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Past Educational Sessions

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

Feb. 17, 2021 FDA-regulated Research: Myth vs. Reality – Part 2: Medical Devices
Although OHRP and FDA regulations are similar, differences exist based on FDA’s unique scope and requirements. These sessions focus on research involving medical devices and the special considerations associated with obtaining IRB approval.

The first recording explains common regulatory terms in the context of FDA-regulated medical device studies, differentiates between clinical investigations requiring Investigational Device Exemptions (IDEs), Nonsignificant Risk device investigations, and IDE-exempt investigations, and how and when to consult the FDA.

The second session covered applying regulatory information from the pre-recorded session to real-life examples of medical device research, using tools to determine which of the five most common device research scenarios applies to your research, identifying supporting documents required for medical device research and completing Buck-IRB application sections required for FDA-regulated medical device research.
September 23, 2020 Human Subjects Research 101: From Inspiration to Approval! video/slide deck
This session explains why we have an IRB process, lists types of human subjects research and levels of review, outlines Ohio State’s IRB review process, and generates an action plan for completing a successful social and behavioral sciences Buck-IRB application. Note: A medically focused session was presented on May 20, 2020, and is available below.
September 10, 2020 FDA-regulated Research: Myth vs. Reality – Part 1: Drugs video/slide deck
This session explains common regulatory terms in the context of FDA-regulated drug studies, assesses which regulations apply to clinical investigations involving drugs or biologics, including when an Investigational New Drug Application (IND) is required, navigates the Buck-IRB application sections and documents required for FDA-regulated drug research, and discusses how and when to consult the FDA.
June 23, 2020 Event Reporting in Human Subjects Research video/slide deck
This session provides an overview of the newly revised event reporting policy, differentiates between investigator, sponsor, and IRB reporting requirements, provides definitions, and discusses case examples.
May 20, 2020 Human Subjects Research 101: From Inspiration to Approval! video/slide deck
This session explains why we have an IRB process, lists types of human subjects research and levels of review, outlines Ohio State’s IRB review process, and generates an action plan for completing a successful Buck-IRB application.
Jan. 30, 2020 Advarra Review of Human Subjects Research video
This session provides an overview of the Ohio State and Advarra submission processes, navigates within the Ohio State and Advarra platforms, describes required submission components, and reviews tips for successful submissions.
Dec. 5, 2019 Amendments and Buck-IRB video/slide deck
The session describes the amendment process, reviews relevant HRPP policies and regulations, provides guidance and tips on amendment submission via Buck-IRB, and presents strategies to facilitate the amendment screening and review processes.
Oct. 22, 2019 Paying Study Participants: Ethical and Practical Considerations video/slide deck
This workshop reviews regulatory guidance and university policy regarding participant payments, discusses how to select the best compensation option for a project, explores case examples of participant payment methods, reviews administrative requirements to pay participants and monitor compensation, and identifies available resources for managing research compensation.
Sept. 10, 2019 Let’s Work Together:
IRB Oversight of Collaborative Research – Part 2		 video / slide deck
This workshop reviews external agreement requirements and corresponding agreements, navigates through the Buck-IRB external collaboration pages, and practices using tip sheets and tools for collaborative research submissions.
Aug. 21, 2019 Let’s Work Together:
IRB Oversight of Collaborative Research – Part 1		 video / slide deck
This presentation provides a general overview of the sIRB model for multi-site research, outlines information specific to Ohio State when using the sIRB model, and reviews study team and site responsibilities under the sIRB model.
July 17, 2019 Waivers of Informed Consent and HIPAA Research Authorization video / slide deck
This presentation provides an overview of informed consent/HIPAA authorization alteration and waivers, discusses regulatory definitions, answers Buck-IRB waiver/alteration questions, and provides case examples, best practices, and resources.

  • Group Activity A – Waivers of Consent Examples (handout)
  • Group Activity B – Instructions – Mock Review of Full Waiver (handout)
  • Group Activity B – Reviewer Checklist for Full Waiver (handout)
  • Group Activity B – Screenshot HIPAA Full Waiver (handout)
  • Group Activity B – Screenshot HIPAA Full Waiver (better responses) (handout)
  • Group Activity C – Instructions – Partial Waiver Request (handout)
  • Group Activity C – Partial Waiver Sample Responses (handout)
  • Elements of Informed Consent (handout)
June 5, 2019 Troubleshooting Informed Consent
 video / slide deck
This presentation identifies common screening questions, examines IRB required modifications related to the consent process, discusses common post-approval monitoring findings, and provides case examples, best practices, and resources.

  • Informed Consent Common Findings  (handout)
  • Informed Consent Standard Operating Procedure (handout)
  • Informed Consent Scenarios (handout)
May 2, 2019 Event Reporting in Human Subjects Research
 video / slide deck
This presentation provides an overview of the event reporting policy, differentiates between reporting requirements, provides definitions, discusses case examples, and review best practices.

  • Event Reporting Case Examples (handout)
  • Event Reporting Determination Guidance (handout)
Apr. 17, 2019 Electronic Informed Consent: Processes, Platforms, and Participants
 video / slide deck
This presentation provides an update regarding OCIO approval of eSignature methods and IRB submission requirements, highlights electronic consent platforms REDCap and Signet, and supplies information on how to conduct informed consent using the available platforms.

  • eSignature for Consent Approval Process (handout)
Apr. 2, 2019 Submission to Western IRB under the Revised Common Rule video / slide deck
This presentation provides an overview of the Common Rule revisions related to submission to the Western IRB (WIRB). Details on the Ohio State and WIRB submission platforms, required submission components, review considerations, and tips are also presented.
Mar. 26, 2019 Privacy Matters: Preserving Privacy in Human Subjects Research
  video / slide deck
This presentation covers how research participants’ privacy is affected by Common Rule revisions, new international regulations, and evolving institutional policies.

  • Privacy Matters Resources (handout)
  • Ohio State Privacy Principles (handout)
  • Privacy Discussion Scenarios (handout)
Mar. 5, 2019 Buck-IRB and Initial IRB Submissions
 video / slide deck
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.

  • Initial Submissions and Buck-IRB (handout)
Feb. 26, 2019 Continuing Review under the Revised Common Rule video / slide deck
This presentation provides an overview of the Common Rule revisions related to continuing review. Details on Ohio State’s annual review requirements, Buck-IRB updates, and case examples are also presented.

  • Tip Sheet: Annual Review Decision Tree (handout)
  • Continuing Review/Annual Status Report Submission Tips (handout)
Jan. 9, 2019 Exempt Research under the Revised Common Rule video / slide deck
This presentation provides an overview of the Common Rule revisions related to exempt research. A description of Ohio State’s implementation plan and exempt research case examples are also presented.
Nov. 27, 2018 Informed Consent Requirements under the Revised Common Rule video / slide deck
This presentation provides an overview of the Common Rule revisions related to informed consent. Details on Ohio State’s transition plan and consent templates are also presented.

  • Electronic Signatures for Informed Consents (handout)
  • Informed Consent – Template Language and Instructions (handout)
  • Informed Consent – Regulatory Changes (handout)
Oct. 16, 2018 Paying Study Participants: Ethical and Practical Considerations video / slide deck
This presentation covers participant recruitment and compensation considerations in both medical and non-medical research. The session reviews regulatory guidance and university policy regarding participant payments, discusses how to select the best compensation option, explores case examples of participant payment methods, reviews administrative requirements to pay participants and monitor compensation, and identifies available resources for managing research compensation.
Sept. 18, 2018 Beyond Regulations: Ethics in Human Research
 video / slide deck
Featured Lecturer: David H. Strauss, MD – Director of Research, Austen Riggs Center
The challenges that researchers encounter go beyond human subjects protection and research integrity as it is traditionally understood and defined by regulations. This lecture brings together regulators and researchers for a comprehensive discussion about the complex ethical dilemmas and challenges researchers face every day.
Aug. 21, 2018 Secondary Analysis of Data and Biospecimens
 video / slide deck
This presentation covers secondary analysis of data and biospecimens at Ohio State including review of regulatory requirements, discussion of IRB review considerations, and examples, scenarios, and available resources.

  • Secondary Research Involving Data and Biospecimens (handout)
Aug. 16, 2018 IRB Submission and Review Processes
 slide deck
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.

  • IRB Submission and Review Process (handout)
July 17, 2018 Hot Topics in Human Subjects Research
 video / slide deck
This presentation covers current topics in human subjects research, including regulatory updates, Ohio State’s implementation of recent human subjects research changes, best practices, and available resources.

  • Hot Topics in Human Subjects Research Resources (handout)
  • Research Protocol and Consent Document Requirements (handout)
Apr. 12, 2018 IRB Amendments and Buck-IRB
 slide deck
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.

  • Tip Sheet: Submitting Amendments in Buck-IRB (handout)
Mar. 20, 2018 Therapeutic Development: Challenges of FDA-Regulated Research
 slide deck
This presentation summarizes the regulations governing development of investigational drugs and medical devices, defines the 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.
Feb. 20, 2018 Electronic Informed Consent in Human Subjects Research video
This presentation 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.

  • Gathering Electronic Signatures for Informed Consents (handout)
Oct. 17, 2017 Common Rule Changes slide deck
This presentation provides an overview of the Common Rule revisions that took effect on January 21, 2019. Regulatory updates from FDA (waivers of consent, expanded access) and NIH (Certificates of Confidentiality) are also addressed.
Aug. 8, 2017 IRB Reliance Models: Collaborating with External Partners
 slide deck
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.

  • Tip Sheet: IRB Reliance (handout)
Mar. 28, 2017 International Research and the IRB slide deck
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.
Oct. 19, 2016 HIPAA Privacy and Security Rules slide deck
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.
June 21, 2016 Data and Specimen Repositories (Medical) slide deck
This presentation covers regulatory requirements, IRB review considerations, and scenarios where repositories may be appropriate. Biomedical research focused.
May 17, 2016 Data and Specimen Repositories (BSS) slide deck
This presentation covers regulatory requirements, IRB review considerations, and scenarios where repositories may be appropriate. Behavioral and Social Sciences research focused.