do not participate in the activities being observed, pursuant to subpart D(45 CFR 46.401 (b)).

Research involves prisoners as participants, pursuant to subpart C(45 CFR 46.305 (a))

Research involves Human Embryonic Stem Cells, pursuant to California Healthand Safety Code Section 125119

The project involves significant physical invasions or intrusions upon theprivacy of participants.

Making Exemption Determinations without Conflict of Interest

Exempt research determinations must not be made by those who might have a

conflicting interest regarding the research.

Those IRB members and consultants involved in reviewing and approving the exempt

determination of Protocol Applications must not participate in the review of protocols in

which they have a conflicting interest see Chapter 6.3 for policies prohibiting suchsituations.

3.5 Policies and Procedures for Exempt Research

STANFORD has written policies and procedures for addressing protection ofparticipants in research exempt from applicable federal regulations. (AAHRPPElement I.3.E)

STANFORD requires protocols qualifying for exempt review to be submitted for IRB

review and confirmation of exempt status. While such research is exempt from the

regulations set forth in 45 CFR 46.101(b), and 21 CFR 56.104 (FDA), and38 CFR 16.101(b) (VA), the research must meet STANFORD HRPP ethical standards

governing the conduct of research. SeeChapter 1.

The IRB ascertains that exempt protocols provide appropriate protection of privacyand confidentiality interests (see Chapter 11).

If there are interactions with participants, requirements for the consent process applyto exempt research, such as providing the following information:

The activity involves research A description of the procedures Participation is voluntary Name and contact information for the investigator.

Exempt Review Process

PDs are required to submit the Exempt Application Form. In reviewing the application,

IRB staff refer to guidance Exempt Review Categories and use the Exemption

Eligibility Checklist to verify:

Whether the PD has requested an appropriate exemption, and

That exemption, if granted, is assigned under the appropriate category.
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The review is performed by IRB staff or IRB members who have the knowledge and

authority to confirm exemption (Chapter 3.4), or refer the protocol for expedited or

regular review.

If a protocol meets the criteria for exemption, a Notice of Exempt Review is generated

and is available for the PD.

If a protocol does not meet criteria for exemption, it is returned to the PD withnotification of failure to meet the criteria. As appropriate, the application is converted

to a Protocol Application for expedited or regular review.

Once a protocol is determined to be exempt, it is not reviewed again unless a

modification application is submitted. There is no continuing review process for

exempt research, as long as the criteria for exemption remain satisfied.

3.6 Federal versus State Requirements

Where applicable in each chapter of the HRPP Manual, STANFORD includes policies,procedures and a description or reference regarding the relevant areas in whichfederal and state law might apply and how they are different, and provides guidanceabout regulatory compliance. (AAHRPP Element I.3.F)

The IRB requires that PDs comply with the local, federal and state laws that areapplicable to their research.

A primary responsibility of the legal counsel to the IRB, who is a non-voting member ofthe IRB, is to provide advice to investigators and the IRB about such laws, particularlycompliance with state laws while acting in accordance with the Common Rule andFDA regulations.

As needed, and in consultation with legal counsel if necessary, IRB staff developeducational materials for investigators and IRB members and staff relating to newstate laws. Examples of such materials are guidancesResearch Surrogate DecisionMakerswhich explains California law, and Consent for Protocols Involving Childrenand Consenting Minors which includes the definitions for guardian under Californialaw.

See Chapter 12 for situations under California Law which have additional

requirements regarding the informed consent process when certain procedures and

uses are involved, and for disclosure requirements for HIV testing under CA Health &

Safety Code Section 121080.California Law ExceptionHealth & Safety Code section 24178(a):

Except for this section and the requirements set forth in Sections 24172 and24176, this chapter shall not apply to any person who is conducting a medicalexperiment as an investigator within an institution that holds an assurance withthe United States Department of Health and Human Services pursuant to Part46 of Title 45 of the Code of Federal Regulations and who obtains informedconsent in the method and manner required by those regulations.
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Laws of Other States (Research Outside of California)STANFORD investigators conduct research in states other than California. As eachstate has different laws, STANFORD investigators are expected to adhere to the lawsof the state in which research is being conducted as well as those of California.

When necessary other attorneys in the Office of the General Counsel or outsideattorneys retained by it can provide direction and interpretation of California and otherstates laws.

3.7 Investigators Conflicts of Interest

Because of the possibility that financial and other personal considerations might affect

research objectivity and harm human subject research participants, STANFORD has

written policies and procedures to identify, review, and manage, minimize or eliminate

conflicts of interest or apparent conflicts of interest of investigators. (AAHRPP

Element I.3.G)

Stanford University has the following policies and procedures regarding conflict of

interest for research carried out at Stanford University, Stanford Hospital and Clinics

(SHC), Lucile Packard Childrens Hospital (LPCH), or the Veterans Affairs Palo Alto

Health Care System (VAPAHCS) or elsewhere and involving: faculty members (all including School of Medicine): Stanford University

Research Policy Handbook- RPH 4.1 Faculty Policy on Conflict of Commitment and Interest, and- RPH 4.2 PHS and NSF Requirements Regarding Financial Disclosures

and Agency Notifications.

Stanford University has a process for annual reporting and certification of

compliance with the Faculty Policy on Conflict of Commitment and Interest. Additionally for faculty members (non School of Medicine only)

Annual Certification of Compliance with Faculty Policy on Conflict of Interestand Commitment

additionally for faculty members (School of Medicine only)- School of Medicine Policy Annual Certification of Compliance with Faculty

Policy on Conflict of Interest and Commitment- School of Medicine Procedures

Policies for staff and students are found at: academic staff member: Stanford University Research Policy Handbook,

RPH 4.4 Policy on Conflict of Interest and Commitment For Academic Staff(See also Chapter 9).

regular staff member: Administrative Guide Memo 15.2 Staff Policy onConflict of Commitment and Interest

student: Stanford University Research Policy Handbook, RPH 2.11Relationships Between Students (including Postdoctoral Scholars) andOutside Entities
http://www.stanford.edu/dept/DoR/rph/4-1.htmlhttp://www.stanford.edu/dept/DoR/rph/4-2.htmlhttp://www.stanford.edu/dept/DoR/rph/4-2.htmlhttp://www.stanford.edu/dept/DoR/opacs/COI_Final_Non-SoM.pdfhttp://www.stanford.edu/dept/DoR/opacs/COI_Final_SoM.pdfhttp://med.stanford.edu/coi/som_proceedures.htmlhttp://www.stanford.edu/dept/DoR/rph/4-4.htmlhttp://humansubjects.stanford.edu/hrpp/Chapter9.htmlhttp://adminguide.stanford.edu/15_2.pdfhttp://www.stanford.edu/dept/DoR/rph/2-11.htmlhttp://www.stanford.edu/dept/DoR/rph/2-11.htmlhttp://www.stanford.edu/dept/DoR/rph/2-11.htmlhttp://www.stanford.edu/dept/DoR/rph/2-11.htmlhttp://adminguide.stanford.edu/15_2.pdfhttp://humansubjects.stanford.edu/hrpp/Chapter9.htmlhttp://www.stanford.edu/dept/DoR/rph/4-4.htmlhttp://med.stanford.edu/coi/som_proceedures.htmlhttp://www.stanford.edu/dept/DoR/opacs/COI_Final_SoM.pdfhttp://www.stanford.edu/dept/DoR/opacs/COI_Final_Non-SoM.pdfhttp://www.stanford.edu/dept/DoR/rph/4-2.htmlhttp://www.stanford.edu/dept/DoR/rph/4-2.htmlhttp://www.stanford.edu/dept/DoR/rph/4-1.html


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recruits, selects, consents, or treats participants, plans to analyze data, or plans to serve as an author on any papers originating from this research, has a

conflicting interest or, whether any person who: is an immediate family member (spouse, dependent child as defined by IRS,

domestic partner of any of the above), or is in a supervisory role to the PD

has a conflicting interest. Similar questions are posed on the applications for

continuing revie

Documents

HRPP Policy Manual