NIH Clinical Trial Integrity Act

Increased Participant Diversity: Sponsors must submit clear and measurable goals for recruitment and retention that reflect the race, ethnicity, age, and sex of the patients or the general population (Section 2(a)(1)).

Reduced Participant Burden: The bill encourages less burdensome follow-up requirements, such as phone or online follow-ups, home visits by nurse coordinators, virtual visits, or the use of wearable technology (Section 2(a)(4)).

Improved Outreach and Knowledge: A national campaign will be conducted to increase awareness among patients and healthcare professionals regarding the need for diverse clinical trials (Section 4(a)).

Support for Community Organizations: The Secretary will establish a grant program for nonprofit private entities, including community-based organizations and faith communities, to test outreach strategies and cover administrative costs for diversifying trials (Section 4(d)).

Addressing Barriers to Participation: The law directs a study to examine actions taken to address barriers to participation and identifies challenges in implementation (Section 2(g)).

Requirements for Increased Reporting: Sponsors are required to share aggregate demographic information and participant retention rates annually, which adds specific reporting duties (Section 2(b)(1)).

Mandatory Education and Training: Researchers and clinical trial supporters must complete specific education and training programs regarding diversity (Section 2(b)(1)(C)).

Mandatory Strategic Plans for Non-compliance: If a trial fails to meet its diversity goals, the sponsor must develop and submit a strategic plan in consultation with advocacy and community-based organizations (Section 2(e)(1)).