Jean Barone, Director, Human Research Protection Office
Melissa Miklos, Associate Director, Human Research Protection Office
Learn about the Do’s and Don’ts when creating your consent document. Words do matter and too often restrictive wording and promises to destroy the data/specimen are included in the consent. This presentation will be discuss best practices and address the following topics:
Human Research Protection Office (HRPO)
Judy Navratil, Research Review Analyst
Allison Gerger, Research Review Analyst
Nena Ansari, Research Review Analyst
Effective January 19, 2018 revisions to the Code of Federal Regulations will require that the informed consent process must begin with a concise and focused presentation of key information.
Carolyn Ivanusic, Research Review Analyst
Dana DiVirgilio, Research Review Analyst
Teresa McKaveney, Research Review Analyst
Jean Barone, CIP - Director, HRPO
Melissa Miklos, MSL, CIP - Associate Director, HRPO
Richard Guido, MD, CIP - Chair, HRPO
The Human Research Protection Office, Research Conduct and Compliance Office, Clinical & Translational Science Institute, and the Office of Research will be presenting “NIH Clinical Trials Requirements, FORMS-E, the Common Rule, and Single IRB: What You Need to Know”. Representatives from each office will discuss what changes have already been implemented, which ones are coming, and the resources available to faculty and administrators to help navigate them. As noted below, the program will be repeated on November 28th.
Jean Barone, CIP - Director, HRPO
Kelly Dornin-Koss, MPPM, RN, CIP, CCRC - Co-Director, RCCO; Director, ECO
Laura Kingsley, MPH, CRA - Senior Associate Director, Office of Research
Shannon Valenti, MBA - Research Facilitator, CTSI
Revisions have been made to modernize, strengthen, and make more effective the Federal Policy for the Protection of Human Subjects (The Common Rule, 45 CFR 46). The final rule is scheduled to be effective on January 19, 2018. Join HRPO leadership to hear an overview of the changes and the types of research they may affect. This will be an informational session intending to deliver a broad stroke on the changes with upcoming sessions focusing on HRPO policies, implementation and the practical considerations of the changes.
Speakers: Richard Beigi, MD, MSc, Associate Professor, Reproductive Sciences, Department of Obstetrics, Gynecology & Reproductive Sciences
Richard Guido, MD, HRPO Chair; Professor, Department of Obstetrics, Gynecology and Reproductive Sciences
Presenter: Jean Barone, HRPO Director
NIH's requirement for use of a single IRB will be effective September 25, 2017. Join Jean Barone to learn about SMART IRB, IRBChoice and other available reliance mechanisms. Attendees will learn the mechanism for requesting use of a single IRB, what to include in a budget, and what type of OSIRIS submission is needed.
Jamie Zelazny, PhD, HRPO Regulatory Affairs Specialist
Richard Guido, MD, HRPO Chair
The Human Research Protection Office is considering changes to the reportable event policies and procedures and we would like your input!
Please join Jamie Zelazny, PhD and Richard Guido, MD at this open discussion forum. They will discuss the current reporting guidelines for the University of Pittsburgh, along with draft policies for future reporting requirements.