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Research Compliance Services News

HSPP- April- May-June, 2018 – Newsletter

Clinical Trials – What you need to Know

Did you know the public clinical trials registry, ClinicalTrials.gov, was created in February 2000 in support of a 1997 federal law requiring public registration of clinical trials? It was designed as a web-based catalog of clinical trials to serve as a resource for the patient and research community alike. The law has since expanded to require more types of clinical trials research to be registered, and for some trials, results are also required to be posted.

Did you know there are at least 4 organizations that may require you to register your study on ClinicalTrials.gov? The FDA, National Institutes of Health (NIH), International Committee of Medical Journal Editors (ICMJE) and World Health Organization (WHO) each have rules about registering. For more details on each, please click here.

Did you know the NIH and ICMJE have expanded their definitions of a clinical trial to include behavioral trials? Click here for NIH’s definition. Click here for the ICMJE definition.

Did you know that for studies that require results to be posted per the federal law with completion dates after 1/18/17, a final version of the IRB-approved protocol document and statistical analysis plan must be uploaded to the ClinicalTrials.gov record? Limited information may be redacted. For details, click here.

Should your study be registered with ClinicalTrials.gov?

For more information, see our webpages or contact Ellen Ciesielski (eciesielski@uchc.edu, 860-679-6004) in Research Compliance Services.

 

Inclusion of Children in Research

When a Principal Investigator (PI) proposes a research project that will involve an intervention or interaction with children, the PI must demonstrate to the IRB that the additional protections afforded to children by regulations have been addressed. The Department of Health and Human Services (DHHS) and the Food and Drug Administration (FDA) have each established regulations governing the inclusion of children in research and the UConn Health IRB has incorporated these regulations into policy.  When proposing a research study that will include children as subjects investigators should review the following material:

  • IRB Policy 2011-006.0, Additional Protections for Certain Populations – General Policy,
  • IRB Policy 2011-006.3, Additional Protections for Certain Populations – Children,
  • Form D, Additional Protections for Children Involved as Subjects in Research

In order for the IRB to approve a research protocol that will enroll children, the IRB must assess the information provided by the PI and be able to determine that the research falls within one or more of the following permissible categories and that the plans for obtaining the assent of the child and permission of the parents are appropriate. The examples provided within each category were taken from the Collaborative Institutional Training Initiative (CITI) Program.

Category 1: Research not involving greater than minimal risk.

Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.

To be approvable under this category, the IRB must find that the research presents no greater than “minimal risk” to children, and that adequate provisions are made for soliciting the assent of the children and the permission of their parents or guardians. The IRB may determine that permission from one parent is sufficient.

Examples of Research Projects That May Fall Within Category 1

  • A study to determine the relationship between maternal age and head circumference at birth. Measurement of head circumference is part of the normal newborn examination, and is therefore minimal risk.
  • A study to determine the incidence of asymptomatic proteinuria in school age children. The research involves the analysis of a voided urine collection, which is minimal risk.

Category 2: Research involving greater than minimal risk but presenting the prospect of direct benefit to the individual subjects.

This category is inclusive of research in which more than minimal risk to children is presented by an intervention or procedure that holds out the prospect of direct benefit for the individual subject, or by a monitoring procedure that is likely to contribute to the subject’s well-being. The IRB may approve research under this category only if the IRB finds and documents that:

(a) The risk is justified by the anticipated benefit to the subjects;

(b) The relation of the anticipated benefit to the risk is at least as favorable to the subjects as that presented by available alternative approaches; and

(c) Adequate provisions are made for soliciting the assent of the children and permission of their parents or guardians.   The IRB may determine that permission from one parent is sufficient.

Examples of Research Projects That May Fall Within Category 2:

A pilot study of a shorter duration of antibiotic treatment for uncomplicated otitis media. The potential benefit associated with the shorter duration of treatment is increased compliance, and a reduced rate of antibiotic-related diarrhea. The risk associated with the shorter duration of therapy is a higher likelihood of treatment failure.

The risk associated with this research (e.g. treatment failure) appears to be greater than minimal but can be justified by the anticipated benefit (reduce rate of antibiotic diarrhea); and there is the prospect of direct benefit to the child (increased compliance, shorter exposure time, and a reduced rate of antibiotic-related diarrhea). If the risk-benefit relationship is as favorable as the one seen with standard care (e.g. use of the antibiotic for standard time frame), this research would be approvable under this category.

Use of a placebo, or routine monitoring for safety, is not considered to provide direct benefit to subjects.

Category 3: Research involving greater than minimal risk and no prospect of direct benefit to individual subjects, but likely to yield generalizable knowledge about the subjects’ disorder or condition.

 

This category is inclusive of research in which more than minimal risk to children is presented by an intervention or procedure that does not hold out the prospect of direct benefit for the individual subject, or by a monitoring procedure which is not likely to contribute to the well-being of the subject. To be approvable under this category, the children to be enrolled must have the disorder or condition under study (i.e. a healthy control group would not be allowable) and the IRB must find and document that:

(a) The risk represents a minor increase over minimal risk;

(b) The intervention or procedure presents experiences to subjects that are reasonably commensurate with those inherent in their actual or expected medical, dental, psychological, social, or educational situations;

(c) The intervention or procedure is likely to yield generalizable knowledge about the subjects’ disorder or condition which is of vital importance for the understanding or amelioration of the subjects’ disorder or condition; and

(d) Adequate provisions are made for soliciting assent of the children and permission of their parents or guardians. In most cases permission from both parents is required.

Examples of Procedures That May Involve Minor Increase Over Minimal Risk:

  • Catheterized urine collection
  • Skin biopsy or bone marrow biopsy
  • MRI scan with sedation

Example of Research That May Fall Within Category 3:

A study to determine the clinical relevance of a new technique to quantitate minimal residual disease (MRD) during therapy for acute lymphoblastic leukemia in children. The study requires one additional bone marrow aspirate be performed during the course of treatment. Therapy for the subject will not be altered based on the results of the assay. However, if it can be shown that the presence of MRD predicts poor outcome, in the future, patients with MRD can receive more intensive treatment and increase their chance of cure.

It can be argued that the risk of a bone marrow aspirate in a child is only a minor increase over minimal risk. Further, the risk appears commensurate with risks inherent in the subject’s actual medical situation, and the research may yield knowledge of vital importance about the child’s disease (leukemia).

Category 4: Research not otherwise approvable which presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children

 

For research not otherwise approvable that presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children the IRB must find and document:

  1. That the research presents a reasonable opportunity to further the understanding, prevention, or alleviation of a serious problem affecting the health or welfare of children; and
  1. b)   For studies funded or supported by DHHS, the Secretary, or for studies subject to FDA oversight the Commissioner, after consultation with a panel of experts in pertinent   disciplines (for example: science, medicine, education, ethics, law) and following opportunity for public review and comment, has determined either:

(1)       that the research in fact satisfies the conditions of one of the aforementioned categories, as applicable, or

(2)       (i) the research presents a reasonable opportunity to further the understanding, prevention, or alleviation of a serious problem affecting the health or welfare of children; (ii) the research will be conducted in accordance with sound ethical principles; (iii) adequate provisions are made for soliciting the assent of children and the permission of their parents or guardians.

General Requirements for Assent and Permission:  

 Assent means an affirmative agreement to participate in research used with those who are not competent or not of legal age to provide informed consent. Failure to object may not be construed as assent.

 For children to participate in research, the IRB must determine that adequate provisions are made for soliciting the assent of the children when in the judgment of the IRB the children are capable of providing assent. The IRB will take into account the ages, maturity, and psychological state of the children involved. The judgment may be made for all children to be involved in research under a particular protocol, or for each child. When the IRB determines that assent is required, it shall also determine whether and how assent must be documented.

The IRB may determine that assent is not a necessary condition for proceeding with the research if the capability of some or all of the children is so limited that they cannot reasonably be consulted or that the intervention or procedure involved in the research holds out a prospect of direct benefit that is important to the health or well-being of the children and is available only in the context of the research.

Permission is the agreement of parent(s) or guardian to the participation of their child in research. Permission is generally documented by have the parent(s)/guardian sign an informed consent document.

For research studies not involving greater than minimal risk (Category 1 ) and research involving greater than minimal risk but presenting the prospect of direct benefit to the individual subjects (Category 2) the IRB may find that the permission of one parent or guardian is sufficient. For research studies involving greater than minimal risk and no prospect of direct benefit to individual subjects, but likely to yield generalizable knowledge about the subjects’ disorder or condition (Category 3), and for research studies not otherwise approvable which presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children (Category 4), both parents/guardians must give their permission unless one is deceased, unknown, incompetent or not reasonably available, or unless only one parent has legal responsibility for the care and custody of the child.

If the IRB determines that a research protocol is designed for conditions or for a subject population for which parental or guardian permission is not a reasonable requirement to protect the subject (e.g., neglected or abused children) it may waive the consent requirements provided an appropriate mechanism for protecting the children who will participate as subjects in the research is substituted, and provided further that the waiver is not inconsistent with Federal, state or local law.

The choice of an appropriate mechanism would depend upon the nature and purpose of the activities described in the protocol, the risk and anticipated benefit to the research subjects, and their age, maturity status and condition.

 

Inclusion or Wards in Research

 Children who are wards of the state or any other agency, institution, or entity can be included in research involving greater than minimal risk and no prospect of direct benefit to the individual subjects, but likely to yield generalizable knowledge about the subject’s disorder or condition (Category 3) or research that is not approvable under a defined regulatory category but that presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children (Category 4) only if the research is related to their status as wards, or is conducted in schools, camps, hospitals, organizations, or similar settings in which the majority of children involved as subjects are not wards.

Each child must have an advocate appointed who has the background and experience to act in, and agrees to act in, the best interests of the child, and who is not associated in any way with the research, researchers, or guardian organization.

 

ResearchMatch training

ResearchMatch.org is a national online recruitment tool, funded by the National Institutes of Health and maintained at Vanderbilt University. ResearchMatch connects researchers with individuals interested in participating in research studies, through its secure, online matching tool. There is no cost to UConn Health researchers to use ResearchMatch.

To learn more about using ResearchMatch for your studies, register for the free ResearchMatch Researcher Webinar Training/Live Demo on Thursday, July 12, 2018 from 3:00 p.m. – 4:00 p.m. The training is open to all research staff. After registering, you will receive a confirmation email with instructions on joining the training.

The team at ResearchMatch will show you how to register your studies, create a cohort of potential volunteers and send out contact messages and surveys. They will also cover how to send a pre-screening (eligibility) survey, contact the volunteers that replied ‘yes’ to your initial message, and manage your enrollment continuum.

To register for the training, click here:

https://attendee.gototraining.com/r/9112903382698216193

For additional information, contact Ellen Ciesielski (eciesielski@uchc.edu; 860-679-6004).

Additional Information on Newly Published Research Policies

The newly published policies for Animal Use in Research, Teaching and Testing and Research Involving Human Subjects revise the existing UConn Storrs policies to establish a uniform regulatory compliance statement that applies to all campuses under which the programs at UConn Health and Storrs operate.  A single, overarching policy will help in the development of other policies and procedures to help facilitate cross-campus initiatives.

Key revisions:

  • Clarification of who the policies apply to (both policies)
  • Revisions to definitions to make them consistent with the regulatory definition (both policies)
  • Clarification regarding the role of the Institutional Official and committees (IACUC and IRB)
  • Clarification of the authority of the attending veterinarian to be consistent with regulatory requirements (Animal Use policy)
  • Clarification of the authority of the IRB to be consistent with regulatory requirements (Human Subjects Research policy)
  • Revisions to the enforcement section to make the sections consistent with other university policies (both policies)
  • Updated list of authorities (both policies)

 

The Human Stem Cell Research policy clarifies and updates the existing University-wide policy regarding the type and scope of research to which the policy applies.

 

The ClinicalTrials.gov policy establishes a new University-wide policy to address FDA, NIH and CMS requirements that applicable trials are registered.

 

Animal Use in Research, Teaching and Testing: https://policy.uconn.edu/?p=113

Human Stem Cell Research Approval: https://policy.uconn.edu/?p=2453

Human Subjects Research: https://policy.uconn.edu/?p=406

ClinicalTrials.gov: https://policy.uconn.edu/?p=7310

 

For additional information, contact Ellen Ciesielski (eciesielski@uchc.edu, 860-679-6004)

 

Revised & New University-Wide Research Policies

 

The Office of the Vice President for Research (OVPR) Research Compliance Services would like to share some important updates regarding university policies for animal use, human subjects, and stem cell research. These policies were revised to be consistent with federal requirements and are now in effect for all campuses, including UConn Health.  A new university-wide policy to address FDA, NIH, and CMS requirements for registration of applicable trials to ClinicalTrials.gov has also been published.

 

Please see links to published policies below.

 

ClinicalTrials.gov: https://policy.uconn.edu/?p=7310

Animal Use in Research, Teaching and Testing: https://policy.uconn.edu/?p=113

Human Stem Cell Research Approval: https://policy.uconn.edu/?p=2453

Human Subjects Research: https://policy.uconn.edu/?p=406

 

For additional information, contact Ellen Ciesielski (eciesielski@uchc.edu, 860-679-6004).

 

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