Human Research Protection Office (HRPO)

Single IRB of Record


Michelle LeMenager, Reliance Specialist, Human Research Protection Office

The National Institute of Health (NIH) issued a federal policy that requires certain types of NIH-funded studies to use a single IRB (sIRB). The goal of this policy is to streamline the IRB review process and it goes in effect on January 25, 2018. Topics to be discussed will include:

Consent Language Does Affect Your Ability to Share Data/Specimens


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:

NIH Clinical Trials Requirements, FORMS-E, the Common Rule, and Single IRB: What You Need to Know


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.

Overview of the New Common Rule

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.

Using SMART IRB & Single IRB Review

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.

Public Input for Changes to Reportable Events Policy


Presenters:
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.