Advocates in Research Working Group Background and Final Recommendations

1. Advocates in Research Working GroupBackground and Final Recommendations Office of Advocacy Relations National Cancer Institute Fall 2009 If you are having any problems accessing this presentation please email nciadvocacywg@mail.nih.gov.

2. Advocates in Research Working Group (ARWG) Final Recommendations – Public Comment Period • The Advocates in Research Working Group has provided final recommendations on the most effective ways to engage individual advocates at the National Cancer Institute (NCI). • The Public Comment period for these recommendations will be open through November 30, 2009. • Provide your comments by November 30, 2009 through email: nciadvocacywg@mail.nih.govor by mail: Shannon Bell Office of Advocacy Relations 31 Center Drive, Room 10A28 Bethesda, MD 20892-2580

3. Research Advocate Background • The goal of involving advocates in research is to enhance the scientific process and improve patient outcomes by providing diverse perspectives. • Advocates have become increasingly involved in the research process over the last several decades. • Within the last decade, the involvement of patient advocates in the research process, particularly in the cancer research process, has been made a priority by the governments of the United States and the United Kingdom. • At the National Cancer Institute (NCI) the Office of Advocacy Relations (OAR) coordinates advocate involvement in NCI activities.

4. 1974- Public members mandated on NCAB. 1996 - NCI Office of Advocacy Relations created 1997 - NCI Director’s Consumer Liaison Group chartered 1998 - NCI involves advocates in peer review for the first time. 2001 - Consumer Advocates in Research and Related Activities program: Advocates involved in all clinical and translational peer review through the CARRA program. Advocates involved in additional types of NCI activities 2007 - NCI Director requests recommendations from the DCLG on how to best engage advocates in NCI activities Timeline Highlights of Advocacy Involvement at NCI

5. Advocacy ContinuumPersonal Advocacy to Community Advocacy to National Advocacy • National Advocacy • Lobby Congress • Professional staff for Komen, ACS... • DOD Peer Review • Community Advocacy • Support groups • Speaking at the local level • Community-based fundraising • Personal Advocacy • Finding information • Getting a second opinion • Knowing what questions to ask • Working for rights around insurance, employment, privacy, etc. The Advocacy Continuum from the National Coalition for Cancer Survivorship (NCCS)

6. Five types of advocacy are: Research, Support, Policy/Political, Outreach & Education, and Fundraising A model developed by Jane Perlmutter, Ph.D., Consultant and Cancer Research Advocate Types of Advocacy

7. Research Advocate - Definition • A research advocate brings a non-scientific viewpoint to the research process and communicates a collective patient perspective. Notes: • A patient perspective is created when a person goes through personal or professional experience with the disease. • A collective patient perspective is created when the person has knowledge of others’ disease experiences and conveys this collective patient perspective rather than their singular experience.

8. NCI Programs and Areas With Current Research Advocate Involvement – A Sample • SPOREs • Cooperative Groups • Cancer Centers • NCI Advisory Boards • Programmatic Steering Committees • Office of Biorepositories and Biospecimen Research (OBBR) • Coordinating Center for Clinical Trials (CCCT) • NCI Community Cancer Centers Program (NCCCP) • Study Steering Committees • Breast Cancer Family Registry • Colon Cancer Family Registry • Publications Review • NCI Professional Judgment (Bypass) Budget • Patient Publications and Websites • Speakers at Scientific Conferences, Meetings, and Workshops • NCI Peer Review • Institutional Review Boards • Data and Safety Monitoring Boards • Editorial Boards

9. Rationale for the Advocates in Research Working Group (ARWG) • Proliferation of NCI programs that would benefit from advocacy involvement or have requested advocate involvement • Growing willingness among NCI staff to involve advocates in roles in addition to peer review and formal advisory boards • Requests by staff for tools and resources to more effectively engage advocates in their work • Available expertise in advocate engagement from both the advocacy community and NCI staff • Requests from the community for guidelines and standards for advocate involvement in research activities • Expressed need for a coordinated, centralized, and systematized process at NCI for advocate engagement

10. ARWG Charge In September, 2007, NCI Director Dr. John Niederhuber asked the DCLG to provide recommendations on how NCI can best involve advocates in NCI activities. In order to accomplish this goal, the Advocates in Research Working Group (ARWG) will: • Harness the knowledge, experience, and leadership of the ARWG to capture a clear picture of where and how advocates are successfully expediting advances in cancer research. • Provide NCI with recommendations for involving advocates across the spectrum of NCI activities in ways that will accelerate progress, benefit patients, and improve public health.

11. Begin with a Federal Advisory Committee NCI Director’s Consumer Liaison Group (DCLG) Federal advisory committee forms a subgroup Working Group - A temporary subgroup of a Federal Advisory Committee that may include external experts in addition to committee members Advocates in Research Working Group (ARWG) Subgroup creates a report The Working Group sends its final recommendations to the Federal Advisory Committee ARWG Report to DCLG The Federal advisory committee forwards the report to the Federal Agency Federal Advisory Committee recommends report to the Agency DCLG votes to recommend the work of the ARWG to the NCI Director Federal Agency Accepts Report Federal Agencies are authorized to solicit advice and recommendations from Federal Advisory Committees NCI Director accepts ARWG report Report is Implemented As resources and conditions allow, the Agency can implement the recommendations NCI Staff implement ARWG recommendations as appropriate Federal Advisory Committee / Working Group Process

12. ARWG: Patients Survivors Caregivers DCLG members CARRA members Cooperative Groups Cancer Centers SPORE programs Researchers Administrators NCI Staff from each Office ARWG Membership

13. Phase I ARWG Membership Kelly Cotter H. Kim Lyerly, James Williams, Jr. Kirby I. Bland Paula Kim Deborah Collyar Peggy Devine Cindy Geoghegan Richard Gorlick Lori Monroe Vernal Branch John Minna Nancy Roach Shamala Srinivas Francine Huckaby Jaye Viner Gerald (Buddy) Leo Shannon Bell Paul A. Bunn, Jr. James Hadley Additional Members in Phases II and III Richard Gorelick Ted Trimble Lisa Stevens Jane Reese-Coulbourne Jennifer Loud Karen Creamer Jane Kennedy Kimberly Myers Margo Michaels Michelle Bennett Nancy Breen Syed Ahmed Jean Lynn Julia Rowland Ann-Gel Palermo Erin Baney Nina Ghanem Jane Perlmutter Brenda Edwards Jeff White Robert Mufson Judith Swan Susan Erickson Margaret Ames Sudhir Srivastava Jeanette Contreras Andrea Denicoff Additional Planning Team Members and In-Depth Interviews in Phase III Meg Gaines Jackie Goldberg Louise Cunningham Mary Jackson Scroggins Susan Brown Sharon Terry Elda Riley Hasnaa Shafik Linda Parreco Lillie Shockney Kathleen Cravedi Juanita Lyle Kay Dickerson Deborah Jaffe Mary Lou Smith Jennifer Loukissas Sandra Thomas Lee Moultrie Jeannie Adler Gwen Darien Jill Bartholomew ARWG Members 13

14. Advocates in Research Working GroupProvide recommendations for involving advocates in ways that accelerate progress, benefit patients and improve public health • Phase I • Review Foundational Documents & Collect Information • Create Framework for Advocacy at NCI • Phase II • Organizational Analysis: • Where & how advocates are being used now • Identify Critical Process Points • Phase III • Develop Implementation Recommendations • Final Report • Immediate Outcome of the ARWG • Process for effectively involving advocates across NCI • Future Outcome • Best practices guide for effectively involving advocates • Immediate Outcome of the ARWG • Process for effectively involving advocates across NCI • Future Outcome • Best practices guide for effectively involving advocates

15. Phase I - Review of Foundational Documents Foundational documents indicate five reoccurring themes: • Roles/Responsibilities of advocates in cancer research • Outcomes of advocate involvement in research • Challenges researchers and advocates face in the advocate involvement process • Tools/Trainings/Models utilized or suggested to involve and train advocates • Other important areas of research advocacy to consider

16. Phase I – Information gathering • Gathered information from advocates and researchers at NCI, DOD, Cooperative Groups, SPORES, Cancer Centers, and nonprofit funding organizations. • Gathered information about structured programs used by various organizations to incorporate advocates in research activities. • Benefits of advocacy involvement in research settings were uncovered.

17. Phase I - Framework for Advocacy at NCI Advisory: Provide recommendations or advice that focuses on strategic directions or broad policy issues • Formal advisory body - Speaking to a group - Participating on a panel Design: Participate in developing new programs or enhancing existing ones • Programmatic site visits - Designing a scientific program Disseminate: Translate and communicate information into the community • Editing materials - Distributing cancer related information Review: Evaluate and analyze research proposals and ongoing research activities • Peer review - Concept review

18. Phase I Subgroups Review Advise Design Disseminate • Review • Advise • Design • Disseminate All groups discussed: • Experience, Skills and Qualifications • Selection Process • Training • Information and Resources • Facilitating Involvement • Communication and Feedback • Evaluation and Tracking • Compensation Experience, Skills and Qualifications Selection Process Training Information and Resources Facilitating Involvement Communication and Feedback Evaluation and Tracking Compensation

19. Phase II Subgroups • Preparation • Necessary Experience • Skill Sets and Qualifications • Training • Initiation • Selection Process • Ethics Issues • Compensation • Activity • Process for Facilitating Involvement • Information and Resources • Maintenance • Evaluation • Tracking • All groups discussed Communication Communication 19

20. Phase II – 8 Initiatives Developed • Comprehensive Assessment to Match Advocates • Create a Code of Conduct • Strengthen the Transparency of Advocate Involvement • Standardize the Process for Advocate Involvement • Identify Training Opportunities • Provide Advocates with Information and Resources • Track and Evaluate Advocate Involvement • Recruit, Retain, and Promote Advocate Involvement

21. Phase II Initiatives Lead to A Primary Recommendation Phase II Initiative Areas: • Recruit, Retain & Promote Advocate Involvement • Comprehensive Assessment to Match Advocates • Standardize the Process for Advocate Involvement • Create Operating Principles • Identify Training Opportunities • Provide Information & Resources • Track and Evaluate Advocate Involvement • Strengthen the Transparency of Advocate Involvement Primary Recommendation: Create a process for advocate involvement with the overarching value of transparency. Identify Training Opportunities Standardize the Process for Advocate Involvement Comprehensive Assessment to Match Advocates Create Operating Principles Provide Information & Resources Strengthen the Transparency of Advocate Involvement Track & Evaluate Advocate Involvement Recruit, Retain, & Promote Advocate Involvement 21

22. Implementation Recommendations from: Recruit, Retain, and Promote Assess and Match Training Information & Resources Engagement Track and Evaluate Phase III Subgroups - Planning Teams

23. Phase III – Developing Implementation Recommendations Top Level Recommendations: • Recruitment: Develop a proactive, systematic approach to recruit a cadre of diverse, highly qualified research advocates and enhance the extent to which NCI staff effectively engage advocates across the research continuum • Assess & Match: Develop a robust assessment and matching process that focuses on identifying Institute needs and engages the right advocate in the right activity at the right time • Training: Provide training, coaching and resources to advocates and NCI staff to ensure participants have the information and tools they need to be effective • Facilitate: The engagement process should be facilitated to enhance relationships and realize desired outcomes • Evaluate: Track and evaluate advocacy involvement at NCI in order to ensure a continuous improvement process and ability to articulate outcomes • Retain & Promote: Retain research advocates and NCI staff and promote successful advocate engagements 23 23

24. 1. Recruitment 1.1 Recruit a cadre of diverse, highly qualified research advocates • Conduct ongoing recruitment of new advocates to engage in NCI: • High performing research advocates not currently engaged with the NCI • Individuals affected by cancer, with an interest in training to become a research advocate* *This strategy is especially important to ensuring a diverse pool

25. 1. Recruitment 1.2 Engage NCI staff in effectively involve advocates • Engender a “culture change” around engaging advocates • Develop relationships with Division Directors and Communications Managers • Make presentations across NCI • Executive Committee • Division-level meetings • NCI’s intramural research festival • Clinical Center Grand Rounds • Scientific fellows and post-docs • Trans-NCI groups: planning, communications, public liaison

26. 2. Assess and Match 2.1 Qualify and maintain a cadre of diverse highly competent research advocates • Create an on-line application module that assesses: • Prior experience • Interest in becoming a research advocate   • Ability to represent a collective patient perspective • Ability to effectively engage in the research process • Understanding of the cancer community  • Primary cancer interests/preferences • Create inclusion and removal criteria to manage the pool of NCI advocates

27. 2. Assess and Match 2.2 Develop a process to evaluate NCI Division, Office and Center (DOC) activities and needs, to engage the right advocates in the right activity and facilitate research-advocate relationships • An understanding of DOC needs and expectations will explored: • Activity deliverables and/or anticipated outcomes • Advocate role (i.e. purpose, environment) • Preferred skill sets • Available resources and training • Compensation such as travel and honoraria • Utilize NCI advocate cadre and community relationships to develop a slate of potential advocates • Facilitate an effective communication through-out the selection process for the duration of the activity • Encourage DOCs to consider engaging advocate at the outset of each new activity/project as appropriate

28. 3. Training 3.1 Create a repository of existing training information and resources to assist advocates in effectively engaging at NCI • Develop an online repository - available to the public • Future: Rating and Comment System • Develop content • Using existing NCI and NIH resources • Solicit resources from the community  • Maintain the repository • Forming a workgroup (internal & external members) • Develop inclusion and removal criteria • Vet resources & manage ongoing resource recommendations • Review post-activity evaluations to identify resource needs

29. 3. Training 3.2 Develop additional resources as necessary • Create and facilitate mentoring • Provide training in how to mentor • Identify opportunities for informal mentoring • New advocates with seasoned advocates • NCI staff or extramural scientist and advocate as appropriate • Identify high priority gaps and partner to develop solutions • Sponsor NCI advocates for external trainings as appropriate • Develop an Advocate Development Plan (ADP) • Encourage advocates to complete annual educational credit • Opportunities to participate may hinge on demonstrated knowledge/skill sets or successful completion of certain courses

30. 3. Training 3.3 Develop resources and processes that support staff • Develop resources (training, fact sheets, etc.) • Provide staff with guidance & support throughout process • Provide examples of how other NCI Divisions, Offices, and Centers (DOCs) are successfully partnering with advocates • Provide informal coaching to staff as needed to optimize interaction with advocates • Connect staff new to engaging advocates with more experienced staff

31. 4. Facilitate 4.1 Support NCI staff and advocates in preparing for the engagement process • The following should be discussed prior to each activity: • Advocate role and responsibility • Expectations of the advocate • Work load, time commitment, expected deliverables • Compensation; travel and honoraria • The role of all other participants and how these intersect • Relevant content; trainings, information, resources • Culture and communication styles • Confidentiality • Dissemination needs • Anticipated outcomes • Need/benefit for a period of training/mentorship

32. 4. Facilitate 4.2 Facilitate the engagement and communication process throughout the activity • An effective communication process should be defined so that feedback is provided at the beginning of each engagement and throughout the activity • During the activity DOC sponsors should introduce the advocates and define their role • For some activities the DOC sponsor may consider identifying a specific time for the advocate(s) to contribute • This may seem artificial, but may benefit newer advocates and/or more formal activities, until advocate participation becomes routine

33. 4. Facilitate 4.3 Develop policy guidance as necessary to facilitate the engagement process 4.3.1 - Term limits 4.3.2 - Compensation 4.3.3 - Ethics/Conflict of Interest (COI) – specific to advocates

34. 4. Facilitate 4.3.1 – Term Limits • Appropriate term limits will be developed for all activities • Term limits will vary based on the type of activity • Natural cycle (grant length, committee charter) • Learning curve (caBIG, Cooperative Groups) • Term limits for leadership and non-leadership positions should be consistent • Established term limits should be adhered to • A period of training/mentorship should be built in for incoming advocates as appropriate

35. 4. Facilitate 4.3.2 – Compensation • No one-size fits all compensation policy can exist • Engaging advocates is accompanied by a fiscal responsibility to provide travel and/or honoraria as appropriate • Travel and/or honoraria arrangements should be discussed with the advocate in advance of the activity Travel: • Advocates should not have to incur unreimbursable expenses • Administrative support can be provided to reduce the burden on NCI Divisions, Offices, and Centers

36. 4. Facilitate 4.3.2 – Compensation – Honoraria • Advocates should be compensated for their time and expertise as appropriate • When other participants are compensated, advocates should be equally compensated • When other participants are volunteering their time, advocates should volunteer their time • When other participants are compensated (by an employer, grant, etc.), NCI should consider compensation for advocates • Employed advocates engaged in an NCI activity during their normal work day should consider refusing an NCI honoraria

37. 4. Facilitate 4.3.2 – Compensation – Honoraria (continued) • Honoraria should adhere to the NIH policy $200/day, pro-rated: • A full day (6+ hours) = standard NIH honoraria of $200 • A half day (2+ to less than 6 hours) = $100 honoraria • Any engagement of 2 hours or less = $50 honoraria • For ongoing activities, honoraria may be provided at the end of a specified period of time (quarterly, annually, etc.) • Honoraria is not always necessary • Activity is a short-term, limited time commitment • An agreement for non-monetary compensation exists • Advocate is attending as a representative of an organization

38. 4. Facilitate 4.3.3. Ethics/Conflict of Interest (COI) • Participants should work with OAR to manage COI issues • Advocates should be held to the same COI standards as NCI staff • Advocates often face additional and different COI issues • A standard COI advocate form will be developed to address: • Known or potential COI issues • Commitment to represent a collective patient perspective • Commitment NOT to represent a single organizational perspective • NCI will explore the need to develop ethics training for advocates

39. 4. Facilitate 4.3.3. Ethics/Conflict of Interest (COI) (continued…) • Advocates who engage with NCI as a contractor must adhere to the following guidelines: • Advocates who contract with NCI should not: • Discuss or promote contract services while engaged as a research advocate • Represent themselves as an NCI research advocate while working as a contractor • Engage with the same project, Division, Office, or Center, as both a research advocate and a contractor • Utilize advocacy activities to develop future opportunities to contract with the NCI 

40. 5. Evaluate 5.1 Overarching Principles • Allow NCI to make evidence-based decisions about when, where & how to engage advocates and invest in advocate programs • Evaluation data should be quantitative or qualitative, as appropriate • Used to assess individual engagements as well as long term trends • Be continuous and flexible to allow for changing needs • Consistent throughout the process to allow for comparison • Establish baseline data first, as necessary

41. 5. Evaluate 5.2 Track and evaluate outcome data in order to understand and articulate the impact of engaging advocates in the research process • Clearly identify advocate contributions • Allow NCI to promote opportunities and manage expectations • Allow NCI to test advocate roles • Advise – Design – Disseminate – Review • Code and sort over time to establish baseline outcome data • Cross match with previously defined contributions (Phase I) • Test 17 previously defined outcomes • Identify new undefined outcomes

42. 5. Evaluate 5.3 Track and evaluate process data in order to assess efficiency and continuously improve the process • Evaluate cost, time, utilization, attrition and satisfaction data • Evaluate all parts of the process • Advocate: satisfaction with training and resources, feedback mechanisms, promotion programs, communication, orientation, preparatory work, clarity of expectations, and overall experience • NCI DOC Sponsor: match between advocate and activity, level of preparation, advocate availability, and quality and outcome of participation • Systemic issues: advocate diversity, recruitment success, effectiveness in meeting DOC needs, repeat engagements, utilization of training resources, equitable compensation, and effective term limits  

43. 6. Retain and Promote 6.1 Retain highly-qualified advocates • Maximize opportunities for advocates to participate • Enhance communication throughout advocate’s tenure • Develop a social networking site for research advocates • Develop incentives for participation including: • Access to scientific journals • Training and mentoring opportunities • Certificate of participation/appreciation 

44. 6. Retain and Promote 6.2 Increase acceptance, knowledge and utilization of advocates across NCI • Create a team science award – advocate/NCI staff team • Individuals who set a standard for effective advocate engagement • Promote successful advocate engagements across NCI • Develop a logo/stamp of approval – advocates were involved in this activity • Develop a training module for researchers • Create information packets for DOCs with benefits, successes, expectations, roles, and logistics

45. 6. Retain and Promote 6.3 Promote successful advocate engagements • Develop success stories that articulate outcomes of advocate engagement and include both the advocate and staff/PI perspective • Advertise success stories: online, displays & posters • Research successes and barriers to advocate/ researcher collaborations • Publish these findings