If Informed Consent is an Ongoing Process, what does re-consent mean?
Presented by: Sharon Flynn, RN, MS, ANP-BC, AOCNS, BMTCN and Elizabeth Ness, MS, BSN, RN
Informed consent is a fundamental ethical requirement in clinical research. It is more than signing a form; it is also a process. Information must be presented in a way to enable an individual to voluntarily decide whether to participate in a research study. This information exchange occurs between the Investigator, research team, and the participant, but may lack documentation to support the research participant’s informed decision to continue participation based on the information exchange.
By the end of this session, the learner will be able to:
- Define re-consent and reaffirmation.
- Explain three types of research situations that warrant participant re-consenting.
- Discuss the clinical research nursing implications for re-consenting research participants.
About the Presenters
Sharon Flynn, MS, RN, ANP-BC, AOCNS, BMTCN
Sharon Flynn is a Nurse Educator within the Clinical Center Nursing Department at the National Institutes of Health. She received her Bachelor of Science from the University of Maryland, Baltimore County and her Master's of Science degree from the University of Maryland, Baltimore as an Adult Nurse Practitioner and Oncology Clinical Nurse Specialist. Ms. Flynn holds board certification as an Adult Nurse Practitioner and is certified as an Advanced Oncology Clinical Nurse Specialist and Bone Marrow Transplant Certified Nurse. She is a member of the National Heart, Lung and Blood Institute Institutional Review Board, serves as an Associate Investigator at NIH, and is a member of the IACRN Education Committee. Ms. Flynn is passionate about the readability of informed consent documents and the genomic education of nurses and research participants. She is currently the co-chair of IACRN's Education committee and a member of the 2019 Conference Planning Committee.
Elizabeth Ness, MS, BSN, RN - Director, Office of Compliance and Education at Center for Cancer Research, NCI
Elizabeth (Liz) Ness brings with her over 35 years of nursing experience and 23 years of clinical research experience. She earned her BSN from Boston College and her MS in Nursing Education from the University of Maryland School of Nursing. Currently, she is the Director of the Office of Education and Compliance at the Center for Cancer Research (CCR), part of the intramural research program (IRP), at the National Cancer Institute in Bethesda, MD. Her primary responsibilities include coordinating, developing and evaluating both educational and quality management activities for the CCR. Prior to working for the NCI, Ms. Ness worked for three years with a firm in Bethesda, MD, two of those years as the Deputy Project Manager for the NCI Cancer Therapy and Evaluation Program Protocol and Information Office. For six years, Ms. Ness was the lead Research Nurse for the Developmental Therapeutics Clinic at Lombardi Cancer Center in Washington, D.C. She is an active member of the Oncology Nursing Society (ONS). She has helped ONS develop 2 web courses related to clinical trials and serves as an author, served as co-editor for the 3rd edition of the ONS Manual for Clinical Trials Nursing and the project team lead for the 2nd edition of the Clinical Trials Nurse Competencies. Ms. Ness is active in International Association of Clinical Research Nurses (IACRN) serving on the Education Committee and as lead nurse planner. In addition to presentations for orientation and other inservices, Ms. Ness has presented nationally and internationally on topics related to clinical trials and professional development at conferences and to cancer centers. Ms. Ness is also a teaching assistant at Drexel’s School of Nursing in the clinical trial research program.