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Human Subjects Protection Program – January-February- March , 2018 -Newsletter

 

Delay of Revised Common Rule and Revised UConn Health IRB Policies  

Implementation of the revised version of the Federal regulation governing federally funded/supported research (i.e. 45 CFR 46, also known as the Common Rule) has been delayed until July 19, 2018. In spite of this delay, the UConn Health IRB has moved forward with implementing several changes that aim to reduce regulatory burden on investigators while still offering protection to research participants, complying with current regulatory requirements and being prepared to comply with the revised requirements.

Several IRB forms, templates and policies have been revised. Understanding the reasons for these changes, what has been changed and to what type of research these changes apply may aid investigators in complying with IRB polices as well as with federal regulations.

The following table lists the UConn Health IRB polices that have been changed, a description of the change and the IRB forms that have been modified due to the policy revisions.

 
Name of the Revised Policy Description of the Policy Change IRB Forms changed due to this Policy Revision
2011-008.0 -Informed Consent – Forms This policy has been revised to include the additional elements of consent put forth in the revised version of 45 CFR 46.

 

These elements, while currently optional, will become required for Federal Funded /Supported (FFS) research only if the proposed revised regulation is implemented. If implemented these elements will be required for FFS research initially approved after the effective date of the regulation or for FFS research approved prior to the effective date of the revised rule that is still enrolling subjects and that is being transitioned to review under the revised rule.

 

While the applicable regulatory criteria for consent will be used as the general premise for all consent forms, when the research is not federally funded or supported, nor subject to FDA oversight, the IRB may exercise judgement when determining if the elements of consent have been appropriately addressed.

 

New elements of consent:

 

*  The prospective subject or the LAR will be provided with the information that a reasonable person would want to have in order to make an informed decision about whether to participate, and will be given an opportunity to discuss that information.

*  The ICF must begin with a concise and focused presentation of the key information that is most likely to assist a prospective subject or LAR in understanding the reasons why one might or might not want to participate in the research. This part of the informed consent must be organized and presented in a way that facilitates comprehension.

 

*  Informed consent as a whole presents information in sufficient detail relating to the research, and is be organized and presented in a way that does not merely provide lists of isolated facts, but rather facilitates the prospective subject’s or LAR’s understanding of the reasons why one might or might not want to participate.

 

*One of the following statements if the research involves the collection of identifiable private information (IPI) or identifiable biospecimens (IB)

(i) A statement that identifiers might be removed from the IPI or IB and that, after such removal, the information or biospecimens could be used for future research studies or distributed to another investigator for future research studies without additional informed consent from the subject or the LAR, if this might be a possibility;   OR

(ii) A statement that the subject’s information or biospecimens collected as part of the research, even if identifiers are removed, will not be used or distributed for future research studies.

 

*  A statement that the subject’s biospecimens (even if identifiers are removed) may be used for commercial profit and whether the subject will or will not share in this commercial profit.

 

*  A statement regarding whether clinically relevant research results, including individual research results, will be disclosed to subjects, and if so, under what conditions.

 

*  For research involving biospecimens, whether the research will (if known) or might include whole genome sequencing (i.e. sequencing of a human germline or somatic specimen with the intent to generate the genome or exome sequence of that specimen).

 

Consent Form Checklist 

 

Consent Form Template

Policy 2011-008.1 – Informed Consent – Process This policy has been changed so that the IRB may approve a non-federally funded or supported research proposal in which an investigator will obtain information or biospecimens for the purpose of screening, recruitment or determining the eligibility of prospective subjects without the informed consent of the prospective subject (and without the need for waivers or alterations), if either of the following conditions is met:

·    The investigator will obtain information related to screening, recruiting or determining eligibility through oral or written communication with the prospective subject.

·    The investigator will obtain identifiable private information or identifiable biospecimens for the purpose of screening, recruiting or determining eligibility by accessing records or stored identifiable biospecimens.

*  In order to access records or specimens for such purposes, there must be an established relationship between the investigator and the individuals whose records /specimens will be reviewed.

*  The investigator may delegate the review to designated UConn Health research staff.

*  Appropriate measures must be in place to protect the confidentiality of the data being utilized.

 

If the revised regulation is implemented in July this provision will be extended to federally funded/supported research.

 

Electronic Informed Consent (eIC) Process

The investigator should give to the IRB access to the e-consent platform to review the usability of the eIC materials to ensure that they are easy to navigate and that the user may navigate forward or backward within the system, or stop and complete the process at a later time. The investigator must also ensure there is a mechanism in place whereby subjects may ask and obtain answers to questions.

 

When eIC is proposes subjects must still be provided the option of the consent process occurring in person using a paper based consent form.

 

 

Text in the IRB application in the section regarding confidentiality has been revised to make it clear that the provisions for protecting the confidentiality of the data as described in the IRB application extend data collected during screening.

 

Policy 2011-008.2 – Informed Consent – Waivers and Alterations This policy has been changed to incorporate the new requirement for a waiver or alteration of consent. Per the new requirement, if the research involves using identifiable private information (IPI) or identifiable biospecimens (IB), the investigator must explain why the research could not practicably be carried out without using such IPI or IB.   This element is now applicable to all research requesting a waiver or alteration.

 

This policy also now includes new option to grant a waiver of documentation of consent for non-federally funded or supported research. This new option may apply when the subjects are members of a distinct cultural group or community in which signing forms is not the norm, the research presents no more than minimal risk of harm to subjects and there is an appropriate alternative mechanism for documenting that informed consent was obtained. The IRB will evaluate alternative mechanisms on a case-by-case basis based on information put forth by the PI.  If the revised regulation is implemented in July this provision will extend to federally funded / supported non-exempt.

 

 

Request for Full or Partial Waiver Informed Consent

 

Request to Waive Documentation of Consent

Policy 2011-008.5 – Informed Consent – Providing and Obtaining Informed Consent

 

This policy has been modified to allow obtaining consent from a “next of kin” for adults who are not mentally retarded.

 

If the potential participant does not have an appointed legally authorized representative (e.g., individuals designated as having power of attorney for health care, individuals designated as health care representatives) next-of-kin for adults who are not mentally retarded can consent on behalf of a prospective subject as defined in institutional policy 2012-05 titled Legal Representative for Health Care Decisions.

 

None
Policy 2011-023.0 – Educational Requirements. This policy has been changed so that human subjects protection training for all research (exempt, expedited, full board or facilitated review), will be verified for all study personnel at the time of initial approval and on an individual basis at the time a request for modification is received to add a person to the study. In order for training to be considered current it must have been completed within the past three years.

 

 

none
Policy 2011-009.3 –Institutional Review Board – Expedited Reviews This policy has been changed so that continuing review may not be required for non-federally funded/supported, non-FDA regulated research.

When continuing review is not required, the approval period for an expedited study will be from the date of approval through the expected completion date of the project.   If necessary the PI may submit an expedited request for modification to continue the study beyond that date.

none

 

Frequently Asked Questions Related to CITI Training, IRIS System and Facilitated Review

 

I completed my CITI human subject’s protection training recently.  Should I submit my CITI Training Certificate to the IRB?

If an external investigator completed CITI training through another institution, s/he must submit proof of having completed human subject’s protection training to the IRB because the IRB does not get automatically notified of such completions.

If the investigator is affiliated with UConn Health, he/she does not need to submit a certificate of completion. The IRB staff receives the CITI Training certificates one day after individuals have completed the training. Designated IRB staff enter the course completion information into a master training list (Excel) posted in the IRB website and into IRIS. This master training list (Excel) is updated every two weeks. Therefore, investigator should check this list often. In order for the IRB to update the training records in the IRIS system investigators affiliated with UConn Health must have logged into IRIS at least once. Therefore, investigator who have never before log into IRIS should do so right after they have completed the CITI Training. To log into IRIS investigator should click on the following link: https://imedris.uchc.edu , enter their UConn Health network credentials in the ID and PW boxes found in the IRIS logging page, and click on Log in.

 

I am going to submit an application to UConn Health IRB for review and approval.

Do I need to request an account in IRIS?

Every individual who is affiliated with UConn Health can use the UConn Health ID and password to log into IRIS. Therefore, individuals affiliated with UConn Health (faculty, staff, students, residents, and fellows) do not need to request an account in IRIS.

 

On the other hand, individuals external to the UConn Health will need to request an account in IRIS. To do so the external investigator must complete the online request form accessible from the IRIS home page. Investigators must complete all the required fields on the form indicating why the account is necessary and with whom at UConn Health he/she will be working. The IRB designated staff may contact the person in UConn Health to confirm that the creation of this account is necessary. Accounts will be created within 1-2 business days.

 

I have completed an application for IRB review in IRIS. I do not see the sections that allow me to attach documents for review? What should I do?

Unfortunately, the IRIS system currently has a glitch that does not transition the application form to the submission package where you can attach documents.  Follow the steps listed below when you get to the last section of the application for initial review and you see a sign stating: “Study Application Completion. You have completed the Study Application process. Click here to go to the …”

  • click on the “Back Button” ( located in the upper right hand corner)
  • Click on “Study Assistant” menu
  • click on “My Studies” sub-menu,
  • Open the study, and there you will find Section 1- Submission Packet to the Review Board.
  • Click on “Save and Continue to the Next Section” to build the following sections of the forms that will allow you to attach documents.

 

I am affiliated with UCONN Health (e.g. faculty member, student, employee, or resident, fellow) and I will be part of a study conducted at another institution. That institution has reviewed and approved the study. Do I need approval from the UConn Health IRB?

Yes, if you are affiliated with UConn Health and you are acting in that capacity, your involvement in a research study engages UConn Health in the research and therefore the UConn Health IRB must be involved.   However, as opposed to conducting a formal review the UConn Health IRB may elect to rely on the IRB of the other institution. To determine if the UConn Health IRB will do this you, you must submit an application for facilitated review to the UConn Health IRB. By submitting this application you will obtain an official determination from the UConn Health IRB as to whether oversight for the study will be deferred to the external IRB. In order for the UConn Health IRB to defer oversight a written agreement must exist between to the two institutions.  This agreement is referred to as an IRB Reliance Agreement.  Investigators may contact the IRB to determine if such an agreement is in place or needs to be established.

 

 

 

Policy Changes for Federally-Funded Human Subject Research

As many of you are aware, the U.S. Department of Health and Human Services (HHS) and several other federal agencies and departments recently issued an interim final rule governing federally funded/supported human subject research.  The implementation of the revised version of the regulation has been delayed until July 19, 2018.  Despite this delay, the Institutional Review Boards at UConn Health and UConn-Storrs will begin implementing some policy changes that are aimed at reducing administrative burden on investigators while still affording sufficient protections to research participants. 

SUMMARY OF CHANGES:

 

Training Requirements:

Compliance with human subject training requirements will be verified at the time of initial approval and at the time an individual is being added to a study through a request for modification.  Training must be current for the individual being added.  To be considered current, training must have been completed and passed within the past three years.  

 

Continuing Review for Non-Federally Funded/Supported Research and Non-FDA Regulated Research:

Non-federally funded/supported research and non-FDA regulated minimal risk research that qualifies for expedited review will be approved for either the anticipated time frame of the project or one year from the date of approval, whichever is greater.  Unless specifically required by the IRB, annual continuing review will no longer be required for this type of research.

  

As the anticipated completion date of the research draws near, investigators may extend the expected completion date if necessary through a request for modification.  Research cannot be conducted beyond the approval period.  If any federal support is obtained after the initial approval the investigator is obligated to inform the IRB, via a request for modification, and annual continuing review will become required.

 

For studies previously approved through the expedited review process, investigators may request transition to this new policy at the time the next continuing review is due or sooner by submitting a request for modification.  Any document currently stamped with an expiration date that is still used in the research would need to be attached to the submission to allow for removal of the expiration date.

 

Please note that federally funded or supported research and FDA regulated research must continue to receive IRB review and approval on an annual basis, at a minimum.

 

Consent – Additional Elements

The proposed regulation contained new elements of consent.  Those elements have been incorporated into the consent form template and the consent checklist used by UConn Health.  Investigators are encouraged to include these new elements in consent documents, but the elements will not be mandated until such time as the revised regulation takes effect. 

 

Consent – Waiver or Alteration

The proposed regulation put forth an additional criteria for granting a waiver of consent that requires an explanation as to why the research could not be practicably carried out without using identifiable private information and/or identifiable biospecimens.  This additional criteria has been incorporated into the request for waiver/alteration forms and will be applied to all research going forward.

 

Consent – Waiver of Documentation

The proposed regulation would have allowed for waiver of documentation of consent when the subjects (or legally authorized representatives of the subjects) are members of a distinct cultural group or community in which signing forms is not the norm, when the research presents no more than minimal risk of harm to subjects, and when there is an appropriate alternative mechanism for documenting that informed consent was obtained.  This option may be utilized for non-federally funded/supported research and non-FDA regulated research.

 

Activity Related to Screening, Recruiting and Determining Eligibility:

For non-federally funded/supported research, a partial waiver of consent will no longer be required for the purpose of screening, recruiting or determining eligibility if either of the following is true:

  • The investigator will obtain information through oral or written communication with the prospective subject or legally authorized representative of the subject (e.g. telephone screening), or
  • The investigator will obtain identifiable private information or identifiable biospecimens by accessing records or stored biospecimens.
    • In order to access records or specimens for such purposes, there must be an established relationship between the investigator and the individuals whose records/specimens will be reviewed.
      • The investigator may delegate the review to appropriately designated research personnel

Investigators are obligated to protect the confidentiality of information collected prior to consent and HIPAA (primarily a concern for UConn Health investigators). This must still be appropriately addressed when protected health information is utilized. 

 

Stamping of Documents:

The expiration date will no longer be noted on documents.  Documents will continue to be stamped with the approval date and investigators will be responsible for ensuring that the most recently approved version of documents are being utilized.   

 

We expect that proactively implementing these changes will help to ease administrative burdens associated with minimal risk research and also to prepare investigators for compliance with the proposed revised regulation, should it be implemented.  

 

If you have questions regarding how these changes impact your current approval or planned submission to the IRB, please contact the IRB Office:

 

The InfoEd IRB-1 and IRB9 study protocol forms as well as the consent form, information sheet, parental permission form and parental notification form templates, were revised to incorporate these changes.  DOWNLOAD THE NEW FORMS PRIOR TO SUBMISSIION OF A NEW STUDY.

 

UConn Health

Mayra Cagganello – 860-679-8802 or by email cagganello@uchc.edu

 

UConn Storrs

Doug Bradway – 860-486-0986 or by email at doug.bradway@uconn.edu

Jerry McMurray – 860-486-5756 or by email at jerome.mcmurray@uconn.edu

Topaz Elements Upgrade – System Unavailable

May 4, 2017 5:00 PM – May 8, 2017 8:00 AM

Updated: April 26, 2017

System Upgrade Planned:
The Office of the Vice President for Research (OVPR), Research IT Services will be working with Topaz Technologies to upgrade the Topaz Elements Animal Protocol and Animal Ordering system to version 3.3 beginning Thursday, May 4, 2017 at 5:00 PM and continuing over the weekend. Service is expected to be restored by Monday, May 8, 2017 at 8:00 AM. The planned upgrade is to improve performance, correct bugs encountered in prior versions of the software, and roll out new features and functionality that have become available since the release of our current version.

Effect on Services:
During the planned outage, users will not be able to login to the system to view, edit, submit, or review animal protocols and orders.

User Required Actions:
Users should save all work and log out of the system prior to the above maintenance window. Users will be able to resume normal use of Topaz Elements upon resumption of service once the maintenance period ends.

If you have questions, please contact the Office of the Vice President for Research eRA Help Desk at era-support@uconn.edu or 860-486-7944.

Sincerely,

eRA Help Desk
Office of the Vice President for Research
Research IT Services
University of Connecticut

OVPR Research Compliance News

The Office of the Vice President for Research (OVPR) Research Compliance Services group would like to share some important updates with the research community at UConn Health.

Institutional Animal Care and Use Committee (IACUC):
A new IACUC policy (effective 2/23/17) requires documentation of veterinary consultation prior to submission of animal care and use protocols if painful/distressful procedures (pain categories D and or E) will be used.  The IACUC also recently updated its policy on expiration dates for drug mixtures used in laboratory animals.  Click here to view the updated policy.

 

Institutional Biosafety Committee (IBC):
The IBC is in the process of implementing new IBC training for researchers through the CITI training program. Researchers will be notified by the IBC in the next few months to take this online training. Please stay tuned.

 

Institutional Review Board (IRB):
The U.S. Department of Health and Human Services and fifteen other Federal Departments and Agencies have issued final revisions to the Federal Policy for the Protection of Human Subjects (the Common Rule). The Final Rule was published in the Federal Register on January 19, 2017.  Some of the changes encompassed within the revised Rule include 1) an expansion of categories of research that may be exempt, 2) elimination of the need for continuing review for research that qualifies for expedited review and for research that has reached the stage of long-term follow-up or data analysis, 3) a broad-consent provision relating to the storage and use of data and specimens in secondary research and 4) additional requirements regarding the consent form.  The compliance date for most of the revisions within the Rule is January 18, 2018.  The compliance date for use of a single IRB for cooperative research is January 18, 2020.  Staff within the Human Research Protections Programs (HSPP) at UConn Health will be revising policies and procedures and offering educational sessions related to these changes.  The research community should continue to follow current policies and procedures until the HSPP publishes revised documents.

 

 ClinicalTrials.gov:
The new NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information covers all applications for funding (including grants, contracts, and other transactions) submitted on or after January 18, 2017 that request support for the conduct of any clinical trial. Studies that are wholly or in part funded by NIH grants submitted on or after this date must be registered and results must be reported on ClinicalTrials.gov.

NIH defines a clinical trial as a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes. Health-related biomedical or behavioral outcome is defined as the pre-specified goal(s) or condition(s) that reflect the effect of one or more interventions on human subjects’ biomedical or behavioral status or quality of life.

Click here for assistance with ClinicalTrials.gov registration.

 

Financial Conflict of Interest in Research Committee (FCOI):
The 2017 Individual Financial Disclosure in Research reporting period started February 8, 2017. In order to remain in compliance with university policy and federal regulations, UConn Health employees who are involved in research are required to complete an annual questionnaire in the UConn Health COI-SMART electronic disclosure system. The deadline to complete is April 30, 2017. We recommend, however, that you submit your disclosure well before the deadline because this process must be completed prior to the institution submitting any grant applications to DHHS agencies on your behalf.  The setup of new and continuation awards will also be delayed until you are in compliance.

If you did not receive an automated e-mail invitation to complete the questionnaire and believe you need to complete the form, or if you have any questions regarding the form or the disclosure requirements, please contact Dr. Gus Fernandez-Wolff in the Office of the Vice President for Research, Research Compliance Services at x8125 or gfernandez@uchc.edu.

 

 

Annual Individual Financial Disclosure in Research

The Office of the Vice President for Research would like to announce that the 2017 Individual Financial Disclosure in Research reporting period has started today. In order to remain in compliance with university policy and federal regulations, UConn Health employees who are involved in research are required to complete an annual questionnaire in the UConn Health COI-SMART electronic disclosure system.

An automated e-mail inviting applicable employees to complete the questionnaire should be in your inbox. The sender name on the e-mail is UConn Health Financial Disclosure in Research.

If you did not receive an automated e-mail invitation and believe you need to complete the form, or if you have any questions regarding the form or the disclosure requirements, please contact Gus Fernandez-Wolff in the Office of the Vice President for Research, Research Compliance Services at x8125 or gfernandez@uchc.edu.

Thank you for your cooperation.

For more information, contact: Gus Fernandez-Wolff at x8125 or gfernandez@uchc.edu

IRIS Upgrade – System Down Time

The Human Subjects Protection Program (HSPP) within the Office of the Vice President for Research would like to inform the research community that the IRIS system is scheduled to be upgraded to version 10.03 during the second week of November. The upgrade is scheduled to begin the morning of Tuesday, November 8th and will require that the system be temporarily taken off-line. We anticipate the system will be available for use on Tuesday, November 15th. Please note these dates and plan accordingly. Another announcement will be sent to confirm when the system is back on-line.

Please note, when the system is brought on-line it will include a new version of the application form. The new application form was developed with input from a working group comprised of IRB staff and members, study coordinators and investigators. It is significantly different than the current application. If you were in the process of completing an application form when the system was shut down for the upgrade, we suggest that you do not convert to the new version when prompted.

Mayra Cagganello continues to offer training in the new version of IRIS, and we strongly encourage you to take advantage of that training. The training schedule is available from the HSPP web site at http://research.uchc.edu/rcs/hspp/ Training manuals will also be posted in the Help section of the IRIS system.

We appreciate your patience during this upgrade process.

If you have questions regarding the upgrade, you may contact Deborah Gibb.
For more information, contact: Mayra Cagganello at cagganello@uchc.edu

ResearchMatch now available to UConn researchers

Research MatchThe Office of the Vice President for Research (OVPR) is pleased to announce that UConn is now part of the ResearchMatch Network. ResearchMatch.org is a national online recruitment tool, funded by the National Institutes of Health and maintained at Vanderbilt University. ResearchMatch connects interested participants with research studies that might be a good “match” for them through its secure, online matching tool. There is no cost to UConn researchers who use ResearchMatch to conduct recruitment feasibility analysis or participant recruitment.

For more information, including the process for using ResearchMatch as a recruitment tool, please contact Ellen Ciesielski in the OVPR Research Compliance Services at 860-679-6004 or email researchmatch@uchc.edu.

New Export Control Policy

The Office of the Vice President for Research (OVPR) would like to announce a new policy related to Export Control compliance, effective 12/14/2015. Intended to protect national security and support foreign policy, export controls are federal laws that regulate how certain controlled information, technology, software, services and goods can be shipped, transferred or transmitted to individuals or organizations overseas.  They also regulate the release of certain information to foreign nationals who are in the U.S. and their ability to work with or have access to certain technologies and software while in the U.S.  This policy has been put in to place to ensure that the University and its employees remain in full compliance with federal regulations, has been approved for all UConn campuses, and can be found at the University’s Policies & Procedures page.

The OVPR has developed resources related to Export Controls to assist faculty and other members of the University community that are available on the Research Compliance Services page.

If you have any questions relating to Export Control and/or this policy, please contact:

Dr. Wesley Byerly
Associate Vice President for Research Integrity and Regulatory Affairs
Office of the Vice President for Research
(860) 679-2230
byerly@uchc.edu