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 20 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 McNair on the Clinical Trial Podcast.
Dr. Lindsay McNair on social media:
Twitter @casuistry
Resources and organizations mentioned in this episode:
The WIRB‐Copernicus Group (WCG)
A Therapeutic Innovation & Regulatory Science paper written by two of Dr. McNair’s colleagues at WCG – David Forster and David Borasky – entitled “Adults Lacking Capacity to Give Consent
When Is It Acceptable to Include Them in Research?
Paying Research Participants: The Outsized Influence of “Undue Influence” by Emily Largent and Holly Fernandez Lynch
Other publications by Holly Fernandez Lynch, JD, MBe
Payment and Reimbursement to Research Subjects – FDA Information Sheet
NIH Clinical Trials Protocol Template
2018 Advancing Ethical Research Conference
Office for Human Research Protections
Accreditation of Human Research Protection Program (AHRPP)
Institutional Animal Care and Use Committee
Journal of Empirical Research on Human Research Ethics (JERHRE)
What insight did you get from this episode with Dr. McNair? Drop me a note in the comment section below. I’d love to hear from you.
