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).
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.
This workshop aims to provide participants with the knowledge and information necessary to have their NIH grant applications and research protocols pass review for human research protections. It will focus on reducing confusion and providing participants with practical tips and solutions to problems and difficulties commonly encountered during IRB review.
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.
Upon completing the workshop, participants will be able to:
8:30 – 8:50 a.m. Welcome: Who We Are, What We Do, and Why We Do it (20 min, Hernandez, OHRP)
This presentation will provide a brief overview of HHS human research protections, including the role of OHRP, and an introduction to the Common Rule and its recent revisions.
8:50 – 10:00 a.m. Review of the Common Rule and Its Application (70 min, Anderson, OHRP)
This presentation will use examples and interactive exercises to explain how to determine whether research activities fall within the scope of the revised Common Rule by addressing regulatory concepts such as research, human subjects, exemptions, and more.
10:00 – 10:15 a.m. Break (15 min)
10:15 – 11:15 a.m. Secondary Research with Data and Biospecimens Under the Revised Common Rule (60 min, Anderson, OHRP)
This presentation will focus on options for conducting secondary research activities under the revised Common Rule, including relevant changes to exemptions.
11:15 a.m. – 12:00 p.m. Approval Criteria for Regulated Human Subjects Research (45 min, Hernandez, 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.
12:00 – 1:30 p.m. Lunch (90 min)
1:30 – 2:45 p.m. Informed Consent from Theory to Practice (75 min, Hernandez, OHRP)
This interactive session will discuss the requirement for informed consent and the informed consent process, focusing on how to increase understandability of information to support good decision-making. This presentation will also provide a summary of changes to informed consent in the revised Common Rule.
2:45 – 3:00 p.m. Break (15 min.)
3:00 – 4:15 p.m. Preparing the NIH Protection of Human Subjects Section and an Overview of NIH’s New Policies – NIH (75 min, Corbett and Kearney, 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.
4:15 – 4:30 p.m. Q & A/ Closing Remarks (15 min, all speakers)