As patients assume an increasingly active role throughout the entire research process—from identification of research questions to study design, execution, and dissemination of results—institutional review boards (IRBs) struggle to define the boundaries of their responsibility around human subjects protection and oversight of investigators and researchers. Challenges to those working in oversight include defining the patients’ role as members of the research team, ensuring that patients are properly informed, and managing patient expectations regarding access to data and control over study endpoints. Furthermore, technological advances and development of applications and gadgets (e.g., Fitbits, Apple ResearchKit, RedCap, etc.) provide new media for participant reporting.
Patient-centered outcomes research (PCOR) is an approach to traditional comparative effectiveness research that is focused on addressing the questions and concerns most relevant to patients. PCOR helps patients and their caregivers communicate with clinicians, researchers, and other healthcare stakeholders and make informed decisions, allowing their voices to be heard in assessing the value of healthcare options. These collaborations are challenging traditional roles and responsibilities of the patient and researcher and are blurring the boundaries between research and clinical care. This webinar focused on the role of patients in PCOR and on the challenges this type of research presents to those tasked with reviewing it. Additionally, presenters considered how the expertise, experiences, and perspectives of patients as researchers can improve the IRB review process, including areas like informed consent and assessment of risks and benefits. (Presented on July 16, 2015)
What will I learn?
After attending this webinar, attendees were able to:
- Understand the nature of patient involvement as active study participants
- Manage patient expectations about getting feedback from physicians and researchers and obtaining access to personal data gathered during a study
- Interact effectively with patients
Who should attend?
This intermediate-level webinar was of interest to IRB members, chairs, and staff as well as human research protections program staff and researchers.
Webinar participants holding the Certified IRB Professional (CIP®) credential may apply 1.5 continuing education credits towards CIP recertification. Learn More »
Schulman Associates IRB provides high quality, rigorous IRB reviews for all phases of research in North America via streamlined processes, customized technology and responsive customer service. We offer dedicated IRB services for research institutions and also offer Clinical Quality Assurance and Human Research Protections consulting via our partner Provision Research Compliance Services.
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