Overview: 45 CFR 46 is called The Common Rule because a number of different federal agencies agreed to abide by this rule when conducting human subjects research. This regulation came out of a national commission charged with reviewing instances of research involving humans where the research participants were not treated appropriately per the existing ethical codes of the time: The Nuremberg Code and the Declaration of Helsinki. With the establishment of 45 CFR 46, any research conducted under the Department of Health and Human Services (DHHS) or any other agency that agreed to this federal regulation was subject to review and approval by an Institutional Review Board (IRB).
This regulation also gave IRBs the flexibility to use an expedited review. Changes to The Common Rule hope to strengthen the consent process and bring the regulation up to date with current types of human subjects research being conducted.
Why should you Attend: The Common Rule, 45 CFR 46, has not been updated since 1974. To keep up with the changing face of research federal agencies have put out guidance documents. Although this provides some clarifications, this can also add to the confusion as different agencies have different interpretations. So, when a study is governed by more than one agency as well as federal laws and state statues, it can make it difficult for the researcher and her team to discern what is most important as well as what must be followed, when This confusion can lead to noncompliance. For those reviewing the studies, working with outdated federal regulations often makes it difficult to determine when certain requirements, such as expedited review, may or may not apply as the examples provided in the federal regulations are outdated.
In addition, there are the wants and needs of the potential research participants. All this has come into play in the proposed changes to the Common Rule, 45 CFR 46.
Areas Covered in the Session:
- Provide a historical perspective on what brought these proposed changes
- Brief review of current literature regarding what research participants want
- Review proposed changes to 45 CFR 46
- Elaborate on changes most relevant to clinical research
- Discuss the potential impact to researchers
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 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.
She has provided consultation regarding ethical, federal, state, and institutional requirements for faculty and staff both in the design and execution of their projects and teaches research ethics and regulatory affairs and the fundamentals of research management to graduate and undergraduate students. More recently, she lead a task force in the development of the Community Engaged Research Program at Washington University. Dr. Fowler-Dixon has simultaneously served as an Independent Consultant, providing expertise and creating supplemental educational materials, including a copyrighted workbook.
Prior to joining Washington University, Dr. Fowler-Dixon was the Educational Development and Learning Specialist for Saint Louis University serving on various committees to improve research, procedures, community outreach, and retention.
LinkedIn Follow us – https://www.linkedin.com/company/mentorhealth
Twitter Follow us – https://twitter.com/MentorHealth1
Facebook Like us– https://www.facebook.com/MentorHealth1