Podcasts about institutional review board irb

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma e Biotech world. Viral vector manufacturers are facing challenges such as high production expenses, low titers, empty capsids, and limited scalability when producing cell and gene therapies. To overcome these challenges, they are turning to next generation production processes to create a cost-effective and robust AAV manufacturing process. This new approach aims to produce higher titers and full capsids, increase efficiencies resulting from high yields, and drive down the cost per dose. By implementing these strategies, manufacturers can improve the productivity of AAV production and bring promising treatments to the market more effectively.Embecta received FDA approval for its insulin patch pump, featuring a larger insulin reservoir based on feedback from people with type 2 diabetes. Meanwhile, Illumina avoided a fine for its acquisition of Grail in a European court victory. The ARPA-H program will focus on AI degradation in medical tools, while a pathology group is suing to block an FDA lab test rule. Additionally, Medtronic's chief medical officer of acute care and monitoring has departed for a new role.The text discusses various updates in the biopharma industry as of September 3, 2024. It covers topics such as the next challenger to Prevner, advancements in AI drug discovery, concerns over suicide risk of obesity drugs, Recursion's lead drug safety, Vaxcyte's positive data for a pneumococcal vaccine, Sanofi's mixed results in MS drug trials, and the value of digital insights in pharma success.A new study predicts a healthcare labor shortage by 2028, with certain states and specialties facing acute shortages. The study also reveals disparities in fighting medical bills, as uninsured and less educated patients are less likely to question their bills. The ARPA-H program will focus on addressing AI degradation in medical tools. Other updates include tracking healthcare worker strikes and data breaches. The use of technology is transforming healthcare to combat challenges such as workforce shortages and shifting care utilization patterns.FDA Commissioner Dr. Robert Califf is considering reforms to advisory committees, including potentially scrapping expert voting in some circumstances. Califf believes that the discussions within these committees may be more valuable to the FDA than the final vote outcomes. Eliminating voting could help clarify the role of advisory committees. Other potential reforms being discussed include addressing conflicts of interest.The text discusses the importance of getting the Institutional Review Board (IRB) review right the first time and introduces a checklist of critical questions to ask potential IRB partners to ensure a smoother review process. By asking the right questions and choosing the right IRB, the review process can be more efficient and effective.Novo Nordisk's drug Ozempic will continue to face shortages into the fourth quarter due to supply issues, even as the company tries to expand its indication. Astellas Gene Therapies is closing its biomanufacturing facility in San Francisco, affecting about 100 employees and shifting manufacturing to North Carolina.In a landscape where consumers are willing to switch brands to save money, it is crucial for brands to establish and maintain loyalty among shoppers. By leading with value, moving consumers from awareness to loyalty to advocacy, and creating connection and community, brands can build brand love even in the face of economic pressures.The text discusses how emerging oncology innovations have led to more effective therapies for cancer patients. The increased investment in cancer research has introduced new treatments such as cell and gene therapies, antibody drug conjugates, and checkpoint inhibitors. Despite these advancements, the industry still faces challenges in expanding access and improving outcomes.

Dean's Chat hosts Drs. Jeffrey Jensen and Johanna Richey are joined by Midwestern University colleagues, Drs. David McVey and Charlotte Bloch from the Office of Research and Sponsored Programs (ORSP) at Midwestern University. The Arizona College of Podiatric Medicine's (AZCPM) faculty works with the team at ORSP when collaborating on research with students, and this episode highlights the effort required to create meaningful research, and submit for Institutional Review Board (IRB) approval. We also discuss common obtacles, solutions, ways to dial in research objectives, and statistical analysis. Research is a team effort, but the roadmap is available to make it less daunting! Enjoy this thoughtful discussion! https://deanschat.com/ https://bakodx.com/ https://bmef.org/ www.explorepodmed.org https://podiatrist2be.com/ https://higherlearninghub.com/  

In this episode of the Global Medical Device Podcast, host Etienne Nichols welcomes back Dr. Mike Drues to discuss the critical aspects of obtaining Institutional Review Board (IRB) approval and interacting with the FDA for medical device clinical trials. They explore the roles of IRBs, the difference between significant and non-significant risk devices, and share invaluable advice on mitigating risks associated with clinical trials. Whether you're a newcomer or a seasoned professional in the MedTech industry, this episode offers essential insights to ensure your clinical studies are compliant and efficient.Key Timestamps:00:01:20 – Introduction to Dr. Mike Drues and his accolades.00:05:30 – Explanation of IRBs and their role in clinical trials.00:15:10 – Differences between traditional and commercial IRBs.00:22:40 – Discussion on significant vs. non-significant risk devices.00:32:00 – Importance of pre-submission meetings with the FDA.00:44:15 – Steps to take when an IRB disapproves your clinical trial.01:00:30 – Practical tips for choosing the right IRB for your study.Quotes:"Most 510 devices do not need clinical data. But if you do, even for a non-significant risk device, vetting that with the FDA in advance is wise." – Dr. Mike Drues"You don't want to create a problem where none exists, but avoiding FDA consultation can lead to costly surprises later." – Dr. Mike Drues"The primary mission of an IRB is to ensure the safety of the patients at that institution." – Dr. Mike DruesTakeaways:Key Insights:Understanding IRBs: IRBs are local entities responsible for the ethical oversight of clinical trials, ensuring patient safety and compliance.Risk Classification: The classification of your device as significant or non-significant risk dictates whether FDA approval is needed for your clinical trial.Strategic Pre-Submission: Engaging in a pre-submission meeting with the FDA can prevent costly delays and ensure your clinical trial meets all necessary endpoints.Practical Tips:IRB Shopping: If faced with an IRB denial, consider alternative institutions or commercial IRBs to avoid delays.Comprehensive Submissions: Prepare thorough submissions for IRBs, including device descriptions, clinical trial protocols, and informed consent forms.Physician Champions: Having a physician advocate at the institution can streamline the approval process and facilitate patient enrollment.Future Questions:How will the evolving landscape of MedTech regulations impact the approval process for new devices?What role will real-world evidence play in future clinical trials for medical devices?How can smaller companies navigate the complexities of FDA and IRB requirements effectively?References:Etienne Nichols on LinkedInMike Drues on LinkedInFDA Guidance on Artificial Intelligence and Medical DevicesFDA Guidance on Avoiding Potential Issues with Your 510(k) SubmissionGood Clinical Practices (GCP) regulations for IRBsMedTech 101:What is an IRB?An Institutional Review Board (IRB) is a committee established to review and approve research involving human subjects. The primary purpose of an IRB is to ensure the ethical and safe treatment of participants in clinical trials.What is an IDE?An Investigational Device Exemption (IDE) allows a medical device to be used in a clinical study to collect safety and effectiveness data. An IDE must be approved by the FDA for significant risk devices before a clinical study can begin.Questions for the...

In this podcast, we explore a groundbreaking shift where clinical research is emerging as a viable care option, known as Clinical Research as a Care Option (CRACO). While the concept seems promising, particularly for patients with conditions like rare diseases or cancer, it introduces a host of concerns. The alignment of Institutional Review Board (IRB) goals with the essence of a clinical study becomes pivotal. If the trial's outcome is already known, it may be labeled a seeding trial, raising ethical and FDA-related red flags. Conversely, administering a drug with uncertain effectiveness to a hopeful patient brings its own set of ethical and legal challenges. This evolving landscape demands careful consideration and resolution of ethical and legal issues associated with integrating clinical research and care. Stay tuned as discussions on this innovative approach continue to unfold.

In this LIBERTY HOUR of Informed Life Radio, Xavier and guest Professor Mark Skidmore discuss Skidmore's shocking peer-reviewed survey study that shows nearly 290,000 people in the U.S. were likely killed by COVID-19 vaccines. They also discuss his exoneration after anonymous complaints lead to a seven-month ethics investigation by the Michigan State University's Institutional Review Board (IRB).Reference Linkshttps://www.publichealthpolicyjournal.com/copy-of-clinical-and-translational-rehttps://mark-skidmore.com/about/https://kirschsubstack.com/p/msu-professor-mark-skidmore-was-exonerated Learn more about your ad choices. Visit podcastchoices.com/adchoicesSee Privacy Policy at https://art19.com/privacy and California Privacy Notice at https://art19.com/privacy#do-not-sell-my-info.

In this LIBERTY HOUR of Informed Life Radio, Xavier and guest Professor Mark Skidmore discuss Skidmore's shocking peer-reviewed survey study that shows nearly 290,000 people in the U.S. were likely killed by COVID-19 vaccines. They also discuss his exoneration after anonymous complaints lead to a seven-month ethics investigation by the Michigan State University's Institutional Review Board (IRB). Reference Links https://www.publichealthpolicyjournal.com/copy-of-clinical-and-translational-re https://mark-skidmore.com/about/ https://kirschsubstack.com/p/msu-professor-mark-skidmore-was-exonerated

In this LIBERTY HOUR of Informed Life Radio, Xavier and guest Professor Mark Skidmore discuss Skidmore's shocking peer-reviewed survey study that shows nearly 290,000 people in the U.S. were likely killed by COVID-19 vaccines. They also discuss his exoneration after anonymous complaints lead to a seven-month ethics investigation by the Michigan State University's Institutional Review Board (IRB). Reference Links https://www.publichealthpolicyjournal.com/copy-of-clinical-and-translational-re https://mark-skidmore.com/about/ https://kirschsubstack.com/p/msu-professor-mark-skidmore-was-exonerated

CathVision this week announced the FDA clearance of its PVI Analyzer and Signal Complexity algorithms for facilitating electrogram interpretation. The regulatory nod makes these artificial intelligence-based tools available to physicians. Fast Five hosts Sean Whooley and Danielle Kirsh explain what the algorithms are used for and what sets them apart from traditional EP recording systems. AngioDynamics received FDA breakthrough designation for its AngioVac system. The designation includes proposed indications for the use of AngioVac in the non-surgical removal of vegetation from the right heart. Find out what the company plans to do with the breakthrough nod and what executives see for the future of AngioVac. Tivic Health is planning to begin its vagus nerve stimulation trial after receiving Institutional Review Board (IRB) approval. Whooley shares details of the study, what the IRB approval means for Tivic and what the company hopes to achieve in the study. New data from a two-year trial of Nevro's spinal cord stimulation trial demonstrated durable pain relief and significant improvements in health-related quality of life. Learn some of the data points from the study and what doctors think about the results of the trial in today's episode. Medtronic's Mahurkar hemodialysis catheters are facing their third Class I recall. More than a million Mahurkar catheters have been recalled since July 2022. Whooley and Kirsh share the issue in this recall and how many devices are affected. Check out the show notes for links to the stories we discussed today at MassDevice.com/podcast.

Dr. Simon Whitney is a family physician and ethicist. He taught at Baylor College of Medicine in Houston, Texas for twenty-two years. He is retired from medical practice but continues to publish and teach about medical ethics.He wrote the book From Oversight to Overkill: Inside the Broken System That Blocks Medical Breakthroughs—And How We Can Fix It (Rivertowns Books, 2023).What Simon is talking about is not the behemoth U.S. Food and Drug Administration (FDA), one of the largest public agencies in the world.The subject of his book is the Institutional Review Board (IRB) system, an institution responsible for preventing abuse of research subjects. It is run by the Office for Human Research Protection (OHRP), a small office within the United States Department of Health and Human Services (DHHS).It is an obscure and little-known bureaucracy.Simon uncovers how a fear-driven bureaucracy frustrates scientists by delaying research from anything between months to years and sometimes preventing important research with no harm to patients, but failing to benefit untold millions.The medical history behind IRBs is fascinating and parallels many other stranded technologies stories.It starts with a flexible system and lots of innovation. Medical self-experimentation was more common. It can be gut-wrenching, but it led to heroic feats of progress.It was public health disasters that led to its demise.Most of all the Tuskegee Syphilis Study became a widely know scandal where the United States Public Health Service (PHS) withheld life-saving treatment from 400 poor African Americans with syphilis to study its effect over 40 years.A gross incidence of ethical misconduct.Yet what followed was an overcorrection. The National Research Act of 1974 led to federal oversight of IRBs, leading to frivolous lawsuits and a bureaucracy stifled in fear of not doing the wrong thing, even at the cost of doing the right thing.The incentives are again stacked against progress.The anatomy of the IRB system going awry is instructive.It teaches us again the need for regulatory innovation and for bold action to correct the excesses of bureaucratic overreach - ideas for inside reform seem feasible, and external inspiration by special jurisdictions can help accelerate this movement.

Discusses the impact of bots on online survey research, what Institutional Review Board (IRB) members should look for when reviewing related protocols, and how IRB members can proactively help researchers mitigate the impact bots may have on their research.Our guest is Myra Luna-Lucero, EdD, the Research Compliance Director at Columbia University's Teachers College. She spearheaded the College's “Ethics & Safety Amid Uncertainty” initiative and co-chaired the Research Compliance & Safety Committee. She has also recently launched the “Research Writing & Ethics” internship program and oversaw an extensive transformation of the College's IRB website. She regularly offers seminars and workshops on research compliance and IRB leadership. A researcher and teacher herself, Dr. Luna-Lucero has studied and published on student motivation in STEM fields, barriers to accessing education for students in rural communities, and community activism.

Anna Shirley lives in Indiana with her husband, and three teens and tweens.  Anna was born and raised in SLC, UT and graduated from the University of Utah in Political Science. For almost 20 years, she has worked at the University of Utah's Institutional Review Board (IRB).  Anna has also written for TodaysMama.com and was active in a local group of Instagram photographers in Indianapolis for several years keeping her involved in social media. For the last 5 years she has served as the Communications Director of the Indianapolis West Stake for The Church of Jesus Christ of Latter-day Saints.  Isha Warriors is celebrating it's First Anniversary! As a big thank you to YOU for being a part of our journey-Annual Teen Membership is 50% off!! Help Keep Isha Warriors ad free!Join Isha Warriors in Prince Edward Island for an incredible Mother/Daughter Retreat this summer! Today's Episode!Being able to use fire revolutionized humankind.  Fire provides warmth and light...and it can also be dangerous, unpredictable and painful.  Social Media is the "fire" of our time that affects humankind in a revolutionary way every day.  It is both a tool and a trap.What are the negative sides of social media?Misinformation, discord, divisionHesitation to interact (we've been burned online before)Time wasterCompare our reality to other's “highlight reel”Social Currency (attributing value to you/your identity)FOMOHarassmentOverwhelmAudit Your Use!  How did that make you feel?How do we choose to act?How do we choose to react?Create a Better Online Experience!Post with purposeWhat is the purpose?  Does it follow the THREE C's? The Three C'sCompassionHow does it serve the people I love? Connection“We should not exaggerate, embellish, or pretend to besomeone, or something we are not. Our content should betrustworthy and constructive.” – David A. BednarCommunity buildingWhat are your spheres of influence?How can you be an influencer? ie Pick 5 people to encourage.Social Media GoalsRemember, social media platforms give us a unique opportunityto flood the earth with positive thoughts, imagery, andmessages.As a parent, use tools to be a "First Responder" instead of a "First Reactor".   Look at these tools as a way to have open loving communication and a way to help guide teens in how to "use fire" safely. https://www.bark.us/learn/bark-home/https://www.aura.com/https://www.qustodio.com/en/https://meetcircle.com/Anna referenced Episode 50: Overcoming OverwhelmPlease consider clicking below to make a one time donation to help "Monday Mindset With Isha Warriors" reach more people across the world!Donate Here

The National Institutes of Health spends about $42 billion on medical research each year, but less than one-eighth of that money is spent specifically on women's health. That may come as a bit of a shock, given that women make up a majority – about 51% – of the population. This underserved market is a huge economic opportunity for med tech companies.That's what Holly Rockweiler discovered as a Fellow at the Stanford Byers Center for Bio Design. So she put her background in biomedical engineering to work and started Madorra Medical, developing solutions to improve the vaginal atrophy and dryness that women experience after menopause or breast cancer. Madorra's flagship product is a handheld home-use device that uses ultrasound to rekindle the body's natural moisture-producing capability. The FDA has granted it breakthrough device designation The first randomized trial has been published, and a second one is on the way, and the company is now working toward the next set of data. Here in Episode #24, Madorra CEO Holly Rockweiler and Andy Rodgers talk about how that data is helping to blaze new trails in women's health. Need to know: There was a commercial about menopause in this year's Super Bowl (Astellas Pharma). That simple fact signals a new era in women's health.  Fundraising can be the most difficult part of bringing a new product to market, and it never goes away. Investors want to know what data has been collected, what payer requirements are, and to see a clear path to market. Piggyback on existing data when you can. For Madorra, there was substantial literature and technology using ultrasound in other therapies, data on vaginal blood flow from sexual arousal studies, and existing ultrasound devices that could be modified to show proof of concept. The nitty-gritty:Vaginal dryness resulting from vulvovaginal atrophy (VVA) affects over half of post-menopausal women and is also common among breast cancer survivors due to treatments that cause estrogen levels to drop. Symptoms include soreness, irritation, pain, increased urinary tract and yeast infection rates, and pain with sexual intercourse. Today, the standard treatment for menopausal symptoms is estrogen therapy. But that comes with risks: breast cancer, heart attack, and stroke. The quandary for doctors and patients alike is whether the benefits of pharmaceutical treatment outweigh the risks. For some patients, the risks are too significant and estrogen therapy is not recommended.   By putting data to work, Madorra created an ultrasound solution that stimulates natural moisture production and eliminates these risks. Madorra's hand-held external device, used on regular basis for 8 minutes, has been producing significant results in 1 to 3 weeks.  The device is shaped to be intuitive as possible to fit naturally and is used with disposable proprietary hydrogel. Safety is always a key issue, and the wide variety of literature on ultrasound therapies – including the fact that it's used on pregnant women – has instilled confidence in patients and clinicians alike. Data that made the difference:Market data from the Stanford BioDesign program helped Rockweiler learn to do an analysis of unmet needs, stakeholders, and market dynamics before taking the big leap.An Institutional Review Board (IRB) feasibility study helped in initial development.Pre-existing data on ultrasound showed that ultrasound therapy in other uses improved blood flow to treated areas. This key finding indicated that it might work on thin friable vaginal tissue as well.Patient data revealed how the condition feels to patients and what they wanted in a product.Bench studies and computer simulations proved invaluable in prototyping.This story is not only compelling because of the ingenious device itself, but it also reveals a broader story about opportunities in the underserved market of women's health.Interesting links:https://www.madorra.com/https://www.ispot.tv/ad/1VAi/astellas-pharma-super-bowl-2023-whats-vms

Covers the challenges that Institutional Review Board (IRB) members face when reviewing research protocols that involve artificial intelligence (AI), strategies for addressing those challenges, current events and trends that may impact human subjects research involving AI, and additional resources that you can utilize if you are involved in this space.Our guest is Tamiko Eto, MS, CIP who manages research compliance at the Division of Research at Kaiser Permanente. Tamiko also serves on the AI Ethics Advisory Board for Northeastern University's Institute of Experiential AI.Additional Resources:HHS definitions of human subject and research: https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/revised-common-rule-regulatory-text/index.html#46.102Nils Nilsson definition of AI: https://ai.stanford.edu/~nilsson/QAI/qai.pdfJoanna Bryson and Jeremy Wyatt definition of AI: http://www.cs.bath.ac.uk/~jjb/web/whatisai.htmlOHRP list of ethical codes and research standards: https://www.hhs.gov/ohrp/international/ethical-codes-and-research-standards/index.htmlSACHRP considerations for IRB review of research involving AI: https://www.hhs.gov/ohrp/sachrp-committee/recommendations/attachment-e-july-25-2022-letter/index.htmlFDA guidance: https://www.fda.gov/medical-devices/digital-health-center-excellence/software-medical-device-samdOSTP blueprint for AI bill of rights: https://www.whitehouse.gov/ostp/ai-bill-of-rights/EU proposed AI Act: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex%3A52021PC0206CITI Program AI content: https://about.citiprogram.org/course/technology-ethics-and-regulations/PRIM&R webinars: https://primr.org/online-learning/webinarsIRB reviewer checklist and decision tree: https://etohconsulting.com/wp-content/uploads/2021/12/ai-hsr-irb-reviewer-checklist-with-decision-tree.pdfWhite paper on IRB review of AI HSR: https://techinhsr.com/2022/08/25/how-to-conduct-an-effective-irb-review-of-artificial-intelligence-human-subjec/

In this episode, Holly Fernandez Lynch and I continue our discussion of clinical research ethics with co-hosts Rahima Ghafoori and Caroline Gozigian (UVA Law '23). In this Part 2 of our interview, we focus on questions of payment, exploitation, and trust. As a reminder, in Part I, Holly introduced the basic regulatory framework governing clinical trials, with a focus on laws and rules impacting payment. She also discussed the benefits of and concerns about human challenge studies, and shared some historical examples. Holly Fernandez Lynch, JD, MBE, is Assistant Professor of Medical Ethics in the Department of Medical Ethics and Health Policy at the Perelman School of Medicine (PSOM), University of Pennsylvania. She has a secondary appointment as an Assistant Professor of Law at the University of Pennsylvania Carey Law School.A lawyer and bioethicist by training, Professor Fernandez Lynch's scholarly work focuses on Food and Drug Administration (FDA) pharmaceutical policy, access to investigational medicines outside clinical trials, clinical research ethics, and the ethics of gatekeeping in health care. Her specific areas of expertise include Institutional Review Board (IRB) quality, payment to research participants, research prioritization, pre-approval access pathways (e.g., Expanded Access, Emergency Use Authorization, and Right to Try), and efforts to balance speed and certainty in drug approvals, including pathways that rely on post-approval trials such as accelerated approval. Links:Lynch HF, Darton TC, Levy J, McCormick F, Ogbogu U, Payne RO, Roth AE, Shah AJ, Smiley T, Largent EA. Promoting Ethical Payment in Human Infection Challenge Studies. Am J Bioeth. 2021 Mar;21(3):11-31. doi: 10.1080/15265161.2020.1854368. Epub 2021 Feb 4. PubMed PMID: 33541252.Shah SK, Miller FG, Darton TC, Duenas D, Emerson C, Lynch HF, Jamrozik E, Jecker NS, Kamuya D, Kapulu M, Kimmelman J, MacKay D, Memoli MJ, Murphy SC, Palacios R, Richie TL, Roestenberg M, Saxena A, Saylor K, Selgelid MJ, Vaswani V, Rid A. Ethics of controlled human infection to address COVID-19. Science. 2020 May 22;368(6493):832-834. doi: 10.1126/science.abc1076. Epub 2020 May 7. PubMed PMID: 32381590.Largent EA, Heffernan KG, Joffe S, Lynch HF. Paying Clinical Trial Participants: Legal Risks and Mitigation Strategies. J Clin Oncol. 2020 Feb 20;38(6):532-537. doi: 10.1200/JCO.19.00250. Epub 2019 Jun 14. PubMed PMID: 31199697.

Holly Fernandez Lynch and I discuss clinical research ethics, including challenge trials, research subject payment, and diversity in medical research with co-hosts Rahima          Ghafoori and Caroline Gozigian (UVA Law '23). In this episode, Holly introduces the basic regulatory framework governing clinical trials, with a focus on laws and rules impacting payment. She also discusses the benefits of and concerns about human challenge studies, and shares some historical examples. In the next episode, Part II of our interview, we explore issues of coercion, inducement, and exploitation more explicitly.Holly Fernandez Lynch, JD, MBE, is Assistant Professor of Medical Ethics in the Department of Medical Ethics and Health Policy at the Perelman School of Medicine (PSOM), University of Pennsylvania. She co-chairs the PSOM Research Ethics and Policy Series (REPS) and serves as Assistant Faculty Director of Online Educational Initiatives in the Department, where she helps lead the Master of Health Care Innovation. She has a secondary appointment as an Assistant Professor of Law at the University of Pennsylvania Carey Law School.A lawyer and bioethicist by training, Professor Fernandez Lynch's scholarly work focuses on Food and Drug Administration (FDA) pharmaceutical policy, access to investigational medicines outside clinical trials, clinical research ethics, and the ethics of gatekeeping in health care. Her specific areas of expertise include Institutional Review Board (IRB) quality, payment to research participants, research prioritization, pre-approval access pathways (e.g., Expanded Access, Emergency Use Authorization, and Right to Try), and efforts to balance speed and certainty in drug approvals, including pathways that rely on post-approval trials such as accelerated approval.Links:Lynch HF, Darton TC, Levy J, McCormick F, Ogbogu U, Payne RO, Roth AE, Shah AJ, Smiley T, Largent EA. Promoting Ethical Payment in Human Infection Challenge Studies. Am J Bioeth. 2021 Mar;21(3):11-31. doi: 10.1080/15265161.2020.1854368. Epub 2021 Feb 4. PubMed PMID: 33541252.Shah SK, Miller FG, Darton TC, Duenas D, Emerson C, Lynch HF, Jamrozik E, Jecker NS, Kamuya D, Kapulu M, Kimmelman J, MacKay D, Memoli MJ, Murphy SC, Palacios R, Richie TL, Roestenberg M, Saxena A, Saylor K, Selgelid MJ, Vaswani V, Rid A. Ethics of controlled human infection to address COVID-19. Science. 2020 May 22;368(6493):832-834. doi: 10.1126/science.abc1076. Epub 2020 May 7. PubMed PMID: 32381590.Largent EA, Heffernan KG, Joffe S, Lynch HF. Paying Clinical Trial Participants: Legal Risks and Mitigation Strategies. J Clin Oncol. 2020 Feb 20;38(6):532-537. doi: 10.1200/JCO.19.00250. Epub 2019 Jun 14. PubMed PMID: 31199697.

There's a lot we can glean from history but sometimes it's not as obvious as you might think. For example, did you know that until the mid-1800's, most of Americans hated tomatoes and that ketchup was originally made from mushrooms? The story behind how Americans came to love tomatoes is quite fascinating, but what is perhaps most interesting is the way our guest applies this knowledge to the realm of cybersecurity. Today we will also learn how one of the most powerful cryptographic techniques to this day originated in the time of the telegraph. Along the way, we'll discuss how humans choose their passwords, how they should be creating passwords, and how often we should be changing our passwords. Anthony Collette is a Senior Consent Form Editor at the largest Institutional Review Board (IRB) in the United States. This regulatory agency has reviewed over 1,000 COVID-19 research studies, conducted at more than 12,000 locations. Mr. Collette analyzes complex medical documents, synthesizes the central concepts, and translates technical jargon into relatable language directed to the non-technical research participant. These skills transfer perfectly to the task of analyzing and understanding the conflicting and often outdated advice given about passwords, stripping away what's unnecessary, and getting down to the actionable core of the issues. Interview Links Anthony Collette: https://www.linkedin.com/in/tonycollette/ Loistava Information Security website: www.LositavaInfoSecurity.comCASTALOT™ Dice Landing Page: https://www.castalotdice.com?utm_source=dragons1 CASTALOT™ Dice Facebook VIP Group: https://www.facebook.com/groups/1317312032055849The History of Tomatoes in America: https://www.amazon.com/Tomato-America-History-Culture-Cookery/dp/1570030006/ NY Times, Secret Life of Passwords: https://www.nytimes.com/2014/11/19/magazine/the-secret-life-of-passwords.html A Look at Telegraph Codes (Steven Bellovin): https://www.cs.columbia.edu/~smb/papers/codebooks.pdf DFLEKT Keyless Entry Protection: https://www.duku.co.uk/dflekt Further Info Get your Dragon Challenge Coin!! https://firewallsdontstopdragons.com/return-of-the-dragon-coins/ Generate secure passphrases! https://d20key.com/#/ Amulet of Entropy teaser: https://twitter.com/HackerBoxes/status/1523318662807298051?s=20&t=dwQFy7ieRMGjRCqgAR7btQ

Liudmila Schafer, MD, FACP, is an Associate Professor of Medicine and board-certified Medical Oncologist, specializing in gastrointestinal malignancies. She levels the playing field of knowledge around cancer treatment, research, health, and wellness helping people make informed decisions and bravely build their best life every day. Dr. Schafer offers strategic knowledge that empowers her patients with personal enrichment, leadership, and lifestyle changes. She served on many national and institutional committees including the Membership Committee and the Executive Council of the American Association for Cancer Education (AACE), Women's Faculty Development Caucus Mentoring Committee (WFDC) for medical students and faculty, and the Institutional Review Board (IRB). As a medical trainee and healthcare professional mentor, she laid the groundwork for a physician education curriculum in hematology/oncology. Dr. Schafer serves as principal investigator and co-investigator for clinical trials and holds certification in Translational Research and a teaching scholar in cancer education. Having received multiple honors and recognition for patient satisfaction from Circle of Excellence, she has been featured in regional and national media outlets and peer-review journals. The author of Success Strategies, a guide to personal empowerment, Dr. Schafer offers realistic success plans that help her readers become better leaders both personally and professionally. https://www.liudmilaschafer.com/ Learn more at https://www.sherisesstudios.com/ and https://www.wealthywomenentrepreneursnetwork.com

Eleanor Criswell discusses her latest article How Psychic Suppression May Impact the Heredity of Psi-Genes and Paranormal Investigator Amanda Paulson on her recent ghost hunt in the Appalachian mountains.  Watch Amanda's investigation here on IG live. Eleanor Criswell, is emeritus professor of psychology and former chair of the psychology department, Sonoma State University. Founding Director of the Humanistic Psychology Institute (now Saybrook University), she is editor of Somatics Magazine, the magazine-journal of the mind-body arts and sciences, and Director of the Novato Institute for Somatic Research and Training. Her books include Biofeedback and Somatics: Toward Personal Evolution, How Yoga Works: An Introduction to Somatic Yoga - She is the originator of Somatic Yoga and Equine Hanna Somatics. Her research interests include biofeedback/neurofeedback, psychophysiology, yoga, mind-body practices, somatics, and meditation. Eleanor is also an Institutional Review Board (IRB) member for the Institute of Noetic Sciences (IONS). Her website Amanda Paulson is a paranormal investigator located in Spokane, Washington. She has been a paranormal enthusiast her entire life but her investigating experience started in 2008 when she joined a ghost hunting team in Billings, Montana. Since moving to Washington in 2010, Amanda has investigated all over the United States and in 2019 began serving as a Representative on the Spokane Historic Landmarks Commission. As a highly sensitive person, Amanda has had experiences with the occult since she was a young child but through a scientific approach, seeks to substantiate paranormal claims with solid evidence and give peace and understanding to those experiencing paranormal activity. As the creator of Pretty Fn Spooky media enterprise, Amanda is a lifelong seeker of the unknown and lover of anything that might make you say, “that's pretty fricken spooky!” Her IG You can listen to NITE DRIFT with Jim Perry LIVE on Sunday nights at 5pm pst ( 8pm est) on KKNW 1150 AM Seattle or at Euphomet.com Join the Euphomet Patreon and gain access to our archive of the Original Series and be a part of LIVE interactive shows JOIN HERE  JIM PERRY | @ItsJimPerry on Twitter | Host, Executive Producer, Founder Produced by Harmony Gonty Follow the show @Euphomet across social media | use #NiteDrift For more - visit www.euphomet.com

Here from the fabulous Juli Reynolds, BSN, RN who had her start before nursing within a church helping people. We take a deep dive into her beginnings as a PACU nurse, as well as how she fell in love with holistic therapies and her certification as an aromatherapist. We discuss her love (as well as my love) for nursing research and what the Institutional Review Board (IRB) means and why they are so important. We discuss how all nurses should be trained by CITI Training (https://about.citiprogram.org/en/homepage/) and how to access and use the IRB to perform studies and eventually publish. Juli describes her new found love in nursing by finding her path with essential oils and the chemistry behind them - including how plants have made our way to modern medicines. She now co-leads the group Essential Oil Nurses, which includes a yearly conference! Learn how to get involved as a PACU nurse as well as how to get involved as a certified aromatherapy nurse. We have a new website! Check out episodes and additional content on https://www.thevirtualclinicalpodcast.com

ONCE UPON A GENE - EPISODE 094 With The Mike and Nasha Part II FOXG1 advocate Nasha Fitter and SYNGAP1 advocate Mike Graglia are leaders in the rare disease community and two of the top parent leaders in the advocacy game. In this episode, they're sharing their knowledge, expertise and experiences in an information-packed masterclass on how to build a rare disease patient advocacy group, get funding and forge a path to a cure.  EPISODE HIGHLIGHTS Where do you start? The first thing to do is to build your team. If you've just been diagnosed and realized there isn't a patient group for your disease, build your team of other parents and recruit friends and family to help you. The next step is to build a scientific advisory board to go to for advice and guidance. How do you make connections with parents and experts? You'll have to do a lot with little knowledge or resources. As you build your team, encourage others to engage with their network and invite others to join the group. Strive to get roles filled for every category- clinician, geneticist, biotech and translational therapy.  How do you engage parents? Repeat your message again and again and realize that getting to a cure isn't a race. Act as a lighthouse to get researchers, clinicians, diagnosed and un-diagnosed families to gather around a common goal. Use the tools within reach- podcasts, newsletters and social media as a digital lighthouse, sending signals out to the community. Get on every platform and engage patients. What is a registry and how do you build one?  It's a legal entity that allows you to collect patient information and disease symptom data. The registry platform should be Institutional Review Board (IRB) approved, which means patients and caregivers have consented to information sharing so they can be counted as a patient and share their information with researchers. Once the registry platform is set up, use social media to explain the benefits and invite patients to join. How do you develop a path to a cure? Search for publications and contact the authors to discuss the research and inquire about developing a treatment. Understand the biology of the disease. If you don't have assets, think about the assets that mimic the core of the disease, making models of the disease for testing treatments and drugs and ensure finding are on open access. While you wait for biotech companies to test on your assets, you can create proof of concepts that make sense and are along your path to a cure. How do you get the money you need? It takes money and you'll need to raise money. You'll never know how much you can raise unless you ask. Invigorate the patient community to raise money and think big. RESOURCES MENTIONED ONCE UPON A GENE - EPISODE 047 - Ciitizen - Take Control of Your Own Medical Records and Advance Research with Nasha Fitter https://effieparks.com/podcast/episode-47-ciitizen-nasha-fitter ONCE UPON A GENE - EPISODE 041 - Time is Brain: SYNGAP Research Fund with Mike Graglia https://effieparks.com/podcast/episode-41-syngap-research-fund SynGAP10 Podcast https://www.syngapresearchfund.org/syngap10-podcast PubMed https://pubmed.ncbi.nlm.nih.gov/ Global Genes https://globalgenes.org/ COMBINEDBrain https://www.combinedbrain.org/ SLC6A1 Connect - Amber Freed https://slc6a1connect.org/ CONNECT WITH EFFIE PARKS Website https://effieparks.com/ Twitter https://twitter.com/OnceUponAGene Instagram https://www.instagram.com/onceuponagene.podcast/?hl=en Built Ford Tough Facebook Group https://www.facebook.com/groups/1877643259173346/ 

Why does the FDA have three systems in place to address and handle risk related to medical devices? Each system serves a different purpose, but are all three actually necessary?In this episode of the Global Medical Device Podcast, Jon Speer talks to Mike Drues from Vascular Sciences about FDA's three systems of risk for medical devices and the unique interdependencies and distinctions between them.Some highlights of this episode include:Three systems for medical device risk from FDA: product classification, significant vs. nonsignificant risk, software level of concern.The FDA's classification system handles risk by classifying medical devices as Class I, II, or III. The higher the class, the higher the risk. The lower the class, the lower the risk. Yet, risk is a broad subject and there are a ton of exceptions.Also, classification numbers/levels used by the FDA in the United States do not translate in a linear way to those in the European Union (EU) and elsewhere. There are similar systems but different rules that are philosophically different. The significant vs. nonsignificant risk system focuses on clinical trials for medical devices. All clinical evaluations of investigational devices, unless exempt, must have an approved investigational device exemption (IDE).The software level of concern is important because it determines the level of documentation required for software development. The default classification for any new medical device is Class III. If it's a new device, it's not well-established and the benefits and risks are relatively unknown.When it comes to labeling, say anything as long as you can prove and support it. When technology stays the same but the labeling claim changes, risk changes. The determination of significant or nonsignificant risk is not made by the FDA or Institutional Review Board (IRB), but the medical device company.The software level of concern consists of Class a, b, and c. Does the software have no possibility of causing injury or damage to health? Is non-serious injury possible? Or, is serious injury or death possible?Memorable quotes by Mike Drues:“Theoretically, the classification of your medical device depends on risk. In other words, the higher the class, the higher the risk. The lower the class, the lower the risk.”“The default classification for any new medical device is Class III, which basically means we set the bar at the highest possible level.”“Oftentimes in regulation, we do things not because they make sense, but because that's the way we've done them in the past.” “The determination of significant or nonsignificant risk is not up to the FDA. It's not even up to your IRB, or Institutional Review Board, it's up to the company.”Links:FDA - Classify Your Medical DeviceFDA - Significant Risk and Nonsignificant RiskFDA - Software Level of ConcernFDA - Product Code Classification DatabaseInvestigational Device Exemption (IDE)De Novo Classification ProcessCenter for Devices and Radiological Health (CDRH)Requests for Feedback and Meetings for Medical Device SubmissionsMike Drues on LinkedInGreenlight Guru Webinar - Advanced Strategies and Tactics for Using the De Novo PathwayGreenlight Guru Webinar - Understanding the Medical Device Classification SystemGreenlight Guru Podcast EP 37: Significant Risk vs. Nonsignificant Risk Devices - What's the Difference? Greenlight Guru AcademyThe Greenlight Guru True Quality Virtual SummitGreenlight Guru YouTube ChannelMedTech True Quality Stories PodcastGreenlight Guru

On this week's episode of the podcast, we discuss protections in place for human research subjects. To start the conversation, we discuss some infamous examples of past injustices conducted in the name of "research" and the regulations they prompted as a result. We highlight four cases: the Holocaust experiments, the Tuskegee Syphilis Study, the work of James Marion Sims, and the case of Henrietta Lacks. We spend some time detailing historical documents and regulations that were developed to protect human subjects that came out of these horrific historical blunders and atrocities. Next, we discuss in detail what "informed consent" means, the rigorous regulatory process for any research involving humans, and the modern-day Institutional Review Board (IRB). We recognize that there continues to exist distrust of science and the medical establishment, particularly among populations of color, and our hope is that this episode sets the stage for future conversations that are needed to address this complex issue.PLEASE NOTE: The discussion and information provided in this podcast are for general educational, scientific, and informational purposes only and are not intended as, and should not be treated as, medical or other professional advice for any particular individual or individuals. Every person and medical issue is different, and diagnosis and treatment requires consideration of specific facts often unique to the individual. As such, the information contained in this podcast should not be used as a substitute for consultation with and/or treatment by a doctor or other medical professional. If you are experiencing any medical issue or have any medical concern, you should consult with a doctor or other medical professional. Further, due to the inherent limitations of a podcast such as this as well as ongoing scientific developments, we do not guarantee the completeness or accuracy of the information or analysis provided in this podcast, although, of course we always endeavor to provide comprehensive information and analysis. In no event may Unbiased Science or any of the participants in this podcast be held liable to the listener or anyone else for any decision allegedly made or action allegedly taken or not taken allegedly in reliance on the discussion or information in this podcast or for any damages allegedly resulting from such reliance.

The Michigan State University (MSU) Human Research Protection Program (HRPP) includes the Institutional Review Board (IRB) committees and the IRB and Compliance offices.

Topic: Frank Pasciuti, Ph.D., is a licensed clinical psychologist and certified hypnotherapist in private practice in Charlottesville, Virginia. He is founder and president of Associated Clinicians of Virginia, which provides psychotherapy and organizational development services to individuals and businesses. Dr. Pasciuti is chairman of the Institutional Review Board (IRB) at The Monroe Institute, in Faber, Virginia, and he collaborates on research related to NDEs, psychic phenomena, and the survival of consciousness at the Division of Perceptual Studies (DOPS), a research unit of the department of Psychiatry and Neurobehavioral Sciences at the University Of Virginia School Of Medicine. He is author of Chrysalis Crisis, How Life's Ordeals Can Lead to Personal and Spiritual Transformation. (Rainbow Ridge books, July 2019) In his seminal book Chrysalis Crisis: How Life's Ordeals Can Lead to Personal & Spiritual Transformation he explains how you can use your life ordeal to bring about personal and spiritual growth. Like the butterfly that struggles to free its wings from the chrysalis cocoon, it can be a struggle to let go of the lingering effects of a crisis. But just as the butterfly's struggle to release its wings also strengthens them for flight, the struggle for growth after a crisis can contribute to personal transformation, and strengthen your flight through life. Such outcomes are possible when ten key areas of human growth are developed. These ten key areas cover a broad range of human functioning. They include your physical, intellectual, emotional, social, and moral development; your identity, intimacy, and existential growth; and your intuitive and spiritual evolution. Chrysalis Crisis examines each of the ten keys areas through the use of case examples drawn from clients in Pasciuti' s clinical practice, ordeals from people close to him, and his own crisis.

What is IRB approval? Do I need one as a grant writer? Do I need one before starting my research? All these questions and more answered as Holly discusses the Institutional Review Board (IRB). Listen to the podcast on iTunes, SoundCloud, Stitcher or watch on YouTube! To share your thoughts: Send Holly an email at holly@grantwritingandfunding.com To help out the show: Leave an honest review on iTunes. Your ratings and reviews really help, and I read all of them! Subscribe on iTunes or on YouTube. Looking for more? Follow us on Instagram @grantwriting_funding

As of May, 2019, only 43 of 50 states require schools to have safety plans and conduct safety drills (Education Commission of the States, 2019). When states mandate schools to have safety plans and conduct safety drills, it is the individual schools left to determine how they will design said plans and drills. In some states, the safety plan must be presented to a school board and submitted to the state Department of Justice. However, without templates and rubrics, there is littler inter-school reliability. What is a “good” safety plan or “effective” safety drill? Nobody knows. STANFORD PRISON EXPERIMENT WAS THE TIPPING POINT FOR PROTECTING HUMAN SUBJECTS. While the Stanford Prison Experiment was originally slated to last 14 days, it had to be stopped after just six due to what was happening to the student participants. The guards became abusive, and the prisoners began to show signs of extreme stress and anxiety. These were university students, assuming assigned roles, as part of an experiment that attempted to investigate the psychological effects of perceived power, focusing on the struggle between prisoners and prison officers. THE MELTDOWN. Similar to the infamous 1963 Milgram shock experiment, Stanford's experiment flew off the rails as subjects in positions of power followed directives that seemingly brought pain or harm to recipients.  Were the subjects acting as prison guards cruel, despicable people? Probably not. But, they were in a university context and a professor was mingling among them. They probably assumed that some measures were in place to prevent harm to recipients - and simultaneously lacked awareness of the endorphin rush they received from exerting their will over others. IRB WAS FORMED. In 1974, universities collectively ratified the Institutional Review Board (IRB) process. The mandate of the IRB is to provide ethical and regulatory oversight of research that involves human subjects by: Protecting the rights, welfare and well-being of human research participants, recruited to participate in research conducted or supported by the university. Psychological and physical welfare are carefully considered and risks are identified and mitigated. WHAT IS COMMON RULE? In 1991, 16 federal agencies formally adopted the core of these regulations in a common Federal Policy for the Protection of Human Subjects also known as the "Common Rule" (Grady, 2015). I propose that adopting the IRB in K-12 settings will increase safety for all drill participants and, through the scientific model, increase efficacy of school safety drills. Common Rule applies, for example, to the Food and Drug Administration and clinical trials for medications. Common Rule was updated in 2019 with greater emphasis placed upon simplifying subject consent forms and clearly explaining potential consequences of participating in studies. IRB or COMMON RULE WOULD ELEVATE SCHOOL SAFETY DRILLS. Schools can establish their own standards for school safety plans and safety drills as long as they are complying with state mandates. In other words, schools IRB or COMMON RULE for these reasons: (1) Corral theatrical intruder drills that might traumatize or physically harm participants. This happens - just do a search on Google for “Intruder Drill Lawsuit”. Also, hyper-realistic drills are not the gold standard. If they were, we would conduct fire drills and tornado drills with similar drama. So, a committee of administrators, teachers, students, parents and board members review each proposed safety drill. (2) Each drill would have at least one learning objective. For example, “If a lockdown is announced during passing time, students would go to a safe location.” You can define “safe” per your site. Another example of a learning objective is, “Emergency responders will learn 3 techniques to engage with students with disabilities.” FOLLOW DR. PERRODIN: Twitter @SafetyPhD and subscribe to The Safety Doc YouTube channel & Apple Podcasts. SAFETY DOC WEBSITE & BLOG: www.safetyphd.com The Safety Doc Podcast is hosted & produced by David Perrodin, PhD. ENDORSEMENTS. Opinions are those of the host & guests. The show adheres to nondiscrimination principles while seeking to bring forward productive discourse & debate on topics relevant to personal or institutional safety. Email David: thesafetydoc@gmail.com LOOKING FOR DR. TIMOTHY LUDWIG, PHD? Dr. Perrodin's “Safety Doc Podcast” negotiates school and community safety. To be informed about industrial safety, please contact Appalachian State University Professor Dr. Timothy Ludwig, PhD, at www.safety-doc.com Resources used in this post: Grady C. Institutional Review Boards: Purpose and Challenges. Chest. 2015;148(5):1148–1155. doi:10.1378/chest.15-0706 https://www.ecs.org/50-state-comparison-k-12-school-safety/ Purchase Dr. Perrodin's Book: Schools of Errors – Rethinking School Safety in America www.schooloferrors.com

Our guest on the show is Dr. Lindsay McNair, Chief Medical Officer for the WIRB-Copernicus Group, a central Institutional Review Board (IRB) overseeing more than 200,000 clinical research protocols and more than 2,700 institutions and 700 local Institutional Biosafety Committees. In her current role, Dr. McNair develops strategic partnerships with pharma/biotech companies for comprehensive ethical and clinical services. She oversees a consulting group which provides consultation on human research protection, ethical trial design, protocol development, development of ethical clinical research policy and practices and much more. Dr. McNair has more than 15 years of experience in clinical research and drug development strategy. She has designed and provided medical monitoring for Phase 1-4 clinical studies in a variety of therapeutic areas, including multiple oncology indications, hepatitis C, multiple inflammation indications (psoriasis, multiple sclerosis) and other areas. Dr. McNair is also an adjunct Assistant Professor at Boston University and teaches in the School of Public Health and in the Master’s of Clinical Investigation graduate programs, on the design and conduct of clinical research studies. She speaks frequently on the ethical conduct of clinical research studies as part of pharmaceutical drug development and improving interactions between ethics committees/ research review boards and the pharmaceutical industry. Dr. McNair graduated from the University Of Connecticut School Of Medicine and trained in general surgery at Boston University Medical Center. She has a Master’s in Public Health (Biostatistics/Epidemiology and Health Policy), and a Master’s of Science in Bioethics (research ethics). Please join me in welcoming Dr. Lindsay McNaire on the Clinical Trial Podcast. This episode is brought to you by CBI Events. The team at CBI has put together a Digital Therapeutics event in New York City on December 3-4, 2018. Topics range from strategies for new digital health projects to perspectives from the venture capital community on investment requirements for digital therapeutics. Whether you’re a pioneer in this space or want to know just the right amount of information to get started, this event is going to value packed for you. Some benefits from your participation in this event include: Learning strategies on how to ensure data integrity Understanding regulatory approaches to digital therapeutics and how to seamless approval in all regions Finding out about payer approval requirements and uncovering changing business models Collaborating with others on standard definitions and approaches to what constitutes a digital therapeutic And much, much, more. If you want to learn and network with others in the Digital Therapeutics space, you should attend the 2018 event in New York City on December 3-4, 2018. As a listener to this podcast, I’ve got an exclusive $500 discount to this event. When I mean exclusive, it really is exclusive. So head over to http://www.cbinet.com/digitaltherapeutics and use the code CTP500 at check-out to get your $500 discount. Register today to get your exclusive $500 off your event ticket using the code CTP500. This offer is only available to the Clinical Trial Podcast listeners.      

A sex hunting anthropologist walks into a mortgage finance institution and out into the world to lead health initiatives globally; this is the fascinating tale of Samson Williams’ health career journey. Samson Williams is an entrepreneur and fintech guru. He has been an epidemiologist for the State of Florida, an Anthrax and WMD expert for DC Dept of Health and currently splits his time between serving on the DC Dept of Health’s Institutional Review Board (IRB), and as the Irish Ambassador for Crowdfunding to the EU and partner at Axes and Eggs, a blockchain and cryptocurrency consultancy based in Washington, DC.   Topics addresses:  How does one go from medical anthropology to a cryptocurrency mining company? How can digital health solutions help in disaster situations?  Potential of blockchain in healthcare?

On this episode of Bear in Mind, Dr. Maria Lahman discusses UNC’s Institutional Review Board (IRB) and ethical dilemmas in social science research.

On this episode, Dr. Katie Linder, the Ecampus research director at Oregon State University, shares some basics of the Institutional Review Board (IRB) review process and application. Segment 1: IRB Basics [00:00-10:08] In this first segment, Katie discusses some of the fundamental components of the IRB that researchers should know. Segment 2: Typical Components of an IRB Application [10:09-19:38] In segment two, Katie describes the common elements of IRB applications. Segment 3: Tips for Success in Working with an IRB Committee [19:39-29:48] In segment three, Katie offers some tips for success when working with an IRB committee. To share feedback about this podcast episode, ask questions that could be featured in a future episode, or to share research-related resources, contact the “Research in Action” podcast: Twitter: @RIA_podcast or #RIA_podcast Email: riapodcast@oregonstate.edu Voicemail: 541-737-1111 If you listen to the podcast via iTunes, please consider leaving us a review.

PRE-CELL! Help 4 HD International is excited to announce that UC Davis will begin recruitment for PRE-CELL which is the lead-in observational study for their future planned stem cell trial for Huntington's disease. Per Terry Tempkin (Clinical Project Manager): "UC Davis has received approval from the Institutional Review Board (IRB), to begin the observational PRE-CELL study." Terry Tempkin went on to say: "We are excited to begin the project and appreciate everything the Huntington's disease community has done to help this project come to fruition. In addition to Dr. Nolta's scientific achievement, and Dr. Wheelock clinical experience, the HD community played an important role in giving a face to Huntington's disease.  The UC Davis Stem Cell Project Executive Committee is very grateful to all of the people who showed up at CIRM public meetings, and created visibility through their activities to educate CIRM about the importance of funding projects to help find a treatment or a cure for Huntington's disease."  Tonight, our incredible special guest is Terry Tempkin from UC Davis Medical Center, and we will be discussing the latest and exciting news regarding PRE-CELL!

All research activities involving the use of human subjects must be reviewed and approved by the Institutional Review Board (IRB) before data collection can begin. Susan Metosky, Senior Compliance Coordinator at the ASU Office of Knowledge Enterprise Development, explains the process for Dr. Elizabeth Segal’s Graduate Social Work Seminar. The graduate students ask critical questions about the process especially when working with high risk participants, from teenagers to prostitutes.