Linda Reuter has been involved with IRB Administration in various capacities for over 30 years, currently serving as the Sr. Director for BRANY IRB. Responsibilities include supervising the IRB staff, maintaining compliance with the IRB SOPs and applicable regulations, supervising pre and post-IRB meeting activities, expedited reviews, continuing reviews, protocol monitoring, continuing education, development of strategic goals for the organization, maintaining AAHRPP accreditation standards, policy maintenance and development, and training/mentoring of IRB staff. Linda formed IRB Consulting, LLC in 2012, providing IRB administrative services, training and education, audit services, and general consulting to numerous IRB programs nationwide.

According to the Food and Drug Administration, the purpose of clinical trials is to study medical products in people. In doing so, consent is critical in clinical trials for these people to understand they are the research subjects and not imply a patient. Consent within research ensures individuals have an informed choice on whether they want to participate in a research study. Informed consent within research is meant to protect human subjects from harm that could occur from participating in research and should always be voluntary.

Resources: 

• https://www.niaid.nih.gov/research/dmid-protocols-informed-consent
• https://www.nsf.gov/bfa/dias/policy/docs/45cfr690.pdf
• https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5980471/
• https://www.fda.gov/patients/clinical-trials-what-patients-need-know/informed-consent-clinical-trials

Linda Reuter has been involved with IRB Administration in various capacities for over 30 years, currently serving as the Sr. Director for BRANY IRB. Responsibilities include supervising the IRB staff, maintaining compliance with the IRB SOPs and applicable regulations, supervising pre and post-IRB meeting activities, expedited reviews, continuing reviews, protocol monitoring, continuing education, development of strategic goals for the organization, maintaining AAHRPP accreditation standards, policy maintenance and development, and training/mentoring of IRB staff. Linda formed IRB Consulting, LLC in 2012, providing IRB administrative services, training and education, audit services, and general consulting to numerous IRB programs nationwide.

Informed consent is critical and a main principle of research ethics in a research study. Consent within research ensures individuals have an informed choice on whether they want to participate in a research study. Informed consent applies to research in the social-behavioral, physical, and medical sciences. Informed consent within research is meant to protect human subjects from harm that could occur from participating in research and should always be voluntary.

Learn more about CITI Program: https://about.citiprogram.org/

Resources: 

• https://www.niaid.nih.gov/research/dmid-protocols-informed-consent
• https://www.nsf.gov/bfa/dias/policy/docs/45cfr690.pdf
• https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5980471/

This episode discusses the impact of online bots on survey research, ethical considerations and implications of using bots in survey research, and potential benefits and unintended consequence.

Myra Luna-Lucero, EdD, is the Research Compliance Director at Columbia University’s Teachers College. She spearheaded the College’s “Ethics & Safety Amid Uncertainty” initiative and co-chaired the Research Compliance & Safety Committee. She has also recently launched the “Research Writing & Ethics” internship program and oversaw an extensive transformation of the College’s IRB website. She regularly offers seminars and workshops on research compliance and IRB leadership. A researcher and teacher herself, Dr. Luna-Lucero has studied and published on student motivation in STEM fields, barriers to accessing education for students in rural communities, and community activism.

Learn more about CITI Program: https://about.citiprogram.org/

Resource: https://www.tc.columbia.edu/institutional-review-board/irb-blog/2022/bots-and-online-human-subjects-research/#:~:text=Researchers%20who%20use%20online%20platforms,posing%20as%20eligible%20human%20participants

Ross Hickey is the Assistant Provost for Research Integrity at the University of Southern Maine (USM.) Ross is the Director of the Maine Regulatory Ethics and Training Center (MeRTEC) at USM. He is an attorney in Maine. His office serves institutions throughout the United States. Ross developed and teaches in the Regulatory Ethics undergraduate program at USM. He helped to develop and teaches in the compliance certificate program at Maine Law and also teaches there as an adjunct. He collaborates with universities in the North Atlantic, such as Iceland and Norway. He sits on the World Affairs Council for Maine.

Research integrity deals with the “best practices” or rules of professional practice or researchers. The United States National Institutes of Health expands on research integrity by stating it is “the use of honest and verifiable methods in proposing, performing, and evaluating research; reporting research results with particular attention to adherence to rules, regulations, guidelines, and following commonly accepted professional codes or norms.” (From:  https://grants.nih.gov/policy/research_integrity/what-is.htm#:~:text=the%20use%20of%20honest%20and,accepted%20professional%20codes%20or%20norms.) 
Responsible conduct of research (RCR) training is an essential component of any research project, regardless of a researcher’s source of funding.

Learn more about CITI Program: https://about.citiprogram.org/

Cecilia Brooke Cholka serves Weill Cornell Medicine as a Human Research and QA Manager and consultant for the PEER Consulting Group. She works to demystify IRB processes and expectations so that researchers and the IRB can work together collaboratively to ensure ethical conduct of research.

An Institutional Review Board or IRB is commonly found at institutions that conduct or participate in research activities. The purpose of the IRB is to evaluate research ethics by reviewing research methods related to their potential harm to different groups. An IRB Administrator is an individual who oversees and manages systems, structures, and operations of the IRB related to policy, process, procedures, and records.

Learn more about CITI Program: https://about.citiprogram.org/

Chirag Shah, Ph.D.,  is a Professor of Information and Computer Science at the University of Washington. He is the Founding Director of InfoSeeking Lab and Founding Co-Director of the Center for Responsibility in AI Systems & Experiences (RAISE). He works on intelligent information access systems with a focus on fairness and transparency.

Artificial intelligence, or AI, is utilized more and more frequently in different settings, including research. AI can be utilized within research by optimizing resources, data, and technology to synthesize and analyze data or problems. With AI in research, so much is still unknown. How do you inform participants of informed consent and protect their data when utilizing AI? How do researchers account for bias or deception while utilizing AI in a research setting? Chirag Shah, Ph.D., discusses these issues and much more on this episode of On Research.

Learn more about CITI Program: https://about.citiprogram.org/

Lou Kavar is a faculty member in psychology at Capella University where he is the lead faculty member for qualitative research and teaches doctoral-level graduate courses in psychology. Lou has taught in higher education at the graduate level for over thirty years. His personal research interest is the integration of spirituality and psychology. He lives in Atlanta, GA. For more information on Lou's writing and work in the area of spirituality, visit his website: loukavar.com.

Graduate students at research institutions in the United States are often required to complete a major research project, such as a thesis or dissertation prior to graduation. In these research projects, graduate students might choose to research what one could deem as a controversial topic. Some topics that might be seen as controversial often include topics that involve religion, sex, gender, race, ethnicity, and other topics. Specifically in qualitative research, the researcher should be aware and consider the insider-outsider perspective prior to beginning their research. For graduate students, they should consult with their graduate or research advisor when engaging in research activities involving controversial topics.

Learn more about CITI Program: https://about.citiprogram.org/

Elizabeth Waddell, has over 20 years in the clinical research industry and is the owner of The CRA Helper. Elizabeth began her clinical research career as an in-house Clinical Research Associate (CRA) and later transitioned to an on-site CRA. Later in her career, she moved into a Line Manager role that focused on training new CRAs prior to launching her own company, The CRA Helper.

What is a Clinical Research Associate (CRA)? A Clinical Research Associate or CRA is a professional within a healthcare setting who oversees research activities, typically related to clinical trials. CRAs can be employed and work in a variety of sectors, including government agencies, pharmaceutical companies, research institutions, and in similar settings. Most CRAs possess an academic degree from a higher education institution in a field related to the healthcare industry. The overall role and tasks of a CRA are outlined and defined by good clinical practice guidelines for clinical trials.

Learn more about CITI Program: https://about.citiprogram.org/