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Topic

Human Subjects Research: What SBIR & STTR Applicants Need to Know

Description

Whether applying for an NIH Small Business Innovation Research (SBIR) or Small Business Technology Transfer (STTR) grant or submitting a contract proposal, you need to be aware of NIH’s human subjects research policies and reporting requirements.

Attend this webinar to learn about:
• NIH’s definition of human subjects research and how it applies to you
• NIH policies for conducting extramural research involving human subjects
• Clinical trial requirements for SBIR & STTR grants and contracts
• Inclusion policies and reporting requirements
• Training and resources available to help you prepare your SBIR or STTR grant application or contract proposal

There will be a question-and-answer session following the presentation. So, don’t miss the chance to interact with NIH small business and human subjects research experts.

ACCESSIBILITY: This webinar will include real-time captioning. To request additional accommodations or for inquiries about accessibility, please contact SEEDinfo@nih.gov at least 5 business days before the event.

RECORDING: A recording and transcript will be posted on the NIH Grants YouTube Channel within 7 business days (https://www.youtube.com/NIHgrants) and on the SEED website (https://seed.nih.gov/)

Time

Oct 18, 2022 02:00 PM in Eastern Time (US and Canada)

Webinar is over, you cannot register now. If you have any questions, please contact Webinar host: OER Webinar.

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Message preview	Hi there, You are invited to a Zoom webinar. When: Oct 18, 2022 02:00 PM Eastern Time (US and Canada) Topic: Human Subjects Research: What SBIR & STTR Applicants Need to Know Register in advance for this webinar: https://nih.zoomgov.com/webinar/register/WN_sGby0-KpRrW1zuvq7KIixw Or an H.323/SIP room system: H.323: 161.199.138.10 (US West) or 161.199.136.10 (US East) Meeting ID: 161 327 1175 SIP: 1613271175@sip.zoomgov.com After registering, you will receive a confirmation email containing information about joining the webinar. ---------- Webinar Speakers Dawn Corbett, MPH (NIH Inclusion Policy Officer @Division of Human Subjects Research (DHSR)) Ms. Dawn Corbett is the National Institutes of Health (NIH) Inclusion Policy Officer in the Office of Extramural Research (OER), where she provides leadership and coordination for trans-NIH efforts to ensure the inclusion of women, racial and ethnic minorities, and individuals across the lifespan in NIH-defined clinical research. Prior to joining OER in 2017, Ms. Corbett held positions at the National Institute of Mental Health for 14 years, where she oversaw program activities to increase diversity, efficiency, and transparency in the mental health clinical research portfolio. Stephanie, Fertig, MBA (HHS Small Business Program Lead @NIH Small business Education and Entrepreneurial Development (SEED) office) Over 15 years at NIH, Ms. Stephanie Fertig has led the development and implementation of multiple programs focused on small businesses and translational research.  She currently oversees the Health and Human Services (HHS) Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs, which include the NIH SBIR & STTR programs. Pamela R. Kearney, MD (Director @NIH Division of Human Subjects Research (DHSR)) Dr. Pamela Kearney is the Director of the Division of Humans Subjects Research in the NIH Office of Extramural Research, which oversees implementation of Human Subjects, Clinical Trials, and Inclusion policies and regulations for the extramural NIH, and serves as the NIH Clinical Trial Policy Officer. She is an Otolaryngologist/Head and Neck Surgeon by training, doing a research fellowship at NIH in Neurolaryngology, before serving as the medical officer for NINDS’s Laryngeal and Speech section. Before coming to OER, she then spent nearly a decade as the Deputy Chair of the Combined Neurosciences IRB for the intramural NIH, where she serve as chair or deputy chair for as many as four duly constituted IRBs at any one time. Lyndi Lahl, RN, MS (NIH Human Subjects Officer @Division of Human Subjects Research (DHSR)) Ms. Lyndi Lahl is the NIH Human Subjects Officer in the Office of Extramural Research (OER) Division of Human Subjects Research (DHSR) where she provides expertise and guidance in the areas of policy implementation and development for NIH-funded human subjects research. Before assuming her role with OER, Ms. Lahl served as a Policy Health Specialist with the National Institute of Allergy and Infectious Disease (NIAID), as a Public Health Analyst with the Office for Human Research Protections (OHRP), and as a Research Nurse Specialist with the National Cancer Institute (NCI), and has served as an IRB member since 2012.

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