Year: 2018

OVPR Quarterly Reports

Dear Colleagues,

Now that data have been finalized, I would like to provide you with several reports relating to sponsored program activity—both research and education/service—managed by Sponsored Program Services within the Office of the Vice President for Research at UConn and UConn Health. Please visit the OVPR website to view the following reports:

  • List of Proposals Submitted: FY18 4th Quarter
  • List of Awards Received: FY18 4th Quarter
  • Proposals, Awards, Expenditures: FY14-FY18Q4

In the reports, data are presented in two ways: by the PI’s Academic Home Department and by the Managing Department or Center/Institute. Please refer to the first pages of the reports for definitions and information regarding the data. Should you have any questions regarding these quarterly reports, please do not hesitate to contact me.

Please note that we have included an additional Summary of Sponsored Program Activity, which includes the Effective F&A rate on awards. This information provides a snapshot of our activity as compared to the same period last year.

The OVPR continues to seek creative solutions that allow UConn and UConn Health to grow our research enterprise through federal funding, industry partnerships, and collaboration with foundations. I am confident we can continue upward trends by continuing to work together, aggressively applying for extramural funding, and pursuing new channels of support for the tremendous research, scholarship, and creative activities taking place every day at UConn and UConn Health.

Thank you for your continued commitment and contribution to our students, to your research and scholarship, and to UConn/UConn Health.

Sincerely,
Radenka

UConn Health, Jackson Lab To Collaborate On Statewide Pain Consortium

UConn Health Hospital Tower

UConn Health, UConn Schools of Medicine and Nursing, and The Jackson Laboratory (JAX) have announced the creation of the Connecticut Pain Consortium, a translational pain research and education collaboration which is the first of its kind in the Connecticut medical community.

The Connecticut Pain Consortium will focus on a problem of national importance: the need for fundamental and translational research on the causes and manifestations of pain, pain management, and education about pain and its ramifications.

The Connecticut Pain Consortium will examine this critical medical issue through several specific initiatives:

  • Establishing a portal for pain-related health care data in Connecticut
  • Providing a platform for basic and translational pain research collaborations that helps leverage state and national resources
  • Leveraging research to provide cutting-edge pain management solutions in clinical and population health settings
  • Raising awareness about the many facets of pain, its management, and the many possible related ramifications, such as opioid addiction
  • Developing a curriculum around pain research and management for health care providers

The consortium will be led by Professor Dr. Reinhard Laubenbacher, a joint faculty member at UConn Health and The Jackson Laboratory, who also serves as Director of the Center for Quantitative Medicine at UConn Health.

To learn more, visit the Connecticut Pain Consortium website.

NIH Asks for Your Feedback on a Future Draft Data Management and Sharing Policy

The Office of the Vice President for Research would like to share some information regarding data sharing with researchers who may be affected.

 

The National Institutes of Health (NIH) issued a Request for Information (RFI) seeking feedback on proposed key provisions to help inform the development of a draft NIH policy for data management and sharing. Submit your comments to NIH by December 10, 2018. Additional information can be found in this NIH blog post, and questions about the proposed provisions may be sent to the NIH Office of Science Policy at SciencePolicy@od.nih.gov

 

NIH will also be hosting a webinar on the proposed key provisions on November 7, 2018, from 11:30 a.m. – 1:00 p.m. ET.

 

For questions, please contact Research Compliance Monitor, Ellen Ciesielski at 860.679.6004.

 

 

 

Will NIH require you to register your basic science research in ClinicalTrials.gov?

The Office of the Vice President for Research would like to share some information regarding ClinicalTrials.gov with researchers who may be affected.

 

NIH has released a Request for Information (RFI), Registration and Results Reporting Standards for Prospective Basic Science Studies Involving Human Participants. This RFI seeks input from the scientific research community and the general public regarding how best to implement the NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information (NOT-OD-16-149) for prospective basic science studies involving human participants. NIH is specifically interested in learning more about studies that meet the NIH definition of a clinical trial (NOT-OD-15-015) but are not defined as applicable clinical trials (42 CFR Part 11), and also meet the definition of fundamental research. You can submit your comments to NIH by November 12, 2018.

 

For questions about ClinicalTrials.gov, please contact Research Compliance Monitor, Ellen Ciesielski at 860.679.6004.

 

Are you liable for ClinicalTrials.gov Civil Money Penalties?

The Office of the Vice President for Research would like to share some information regarding ClinicalTrials.gov with researchers who may be affected.

 

On September 18, 2018, the Food and Drug Administration (FDA) announced a draft guidance titled Civil Money Penalties relating to the Clinical Trials.gov Data Bank. The guidance addresses how the FDA Centers (Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, and Center for Devices and Radiological Health, for drug, biological, and device products, respectively) identify whether parties have failed to submit required clinical trial registrations, results, or certifications, or knowingly submitted false or misleading information.

The guidance explains that when a responsible party has potentially failed to comply with its disclosure obligations, the FDA will send a Preliminary Notice of Noncompliance Letter, and allow the responsible party 30 days to make corrections. If the FDA determines that the responsible party has still failed to comply, the FDA may issue a Notice of Noncompliance, assess civil monetary penalties, or seek an injunction and/or criminal prosecution. The statutory maximum for civil penalties is “not more than $10,000 for all violations adjudicated in a single proceeding,” plus “not more than $10,000 for each day that the violation continues” past the 30-day notification period.

The deadline to submit your comments to the FDA on this draft is November 20, 2018.

 

  • To check if your trial meets the criteria for ClinicalTrials.gov registration and results posting set forth by the FDAreview this checklist. 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, review this checklist to see if it meets the NIH’s broad definition of a clinical trial and will require registration and results posting. 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.

 

For questions about ClinicalTrials.gov, please contact Research Compliance Monitor, Ellen Ciesielski at 860.679.6004.

 

HSPP- July-August-September, 2018- Newsletter

AAHRPP Site Visit 2018

 The Association for Accreditation of Human Research Protection Programs (AAHRPP) is an independent, non-profit accrediting body that works to protect the rights and welfare of research participants and promotes high-quality research through an accreditation process.

UConn Health’s Human Subjects Protection Program (HSPP) achieved AAHRPP accreditation in 2006.  As an accredited organization, our HSPP must periodically apply for re-accreditation.  This is a two-step process.  Step 1, which has been completed, consisted of AAHRPP reviewing all of our policies and procedures to ensure they meet regulatory and accreditation standards.  Step 2 is an onsite visit by AAHRP representatives to ensure that our policies and procedures are followed.  While specific dates have not yet been determined, the next accreditation site visit will occur in the spring of 2019.

During the site visit, representatives from AAHRPP will conduct interviews and review studies records to ensure that policies and procedures have been implemented effectively.  AAHRPP representatives will interview the Institutional Official (Wesley Byerly), IRB members, HSPP staff, investigators and research study team members, and individuals that represent various research compliance functions, such as radiation safety, research pharmacy, scientific review, and conflicts of interest.  Individuals selected for such interviews will be asked questions about regulatory and ethical issues related to research with human participants and how they interact with the IRB. Investigators and research staff will also be asked about the conduct of their research studies.

In general, topics that may be included during an AAHRPP interview process include:

  1. Familiarity and compliance with HSPP/IRB polices and procedures
  2. Roles and responsibilities of investigators and research staff
  3. Obtaining and documenting informed consent
  4. Conflict of interest disclosures
  5. Minimizations of risks to research participants and protecting human subject’s rights and welfare
  6. Types of training individuals have received in human subject’s protections.

If you are selected for an interview, you will be notified a few weeks prior to the site visit.  An educational handout will be provided to help you to prepare.

In addition, you can request an educational session with the Educational Specialist to learn more about the site visit and possible interview questions.

 

Are you liable for ClinicalTrials.gov Civil Money Penalties?

 On September 18, 2018, the Food and Drug Administration (FDA) announced a draft guidance titled Civil Money Penalties relating to the Clinical Trials.gov Data Bank. The guidance addresses how the FDA Centers (Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, and Center for Devices and Radiological Health, for drug, biological, and device products, respectively) identify whether parties have failed to submit required clinical trial registrations, results, or certifications, or knowingly submitted false or misleading information.

The guidance explains that when a responsible party has potentially failed to comply with its disclosure obligations, the FDA will send a Preliminary Notice of Noncompliance Letter, and allow the responsible party 30 days to make corrections. If the FDA determines that the responsible party has still failed to comply, the FDA may issue a Notice of Noncompliance, assess civil monetary penalties, or seek an injunction and/or criminal prosecution. The statutory maximum for civil penalties is “not more than $10,000 for all violations adjudicated in a single proceeding,” plus “not more than $10,000 for each day that the violation continues” past the 30-day notification period.

The deadline to submit your comments on this draft, electronically or by paper, is November 20, 2018.

  • To check if your trial meets the criteria for ClinicalTrials.gov registration and results posting set forth by the FDA, see the checklist found here. 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, check here to see if it meets the NIH’s broad definition of a clinical trial and will require registration and results posting. 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.
  • For questions about ClinicalTrials.gov, please contact Research Compliance Monitor, Ellen Ciesielski at 860-679-6004

 

Does NIH require you to register your basic science research in ClinicalTrials.gov?

 NIH has released a Request for Information (RFI), Registration and Results Reporting Standards for Prospective Basic Science Studies Involving Human Participants. This RFI seeks input from the scientific research community and the general public regarding how best to implement the NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information (NOT-OD-16-149) for prospective basic science studies involving human participants. NIH is specifically interested in learning more about studies that meet the NIH definition of a clinical trial (NOT-OD-15-015) but are not defined as applicable clinical trials (42 CFR Part 11), and also meet the definition of fundamental research. You can submit your comments here by November 12, 2018.

 

Access to Investigational Drugs through  Clinical Trials, the Expanded Access Program, or  the Right-to-Try Law

An investigational drug is one that has been tested in a laboratory and in animals and is being studied in human for efficacy and safety. Investigational drugs are not yet approved by the Food and Drug Administration (FDA) for use in the general population.

There are various mechanisms through which patients may obtain access to an investigational drug. These mechanisms include 1) clinical trials 2) the FDA’s expanded access program or 3) the recently passed Federal law known as the Right to Try Law. Each of these mechanisms will be discussed below and then compared in table format.

Clinical Trials: The standard mechanism for obtaining access to an investigational drug is through participation in a clinical research trial. A clinical research trial is conducted in accordance with a formal research protocol and its purpose is to evaluate the effectiveness and safety of an investigational drug. To participate in a clinical trial the patient must have the disease or disorder that is being studied and must also meet any specific inclusion or exclusion criteria defined in the research protocol. Patients can search for clinical trials that are being conducted at https://clinicaltrials.gov/.

Expanded Access Program: If participation in a clinical trial is not possible, access to an investigational drug may be sought through the FDA’s Expanded Access Program (EAP).

Access through the EAP may be appropriate when all of the following criteria are met:

  • The individual must have a serious/immediately life-threatening disease or terminal condition.
  • There must not be a comparable or satisfactory alternative therapy to diagnose, monitor, or treat the disease or condition.
  • The individual is unable to participate in a clinical trial.
  • Potential patient benefit justifies the potential risks of treatment.
  • Providing the drug to the patient will not interfere with the conduct of the clinical trial.

To apply for expanded access, the patient’s physician should first submit a request to the manufacturer of the investigational drug to obtain approval for the use of the product outside of the clinical trial setting. The manufacturer is under no obligation to approve such requests. If the manufacturer will provide the drug, the physician must then submit a request for approval to an Institutional Review Board (IRB) and to the FDA. An IRB is a committee that reviews the plan for the use of the drug to ensure that the rights and welfare of the recipient are protected. If FDA and IRB approval is provided, in the majority of cases the doctor must obtain informed consent from the individual who will receive the drug.  The individual’s consent is documented by signing an informed consent form that, among other things, describes the potential risks associated with the drug. More about the FDA’s Expanded Access Program is available at https://www.fda.gov/NewsEvents/PublicHealthFocus/ExpandedAccessCompassionateUse/default.htm

Right to Try Law: The Right-to-Try Law (RTT) was enacted on May 30, 2018. It is intended to provide terminally ill patients a more streamlined mechanism for access to investigational drugs. The Right to Try Law provides a right to request access to the drug. The manufacturer of the drug is under no obligation to grant such requests.

Like the EAP, the RTT law allows for the use of an investigational drug by a patient who has been diagnosed with a life-threatening disease or condition, who has exhausted approved treatment options, and who is unable to participate in a clinical trial involving the eligible investigational drug. An eligible investigational drug means a drug for which a Phase 1 clinical trial has been completed but the drug has still not been fully approved by the FDA. A Phase 1 clinical trial is done primarily to determine the dose of the drug that may be given safely to humans. Determining whether the drug is actually effective comes in later phases of the trial.

Unlike the EAP, the RTT law eliminates the need for approval from the FDA and Institutional Review Board and it provides the sponsor and physician protection from liability associated with harm caused by use of the investigational drug. While the RTT law does specify that the treating physician must obtain the informed consent of the patient, unlike the EAP, the RTT law does not specify the required elements of that informed consent.

Because the RTT law is fairly new, it is not yet clear whether this mechanism will be accepted by manufacturers of investigational drugs.

The following table describes the major similarities and differences of the three current processes by which seriously ill patients may obtain access to investigational drugs.

 

Clinical Trials Expanded Access Program Right –to Try-Law
Who can participate? Patients with a condition for which a drug is being developed who meet the inclusion criteria for the trial.

 

Patients with a serious/immediately life-threatening disease or terminal condition, unable to participate in a clinical trial. Patients with a serious/immediately life-threatening disease or terminal condition, unable to participate in a clinical trial.

 

Investigational Drug Not FDA Approved Not FDA Approved Not FDA Approved, Phase 1 trial completed

 

FDA Approval Required Required Not Required
IRB Approval Required Required Not Required
Informed Consent Required and must include specific elements required by regulation

 

Required and must include specific elements required by regulation

 

Required, but no specific elements are identified

 

 

Manufacturer Obligated to Provide the Investigational Drug Yes, to those individuals  who provide informed consent to participate in the trial No No
Liability waived for any risk associated with Drug No No Yes

 

How can I learn about research studies that are looking for volunteers?

To find ongoing studies that are currently recruiting participants at UConn, you can explore the following online listings:

To search for trials recruiting nationally, please check out the websites below:

 

New OVPR Website

The Office of the Vice President for Research is pleased to present a new and improved website. The new site is still home to all of the important information you need to take care of the day-to-day of your research projects, just in a prettier package. There is some new information as well, including:

  • Cross Campus Collaboration resource page
  • Training page related to all types of research-related trainings

Please note that the OVPR’s new sites for information pertaining to Storrs, the regional campuses, and UConn Health have new URLs. If you have bookmarked pages, you will need to update to the new URLs.

If you are having trouble locating something you need, please don’t hesitate to contact the relevant service unit. Visit the OVPR Contacts page to find the office or OVPR team you need.

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)