HSPP Newsletter – April, May, June, 2022
FDA Warning Letter Regarding the Failure to Ensure IRB Continuing Review and Approval of Protocol
Inspections of clinical trials are conducted as a part of the U.S. Food and Drug Administration (FDA)’s Bioresearch Monitoring Program. These inspections are designed to evaluate the conduct of research and to help ensure that the rights, safety, and welfare of human subjects have been protected. Below you will find a short summary of a warning letter issued because of the failure to obtain continuing review of a study and failure to perform study procedures as required by the protocol.
Warning letter to Sabine S. Hazan, M.D.
On February 28, 2022, the FDA issued a warning letter to Dr. Hazan. The FDA officials who inspected the study concluded that the investigator did not adhere to the FDA regulations governing the conduct of clinical investigations and the protection of human subjects. Dr. Hazan failed to obtain continuing review and approval for her study. Specifically, her study IRB approval lapsed. During the course of this lapsed period, she enrolled and randomized subjects into the protocol, and administered investigational drugs to subjects. In addition, she was unable to provide a corrective action plan to prevent the recurrence of this type of violation in the future.
The FDA emphasized that the failure to ensure continuing IRB review and approval, impeded the IRB’s ability to determine the adequacy of the application to conduct the protocol. This raised significant concerns about the extent to which subjects’ rights and welfare were protected at that site during the lapse in approval.
For more details about the inspection of this study and the findings of the FDA please review the Warning Letter – Sabine S. Hazan, M.D. February 28, 2022
Warning letter to Smitha C. Reddy, M.D. / ACRC Studies, LLC
On May 27, 2022, the FDA issued a warning letter to Dr. Reddy. The FDA officials who inspected the study concluded that the study as it was implemented raised significant concerns about the safety of subjects enrolled and the reliability of data at that site.
Dr. Reddy failed to ensure that the investigation was conducted according to the investigational plan. Specifically, the investigator did not ensure subjects randomized to an assigned treatment arm received the correct drug for that group, and there was a failure to adhere to procedures for the blinding of staff.
The FDA emphasized that the principal investigator is ultimately responsible to ensure that the study is conducted properly and in compliance with FDA regulations, both to protect the rights, safety, and welfare of study subjects and to ensure the integrity of study data. Additionally, the FDA required corrective actions to include retraining of the investigator on study drug administration, not just study staff.
For more details about the inspection of this study and the findings of the FDA please review the FDA Warning letter to Smitha C. Reddy, M.D./ACRC Studies, LLC
Office of Human Research Protection (OHRP) – Resources
The Office of Human Research Protection (OHRP) has launched two interactive programs to help explain the expectations for investigators in applying the Common Rule review criteria of equitable selection of subjects in research and minimizing research risks for participants. These resources are valuable for investigators to understand and fulfill these specific requirements for protecting human participants in research.
To access these interactive programs click on links below.
Equitable Selection of Subjects : This is a 30-minute scenario which examines how investigators could apply the concept of equitable selection of subjects in research
Minimizing Risks in Research : This is a 30-minutes scenario which examines the concept of research risks and how these risks to participants could be identified and minimized.
Human Subjects Training – Frequently Asked Questions
I am a new resident/student at UCONN Health and I completed CITI Training under my affiliation with a former institution. Is that CITI Certificate valid at UConn Health?
If an individual is to be included in an IRB application and that person has recently become affiliated to UConn Health (e.g. a new student), that person should attach the CITI Training certificate completed under his/her former affiliation. If the courses previously completed are comparable to the ones required by UCONN Health IRB that individual will not need to complete additional training. If not, he/she must complete training under his/her affiliation to UConn Health. The CITI Program will give credit for any modules he/she have completed under other institution’s affiliation and will require completion of modules that are specific to UConn Health.
To affiliate an account in the CITI Program with UConn Health, individuals should log into the CITI program, and click on “Add Affiliation” listed under the “Courses” Menu. To
find UConn Health in the drop down box, the following words “University of Connecticut“ must be typed. Then, select “University of Connecticut Heath Center”. To complete the process, check the box next to the statement: “I AGREE to the Terms of Service for accessing CITI Program materials” and check the box with the statement: “I affirm that I am an affiliate of University of Connecticut Heath Center.” Last, click on “Continue.”
To select the correct learning group and courses, follow the “Course Enrollment Questions” posted at https://ovpr.uchc.edu/services/rics/hspp/citi-instructions/
Recent Articles Published by a Central IRB
What do I do about Incidental Findings in Research? If you are conducting research that has a potential to uncover an incidental finding, it is best to plan ahead for how you’ll treat the result and if you plan to return that result to a participant. This article describes the plans and consideration to communicate incidental findings to research participants.
eClinical Regulatory Trends Impacting Clinical Research For the past two years, the clinical research industry has seen an acceleration in staff shifting to a remote, work from home model. While this was initially in an effort to keep everyone safer from the COVID-19 pandemic, many organizations are permanently moving toward a remote or hybrid work model for their staff. This article discusses how has this shaped current regulatory trends, the benefits of eClinical suite, and the consideration when adopting an eClinical suite.
IRB Forms – Update
Added new contact information to the following forms:
- Human Subject Research Determination Form.doc
- dbGaP Access Request Form for IRB Certification.docx
- Participant Feedback Form.doc
- Participant Feedback Form in Spanish.docx
- HIPPA Assurance of Preparatory to Research or Decedent Research .doc
- Instructions for Students Residents or Fellows Doing Research_at_Hartford HealthCare_or_CT Children’s Medical Center.docx
Added Federal required Overview section to:
Upcoming changes in at the HSPP/IRB and the OVPR
- Vice President for Research: Dr. Pamir Alpay has been appointed Interim Vice President for Research, Innovation & Entrepreneurship while Dr. Radenka Maric is serving as Interim President of the University of Connecticut.
- Associate VPR and Institution Official: Dr. Victor Hesselbrock has been named Interim Associate Vice President for Research Integrity and Regulatory Affairs and Institution Official following Dr. Byerly’s departure.
- Manager and Deputy Director of HSPP: Deb Gibb retired June 1, after 19 years with the HSPP. Julia Blair will serve as interim manager of the HSPP.