Research during COVID – Research Activity Level 3
As you are aware ̽̽/̽̽MC is at Research Activity Level 3 as February 1, 2021. More information and updated screening tools can be found on the IRB COVID-19 Information page.
Research Not Involving Human Subjects – New Researcher Self-Determination Tool
The Committee is excited to roll out a new Qualtrics survey tool that researchers may use to make their own determinations of a specific type of research. Research that does not involve human subjects, as defined by the regulations, does not require IRB review. These forms are no longer submitted through ̽̽Click.
Who is a human subject?
Under regulation 45 CFR 46.102(e), the definition of a human subject is
(1) Human subject means a living individual about whom an investigator (whether professional or student) conducting research:
(i) Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or
(ii) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.
If the research includes human subjects, the project requires prior IRB review and approval.
Who is not a human subject?
The regulations do not provide a definition, but these are common scenarios where individuals are involved in research, but their involvement does not fit the definition of a human research subject.
Decedents: Definition of human subject includes the requirement to be “living individuals”.
Individuals Not Readily Identifiable: De-identified data (HIPAA identifiers removed, code may exist but cannot be derived or related to information about individual, cannot be translated to identify individual; and covered entity does not use or disclose the code or the mechanism for re-identification) and individuals who are not readily identifiable are not human subjects. A dataset may contain HIPAA identifiers but might still not be readily identifiable. For example, data obtained from the PHIS dataset or Medicaid is not considered readily identifiable even though there are birth dates because the data comes from the entire nation.
Inanimate Objects: The subject of the research could be about institutions, programs, or hospitals and not about the individuals who are in those programs. For example, a survey could inquire about a training program, hospital or other institution and requiring information that doesn't contain information about individuals. In this case, even though a person fills out the questionnaire, the research is not about them as individuals – it is about the program in which they work.
The new survey tool is very short and provides an email certificate of determination for your records or for any requests for documentation from sponsors or journals. The survey data will be kept by the IRB for quality assurance purposes.
Educational Opportunities
The March 16th IRB on-line presentation, “Obtaining and Documenting Informed Consent of Non-English Speaking Research Participants,” is available here.
The IRB has developed a new checklist for researchers to assist with development of research protocols. This checklist includes information necessary for IRB review. If checklist items are missing or not fully developed within the submitted protocol, the IRB is unable to make its determinations. Inclusion of the checklist information will ensure the criteria for IRB approval for research has been met. A well-developed protocol, with this information included, will facilitate a smooth and timely IRB review and approval process.
IRB Policies and Procedures Update
This is the quarterly summary update of the IRB Policy and Procedure document. The following sections have been altered with minor changes, unless otherwise noted.
1.1 Introduction to the Boards
3.5 Research Not Involving Human Subjects (updated with new self-determination tool)
6.0 Conflict of Interest (revised to address updated ̽̽ COI Policy)
8.1.1. Elements Found in a Standard Protocol (recruitment moved to separate section)
8.1.3 Plans for Recruitment/Screening/Retention (split from section above)
8.1.4. Participant Compensation
8.10 Research Conducted in Public Schools (new)
10.5 Student Educational Records (removed and moved into new section 8.10)
11.0 Certificates of Confidentiality
14.6 Fees for Committee Review (review fee for exempt projects supported by industry)
15. Modification to Previously Approved Protocol (criteria to determine amendment vs new protocol)
18.0 Reportable New Information (includes unanticipated problems and adverse events)
24.2. Research Involving Prisoners – Subpart C
24.4 Non-English-Speaking Individuals Participating in Research
Form Changes/Consent Template Updates
- Exempt Application forms were all updated to remove redundancies to ̽̽Click-IRB questions
- Not Human Subject Determination form removed and replaced with Self-Determination Tool
- ̽̽ Local Context Document when relying on another institution
- Modification to Medical and Behavioral Consent Templates to include
- Revised Certificate of Confidentiality language
- Revised Financial Conflict of Interest language
- Inclusion of language that addresses access to MyChart when participant enrolled in single-blinded protocol
̽̽Click-IRB Quick Tip
Modification descriptions should be specific to the modification and should not include other unrelated comments. This is necessary as the description is automatically included within the modification approval. Unrelated comments meant for IRB analysts should be placed as a comment on the workpage.
̽̽MC Corner
Data Management Office (DMO) - Update
The DMO has posted a new version of the Research Data Request Form. It is now called the DMO Template Research form and is a required supplemental document for all research data requests to the DMO going forward. Researchers may find information and the form here on the . Please contact Elizabeth.Carter@̽̽Health.org with any questions.
Investigational Drug Services (IDS) - Policy Pharm3
̽̽MC is updating its current policy to require feasibility review by IDS of all protocols that include investigational drugs or approved drugs used in an investigational manner. For this feasibility review, researchers will submit their protocols in ̽̽Click-IRB. Upon receipt, your IRB Analyst will assign a pharmacy ancillary review and await the decision prior to beginning review or adding to a Committee agenda.
Also new to the policy is information and processes regarding the ̽̽MC Infectious Disease Practice Committee (IDPC). The IDPC is a subcommittee of the Pharmacy and Therapeutics Committee focused on antimicrobial stewardship within the hospital. IDPC review is required for any protocol that involves antimicrobials prior to IRB submission in ̽̽Click-IRB. Researchers must submit the protocol to the IDPC co-Chairs who will review and provide either an approval or denial of approval to conduct this work in the hopsital.
Questions about these updates should be forwarded to Michele.Corriveau@uvmhealth.org.
From the Office of Clinical Trials
COVID-19 Updates
Considering the constantly evolving guidance from the CDC, VDH and medical and research leadership at ̽̽, LCOM, and ̽̽ Medical Center, please be sure to check on the most up-to-date research related policies on the OCTR Commons Page.
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Our current COVID-19 Screening tool (accounting for COVID-19 vaccination status) can be found using the link above, listed under Research Participant Communications.
̽̽ Health Network Research 3 – “Informed Consent/HIPAA Authorization and Confidentiality Requirements”
The policy was updated to include language regarding Electronic Consent (eConsent) and to clarify that if a study meets the Joint Commission’s definition of a clinical trial, “a clinical trial is defined as an experimental study in which research subjects are recruited and assigned a treatment/intervention and their outcomes are measured based on the intervention received,” then a copy of the executed consent form is required to be uploaded to the patient’s medical record.
Instructions on how to include a signed consent form into a patient’s Epic record can be found under the “How to” column on our Commons site.
21st Century Cures Act – Starting April 5
On April 5, ̽̽ Medical Center Electronic Medical Record patient portals will default to releasing notes and reports upon completion with very limited exceptions. The , which is a federal law, requires the immediate release of inpatient and outpatient progress notes, laboratory, radiology and pathology reports to the patient’s Electronic Health Record portal.
ACTION REQUIRED – Related to your research: The research team needs to think about data that is included in your notes or notes of your colleagues that may inadvertently unblind or effect the integrity of the research being conducted. Examples of studies that may be affected are, surgical interventions or device studies, the OP note would need to be individually identified as a note that should not to be shared in the patient’s Electronic Health Record portal “My Chart”, or lab results (PK) or other testing, and radiology reports that denote specifics of a device that was placed, etc.
Local guidance regarding this change can be found on the OCTR Commons Page – 21st Century Cures Act
Reminder - Mandatory Research Staff Training – August 2021 Deadline Approaching
The Larner College of Medicine, in conjunction with The Office of Clinical Trials Research, is requiring that all research staff engaged in at LCOM and the ̽̽ Health Network complete LCOM Research Professionals Training, Fundamentals in the Conduct of Clinical Research Training Program. This requirement applies to all research staff who are involved in the conduct of research involving human subjects, irrespective of funding source supporting the research activity (which includes, but is not limited to; Research Coordinators, Research Nurses, Research Health Care Professionals and Regulatory Staff or individuals fulfilling these roles).
Researchers are required to ensure that all members of their research team are compliant with this institutional requirement. For new employees, the deadline for compliance with this requirement is prior to the end of their probationary period. Current research staff were given a year within which to complete this required training, which was announced in August 2020 and provided a deadline of no later than 08/01/2021.
To date we have conducted nine sessions engaging a total of 86 participants. Our next scheduled session will be in May. .