STANFORD employs several mechanisms for communication and education to increase public awareness and educate potential research participants.

20.1 On-line Resources and Educational Materials

Section revised: 3/13/13

STANFORD conducts activities designed to enhance understanding of human research by participants, prospective participants, or their communities, when appropriate. These activities are evaluated on a regular basis for improvement. (AAHRPP Element I.4.B.)

Human Subjects Research website

The Human Subjects Research website contains:

· The For Participants page which provides information and resources about participating in research for participants, prospective participants, and community members, including:

- Frequently asked questions (FAQs)

- Link to a listing of current clinical trials taking place at STANFORD Definitions of research terms (e.g. clinical trials, including the various phases and informed consent)

- General information on the rights of research participants and questions to ask before agreeing to participate in research

- Links to OHRP brochures: Becoming a Research Volunteer: It's Your Decision (in English and Spanish)

- Links to entities and organizations where research information can be obtained (e.g. National Cancer Institute, FDA and OHRP)

- Contact information for inquiries about current research at STANFORD

- Link to the Circle of Supporters of the Center for Information and Study on Clinical Research Participation (CISCRP) website (see below.)

Association for the Accreditation of Human Research Protection Programs (AAHRPP)

AAHRPP is an independent, non-profit accrediting body, ensuring that accredited programs, such as the Stanford Human Research Protection Program (HRPP), meet rigorous standards for quality, participant protection, and ethically sound research.

Information about accredited programs, and about being a research participant, is available on the AAHRPP website.

Circle of Supporters of the Center for Information and Study on Clinical Research Participation (CISCRP)

STANFORD is a member of CISCRP, a nonprofit group dedicated to educating and informing the public, patients, medical/research communities, the media, and policy makers about clinical research participation.

Stanford Cancer Institute

The Stanford Cancer Institute publishes a newsletter and maintains a research-related website that promotes public awareness and participant education. See the Stanford Cancer Institute website Outreach Programs and Public and Professional Education pages. It also offers prospective participants information on available research opportunities and other research related topics.

Other STANFORD Resources

· Other departments at STANFORD provide web-based information on current research opportunities (e.g. Bipolar Disorders Clinic, Stanford Prevention Research Center).

· The Stanford Health Library is a free public consumer health information library that provides scientifically based medical information to help people make informed decisions about their health and their health care. The Health Library is a community service of Stanford Hospital and Clinics (SHC).

· The Stanford Mini Med School, available to the general public, features more than thirty scientists and physicians from the School of Medicine, and offers a dynamic introduction to the world of human health and the groundbreaking changes taking place in medical research and health care today. Significant parts of the course are available online for free.

· The Veterans Health Administration offers information on a variety of research topics.

20.2 Participant Research Inquiries

Section revised: 3/13/13

Participant inquiries about clinical studies are handled by the Stanford Center for Clinical and Translational Education and Research (Spectrum). Inquiries received by RCO staff are forwarded to Spectrum. Using a database of studies, the Spectrum staff provides contact information to prospective participants for active research being conducted at STANFORD.

The Human Subjects website For Participants summarizes resources for obtaining information and contacting appropriate individuals/offices, including the Spectrum resource page Patients & Community.

20.3 Outreach

Section revised: 3/13/13

· Center for Information and Study on Clinical Research Participation (CISCRP) – The Research Compliance Office and STANFORD researchers participate in the AWARE for All program – Clinical Research Education Days. These educational programs are held in metropolitan areas and are free and open to the public. They include thank you receptions for local clinical research participants, informational workshops with renowned physicians and researchers, health screenings and additional educational resources. (See CISCRP website)

· Spectrum administers Research Match, a website to bring together people who are trying to find research studies, and researchers who are looking for people to participate in their studies. The Research Match registry is free and secure, and anyone can join.

· Office of Community Health (OCH) supports informed, committed, and sustained community engagement in local health issues.

· The Stanford Health Library is sponsored by Stanford Hospital & Clinics, and provides scientifically-based free health and medical information.

· Stanford Continuing Studies often offers courses and sponsors free public events covering the life sciences and related topics.

· The Stanford Blood Center, in collaboration with “Café Scientifique”, presents lectures on health and medical research-related topics which are free and open to the public.

· Clark Center Lectures: The Bio-X Program supports, organizes, and facilitates life bioscience interdisciplinary research by successfully bridging the disciplines of biology, medicine, engineering, computation, and physics to advance biomedical knowledge. The James H. Clark Center is the hub of Bio-X, and a variety of events are hosted at the Center. These events are open to the public. Some major programs are: Bio-X Interdisciplinary Initiatives Symposium; Bio-X Frontiers in Interdisciplinary Biosciences; Bio-X Annual Symposiums; and Bio-X Fellows Symposium.

Expansion of these mechanisms to provide additional information such as new educational brochures, participation in outreach activities, and utilization of other educational resources is a goal of the Continuous Quality Improvement team of the Research Compliance Office (RCO).

20.4 Evaluation

Section revised: 3/13/13

Evaluations take place in an ongoing manner. The various organizations cited in the previous sections of this chapter evaluate their impact on an ongoing basis. For instance, course evaluation surveys are routinely used as part of Stanford’s Continuing Studies courses; Spectrum has a Tracking and Evaluation Program (and in a recent study performed by Spectrum over 1000 past research participants were asked to respond to a comprehensive survey); CISCRP conducts surveys regarding public opinion on clinical research on a regular basis, and makes their survey results available.

All IRB staff, members and Chairs are requested to report both positive and negative feedback about all HRPP outreach activities, (wherever the feedback originates), to the IRB Education staff, who track this input in order to make changes to improve outreach activities.

20.5 Community Participation in Research

Section revised: 9/11/13

STANFORD promotes the involvement of community members, when appropriate, in the design and implementation of research and the dissemination of results. (AAHRPP Element I.4.C)

For certain types of studies it might be appropriate to involve individuals from the community in which the research will take place, in the design and conduct of the research. Stanford University supports and facilitates such community participation through a number of initiatives which address community-based issues, and by supporting researchers with programs that address issues of importance to the community in which we operate. These efforts may involve close collaboration with constituent communities and interest-groups.

Information for the community at large and potential research participants is available on numerous websites supported by the University, and informational literature is distributed locally to community organizations, clinics, and other locations.

As appropriate to their study, researchers are encouraged to contact resources at Stanford for information on engaging and involving the community in research.

Stanford resources

Stanford resources include:

· The Office of Community Health (OCH): Builds opportunities for substantive community engagement among medical, graduate and undergraduate students; supports and develops faculty engagement in community health; promotes the translation and dissemination of scholarly work on health issues affecting local communities; and responds to community-health related needs and inquiries from students, faculty, health professionals and members of the surrounding community. The objective of the Office of Community Health Research Program (OCHRP) is to establish and promote a new culture in which community engagement and the translation of research findings from the bedside to the community, and the flow of new research questions from the community back to the investigators, are key components of success.

To reach this objective, OCHRP:

- Strengthen community partnerships and facilitate two-way communication on research goals by providing a single point-of-contact for community groups, achieved in part by collaboration between the office and a broadly representative community advisory board.

- Build the capacity for community-based outcomes research at Stanford by providing staff support, expert consultation, and training.

- Integrate faculty and staff who have expertise in community-based and outcomes research into the Center for Innovative Study Design (CISD).

- Create systems to facilitate research partnerships that will increase the diversity of research participants represented in our clinical studies.

- Promote active dissemination of research results by using existing partnerships, shared clinical information systems, and experience in implementation science to effectively translate and incorporate new evidence-based science into clinical practice.

Community based participatory research is not limited to the School of Medicine, but may involve collaboration between the Stanford University Schools – for example, research on obesity prevention involving faculty of the School of Medicine and the School of Education.

Additionally, the OCH uses resources of the Community-Campus Partnerships in Health, and works with a number of community partner organizations such as free clinics, local schools and school districts, community health centers, and advocacy programs.

For more information on the goals, and current and planned programs and activities of the OCH, see the OCH Strategic Plan.

· Scholarly Concentration in Community Health: This is a School of Medicine -required course for first year medical students, involving research carried out in partnership with community organizations.

· An annual Community Health Symposium organized by medical students highlights and disseminates student work in the community, co-sponsored by OCH and the Stanford Center for Clinical and Translational Education and Research (Spectrum)

· Public Health Research: Research into the socioeconomic, environmental and behavioral determinants of disease.

· Stanford Prevention Research Center (SPRC): Conducts interdisciplinary research into the determinants of chronic disease; develops community-based prevention strategies.

· Department of Health Research and Policy: Supports biostatistical and epidemiological research into pressing public health issues.

· The Center for Innovative Study Design (CISD): Provides support in study design or access to other useful resources for investigators involved in community-based research.

· Population Health Sciences Initiatives: The aim of the program is to achieve the “translation” of new technologies and therapies from the laboratory to the patient and community. The Stanford Prevention Research Center (SPRC), Primary Care and Outcomes Research Center (PCOR), and Biomedical Informatics Research Center (BMIR), are among the world’s leaders in population based research. To promote the success of this initiative, the department is creating a new Quantitative Sciences Unit comprised of biostatisticians and data analysts; Center for Quality and Effectiveness; and an expanded program of contemporary clinical epidemiology linked to clinical genomics. These programs, along with existing programs in SPRC and General Internal Medicine, will form the core of a new Center for Patient and Population Research.

· HAAS Center for Public Service - Community-Based Research Fellows Program: Supports teams of faculty, students, and community partners in conducting research that addresses community-identified research needs.

· Under the Office of the Vice Provost and Dean of Research, the Freeman Spogli Institute for International Studies’ Center for Health Policy (CHP), and the School of Medicine’s Center for Primary Care and Outcomes Research (PCOR) - operating under the joint working name of Stanford Health Policy - conduct multidisciplinary research into critical health policy and health-care delivery issues. Community stakeholders are included, for example, when:

- Stanford Health Policy promotes interaction among leading researchers, clinicians, healthcare executives, policymakers and members of the public by hosting seminars, lectures and roundtables. These forums provide vital opportunities for the health policy community at Stanford and in the San Francisco Bay Area to share ideas and expertise.

· School of Education: Supports various programs and projects affecting the local and broader communities. For example:

- The John W. Gardner Center for Youth and Their Communities (JGC) partners with communities to research, develop, and disseminate effective practices and models for developing well rounded young people. The School Redesign Network (SRN), associated with the Stanford Center for Opportunity Policy in Education (SCOPE) partners with a local high school to showcase a teacher-led redesign effort to other school and school district leaders (administrators, principals, teachers, school board members, and parent leaders).

· School of Humanities and Sciences: Within this school:

- The Institute for Research in the Social Sciences (IRiSS) is home to the Research Experience Program (REP), a mutually beneficial research collaboration between Stanford University and local community colleges. The REP enriches the student experience by allowing community college students to participate in social science research projects, and gain exposure to the research process, as well as also expanding the pool of research subjects available for Stanford researchers, enabling them to conduct more robust and timely experiments. Participating community college instructors are designated as Affiliates of IRiSS and invited to participate in IRiSS and MAPSS (Methods of Analysis Program in the Social Sciences) events held at Stanford.

Considerations for IRB Review

In addition to applying all relevant federal, state and local regulations and Stanford policies, when reviewing such research, the IRB may consider the following, as pertinent to the type of research proposed:

· The appropriate community, and community representatives have been identified

· The research plan involves collaboration and communication between researchers and community in research design, conduct, and dissemination of results as appropriate

· It is recognized that the design and conduct of each phase of the research may be a somewhat iterative process, as researchers and community members gain knowledge and familiarity with the process

· Additional expertise will be called upon as needed to provide input on cultural or local context, or other special circumstances

· In addition to traditional research publication routes, results will be disseminated in ways that are accessible and intelligible to the community involved in the research

· Possible impacts of the research on the community beyond the life of the current project are addressed.