Full-Day Workshop on Human Research Reviews: Mastering the Process

Human Research Reviews: Mastering the Process

This optional pre-seminar workshop is a collaboration between the HHS Office for Human Research Protections (OHRP) and the NIH Office of Extramural Research (OER).

Wednesday, May 15, 2019  DRAFT AGENDA

Cost:  $110

Participation in this full-day workshop could fulfill the NIH human subjects training requirement for key personnel.  Participants who complete the workshop will be given a certificate of completion.

Full Day Workshop: 8:30 a.m. – 4:30 p.m.

This workshop aims to provide participants with the necessary information to successfully navigate their NIH grant applications and research protocols through human research protections review. It will provide attendees with a general understanding of the federal regulations and policies on protecting human subjects in research and how to apply them to research protocols, as well as practical advice on how to master the human research review process. Updates on the regulations and NIH policies will be discussed as appropriate.

Target Audience

This workshop is primarily intended for investigators applying for NIH grants to conduct human subjects research or submitting human research protocols for IRB review. This workshop is also suitable for new IRB administrators and reviewers as a basic training on the federal policies for human research protections.

Learning Objectives

Upon completing the workshop, participants will be able to:

  • recognize whether a proposed activity is human subjects research according to the regulations and key ethical principles, and explain how to apply the regulations when appropriate;
  • understand the NIH policies on human subjects research protections, the related NIH peer review process, and the expectations for completing the Protection of Human Subjects section in the NIH grant application;
  • describe the role of the IRB in reviewing and approving research, and the criteria it must consider; and
  • understand how to navigate the IRB process; and
  • describe the investigator’s role in protecting human subjects in research and the key features of the informed consent process.

Workshop Agenda  (Please check back for updates.)

8:30 – 8:45 a.m. Introduction and Logistics

8:45 – 9:45 a.m. A Review of the Common Rule and Its Application (60 min, OHRP)

This presentation will begin with a brief overview of HHS human research protections and explain OHRP’s role in protecting human subjects. It will explain recent revisions to the Common Rule, incorporating relevant ethical principles. The rest of the presentation will focus on how to determine whether research activities fall within the scope of the revised Common Rule.

9:45 – 10:30 a.m. Secondary Research with Data and Biospecimens Under the Common Rule (45 min, OHRP)

This presentation will focus on options for conducting secondary research activities under the revised Common Rule, including relevant changes to exemptions.

10:30 – 10:45 a.m. Break (15 min)

10:45 – 12:00 p.m. Preparing the NIH Protection of Human Subjects section and an Overview of NIH’s New Policies – NIH (75 min, NIH)

This presentation will walk participants through preparing the Protection of Human Subjects section of an NIH grant application. It will provide an overview of the grant review process and discuss the criteria reviewers use to determine if the application has included adequate protections for human subjects. This session will conclude with a brief overview of new policies being implemented by NIH, including the policy on single IRB review of cooperative research and policies relevant to clinical trials.

12:00 – 1:30 p.m. Lunch (90 min.)

1:30 – 2:30 p.m. What Investigators Should Know About IRB Review (60 min, OHRP)

This presentation will discuss the role of IRBs in human research protection and the regulatory criteria IRBs use to review research proposals. The presenter will explain how to prepare a research proposal that addresses the regulatory requirements and help investigators understand their responsibilities with respect to IRB review. Regulatory discussion will focus on the revised Common Rule.

2:30 – 3:00 p.m. What’s New in Informed Consent (30 min, OHRP)

This presentation will provide a summary of changes to informed consent in the revised Common Rule, including required changes and new flexibilities.

3:00 – 3:15 p.m. Break (15 min.)

3:15 – 4:00 p.m. Informed Consent: Putting it into Practice—OHRP (45 min, OHRP)

This interactive session will discuss the informed consent process, and focus on how to increase understandability of information to support good decision making. Discussion will include organizational tips and key information requirements.

4:00 – 4:30 p.m. Q & A/ Closing Remarks – all speakers (30 min.)

This short session will provide participants with the opportunity to ask remaining questions or clarify earlier points.

All Tracks