Patient Advocacy Organizations, Industry Funding, and Conflicts of Interest

Supplementary Online Content

Rose SL, Highland J, Karafa MT, Joffe S. Patient advocacy organizations, industry funding, and conflicts of interest. JAMA Intern Med. Published online January 17, 2017. doi:10.1001/jamainternmed.2016.8443

eTable 1. Search Terms Used to Identify Organizations

eTable 2. Inclusion and Exclusion Criteria

eTable 3. Sensitivity Analysis Comparing Survey Responses of Executive and Non-Executive Respondents of Patient Advocacy Organizations (PAOs)

eFigure. Survey

This supplementary material has been provided by the authors to give readers additional information about their work.

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Aagenaes Syndrome Anoxia Carcinoid Aarskog Syndrome Antiphospholipid Syndrome Carcinoma Aase-Smith Syndrome II Antley-Bixler Syndrome Cardiac Abdominal Cystic Phenotype Cardiogenic Lymphangioma Anxiety Cardiogenic Shock Abdominal Obesity Metabolic Aphasia Cardiomyopathy Syndrome Apraxia Cardiovascular Achondroplasia Arrhythmia Carotid Artery Disease Achromatopsia Arteriosclerosis Celiac Acid Lipase Disease Arthritis Central Cord Syndrome Acoustic Neuroma Asperger Syndrome Cervical Cancer Acquired Hyperostosis Aspergers Chondrodysplasia Punctata Syndrome Asthma Acrocephalosyndactylia Chordoma Astrocytoma Addison Disease Churg-Strauss Syndrome Ataxia ADHD Colon Cancer Atherosclerosis Adie's syndrome Colorectal Cancer Atrial Adrenal Hyperplasia Conduct Disorder Atrial Fibulation Adrenoleukodystrophy Congenital Heart Atrial Septal Defect Agnosia Congenital Heart Defects Attention Deficit Disorder Agoraphobia Congenital Hypothyroidism Autism Aicardi Syndrome COPD Autistic AIDS Coronary Autoimmune Albinism Coronary Heart Disease Autoimmune Allergy Corprophagia Lymphoproliferative Syndrome Craniopharyngioma Alopecia Areata Autonomic Dysreflexia Creutzfeld-Jakob Disease ALPS Batten Disease Delirium ALS Bile Duct Dementia Alstrom Syndrome Binge Eating Depression Alzheimer Bipolar Disorder Dermatitis Alzheimer’s Bone Disease Diabetes American and Heart and Bone Marrow Disease and Advocacy Association Bosom Amputation Disease and Association Brain Amputee Disease and Coalition Brain Cancer Amyotrophic Lateral Sclerosis Disease and Family Breast Cancer Anal Cancer Disease and Foundation Bulimia Anemia Disease and Organization Burkitt's Lymphoma Anencephaly Disease and Society Camurati-Engelmann Syndrome Aneurysm Disease Association Canavan Angina Disease Coalition Cancer Angiomatosis Disease Foundation Cancer Anorchia Disease Network Capgras Syndrome Anorexia Disease Organization

Downloaded From: https://jamanetwork.com/ on 10/01/2021 Disease Society Heart and Group Lou Gehrig Dravet Heart and Network Lung Cancer Dwarfism Heart and Organization Lupus Dyscalculia Heart and Rhythm Lymphoma Dyslexia Heart and Society Marfan Dysomnias Heart Attack Marfan Syndrome Dysostoses Heart Block McBride Dysplasia Heart Disease Melanoma Eating Disorders Heart Failure Meningitis Encephalomyletis Heart Murmur Mental Disorder Encephalopathy Heart Palpitations Mental Health Enchondromatosis Heart Transplant Mesothelioma Encopresis Heart Valve Disease Metabolic Syndrome Endocarditis Hemangioendothelioma Microphthalmic Ependymoma Hemiplegia Mitral Epilepsy Hemochromatosis Mitral Valve Prolapse Epilepsy and Association Hemolytic anemia Mulibrey Nanism Epilepsy and Organization Hemophilia Multiple Chemical Sensitivity Esophageal Cancer Heritable Multiple Personality Disorder Familial Histiocytosis Muscular Dystrophy Familial Dysautonomia HIV Musculoskeletal Felty's Syndrome Hodgkin Multiple Sclerosis Fibromuscular Huntingtons Disease Myasthenia Gravis Fibrous Dysplasia Hydrocephalus Myelodysplastic Focal Dermal Hypoplasia Hyperostosis Myeloma Funnel Chest Hypertension Myeloma Gambling Hypophosatasia Myeloproliferative Gastric Cancer Hypotension Myositis Gaucher Hypotonia Neoplasm Genetic Inflammatory Nerve Gigantism Inherit Neuritis Glioma Kaposi Sarcoma Neuroblastoma Glomerulonephritis Kawasaki Disease Neurological Graves Disease Kidney Cancer Non-Hodgkins Guillian-Barre Syndrome Kippel-Feil Syndrome Obsessive Compulsive Disorder Head and Neck Kyphosis Opioid Head Injury Lambert-Eaton Myasthenic Oral Cancer Health Advocacy Syndrome Orofaciodigital Syndromes Health and Consumer Laron Syndrome Orthopedic Health and Society Laryngeal Osteoarthritis Health Organization Learning Disabilities Osteochondroma Heart Leukemia Osteochondroma Heart and Advocacy Leukoencephalitis Osteogenesis Heart and Association Limb Osteoid Osteoma Heart and Consumer Little People Osteomalacia Heart and Foundation Long QT Syndrome Osteomyelitis

Downloaded From: https://jamanetwork.com/ on 10/01/2021 Osteoporosis Skin Cancer Osteosarcoma Sleep Disorder Osteosclerosis Social Phobia Ovarian Cancer Spina Bifida Paget's Disease Spinal Cancer Pain Spinal Cord Injuries Palsy Spinal Muscular Atrophy Pancreatic Cancer Spinal Stenosis Panic Disorder Spinal Tumor Parasomnia Spine Parkinson’s Disease Spondylitis Patient Advocacy Squamous Patient and Coalition Stomach Cancer Patient and Group Stroke Patient and Organization Support Group Patient Coalition Syndactyly Patient Group Synostosis Patient Organization Tay Sachs Penile Cancer Testicular Penis Tetralogy of Fallot Pericarditis Thanatophoric Dysplasia Peripheral Arterial (Artery) Thymoma Disease Thyroiditis Phobia TMJ Pica Tongue Cancer Platybasia Tourette Syndrome Polio Tumor Post Traumatic Stress Disorder Type 1 Diabetes Prostate Uterine Cancer Prostate Cancer Vaginal Cancer Proteus Syndrome Varicose Veins PTSD Vascular Pycnodysostosis Vasculitis Reactive Attachment Disorder Ventricular Septal Defect Rectal Von Hipple Landau Syndrome Renal Cancer Vulvar Retinoblastoma Waldenström Reynaud's Disease Macroglobulinemia Rhabdomyosarcoma Weill-Marchesani Syndrome Rheumatoid Arthritis Wilms Tumor Rubinstein-Taybi Syndrome Sarcoma Schizophrenia Scoliosis Sézary syndrome Sisters and Network

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eTable 2. Inclusion and Exclusion Criteria

Inclusion Criteria Exclusion Criteria

• Operates outside of the government • Primarily serves populations outside of the United States • Concerns itself with those affected by medical conditions and/or the medical system (patients, • Serves local population only consumers, family members or caregivers) • Fundraising only, no other activities • Works specifically and primarily toward a mission of helping affected individuals. • Primarily focuses on research activities

• Affected individuals are involved in the • Is a social services organization development and administration of the organization. • Is a medical services organization • The collective identity of the group is based upon a • Sole activity is running a camp disease or illness experience • Financial institutions or insurance companies

• Governmental organizations

• Professional organizations

• No website

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eTable 3. Sensitivity Analysis Comparing Survey Responses of Executive and Non-Executive Respondents of Patient Advocacy Organizations (PAOs) Non-Executive Executive Responders Responders (N=43) (N=246) Respondent and PAO Demographics n N (%) n N (%) P Value

Respondents Gender: Female 40 35 (88) 239 170 .030a (71) Respondents Race: White 41 36 (88) 236 221 .19b (94) Respondent had worked more than> 5 years for 41 25 (61) 240 178 .081a PAO (74) Respondent or family member has the disease that 42 12 (29) 238 139 <.001b is the focus of the PAO (yes/no) (58) Number of years respondent was involved with 40 7 [5, 13] 231 13 [8, .002c patient advocacy 20] PAO is a tax exempt, not-for-profit entity (yes/no) 43 42 (98) 237 235 .39b (99) PAO has a singular disease focus (yes/no) 43 29 (67) 245 174 .64a (71) PAO has any paid employees (yes/no) 43 35 (81) 245 170 .11a (69) . Number of paid employees (median [IQR]) 34 4 [2, 9] 161 3 [1, 8] .28c PAO has a Board of Trustees/Directors (yes/no) 43 40 (93) 244 236 .22b (97) Number of PAO members (median [IQR]) 35 12 [8, 2000] 217 23 [9, .79c 1000] Diseases or Conditions that PAO addresses:† . Genetic or Rare Disorders 43 12 (28) 245 77 (31) .64a . Cancer 43 18 (42) 245 58 (24) .013a . Neurological Disorders 43 4 (9) 245 48 (20) .11a . Mental Disorders 43 2 (5) 245 21 (9) .55b . HIV/AIDS 43 3 (7) 245 17 (7) .99b . Orthopedic or Musculoskeletal Disorders 43 3 (7) 245 15 (6) .74b . Cardiovascular Disorders 43 4 (9) 245 11 (5) .25b . Digestive Diseases 43 4 (9) 245 11 (5) .25b . Endocrine Disorders/Diabetes 43 0 (0) 245 13 (5) .23b . All diseases/broad based health advocacy (not 43 0 (0) 245 13 (5) .23b disease-specific) . Respiratory/Pulmonary Diseases 43 3 (7) 245 10 (4) .42b . Neuro-Muscular Disorders 43 0 (0) 245 12 (4) .22b . Reproductive Issues 43 2 (5) 245 9 (4) .67b . Infectious Diseases (Excluding HIV/AIDS) 43 0 (0) 245 8 (3) .61b . Addictions 43 0 (0) 245 5 (2) .99b † This is a non-mutually exclusive category. PAOs could select multiple disease areas of interest. a=Pearson's chi-square test, b=Fisher's Exact test, c=Kruskal-Wallis test

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eTable 3 (Continued). Sensitivity Analysis Comparing Survey Responses of Executive and Non- Executive Respondents of PAOs Non-Executive Executive Responders Responders (N=43) (N=246) Organizational Information and Activities n N (%) n N (%) P Value PAO has endowment (yes/no) 39 9 (23) 244 63 (26) .71a . Endowment is over $1 million (yes/no) 8 4 (50) 63 17 (27) .22b a Respondent is very or moderately 41 36 (88) 243 208 (86) .71 confident that PAO will be financially stable over the next three years b PAO owns equity in any for-profit 40 2 (5) 243 9 (4) .66 companies PAO participates in: . Education 43 43 (100) 246 243 (99) .99b . Fundraising 43 42 (98) 246 235 (96) .99b . Interacting with patients and families 43 41 (95) 246 229 (93) .75b . Research 43 31 (72) 246 202 (82) .13a . Policy 43 30 (70) 246 188 (76) .35a a PAO funds research 43 16 (37) 246 100 (41) .67 13 181,394 99 200,000 .88c Approximate dollar amount the PAO [100,000, [35,000, provided to research funding in the last 300,000] 400,000] complete fiscal year (median [IQR])

Research funding amounts: . $1 million or more 13 2 (15) 99 17 (17) .99b . $10 million or more 13 0 (0) 99 4 (4) .99b

Fundraising activities: . PAO seeks individual donations 43 40 (93) 246 205 (83) .10a . PAO seeks corporate donations 43 34 (79) 246 179 (73) .39a . PAO collects membership dues 43 9 (21) 246 69 (28) .33a a=Pearson's chi-square test, b=Fisher's Exact test, c=Kruskal-Wallis test

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eTable 3 (Continued). Sensitivity Analysis Comparing Survey Responses of Executive and Non-Executive Respondents of PAOs Non-Executive Responders* Executive Responders* Fundraising (N=43) (N=246) Sources Over Past n 0% 1- 26- 51- 76- 100% n 0% 1-25% 26- 51- 76- 100% P Three Years 25% 50% 75% 99% 50% 75% 99% Value Donations from 40 2(5) 21(53) 5(13) 3(8) 7(18) 2(5) 237 15(6) 96(41) 37(16) 42(18) 39(17) 8(3) .48c individuals Donations or 41 11(27) 18(44) 4(10) 6(15) 2(5) 0 (0) 235 83(35) 102(43) 29(12) 10(4) 11(5) 0 (0) .16c grants from for- profit companies Fundraising 40 5(13) 21(53) 9(23) 2(5) 2(5) 1(3) 235 64(27) 76(32) 51(22) 28(12) 15(6) 1(0) .67c events Membership 40 32(80) 5(13) 2(5) 0(0) 0(0) 1(3) 233 162(70) 50(22) 11(5) 5(2) 3(1) 2(1) .20c dues Investment 40 29(73) 8(20) 1(3) 1(3) 0(0) 1(3) 234 156(67) 76(33) 1(0) 1(0) 0(0) 0(0) .66c income Foundations 40 21(53) 18(45) 0(0) 0(0) 1(3) 0(0) 235 130(55) 82(35) 18(8) 4(2) 1(0) 0(0) .96c Grants from 41 27(66) 7(17) 4(10) 2(5) 0(0) 1(3) 235 188(80) 23(10) 14(6) 6(3) 4(2) 0(0) .047c government sources Proceeds from 40 23(58) 14(35) 2(5) 1(3) 0(0) 0(0) 233 162(70) 64(28) 1(0) 4(2) 1(0) 1(0) .11c specially made or marketed products or services (including food) Other 40 34(85) 2(5) 1(3) 2(5) 0(0) 1(3) 228 198(87) 15(7) 9(4) 3(1) 2(1) 1(0) .68c *Statistics presented as N (column %). c=Kruskal-Wallis test (comparing the response distributions)

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eTable 3 (Continued). Sensitivity Analysis Comparing Survey Responses of Executive and Non-Executive Respondents of PAOs Non-Executive Executive Responders P Responders Value (N=43) (N=246) Organizational Financial Details and n N (%) n N (%) Perceptions of Conflicts of Interest (COI) Policies PAO’s total revenue for the last complete fiscal year (median 36 552,812 [93,000, 236 277,500 [64,000, .36c [IQR]) 1,244,260] 1,200,000] a PAO received for-profit funding (yes/no) 31 20(65) 214 145(68) .72 . Received > 50% from Industry 18 3(17) 142 16(11) .45b c Approximate dollar amount PAO received in financial support 30 8500 [0, 100,000] 213 15,000 [0, 110,000] .55 from for-profit companies (median [IQR]) Approximate dollar amount received in financial support from for-profit companies: . < $9,999 30 15(50) 213 90(42) .42a . $1,000,000+ 30 3(10) 213 18(9) .73b a Financial COI very/moderately relevant to PAOs in general 37 25(68) 232 195(84) .016 a PAO’s policy is very good at addressing the most important 25 12(48) 146 82(56) .45 issues/likely areas of conflict (among those with COI policy) a=Pearson's chi-square test, b=Fisher's Exact test, c=Kruskal-Wallis test

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. Pharmaceutical, device, and biotechnology companies 19 15 [0, 100] 141 50 [0, 100] .56c . Food, nutrition, and agricultural companies 19 0 [0, 0] 140 0 [0, 0] .94c . Apparel and beauty companies 19 0 [0, 0] 140 0 [0, 0] .61c . Hospitals or health insurance companies 19 0 [0, 0] 139 0 [0, 5] .53c . Financial industry 19 0 [0, 20] 139 0 [0, 0] .030c . Other 20 0 [0, 68] 141 0 [0, 55] .86c c=Kruskal-Wallis test

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eFigure. Survey

Advocacy Organizations and Corporate Relationships: Exploring Conflict of Interest Policies

This questionnaire explores patient/disease advocacy organizations’ financial relationships with industry. Our goal is to better understand these partnerships and to obtain the opinions of key leaders about how such organizations manage these financial relationships and corporate partnerships. By completing this questionnaire, you will provide us with valuable information that will be used to inform policy recommendations that organizations can use to manage relationships with industry. Management of these financial relationships is an important part of maintaining public trust in advocacy groups. Though we have gathered data from many public sources, we want to be as accurate as possible and very much appreciate your help with questions that remain.

Please be assured, we will not present or publish the information you share with us in any way that would permit identification of you or your organization.

We hope you find completing this questionnaire to be useful. If you wish, we will share our findings with you once analysis is complete.

We are including a $25 American Express gift certificate to show our appreciation for your time and effort. Thank you in advance for your participation.

This study is being conducted by investigators from the Cleveland Clinic, in conjunction with the Survey and Data Management Core at the Dana-Farber Cancer Institute in Boston. It is supported by the Edmond J. Safra Center at Harvard University.

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Questionnaire Instructions

Your participation in this study is voluntary and you may skip any questions.

Your answers are confidential. No information will be presented or published in any way that would permit identification of any individual or organization.

Furthermore, we will not be publishing a list of the names of organizations that participated in this survey.

The questionnaire will take approximately 15 minutes to complete.

You are receiving a $25 American Express gift certificate to show our appreciation for your input.

For more information on this questionnaire, please email Susannah Rose, PhD, at: ([email protected]) or call: 216-444-0849.

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A. Background Information

This survey is intended to be completed by individuals who are in leadership positions within patient or disease advocacy organizations, including (but not limited to) President, Chief Executive Officer, Chief Financial Officer, Senior or Executive Vice President, or other senior positions with operational or financial responsibility for the organization.

In the item that follows, please indicate whether you consider yourself to be in a leadership position as defined here. If you are not in a leadership position, we will ask you to provide us with the name and contact information of someone in your organization who is in a leadership position, and whom we can invite to complete the survey about your organization.

1. Are you a currently in a leadership position within your organization?

 Yes If yes, which of the following best describes the position you hold at your organization?

 President or Chief Executive Officer

 Chief Financial Officer

 Executive Director

 Senior/Executive Vice President

 Other (please describe):______

 No

If you answered “NO”, you do not have to complete the questionnaire. Please return your survey using the self- addressed stamped envelope. Thank you for your time.

Would you please give us the name and contact information for

a leader at your organization who could address questions about your organization’s relationships with industry? ______

______

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The following questions are about patient (or disease) advocacy organizations. A patient advocacy organization is defined as an organized group that concerns itself with medical conditions and works primarily toward a mission of helping or advocating for affected individuals and their families, friends and caregivers. Such a group may be focused upon a specific disease or group of diseases, or it may be broader in its scope. For example, the focus of the group can be on assisting patients and families, improving and funding research, seeking policy changes, as well as a wide-range of other activities.

2. Would you characterize your organization as a patient/disease advocacy organization, as defined above?

 Yes If no, how would you characterize your organization?  No ______

3. Is your organization a tax exempt, not-for-profit entity?

 Yes  No

4. What general category of diseases or conditions does your organization address? Please check all that apply.

 Cancer  Cardiovascular Disorders  Mental Disorders  Orthopedic or Musculoskeletal Disorders  Neurological Disorders (e.g. Parkinson’s Disease, Cerebral Palsy)  Endocrine Disorders (Including Diabetes)  HIV/AIDS  Infectious Diseases (Excluding HIV/AIDS)  Respiratory/Pulmonary Diseases (e.g. COPD, Emphysema)  Neuro-Muscular Disorders (e.g. Muscular Dystrophy)  Addictions  Genetic or Rare Disorders  Digestive Diseases  Reproductive Issues  All diseases/broad based health advocacy (not disease-specific)  Other (please specify):______

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5. In what year was your organization founded? ______

6. Does your organization have any paid (non-volunteer, full-time or part-time) employees?

If yes, approximately how many full-time paid staff does  Yes your organization employ? ______ No

7. Does your organization have a Board of Trustees/Directors or similar governing body?

 Yes  No

8. Approximately how many members does your organization have? ______

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B. Organizational Activities

In this section, we will ask about your organization's activities in the areas of Education, Biomedical and Clinical Research, Policy/Advocacy, Interactions with Patients and Families, and Fundraising.

Please check the boxes for all the activities that your organization performed within the last complete fiscal year.

9. In the last complete fiscal year, did your organization or any of your staff do any of the following in the area of EDUCATION? Please check all that apply.

 Speak at a public forum such as a conference, or educational event etc.  Distribute or publish educational materials or brochures for patients/families  Sponsor educational events for patients/families  Sponsor educational events for professionals  Issue press releases  Send out a newsletter or other official correspondence to members  Other educational efforts (please specify): ______

10. In the last complete fiscal year, did your organization or any of your staff do any of the following in the area of BIOMEDICAL AND CLINICAL RESEARCH? Please check all that apply. If yes, approximately what dollar amount did you commit to  Fund research funding research in the last complete fiscal year? $______

 Disseminate research results (through newsletters, press releases or other print or online materials)  Review research proposals for other funders (e.g., participate in proposal review boards like the Department of Defense, or the National Institutes of Health)  Provide recognition or awards for research accomplishments  Meet with medical researchers  Hold a meeting or event focused on research results, activities or plans  Conduct research  Assist with recruitment of research participants or development of participant registries  Collaborate with one or more companies on a biomedical or clinical research project  Maintain a data and/or specimen bank for use by outside researchers  Other research efforts (please specify): ______

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11. In the last complete fiscal year, did your organization or any of your staff do any of the following in the area of POLICY/ADVOCACY ACTIVITIES? Please include activities at both state and federal levels. Please check all that apply.

 Speak with legislators or their staff  Speak with regulatory agency heads or their staff (NIH, FDA, CDC, DOD, etc.)  Encourage individuals to meet or contact legislators or their staff  Encourage individuals to contact agencies  Encourage individuals to vote  Hold a march, protest, or demonstration  Support particular legislative initiatives  Present information to a governmental committee or panel  Encourage individuals to reach out to media on issues of concern to your organization  Engage with lobbyists  Meet with representatives from funding agencies  Other advocacy activities (please specify): ______

12. In the last complete fiscal year, did your organization or any of your staff do any of the following in the area of INTERACTION WITH PATIENTS/FAMILIES? Please check all that apply.

 Offer patient referrals to community resources  Maintain a patient support line  Offer counseling services  Provide patients or their families with financial assistance to help address their medical or non-medical needs  Organize support groups  Provide information on medications or treatments  Directly provide medical services  Provide online communities (blogs, mailing lists, forums, Facebook, etc.)  Facilitate a medication access program  Provide information on clinical trials  Other support services (please specify): ______

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13. In the last complete fiscal year, did your organization or any of your staff do any of the following in the area of FUNDRAISING? Please check all that apply.

 Engage in direct marketing, such as advertising in magazines or advertising online  Conduct annual appeals (yearly organized efforts to request donations from a broad audience)  Seek individual donations  Seek corporate donations  Engage in cause-marketing (receiving contributions linked to the sale or dispensing of a specially made or branded product)  Hold fundraising events (e.g., walks, runs, gala dinners, balls, etc.)  Seek grants from private foundations  Seek grants from government sources  Seek grants from for-profit companies  Collect membership dues  Earn income (e.g. sell services, products, consult, lease space, etc.)  Other fundraising efforts (please specify): ______

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C. Organization Financials

Unless otherwise noted, questions in this section ask about events that occurred within the last complete fiscal year, or the fiscal year that most recently ended.

14. Approximately what was your organization’s total revenue for the last complete fiscal year? Your best estimate is fine.

$______

15. Averaging over the past 3 years, approximately what portion of your revenue was derived from each source listed below? Your best estimate is fine. You do not need to provide exact percentages.

0% 1-25% 26-50% 51-75% 76-99% 100%

Donations from

individuals Donations or grants from

for-profit companies

Fundraising events

Membership dues

Investment income

Foundations Grants from government

sources Proceeds from specially made or marketed products or services (including food, clothing, etc.) Other (please specify):

______

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16. In the last complete fiscal year, approximately what dollar amount did your organization receive in financial support from for-profit companies (including donations, cause- marketing, investments, grants, etc.)? Your best estimate is fine.

$______

a. Approximately what percentage of this financial support from for-profit companies came from each of the following sectors? Responses should total 100%.

Pharmaceutical, device, and biotechnology companies ______% Food, nutrition, and agricultural companies ______% Apparel and beauty companies ______% Hospitals or Health Insurance Companies ______% Other (please specify): ______%

 My organization did not receive any donations/contributions from any for-profit companies

17. Does your organization have an endowment (a reserve of money set aside for the purpose of earning investment income)?

If yes, approximately what is the value of your organization’s  Yes endowment?  No  Less than $99,999  $100,000-$499,999  $500,000-$999,999  $1 million to $10 million  $10 million or over

18. Does your organization own equity in any for-profit companies?

If yes, approximately how much are these investments worth in  Yes total?  No  Less than $99,999  $100,000-$499,999  $500,000-$999,999  $1 million to $10 million  $10 million or over

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19. How confident are you that your organization will remain financially stable (i.e. your organization’s funding will grow or remain relatively stable from year to year and/or your organization will be able to cope with changes in funding) over the next 3 fiscal years?

 Very confident  Moderately confident  Not very confident  Not confident at all

20. Does your organization provide financial support to for-profit companies?

 Yes  No  Unsure

If yes, please briefly explain:

______

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D. Corporate Relations Policies

In this section, we ask questions about your organization’s relationships with for-profit companies. Many financial relationships with companies result in benefits, but leaders of patient advocacy organizations sometimes struggle with how to best partner with industry.

Some leaders may be concerned that such corporate relationships represent organizational level (institutional) financial conflicts of interest. According to the Institute of Medicine, “conflicts of interest arise when an institution’s own financial interests or those of its senior officials pose risks of undue influence on decisions involving the institution’s primary interests.”(p.218)

Individual level financial conflicts of interest, on the other hand, occur when a professional’s judgments or actions related to their primary responsibilities are at risk of being compromised by financial interests.

Lo, B., et al., Conflict of interest in medical research, education, and practice. 2009, Washington, DC: National Academies Press. Xxi

21. How relevant is the issue of organizational financial conflicts of interest to patient advocacy organizations in general?

 Very relevant  Moderately relevant  A little relevant  Irrelevant

22. How relevant is the issue of organizational financial conflicts of interest to your organization in particular?

 Very relevant  Moderately relevant  A little relevant  Irrelevant

23. Does your organization have a written organizational conflict of interest or corporate relations policy?

 Yes  No  Unsure

If your organization does not have written policies, please go to Question 25, page 14.

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For the following question, please refer to your organization’s written policies regarding corporate relations (or organizational conflicts of interest).

24. In your opinion, how good are your organization’s written policies at:

N/A

Very Very (not Good Fair Poor covered Good Poor in policies)

Addressing the most important issues and likely areas of conflict? Presenting information in a way that is easy to understand? Describing who is responsible for revising, monitoring, and enforcing the policies? Preventing your organization from undertaking potentially risky activities? Offering useful guidance for managing your organization’s relationships with funders / industry? Detailing specific actions that should be taken in the event of a potential conflict of interest?

Limiting activities which you personally find undesirable? Describing actions that should be taken in the event of a violation of conflict of interest polices?

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25. Does your organization have written policies that restrict individual employees’ financial relationships with for-profit companies?

 Yes  No  Unsure

If yes, which relationships are restricted?

Yes No Unsure

Advising/consulting

Accepting gifts or honoraria

Funding of educational activities

Investments

Licensing agreements Payment for research participation in industry sponsored trials

Food and/or beverages

Travel (reimbursed or provided) Other (please specify):

______

26. Does your organization have policies that limit the amount or percentage of funding that a single for-profit company can contribute to your organization?

 Yes  No  Unsure

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27. Does your organization have any of the following protections against conflicts of interest?

Yes No Unsure

Separation of administrative or executive functions from fundraising functions.

Written ethical principles and standards regarding conflicts of interest.

Education of employees and volunteers about conflicts of interest.

A conflict of interest committee or board.

Policies for internally reporting/disclosing potential conflicts of interest.

Policies for disclosing potential conflicts of interest externally, such as on a website, in annual reports, etc.

28. During the last 3 complete fiscal years, has your organization declined a contribution because of concerns about conflicts of interest related to a corporation?  Yes  No  Unsure 29. In the last 3 complete fiscal years, has your organization ever perceived any pressure to conform its positions to the interests of corporate donors or partners?

If yes, please provide an example. You do not need to include any names of organizations. ______ Yes  No ______

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30. Does your organization make information about any of the following available to the public?

Yes No Unsure N/A

Fundraising activities

Cause-marketing

Sources of funding

Names of individual sponsors or donors

Names of corporate sponsors or donors

Exact or approximate monetary value of contributions received from corporate donations

Specific uses for particular donations (e.g., to sponsor a walk or race; to support research; to cover administrative costs)

Conflict of interest or corporate relations policies

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This next set of questions asks about possible policy suggestions to manage financial conflicts of interest among patient/disease advocacy organizations.

31. For each strategy below, please indicate its effectiveness in addressing the potential influence of corporate financial relationships on an organization’s decision making.

Neither Very Somewhat effective Somewhat Very effective effective nor ineffective ineffective ineffective

Increasing government oversight and regulation of financial relationships. Improving disclosure of conflicts of interest and financial relationships inside the organization.

Public disclosure of financial relationships. Having a conflict of interest committee or board. Educating employees about financial conflicts of interest. Separating fundraising responsibilities from administrative responsibilities. Placing limits or restrictions on the amounts of donations. Developing ethical principles and standards against financial conflicts of interest.

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32. The following statements ask about organizational conflict of interest policies. Please tell us how strongly you agree or disagree with each statement.

Neither Strongly Strongly Agree agree nor Disagree disagree agree disagree Institutional conflict of interest policies are burdensome in terms of time and personnel hours. Institutional conflict of interest policies promote

public trust in my organization. Institutional conflict of interest policies jeopardize

important corporate relationships. Institutional conflict of interest policies make my organization more attractive to corporate donors/partners. My organization struggles to develop corporate relations policies that help us maintain our independence. Organizations like mine should adopt conflict of interest policies that restrict certain corporate relationships Institutional conflict of interest policies generally

make it difficult to complete projects with researchers.

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33. Do you think that policies for disclosure of financial information should be uniform across all patient/disease advocacy organizations in the U.S.?

 Yes  No

Why or why not? ______

______

34. In your opinion, should patient/disease advocacy organizations publicly disclose financial relationships with industry partners?

 Yes  No

Why or why not? ______

______

35. What suggestions do you have for policies that patient/disease advocacy organizations can use to manage their financial relationships with corporations? ______

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36. Please use the space below to discuss your thoughts regarding advocacy organizations, industry relationships and/or conflict of interest policies. Any thoughts or suggestions are helpful to us. ______

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E. Demographic Information

37. What is your age range?  Yes, Hispanic or Latino/ Latina

 No, not Hispanic or Latino/ Latina  Under 30 43. What is your highest level of  30 - 39 education?  40 - 49  High school  50 - 59  2-year college degree  60 - 69  4-year college degree  70 - 79  Masters-level graduate training  80 or over (includng nursing, social work, 38. What is your gender? MBA, MPA, etc.)

 Doctoral-level graduate training  Male (including JD, PhD, MD, etc.)  Female  Other (please specify): 39. How long have you worked for your ______current organization? ______years 44. Do you or a family member have the disease that is the focus of your 40. How long have you been involved with organization’s activities? patient advocacy? ______years

 Yes 41. What is your race? Please choose all that apply.  No

 Prefer not to answer  White

 Black or African American

 Native Hawaiian or Other Pacific Islander  Asian  American Indian or Alaska Native  Other (please specify): ______

42. Are you Hispanic or Latino/ Latina?

Thank you for your assistance with this questionnaire. Your answers and identity will remain confidential.

Please return your completed survey in the self-addressed stamped envelope.

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