Louise Winstanly, LLB (Hons), MSB, is a lawyer and bioethicist. She has chaired UNC’s Biomedical Institutional Review Board B since 2013. Winstanly first joined UNC’s faculty in 2010 and holds multiple appointments:
- Adjunct Assistant Professor in the Department of Public Health Leadership and Practice at UNC’s Gillings School of Global Public Health
- Associate Faculty for the UNC Centre for Bioethics
- Adjunct Assistant Professor in the Department of Social Medicine.
Originally from South Africa, Winstanly received her LLB (Honors) Business Law Degree from London Guildhall University (United Kingdom) and an MS in Bioethics from Union Graduate College. Before coming to UNC, she worked in Japan for nine years for Simpson Thacher & Bartlett LLP and Nishimura & Partners. She is currently admitted to practice law in New York State.
Winstanly is a member of:
- UNC Hospital Ethics Committee
- Food Bank of Central & Eastern North Carolina Board of Directors
- Board of North Carolina Arts Council
- New York State Bar Association
- American Bar Association
- NCMS Ethical and Judicial Affairs Committee
Why were you interested in joining the IRB?
It was the next step for me after obtaining my Masters in Science in Bioethics – to be a part of the research process, to ensure the safety and dignity of individuals involved in scientific advancements, and to lend an ethical lens to research protocols was of great interest to me.
How does your background and experience inform your review process?
I am very fortunate to have lived on four continents. The cross-cultural experience has helped me understand different environments and needs as well as different perspectives to larger issues. This combined with my law and ethics training help provide me with structure and critical thinking.
As a lawyer and ethicist, how does your perspective differ from a member with a medical background?
I can’t speak for my medical colleagues, but my degrees have provided me with the structure to problem solve, find solutions and approach issues from an ethical lens. Different perspectives and diversity in the membership of IRB Boards is critical. Life experiences differ in many ways and such experiences benefit sound discussion and the review process.
What types of studies are the most challenging to review?
Ethical issues that relate to capacity of participants, where Legally Authorized Representatives (LAR) and Guardians are necessary to make decisions on behalf of the participant. Evaluating self determination of the participant with the role of the LAR/Guardian is important.
Evaluation of the ethical implications of new technologies, AI, and data sources are also particularly challenging.
What is the most common reason your board defers a study?
Lack of information in both application and informed consent document. Without the proper information, it is difficult to determine risk – a no, no with regards to the regulations.
Is there a recurring problem in research applications that annoy you?
Nothing truly annoys me. However, the use of acronyms makes applications more difficult to read; and informed consent documents that do not clearly explain the risks, benefits, and study design add time to the review process. In addition, studies that have both research and standard of care components. The delineation of these activities need to be well described, as they both create implications with regards to the research and review process.
What advice do you have for researchers submitting to the IRB for the first time?
More is better! Tell us the full story of your research: how, when, where, what and why. Familiarity with the OHRE website and the trainings provided including the OHRE SOPs – there is a lot of information provided. Don’t be afraid to ask a question or reach out for help!