January Newsletter

Out with the old, in with the new! Happy New Year from OHRP!

What are the expectations for IRB reviews? Check out our new interactive training programs!

OHRP is launching two interactive programs to help explain the expectations for IRB reviewers and investigators in applying the Common Rule review criteria of equitable selection of subjects in research and minimizing research risks for participants. These resources will be most valuable for training investigators and new IRB staff and members, particularly community members, on how best to understand and fulfill these specific requirements for protecting human participants in research!

Access these interactive programs on the Human Research Protection Training page of our website:

https://www.hhs.gov/ohrp/education-and-outreach/online-education/human-research-protection-training/considerations-for-reviewing-human-subjects-research/index.html

Didn’t get a chance to attend the 2021 NIH Regionals? Watch recordings of OHRP presentations on human subjects research and investigator responsibilities for protecting participants in research!

What is Human Subjects Research? A Review of the Common Rule and its Application provides helpful explanation on the complex concept of human subjects research and how to address related considerations in the NIH grant application process.

What Investigators Need to Know About IRB Review helps investigators understand the thoughts and considerations needed for writing a successful plan to protect human research participants that would pass the muster of reviewers.

Please share these videos with investigators to help them with the NIH grant application and IRB review process.

Access these videos here: https://www.hhs.gov/ohrp/education-and-outreach/online-education/videos/index.html

Not sure how to file or update an FWA?

Check out our new video Review of the Federalwide Assurance (FWA) Application Form and How to Complete It and other associated resourcesat: https://www.hhs.gov/ohrp/register-irbs-and-obtain-fwas/fwas/resources-on-how-to-file-an-fwa-and-related-resources/index.html

OHRP’s Incident Reporting Form is now an online form!

OHRP’s incident reporting system now uses an online form for submission of unanticipated problems involving risk to subjects or others, serious or continuing noncompliance with 45 CFR 46, or suspension or termination of IRB approval to OHRP.

Institutions are required to submit all incident reports to OHRP electronically using the online form starting January 2, 2022. After this date, if an IRB or institution believes it lacks the ability to submit incident reports electronically via the online form, it will need to contact OHRP at IRPT.OS@hhs.gov to explain why it is unable to submit the incident report electronically. To access the online form and submit incident reports, navigate to OHRP’s Reporting Incidents page: https://www.hhs.gov/ohrp/compliance-and-reporting/guidance-on-reporting-incident/index.html.

Tips for completing the form:

Information provided on the online form is submitted directly to OHRP’s database for processing. Each field must be completed with the required information regarding the incident. References to attached documents in lieu of completing the form will not be accepted. Users are permitted to provide additional attachments to supplement the report, as needed.

Submission confirmation:

Upon submission of the report, users will receive an automatic email message confirming successful submission. In addition, a detailed confirmation containing the information submitted in the report will be provided via email, generally within a few business days.

Get the summary report and view the archived videos on Third-Party Research Risks!

Didn’t get a chance to attend our 4th Annual Exploratory Workshop on Third-Party Research Risks? No problem! Visit the event website at https://www.hhs.gov/ohrp/education-and-outreach/exploratory-workshop/2021-workshop/index.html. Here you will be able to watch the archived videos of both event sessions, access slides, read the event summary report, and more!

OHRP is seeking institutional collaborators to host Research Community Forums (RCFs) in 2023 or later.

Contact us now at ohrp-edu@hhs.gov if you are interested in co-hosting a RCF with us in 2023 or later. RCFs can be either in-person or virtual, and OHRP provides a small sponsorship for the event. Please check out our website at https://www.hhs.gov/ohrp/education-and-outreach/educational-collaboration-with-ohrp/research-community-forums/index.html for details.

Don’t miss this valuable opportunity! We look forward to partnering with you soon!

Mark your calendars! May 11 & 12, 2022 are the dates for our next virtual RCF with Northwell Health in Long Island, New York.

Our next RCF If You Can Make it Here (During a Pandemic) You Can Make It Anywhere: Lessons Learned from the New York Research Landscape will be conducted virtually in collaboration with Northwell Health on May 11-12, 2022. For more information, visit: https://www.eventbrite.com/e/ohrpnorthwell-health-research-community-forum-tickets-234473314997