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.
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
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.
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.