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Public Health Organizations Urge HHS to Remove Financial Barriers in Clinical Trial Participation

Changes Would Particularly Benefit Patients in Remote and Rural Communities Who Are Disproportionately Underrepresented in Clinical Research

August 24, 2026
Today, the American Cancer Society Cancer Action Network (ACS CAN), joined by 128 other patient advocacy groups, public health organizations and professional societies, submitted a letter responding to the request for information (RFI) issued by the U.S. Department of Health & Human Services (HHS), Office of Inspector General (OIG) regarding creating a safe harbor for sponsors of clinical trials to pay patient costs of participation in the studies.  The safe harbor would make it clear that payment of such costs does not violate the Anti-Kickback Statute (AKS). The RFI comes after several years of public health organizations calling for the adoption of a new AKS safe harbor that would permit clinical trial sponsors to offset certain participation costs that prevent many from joining lifesaving research.

The comments below are excerpts from the letter and reflect continued support for the adoption of such a safe harbor by the undersigned organizations:

“Although clinical trials are […] ‘the gold standard of clinical research and provide critical evidence for new treatments,’ clinical trial sponsors struggle to enroll patients. Indeed, remarkably—and sadly— an estimated 30% of clinical trials conducted between 2011 and 2021 were suspended or terminated after failing to reach [their] enrollment target.

“Under these circumstances, it is not surprising that a 2026 study found that 89 percent of cancer patients indicated they would be more likely to enroll in a cancer clinical trial if sponsors supported them financiallySimilarly, in a 2025 study, 86 percent of patients cited expenses as influencing their decision to participate in a clinical trial.

“Also not surprisingly, those living in remote or rural areas had ‘more than twice the risk of financial hardship compared to those traveling shorter distances’; and this is exacerbated by the fact that patients who have low incomes may be more likely to live in areas with less health care or clinical trial resources and thus be required to travel farther distances to a site that offers cancer clinical trials.

“Taken together, this evidence demonstrates that the financial and logistical burdens associated with clinical trial participation—particularly the added travel and cost burdens borne by rural and low-income patients—represent a substantial and well-documented barrier to enrollment, one that directly undermines the ability of clinical trials to reach their targets. Given the clear and consistent data showing that patients are significantly more likely to enroll when financial support is available, we urge that measures enabling sponsors to cover trial-related travel, lodging, and other out-of-pocket expenses are not merely beneficial but essential to improving clinical trial participation and, ultimately, advancing research for all Americans.”

Read the full letter here.

The organizations that signed onto the letter include:

American Cancer Society Cancer Action Network

1Day Sooner

Academy of Oncology Nurse & Patient Navigators

Academy of Physicians in Clinical Research

ADAP Advocacy Association

Adolescent and Young Adult Cancer Coalition

Alliance for Patient Access

Alliance for Women's Health & Prevention (AWHP)

American Association for Cancer Research (AACR)

American Association of Clinical Urology (AACU)

American Lung Association

American Society for Transplantation and Cellular Therapy

American Society of Hematology

American Society of Pediatric Hematology/Oncology

AnCan foundation

Anxiety and Depression Association of America

Association for Clinical Oncology (ASCO)

Association for the Accreditation of Human Research Protection Programs, Inc.

Association of American Cancer Institutes

Association of Black Cardiologists

Association of Northern California Oncologists

Association of Pediatric Hematology/Oncology Nurses (APHON)

Biomarker Collaborative

BlackDoctor

Brem Foundation to Defeat Breast Cancer

Cancer Active, Inc.

Cancer Support Community

Caregiver Action Network

Carolina BioOncolgy Institute & BioCytics Human Applications Lab

Cervivor, Inc.

Cheeky Charity

Children’s Brain Tumor Foundation

Coalition of Skin Diseases

Colon Cancer Coalition

Colorectal Cancer Alliance

Community Access National Network

Community Liver Alliance

Community Oncology Alliance (COA)

Connecticut Oncology Association

Crohn's & Colitis Foundation

Debbie’s Dream Foundation: Curing Stomach Cancer (DDF)

Depression and Bipolar Support Alliance (DBSA)

Derma Care Access Network

Digestive Disease National Coalition

Epilepsy Foundation of America

Esophageal Cancer Action Network (ECAN)

Exon 20 Group

Fight Colorectal Cancer

FORCE: Facing Our Risk of Cancer Empowered

Friends of Cancer Research

Gaucher Community Alliance

Gerontological Society of America

GI Cancers Alliance

Global Colon Cancer Association

GO2 for Lung Cancer

Haystack Project

Hope for Stomach Cancer

ICAN, International Cancer Advocacy Network

Illinois Medical Oncology Society (IMOS)

International Myeloma Foundation

Kidney Cancer Association

KidneyCAN

LESLIE'S WEEK a Stage 4 Breast Cancer Nonprofit

Livestrong

Living Beyond Breast Cancer

LUNGevity Foundation

Lupus and Allied Diseases Association, Inc.

Lupus Foundation of America

Lymphedema Advocacy Group

Maryland-DC Society of Clinical Oncology

Medical Oncology Association of Southern California (MOASC)

Melanoma Research Alliance

Melanoma Research Foundation

Men's Health Network

MET Crusaders

METAvivor

Multiple Myeloma Research Foundation

Myasthenia Gravis Association

National Alliance of State Prostate Cancer Coalitions

National Association of Hispanic Nurses

National Black Nurses Association

National Brain Tumor Society

National Cancer Registrars Association

National Coalition for Infant Health

National Comprehensive Cancer Network (NCCN)

National Health Council

National Hispanic Health Foundation

National Hispanic Medical Association

National Kidney Foundation

National Minority Quality Forum

National Patient Advocate Foundation

National Scleroderma Foundation

NCODA (Network for Collaborative Oncology Development and Advancement)

NRG1 Energizers

Ohio Hematology Oncology Society

Oklahoma Society of Clinical Oncology, Inc.

Oncology Nursing Society

Ovarian Cancer Research Alliance

Parkinson's Foundation

Patient Empowerment Network

PDL1 Amplifieds

Pennsylvania Prostate Cancer Coalition (PPCC)

PlusInc

Prevent Blindness

Prevent Cancer Foundation

Preventive Cardiovascular Nurses Association

Prostate Health Education Network

Rural Minds

Sharsheret | The Jewish Breast & Ovarian Cancer Community

Shercare

Society For Clinical Research Sites

Society of Utah Medical Oncologists (SUMO)

Stupid Cancer, Inc.

Susan G. Komen

The Headache and Migraine Policy Forum

The Prostate Cancer Clinical Trials Consortium

Tigerlily Foundation

Triage Cancer

Triple Negative Breast Cancer Foundation

Twisted Pink

Unite for HER

US Hereditary Angioedema Association

UsAgainstAlzheimer's

wAIHA Warriors

Women As One, Inc.

Young Survival Coalition

Your Prostate Cancer.help

ZERO Prostate Cancer

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Maria Rosario Gonzalez Albuixech
Senior Director, Media Advocacy and Communications
Walpole
Trista Hargrove
Director, Media Advocacy - Health Equity