human research 2014 - Ethical Issues in Human Subjects Research

Overview: This webinar is a compilation of information in areas that generate the most questions for human subject's researchers when conducting research internationally. Discussed in this webinar will be: 45 CFR 46.111 (a)(2) which states, "In evaluating risks and benefits, the IRB should consider only those risks and benefits that may result from the research (as distinguished from risks and benefits of therapies subjects would receive even if not participating in the research)." So what is risk assessment and how does that affect you? The Criteria for Approval found in both the FDA and HHS regulations stipulates what will be looked at during the approval process yet many do not know how, under which conditions, their study is reviewed and therefore do not anticipate possible questions in their study design.
The Federalwide Assurance is required for NIH funded studies. It is a written assurance filed with the Office for Human Research Protections (OHRP) that outlines under which terms a study will be reviewed, approved, and conducted. Even if the study is not NIH funded the principles in the Federalwide Assurance apply. Because of this assurance, additional criteria get applied to studies. When does that happen? Why? Can it be avoided? These questions and more will be answered by learning the information presented in this webinar.
Why should you attend: All researchers want their studies be reviewed and approved quickly. Most investigators do not think about regulatory criteria when designing a study. Complicating matters is the current trend to conduct research in private physician offices and other community venues. Although this makes research more accessible to potential participants, it also invokes another set of regulations and requirements.
The consent document and process are always areas that generate questions. What can and cannot be used? Why? What is allowable? Risks, benefits and how those are viewed and accessed also confound and befuddle individuals working in this field. Knowing what to consider and what the possible stumbling blocks could be, make getting an approval to conduct human subject's research easier. Attendance at this webinar will do just that. It will not only give you a working knowledge of the areas that create the most confusion, it will also give you an understanding that will help you avoid or work through these areas faster and be of assistance to those around you.
Areas Covered in the Session:
Assurances: What are these? What do they stipulate? How they affect you as a researcher
Criteria for review. What to think about and consider when developing or conducting your study
Consent and assent. What is required? What choices do you have?
Community research. What is involved when you ask a private physician to conduct your study or to recruit from his/her clinic?
Risk/Benefit Assessment. What is it? Who makes the determination? What does that determination mean with regards to additional requirements? What is allowable?
Who Will Benefit:
Principal Investigators / Sub-investigators
Clinical Research Scientists (PKs, Biostatisticians,)
Safety Nurses
Clinical Research Associates (CRAs) and Coordinators (CRCs)
Recruiting Staff
QA / QC auditors and Staff
Clinical Research Data Managers
Human Research Protection Professionals
Sarah Fowler-Dixon, PhD, CIP is Education Specialist and instructor with Washington University School of Medicine. She has developed a comprehensive education program for human subject research which has served as a model for other institutions. She crafted budgets, policies, procedures, reporting, and training for the new program. She has initiated the planning, development, authorship and implementation of many human subjects research policies, practices, guidelines, submission and reviewer forms often working with state and federal authorities.
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clinical informatics,medical ethical issues,FDA compliance,Clinical Research,Clinical Trials,Human subject research,medical research, Sarah Fowler-Dixon