HSPP- January-February -March, 2023 – Newsletter
Important Updates about the COVID-19
Single Institutional Review Board (IRB) Exception
Based on current COVID-19 trends, the U.S. Department of Health and Human Services (HHS) is planning for the federal Public Health Emergency (PHE) for COVID-19, declared under Section 319 of the Public Health Service (PHS) Act, to expire at the end of the day on May 11, 2023. The Office for Human Research Protections (OHRP) is sending this announcement in anticipation of the PHE expiration.
On October 8, 2020, OHRP, on behalf of HHS, issued an exception determination as permitted by 45 CFR 46.114(b)(2)(ii) stating that certain categories of cooperative research supported or conducted by HHS and subject to the 2018 Requirements are not required to comply with the single IRB mandate in 45 CFR 46.114(b)(1). The full text of the exception can be found here: https://www.hhs.gov/ohrp/regulations-and-policy/single-irb-exception-determinations/october-2020-exception-determination/index.html
Use of this exception is permitted for research that is ongoing or initially reviewed by the IRB during the COVID-19 public health emergency declared by the Secretary of HHS when reliance on a single IRB would not be practical and when the HHS division supporting or conducting the research approves the use of the exception. OHRP granted this exception due to the unprecedented burden and disruption to the research enterprise caused by the COVID-19 public health emergency, which also necessitated urgent research responses.
Institutions and IRBs should be cognizant of the impact that conclusion of the COVID-19 public health emergency will have on the ability to use this exception. Specifically, as of the date of the conclusion of the public health emergency, the exception will expire and cannot be applied to additional studies. Research for which the HHS division supporting or conducting the research study has already approved the use of the exception will continue to be excepted from the single IRB requirement, since the exception applies for the duration of the research.
Please direct questions to OHRP@hhs.gov or to the HHS division supporting or conducting a particular research activity.
An HHS fact sheet on the COVID-19 PHE transition roadmap can be found here: https://www.hhs.gov/about/news/2023/02/09/fact-sheet-covid-19-public-health-emergency-transition-roadmap.html
UConn Health Human Subjects Protection Program (HSPP)
External Research Use of UConn Health
External investigators (non-UConn Health personnel) who would like to conduct research recruitment activities at UConn Health which do not engage UConn Health, should complete and submit the Request for UConn Health as a Recruitment Site -Without Engagement and any approved recruitment materials to email@example.com.
External investigators who are in need of UConn Health resources for their research studies are to complete and submit the Confirmation of Available Resources Form (incl Inpatient Stays) . In this form, the investigator should describe all the resources that will be required for the research study. Completed forms and a copy of the approved protocol are to be submitted to firstname.lastname@example.org for approval by research and hospital administration. External protocols should describe the use of UConn Health as a research site. Researchers will need form approval in order to use resources at UConn Health for research.
Frequently Asked Questions
Q: When can I close my study with the IRB?
- If the study is an exempt study, the principal investigator (PI) may allow the IRB approval to expire. If so, the IRB will administratively close the study, which does not invalidate the exemption. The research, as proposed to the IRB, may continue. It is not necessary to keep the exemption actively registered with the IRB.
- If the study is a non-exempt study ( e.g., Expedited or full board studies) the PI can only close the study:
- If the research was not conducted or was canceled, or
- If each of the following conditions exist:
- The research is permanently closed to the enrollment of subjects
- The subjects have completed all research-related interventions
- The research is no longer active for long-term follow up of subjects
- Data has been de-identified.
Q: I am a Principal Investigator of an active /currently approved study. I am going to retire from UConn Health. Do I need to close my active studies?
- When a PI terminates employment with UConn Health, the PI should submit a modification form requesting transfer of the study to another eligible Principal Investigator. Alternatively, the PI may submit a closure form to the IRB.
- If the retired investigator has become an Emeritus professor for UConn Health, he/she can keep the study open and continue as the Principal investigator or co-investigator of the study. Approval from the HSPP Director is required in these cases.
Q: How do I close an IRB approved study?
- The PI should submit a Study Closure form through the iRIS system. The closure form should be submitted before the expiration of IRB approval.
- The investigator can also submit a closure form after he/she has received a notice of lapse of approval.
Q: How does the IRB process expired studies, lapsed studies and closure forms?
- When a closure form is submitted, the IRB will review any new information provided in the closure form and determine whether any additional action is required on the part of the IRB or the investigator. Upon review of the closure form, the status of the study is changed in the iRIS system (e.g., “Closed by PI”) and an outcome letter is issued confirming the closure.
- For non-exempt studies: if approval for continuation is not sought, or a request to extend the expected completion date has not been received within a reasonable time frame (e.g. 30 days), IRB staff will administratively close the study and send a written notification to the Principal Investigator of the administrative closure.
- For exempt studies: when approval has expired and a closure form has not been submitted, the IRB will administratively close the study. (see prior question about closure of exempt studies)
- For lapsed studies for which a response to contingencies has not been received within a reasonable time frame (e.g. 30 days) the study may administratively be closed. The IRB will send a written notification to the PI. Prior to closure the IRB will issue a final request for response by email to the PI and study contacts and the PI will be given a reasonable period within which to respond (e.g. one or two weeks)
Q: What are the expectations of the IRB with my closed studies?
- Ensure that all research-related activities, interventions or interactions with human subjects have been completed at the site(s) approved under the Principal Investigator’s IRB application at the time a closure form is submitted to the IRB or at the time of approval expiration, whichever occurs first.
- The PI will continue to maintain confidentiality protections of the data as outlined in the protocol, consent and IRB documents.
- Ensure that all subject identifiers connected with the research data have been destroyed in compliance with an approved Waiver of Health Insurance Portability and Accountability Act (HIPAA) Authorization (if applicable) and if the investigator indicated in the IRB application that all subject identifiers would be destroyed upon completion of the research.
- Retain research records in accordance with IRB Policies 2011-024.0.pdf – File Requirements & Record Retention Requirements and 2015-024.1.pdf – Record Retention Format.
- Ensure any specific regulatory and/or sponsor requirements are met for record retention or submission of reports.
- If after a study is closed, the investigator seeks to engage in an activity such that the criteria for closure listed above would no longer be met, the Principal Investigator must submit a new application for IRB review and approval for the use of the previously collected data.
Office of Human Research Protection (OHRP)
Short Videos – Educational Resources for Investigators
The Office of Human Research Protection has posted a series of short educational videos on research with private information and biospecimens. These videos are titled: “Regulatory Options for Secondary Research with Private Info and Biospecimens Part 1 and Part 2.”
Part 1 of these videos explains how to apply the regulations when doing research with data and/or biospecimens under the revised common rule.
This video discusses the concept of secondary research and how secondary research can be done under the revised Common Rule.
Definitions and examples of the following concepts are described in detail:
- What is secondary research and identifiable information.
- What is secondary research with nonidentifiable materials
- What is secondary research with identifiable materials
- Doing research with coded biospecimens and/or coded private information -When is human subject research?
Part 2 discuss how to address consent and HIPAA in a primary study when the investigator plans to share identifiable information for secondary research.
Investigators who watch the above videos should keep in mind that Exemption Categories 7 and 8 are not utilized at UCONN HEALTH.
Office of Human Research Protection (OHRP)
NIH Grants Conference in December 2022- Recording
The Office of Human Research Protection has made public the recording of a presentation provided last December 6, 2022 at the virtual NIH Grants Conference:
The presentation “ How Do I Know if a Research Study is Human Subjects Research and What Does that Really Mean? “ explains what makes a study “human subjects research” under the Common Rule, what responsibilities that entails, and what flexibilities may be available to simplify review for human research protections.
This presentation explains in detail our UConn Health Human Subject Research Determination Form.doc definitions and provides examples of research determinations.
UConn Health IRB Polices Revisions
The following UConn Health IRB Policies have been updated with language related to the 2019 revised common rule:
- 20112011-007.0.pdf– Definitions Applied to Policies (3/16/2023)
- 2011-006.2.pdf– Additional Protections – Prisoners (3/16/2023)
- 2011-008.0.pdf– Informed Consent – Forms (3/16/2023)
- 2011-008.2.pdf– Informed Consent – Waivers and Alterations (3/16/2023)
- 2011-008.4 .pdf– Informed Consent – Short Form (3/16/2023)
- 2011-009.3.pdf– Institutional Review Board – Expedited Reviews (3/16/2023)
Personnel Changes at the HSPP/IRB
New Research Compliance Monitor in HSPP: After working at UConn Health for many years as a research associate/coordinator, Rebecca Burke has joined our team as Research Compliance Monitor for the HSPP. You can reach Rebecca at email@example.com and 860-679-3054.