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Research Compliance Services News

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. 



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


UConn Storrs

Doug Bradway – 860-486-0986 or by email at

Jerry McMurray – 860-486-5756 or by email at

InfoEd Serving Storrs/Regional Campuses Restored

The Office of the Vice President for Research (OVPR) would like to notify researchers and administrators that planned maintenance to the InfoEd portal and associated systems has been completed. The InfoEd portal stores IRB and IACUC protocols, conflict of interest (COI) disclosures, and proposals for Storrs and the regional campuses. Service has been restored as of 1:00 PM on Friday, June 23, 2017.

Users may now login, create, modify or view proposals, IRB and IACUC protocols, and financial conflict of interest disclosures. Data systems that also rely on InfoEd should be updating data and connecting accordingly.

Thank you for your patience and cooperation as we conducted this necessary database move.

Should you have any questions or have difficulty accessing the system, please contact the eRA Help Desk at or 860-486-7944.

CITI Program Website Now Secured by UConn NetID

The Office of the Vice President for Research (OVPR) is pleased to announce that training offered through the CITI Program website is now secured by the UConn Single Sign-On NetID. Faculty, staff, and students at the Storrs and regional campuses will now be able to access the CITI Program website using their UConn NetID and password, instead of/in addition to a specific CITI Program website username and password.

The CITI Program is used by OVPR Research Compliance Services and UConn faculty, staff, students, and affiliates for online training related to animal care and use, biosafety, research with human subjects, NIH Good Clinical Practice, and Responsible Conduct of Research. Since partnering with CITI, over 20,000 UConn learners have used the CITI Program website to fulfill their regulatory training requirements.

Utilizing the UConn Single Sign-On makes it easier for faculty, staff, graduate and undergraduate students to access the CITI Program training courses with their existing UConn NetID and eliminates a unique username or password specifically for the CITI Program. It also assures faculty, staff, and student learners using CITI are correctly identified in training reports, making it easier to tell if the appropriate coursework has been completed.

To take advantage of this new feature, simply log in through our institution on the CITI Program website at instead of using your existing CITI login credentials. Further information about CITI Training requirements for the UConn IRB can be found on our website at


If you have any questions, please contact Matthew Cook at 860-486-1698 or

NIH Good Clinical Practice Training Requirement

March 17, 2017

Notification of NIH Good Clinical Practice Training Requirement

Effective:  January 1, 2017

The Office of the Vice President for Research (OVPR) would like to inform faculty involved with clinical trials about the NIH Good Clinical Practice Training requirement, effective January 1, 2017.

On September 16, 2016, the National Institutes of Health (NIH) issued a new policy for all NIH funded investigators and site staff who are involved in the conduct, oversight, or management of clinical trials (see Notice Number: NOT-OD-16-148). A clinical trial is defined by NIH 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.

The policy establishes that these NIH awardees and clinical trial staff* should be trained in Good Clinical Practice (GCP) consistent with the principles for the International Conference on Harmonisation (ICH) E6. Please note that this requirement pertains to trials of behavioral interventions as well.  According to the NIH, “The principles of ICH (E6) apply generally to all clinical trials. Some measures, e.g., reporting of adverse drug reactions to regulatory authorities, are pertinent specifically to trials of interventions involving drugs and devices, rather than to trials of behavioral interventions.  However, the underlying principle of safety monitoring and reporting is relevant to all clinical trials and can be a guide to behavioral investigators in their monitoring and reporting of safety events to relevant oversight bodies, e.g., the Institutional Review Board.”

The training requirement is effective as of January 1, 2017 and personnel are expected to complete it by April 30, 2017.  The requirement will be satisfied through completion of an on-line training module approved by the Associate Vice President for Research Integrity and Regulatory Affairs. UConn will use on-line modules provided through the Collaborative Institutional Training Initiative (CITI) for GCP.

Investigator Procedural Steps

  • CITI Training Course Login:

Individuals log in to the CITI website ( to complete GCP training.  Review question 8 and select a module(s) based on your primary research function.

  • Principal Investigators are responsible for ensuring that key personnel (as defined in note below) complete the GCP Training course by April 30, 2017.  This responsibility extends to personnel added during the course of the study by amendment.
  • The NIH application should be completed correctly to identify that the project is considered a clinical trial as defined above and in accordance with the NIH Grants Policy Statement.

IRB Staff Responsibilities

IRB Staff will verify that all applicable investigators and site staff have completed the required training. Verification will be study specific and done for all ongoing and new NIH funded clinical trials.  To be considered valid and current, the GCP training must be renewed every three years.  Failure to complete GCP training for new NIH funded clinical trials or to renew GCP education every three years may impact the ability to access your NIH funds and to obtain or maintain IRB approval.

If you have any questions, please contact Doug Bradway at 6-0986 or by email at

* Individuals identified by the investigator, who are responsible for study coordination, data collection and data management. The central focus of clinical trial staff is to manage participant recruitment and enrollment, to maintain consistent study implementation, data management, and to ensure integrity and compliance with regulatory and reporting requirements. These individuals may also seek informed consent from prospective participants, enroll and meet with research participants, and collect and record information from research participants. Clinical trial staff may also be called the research coordinator, study coordinator, research nurse, study nurse or sub-investigator.

ResearchMatch now available to UConn researchers

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

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

New Export Control Policy

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

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

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

Dr. Wesley Byerly
Associate Vice President for Research, Research Compliance Services
Office of the Vice President for Research
(860) 679-2230

Thanksgiving Holiday Closing Notice

The Office of the Vice President for Research will be closed for business on Friday, November 27, 2015 including:

  • Sponsored Program Services (860-486-3622)
  • Research Compliance Services (860-486-8802)
  • eRA Help Desk (860-486-7944)

Please contact the appropriate office in advance, should you anticipate a need for assistance.

On behalf of the Office of the Vice President for Research, Happy Thanksgiving!

IBC Policies & Procedures Updates

IBC Policies & Procedures

The IBC policies and procedures were developed to define the compliance requirements pertaining to research operations at the University of Connecticut. The document was designed to ensure that all research and instructional activities using biohazardous materials (e.g. r/sNA, viruses, bacteria, fungi, etc.) comply with the current editions of the NIH Guidelines for Research Involving Recombinant Synthetic Nucleic Acid Molecules (NIH Guidelines) and Biosafety in Microbiological and Biomedical Laboratories (BMBL). All Principal Investigators (PI) and laboratory personnel must adhere to the policies and procedures in the conduct of their research and the management of their laboratories. Click here for the IBC Policies & Procedures.

Laboratory Specific Biosafety Manual (LSBM)

The LSBM is an extension of the Biological Safety Manual providing detailed risk assessments of the biohazards associated in a PI’s lab. The LSBM is only required for BSL-2 labs with risk group 2 or above agents. Additional requirements can be found in the supportive document, Biohazardous Material Incident Management. LSBMs must be complete and available at the time of the PI’s 2016 biosafety inspection.


  • We have streamlined the process by providing a template that satisfies regulatory mandates, the NIH Guidelines and BMBL guidelines.
  • Incident Standard Operating Procedures (SOPs) for spills and exposures have been provided.
  • Biological agent risk assessments and SOPs, for some commonly used pathogens, will be supplied to assist PI’s with the new requirement. Check the IBC website for continuing updates and additional examples.
  • Faculty members with a similar binder, but who are missing required components may simply add those sections to their existing binders and store them in a central location in their labs.
  • All lab personnel are required to be trained on the contents of their PI’s LSBM.
  • The document will be a requirement for securing future IBC approvals.
  • Click here for the Laboratory Specific Biosafety Manual.

Questions on the IBC Policies & Procedures or LSBM? Contact Danielle Delage at (860) 486-1838.

Biological Safety Manual

The Biological Safety Manual was developed as the corresponding text to the Biosafety General training, and is the reference material to build laboratory specific biosafety programs and the LSBM. This resource is a collection of the materials and information presented during biosafety trainings and audits.


  • We have made it easier for you to find the Biosafety information you need by assembling it in one document with links to the BMBL guidelines and other regulatory agency standards.
  • The document is searchable, and the table of contents uses links to allow quick access to the specific information you need.
  • Click here for the Biological Safety Manual.

Questions on the Biological Safety Manual? Contact David Cavallaro at (860) 486-3613.


IRB Policy Change: Review of Research Methods Courses

The UConn Storrs Institutional Review Board (IRB) previously required that a protocol application be submitted to the IRB for any study for which human subjects research is the intent and the researcher proposes to use or involve human subjects student research projects conducted as part of Research Methods Courses.

As of July 1, 2015, that policy has been revised as follows:

A protocol application must be submitted to the IRB for any Research Methods Course where student human subjects research projects meet the regulatory definition of research: “Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.” Examples of this include: whole class projects where students are assisting the faculty member to collect data for the faculty’s own research purposes, those classes where each research project is designed to support a Master’s Thesis or a Dissertation, research projects intended to generate data that will be directly used for publication or presentation, or research projects designed to support further research (e.g., having students collect pilot data to support a future grant application or larger research project). Currently approved Research Methods Course protocols that meet the definition of research must be submitted for re-approval.

Any Research Methods Course where the goal of the student human subjects research projects is solely to provide an educational experience for the students that does not meet the regulatory definition of research will no longer require submission of a protocol application to the IRB.  Presentations of the data in the context of the class does not meet the definition of research.  Any individual or group projects within this course that do meet the definition of research must be submitted to the IRB as stand-alone protocols for review and approval.  Note that any currently approved Research Methods Course that does not meet the definition of research does not require submission to the IRB for re-approval.

Course instructors are encouraged to contact Doug Bradway at 860-486-0986 or by email at with any questions.


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