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Program in Accelerated Therapeutics for Healthcare (PATH)

PATH is a partnership that includes the Office of the Vice President for Research (OVPR), the School of Pharmacy, and the School of Medicine to accelerate the translational pathway for researchers to convert their discoveries to new medical therapeutics. Under PATH, funding will be provided to academic research programs designed to quickly develop novel therapeutic approaches focusing on well validated molecular targets for a specific disease areas with an unmet treatment need in the current commercial marketplace. Projects focusing on a wide range of therapeutic interventions (small molecule, biologic, antibody, peptide, gene therapy) are eligible for consideration. Projects related to medical diagnostics, medical devices, and digital health are not eligible. Two levels of funding will be available through this mechanism: PATH Trailblazer Grants will provide up to $10K for preliminary work in support of treatment development while PATH Ascent Grants will provide $75K-$150K to accelerate the development of promising therapeutics.

To learn more about the program, visit the OVPR Storrs site.

Convergence Awards for Research in Interdisciplinary Centers (CARIC)

CARIC is an initiative of the Office of the Vice President for Research (OVPR) that supports the development of collaborative interdisciplinary teams to bid for major (>$5M) federally funded initiatives, such as research centers. CARIC provides funding for planning, outreach to strategic partners, and proof-of-concept research activities that will prepare the team to bid competitively for these prestigious federal awards. All applications must demonstrate that the teams proposed are new collaborations that cross traditional disciplinary boundaries or include a significant expansion/deepening of existing interdisciplinary collaborations. The federal funding initiative being targeted must be identified explicitly.

To learn more about the program, visit the OVPR Storrs site.

2019 CARIC Award Recipients Announced

Dear Colleagues,

I am pleased to announce that two teams have been selected for funding in the inaugural cycle of CARIC (Convergence Awards for Research in Interdisciplinary Centers).

CARIC supports the development of collaborative, interdisciplinary teams bidding for major federally funded research initiatives. These initiatives can include large, multi-million-dollar research grants or even entire research centers.

2019 CARIC Awards:

  • David Rowe, Director of the Center for Regenerative Medicine and Skeletal Development
    Bed to Bench (BTB) Collaboration for Skeletal Research
  • Yu Lei, Castleman Distinguished Professor, Chemical and Biomolecular Engineering
    Exposure, Health Effects, Sensing and Remediation of Emerging Contaminants Superfund Research Program (SRP) Center

The CARIC program will provide these projects with funding of up to $150,000 to support planning, outreach to strategic partners and proof-of-concept research for a year, with the possibility for renewal. This initial funding allows researchers to develop more competitive bids for prestigious national awards.

To learn more about CARIC, visit the website of the Office of the Vice President for Research.

Sincerely,

Dr. Radenka Maric
Vice President for Research
UConn/UConn Health

HSPP- October-November-December, 2018

Overview of Major Changes to the Common Rule (45 CFR 46)

The revised version of the regulation governing human subjects research (i.e. 45 CFR 46 also known as the Common Rule) became effective January 21, 2019. Accordingly, several IRB forms, documents templates, policies and the IRB applications in IRIS have been revised. It is the intention of the IRB that all federally funded/supported research will be brought into compliance with the revised regulation at the time of the continuing review that occurs on or after January 21, 2019.   Until such time as that review occurs those studies are considered grandfathered under the previous version of the regulation.  Investigators may request to transition to the revised regulation soon by submitting a request for modification.

 

The following sections contain a summary of the major changes.

The Consent Form Template and Consent Checklist have been revised to incorporate seven new elements of consent for federally funded/supported research. The new requirement regarding process and the new 7 elements of a consent are as follows

  • Consent 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 to 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):
  • 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
  • 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
  • If applicable, 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
  • If applicable, a statement regarding whether clinically relevant research results, including individual research results, will be disclosed to subjects, and if so, under what conditions
  • If applicable, 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).

For those approved federally funded/supported research studies that are actively enrolling subjects, investigators should submit either at the time of continuation or through a request for modification a revised consent form with the new required elements. Until such time as this review occurs studies are considered grandfathered under the current version of the Common Rule. Subjects will not be required to be re-consented based solely on these changes.

For federally funded/supported studies that are closed to new enrollment the consent form will need to be revised only if there is another reason that triggers a change to the document. For example if new risks are being disclosed, at the time the consent is revised to incorporate the new risk the consent would also have to be brought into compliance with the new requirements.

For previously approved non-federally funded/supported research, no changes are necessary; however, these new elements will be used as the guiding principle of consent elements moving forward.

To learn more about the new elements of consent please review IRB Policy 2011-008.0.pdf– Informed Consent – Forms

The revised regulation expands the definition of Legally Authorized Representative to now recognize that if State law is silent legally authorized representative means an individual recognized by institutional policy as acceptable for providing consent in the non-research context on behalf of the prospective subject to the subject’s participation in the procedure(s) involved in the research.

To learn more about the new changes to the consent process please review IRB Policy 2011-008.5.pdf – Informed Consent – Providing and Obtaining Informed Consent

 

Waiver/Alteration of Consent: When a waiver or alteration of consent is requested the following additional criterion must be met in order for the IRB to grant the waiver/alteration.

  • If the research involves using identifiable private information or identifiable biospecimens, the research could not practicably be carried out without using such information or biospecimens in an identifiable format.

If a waiver is still necessary (see below) for federally funded/supported studies investigators must be sure to address this additional element at the time the study is transitioned to the revised rule.

The revised regulation allows for certain activities regarding screening, recruiting or determining eligibility (e.g. telephone screening or chart reviews for the purpose of determining eligibility) to occur without a waiver/alteration if either of the following conditions are met:

  • The investigator will obtain information through oral or written communication with the prospective subject or legally authorized representative, or
  • The investigator will obtain identifiable private information or identifiable biospecimens by accessing records or stored identifiable biospecimens.

 

The above change has been already be implemented for non-federal studies, and as of January 21, 2019 will be implemented to federally funded studies. If a waiver had been previously approved but is no longer necessary, that document should not be included in the submission packet at the time the study is transitioned to the revised rule.

Note:   There has been no change to HIPAA and there must be adequate measures in place to protect the confidentiality of any information collected for the purpose of screening, recruiting or determining eligibility prior to informed consent.

To learn more about the new changes to the waiver of consent please review IRB Policy 2011-008.2.pdf – Informed Consent – Waivers and Alterations

 

Waiver of Documentation of Consent: There is a new provision for allowing for waiver of documentation of consent. Documentation of consent may also be waived if the subjects or LAR are members of a distinct cultural group or community in which signing forms is not the norm, that the research presents no more than minimal risk of harm to subjects and provided there is an appropriate alternative mechanism for documenting that informed consent was obtained.

To learn more about the new changes to the waiver of documentation of consent please review IRB Policy 2011-008.2.pdf – Informed Consent – Waivers and Alterations

 

Changes to Continuing Review Requirement: Unless otherwise required and justified by the IRB, continuing review will no longer be required for non-FDA regulated federally funded research that meets the criteria for expedited review.

 

Investigators who have non-FDA regulated federally funded research that qualifies for expedited review will be asked to provide an expected completion date of the research, which will become the expiration date of IRB approval.   For previously approved research this may be provided as part of one last request for continuation (e.g. if IRIS has already generated a continuing review due task) or as part of a request for modification. The PI will be required to submit a request for modification to extend this expected completion date if necessary.   The IRB may require justification for the expected completion date as it deems appropriate.

Note:   Continuing review is still a requirement for all FDA regulated research even if all subjects are in long-term follow-up or the research is in data analysis. The IRB has already implemented this practice for expedited research that is not federally funded or subject to FDA oversight.

 

New Exempt Categories : There have been several revisions to the types of research that may be exempt and the exemptions may now apply to research that only incidentally includes prisoners as subjects (e.g. the research is aimed at involving a broader subject population and only incidentally includes a subject who became incarcerated after providing consent). These categories are applicable regardless of funding source. The new exemption categories are described in the form titled Request for Exemption

Any study previously granted an exemption remains grandfathered under that exemption.

Studies that had been approved through the expedited process that may qualify for exemption under the revised regulation will be transitioned to exempt status on a case-by-case basis as requests for continuation or modifications are received.

To learn more about the revised Exempt categories please review Policy # 2011-009.2.pdf – Institutional Review Board – Exemptions

 

Changes to the Initial Application Form in IRIS:   The IRB application form in IRIS has been edited. The request for Exempt status categories and Expedited review categories have been removed from the application and are now described in two separate word documents to be attached to the application form in IRIS. The following forms have been published in the IRB website:

  1. The following IRB forms have been updated and published in the IRB website:
  • Application Checklist for Expedited Review (to reference request for expedited review form)
  • Application Checklist for Exemption (to reference request for exemption form)
  • Consent Checklist Addendum to Transition to Revised Rule (lists only new elements of 45 CFR 46 to incorporate into prior version of ICF for studies approved prior to 1/21/2019)
  • Human Subject Determination Form (based on updated definitions and activities that are deemed not to be research)

 

RESEARCHMATCH NOW AVAILABLE IN SPANISH!

ResearchMatch (RM) is the national online recruitment tool that matches people interested in participating in studies with researchers throughout the U.S. There is no cost to UConn Health researchers to use ResearchMatch. Once you register as a researcher, you can review the population characteristics of the ResearchMatch registry, which includes over 135,000 people from every state in the country.

*NEW* ResearchMatch has just launched a Spanish version of the website inviting Spanish speakers to sign up in Spanish. Researchers from UConn Health are now able to connect with and recruit Spanish-speaking volunteers for their studies.

If you would like to use ResearchMatch, you will need IRB approval for this recruitment method, including approval of the contact message emailed to volunteers. ResearchMatch can be added to an already-approved study via a modification.

Interested in using ResearchMatch? Sign up now, attend an online training, or visit our webpage or contact Ellen Ciesielski for more information.

Already registered with ResearchMatch and want to recruit Spanish-speaking volunteers? Submit your ResearchMatch contact message and other materials translated into Spanish (consent form, questionnaires, etc.) for IRB approval and ensure you are prepared for inquiries from Spanish-speaking volunteers.

Innovate Stamford

Stamford campus at night

(Photo by Chuck Choi)

UConn and Innovate Stamford have partnered to provide a platform of new programs that will strengthen Stamford's position as a leader in technology, innovation, and entrepreneurship.

In 2017, Innovate Stamford formed and was catalyzed with a $2 million grant from CTNext, a state-funded subsidiary of the quasi-public venture capital firm Connecticut Innovations. The grant designates Stamford as an “Innovation Place,” a hub for innovation, entrepreneurship and business growth. This is part of a statewide effort to build a more robust community of entrepreneurs and accelerate startup growth by providing access to talent, space, industry expertise, services, skill development, and capital.

The UConn-Innovate Stamford collaboration leverage's UConn's research infrastructure, expertise, and facilities.  There are currently three phases of program development:

  • Summer Internships:  UConn's Office of the Vice President for Research is administering the UConn-Innovate Stamford Internship Program to help connect talented students and Stamford businesses.  As part of a two-month internship, 50 UConn undergrads will work with Stamford companies in a variety of areas, such as marketing, engineering, digital media, and computer science.  Student interns receive a $5,000 stipend, as well as free accommodation in the UConn Stamford campus housing.
  • Experiential Learning with Accelerators:  The second phase of the initiative will involve the establishment of accelerator teams. In this experiential learning program, students will be paired with a Stamford startup company and will delve deeper into the inner workings of such small businesses. The program will run through the academic year, and will involve attending an orientation class, spending 10-hours per week on a project outlined by the startup company, and completing corresponding assignments as a part of the experience. This program will build on the success of Accelerate UConn, an NSF I-Corps site run by the Connecticut Center for Entrepreneurship and Innovation in the School of Business.
  • UConn Technology Incubation Program (TIP):  The third phase will include an expansion of UConn's programs in customer discovery, technology transfer, venture development, and R&D support.  A key objective is to extend UConn's Technology Incubation Program through the creation of a fully-fledged physical incubator in Stamford.  This will strengthen Stamford's ability to attract, support, and grow early to mid-stage companies, and will encourage entrepreneurial and corporate engagement, global outreach to new talent, and industry partnerships.

For more information about the UConn-Innovate Stamford collaboration, contact:

Mark Aindow, PhD
Executive Director for Innovation,
External Engagement, and Industry Relations
m.aindow@uconn.edu
860.486.1339

Active and Pending Support

Also known as “Other Support” or “Current and Pending Support”

Generally, sponsors request information on active (current/awarded) and pending support to evaluate potential scientific and/or commitment overlaps. In asking for identification of “other support” in a grant application, a funding agency’s interests include, but are not limited to, identifying and eliminating duplication of funding for specific budgetary items, understanding the investigator’s capacity to complete projects (e.g., effort available), protect national security or economic interests, and assess potential conflicts of interest.

Active and pending support includes all financial resources whether funded through the University or not such as Federal, non-Federal, commercial or organizational support, available in direct support of an individual’s research endeavors, including, but not limited to, research grants, cooperative agreements, contracts, or organizational awards. This includes research support from foreign governments or entities. Other support does not include training awards, prizes, or gifts.

National Institutes of Health (NIH)

In a letter issued by Dr. Francis Collins, Director, National Institutes of Health, the NIH asks institutions to “make sure that, in accordance with the NIH Grants Policy Statement, all applications and progress reports include all sources of research support, financial interests, and relevant affiliations.” The appropriate vehicle for such submission is the “Other Support” or “Active and Pending Support” sections of applications and reports. In providing this guidance, NIH specifically identified areas of concern, including:

  1. Failure by some researchers working at NIH-funded institutions in the U.S. to disclose substantial resources from other organizations, including foreign governments, which threatens to distort decisions about the appropriate use of NIH funds.
  2. Diversion of intellectual property in grant applications or produced by NIH-supported biomedical research to other entities, including other countries; and
  3. In some instances, sharing of confidential information by peer reviewers with others, including in some instances with foreign entities, or otherwise attempting to influence funding decisions.

These concerns reinforce the importance of accurately disclosing active and pending support during the proposal process. Such disclosure needs to be submitted for all key personnel and needs to include all financial resources, whether federal, non-federal, industrial, non-profit, other universities or research institutions, both foreign and domestic, and sub-contracts.

As a reminder, applicants are required to indicate whether a grant project includes a “foreign component” in the proposal and if yes to include a justification document. If after award, an applicant wishes to add a foreign component prior NIH approval is required. A foreign component is defined in the NIH Grants Policy Statement, Section 1.2, as performance of any significant element or segment of the project outside the United States either by the recipient or by a researcher employed by or affiliated with a foreign organization, whether or not grant funds are expended.

See also Statement on Protecting the Integrity of U.S. Biomedical Research which concerns address the requirements to follow NIH Policy as it relates to other support, disclosure of foreign components and disclosure of financial interests.

National Science Foundation (NSF)

The National Science Foundation (NSF) expects that PIs and senior personnel will list any activity that provides funding to their work and/or a commitment of time by the individual in the same manner as described in the previous section for NIH using the Current and Pending section of proposals.

The National Science Foundation also requires that PIs submit information about collaborators and other affiliations for senior project personnel. This information is in addition to Current and Pending Support and may include advisor/advisee relations, coauthors, editorships, business or family relationships that are relevant to peer review. Templates for the tables in which these elements are reported are found in NSF’s Proposal & Awards Policies & Procedures Guide (PAPPG).

As a reminder, applicants are required to indicate whether a grant project includes “international activity” in the proposal. If international activity is contemplated after award, NSF prior approval is required.

Links and Resources

National Institutes of Health

“NIH Grants Policy Statement.”
https://grants.nih.gov/grants/policy/nihgps/nihgps.pdf

“Other Support” in Grants & Funding.
https://grants.nih.gov/grants/forms/othersupport.htm

“Biosketch Format, Instructions and Samples.”
https://grants.nih.gov/grants/forms/biosketch.htm

National Science Foundation

Proposal & Award Policies and Procedures Guide
https://www.nsf.gov/publications/pub_summ.jsp?ods_key=papp

“Current and Pending Support”
https://www.nsf.gov/pubs/policydocs/pappg18_1/pappg_2.jsp#IIC2h

“Synergistic Activities”
https://www.nsf.gov/pubs/policydocs/pappg18_1/pappg_2.jsp#IIC2fid

“Collaborators and Other Affiliations Information” and link to “Frequently Asked Questions (bottom of page)
https://www.nsf.gov/bfa/dias/policy/coa.jsp

Technology Incubation Program (TIP)

UConn offers expansive innovation and entrepreneurship capacity developed in response to state and national needs, and is well positioned to help your business start, compete and grow. Its Technology Incubation Program (TIP) offers startups and expanding R&D operations the opportunity to locate on UConn campuses and to leverage University resources to enable their success. Offering a collaborative entrepreneurial environment, TIP provides access to business and technical talent as well as world class R&D capacity as part of UConn’s vibrant entrepreneurial ecosystem.

Visit TIP at tip.uconn.edu

Salary Charging

Sponsors, mostly federal but also some non-federal, impose a salary cap or salary limitation as a requirement in proposing and when accepting an award. A salary rate cap or limitation of salary imposed by a sponsor may be due to one of the following:

  • The Consolidated Appropriations Action, 2014 (H.R. 3547/Public Law 113-76) the Department of Health and Human Services’ (DHHS) agencies with the exception of the FDA (funded under the USDA appropriations bill) and the Indian Health Service (funded under the Department of Interior appropriations bill) are required to:
    • Impose a salary rate cap applicable to grants, cooperative agreements and contracts (with the exception of those that are clearly defined to be exempt from the cap) for all DHHS agencies (i.e. HHS, NIH, AHRQ, CDC, HRSA, SAMHSA, etc.).
    • Sets the salary rate cap at the Executive Level II of the Federal Pay schedule.
  • Sponsors (federal and non-federal) other than the sponsors identified above may have a salary reimbursement request limitation as a matter of policy (Ex. NIH K awards and NSF Awards); and
  • Sponsors (federal or non-federal, including subawards or pass-thru awards) may have a salary rate cap that may be program specific limiting the recovery of salary.

For more information:

http://www.hhs.gov/grants/contracts/contract-policies-regulations/salary-rate-limitation/index.html
https://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-049.html
http://grants.nih.gov/grants/policy/salcap_summary.htm

Award Management System

Award Management System (AMS) supports pre-award requests and automated notifications of award setups, in addition to the electronic Labor Redistributions (LDCAs), Effort Reporting, Committed Effort Management and the My Funding grant review module. Over the coming year, the system will be expanded to include other grant management functions.

Link to AMS: https://ets.uchc.edu

Request AMS Access

AMS uses a single-sign on portal which means it uses your UCH assigned User Name and Password. Employees are automatically registered in AMS. Please contact Ella Sun at esun@uchc.edu or at 860-679-8961 if you are a new user in AMS so you can be assigned an appropriate position which will activate your account in AMS.

AMS Help-AMS Quick Guides

Committed Effort

Committed effort that is promised to a sponsor (as part of the proposal) for principal investigators (PIs), co-principal investigators and key personnel is available for review by faculty and departmental staff at UConn Health via the Committed Effort Report which can be accessed from AMS. These reports are entered and tracked by the AMS-Committed Effort module.

  • Fund Setup Team enters all faculty member’s and key personnel’s committed effort based on the grant application when completing the fund setup.
  • Fund Setup Team deletes/edits faculty member and key personnel’s existing committed effort if change in committed effort is approved by the sponsor.
  • It is expected that the PIs and his/her department administrators will report significant reductions in committed effort for PIs and additional key personnel to sponsors.