Ethics and regulatory onboarding documentation for 2 of the NIH Pragmatic Trials Collaboratory’s newest studies is now available. The documents include meeting minutes and supplementary materials summarizing recent discussions of ethics and regulatory issues associated with the LungSMART trial and the STEP-2 trial.
The consultations took place by video conference and included representation from the study teams, members of the NIH Collaboratory’s Ethics and Regulatory Core, NIH staff, and NIH Collaboratory Coordinating Center personnel.
LungSMART will test telehealth interventions designed to address logistical barriers and hesitancy around completing lung cancer screening among patients receiving care in community health centers in Utah.
- Learn more about LungSMART.
- View the ethics and regulatory documentation for LungSMART.
The STEP-2 trial will evaluate the comparative effectiveness and cost-effectiveness of in-clinic vs mailed distribution of human papillomavirus (HPV) self-sampling kits to improve cervical cancer screening rates among patients receiving care in community health centers in Oregon and Washington.
- Learn more about STEP-2.
- View the ethics and regulatory documentation for STEP-2.
LungSMART and STEP-2 are the first NIH Collaboratory Trials to be supported by grant awards from the National Cancer Institute.
Ethics and regulatory documentation for all of the NIH Collaboratory Trials is available on our Data and Resource Sharing page.