As 2021 draws to a close, we’re pleased to share this year’s final round-up of upcoming non-Ohio State events, webinars, and workshops that may be of interest to human subjects researchers, research staff, and IRB members. As usual, all events are free and open to the public but may require pre-registration.
After you peruse the educational offerings, keep reading for updates about ORRP investigator tools and recordings from webinars and conferences from the past year.
December external education sessions
2-day Webinar Series
FDA Clinical Investigator Training Course Update
- Tuesday, December 7, 1 – 5 p.m.: Scientific Updates for Clinical Investigators
Topics include: Gene therapy and CarT therapy; innovation in oncology clinical trial design; medical products for the prevention and treatment of COVID-19 and Emergency Use Authorizations; diverse representation in clinical trials - Wednesday, December 8, 1 – 4:30 p.m.: Operational Updates for Clinical Investigators
Topics include: Trial approaches including master protocols, decentralized clinical trials, digital health technologies, and use of real world data/evidence; drug repurposing; FDA’s new research IND portal; investigator responsibilities as applied during COVID-19 - Hosting organization: FDA Center for Drug Evaluation and Research (CDER)
- CE credits: RAC, SOCRA, RQAP, ACRP
- Learn more, view the agenda, and register.
Webinar
FDA Forecast: What’s Next for the FDA in 2022?
- Date: Tuesday, December 7, 12 to 1 p.m.
- Hosting organization: POLITICO’s AgencyIQ
- Learn more and register.
Webcast
Conversation on Cancer: 50 Years and Counting: Engaging the Generations on Future Cancer Equity Opportunities
- Date: Monday, December 13, 2 – 3:30 p.m.
- Hosting organization: FDA Oncology Center of Excellence
- Learn more and register.
Webinar
FDA Drug Topics: Overview of Expanded Access Program (EA) and EA eRequest Site
- Date: Tuesday, December 14, 1 – 2 p.m.
- Hosting organization: FDA Center for Drug Evaluation and Research (CDER)
- Learn more and register.
Webinar
SMART Talk: When You’re Not the Reviewing IRB – The Impact of Using External IRBs
- Date: Wednesday, December 15, 2 – 3 p.m.
- Hosting organization: SMART IRB
- Learn more and register.
Livestream Lecture
COVID-19, International Law, and Data Governance
- Date: Thursday, December 16, 12 – 1 p.m.
- Hosting organization: National Institute of Allergy and Infectious Diseases (NIAID)
- Learn more and livestream on the day of the event (no registration required).
Livestream History of Medicine Lecture
Molecular Medicine in the War on Cancer: Success or Failure?
- Date: Thursday, December 16, 12 – 1 p.m.
- Hosting organization: National Institutes of Health Office of NIH History & Stetten Museum
- Learn more and livestream on the day of the event (no registration required).
ORRP Investigator tool updates
Some of our most popular resources for researchers are our topic-specific investigator tools for collaborative research, FDA-regulated drug research, and FDA-regulated device research.
You can find all three packets on our Investigator Guidance page under “Investigator/Staff Guidance by Topic.”
Investigators conducting research with medical devices will want to check out our revised device tools, which include an update to the “Common Medical Device Research Scenarios” decision tree.
Now Available: Recordings from OHRP, FDA, and others
Despite the pandemic, 2021 has produced a number of informative virtual conferences and webinars on topics pertaining to human subjects research. Many of those sessions are now available to stream at no charge. Check out the links below to browse available content.
Dallas Research Community Forum (June 2021)
The Office of Human Research Protections (OHRP) has added six recordings from this summer’s research forum to their Luminaries Lecture Series on the following topics:
- Finding the Key in Key Information
- What is Identifiable? HIPAA vs. the Common Rule
- Saving Lives with Community-Based Research
- Crossing Borders: Transnational Research and Human Subjects Protections
- The Yale Model and Our Partnered Approach: Increasing Clinical Trial Representation Through Community Collaboration and Innovation
- Community Consultation in Dallas Fort-Worth: An Opportunity to Learn from Our Neighbors
Resources on Research Involving American Indian/Alaska Native (AI/AN) Populations
OHRP also released materials from their August 2021 virtual workshop, Supporting Ethical Research Involving American Indian/Alaskan Native Populations. Find slides, summary report, and the videocast recording here.
In addition, be sure to check out “Celebrating National Native American Heritage Month: A Timeline of Important Events” from the Ampersand blog. Many of us in the field of human research protections are familiar with the infamous genetics research conducted on the Havasupai tribe in the 1990s but know little else of research involving AI/AN peoples or their contributions to science and community-focused research design. The blog post provides a nice overview and is worth a read.
FDA Regulatory Education for Industry (REdI) Annual Conference (July 2021)
For the first time, this year’s REdI conference brought together the Center for Drug Evaluation and Research (CDER), the Center for Devices and Radiological Health (CDRH), and the Center for Biologics Evaluation and Research (CBER). The week-long virtual conference covered regulatory and policy updates at FDA, as well as hot topics in the development and marketing of medical products. Access the agenda and recordings here.
NIH Virtual Seminar on Program Funding and Grants Administration (November 2021)
Most sessions from November’s virtual seminar have been uploaded to the NIH Grants YouTube channel. Whether you’re a new investigator seeking help on putting together an NIH proposal, an administrator navigating the grant management system, or a seasoned NIH awardee curious about updates to NIH policies and funding priorities, there’s something for everyone who works in federally funded biomedical research and administration.
Multi-Regional Clinical Trials (MRCT) Center of Brigham and Women’s Hospital and Harvard
Controverted Issues subscribers will recognize MRCT webinar, as we frequently include them in our education round-ups. Their archive of 2021 events–most of which are available to view on demand–can be found here. Topics that may be of particular interest include the following:
- Advancing International Pediatric Clinical Research: Informing the Future from COVID-19 Lessons Learned
- Simplifying the Complexity of Translation in Clinical Research
- Improving Inclusion of Persons with Disabilities in Research
- Inducement or Fair Compensation? Impact on Diverse Participation
The Education Round-up is intended for informational purposes only. While we will only share events hosted by well-known/reputable organizations, inclusion does not constitute official endorsement by the Office of Responsible Research Practices.