The US Department of Health and Human Services (HHS) (and other Federal Agencies) plans to implement the revised version of the Federal Policy for the Protection of Human Subjects, or “Common Rule,” on January 19, 2019. I arrived in sunny San Diego early morning Wednesday, November 14, for the 2018 Advancing Ethical Research Conference (AER18) on a mission to learn everything I could about these federal policy changes.
My first stop was the AER18 Preconference Program, Implementing the Revised Common Rule. The Grand Hall at the Manchester Grand Hyatt was packed with hundreds of people seated around several round tables. You could feel the anticipation in the room as speakers Ivor Pritchard, PhD, Senior Advisor to the Director of the Office for Human Research Protections, and Ada Sue Selwitz, MA, from the Executive Integrity/Compliance Office at the University of Kentucky took to the stage.
The presenters proposed several questions to the audience, including: “What are the implications of these revised regulations for IRB program operations?” and “What changes need to be made in administrative processes and procedures to promote compliance with the new Federal Policy?” To answer these questions, the presenters compared the revised Federal Policy regulations to the pre-2018 Common Rule in a systematic fashion, often toggling between the two in their presentation slides. Attendees shuffled through handouts and took scrupulous notes as the speakers presented information.
As a new conference attendee and recently promoted research compliance manager, I was eager to hear from these experts about the revised Common Rule regulations. Admittedly, I was apprehensive about how to implement them efficiently. I expected a slide-to-slide lecture format for this presentation. However, I was pleasantly surprised the session was interactive and included audience call-and-response activities where attendees engaged with case studies and were asked to interpret and comment on them using the new regulations. The presenters guided preconference attendees through several case study examples and offered an approachable way to test their knowledge of the new regulations, get immediate feedback, and compare their interpretations with other attendees.
The preconference presenters covered many topics and provided insightful information about the Revised Common Rule, which:
- Offers better protections for human subjects involved in research
- Removes research ambiguity for exempt categories and secondary data analysis
- Manages broader research (e.g., large public or private databases, biospecimen repositories, and electronic health records)
- Updates the inclusion category of vulnerable populations and revises research terminology (e.g., “individuals with impaired decision-making ability” replaces “mentally disabled persons”)
- Recognizes diverse technology and its use in research activities
- Eliminates continuing reviews for low risk expedited studies
- Reduces regulatory burdens by requiring less time reviewing minimal risk studies and more time on reviewing high-risk studies
We all expect learning curves, internal policy decision-making, and information-sharing challenges with these regulation changes. Fortunately, PRIM&R offers resources to help guide us for the upcoming Revised Common Rule launch.
Myra Luna-Lucero, EdD, is a Research Compliance Manager at the Teacher's College of Columbia University. As a researcher and teacher, people are her highest priority and she instinctively communicates personal concern with others. She is an adept communicator who thrives on face-to-face interactions with a diverse body of students, faculty, and staff. She brings these qualities to her work to empower others to make informed decisions and reach their goals. She encourages researchers to ponder the roles they might play in the alleviation of the troubling inequities that continue to shape our world. She guides researchers on how to treat everyone as autonomous decision-makers who possess unique opinions. I present campus workshops on the importance of ethics, confidentiality, and protecting vulnerable populations. She meets individually with researchers to strategize ways to protect human subjects and do good work in the world.
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