HSPP- July-August-September, 2020- Newsletter

Informed Consent Process and Documentation

 One of the most important aspects of conducting non-exempt human subject research is obtaining the legally effective informed consent of the subject or the subject’s legally authorized representative (LAR) before involving the subject in the research.  Study personnel who will be obtaining consent should be familiar with the following IRB policies

  • 2011-008.0 – Informed Consent Forms
  • 2011-008.1 – Informed Consent Process
  • 2011-008.5 – Informed Consent, Providing and Obtaining Informed Consent

Exceptions to the above noted policies may be granted by the IRB if certain criteria are met.  Those exceptions are described in IRB policy 2011-008.2.pdf – Informed Consent, Waivers and Alterations.

The following section presents a general overview of a correct informed consent process and documentation of consent.  Examples of non-compliance with the process and documentation of consent are also provided.


Informed consent process and documentation:  

  • The consent process occurs in a private setting.
  • The consent process starts with a potential participant being given the opportunity to review the informed consent form and is followed by a discussion about the research.
  • The process is free of coercion or undue influence.
  • The process occurs under circumstances that provide the prospective subject, sufficient time to discuss, ask questions and consider whether or not to participate.
  • Once an individual has had all his/her questions answered and has had ample time to consider the information s/he decides whether or not to participate.
  • Unless documentation of consent has been waived by the IRB, the informed consent process is documented by use of an IRB approved informed consent form.
    • The IRB approved consent form must be signed and dated by the subject (or legally authorized representative) and the person obtaining consent.
    • All names, signatures and dates should be entered in the document on the same date and at the same time.
    • After the signatures are obtained the participant must be provided with a copy of the complete signed informed consent document.
    • Documentation of the initial informed consent process may be supplemented by notes in a research chart that indicate on-going discussions with the subject at subsequent study visits.
    • At the conclusion of the consent process investigators should provide a Research Participant Feedback form to the subjects.


Examples of Non-Compliance with the Consent Process

  • Consent for participation obtained from next of kin, spouse or other individual in a study that does not have IRB approval to obtain consent from a legally authorized representative (LAR).
  • Consent obtained from individual who is not part of the approved study team.
  • Research interventions occurred prior to obtaining consent.


Examples of Non-Compliance with Documentation of Consent

  • Consent form is not signed by the subject
  • Consent form is not signed by the person obtaining consent.
  • Dates of signature are either missing, incomplete or incorrect.
  • The original consent document is not retained.
  • Dates contained corrections, which obscured the original entry.
  • The most recent version of the approved consent form was not used when consent was obtained


Mayo Clinic Expanded Access Program (EAP) – Update

 On August 23, 2020, the US Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for convalescent plasma for the treatment of hospitalized COVID-19 patients. Click here for more information regarding the Emergency Use Authorization (EUA) announcement.  The Emergency Use Authorization (EUA) is currently active and represents the preferred means of administering convalescent plasma.

For additional information, please consult the US FDA fact sheet for health care providers, available at: https://www.fda.gov/media/141478/download

New patient enrollment in the Mayo Clinic EAP is not authorized after August 28, 2020.

Order of convalescent plasma under the Mayo Clinic EAP is not authorized after August 31, 2020.

Participating sites are required to complete data follow-up forms for all patients enrolled in the Mayo Clinic Expanded Access Program (EAP).

 Please visit our website for additional information:https://www.uscovidplasma.org/


Expanded Access for Treatment Use, Including Single Emergency Use – IRB Policy Update


Uconn Health‘s Human Subjects Protection Program (HSPP) policy 2011-022.2.pdf – Investigational Drug/Biologic – Expanded Access for Treatment Use, Including Single Emergency Use  has been revised.  This revision is to inform clinicians who intend to use the Expanded Access Program in a single emergency case that if time permits, prior to the emergency use, the prescribing clinician should complete an application for expedited review in the iRIS submission system.  The application in iRIS -Section 1, should indicate the type of research as: “Expanded Access –Single Patient.”

Within the online application the clinician must also describe his/her intent to utilize an investigational drug for a therapeutic reason at least 24 hours prior to the planned date of the first administration of the drug.  In addition, an email notification should also be sent to a Regulatory Specialist (RS) within the office (IRB contact information available at http://research.uchc.edu/rcs/hspp/) to alert the IRB of the situation such that the submission can be prioritized for review.

If prior review is not possible, the submission in iRIS is to be made within 5 business days of the drug administration.

Expedited review may be requested also for a single patient COVID-19 Expanded Access request for which a waiver of the requirement for full board review has been granted by the FDA in accordance with the FDA guidance that review by the IRB Chair or designee is sufficient.

The documents required for an Expanded Access Expedited submission are described in detail in the new published Application Checklist – Single Patient Expanded Access .docx


IRB Forms – Update

 The Application Checklists have been updated to reference when additional approvals from I.T. may be required to ensure that data security measures are adequate.

The application checklists for Exempt status, Expedited review, Full board review and Facilitated review, now include the following requirement:

If Institutional standards for data security, inclusive of standards for use of data encryption, are not being used on all devices (e.g. desktop, laptop, thumb-drive, other mobile devices) used to store/transfer data, approval from I.T. for use of alternate data security plan.  Contact Carrie Gray with questions (860) 679-2295, cagray@uchc.edu.  If not provided the IRB application should indicate data encryption is being used and implies Institutional standards are being followed.

The Initial Application form in iRIS now contains this note:  Study personnel must be aware of and comply with relevant IRB policies and institutional policies for data security. Links to IRB and UConn Health policies are available from the HSPP website at https://ovpr.uchc.edu/services/rics/hspp/policies/ and https://ovpr.uchc.edu/services/rics/hspp/policies/uch-policies/

Institutional data security standards, inclusive of standards for use of encryption, must be followed unless approval from I.T. to deviate from Institutional standards is obtained.  Contact Carrie Gray with questions (860) 679-2295, cagray@uchc.edu

 The Main Consent Form Template .doc  has been revised to include text in the sections regarding confidentiality for studies that use the medical record.  This was added because of the ability to share EMRs across institutions.   New submissions must use the latest revised consent form template. Approved studies are not required to change their consent forms.  The revision to that section includes that any clinical/provider that subjects see, whether at UConn Health or elsewhere, may potentially have access to the information in their medical record.


New FDA Guidance for Civil Money Penalties for ClinicalTrials.gov- Non-Compliance


On August 14, 2020, the Food and Drug Administration (FDA) published new guidance titled “Civil Money Penalties relating to the Clinical Trials.gov Data Bank.” The guidance clarifies how the FDA identifies whether responsible parties have failed to submit required clinical trial registrations or results to ClinicalTrials.gov, or knowingly submitted false or misleading information, and details the applicable fines, including “$10,000 for each day that the violation continues” and potential civil or criminal penalties.

Applicable clinical trials include those evaluating at least one drug, biological, or device product regulated by the FDA.

If your NIH-funded study involves human subjects, you can use the NIH decision tree to determine if it meets the NIH’s broad definition of a clinical trial and will therefore require registration and results posting.

For more information about ClinicalTrials.gov, including assistance with registration, please contact Research Compliance Monitor, Ellen Ciesielski at eciesielski@uchc.edu