Office of Responsible Research Practices
The Ohio State University

ORRP Education Sessions

PowerPoint slides, session handouts, video recordings, and tips sheets from various ORRP presentations are located below.  All PowerPoint presentations are available as PDF documents.

Common Rule Changes

This presentation provides an overview of the Common Rule revisions that are scheduled to take effect on January 19, 2018.  While the Rule implementation will likely be delayed until January 2019, the workshop describes the upcoming changes in regulatory requirements that are intended to reduce administrative burden and better protect participants in research. Regulatory updates from FDA (waivers of consent, expanded access) and NIH (Certificates of Confidentiality) are also addressed.

Data and Specimen Repositories

Focus on regulatory requirements, IRB review considerations, and scenarios where repositories may be appropriate.

This workshop explains the use of electronic systems and processes to obtain informed consent, describes the available Ohio State electronic consent platforms, discusses how to select the most appropriate method for specific projects, and reviews available resources and guidance.

Event Reporting

This workshop provides an overview of the revised event reporting policy, differentiates between investigator, sponsor, and IRB reporting requirements, and contains multiple examples.

HIPAA Privacy and Security Rules

This presentation includes a review of the HIPAA research authorization form, waivers of HIPAA research authorization, a review of device encryption policies, and tips on how to keep your research data secure.

Human Subjects Research and the HIPAA Privacy Rule

This presentation covers the measures needed when performing research involving Protected Health Information (PHI) and reviews the rules and requirements for accessing and disclosing PHI under HIPAA for research with a focus on non-medical center personnel.

Initial IRB Submissions and Buck-IRB

This presentation provides an overview of the Buck-IRB system and how to navigate through the Ohio State IRB initial application (not external or exempt), identifies documents that typically accompany a complete application, discusses common pitfalls and tips for successful submission, and focuses on application sections specific to medical research.

International Research and the IRB

This presentation focuses on regulatory requirements, review considerations (e.g., informed consent process), and the cultural context to be considered when planning an international project.

IRB Amendments and Buck-IRB

This presentation describes the amendment process, reviews relevant HRPP policies and regulations, provides guidance and tips on amendment submission via Buck-IRB, and explains how to expedite the amendment screening and review processes.

IRB Reliance Models: Collaborating with External Partners

This presentation includes a description of possible IRB review models, including single IRB (sIRB) of record, ceded reviews, IRB Authorization Agreements, external Individual Investigator Agreements, SMART IRB, and the associated Buck-IRB submission processes.

IRB Submission and Review Processes

The session explains the oversight requirements for research involving human subjects, provides regulatory background and definitions, specifies review processes and categories of expedited and exempt research, and identifies submission components and available resources.

Secondary Analysis of Data and Specimens

Part 1 includes information on how to determine whether review is required at Ohio State, how to determine whether the project constitutes human subjects research, and when Ohio State personnel need review for multi-institutional projects involving the transfer of data and specimens.

Part 2 covers the different review types (exempt, expedited IRB, convened IRB) for those projects that do require human subjects research review, the submission process, as well as the consent and HIPAA authorization considerations for secondary use projects.

Therapeutic Development in Academia and the Challenges of FDA-Regulated Research

This presentation summarizes the regulations governing development of investigational drugs and medical devices, defines FDA’s role in reviewing drug and medical device clinical trials, explains what to expect during FDA inspections of clinical trials, and identifies investigator resources.

Focus on regulatory requirements, IRB review considerations, and scenarios where waivers may apply.