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

 

HSPP- April- May-June, 2020- Newsletter

The Integrated Research Information System (iRIS ) is the electronic system used by research personnel and the Institutional Review Board (IRB) for the submission and review of research projects involving human participants.  On March 21, 2013, iRIS was successfully implemented.   To support said implementation, one on one training of researchers as well as weekly group sessions were carried out.  These training sessions are still available to all investigators as are iRIS-training manuals.  To schedule a training session e-mail Mayra Cagganello (cagganello@uchc.edu). To obtain a training manual click on the Help button found in your iRIS Homepage.

This present Newsletter has been prepared to address the most common and current difficulties observed when investigators navigate the system.   In the majority of the cases, these difficulties have caused delays in approval.   In addition to the training options noted above, it is highly recommended that all iRIS users read this newsletter to increase knowledge of the system thus preventing delays in approvals.

 The Most Common Mistakes with Revisions of Documents in iRIS

 

Once a submission is received by the IRB in iRIS, an IRB Regulatory Specialist (RS) conducts a  pre-review of that submission.  If the RS determines that corrections or additional documentation is needed before the submission can be formally reviewed by the IRB, the RS will return the submission to the study team either in a Submission Correction Form or in a Submission Response Form describing the corrections that are necessary.

 

The following section describes the major issues observed when investigators are submitting revised documents in the above mentioned submission forms.

Issue #1: Investigators upload revised documents to the system section for Protocol items rather than to the Submission Form .

The corrections requested must be made within the Submission form sent by the IRB (e.g., the Submission Correction Form or the Submission Response Form).  The IRB does not have access to your Study’s Protocol items. The IRB will only see and review documents uploaded/attached to the Submission Forms.

 

Issue #2: Investigators upload edited documents to the Submission Form as brand new documents instead of creating an iRIS revision.

If a contingency requires you to revise a document that you have submitted in previous rounds, you should follow the steps found in the iRIS User Manuals to revise the documents that are in the system.

• If you have received a Submission Correction Form, please use the instructions found in the iRIS User Manual titled:   Responding to a Correction Task- Manual 3.
• If you have received a Submission Response Form, please use the instructions found in the iRIS User Manual titled:   Responding to a Response Task – Manual 4.

 

 

iRIS Sign –off Notifications

 Once a submission form has been routed for sign off, the iRIS system generates emails to notify the research team members and principal investigator that they need to log into iRIS and apply their sign off.

Depending on whose signature is required, the e-mail sent to the study team members will have a different message.

Below are two possible messages the study team can receive when sign off are required. The subject line of the notification indicates who needs to sign off.

• A “Protocol Sign-off Notification” is sent to all members of the study team with a subject line stating:  Member of Research Team – Initial Notification for Review and Signoff.  In this case, all members of the study team need to log into iRIS and sign off (e.g., an initial submission application form).

The body of the email will specifically state that the study is in need of signatures from one or more team members of the team in order to continue the submission process to the IRB.

 

 

• A “Principal Investigator Signoff Notification” is sent to all members of the study team.
• However, the subject line indicates that this is a Principal Investigator Signoff Notification.  In this case, the submission has been routed only to the Principal Investigator for sign off (e.g., a Response form, an initial Modification Form, Continuation Form, Problem Report Form, and Closure Form,).  Even though the PI sign off is the only one required, all study team members receive the notification so that they are aware that the PI needs to do so.

 

The body of the email will state PI Signoff Needed.

Investigators should review the content of the notifications to determine whether to log into iRIS to sign off.  Many investigators log into iRIS with the intention to sign off on a submission, however, their signatures are not required.

 

iRIS Frequently Asked Questions (FAQ)

Q: Who needs to request an account to access iRIS?

A: If you are affiliated to UConn Health (e.g., if you are a student, a resident, a fellow, a faculty member, or staff), by virtue of said affiliation you already have the ability to log in to iRIS.  Your UConn Health network’s credentials are to be used to log into iRIS.

 

Individuals who are external to UConn Health (e, g., a UCONN Storrs student or faculty, a Hartford Hospital physician, etc.) who need access to iRIS should request an external account in iRIS.   An online request form must be completed by clicking on the Request New Account option found in the iRIS logging page. The person requesting the account should provide an explanation as to why the account is necessary and with whom at UConn Health the researcher will be associated.

 

An email request to create an account in iRIS is not adequate to generate an account in iRIS.  The information provided in the on-line request form is necessary to build an account for an external user.  To avoid inaccurate information this online request form should be completed by the person in need of the account.

 

Q: I am unable to log into iRIS.  What should I do? 

A: Internal Users (Investigators Affiliated to UConn Health):  If you are having trouble accessing iRIS with your UConn Health network credentials, please try to verify the following prior to contacting the HSPP/IRB office:

• Your network credentials are case sensitive.  Check the basics such as cap lock or number lock issues.
• Ensure that your UConn Health password has not expired (you can test this by rebooting your personal computer).
• If you recently changed your password, please try rebooting your personal computer before logging into IRIS.
• Make sure you are not coping and pasting your credentials into the iRIS’s log in boxes.  Your user ID and password must be typed into the iRIS log in boxes.
• If you are still experiencing problems using your UConn Health credentials, please contact the UConn Health help desk at x4400.

External Users (Investigators NOT Affiliated to UConn Health):  If you are having trouble accessing iRIS with the credentials provided when your account was created, you do not need to request another account. Please, do the following:

• The iRIS accounts of external users are active for a maximum of an 18-month period.   If you have not used iRIS for a long time and you think your account has expired, send an email to Mayra Cagganello ( cagganello@uchc.edu ) requesting an extension of your account.
• If your account is active ( is not expired) but you forgot your iRIS User ID, send an email to Mayra Cagganello ( cagganello@uchc.edu ) requesting your iRIS User ID.
• If you know your iRIS User ID but can’t remember your password, you will need to retrieve your password from iRIS.  To do so, click on the “I forgot my Password” tab found in the iRIS logging page . Enter your iRIS User ID in the box provided, and 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 have tried to retrieve your password but have not received an email from iRIS with your password, it may be that your email address in your iRIS account is no longer valid.    If you  have a new email address, email your new email address to  Mayra Cagganello ( cagganello@uchc.edu ) with a request to update your email address in iRIS.

Q:  Who Needs to Sign off on Submissions in iRIS?

The table below explains:

 

Form	Who is Required to Sign
Initial submission form for a new study	All key study personnel identified on the application form, excluding those who are listed only as a contact person.
Correction form	Any member of the study team, most often the study coordinator.
Response form	The Principal Investigator (PI)
Continuation Form	The Principal Investigator (PI)
*Modification Form	The Principal Investigator (PI)
Problem Report Form	The Principal Investigator (PI)
Closure Form	The Principal Investigator (PI)
When only the PI is required to sign the form on the routing sign-off sheet, the boxes next to the names of the other key study personnel should be unchecked.   *When new personnel are being added to the study through a request for modification, they will be asked by the IRB to sign off as a contingency for approval.

When a Submission form is routed for sign off and other members of the study team are checked for sign-off, you should uncheck the boxes next to their names to deselect them as shown in the screen shot below.  Likewise, initial continuations, modifications, problem reports and closure forms only require the Principal Investigator (PI) sign off.  If other members of the study team are listed in the routing sign off sheet, you can uncheck the boxes to deselect their names .

 

Q: I am submitting a modification form to add new personnel to an approved study. However,   when routing the modification form for sign off I am unable to find the name of the new investigators in the Sign off Submission Routing list.

A: When a Modification Form is created in iRIS, such form works as a “request” made to the IRB.    Only principal investigators are required to sign off on an initial Modification Form.

When routing this form for sign off, the investigator working on the form will not find the names of the new personnel in the Sign off Submission Routing list.  This is because this request will be granted after the IRB has verified that the new personnel has complied with the human subjects protection training (e.g., CITI Training) requirement.    Moreover, the iRIS the system verifies whether the new added personnel has a valid iRIS account.

 

After the IRB staff and IRIS system have confirmed that the new personnel has met these requirements, an IRB Regulatory Specialist will add the names of the new personnel to the Key Personnel section of the study allowing the new investigator access to the study.

The IRB Regulatory Specialist then returns the Modification Form to the study team in a Correction Form with a contingency for approval.  The contingency will require that the new personnel sign off to accept his/her role in the study.   At this point, the study team working in the Correction Form will find the names of the new personnel in the Sign off Submission Routing list. 

  

Q: I routed a submission form to the IRB a while ago.  I have not hear from the IRB.   I see that the track location of the form states that is “Waiting for Finalization of Routing List.”  What should I do?

 A: In order for a form to arrive to the IRB queue in IRIS, the person submitting the form must complete several steps to route the form for sign off.   When all sign offs on the form have been completed, the system moves the submission form to the Submission box of the IRB in IRIS.

Whenever an investigator sees a yellow square under the “Track Location” that means that the form built in iRIS was never routed for sign off .

In the example below, the submission Correction Form is waiting for someone from the study team to route the form for signatures.

To route the form to the person who has responded to the contingencies, the following steps must be completed.  Begin by clicking click on the magnifier glass located on the yellow box under the Track Location.   Second, click on the “Routing Assignment List” (icon with the two heads).  Manually uncheck the boxes next to the names of the other members of the study team to deselect them.  Then, click on Save and continue twice.  If you are not the person who needs to sign off, log out. The submission will be in the iRIS homepage of the person whose signoff is required.

If you are the person who needs to sign off you will see the “approve” radio button.  Click on the approve radio button and enter your credentials to sign off.   Finally, click on Save to save your sign off.

 

Q:  How do I know if the IRB received my submission.

A:  Your  submissions forms are in the IRB inbox in iRIS when you see a green box under the Track Loction stating “Routing in Process.”

New iRIS users should use the iRIS User Manuals to ensure all the steps for routing submissions to  the IRB have been completed.

 

Office of the Vice President for Research (OVPR)

COVID-19 Guidance for the UConn Health Research Community

The Office for the Vice President for Research (OVPR) website has posted a COVID-19 Guidance for the research community at UConn Health.  Information about the impact and changes caused by the COVID-19 outbreak on research activities are described on this guidance.  Information on this web site is updated frequently.

 

 

IRB Policies – Revisions

 IRB Policy 2011-015.0. -Recruitment and Payment and policy 2011-011.0- Research Personnel have been revised to better outline the requirements and expectations for recruitment of UConn Health patients.  The policies denote, among other items, that the person who first approaches a patient about research participation must be someone with an existing treatment relationship with the patient and that members of the study team (e.g., principal investigators, co-investigators, study coordinators, consenters, etc.) interacting with the patient-participant must be affiliated with UConn Health (e.g. faculty appointment, employee, student, intern, volunteer).

If the study submitted for review has a Principal Investigator who is not a paid UConn Health faculty member, there must be a paid faculty member from UConn Health as a co-investigator on that study who is responsible for patient involvement.

  

IRB Forms – Update

The following forms have been revised:

• Consent checklist – Addendum for Genetic Research – This form was revised to clarify wording and to re-order the elements of consent.
• Main Consent Checklist – This form was revised to add elements for inclusion of any requirements imposed by a specific funding Institute, Office or Center within NIH related to data sharing (added in the NIH section of the checklist)
• Main Consent template – This template was revised to add instruction for investigators to check whether the funding entity has any specific requirements regarding data sharing language and if so to include it.    The NIAAA suggested language was provided as an example.

 

Connecticut Law Raises Legal Age to Buy Smoking Products to 21

 As of October 1, 2019, the State of Connecticut change the legal age for smoking from 18 to 21. UConn Health investigators who are conducting studies with tobacco products should review their studies and as needed revise them to comply with this new law in Connecticut.

 

 

NIH Update: Guidance for NIH-Funded Clinical Trials and Human Subjects Studies Affected By Covid-19

The National Institute of Helath ( NIH) has published the following guidance NOT-OD-20-087 outlining the flexibilities available to recipients impacted by COVID-19 for delays to ongoing research, delays to research progress for NIH-funded clinical trials and human subject studies, and unanticipated costs.

 

 

Disclosure Form for Work Submitted to Medical Journals

As stated by Darren B. Taichman, MD, PhD; Joyce Backus, MSLS; and Christopher Baethge, MD; et al, in their published article titled “A Disclosure Form for Work Submitted to Medical Journals.  : A Proposal from the International Committee of Medical Journal Editors” the International Committee of Medical Journal Editors (ICMJE) adopted the “ICMJE Form for the Disclosure of Potential Conflicts of Interest” as a mechanism for collecting and reporting authors’ relationships and activities that readers might consider relevant to a published work.

 

The ICMJE has proposed changes to this disclosure form to enhance transparency and accuracy in the information captured by this form. The ICMJE is requesting feedback about the proposed new form.  Comments received by April 30, 2020 will be consider for the finalization of the revised version.  The current ICMJE Form for the Disclosure of Potential Conflicts of Interest is available and downloadable in PDF at their website.  To enter your comments on the proposed form, please click here.

 

 

Recent Articles Published by Central IRBs

ADVARRA IRB:  

Key Biosafety Considerations for Coronavirus Research: This article provides an overview of the coronavirus and describe strategies for developing medical countermeasures to combat the recent outbreak.  A description of the opportunities, risks, and risk mitigation strategies for coronavirus are also discussed in this article.

Beyond the Regulations: More Considerations for Emergency Research: this article describes what the researchers and research organization must know about “Emergency Research.” The authors explain emergency research is only feasible if a plan is in place.  These plans include but are not limited to the establishment of a front-line staff communication plan, an evaluation of clinical operations, and a plan to respond to media inquiries.

 

Western IRB (WCG):

Your 5 Questions About Enrollment Assistants Answered: In this article WCG describes the services they provide through “Enrollment Assistants” (EAs) for recruitment, and enrollment in clinical studies.  Mark Summers, president of patient engagement from WCG addresses the following questions: (1) how can a person from outside the study team legally work at a site? (2) How accepting are sites of EAs–especially sites that have never worked with one? (3) Are EAs trained onsite or by WCG Three Wire? (4) Would an Enrollment Assistant be more beneficial to, say, a large academic center than to a small standalone research site? (5) How do you keep track of your enrollment performance metrics?

COVID-19 Preparedness for Health Care Institutions: Insights Paul Biddinger, MD and Scott Gottlieb, MD:  This article is a summary of takeaways and key points from the March 13, 2020 webinar sponsored by WCG.

 

 

 

Regulatory Framework for Research with Mobile Applications

 

The following information was drawn in large part from the CITI Program’s module titled “Mobile Apps and Human Subject Research.” The content of this module is copyright.  Uconn Health obtained permission to use this module from the CITI Program.

A mobile application (mobile app or app) is a type of application software designed to run on a mobile device, such as a smartphone or tablet computer.  Medical mobile apps (MMAs) are medical devices that are mobile apps, meet the definition of a medical device and are an accessory to a regulated medical device or transform a mobile platform into a regulated medical device.

Research with apps may be subject to multiple federal regulations such as 45 CRF 46 (The Common Rule), the U.S. Food and Drug Administration (FDA) regulations (including 21 CFR 11), and the Health Insurance Portability and Accountability Act (HIPAA) rule.  Specifically, the FDA regulates mobile health technologies that meet the definition of a medical device.  When a covered entities or business associates use software and mobile applications store or transmit protected Health information (PHI) this falls within the jurisdiction of the Office of Civil Rights (OCR) under the Department of Health and Human Services (HHS).   Researchers may use the information provided on the FDA website to determine if an app meets the definition of a medical device regulated by the FDA. Researchers may use the interactive tool developed by the Federal Trade Commission (FTC), in conjunction with HHS, the Office of the National Coordinator for Health Information Technology, the OCR, and the FDA to determine which laws apply to mobile health applications

 

When using apps in research investigators should consider the following points:

• If Consent occurs via an app the investigator should be aware that the consent document must contains all the required elements required by the Common Rule. The risk of hacking posed by the electronic consent is to be described in the consent document.
• The requirements of the IRB for an electronic informed consent process are described in the IRB Policy #  2011-008.1.pdf – Informed Consent – Process –page 4.
• Ample time to contemplate participation and ask questions will also be applicable to electronic consent, therefore  app-based consent should contain a functionality to satisfy this requirement described in the IRB Policy # 2011-008.5.pdf – Informed Consent – Providing and Obtaining Informed Consent  
• Because mobile apps may use, collect, store, and share data, researchers should communicate the risks of the mobile device security to the subjects and the measures in place to minimize the chance of a breach of confidentiality.   If a mobile app is being used to collect protected health information the researcher must obtain an assessment from UConn Health’s I.T. department that the app is HIPAA compliant.

  

• The “Terms of Services” (TOS) and/or “End-User License Agreements” (EULAs) associated with the mobile apps, and devices are between the user and the service/provider, not the user and the researchers.  Agreeing to TOS/EULA is different from consenting to participation in research. These agreements may require review by the IRB because they are materials for the subjects, and may include information that would affect a subjects’ decision to enroll in a study.  Differences between these documents and the consent form should be communicated to the subject.

 

• When the research may result in collection of incidental data (e.g. use of a mobile fitness app), the researchers must indicate to the IRB what incidental data they may collect, and if this data will be disclosed to subjects.  In addition, investigator should clarify whether they will keep that data and if so provide the plans to protect that data.

 

UConn Health Institutional Policy for Mobile Devices &  Consequences of Non-Compliance with HIPAA Rules

 According to UConn Health Institutional Policy # 2008-03 –  Mobile Computing Devices (MCD) Security, confidential or restricted data is not authorized to be stored on either a UConn Health or non-UConn Health Mobile Computing Devices ( MCDs) unless all the criteria below are met:

 

1. The device stores only the minimum data necessary to perform the function necessitating storage on the device.

 

2. Information is stored only for the time needed to perform the function.

 

3. The device requires a password for access and is encrypted using methods authorized by the UConn Health IT Department.

 

In addition, users may not bypass or disable UConn Health required security mechanisms, and unauthorized physical access, tampering, loss or theft of an MCD must be reported to UConn Health Public Safety.

 

Failure to adhere to this institutional policy and associated procedures may result in sanctions as per applicable UConn Health policy.   Failure to adhere to this policy could also lead to monetary fines imposed by the Office of Civil Rights  should a breach occur.  For example, the University of Rochester Medical Center ( URMC) filed a breach reports with the Office for Civil Rights (OCR) of the U.S. Department of Health and Human Services (HHS) in 2013 and 2017 following its discovery that protected health information (PHI) was impermissibly disclosed through the loss of an unencrypted flash drive and theft of an unencrypted laptop, respectively.  To settle the violations of the Health Insurance Portability and Accountability Act (HIPAA) privacy and security rules, the URMC agreed to pay $3 million to the Office for Civil Rights and follow a corrective action plan.  A description of their corrective action plan and the two years of compliance monitoring have been posted in the HHS website.

To learn the provisions/controls defined by UConn Health IT Security when using institutionally owned devices or personally owned devices and the MCD’ user responsibilities, please review the Mobile Computing Devices (MCD) Security Institutional Policy # 2008-03.

  

Clarifying the CDA Process: A  Researcher’s Guide to Handling Confidentiality Agreements

 By Dr. Cherron Payne, Esq.

  

Introduction

The administration of a research study may be an arduous process for researchers and staff.  Moreover, the legal aspect concerning research agreements may also be equally perplexing. Thus, this article is intended to clarify the proper procedure for handling confidentiality agreements.

 

Confidentiality Agreements

 The nomenclature of confidentiality agreements is varied; some agreements are called confidential disclosure agreements, non-disclosure agreements or NDAs, and mutual disclosure agreements.  Although the title of the agreement may vary, the agreement serves the general purpose of protecting the confidential information that is disclosed by research sponsors. Confidentiality agreements will hereafter be referred to as a “CDA”.

 

Before a study commences, the sponsor needs to disclose information for the researcher to evaluate his or her interest in the study.  The disclosed information is often confidential because it contains proprietary information or trade secrets often in the form of models, prototypes, notes, diagrams, documents, reports, memoranda, and other forms of intellectual property. Therefore, it is imperative that researchers manage confidential information in accordance with the terms and expectations of the CDA.  A researcher’s failure to properly safeguard confidential information may impose serious legal ramifications upon UConn Health.  Moreover, breaching the terms of a CDA, or improperly disclosing confidential information, may also cause study sponsors to cease sponsoring UConn Health’s research.

 

Procedural Steps for Researchers

 In order to avoid legal pitfalls, there are specific steps that a researcher or principal investigator “PI” must follow when a confidentiality agreement is received.

1. The PI should first e-mail the CDA to the proper contract specialist.  The PI should also e-mail the research sponsor’s contact information to the contract specialist.  If the researcher is uncertain as to the appropriate contract specialist, then the researcher may contact Sponsored Program Services at 860-679-4040, by e-mail at sps@uchc.edu, or by reviewing the website of the Office of the Vice President for Research at   https://ovpr.uchc.edu.  The PI should never sign a CDA or agree to its terms without a contract specialist negotiating the agreement.
2. If a PI receives a research study agreement without receiving a CDA, the researcher should (a) ask the study sponsor to send a CDA or (b) ask the contract specialist to request the CDA. The study agreement should not be negotiated before the CDA has been negotiated and signed.
3. While negotiating the CDA, the contract specialist may have questions for the researcher or may require additional information. Researchers must furnish said information in a timely manner to avoid a delay in the negotiation.
4. After the CDA has been negotiated, it is sent to the principal investigator for signature.  The PI should read the agreement before signing, in order to be cognizant of the CDA terms and to properly safeguard confidential information.  If there are any questions regarding the terms of the agreement, a PI may ask the following contacts for clarification:  (a) the contract specialist, (b) the Director of Sponsored Program Services at hudobenko@uchc.edu, or (c) the Executive Director, Sponsored Program Services and Faculty Services at laura.kozma@uconn.edu.
5. After the CDA has been reviewed, the researcher signs the agreement and promptly returns it to the contract specialist.

 

When the contract specialist receives the fully executed CDA, a copy will be returned to the researcher or the research staff.  A fully executed copy of the CDA should be retained by the researcher to ensure compliance with the agreement.

 Recent Articles Published by Central IRBs

ADVARRA IRB:

Reporting to the IRB: What NOT to Report:  This article provides an overview of what the regulations do and do not say about IRB reporting requirements. 

Should Social Media Be Part of Your Research Toolbox?    This article discuss the benefits, the risk and the applicable regulatory requirement when using social media for recruitment and retention:

 

Western IRB (WCG):

 An Overview of the Recent SACHRP Recommendations Around Payments in Clinical Research The U.S Department of Health and Human Services Secretary’s Advisory Committee on Human Research Protections (SACHRP) has approved two sets of recommendations regarding payments in research.  The first set of recommendations identified a number of considerations for IRBs when evaluating the acceptability of incentives payments.   The second set of recommendations addresses those studies that ask potential research participants to bear some or all of the cost of the research.  SACHRP’s issued several questions prospective subjects and IRBs should ask when participants are required to pay for access to the experimental intervention.

 

How to Mitigate Placebo Response, Test, Train and Control Expectations in Analgesic clinical trials   This article discusses the importance of training patients to be able to report their symptoms more accurately and the importance of staff training.

 

IRB Forms – Update

The Pharmacy section of Appendix A.to the application and the application checklists have been revised to reflect the change in pharmacy contact to Jennifer Czerwinski, 860-679-2085, jczerwinski@uchc.edu

 The HIPAA Request for Alteration or Waiver of Authorization.doc was modified to allow a brief description of the PHI to be used/accessed with reference made to documents within the submission that describe the information in more detail.

 The HIPAA authorization form was revised to delete reference to the Office of Research Compliance as it is no longer a stand-alone office and to change reference to John Dempsey Hospital to UConn Health and to change HSPO to HSPP.

 The Human Subject Research Determination form was revised to provide more instruction regarding the attachment of documents related to the funding source of a project.

The instructions for reliance on ADVARRA IRB were revised to reflect changes to the consent language template and the instructions for reliance upon WIRB were revised to add reference to the site number assigned to UConn Health.

Why should I register my study on ClinicalTrials.gov?

• If you wish to comply with the ICMJE policy (followed by the BMJ, JAMA and many others journals) requiring registration as a condition of consideration for publication, you may voluntarily register your study with ClinicalTrials.gov. You must register prior to subject enrollment.

 

• If your clinical trial is NIH funded, in whole or in part, you are required to register the study and report results on ClinicalTrials.gov.

 

• If your clinical trial is funded by a Federal department or agency, the Revised Common Rule requires that your consent form be posted on a public platform, like ClinicalTrials.gov, after the trial is closed to recruitment, and no later than 60 days after the last subject visit.
• If your clinical trial evaluates at least one drug, biological, or device product regulated by the FDA (See this decision checklist for more details), regardless of funder, you are required to register and post results on ClinicalTrials.gov.

 

For assistance with ClinicalTrials.gov, see our webpages and contact UConn Health’s ClinicalTrials.gov Administrator, Ellen Ciesielski (860.679.6004) in Research Integrity and Compliance Services.

 

Research Advertisement Reminder

 

All methods and materials to recruit participants for research require IRB review prior to implementation. Please be sure all recruitment materials (e.g., text of announcement) are IRB-approved before submitting an announcement for publication.  Announcements must include IRB# and name of approving IRB (if not the UConn Health IRB).  For guidance, visit: UConn Health IRB  and  Guidelines for submitting recruitment announcements  

 

Managing Research Studies

 Managing research studies efficiently and effectively requires leadership, planning, collaboration, and communication.

The Principal Investigator (PI) is responsible for the overall management of an approved study. Management of a study encompasses the ethical, technical, administrative and fiscal elements of the research study.

The PI is responsible for ensuring that the research team is oriented to the protocol and aware of their responsibilities. The study team should have specific details about the plans to accomplish the goals and procedures of the study, inclusive of plans for recruitment, consenting of subjects, data and safety monitoring, and protections for privacy and confidentiality.

The PI is also responsible for ensuring that adequate resources are available to conduct the study, including equipment, supplies, and storage space at UConn Health and in any outpatient facilities. Prior to seeking IRB approval, the PI should communicate with the leadership of any ancillary areas that may become involved with the research to ensure the area can commit the necessary resources (e.g. staff, hospital beds, equipment etc.).

Communicating with appropriate areas to ensure resources are available and educating all members of the research team on their roles and responsibilities will help to ensure that the research is implemented in a safe and compliant manner.

 

Human Subjects Training- Educational Requirements

 

I completed CITI Training under my affiliation with a former institution.  Is that CITI Certificate valid at UConn Health?

CITI Training completed within the last three years may satisfy the UConn Health IRB requirements.  However, the IRB reserves the right to require that an individual complete additional modules.

The IRB encourages individuals who are new to UConn Health (e.g. a new student, new faculty member) to complete CITI training under their new affiliation with UConn Health. When completing modules under the new affiliation to UConn Health the CITI Program will provide credit for any overlapping modules completed under another institutional affiliation and will require completion of any modules that are specific to UConn Health requirements.

To affiliate one’s account in the CITI Program with UConn Health, individuals should log into the CITI program, and click on “Add Affiliation” listed under the “Courses” Menu.  To find UConn Health in the drop down box, the following words “University of Connecticut” must be typed.  Then, select “University of Connecticut Health Center”.  To complete the process, check the box next to the statement: “I AGREE to the Terms of Service for accessing CITI Program materials”   and check the box with the statement: “I affirm that I am an affiliate of University of Connecticut Heath Center.” Last, click on “Continue.”

To select the correct learning group and courses, follow the “Course Enrollment Questions” posted at  https://ovpr.uchc.edu/services/rics/hspp/citi-instructions/

 

I will be conducting a Clinical Trial at UConn Health.  Should I complete the “Good Clinical Practice (GCP)” course?

It depends on whether or not the clinical trial is supported by the National Institutes of Health (NIH). The GCP training is a requirement if the clinical trial is an NIH funded trial.  The Human Subjects Protection Program/IRB strongly encourages researches who are involved in clinical research trials not supported by the NIH to complete the GCP course.

 

Reporting Non-Compliance to the IRB

Principal Investigators are responsible for being knowledgeable of and following the IRB policy for reporting non-compliance (i.e.  Policy 2009-002.0.pdf – Reporting Non-Compliance to the Institutional Review Board).   Noncompliance is defined in Policy 2011-007.0 as any action that is taken or occurs that is not in accordance with an IRB approved study, IRB polices or regulations or that represents a failure to follow the requirements and/or determinations of the IRB.

Principal investigators (PIs) should report to the IRB any non-compliance that was within the control of the research team within 5 business days of becoming aware of the event.  To do so, PIs should complete and submit a Problem Report Form through the IRB online submission system, iRIS.  When the non-compliance was not within the control of the research team it should be reported at the time of continuing review.  If continuing review is no longer a requirement, non-compliance that was not within the control of the research team should be documented and tracked by the study team and available for review should the study be selected for audit.

Whenever any non-compliance is reported, the investigators should describe the details of the event, the underlying causes of the noncompliance and the actions that have been taken or will be taken to correct the problem and to prevent a subsequent occurrence. PIs should also describe whether the occurrence suggests that subjects or others are placed at an increased risk of harm.  This information allows the IRB to accurately assess the situation to determine whether the non-compliance rises to the level of serious and or continuing non-compliance as defined in IRB Policy 2011-007.0 – Definitions Applied to Policies. If the event does rise to the level of serious and/or continuing non-compliance there may be additional reporting required if the research is Federally funded or subject to FDA oversight.

If there is any question about whether reporting is required it is always better to err on the side of caution and report the issue.   PI’s are also encouraged to contact one of the Regulatory Specialists to discuss any questions about reporting requirements.

 

 Are you responsible for updating a ClinicalTrials.gov record?

 Are you responsible for updating a ClinicalTrials.gov record? You may want to subscribe to the new ClinicalTrials.gov bulletin “Hot off the PRS!” The bulletin details recent updates to the Protocol Registration and Results System (PRS) as well as new resources for PRS users. Enter your email address next to “Receive Updates” at the top of their webpage to subscribe. For help with registering your record or related questions, contact UConn Health’s PRS Administrator, Ellen Ciesielski at 860.679.6004 or eciesielski@uchc.edu.

 

IRB Forms – Update

 The Instructions for Requesting Reliance Upon Advarra IRB.docx  have been update to reflect the new contact names at Advarra IRB.  Investigators may contact Kathleen Rankin or Ashley Carpenter for guidance in making a submission to Advarra IRB.

 

Recent Articles Published by Central IRBs

Advarra IRB:

• Gene Therapy: Gene therapy research is at the forefront of a coming boom in the clinical setting. Understand the  growth, risks, and regulatory requirements by reading How Centralized IBC Review Can Benefit Gene Therapy Research
• IRB Review of Participant Compensation: IRBs are in charge of reviewing the amount of payment, as well as the method and timing of disbursement, to ensure that the payment plan does not present potential undue influence. Participant compensation is often a complicated matter, what an IRB should consider is discussed at Compensating Clinical Trial Participants: The Basics  

Western IRB (WCG):

• Participants Training has a direct impact in achievement the objectives in Clinical trials: Lack of training, particularly for patients, creates variability detrimental to trial findings, says Nathaniel Katz, founder and chief science officer of WCG Analgesic Solutions. To learn more about this topic click on: Lack of Training Compromises Trial Results.
• Recruitment: Recruitment is what drives a study. No patients, no research, right? Sites, sponsors and CROs know they need to do it, but they don’t really consider all the implications or differing strategies to recruitment .To learn more about this topic click on: What You Don’t Know About Patient Recruitment Can Impede the Success of Your Trial

 

Reporting Race and Ethnicity Data when Requesting Continuing Review

 “Researchers assumed that what they learned about white male participants could safely applied to anybody, regardless of gender, race, ethnicity or other variables.  We now know that this is not true.  When you are communication about research results, it’s vital not only to explain how a study was done, but was being studied,” says Dr. Eliseo J. Perez-Stable, Director of the National Institute on Minority Health and Health Disparities in his article titled: Communicating the Value of Race and Ethnicity in Research.

In August of 2001, The National Institute of Health (NIH) issued a policy which adopted the 1997 Office of Management and Budget (OMB) revised minimum standards for maintaining, collecting, and presenting data on race and ethnicity for all grant applications, contract and intramural proposals and for all active research grants, cooperative agreements, contract and intramural projects.  The goal of this policy is to ensure that the distribution of study participants by sex/gender, race and ethnicity reflects the population needed to accomplish the scientific goals of the study.

UConn Health IRB Main Consent Form Template .doc contains an Addendum Form titled “Personal Census Data”.  This form provides a mechanism for capturing the representation from  racial and ethnic groups in research studies conducted at UConn Health. This addendum form provide instructions to investigators, to present this form to subjects at the time of consent for completion.

The categories and definitions in the “Personal Census Data Sheet” are commonly used for federal data collection purposes. The form’s standards consist of two categories for ethnicity: “Hispanic or Latino” and “Not Hispanic or Latino” and five categories for race: American Indian or Alaska Native, Asian, Black or African American, Native Hawaiian or Other Pacific Islander, and White.

Investigator with full board studies or expedited submissions requiring continuing review are required to report this data at the time of request for continuing review.

Investigator should count all subjects who provided consent since the start of the study, including subjects who were screen failures or withdrew.  Investigators should indicate by gender the number in each racial/ethnic group. The total reported numbers should equal the total reported since the start of the study in the first table (e.g. first request for continuing review).

The table to be completed within the continuation form in IRIS is provided here for reference.

 

Ethnic Category	Females	Males
Hispanic or Latino
Not Hispanic or Latino
Unknown
Racial Category
American Indian/Alaska Native
Asian
Native Hawaiian or Other Pacific Islander
Black or African American
White
More Than One Race
Unknown or Not Reported

 

UConn Health’s Human Subjects Protection Program Receives Reaccreditation from the Association for the Accreditation of Human Research Protection Programs (AAHRPP)

 The Association for Accreditation of Human Research Protection Programs (AAHRPP) completed a site visit at UConn Health in April 2019.  During this visit, IRB members and staff, investigators and study coordinators, and others involved with research oversight were interviewed, and study research records were reviewed.  In June 2019, the AAHRPP Council on Accreditation awarded full reaccreditation to UConn Health’s Human Subjects Protection Program (HSPP), confirming that all standards for re-accreditation were fulfilled.   This reaccreditation is for five additional years. The final report issued by AAHRPP commends the HSPP for demonstrating an unusually high degree of integration among the areas responsible for research oversight.

 

Documentation of Consent

Unless the requirement to document consent has been waived by the IRB, the IRB approved consent form must be signed and dated by the subject (or legally authorized representative) and the person obtaining consent.

Notes in a research chart that indicate on-going discussions with the subject at subsequent study visits may supplement documentation of the initial informed consent process.

The following are examples of issues found with documentation of consent during recent internal audits at UConn Health.

• The date of consent differs between the subject and the person obtaining consent.
• The date of consent is left blank by the subject and/or the person obtaining consent..
• The date of signature is incomplete or incorrect.
• The informed consent form is missing the signature of the person obtaining consent.
• The person obtaining consent enters the date of the subject’s signature.
• Consent for participation obtained from legally authorized representatives when the study approval requires the subject to provide consent.
• Consent was obtained by people not approved as consenters by the IRB.
• Subjects consented with expired consent documents.
• Consent forms containing a correction to the signature and/or date which obscured the original entry.

To ensure consent is appropriately documented the following points should be considered:

• The principal investigator and study team members should use the most recently approved stamped and dated consent form when obtaining consent.
• Subjects should sign the consent form in the presence of, and at the same time as, the consenter.
• Persons obtaining informed consent should review the forms once they are signed/completed and before the subject leaves that day, to ensure that all signatures and dates are properly entered on the forms.
• In the event that a form is found to be incomplete (e.g., a date is missing) if the error is not discovered while the subject is present, the research staff should prepare a note to file attesting to the fact that they witnessed the signing of the form, and the date that it was signed.  The original consent form must be retained, and the subject should make the corrections at the earliest opportunity.
• Any problem with documentation of informed consent should be reported to the IRB using a problem report form within five days of becoming aware of the non-compliance.
• Approved consenters should review HSPP Policy 2011-008.1.pdf – Informed Consent – Process  and Policy 2011-008.5.pdf – Informed Consent – Providing and Obtaining Informed Consent  

 

Guidance for Posting Clinical Trial Consent Forms

Last January 2019, the revised version of 45 CFR 46, the federal regulation for the protection of human subjects in research, which is also known as the Common Rule, went into effect.  One of the revisions requires that for any clinical trial conducted or supported by a Common Rule department or agency, one IRB-approved consent form that was used to enroll subjects be posted on a publicly available federal website within a specific time frame.   UConn Health IRB has posted a Guidance for Posting Clinical Trial Consent Forms to help the research community to fulfill this obligation.

 

IRB Forms – Update

 Investigators should always use the latest version of the IRB forms posted in the IRB website.  Listed below, are the forms revised during the past three months. Within the parenthesis is the date when forms were revised.

• Instructions for Requesting Reliance Upon Advarra IRB.docx (4/24/2019 – template consent language updated per Advarra requirement)
• Confirmation of Resources for Inpatient Stays.docx (4/25/2019 – added comment section in sign-off area)
• Request for Full or Partial Waiver Informed Consent.doc (4/25/2019 – added note that approval of waiver not applicable to information/samples if original consent stated there would be no future use of information/samples)
• Application Appendix A.doc (CRC Resource Request) (5/21/2019 by CRC)
• Application Checklist for Initial and Continuing Review Full Board.docx (6/25/2019 – changed pharmacy contact)
• Application Checklist for Initial Exempt Application .doc(5/1/2019 – removed CICATS references)
• Application Checklist for Initial and Continuing Review Expedited .doc (6/25/2019 – changed pharmacy contact)
• Application Checklist to Request Facilitated Review for Industry or Cooperative Group Sponsored Study, or study utilizing the SMART IRB Initiative.docx (6/25/2019 – changed pharmacy contact)
• Main Consent Form Template .doc (6/12/2019 – changed reference Health One to EPIC, added reminder about mobile device security, rather than instructional text/samples about when FDA/DHHS/Sponsor can inspect records changed to “as may be applicable” and reference all three.)
• HIPAA Authorization to Use and Disclose.doc (6/28/2019 – deleted instructional text at top of form)
• HIPAA Authorization to Use and Disclose – Spanish.doc 6/28/2019 )

 

Personnel Changes to the Scientific Review Committee

 Dr. Doug Peterson who has served as the Chair of the Scientific Review Committee (SRC) for over a decade has stepped down as Chair. Dr. Julie Wagner is now the SRC Chair and Dr. Peterson will continue to serve on the SRC as a member until November 1.

The following three faculty members have been appointed to serve on the SRC.

• Dr. Efthimia Ioannidou, Professor/Clinical, Periodontology
• Dr. Ivo Kalajzic, Professor/Basic Science, Center for Regenerative Medicine
• Dr. Tannin Schmidt, Associate Professor/Basic Science, BioMedical Engineering

 

In Memoriam – Pamela Engelson Colwell

Our dear friend and colleague, Pamela E. Colwell (Pam) passed away on Wednesday, June 26, 2019.  Pam worked for the IRB for the last 15 years as a Regulatory Specialist and IRB member. Pam was an amazing team member, taught multiple IRB members, and played a pivotal role in the implementation of the iRIS submission system.  Please refer to the following link for information regarding services and memorial donations. http://northhavenfuneral.com/obituary/pamela-engelson-colwell/