Lindsay McNair, MD
Adjunct Assistant Professor, Epidemiology - Boston University School of Public Health
Biography
Lindsay McNair, MD, MPH, MSBioethics is the Chief Medical Officer for the WIRB-Copernicus Group (WCG). Dr. McNair has extensive experience in the pharmaceutical industry working in clinical research and drug development. Prior to joining WCG, she was a consultant to pharmaceutical and biotechnology companies, providing medical guidance on clinical development strategies and study designs for new drug studies, and medical oversight of all phases of clinical trials. Dr. McNair is adjunct faculty at Boston University and teaches graduate-level courses on the scientific design of clinical research studies, research ethics and the responsible conduct of research, and the development of clinical study protocols. She now oversees the physician team within the WCG IRBs, and provides consultation to institutions and pharma/biotech companies on a wide range of issues related to protocol design, regulatory compliance, human subject protection, and ethical policy development (compassionate use, etc).
Dr. McNair graduated from the University of Connecticut School of Medicine and trained in general surgery at Boston University Medical Center. She completed her Master’s in Public Health at Boston University concentrating in Biostatistics/Epidemiology, and her Master’s of Science in Bioethics at Union Graduate College concentrating in research ethics. She was a member of the Institutional Review Board at Boston University Medical Center, and founded and chaired the Human Subject Protection Committee at Vertex Pharmaceuticals. She was a site visitor for the Association of the Accreditation of Human Research Protection Programs (AAHRPP). Dr. McNair serves on committees including the Multi-Regional Clinical Trials Center at Harvard, and is an associate editor of the Journal of Empirical Research on Human Research Ethics.
Education
- University of Connecticut, MD
- University of Connecticut, MD Field of Study: Medicine
- Boston University, MPH Field of Study: Health Administration/Education
- Trinity College, BS Field of Study: Biology
Websites
Publications
- Published on 8/1/2022
Hart PA, Andersen DK, Lyons E, Cote GA, Cruz-Monserrate Z, Dworkin RH, Elmunzer BJ, Fogel EL, Forsmark CE, Gilron I, Golden M, Gozu A, McNair L, Pandol SJ, Perito ER, Phillips AE, Rabbitts JA, Whitcomb DC, Windsor JA, Yadav D, Palermo TM. Clinical Trials in Pancreatitis: Opportunities and Challenges in the Design and Conduct of Patient-Focused Clinical Trials in Recurrent Acute and Chronic Pancreatitis: Summary of a National Institute of Diabetes and Digestive and Kidney Diseases Workshop. Pancreas. 2022 Aug 01; 51(7):715-722. PMID: 36395394.
Read At: PubMed
- Published on 2/16/2022
McNair L. Ethical and regulatory oversight of clinical research: The role of the Institutional Review Board. Exp Biol Med (Maywood). 2022 Apr; 247(7):561-566. PMID: 35172623.
Read At: PubMed
- Published on 2/26/2020
Cooper JA, McNair L. Authors' Response to "Comment on the Proposed Institutional Review Board Retrospective Review of Research". J Empir Res Hum Res Ethics. 2020 07; 15(3):232. PMID: 32102599.
Read At: PubMed
- Published on 12/6/2019
Cooper JA, McNair L. Retrospective Review of Research. J Empir Res Hum Res Ethics. 2020 07; 15(3):227-228. PMID: 31808710.
Read At: PubMed
- Published on 5/1/2018
McNair L. Keeping a Focus on Research Ethics. Ther Innov Regul Sci. 2018 05; 52(3):267. PMID: 29723061.
Read At: PubMed
- Published on 4/8/2018
Anderson E, McNair L. Ethical Issues in Research Involving Participants With Opioid Use Disorder. Ther Innov Regul Sci. 2018 05; 52(3):280-284. PMID: 29714588.
Read At: PubMed
- Published on 1/25/2016
Li RH, Wacholtz MC, Barnes M, Boggs L, Callery-D'Amico S, Davis A, Digilova A, Forster D, Heffernan K, Luthin M, Lynch HF, McNair L, Miller JE, Murphy J, Van Campen L, Wilenzick M, Wolf D, Woolston C, Aldinger C, Bierer BE. Incorporating ethical principles into clinical research protocols: a tool for protocol writers and ethics committees. J Med Ethics. 2016 Apr; 42(4):229-34. PMID: 26811365.
Read At: PubMed
- Published on 12/1/2015
McNair LA, Biffl WL. Assessing Awareness and Implementation of a Recommendation for Surgical Innovation Committees: A Survey of Academic Institutions. Ann Surg. 2015 Dec; 262(6):941-8. PMID: 25373465.
Read At: PubMed
- Published on 12/1/2015
Cooper JA, McNair L. Sham Surgery Research. J Empir Res Hum Res Ethics. 2015 Dec; 10(5):496-8. PMID: 26564946.
Read At: PubMed
- Published on 4/1/2015
Cooper JA, McNair L. How to distinguish research from quality improvement. J Empir Res Hum Res Ethics. 2015 Apr; 10(2):209-10. PMID: 25819760.
Read At: PubMed
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