Communications This module discusses an overall approach to developing a broad National Biospecimen Network (NBN) communications effort to attain support from the public, patients, and the research community. For the purposes of this discussion, NBN communications refers to all efforts— education and training, outreach, and public relations activities—to market the NBN to its key constituencies and to develop and maintain clear communication with all participants in the system. 5.1 Introduction The success of the NBN will depend fundamentally on its ability to engage the research and clinical care communities and the public from the very outset of the project. Open and effective communication with all parties who might be involved with the NBN will be a critical tool for engagement. Members of the National Dialogue on Cancer (NDC) Tissue Access Working Group (TAWG) recognized the importance of educating stakeholders as a means of encouraging participation in a national biospecimen system. Education about privacy, confidentiality, and other ethical issues should be an integral part of the overall master plan of a national biospecimen resource. Information about tissue banking and the NBN informed consent process must be well communicated to all participants, including patients, institutional review boards (IRBs), and professional associations. With effective education about the program, it will be possible to advance with public, professional, and patient support behind the issues to overcome sociopolitical barriers. The educational needs of each of the stakeholders will be different. These needs will drive the development of an overall education program about the national resource, and the separate components targeted to each of the major stakeholders. 5.2 Background A well-planned, comprehensive communications strategy could effectively overcome barriers to support by the various groups from whom participation in the NBN is most highly sought. This module examines: The nature of potential barriers to the collection and use of biospecimen tissue and related information The components of a successful communications strategy that could overcome these potential barriers Specific recommendations for how the NBN could develop a communications strategy, starting at the earliest stage of NBN planning, and maximize visibility and use of the resulting valuable resource 5.2.1 Considerations in the Acquisition and Use of Tissues With better supported biospecimen resource sharing facilities, researchers will be better able to obtain appropriate biospecimen samples and related information so critical to scientific discovery. Researchers may fail to use a resource for a number of reasons. The usual and most obvious reason is that they are not aware that it exists. However, other more subtle factors may be at work. The costs may be prohibitive, the number of available samples may be inadequate for their research needs, or the samples may not be sufficiently annotated or linked to appropriate clinical data for their research needs. On the supply side, most patients are willing and eager to participate, but may find few organized opportunities in the community hospital setting. Potential tissue donors should have ample opportunities to learn about the importance of tissue in clinical research, and the steps to take in order to donate; and to receive assurances that they will be apprised of the outcome of the research and about privacy and confidentiality issues. A broad and effective NBN communications plan will help overcome these possible barriers by helping to manage expectations and correct misperceptions, and by fully acquainting all parties with NBN policies and procedures. In the past, efforts like the NBN may have been less than successful because communications planning was not considered a key part of the development process and start-up effort. Communication (particularly to patients) has not been a major priority for many existing resources.1 By contrast, communications planning for the NBN will begin with the earliest planning phase and will be carried out in conjunction with the overall development of the project and at the Operations level (see 6. Governance and Business Models). Communications, at every stage, will reflect other policy decisions taken by the NBN. 5.2.2 Multiphase Approach to the NBN Communications Efforts The NBN tissue bank will involve a multistaged process of tissue collection, pathologic evaluation, preparation, storage, retrieval, and distribution for use. Each of these stages will have a different set of communications issues, key players, and desired outcomes. NBN communications programs will handle each stage as a discrete effort, with its own strategy, message, and evaluation mechanism. One of the first steps in developing an NBN communications plan will be a careful needs assessment for each stage of the process and for each stage in the development of NBN. The NBN communications activity will be an ongoing process. It will not be sufficient to develop a single campaign to alert researchers to the availability of a resource. Effective communications planning will have to encompass both the initial education campaign and ongoing education/outreach and public relations efforts. The NBN will employ a well-established, evidence-based model in planning the NBN communications activity. The model, which has been used successfully in planning and executing large-scale communications efforts surrounding health and social issues, is broadly referred to as social marketing. The approach is based upon classic marketing principles, which place an emphasis on careful preplanning, based on effective research. By using up-front research to identify specific targets, planners can divide potential audiences into subgroups. Planners can target specific messages to a particular group, using media and channels known to be effective in reaching that audience. This approach avoids the common mistake of developing an expensive outreach/education effort, only to discover that the messages chosen have no resonance with the target audience, and/or that the methods used to communicate the messages do not even reach the intended audiences. The social marketing process is systematic and continuous; research-based decisionmaking at every phase feeds back into the process. There are seven general stages to the process, as depicted in Figure 5-1. Figure 5-1: Evidence-Based Process to Develop a Communications Plan for the NBN 5.2.2.1 Analysis The most important stage of the process is the preliminary analysis. In this early phase, the NBN will gather information to address the following questions: What is the NBN trying to communicate, and to whom? Who needs information about the NBN, and what specific information do they need? When is the information needed, and in what context? What barriers exist to communication? What are the optimal ways to reach various constituents with respect to both the type of media and the channels through which the media will pass? Patients will have different needs at different times in the process. For example, potential donors will need information about research and the NBN in general, and about the benefits of participation. They may need additional information about how to donate specimens and about their rights as donors at the time of surgery, and again after their tissue has been banked. The planning process must take into account these disparate needs and their timing, and should develop a systematic strategy that meets the needs effectively and efficiently. 5.2.2.2 Planning and Strategy Development The communications plan, developed as a working document, should present the background issues and provide direction for how the communications strategy will unfold. This plan should discuss the key audiences and delineate the specific information needs and interests of each target group, the ways in which each group typically obtains information, and the type of language most appropriate for each group. At this stage, program planners also will build in evaluation steps to ensure that the various activities are having their desired effect and that resources are being used most effectively. 5.2.2.3 Selecting and Developing Channels and Materials Once the preliminary communications plan is in place, planners can begin developing the education programs. Information needs that were identified during the analysis phase will be converted into specific messages. Planners will select the types of materials and the channels best suited to both the audience and messages to be communicated. If preliminary analysis indicates, for example, that researchers need training in the use of the NBN resources, planners will consider the best format available for conducting such training. They might use any of the following techniques: Formal continuing education courses, involving paper-based instruction, CD-ROM, or a Web-based system Informal training through articles in professional journals Training sessions at professional meetings The NBN planners will select those channels that are most likely to have the desired outcome and reach the optimal number of end users at the lowest cost, and then develop the materials consistent with the research findings. The materials will be tested with the target audience to ensure that they have their desired effect. Based on the results of the testing, the materials can be modified to improve effectiveness. 5.2.2.4 Implementation After the materials are ready for distribution, the education effort will be implemented. It will be important to monitor the program to ensure that it is developing as planned. Process monitoring may include, for example, assessing whether distributors of materials have received them, whether public service pieces were placed as planned, and whether posters appeared in correct locations. 5.2.2.5 Assessing Effectiveness and Providing Feedback After the education efforts have been in place for some time, planners will evaluate whether the program is having the intended results. The evaluation method will depend, in part, upon the desired objective (for example, if the program were designed to increase the public’s knowledge of the NBN, or if the program were designed to increase patient participation rates). The results of the evaluation efforts would be fed back into the communications planning process, so that refinements to the approach can be made. 5.2.3 Developing the Communications Plan An effective way for the NBN to develop the communications plan is to obtain the services of a professional communications firm to assist with formalizing and implementing the NBN communications plan. With the completion of the preliminary work conducted in the planning phase, the NBN will have created a document that could be used in developing more specific tasking plans. There are a number of available contracting vehicles specifically designed to obtain communications-related services, which the NBN could use to procure the desired services. 5.2.4 Key Issues to Consider in the Communications Planning Effort The NBN Design Team raised a number of issues that will need to be addressed in the development of the NBN. Many of these may be effectively resolved through the communications activities of the NBN. 5.2.4.1 Communicating Research Information to Patients Patients are increasingly aware that test and research results from their tissues might be used to develop new therapies and identify risk factors that may be useful for their own disease. Returning research results to patients, however, raises major concerns. Patient/physician reliance upon unvalidated results for clinical decisionmaking has caused harm to patients. 2 It is important that research results be validated and done in a reliable (e.g., Clinical Laboratories Improvement Act approved) laboratory before they are used for clinical decisionmaking. There is a potential risk of liability in providing information to patients at too early a stage in the research. The release of preliminary research results can lead to anxiety or requests for unnecessary procedures by uninformed patients. Donors will not have access to research results directly related to their specimen, but only to a class of data. This topic is further discussed in 2. Management of Ethical and Legal Issues. 5.2.4.2 Communicating General Information on Research Results to the Public The NBN will need to devise a strategy for communicating general research results in a way that satisfies participants’ needs for information, researchers’ desires to withhold their results until they are published or until patents are applied for, and physicians’ desires to protect their patients from the harm that can come from the release of premature research results. Consumer advocates should be engaged in the communications process. The challenge will be managing expectations from different constituencies and facilitating the balance between the responsible use of results by consumers and clinicians on the one hand, and the free availability of information demanded by scientists on the other. Useful models for making data available to patients include the approaches taken by First Genetic Trust (FGT) and IMPATH, Inc.3 5.2.4.3 Encouraging Equal Participation Among all Groups The importance of having the NBN reflect the broad diversity of the U.S. population has been discussed elsewhere (see 2. Management of Ethical and Legal Issues and 3. Biospecimen and Data Collection and Distribution). Sociocultural values, economic disparities, and structural and institutional barriers all contribute to perpetuating significant health disparities among minority populations in the United States. NBN outreach efforts will play a key role in reaching this objective. Special consideration must be given to the education and information needs of special populations, and to the challenges they face in participating in the system. A careful review of those repositories that have made an effort to increase minority representation, as illustrated in the RAND Report, will help the NBN plan this part of the outreach program. 5.3 Assessment of Stakeholders This module has described communications planning as an information-based process in which each stage depends upon the information gathered in the previous stages. The very first step is to conduct a careful assessment of information needs of various NBN stakeholders. Each stakeholder group has specific concerns and needs that will require tailored educational approaches. Education of stakeholders will encourage overall participation in the system and, in particular, will facilitate the consent process as a precursor to tissue collection. This section presents a very preliminary needs assessment of those involved with the NBN. The NBN planners will want to reevaluate these needs before developing a communications plan. This preliminary assessment will, however, be useful in defining the general requirements for the NBN communications plan. The various components of the education program will need to be implemented using various methodologies in multiple settings. NDC TAWG members have suggested, as an intermediate goal, the use of educational forums at professional societies.4 5.3.1.1 The General Public The public’s concern with privacy and confidentiality may make some patients unwilling to donate tissue. Perceptions about tissue donation and research, and underlying sociocultural factors may affect the creation, implementation, and operation of a national biospecimen resource. For a variety of reasons, racial, ethnic, and cultural minorities have demonstrated lower rates of living and cadaveric organ and tissue donation for transplantation.5 The lower donation rates have lead to disparities in health outcomes as some minority groups are over-represented on the organ waiting lists because of their higher rates of diseases such as end stage renal disease. These same factors may also affect the willingness of those groups to donate tissue for research. The consequent lack of adequate samples from subgroups of the population could impede the development of effective interventions or treatments targeted to these groups. Recent education efforts, such as the National Minority Organ and Tissue Transplant Education Program (MOTTEP), aimed at improving organ donation rates among some ethnic minority groups seem to have met with some success, and may also help promote a willingness to donate tissue for research among these group and may serve as models or collaborative opportunities for minoritytargeted NBN education programs.6 An education program for the general public that helps to raise the overall level of understanding about biomedical and clinical research, addresses widely held misperceptions, and eases fears about privacy and confidentiality, could be very effective for promoting the NBN purpose. Increased knowledge about basic biomedical and clinical research and the benefits to research participation will form the backdrop for a specific program to encourage the public’s willingness to participate. Even at this general level, in order to be effective, education efforts must be culturally sensitive and designed with an appreciation for the different attitudes toward biomedical research and how they color a group’s perception of and attitudes toward involvement in research. 5.3.1.2 Patients (Potential Donors) In addition to the general information developed for the public, the education program for patients should consider a number of additional concepts. Ethical concerns, the informed consent process, and what to expect Guarantee of privacy and confidentiality, and how this will be accomplished Future access to tissue and residual rights with tissue and information Future access to research results Education for patients must be culturally sensitive. It must respect the basis of cultural barriers to participation, while providing enough accurate information to allow the potential participants to consider reasonable alternatives. 5.3.1.3 Family Physicians and Oncologists The education program for the family physician and oncologist should focus on several types of information. Benefits of the NBN for research and therapies Information about how to counsel patients regarding tissue donation options Sociocultural issues that might influence their patients’ willingness to discuss and participate in the system General information about the informed consent process and what to expect 5.3.1.4 Surgeons and Radiologists The education program for surgeons/radiologists should focus on the following points. Benefits of the NBN for research and therapies Information about how to counsel patients regarding tissue donation options Specimen collection standards Pathologists and surgeons may be reluctant to provide tissue for research because of liability concerns related to protection of privacy. An effective education program also will address these concerns.7 5.3.1.5 Pathologists, Biospecimen, and Clinical Data Banking Staff The education program for the pathologists and staff responsible for banking biospecimens and clinical data should include specimen collection, preparation standards, and quality-control procedures. 5.3.1.6 Researchers The education program for the researchers should focus on several issues: Benefits of using the system How to access and use the system Regulatory requirements governing access to and use of tissue samples and associated information, and what they need to do to comply NBN will reach the research community through a variety of methods, including public advertisements, Web sites, and exhibits at national meetings. Additional outreach activities might include the following: Education forums at broad-based and discipline-specific professional societies involving pathologists, radiologists, and ethicists (e.g., American Association for Cancer Research, American Society for Clinical Oncology) NDC activities at, for example, the Public Responsibility in Medicine and Research meetings, where ethics groups gather Publications in high-impact media and biomedical research journals 5.3.1.7 Community-based Institutions It will be important to create incentives for the healthcare community to participate in the NBN program. A communications program will need to answer the hospitals’ question, “What is our role?” The education program for the community-based institutions will have to provide information on several topics: Benefits of participating in the system Impact on staff from participation in the system Kind of training required Role of consent counselors to educate patients/donors about patient issues Training of staff about collection and preparation of biospecimens for storage Training of IRBs for new role in the consent process and infrastructure provided 5.3.1.7.1 Hospital Admissions Staff The hospital admission staff is likely to be one of the earliest points of contact with potential donors. They must understand not only the benefits of research and participation in general, but also the critical role of hospitals in the process. The education program for the hospital admissions staff should focus on several areas: Benefits of participating in the system The vital role of the community-based institution in the acquisition process General information about the standardized and institutional informed consent process How to implement the standardized and institutional informed consent process, and what issues and questions to expect Training in how to answer questions about the use of specimens for research 5.3.1.7.2 Local Institution Review Boards The education program for members of local IRBs should focus on a number of areas: Benefits of supporting the system Role in protecting the patient in a new national system The need to allow patients to make their own choices about participation in the research process How to address tissue donation options General information about the standardized and institutional informed consent process and what to expect, and why standardized consent is so valuable in genetic research 5.3.1.8 Patient Advocacy Groups The education program for the advocacy groups should include: Benefits of the NBN to patient health Presentation of tissue donation options to their membership Sociocultural issues that might influence patients’ willingness to participate Information about the informed consent process and the patient’s right to retrospectively revoke consent Clarification that donors can expect to obtain generalized, not individualized, results deriving from their donation 5.3.1.9 Existing Repositories The NBN should be clear in how it can serve as an additional resource that will help support research activities that current repositories were not designed to undertake. It will be important for the NBN to craft messages that reflect the collaborative spirit and open access inherent in its purpose. 5.4 Summary of Key Findings and Recommendations In order for the NBN to succeed, it must be supported by many groups: Patients/potential donors, researchers, clinicians, academic institutions, hospitals, and commercial interests. This support will require a well-developed, comprehensive communications plan initiated at the earliest stage of the NBN project and sustained from development through implementation. Through a comprehensive program of education and training, outreach, and public relations, the NBN will promote a clear, accurate, and consistent set of messages about the resource. The information campaign will help to manage expectations and provide information about NBN policies that will encourage widespread confidence and trust in the new system. The following section provides more detail on specific recommendations. Organizational Issues Effective communications among stakeholders should be considered a high priority for the NBN, and planning of the communications program should begin as early as possible. The NBN communications program should be broad and comprehensive, to meet a variety of communications needs and directed toward diverse stakeholders. Communications should be structured to ensure consistency of the NBN message throughout the planning, development, and implementation of the NBN program. The NBN should employ an evidence-based model in planning NBN communications. Under this model, planners identify the various audiences and determine their particular needs. Based on that information, the planners design a strategy to tailor messages to each specific audience, using appropriate media and effective channels of delivery. Primary Communications Needs Expectations Management. The NBN should design a communication strategy that clarifies NBN’s role and minimizes unrealistic expectations among different stakeholders (e.g., patients, researchers, potential financial sponsors, advocacy groups). Minority Participation. The NBN should design and implement communications strategies to encourage underrepresented ethnic and racial groups to contribute tissue samples. This will ensure a just system and a high-quality data bank that is capable of the highest level of research. Longitudinal Data. To develop high-quality longitudinal data, the NBN should develop a communication strategy that encourages patients to make a long-term commitment to providing the NBN with data (and possibly subsequent specimens). Informed Consent and Communications. The NBN should develop model methods for obtaining informed consent from patients, and model materials (including forms) explaining the consent process. Clinician and Researcher Marketing. The NBN is only successful if researchers use it to make new discoveries to accelerate progress against cancer. The NBN must place a strong emphasis on encouraging clinicians to participate in the system and encouraging researchers to use the resource as much as possible. Crisis Management. The NBN should design a communications strategy that, from the beginning, can handle unexpected crises—be they issues of technology, flawed human character, or political developments.

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Footnotes 1 Eiseman E., Brower J., Olmsted S., Clancy N., and Bloom G. (2003). Case Studies of Existing Human Tissue Repositories: “Best Practices” for a Biospecimen Resource for the Genomic and Proteomic Era. RAND Science and Technology. (August 28). 2 Eisen A. and Weber B.L. (2001). Prophylactic Mastectomy for Women with BRCA1 and BRCA2 Mutations – Facts and Controversy. N. Engl. J. Med., Vol. 345, No. 3 (July 19): 207-208. 3 IMPATH, Inc., is a private company formed in 1988 to improve outcomes for cancer patients by providing cancer information and analyses. IMPATH’s mission is “to develop and offer innovative products and services that lead to more accurate diagnosis and more effective treatments for cancer patients.” Two key components of IMPATH’s integrated services to help accelerate the drug discovery and development process are its unique GeneBank tissue and serology archive, which is linked to longitudinal data, and the IMPATH Clinical Trials Network. IMPATH has a database of over 1 million patient profiles and outcomes data on over 2.3 million individuals. See www.impath.com for more information about the company. Additional information about FGT can be found in Appendix R and on the FGT Web site, www.firstgenetic.net. 4 TAWG Meeting Summary, January 2003, p. 13. http://www.ndoc.org/Jan_2003_meeting_summary.pdf 5 Verble M., et al. (2002). A multiethnic study of the relationship between fears and refusal rates. Prog. Transplant., Vol. 12, No. 3 185-190.; Boulware L.E., et al. (2002). Understanding disparities in willingness to donate blood and cadaveric organs. Medical Care, Vol. 40:85-95; Boulware L.E., et al. (2002). Determinants of willingness to donate living related and cadaveric organs: identifying opportunities for intervention. Transplantation, Vol. 73:1683-1691. 6 Callender C.O., et al. (2002). Increasing living donations: Expanding the national Mottep commnirt Grassroots model. Transplantation Proceedings, Vol. 34, No. 7 (November 2): 2563-2564; Callender C.O., et al. (2002). National MOTTEP: Educating to prevent the need for transplantation. Ethnicity & Disease, Vol. 12, No. 1 (Winter): SI34-SI37. 7 NDC Forum II Meeting Summary, March 2003, p. 20.

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