Unifying Research S2E4 - HRPP vs IRB and Participant Christine

Unifying Research S2E4 - HRPP vs IRB and Participant Christine

In the fourth episode of Unifying Research, I sit down with an executive director of an HRPP at a leading academic medical center and research institution to discuss the difference between a Human Research Protection Program and an IRB. I also talk with a research participant who, after participating in several studies, has spent her career inside the research industry working to improve things based on her own experiences. My research expert guest is Adam McClintock, the Executive Director of HRPP at the University of Alabama at Birmingham. Adam has over two decades of experience in the research industry and shares some much needed guidance on the differences between an HRPP and an IRB. He explains the importance and encourages the industry to think about how we can start measuring effectiveness of our HRPPs. My research participant guest is Christine Melton-Lopez. Christine is a research expert herself, but before that, she participated in multiple research studies. She shares the good, the bad, and the ugly of her experiences participating in different studies through college and beyond. Her stories help illuminate that while research isn't perfect, it's still a very hopeful and meaningful endeavor. Christine shares some wonderful questions to ask when you're considering participating in a study.  Additional resources: * Connect with Adam McClintock on LinkedIn [https://www.linkedin.com/in/mcclintock22/] * Connect with Christine Melton-Lopez on LinkedIn [https://www.linkedin.com/in/christine-ml-569762402/] * Learn more about the UAB Research Program [https://www.uab.edu/research/home/irb] * Learn more about the AEREO program [https://www.med.upenn.edu/aereo/]     * Learn more about Univo's partners working together to bring the patient's voice to research: * Clinical Trials For All [https://www.clinicaltrialsforall.org/] * Savvy Cooperative [https://www.savvy.coop/] * Inspire [https://www.inspire.com/] * Children's Flight of Hope [https://www.childrensflightofhope.org/] * The Patient View [https://the-patientview.com/] * AAHRPP [https://aahrpp.org/]

Unifying Research S2E3 - Research Administration and Participant Caregiver

In the latest episode, I speak with a research expert on the administrative side of running a program at a Cancer Clinical Trials Office. I also speak with a caregiver of someone in a research study. My research expert guest is Michelle Marcum, the Senior Director of Clinical Trials at the University of Cincinnati Cancer Center. Michelle discusses what it looks like to run a clinical trials program in an academic medical center and cancer center. She also shares how her program is managed through the lens of a mission-driven patient-first model. My patient guest this episode is unique. I speak with Brian Blackmon, a caregiver for a research participant. Better understanding the role of a caregiver in a research participant's experience is so important, yet there aren't many of these conversations taking place. Brian does a great job of explaining the challenges and opportunities for improvement for this vital role. Additional resources: * Connect with Michelle Marcum on LinkedIn [https://www.linkedin.com/in/michelle-marcum-25202722a/] * Connect with Brian Blackmon on LinkedIn [https://www.linkedin.com/in/brianblackmon/] * Learn more about the University of Cincinnati Cancer Center Clinical Trials [https://med.uc.edu/institutes/cancer/clinical-trials/overview] * The Caregiver Action [https://linkprotect.cudasvc.com/url?a=https%3a%2f%2fwww.caregiveraction.org%2f&c=E,1,NLlAsveRDzSCUUi7QlVUQm1PqGDHuUEf1TgeWjgkuybqQZyWEdvFtL8WbqWw1IZdkaAn6lhU-EeEhvd8YrPvW15451OLuzSsEpRAUjnGMa0H&typo=1] - a resource for caregivers of research participants * Connect with Univo [https://www.univo-group.com/] to learn more about our mission and services     * Learn more about Univo's partners working together to bring the patient's voice to research: * Clinical Trials For All [https://www.clinicaltrialsforall.org/] * Savvy Cooperative [https://www.savvy.coop/] * Inspire [https://www.inspire.com/] * Children's Flight of Hope [https://www.childrensflightofhope.org/] * The Patient View [https://the-patientview.com/] * AAHRPP [https://aahrpp.org/]

Unifying Research S2E2 - Research Compliance and Patient Stephanie

In season two, episode two of Unifying Research, I had the pleasure of sitting down with a research compliance expert and a wonderful patient willing to share her personal story.  Our research expert this episode is Kate Cohen, a lawyer by training and Chief Compliance Officer at SIU Medicine. With a strong background in research compliance and human subjects protection, Kate helps us break down the silos between compliance, privacy and the role of the IRB.   Our patient guest this episode is Stephanie Gabriel. Stephanie shares her incredible journey dealing with PMDD, a misunderstood and often misdiagnosed disorder. Struggling from an early age, Stephanie never stopped looking for answers, which led to a research opportunity that ultimately changed the course of her life.   Additional resources: * Connect with Kate Cohen on LinkedIn [https://www.linkedin.com/in/katherine-cohen-jd/] * The Seven Elements of Compliance Program [https://oig.hhs.gov/compliance/general-compliance-program-guidance/] * Learn more about HIPAA and Research [https://www.hhs.gov/hipaa/for-professionals/special-topics/research/index.html] * Connect with Univo [https://www.univo-group.com/] to learn more about our mission and services     * Learn more about Univo's partners working together to bring the patient's voice to research: * Clinical Trials For All [https://www.clinicaltrialsforall.org/] * Savvy Cooperative [https://www.savvy.coop/] * Inspire [https://www.inspire.com/] * Children's Flight of Hope [https://www.childrensflightofhope.org/] * The Patient View [https://the-patientview.com/] * AAHRPP [https://aahrpp.org/]

Unifying Research S2E1 - Patient Negative One and Christine Von Raesfeld

In season two, episode one of Unifying Research, I had the pleasure of sitting down with a true research innovator and a rare disease patient with a fascinating story.  Our research expert this episode is Kaye Doiron, an innovator and serial entrepreneur, who is helping to redefine how we think about clinical trials. Whether it's her Patient Negative One concept, or her new AI-driven tool for research sites, Kaye understands how to take novel ideas and make them reality.  Our patient guest this episode is Christine Von Raesfeld. Christine is a rare disease patient who has used her lived experience, along with other advocates, as the foundation for the Patient AI Rights Initiative, which offers a clear framework to help individuals understand what the rise of AI means for autonomy, ethics, and trust. Additional resources: * Connect with Kaye Doiron on LinkedIn [https://www.linkedin.com/in/kaye-doiron-209b5487/] * Connect with Christine Von Raesfeld on LinkedIn [https://www.linkedin.com/in/cvonraesfeld/]  * Learn more about Patient Negative One [https://www.linkedin.com/pulse/first-patient-your-test-run-kaye-doiron-wpz5e/] * Learn more about Research Works Inc. [https://www.research.works/] * Learn more about the Light Collective [https://lightcollective.org/] * Check out the AI Rights for Patients Initiative [https://lightcollective.org/wp-content/uploads/2024/06/Collective-AI-Rights-For-Patients-v_2.0.pdf] * Connect with Univo [https://www.univo-group.com/] to learn more about our mission and services     * Learn more about Univo's partners working together to bring the patient's voice to research: * Clinical Trials For All [https://www.clinicaltrialsforall.org/] * Savvy Cooperative [https://www.savvy.coop/] * Inspire [https://www.inspire.com/] * Children's Flight of Hope [https://www.childrensflightofhope.org/] * The Patient View [https://the-patientview.com/] * AAHRPP [https://aahrpp.org/]

Unifying Research - Decision Making in Research and Patient Jess

In the seventh episode of Unifying Research, I sit down with a clinical research leader to discuss the psychology of decision making in our industry. Then, I had the privilege of speaking with a unique research participant – someone who has participated in over 15 studies and has over 15 years’ experience working in the research industry.  My research expert guest is Mitch Hible, the Founder and CEO of Diversitrials and Chief Strategy Officer at Clinical Research Pro. Mitch has two decades of experience in our industry and is a true entrepreneur at heart. As we discuss decision making in our industry, Mitch shares some great practical advice for all of us. The patient-side guest for this episode is Jess Thompson. Jess has been participating in research studies since college, and her experiences in each study have helped shape her career path in the research industry.   Additional resources: * Connect with Mitch Hilbe on LinkedIn [https://www.linkedin.com/in/mitchell-hilbe/] * Connect with Jess Thompson on LinkedIn [https://www.linkedin.com/in/jessthompsonpmp/]  * Learn more about Diversitrials [https://diversitrials.com/] * Learn more about Clinical Research Pro [https://www.clinicalresearchpro.com/] * Learn more about the Clinical Research Justice League [https://clinicalresearchjusticeleague.org/] non-profit * Connect with Univo [https://www.univo-group.com/] to learn more about our mission and services     * Learn more about Univo's partners working together to bring the patient's voice to research: * Clinical Trials For All [https://www.clinicaltrialsforall.org/] * Savvy Cooperative [https://www.savvy.coop/] * Inspire [https://www.inspire.com/] * Children's Flight of Hope [https://www.childrensflightofhope.org/] * AAHRPP [https://aahrpp.org/]