February Newsletter

New! Interactive Informed Consent Training Program

Informed consent is a critically important process of communicating respectfully with research participants. A well written consent form provides potential participants with the necessary information about the study to make an informed decision about participation. The effort put into writing a participant-centered informed consent is not only an ethical imperative but could also facilitate recruitment and retention.

OHRP is excited to present our brand new Interactive Online Training for Writing Participant-Centered Informed Consent. The program has 6 modules and offers a comprehensive training to help the research community create, design, and review consent forms or templates for research participation in a way that helps participants understand the content and anticipates their needs. A printable certificate is available upon completion. We encourage you to review this training whether you are an investigator, a research coordinator, an IRB reviewer, or someone designing a consent form for an online platform.

Click here to access!

Join us on Friday, February 23 at 12 noon EST for a brief demonstration of the program. No registration is required. Bookmark the zoom link here.

Register now for OHRP’s webinar “The Principles of the Belmont Report and the Ethics of Human Research”, presented by OHRP’s Senior Advisor to the Director, Dr. Ivor Pritchard!

Join us on Thursday, February 29 at 3:30-4:45 pm EST to hear Dr. Ivor Pritchard talk about the Belmont Report ethical principles of justice, beneficence, and respect for persons, their application to research involving human participants, and how they may have evolved in response to changes in society and the research landscape.

Registration is required. Attendance certificate will be provided to registrants. Click here to register!

A Brief Overview of SACHRP - video and slides now available!

If you have been wondering about what the Secretary’s Advisory Committee on Human Research Protections (SACHRP) does, where their recommendations go, and how you can use them, watch a short video about it on our website.

Click here to access!

The next OHRP Research Community Forum (RCF) will be at the University of Miami on April 10th & 11th, 2024!

Join OHRP in Coral Gables, FL as we co-host the next RCF, “Curating Connection”, with the University of Miami, the University of Florida, and the Johns Hopkins University!

On Day 1, participate in OHRP-led interactive sessions to learn how to apply the regulations at 45 CFR 46 through case scenarios. Attendees with working knowledge of the regulations will find these sessions particularly helpful. Apart from morning plenary sessions, Day 2 offers three tracks in the afternoon for attendees to choose from: Development of Human Research Protection Programs (HRPP), Data Protection and Integrity, and Increasing the Diversity of Research Participants.

This RCF will meet the educational needs of HRPP and IRB administrators, IRB members, researchers, and study teams involved in biomedical and/ socio-behavioral human subject research.

Review the agenda and register now to save your spot!

Save the date: Friday, July 12, 2024

On Friday, July 12^th, OHRP will be hosting a virtual event to commemorate the 50^th anniversary of the National Research Act. Details coming soon!

Reminder: OHRP’s resources on Subpart C - Additional Protections for Research with Prisoners

45 CFR 46 Subpart C outlines additional regulatory protections for research involving prisoners. OHRP offers numerous resources to help you understand how to apply this subpart to relevant research conducted or supported by HHS. For the basics, check out our webinar on Prisoner Research 1: 45 CFR Subpart C—Basics (youtube.com) and review our FAQs on Prisoner Research FAQs | HHS.gov. If you’re looking to submit a certification to conduct prisoner research, be sure to follow the instructions available here - Subpart C Certification Request to OHRP | HHS.gov. For any other inquiries related to Subpart C, get in touch with OHRP by sending an email to SubpartC@hhs.gov.

Announcing Updates to OHRP’s Compliance Oversight Assessment Webpage!

The Office for Human Research Protections (OHRP) is pleased to announce the release of updated compliance oversight procedures for assessments document on OHRP’s webpage “OHRP’s Compliance Oversight Assessments (2024).”  This document summarizes the procedures used by OHRP in performing compliance assessments of institutional review boards (IRB) and research institutions’ Human Research Protection Programs (HRPP) that are under OHRP’s jurisdiction.

This document provides information on the following topics:

• What types of compliance assessments does OHRP conduct?
• What prompts an OHRP investigation?
• How does OHRP evaluate complaints or other information indicating noncompliance?
• What other mechanisms does OHRP use to address complaints or other indications of noncompliance?
• How does OHRP select Institutions or IRBs for evaluations?
• How does OHRP conduct evaluations of IRBs or Institutions?
• What are possible outcomes of OHRP compliance assessments?
• How can the public and government entities access OHRP compliance assessment records?

The updated information can be found at the following link: https://www.hhs.gov/ohrp/compliance-and-reporting/evaluating-institutions/index.html