The FDA Calls For Culturally-Informed Research, But What Do We Understand About The Sikh Community?

By Ekta Grewal, founder, Sikhs in Clinical Research

The Sikh community across the United States represents a vibrant and growing population, estimated to be more than half a million, spread across different states. Many are first- or second-generation immigrants whose cultural, linguistic, and religious identities play a role in their health, decision-making, and interactions with the healthcare system.

Despite the size and visibility of the community, there remains a gap in available health data specific to the Sikh community in the U.S. Little research has been done or published about the experiences of Sikhs with American health care system.¹  Yet, the FDA — through its December 2025 guidance — states that “[d]ifferences in response to medical products (e.g., pharmacokinetics, efficacy, or safety) have been observed in racially and ethnically distinct subgroups of the U.S. population. These differences may be attributable to intrinsic factors (e.g., genetics, metabolism, elimination), extrinsic factors (e.g., diet, environmental exposure, sociocultural issues), or interactions between these factors”. ²

For the clinical research industry, this represents both a responsibility and an opportunity. If pharmaceutical companies truly want to develop the best possible treatments, they must include the very people who will be using them. But without intentional engagement, Sikh patients may remain invisible in datasets, and treatments risk being developed without a full understanding of how genetics, diet, lifestyle, and sociocultural factors influence outcomes in this population. Meaningful inclusion requires early partnerships with Sikh community groups such as Sikhs in Clinical Research (SICR), investment in culturally grounded education, and cultural training for healthcare professionals and research sites, along with co-creation of research pathways that respect faith practices and lived realities for long term sustainability.

To that end, SICR has hosted more than 50 culturally grounded community engagement events across over 15 states, connecting with Sikh elders, parents, young adults, and families. Through these initiatives, SICR has focused on disease awareness, promotion of preventive screenings, and raising awareness of clinical research through trusted, community-based outreach and education. More recently, these on-the-ground efforts expanded to include structured feedback surveys and open conversations about health within the community. The majority of participants reported learning about clinical research the first time through SICR’s events.³

Disease Burden In The Sikh Community

In 2025, Sikhs in Clinical Research conducted health surveys as part of the community outreach at Sikh places of worship (Gurudwaras) across different states in the U.S. Every conversation carried its own meaning. Behind each face was a story, a health struggle quietly endured, or a hope for better care for themselves or a loved one. The surveys helped us understand the disease types most affecting the community and where more education, awareness, representation, and support are needed.

Cardiology

Cardiovascular conditions have emerged as a central health concern within the community. These include hypertension, heart attack, stroke, and chest pain, with hypertension being the most commonly reported. SICR survey data revealed that 241 out of 400 individuals reported having a cardiovascular condition. Available evidence suggests the Sikh population, similar to other South Asian groups, is at high risk for cardiovascular disease due to a combination of traditional and unique risk factors, including central adiposity, dietary patterns, physical inactivity, and genetic predispositions. ^4,5 

Endocrinology

Similarly, endocrinological conditions were highly prevalent, affecting 140 of the 400 individuals, with diabetes and cholesterol accounting for most cases. Both Type 1 and Type 2 diabetes were reported within the community. However, Type 2 diabetes was significantly more common. Multiple studies have identified the complex factors contributing to the elevated risk of Type 2 diabetes in the Sikh community. Genome-wide association studies have identified specific genetic loci associated with Type 2 diabetes in Sikhs. ⁵ Language barriers, social and environmental barriers, cultural stigma, and occupational constraints particularly among immigrant Sikh community often limit access to preventive healthcare.⁶ Additionally, many Sikh men work in occupations that can lead to sedentary lifestyles, high stress levels, and poor dietary habits, all of which increase diabetes risk. Compounding these challenges, many individuals remain unaware of their diabetes status due to missed medical visits and limited access to routine health screenings, resulting in late-stage diagnoses and more severe health complications. ^6,7  Moreover, thyroid disorders and vitamin D deficiency were also commonly seen in the survey data.

Rheumatology

Rheumatologic conditions, including arthritis and chronic knee pain, were also reported in the community, affecting 51 of the 400 individuals, with a higher prevalence among Sikh women. Cultural barriers further increase the burden of conditions like arthritis.  ^,8

Neurology and Psychiatry

Neurological and psychiatric conditions were noted within roughly 10% of the community surveyed. Neurological disorders, including Alzheimer’s disease, Parkinson’s disease, dementia, migraine, ALS (Amyotrophic Lateral Sclerosis), multiple sclerosis, and autism (31 out of 400 individuals), and psychiatric conditions, such as depression, brain trauma, schizophrenia, and addiction (23 out of 400 individuals), were observed.

Oncology

The incidence of cancer is rising, and the Sikh community is no exception. The survey identified cases of breast, prostate, thyroid, stomach, pancreatic, ovarian, and colorectal cancers (24 out of 400 individuals). In some responses, participants reported cancer without specifying the type. Both genetic and environmental factors contribute to this increasing burden. Identified genetic risk includes the GG genotype of the MCP-1-2518 A/G polymorphism, while environmental factors such as obesity, reduced physical activity, and dietary shifts away from traditional plant-based, home-cooked meals have also been associated with increased breast cancer prevalence. ⁹

Dermatology

Skin conditions, including atopic dermatitis and vitiligo, were reported by 21 out of 400 individuals.

Ophthalmology

Eye conditions, including glaucoma, cataract, and reduced vision, were reported by 19 out of 400 individuals. 

Pulmonology

Respiratory conditions, such as pneumonia, chronic obstructive pulmonary disease (COPD), and asthma were reported by 15 out of 400 individuals.

Additional findings in the survey included gastroenterology and hepatology conditions, such as constipation, bloating, fatty liver, and Wilson’s disease; hematology concerns, such as anemia and thalassemia minor; immunology issues, such as urticaria and gluten allergy; and orthopedic problems, including neck and ankle pain, heel bone outgrowth, and scoliosis.

This data reveals a deeper truth about how diseases show up in the Sikh community. Health conditions do not impact all populations in the same way nor do the treatments and medications developed to address them  Without accurate representation in research data, these differences go unrecognized and untreated. 

Awareness Campaign Outcomes

Additionally, SICR conducted awareness campaigns for breast cancer and diabetes during October and November 2025, coinciding with Breast Cancer Awareness and Diabetes Awareness months. During these events, community members completed disease-specific surveys, whose insights are revealed below.

Diabetes Awareness Survey Results

The data revealed that diabetes is prevalent among both men and women, with the majority of affected individuals aged 45 years and older, though cases were also observed in younger individuals, highlighting early risk within the community. A strong family history of diabetes was common among those diagnosed, underscoring genetic and shared lifestyle influences (75%). When asked about screening and check-ups, only a portion of participants (42%) reported checking their blood sugar at home, and half of the individuals (50%) indicated that they underwent regular diabetes screening.

However, following education on diabetes prevention and the importance of A1C/glucose screening, there was a noticeable increase in participants (92%) expressing willingness to pursue regular screenings in the future. Several individuals (50%) also reported experiencing diabetes-related complications, including issues affecting vision, nerves, and overall health. Although many individuals (50%) already knew that maintaining a healthy lifestyle, such as eating a healthy diet, exercising regularly, and limiting alcohol consumption, reduces the risk of diabetes, the remaining 50% reported that they learned this information during the event. These findings reinforce the importance of continued community-based education, including early screenings to support timely diagnosis, prevention, and better long-term health outcomes. 

Breast Cancer Awareness Survey Results

Women who participated in an awareness event and completed this survey ranged in age from 31 to 60 years. The completed surveys indicate that the event positively influenced participants’ awareness and understanding of breast cancer prevention and early detection. While some participants reported prior knowledge of mammograms, breast self-examinations, and risk factors such as family history, many indicated learning new information through the event. Participants also demonstrated improved understanding of how lifestyle factors, including a healthy diet, regular physical activity, limiting alcohol consumption, and avoiding smoking, can reduce breast cancer risk. Importantly, respondents (100% of the women aged more than 40) expressed increased willingness to pursue mammograms and perform regular self-examinations (100%) following the event, suggesting a meaningful shift toward proactive health behaviors. 

SICR has been amplifying patient voices through patient perspective videos, which provided an opportunity to interview breast cancer survivors and hear powerful, first-hand reflections on their healthcare journeys. 

“You have to be your own advocate. It’s your body,” -explained Lilly Kaur.

“None of my doctors ever told me that a clinical research option exists. I would love to participate in it,” said Jasbir Kaur.

It is important to note that these findings are based on a limited number of respondents. Not all community members completed the surveys, and participation varied across events. As such, while these results provide meaningful insights into health needs, they should be interpreted as indicative rather than comprehensive. Ongoing efforts need to be continued to engage more individuals to capture a bigger picture of the health needs of the Sikh community in the U.S.

From Data To Action

Disease awareness and health literacy remain central priorities of SICR. Providing simple, accessible education about symptoms, prevention, and early screening encourages individuals to take proactive steps in their health journeys. When people feel informed, they are far better equipped to make decisions that benefit themselves and their loved ones.

For the Sikh community, health decisions are deeply shaped by faith, family, and trust. Individuals often prioritize family needs over their own health and delay seeking care until symptoms become severe. Cultural norms, language barriers, and stigma, particularly around chronic illness, mental health, and cancer, can limit open dialogue with clinicians and discourage participation in clinical research. Many Sikh patients, particularly elders, face language and cultural barriers when accessing healthcare. To address this gap, SICR has created healthcare resources in the Sikhs native language¹⁰, Punjabi, ensuring patients can understand, ask informed questions, and feel confident in their care. SICR has also developed a Sikh Patient Guide for Healthcare Workers¹¹, designed to help providers better understand the Sikh faith, values, and practices, so they can deliver culturally competent care and be able to build trust with the Sikh community.

Our goal is simple, but the need is great: to reach more people and improve health outcomes for all. The number of individuals who need this support is large, and we cannot do it alone. More resources, stronger partnerships, and collective commitment are essential. This is our call to industry partners, healthcare leaders, researchers, and all who believe in equity: let’s come together.

References:

1. Health challenges faced by Sikh community members in America
2. Enhancing Participation in Clinical Trials — Eligibility Criteria, Enrollment Practices, and Trial Designs | FDA
3. Building Awareness in Clinical Research: Community Engagement Data & Outcomes - Sikhs in Clinical Research
4. Cardiovascular Disease in the Sikh Community: Understanding the Need for Better Representation in Research - Sikhs in Clinical Research
5. Kooner JS, Saleheen D, Been LF, et al. (2013) Genome-wide association study identifies a novel locus contributing to type 2 diabetes susceptibility in Sikhs of Punjabi origin from India. Diabetes. (https://diabetesjournals.org/diabetes/article-abstract/62/5/1746/42881)
6. Lim, S., Wyatt, L.C., Chauhan, B., Zanowiak, J., Kavathe, R., et al. (2019). A culturally adapted diabetes prevention intervention in the New York City Sikh Asian Indian community leads to improvements in health behaviors and outcomes. Health Behavior and Policy Review. (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6894424/
7. Diabetes in the Sikh Community: Understanding the Need for Better Representation in Research - Sikhs in Clinical Research
8. Sanderson, T., Calnan, M., & Kumar, K. (2015). The moral experience of illness and its impact on normalisation: Examples from narratives with Punjabi women living with rheumatoid arthritis in the UK. Sociology of Health & Illness. (https://doi.org/10.1111/1467-9566.12304)  
9. Breast Cancer: A Growing Health Concern - Sikhs in Clinical Research
10. Resources - Sikhs in Clinical Research  
11. Handbook_for_healthcare_workers FINAL.pptx

About The Author

Ekta Grewal is the founder of Sikhs in Clinical Research (SICR), driving health equity, education, and patient advocacy through awareness programs. Under her leadership, SICR has hosted numerous clinical research awareness events across different states in the U.S. She emphasizes the need to increase representation in clinical research and to strengthen patient and community engagement. Her interests include expanding access to interpreter/translation services, addressing logistical barriers in low-resource settings, and understanding how health beliefs, cultural differences, patient comprehension, education, communication, and perceptions of clinical research influence clinical trial participation decisions among diverse populations.