• SKIP TO CONTENT
  • SKIP NAVIGATION
  • Patient Resources
    • COVID-19 Patient Resource Center
    • Clinical Trials
    • Search Clinical Trials
    • Patient Notification System
    • What is Clinical Research?
    • Volunteering for a Clinical Trial
    • Understanding Informed Consent
    • Useful Resources
    • FDA Approved Drugs
  • Professional Resources
    • Research Center Profiles
    • Clinical Trial Listings
    • Market Research
    • FDA Approved Drugs
    • Training Guides
    • Books
    • eLearning
    • Events
    • Newsletters
    • JobWatch
    • White Papers
    • SOPs
    • eCFR and Guidances
  • White Papers
  • Trial Listings
  • Advertise
  • COVID-19
  • iConnect
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » OHRP Weighs in on Protecting Research Participants During COVID-19 Pandemic

OHRP Weighs in on Protecting Research Participants During COVID-19 Pandemic

April 13, 2020

Sponsors and investigators conducting federally funded research do not need IRB approval for actions taken in response to the threat of COVID-19 as long as those actions are for public health or clinical treatments purposes rather than research, according to a new guidance from the Office for Human Research Protections (OHRP).

Investigators also are permitted to make changes to approved research plans without prior IRB approval when responding to an immediate threat to patients.

OHRP’s guidance provides recommendations for following the patient protection requirements in the Common Rule (45 CFR 46) when a federally funded research project is impacted by the virus, including releasing identifiable information about research subjects to a public health authority. Investigators must comply with federal, state and local laws that require disclosure of a research subject’s positive COVID-19 test results, the guidance says, adding that the subject should be informed of the disclosure.

OHRP also says the recently issued FDA guidance on conducting trials during the pandemic is consistent with the Common Rule’s patient protection requirements and may be followed by investigators whether or not they are conducting FDA-regulated research.

To read the guidance, click here: https://bit.ly/3e9FVCB.

COVID-19
  • Related Directories

    Olumiant (baricitinib)

    Veklury (remdesivir)

    Comirnaty (COVID-19 Vaccine, mRNA)

Upcoming Events

  • 24May

    Powering an Effective Oversight Strategy with Clinical and Operational Insights

  • 25May

    2022 WCG Avoca Quality & Innovation Summit: Own the Future

  • 28Jun

    Effective Root Cause Analysis and CAPA Investigations for the Life Sciences

  • 16Oct

    WCG MAGI's Clinical Research Hybrid Conference - 2022 West

Featured Products

  • Spreadsheet Validation: Tools and Techniques to Make Data in Excel Compliant

    Spreadsheet Validation: Tools and Techniques to Make Data in Excel Compliant

  • Surviving an FDA GCP Inspection

    Surviving an FDA GCP Inspection: Resources for Investigators, Sponsors, CROs and IRBs

Featured Stories

  • Protocol-360x240.png

    Avoid Deviations by Making Protocol Review a Team Effort

  • SelectionProcess-360x240.png

    Give Us a Voice: Sites Clamor for a Say on Vendor Selection

  • Convince-360x240.png

    Use Data and Details to Convince Site Leadership to Add Staff

  • AsktheExpertsBadge-360x240.png

    Ask the Experts: Listing Trial Staff and Others on the Statement of Investigator

Standard Operating Procedures for Risk-Based Monitoring of Clinical Trials

The information you need to adapt your monitoring plan to changing times.

Learn More Here
  • About Us
  • Contact Us
  • Privacy Policy
  • Do Not Sell My Personal Information

Footer Logo

300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

Phone 617.948.5100 – Toll free 866.219.3440

Copyright © 2022. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing