Establishing Ethical Standards for Informed Consent and Counseling for Multi-Cancer Early Detection Testing

/ ABSTRACT Candidate: Dr. Eric Blackstone is a bioethics research fellow with extensive cancer research experience and training in qualitative methodology and bioethics. Dr. Blackstone conducts theoretical and empirical research to support ethical delivery of cancer care and promote value-concordant decision-making. His long-term goal is to improve the ethical conduct of cancer care and research by becoming a highly productive independent investigator whose research will be used to inform policy and develop interventions to support patients and their families as they make challenging decisions during their cancer journeys. Background: Novel blood-based multi-cancer early detection (MCED) tests present an opportunity to significantly expand screening efforts due to their ability to detect over 50 types of cancer from one blood draw. It is currently unknown whether MCED tests detect cancers early enough to alter disease course and improve survival, however. Despite this lack of evidence, MCED testing is already commercially available at significant cost. The speed with which this technology is being disseminated despite inconclusive evidence regarding benefits and risks raises critical ethical concerns. Research Plan: The objectives are to evaluate patient comprehension of key MCED information and experiences with informed consent and results counseling (Aim 1), and to elicit attitudes and ethical concerns of oncology and primary care clinicians regarding MCED (Aim 2). These data will inform creation of ethical guidelines for implementation of this technology through a modified Delphi process to achieve consensus among bioethicists and cancer early detection experts (Aim 3). These ethical guidelines and findings from previous aims will guide development and pilot testing of a web-based intervention to optimize MCED informed consent and results counseling (Aim 4). Career Development Plan: Under the mentorship of highly successful researchers and clinicians, Dr. Blackstone will gain expertise through a comprehensive training plan focused on (1) quantitative and mixed methodology, (2) behavioral intervention development, and (3) professional development. These skills combined with mentored research experience will facilitate Dr. Blackstone’s transition to independence and make him a strong candidate for future R01 or similar funding. Environment: Dana-Farber Cancer Institute is home to one of the only MCED Clinics in the nation, and they are committed to being ethical leaders in MCED. The proposed research will be conducted under the mentorship of Drs. Gregory Abel, Catherine Marinac, and Elizabeth O’Donnell. Dr. Blackstone will receive additional guidance from an advisory committee with expertise in developing and testing interventions for cancer early detection and improving informed consent in oncology. Project Number: 1K99CA307630-01 | Fiscal Year: 2026 | NIH Institute/Center: National Cancer Institute (NCI) | Principal Investigator: Eric Blackstone | Institution: DANA-FARBER CANCER INST, BOSTON, MA | Award Amount: $134,919 | Activity Code: K99 | Study Section: Special Emphasis Panel[ZRG1 CDPT-P (56)] View on NIH RePORTER: https://reporter.nih.gov/project-details/11282712