Vulnerable Subjects: What the Regulations Don’t Say

Presenter: Robert Romanchuk
Original Air Date: December 14, 2011
Expiration Date: December 12, 2012
Contact Hours: Earn 1.5 ACRP or CBRN contact hours (only the purchaser is eligible)
Level: Intermediate
Cost: $119 Regular Rate; $79 Member Rate

Try Before You Buy

Overview:
The abuse of vulnerable subjects in the course of human research has been a driving force behind subject protections regulations. Though specific protections are mandated for a few clearly defined categories of vulnerable subjects (children, pregnant women, prisoners, etc.), GCP/ICH also mandate "additional safeguards" or “special attention” for all subjects "likely to be vulnerable" (45CFR46.111[b]).

Who are these "other" vulnerable subjects and in what way can additional safeguards be applied?

This Webinar will cover:

1. A definition of vulnerability
2. A brief review of the history of abuse of the vulnerable
3. A review of the applicable regulations for specific populations.

For research practitioners to extrapolate to areas not covered specifically by regulation, a working understanding of what constitutes vulnerability and its ethical underpinnings will provide the tools needed to provide protection for all vulnerable subjects.

What You Will Learn:
Through interactive discussion and case histories, attendees will be able to apply the principles governing the protection of vulnerable subjects in various settings by proposing specific protective mechanisms to each case.

Teaching tools will include:

1. A slide handout
2. Polling questions
3. Case studies
4. Live question-and-answer session

Upon completion of this webinar, attendees should be able to:

1. Explain the concept of vulnerability in human research and its historical and ethical roots.
2. Design an ethical construct that defines vulnerability in its different expressions as well as the protection that should be applied to each.
3. Evaluate the presence of vulnerability and be able to respond by providing appropriate protections.

Who Will Benefit from This Webinar:
This webinar is intended for Clinical Research Associates (CRAs), Clinical Research Coordinators (CRCs), Clinical Research Administrators, Pharmaceutical Physicians, and Principal Investigators working for Biotech Companies, Contract Research Organizations (CROs), Device Companies, Institutional Review Boards (IRBs), Pharma Companies, and Site Management Organizations (SMOs). Professionals from all strata in the clinical research enterprise will find it informative and practical.

See What Others Have to Say About This Webinar
“After attending this webinar, I am more prepared to communicate with the IRB to find solutions about working with vulnerable subjects.”

“I will make an effort to further determine a subject's understanding of our studies.”

“I will pay closer attention to what is meant by ‘vulnerable patient population’.”

Read More ACRP Webinar Attendee Testimonials

Meet Your Presenter
Bob Romanchuk is the Director of Novant Clinical Research Institute in Winston-Salem, NC. Novant Health community health system has 13 hospitals, over 400 physician practices, and multiple ambulatory and imaging centers. Bob’s experience includes starting up and running a central clinical trials office, organizing and managing a local IRB and conducting site audits for central IRBs. He holds certifications as a Certified IRB Professional (CIP), Certification in Health Research Compliance (CHRC), certification as a Clinical Research Contract Professional (CRCP) and CCRC.

Disclosure Statement
Bob Romanchuk states that he has no actual or potential financial conflict of interest in relation to this program.

Program Numbers

Continuing Nursing Education
The California Board of Registered Nursing (Provider Number 11147) approves the Association of Clinical Research Professionals (ACRP) as a provider of continuing nursing education. (Program Number 11147-2011-REP-327).

Association of Clinical Research Professionals
The Association of Clinical Research Professionals (ACRP) provides 1.5 contact hours for the completion of this educational activity. These credits can be used to meet the certification maintenance requirement. (Program Number ACRP-2011-REP-327).

Continuing education credits/contact hours are awarded with the completion of an online evaluation form, which must be completed before the expiration date. Upon submission of the evaluation form, a link to the printable certificate will be made available on the attendee’s ACRP personal page.