HSPP Newsletter – July, August, September, 2023

 

Quality Improvement (QI) Projects  & Human Subjects Research

    

When a project is planned with a goal of improving the performance of a departmental practice in relationship to an established standard, the activity is called quality improvement (QI).

Most quality improvement projects are not subject to the Department of Health and Human Services (HHS) regulations- the common rule. However, in some cases, quality improvement activities are designed to carry out a research study. In these cases, the regulations for the protection of subjects in research may apply.

To determine whether a quality improvement activity is also a human subject research project, the following questions should be addressed in chronologic order:

• Does the activity involve research?
• Does the research activity involve human subjects?
• Does the human subject research qualify for an exemption?

If the answer to the first or second question is no, the activity is only a QI project.

If the answers to each of the first two questions is yes, then the QI project is considered a human subject research project. The third question will be to determine whether your study will qualify for exempt status. If the research does not appear to qualify for exempt status, you will need to determine if it qualify for expedited or full board review.

If an investigator is not sure as to whether a QI project is also human subject research, it is recommended that a Human Subject Research Determination Form.doc be submitted to the IRB to obtain an official ruling before the activity commences.

When investigators submit a determination form, the IRB will evaluate multiple factors to make a determination. Some of the factors to be considered include, but are not limited to: the primary intent of the project.  The IRB will consider the QI project a research study when the primary intent of the project is to produce generalizable results, or when the project will impose risks beyond the standards of care, and/or when the project includes randomization.

As an example of IRB considerations, the table below describes the IRB questions to determine whether an educational project is only a QI project.

When a QI project in an educational setting is part of a formal curriculum and participation in such project is not a choice, the activity will be considered only QI as long as the results of the project will only be shared with the program/department implementing the QI project.

On the other hand, when a QI project in an educational setting is not part of a formal curriculum and participation in such project is voluntary, the activity will be considered human subjects research as long as the results of the project will be shared outside of the institution implementing the QI project.

 

Guidelines for Determining Whether Educational Activities                                                  are Quality Improvement Projects or Exempt Research
	QI	Exempt Review
Is the educational activity  part of the formal curriculum (i.e., it would be offered/required regardless of the evaluation)?	Yes	No
Is the activity designed to continuously improve the quality of an educational offering?	Yes	No
Is there an intent to share the results beyond that department/program that is offering the educational activity?	No	Yes
Is participation in the evaluation of the educational activity voluntary?	No	Yes

If investigators self-determine that IRB review is not necessary for a proposed project, they need to know that IRB approval cannot be granted retrospectively.  In addition, federal regulations have made it clear that any publication describing a project as “research” must have received prior IRB review and approval.

 

Example of a Quality Improvement Project

At the time of patient registration existing hospital policy requires data points A, B and C to be collected.  The patient registration center implements use of a registration template form to improve collection of data points A, B, and C.  Six months later the patient registration data is analyzed to see if use of the form improved collection of the required data points.

 Research Consideration: there is no hypothesis or experimental question being asked so the definition of “systematic investigation” is not met and therefore the definition of research is not met; and the intention is to improve compliance with an existing and accepted policy not to contribute to generalizable knowledge.

 HIPAA Consideration:  HIPAA allows for conducting quality assessment and improvements activities related to health care operations provided that the obtaining of generalizable knowledge is not the primary purpose.  The minimum necessary information should be used.

To learn more about how the DHHS views quality projects in relation to the regulations for human subjects research please click on Quality Improvement Activities FAQs | HHS.gov

 

 

Human Subjects Protection Training through the Collaborative Institutional Training Initiative (CITI)

Frequently Asked Questions

 

 

I am submitting an application for Exempt Status.  Do I need to complete Human Subjects Protection Training? If so, why?

Training of study personnel is required regardless of whether the research qualifies for exempt, expedited or full board review, or whether the facilitated review process is utilized.

 

 I am a new UConn Health investigator.  What is the CITI Training I should complete?

All key study personnel listed on an IRB application for either an initial submission or a request for modification must have a current/valid training in the protection of human subjects.

Investigators who are completing human subjects training for the first time should first select the user group most applicable to the type of research with which they will be involved.  Prior to enrolling in any CITI Training course, the Investigators should respond to the CITI course enrollment questions within the CITI program also posted in the IRB website page.

UConn Health IRB Requirements for new investigator/new affiliated staff are as applicable:  the Basic or Refreshment course of (1) Biomedical Investigators and Study Personnel, (2) Social and Behavioral Investigators and Study or (3) Students.

Investigators who are renewing their training, can select the Good Clinical Practice course to satisfy the requirements.

 

 I am adding an external investigator to my study. Does he/she needs CITI Training? If so, what is the training course this investigator should complete? 

As per IRB policy 2011-023.0.pdf – Educational Requirements, if an investigator is external to the UConn Health, they must submit proof of having completed human subjects protection training.  These certificate can either be sent to cagganello@uchc.edu or be attached to the submission.  The Training certificates submitted will be evaluated by the IRB staff to verify that the courses completed are the required by UConn Health IRB.

The IRB reserves the right to require the external investigator to complete additional training.

 

 I completed my CITI Training a while ago, how can check if my CITI Training is up to date?

The IRB has a webpage dedicated to Human Subjects Training. Investigators or coordinators in need of checking CITI Training status for themselves of others may access the master training list.xlsx (Excel) which is updated approximately every two weeks.

In addition, investigators iRIS account are updated within 1-2 weeks with the CITI Training Reports.  To check the status of your CITI training in iRIS you can complete these steps: Click on “My Assistant” Menu, and then click on “My Account Information” sub-menu.  Go to the menu titled– Training History.  You will be able to see your Courses Completion and Expiration date.

 

I would like to complete a refresher course in the CITI Program.  However, the system prompts me to complete a Basic course.  What can I do to complete a refresher course? 

You need to complete the course that is due according to your previously completed course work.   The CITI Program has been set to require the users to complete a refresher course only when the last completed course of the chosen group was a Basic course.  This is required because the information in the modules is updated constantly and a basic course is the only venue to learn the new information. See example of a course completion history below.

 

 

Integrated Research Information System (iRIS)

Frequently Asked Questions

 

Who needs to request an account to access iRIS?

Investigators with an email address ending in ——@uchc.edu should not request an account in iRIS since they already have an account in iRIS.  These investigators are considered internal investigators. As stated in the iRIS logging page the investigator’s UConn Health network username and password are to be used to log in to iRIS.

On the other hand, individuals who need access to iRIS but are not affiliated to UConn Health /do not have an UConn Health username and password (e.g., a Hartford Hospital clinician) need to request an account in our iRIS system.  An online request form must be completed by clicking on the Request New Account option found in the iRIS logging page.   To avoid inaccurate information this online request form should be completed by the person in need of the account.

 

I need to add an UConn Health investigator to my study.  However his/her name is not found in the iRIS data base.  Should this investigator request an account in iRIS?

 As stated in the previous FAQ, internal investigators do not need to request an account in iRIS.   You can search for the investigator’s name either in the iRIS database or in the LDAP directory.

The iRIS data base contains the names/accounts of investigators who have logged into iRIS at least once. If the internal investigator you are trying to add has never before logged in to iRIS, his/her name/account will not be found in the iRIS database.

The LDAP directory contains names/accounts of those investigators who have not logged into iRIS ever.  Therefore, when you are trying to find the account of an internal investigator you should search in the LDAP directory.

 

I am having trouble logging into iRIS.  Can I retrieve my iRIS logging credentials from the iRIS submission system?

If you are an Internal Investigator, iRIS does not storage internal users passwords.

Your current network ID and password should allow you to gain access to the system.  If you know your password is active, go to https://imedris.uchc.edu and use your network ID and PW to log into IRIS (use the same ID and PW you use to access your UConn Health email account).

If you are still experiencing problems using your UConn Health credentials, please contact the UConn Health help desk at 860-679-4400.

 

 If you are an External Investigator, and you do not remember your iRIS ID, send an email to cagganello@uchc.edu requesting your iRIS ID.

If you need to retrieve your password follow click on the “I forgot my Password” tab found in the iRIS logging page.  Enter your iRIS User ID in the box provided. Then click on the “Send Password” tab. The IRIS system will send your password to the e-mail address found in your iRIS account.

If you are still experiencing problems using your credentials, please call 860-679-8802 or email cagganello@uchc.edu

 

I am an external investigator with an account in iRIS.  I need to change the email address in my iRIS account.  How can I do that?

To edit the email address noted in your iRIS account you will need to log into your iRIS account.  Once you have logged into iRIS, complete the following four steps. Click on “My Assistant” Menu, then click on “My Account Information” Sub-menu.  The system will open your Profile.  In there you can edit your email address.  To save the changes, click on the Save Section icon.

Investigators can also download the External Users- iRIS User Manual’s Instructions to Change Your Password & Email address from the iRIS help icon found in their iRIS Homepage.

 

 

U.S. Federal & Drug Administration (FDA) Warning Letters

 

FDA warning letter to Angela M. Stupi, Clinical Investigator

The investigator was cited for failing to ensure the investigation was conducted according to the investigational plan [21 CFR 312.60]

Failure to ensure that subjects met eligibility criteria before enrollment in the study.

Failure to ensure that the study drug was administered to subjects in specific body locations as required by the protocol

The warning letter also goes over how the clinical investigator’s written response did not provide sufficient details about their corrective action plan.

 

FDA warning letter to Randy Epstein, Clinical Investigator (Sponsor)

The investigator was cited for conducting research on an investigational drug without an IND, as well as failure to maintain adequate records showing the receipt, shipment, or other disposition of the investigational drug.

The warning letter goes over how the clinical investigator’s written response did not provide adequate corrective action plans.

 

FDA warning to Mobeen Mazhar, Clinical Investigator

The investigator was cited for failing to ensure the investigation was conducted according to the investigational plan [21 CFR 312.60], and failure to obtain informed consent in accordance with the provisions of 21 CFR part 50 [21 CFR 312.60 and 21 CFR 50.20].

 

 

Educational Resources for Investigators

Office of Human Research Protection (OHRP) Webinars on 45CFR46

 

The Office of Human Research Protection has posted the following webinars recordings and slides:

Respecting Persons- From Basic Requirements to Embracing Participant- Centered Informed Consent 

This presentation reviewed ethical principles, discussed regulatory requirements for informed consent, and offered strategies to develop high-quality, participant-centered informed consent documents and discussions.

View Slides – PDF

View Recording

 

Unlocking the Mysteries of the §46.111 Criteria for IRB Approval of Research

 This presentation explains the criteria for IRB approval of research and includes case studies and interactive quizzes to demonstrate the way the criteria can be applied.

Access Video here

View slides – PDF

 

Doing Research with Data and Biospecimens under the Common Rule Part 1 – What Researchers should know

This presentation explained how the Common Rule applies to secondary research with data and biospecimens.

View Slides – PDF

View Recording

 

Doing Research with Data and Biospecimens under the Common Rule Part 2 – How Does that work with Repositories and Future Use

This presentation explained how the Common Rule applies to research repositories.

View Slides – PDF

View Recording

 

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 irb@uchc.edu.

 

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 irb@uchc.edu 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.

 

Study Closures

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 burke@uchc.edu and 860-679-3054.