Stanford University Office of the Dean of Research

Human Research Protection Program (HRPP)

DOMAIN I: ORGANIZATION

Chapter 4: Knowledge of Human Research Protection Requirements

STANFORD* ensures that all personnel reviewing, conducting, or supporting human research demonstrate and maintain sufficient knowledge of the ethical principles and federal, state, and local requirements for protecting research participants. (AAHRPP Standard I-4)

4.1 Education of Individuals Responsible for Human Research

STANFORD evaluates and contributes to the improvement of the qualifications and expertise of individuals responsible for protecting the rights and welfare of research participants. (AAHRPP Element I.4.A)

At STANFORD, education and training are provided to all individuals involved with the HRPP. The HRPP Manual specifies education requirements for IRB members, IRB staff, and key personnel on the research term (see Chapter 4.2). The RCO works with Stanford University schools and departments, the VAPAHCS, and other institutions, to offer comprehensive education to the STANFORD research community.

Education is offered in many areas of research, including ethical standards, related both to research and to professional conduct, STANFORD policies and procedures, and applicable federal, state, and local law. The foundation of ethical training at STANFORD is familiarity with The Belmont Report at http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.htm, which is made available at training sessions and on the Human Subjects Research website.

Research Compliance Office (RCO) Staff

The Research Compliance Office (RCO) has two full time staff, the HRPP Education Specialist and the IRB Training Specialist, dedicated to HRPP education. They develop and provide education for IRB members, IRB staff, and the research community regarding human research protections.

Evaluation of Qualifications

In addition to receiving training on human subject research protections (described in Chapter 4.2), IRB members and IRB staff are reviewed periodically to evaluate their understanding of the HRPP (ethical principles, policies and procedures, and regulations).

IRB staff qualifications are reviewed during the hiring process and annually or as needed to ensure a high level of commitment to the HRPP.

IRB member qualifications are reviewed by the HRPP Associate Director during the recruitment process, and IRB members are formally appointed by the Vice Provost and Dean of Research. IRB members, including IRB Chairs, are evaluated yearly to ensure that their service on the IRB contributes to the ethical and regulatory review of research at STANFORD. Feedback from these evaluations is communicated to each IRB Member by the IRB Training Specialist and to each IRB Chair by the RCO Director.

Investigators at STANFORD are evaluated according to individual institution, school, and department policies.

The Continuous Quality Improvement (CQI) program (described in Chapter 3.13) evaluates the effectiveness of the education provided. Results of the CQI evaluations are used to adjust the content of educational materials, improve delivery methods and identify appropriate audiences, and to communicate with the other components of the HRPP about updating their education and training.

Contributing to the Improvement of Expertise

New IRB members and IRB staff receive orientation to the STANFORD HRPP. All IRB members and IRB staff receive regular, ongoing training and continuing education. In addition, the IRB Training Specialist announces opportunities for continuing education in human research protections on a regular basis. IRB member and IRB staff attendance is encouraged at regulatory and professional meetings and conferences both locally and nationally, and for web broadcasts and seminars at STANFORD and in the greater community. Additionally, the RCO supports and encourages professional certification for qualified IRB staff.

Before IRB members can review protocols according to expedited review procedures, they must meet additional training and participation requirements. Members who review according to the expedited procedure are appointed by an IRB Chair. In addition, the RCO provides specific training tailored to the review of certain protocol types, e.g. the facilitated review for Central IRB (CIRB), protocols involving stem cells or biohazardous materials. IRB members’ expertise is considered when assigning primary reviewers (see Chapter 7).

Educational Materials and Resources

The STANFORD research community, IRB members, IRB staff and other individuals responsible for the protection of human research participants have access to a wealth of educational material, available online and in printed format, or offered as courses or workshops. They include, among others:

· The STANFORD HRPP Manual

· IRB educational materials, FAQs, and regular or ad hoc communications from the RCO

· Human Subjects Research website, providing instructional information, document templates, forms, and guidances

· The Office of the Dean of Research website

· The eProtocol electronic protocol submission system, providing instructional text and explanation as part of the application

· eProtocol training

· The Stanford University Research Policy Handbook, in particular, RPH 7.7 Human Subjects in Research

· PI-ship Handbook from the Office of the Dean of Research

· HIPAA training

Additional education is provided through classes, training courses, workshops, and seminars offered by the RCO and other HRPP component organizations.

Education Planning

Before the beginning of a new IRB Year (October 1), the HRPP Education and IRB Training Specialists meet with the CQI Associate Director to design the education plan. The plan incorporates input received from IRB members, IRB staff and investigators, and from CQI monitoring and evaluation activities. Trends in research at STANFORD are considered, and new federal, state or local regulations (or published guidances) are integrated. Compliance activities (e.g., internal and external audits) also provide input into the education plan, which is presented to the RCO Director and other senior managers for review and approval.

4.2 Required Training in Human Research Protections

STANFORD has the following written policies and procedures requiring all individuals involved with the Human Research Protection Program to understand and apply their obligation to protect the rights and welfare of research participants. (AAHRPP Element I.4.B)

Completion of human subject training by all staff working on a research project (all investigators and other study personnel, including all persons who are responsible for the design, conduct, data analysis or reporting) is one of the requirements for protocol approval by the IRB. Protocol Directors, as part of the protocol submission process, acknowledge their obligation to protect the rights and welfare of research participants. See Protocol Application “Obligations” section.

Stanford provides access to the required training through an interactive online tutorial - CITI (Collaborative IRB Training Initiative) Course in The Protection of Human Research Subjects. CITI offers a basic (initial) course and then a refresher course which must be taken every two years. The required training has been customized for different learner groups (medical and nonmedical investigators, IRB members, IRB staff, and Institutional Officials).

At the completion of the required modules, the learner can download, save and print a certificate of completion from the CITI website. Individual investigators must maintain their own records. It is the responsibility of the Protocol Director to ensure completion of the required training by all study personnel, including all persons who are responsible for the design, conduct, data analysis or reporting, and to have all certificates of completion available for inspection.

The training records of IRB Staff, IRB Members and Institutional Officials are maintained in the RCO.

RCO and IRB Staff Required Training

Training	IRB Staff CQI Staff RCO Sr. Management	Office Support IT Personnel
RCO orientation for new staff	x	x
HRPP Orientation for new staff	x	As needed
Human Subjects Tutorial (CITI)	x	x
CITI group(s)	6	6
HIPAA training	x	x
Continuing HRPP education	x	As needed

· IRB Staff = IRB Managers, IRB Associates, and their supervisors.

· CQI Staff = HRPP education and training staff, compliance staff, and records and documentation staff, and their supervisors

For newly hired RCO staff involved in the HRPP:

· HRPP Orientation is a three-month process managed by the IRB Training Specialist.

· CITI training must be completed within 30 days of employment in RCO, and must be renewed every two years.

· HIPAA training must be completed before handling Protected Health Information (PHI) or within 30 days of employment at Stanford, and must be renewed according to institution requirements. (Administrative Guide 23.10)

See the Stanford University general policies (Administrative Guides) regarding Employee Training.

IRB Members Required Training

Training	Medical IRB Members and Chairs	Nonmedical IRB Members and Chairs	Ex-Officio IRB Members
HRPP orientation for new members	x	x	If needed
Human Subjects Tutorial (CITI)	x	x	x
CITI group(s)	3	4	3 and/or 4, or 6*
HIPAA training	x	N/A	If on a medical IRB
Continuing HRPP education	x	x	x

*Ex-officio members who sit only on medical panels must take CITI Group 3.

Ex-officio members who sit only on nonmedical panels must take CITI Group 4. Ex-officio members who sit on both medical and nonmedical panels must take CITI Groups 3 and 4. Ex-officio members who are also RCO staff, must take CITI Group 6.

The IRB Training Specialist maintains training records for all IRB Members.

Institutional Officials Required Training

Institutional officials at Stanford University and the VAPAHCS must take CITI

Group 5. If an institutional official is also an investigator or an IRB member, additional CITI Groups might be required.

The IRB Training Specialist maintains training records for Institutional Officials.

Investigator Required Training

STANFORD requires that Protocol Directors and other key personnel involved in the design or conduct of a project, including those projects that may be deemed exempt under 45 CFR 46, provide evidence of training and qualifications by submitting relevant documentation as requested by the sponsor, IRB, or regulatory authorities. See Chapter 15.1.

The IRB-required training of investigators and other key personnel must be completed prior to IRB protocol approval.

Key personnel: all investigators and other study personnel, including all persons who are responsible for the design, conduct, data analysis or reporting of research that involves human subjects. Key personnel may include faculty, staff, students, or visiting or contract personnel, persons who obtain informed consent, administer surveys, or collect private or personal information from individuals.

The IRB training requirement applies to individuals working under the auspices of Stanford University, whether at Stanford facilities or at another location, and regardless of their institutional affiliation or source of funding. In the event that individuals from other institutions (“third-party” or contract employees) conduct research under the auspices of STANFORD, they must complete human subjects protections training, but may do so at their home institution. A letter, certificate, or email notification by a representative from their home institution will satisfy this requirement. Such individuals may also take the STANFORD CITI modules, if desired. All IRB-required training completion records must be maintained by the STANFORD Protocol Director.

Training	SU, SHC, and LPCH Investigators	VA Investigators
Human Subjects Tutorial (CITI)	Group 1 (medical) Group 2 (nonmedical)	Contact the VA Research Administration
HIPAA training	As required by employing institution

Examples of training required of investigators per other STANFORD, non-IRB, policies, typically prior to engaging in research are listed below. Refer to individual entities and departments for more information.

· Managing Cost Issues (Office of Research Administration)

· Sponsor-Investigator Training (SPCTRM, CCTO)

· ABCs of Research (Office of Research Administration)

· Ethics training courses and resources (Stanford Center for Biomedical Ethics, or Program for Ethics in Society)

· Stewardship and Compliance for PIs (Office of the Dean of Research)

· PI Health and Safety Training (School of Medicine)

· Sponsored Projects Administration Overview (Office of Research Administration)

· Human Embryonic Stem Cell Research Tutorial (Office of Research Administration)

· Environmental health and safety training (Environmental Health and Safety)

· VHA Handbook 1200.5 Chapter 5 at http://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=418.

Individual investigators maintain their own training records for CITI, HIPAA, and any other required training.

The HRPP Education Specialist is a resource for any questions regarding HRPP education for the research community.