The Human Research Protection Program has dedicated resources to assist you with:

  • Human subject-related questions you may have as you prepare a proposal for submission to a sponsor

  • Writing a human subjects protocol application that meets regulatory requirements

  • Preparing for a regulatory site visit by the FDA or study sponsor

  • Ensuring your research practices meet regulatory standards and adhere to your protocol via the Quality Assurance / Quality Improvement program.

Contact us to request any of the above!


TEA Time

HRPP is here to help!

We want to answer your questions about human subjects research @ Brown. We are holding open hours on Tuesday afternoons from 1:00 pm - 2:00 pm. Click the button below to reserve your spot!

HRPP is pausing TEA Time during December in preparation for Winter Break. Please use the Request A Meeting option if you have questions about human subjects research.

 

RSVP

 

Visit our Learning Library to access past workshops and presentations

Upcoming IRB Workshops

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Black Lives Matter in Research: Building Transdisciplinary Collaboratives and Approaches to Addressing Racism in Research

This event will bring together a community of researchers and human subjects professionals into the discussion of Black Lives Matter and its intersectionality with research design and research methodologies. Within the greater context of racism there is a need for exploration of how researchers, research administration and human subject professionals can work together to address inclusivity, beneficence, exclusionary design, participation issues, representation and more.

Wednesday, November 3, 9:30 - 1 pm; and Thursday, November 4, 10:00 - 1:35 pm | Registration is required

NOTE: This webinar is being presented by Montclair State University and may not encompass Brown-specific policies and procedures. For further clarification or inquiries, please Request a Meeting with HRPP staff.

Find more details here

 

OHRP Presents: What is Human Subjects Research? Defining Research involving Human Participants and Getting It Through Reviews

The 2021 NIH Virtual Seminar on Program Funding and Grants Administration - "Empowering the Research Workforce to Fuel Scientific Discovery" - has been designed to provide researchers with an opportunity to learn about the NIH grants process, programs, and policies directly from NIH & HHS experts.

This event is intended to help:

  • Demystify the application and review process;
  • Clarify federal regulations and policies; and
  • Highlight current areas of special interest or concern.

This OHRP presentation is on Day 4 - focusing on Human Subjects, Mini-Case Studies, & Special Topics. 

Target audience:  Those who are new to working with the NIH grants process – administrators, early stage investigators, researchers, graduate students, etc  .

Thursday, November 4, 1:00 - 2:45 pm | Registration is required

NOTE: This webinar is being presented by OHRP and may not encompass Brown-specific policies and procedures. For further clarification or inquiries, please Request a Meeting with HRPP staff.

Find more details here

 

Adapting, Adopting, and Succeeding in a Decentralized Landscape

Decentralized clinical trials are gaining momentum as sponsors, CROs, vendors, and sites work to adopt remote workflows and remove participation barriers in clinical research. Despite its increased popularity, conducting decentralized research is undefined, and many industry stakeholders are still working to overcome operational and regulatory challenges.

In this panel discussion, representatives from industry, research sites, and academia explore the impact of decentralized models on the research landscape. This includes discussing observed trends at the site and sponsor level, examining obstacles to conducting innovative research, and proposing opportunities for improvement that still remain.

Learning Objectives:

  • Recognize key impacts of decentralized trials on your research operations and regulatory processes
  • Review practical strategies to bring back to your organization to better conduct decentralized researcH
  • Discuss the evolving roles and responsibilities of sponsors, CROs, and sites in training, technology, inclusion of underserved populations, and more
  • Explore lessons learned from some of the research industry’s biggest players in their efforts to adapt to and adopt decentralized workflows

Thursday, November 4: 1:00 - 2:30 pm | Space is limited | RSVP required

NOTE: This webinar is being presented by Advarra and may not encompass Brown-specific policies and procedures. For further clarification or inquiries, please Request a Meeting with HRPP staff.

Find more details here

 

IRB Protocol Noncompliance: When Research Goes Rogue, What Next?

This webinar discusses researcher noncompliance with IRB-approved protocols. Noncompliance determinations can seem clear-cut, but they are often nuanced. There are many factors to consider when making a determination. These include the institution’s written policies, procedures, and other documents available to researchers and reviewers.

During this interactive webinar, attendees will explore case examples and some of the different corrective actions that could be required of a researcher. It is hoped that through sharing examples from one institution’s approach, attendees can clarify potential improvements to their own integrity and compliance programs.

Thursday, November 12, 2:00 - 3:00 pm | Limited registration | Waiting list available

NOTE: This webinar is being presented by the CITI Program and may not encompass Brown's IRB Policy on Reportable Events and Noncompliance. For further clarification or inquiries, please review and/or Request a Meeting with HRPP staff.

Find more details here