uconn

Types of Research

While FDA-regulated and other biomedical studies are conducted on campus, the research conducted at UConn Storrs is primarily social/behavioral in nature. Although federal regulations for the protection of human participants cover both biomedical and social/behavioral research, they are not specific regarding the various types of social/behavioral research. Therefore, the IRB developed the guidance to assist in the development and review of Qualitative/Ethnographic, Focus Groups, Oral History and other types of social/behavioral research. The guidance is available on the IRB website.

Review of Studies Conducted in Foreign Countries

Research conducted by UConn investigators in foreign countries remains under UConn purview and guidelines. While adjustments may be made to some requirements to respect cultural differences, our standards for ethical conduct are not relaxed.

The IRB may require that research projects be approved by the local equivalent of an IRB before the IRB will grant final approval. Where there is no equivalent board or group, investigators must rely on local experts or community leaders to provide approval. The PI must provide the IRB with documentation of this “local approval” and documentation of the authority and expertise of the individual or group who granted approval. There must also be detailed plans in place for local monitoring of studies that pose more than minimal risk to participants. Researchers must describe what, if any, knowledge or experience they possess regarding the language and culture of the country in question. If the IRB is not satisfied with the review of local experts and/or the plans for continued monitoring there is the possibility that the study will not be approved.

The IRB may seek guidance first from OHRP’s International Compilation of Human Subject Research Protections or it may contact OHRP to determine whether procedures described by a foreign institution afford protections that are at least equivalent to U.S. regulations 45 CFR 46.101(h) and may be substituted for the U.S. regulations. Under this provision, OHRP investigates the foreign country’s guidelines for human participants research, and if the foreign guidelines are found to be equivalent to U.S. regulations, the investigator is permitted to substitute those foreign procedures.

Research Requiring Review More Frequent Than Annually

The IRB will require that continuing review occur more often than annually in the following circumstances:

The research involves the use of procedures that have not been studied in humans.
The research is expected to result in a high frequency of morbidity or mortality.
The investigator has a history of serious or continuing noncompliance that the IRB believes necessitates closer monitoring.
Any other situation in which the IRB believes that more frequent continuing review is warranted.

Verification from Sources Other Than Investigators:

The IRB will require independent verification from sources other than the investigator that no material changes (i.e. changes that are both relevant and consequential) have occurred since previous IRB review in the following situations:

When there is inconsistency in the information presented by the investigator to the IRB and those inconsistencies cannot be easily resolved.
When the IRB questions the ability or the willingness of the investigator to provide accurate information.
When concerns have been raised, via continuing review or from other sources, that material changes have been implemented without IRB approval.
Other circumstances for which the IRB deems independent verification is needed.

In most cases the Research Compliance Monitor will conduct the verification. The monitor has access to all research data and may observe the research and consent process. The IRB may require that an ad-hoc consultant with particular expertise review the research activity. Such consultants will not have a professional or financial interest in the research. The IRB Chair may determine who will act as the consultant and will also confirm that no conflicts exist. The individual performing the verification will provide the IRB staff with a written statement of the verification. The IRB staff will make this information available to the IRB members and also place a copy in the IRB study file.

Scientific Review

The Common Rule and corresponding FDA regulations require the IRB to determine that the study is designed so that risks to participants are minimized and justified by potential benefits (refer to 45 CFR 46.111(a)). Therefore, the IRB will carefully consider the study design and overall scientific quality of each study, particularly those studies that are investigator-initiated and/or unfunded. In evaluating the scientific design, the primary reviewer (exempt and expedited studies) or the primary reviewer and convened IRB (full board studies), will consider the following:

clarity of the research question
appropriateness and efficiency of design
rigor and feasibility of methods
qualifications and expertise of the research team
scholarship and pertinence of background material and rationale
adequacy of sample size and relevance of controls and
the validity of the statistical analysis plan.

When necessary the IRB may ask consultants with additional expertise to review the research study.

Categories of Study Status

Submissions to the IRB will fall into one of the status categories noted below:

Approved – This decision is used when a study is given final approval either through the exempt, expedited, or full board review process. Final approval of a full board study means that all modifications initially required have been addressed. If the study is approved through the expedited or exempt review process, the specific category by which expedited or exempt review is permissible is noted. A study can begin only after final approval is granted. This category is also used to reflect approval of requests for continuations and amendments.
Modifications Required in Order to Secure Approval – This decision is used when the full board has reviewed a study at a convened meeting and requires minor modifications before final approval will be given. This category may also be used for expedited review, requests for continuation (re-approval), and amendments. Upon satisfactory response to the request for modifications, the Chair or his/her designee is authorized to grant final approval without re-review by the full board. The IRB may also request that the PI make modifications to an application for initial or continuing expedited or exempt review. This is communicated to investigators through letters from the IRB. Final approval of an expedited or exempt study means that the requested modifications initially identified have been satisfactorily addressed.
Deferred – This decision is used when the full board has reviewed a study at a convened meeting and has significant concerns with the protocol, consent document or other relevant material, or requires substantive clarifications on issues that relate to the required criteria for approval. For example, if the protocol contains insufficient information to assess the nature and purpose of the study, or if the IRB requires clarification as to why a procedure is being followed in the study, the study will be deferred until the convened IRB can determine that risks to participants are minimized. The PI is encouraged to make a point-by-point response in writing, and must resubmit the application for full board review. This category may also be used for requests for continuation and amendments.
Disapproved – This decision is used when the full board reviews a study and determines that one or more of the elements required for approval (refer to Criteria for Approval section) has not been met, and in the Board’s opinion, cannot be satisfied through revisions to the application (for example, if the Board determines that balance of risks to benefits is unacceptable). This category may be used for requests for continuation and amendments. The decision is made by the convened IRB. Protocols may not be disapproved by the expedited or exempt review mechanism.
Tabled – This category is used only when a study is not reviewed at the meeting for which it was originally scheduled, for example, due to loss of quorum. This category may also be used for requests for continuation and amendments.
Closed – This decision is used to reflect that a study is closed/completed. An investigator may request closure of a study when the research project will no longer be pursued, or when data analysis is finished, and the essential work of the study is completed.
Terminated – This decision is used to reflect that a study has been closed by the IRB. A study may be terminated due to failure to request continuing review beyond a 30-day grace period after the study expiration date. The IRB may terminate a study for noncompliance or due to the occurrence of serious or unexpected risks to participants. Termination of previously approved research is defined as a permanent withdrawal of study approval that requires all study related activity to cease. The investigator will be notified of studies terminated by the IRB. Terminations are not reportable events.
Suspended – This decision is used to reflect the imposition of a temporary hold on any or all research activity associated with a study, or a permanent stop to some portion of a previously approved research activity.

IACUC Forms

Animal Care and Use Protocol Form (IACUC-1)

Petition to Exempt Activities Using Invertebrates, Biological Materials, or Animal Observation in Teaching or Research (IACUC-2)

Owner Consent Form (Appendix B)

Personnel Assigned to Work on Animal Research Protocols (Appendix C)

Use of Hazardous Agents (Appendix D)

Consideration of Alternatives (Appendix E)

Surgery (Appendix G)

Occupational Health & Safety Animal Handler Form
Must be completed along with the IACUC-1 form and submitted to the appropriate department.

Animal Care Services Forms

References and Checklists

Checklist of Required Documentation

Checklist of Required Content

External Investigator FCOI Disclosure Form

If you need a financial disclosure form for an external (non-UConn) subrecipient that does not have a Financial Conflict of Interest policy, please see https://ovpr.uconn.edu/services/sps/proposals/forms/

InfoEd

Human Subject applications, protocols and associated supplemental materials are submitted to the UConn Storrs and Regional Campus IRB using the Human Subjects / IRB Module of the UConn InfoEd eRA Portal at https://www.infoed.uconn.edu.

See the Human Subjects / IRB How To Guides for more information about the using the InfoEd (Storrs) eRA portal including step-by-step instructions for creating initial IRB protocols and other types of protocol submissions (modifications, requests for continuation/closure, and protocol deviations or adverse events).

For technical assistance using the InfoEd eRA Human Subjects module, email era-support@uconn.edu or call 860.486.7944. The eRA Help Desk is staffed Monday-Friday, 8:00 AM – 4:30 PM.

Proposal (Pre-Award) Forms

SPS must receive proposals and supporting documents at least 5 working days prior to the program deadline to ensure review and sign-off.

Internal Proposal Review Form
Required to be completed for all new proposals, requests for supplements, continuations, and renewals to be reviewed and approved by SPS. Save form to your PC before filling out the form. Note: for preproposals and letters of intent, signatures are not required.

Instructions:

Distribution of Credit.

Program Type Definitions & Examples.

Key and/or Responsible Personnel Supplemental Form
Required to be completed for all proposals with more than eight Multiple PIs, Co-Principal Investigators, or other Key and/or Responsible Personnel. Save form to your PC before filling out the form.

Cost Share Form
Required to be completed for all proposals committing cost sharing. All cost sharing requires the written approval (documented by signature or other written form) from the appropriate individual providing the cost sharing. This form is not required for salary over the cap. Save form to your PC before filling out the form.

SPS Proposal Cover Page
Required to be completed by the PI and signed by SPS signatory if sponsor does not provide a document to be signed by SPS signatory including applications where UConn submits as a subawardee.

Attachment for Human Stem Cell Research
For all research that involves the use of human stem cells or human embryos, and for all research projects submitted to the State of Connecticut Regenerative Medicine Research Fund (RMRF).

Information and Compliance Form for Subrecipients
Required to be completed by the Subawardee and signed by Subawardee signatory.

External Investigator Financial Disclosure Form
Required to be completed by all responsible personnel from other institutions who do not have a compliant Financial Conflict of Interest policy.

NASA Certification
Required to be completed when seeking funding from NASA.

NIH Multiple PI Certification Form
Required to be completed and signed by PIs from other institutions involved in multiple PI applications.

NIH NRSA Fellowship Certification Form
Required to be completed by Individual Fellow and submitted with all NIH PHS 416-1 grant applications, PHS 416-9 progress reports, and prior approval requests. Save the form to your PC before filling out the form.

NSF Safe and Inclusive Working Environment Resource Document (includes Plan Template)
Plans must be provided to Pre-Award Services for all National Science Foundation proposals involving off-campus or off-site research.

Request for Approval to Serve as Principal Investigator Form
Required to be completed by employee requesting approval to serve as PI or Co-PI who are normally considered ineligible and submitted to SPS for approval.

Electronic Research Administration Forms

InfoEd User Account Information Request Form
Use this form if you have forgotten your InfoEd Username/Password or are unsure if you have a user account.

Research.gov Account Registration Form
Investigators who wish to obtain NSF funding are required to register with the Research.gov. Complete this Research.gov form if you need to establish a user account. Once completed, SPS will receive an email notification from Research.gov and approve the registration. Step-by-step instructions can be found in the Account Registration Guide.

NIH eCommons Account Request
Investigators who wish to obtain NIH funding are required to register with the NIH e- Commons system. Complete this form if you need to establish a user account.

dbGaP
Use this form to request access to data sets from the appropriate dbGaP Data Access Committee.

IBC Review & Approval

PIs must complete and submit an IBC registration/biological summary to register research or teaching activities that involves the use of biological materials. Biological materials may include, but is not limited to the following:

Recombinant / synthetic nucleic acid (rsNA) molecules
Bacteria and their phages and plasmids
Viruses, viral vectors, and their particles (including prions)
Biological toxins
Fungi
Parasites
Human and non-human primate tissues, body fluids, blood, blood byproducts, and cell lines
Transgenic and wild type animals and plants, as well as animal remains and insects that may harbor zoonotic pathogens

The UConn IBC for Storrs and Regional Campuses, use an electronic database called HuskySMS (Powered by SciShield), to review and approve registrations and amendments. The lab must be bio-enabled by the IBC Coordinator. Please contact the IBC office via email, ibc@uconn.edu, to begin the registration process.

To access HuskySMS, use the following url, uconn.scishield.com. Personnel can log in using their UConn NetID and password.

If you have any questions about HuskySMS and need help, please feel free to contact ibc@uconn.edu with “HuskySMS Support” in the subject line.

The IBC registration process solicits information to describe how biological materials are being used in the lab, the source and nature of the rsNA constructs, host/vector systems, potential risks to human health and the environment with emphasis on practices, as well as engineering controls used to contain potentially biohazardous materials.

Please note that activities involving RG2 organisms as host-vector systems, cloning RG2 DNA into non-pathogenic bacteria, use of infectious or replication-defective viral vectors, as well as rsNA constructs in animals or plants must not begin until the committee has reviewed and approved the submission.

IBC Review & Approval Process

After submitting the completed biological summary, the following steps occur:

Step 1: Notification of Receipt of Registration Once a biological summary is submitted and is ready for review, an email notification will be sent to the PI indicating that the registration status has changed to under EHS Review.

Step 2: Preliminary Review All new biological summaries will undergo a preliminary review by the IBC Coordinator and the IBSO. The IBC Chair will conduct preliminary reviews as deemed necessary by the IBSO and IBC Coordinator. The PI will be notified by email with any requests to modify the biological summary. The PI will then make any necessary changes to the registration and contact the Coordinator within HuskySMS to ensure changes have been submitted, thereby making it suitable for committee review.

Step 3: Classification of Experiments PIs make an initial classification of their rsNA experiments based on the NIH Guidelines. The IBC Coordinator and IBSO, in consultation with the Chair or an IBC primary reviewer (as needed), screen the registration to verify the PI’s initial classification. The IBSO and the IBC Coordinator make the final determination for the level of review required.

Step 4: IBC Review Once the registration has been classified, it is placed into one of the two review categories below:

Full Committee Review & Approval

Projects in the following categories generally require full committee review prior to the initiation of research:

- Projects involving microorganisms that are pathogenic to humans and/or animals (Risk Group 2 or higher),
- Projects involving organisms that could have a significant impact on the environment if accidentally released from the lab (i.e. exotic plants, non-indigenous plant pathogens or regulated insects),
- Projects involving activities that are subject to the NIH Guidelines, section III-A through III-D, and require containment under BSL-2, BSL-3, or involve large scale production under BSL1-LS or BSL2-LS,
- Human gene therapy trials subject to NIH Guidelines, section III-C,
- Registrations involving a contentious issue that the IBSO is not able to resolve,
- Projects classified as III-E under the NIH Guidelines will be reviewed by the full committee at the next regularly scheduled meeting. The IBSO will conduct primary reviews for registrations that fall into Section III-E. During the IBC meeting, the committee will vote for approval of all listed III-E protocols. Note: PIs will be notified if their registration falls into this category, as research activities may be initiated upon submission to the IBC.

Administrative Approval by IBSO

The IBC has delegated authority to the IBSO to approve minor administrative matters with notification to the full committee during the next regularly scheduled meeting. Minor administrative matters include but are not limited to:

- IBC Registrations/biological summaries that are classified under III-F of the NIH Guidelines,
- Minor amendments that do not affect the originally assigned biosafety level(s), risk group, or NIH classification(s),
- Addition of grant titles utilizing the same host/vector systems,
- Non rsNA registrations.

Step 5: IBC Decision

All committee decisions are communicated to the PI in writing.

For registrations requiring full committee review, one of five determinations below will be made:

Approved – The IBC Registration was approved as written.

A letter approving the registration will be signed by the Chair and sent to the PI. Copies of the approval letter will also be provided to Sponsored Programs Services (SPS), the Department Head, and other applicable RCS committees (IRB, IACUC, and SCRO).

Approved with Administrative Edits – The IBC Registration will be administratively approved by the Chair once the PI certifies and submits administrative edits made by the IBC Office.

The IBC Coordinator will send an email to the PI within HuskySMS, requesting their review and certification of administrative changes made by the IBC Office. The PI will have 14 days from the date of the ‘Administrative Edits’ email, to submit the revised bio-summary. If PIs cannot meet this deadline, they must contact the IBC Coordinator or the IBC Chairperson, to request an extension.

Approved with Minor Revisions Requested – The IBC Registration will be administratively approved by the Chair pending satisfactory receipt of additional information.

The IBC Coordinator will send an email to the PI within HuskySMS, requesting additional information. The PI will have 14 days from the date of the ‘needs additional information’ email, to submit their revisions. If PIs cannot meet this deadline, they must contact the IBC Coordinator or the IBC Chairperson, to request an extension.

Deferred/Major Revisions Requested – This decision is used when the full committee has reviewed a registration at a convened meeting, where there are significant concerns with the registration or other relevant material. The registration may require significant clarifications in order to conduct an adequate risk assessment.

A letter stating the reasons for deferral and date to resubmit for full committee review will be signed by the Chair and sent to the PI.

Rejected – The IBC Registration was not approved.

A letter stating the reasons for not approving the registration will be signed by the Chair and sent to the PI.

Search for IRB Protocols

The basic search includes PI, Protocol Number, Investigator, Approved to date, Title, and status. Other seach options are available by clicking Additional Search Options.

Click My Human Subjects.
Click Search For.
Enter your search criteria.
Click the Open/Locate button.
If necessary, use the Next and Previous buttons to navigate through the results.

Tips

Drop down menus for certain search criteria fields allow you to search for soundex matches using phonetic algorithms.
An asterisk (*) can be used in a search box to conduct wildcard searches if you do not know the full name, etc. or if you would like the system to present multiple options. For example, if you would like to find the name Erik Anderson, but cannot recall if his name is Anderson or Andersen, enter Anders*n in the search box to view all the available options. You can also add * after entering the first several characters to find results beginning with your entry.
Use an exclamation (!) in a search box to search for similar sounding words.
To find protocols using a date, use the pull down next to a date search field to specify the exact date (=), a date before the one you enter in the field (<), or a date after the one you enter in the field (>).

Click here for a printable PDF of these instructions.

For technical issues with InfoEd, please call 860.486.7944, email eRA-support@uconn.edu.

Reset/Change InfoEd Password

The InfoEd portal is secured with your UConn NetID single sign-on. If you have forgotten your NetID or password, call the University Information Technology Services (UITS) Service Desk at 860.486.4357 or email at helpcenter@uconn.edu. You can also access the NetID website (https://netid.uconn.edu) to obtain your NetID and change/reset your password.

How To: Change Your InfoEd (NetID) Password
How To: Reset You Forgotten InfoEd (NetID) Password

Frequently Requested Information

Addresses

Official Address

For all proposals, applications and communications

University of Connecticut
Sponsored Program Services
438 Whitney Road Ext., Unit 1133
Storrs, CT 06269-1133
Telephone: 860-486-3622
Fax: 860-486-3726

Email: preaward@uconn.edu

Authorized University Official (Sponsored Programs)

Tracy Bourassa, Senior Director, Sponsored Program Services
Email: preaward@uconn.edu

Cognizant Agency (Audit & Federal Cost Rate Approval Authority)

U.S. Department of Health and Human Services
Division of Cost Allocation
26 Federal Plaza, Room 41-122
New York, NY 10278
Contact: Mr. Darryl W. Mayes, Director
Telephone: 212-264-2069

Award Checks

Payable to: University of Connecticut

Mailed to: University of Connecticut

Sponsored Program Services
Attn: Crystal Lawton
438 Whitney Road Ext., Unit 1133
Storrs, CT 06269-1133
Telephone: 860-486-3893
Email: spsfinance@uconn.edu

Numbers and Codes

Applicant Organization	University of Connecticut
Type of Organization	State non-profit institution of higher education
Tax Exemption Status	Governmental Information Letter Private Foundation Informational Letter
Congressional District	CT-002
CAGE Commercial and Govt Entity	01NY7
CED Commercial Establishment Code	61521915B
DUNS	614-20-9054
Entity Identification Number	06-0772160
FICE Federal Interagency Committee on Education	Storrs – 001417 Stamford – 000061 Waterbury – 000063 Hartford – 000060 Avery Point – 000064 Torrington – 000062
HHS Institutional Profile Number	1506602
NAICS North American Industry Classification System	611310
NIH Identification	1506602
NSF Awardee Organization Code	0014175000
SIC Standard Industrial Classification Number	8221
State Agency Business Unit	UOCM1
SAM Expiration Date	April 10, 2025
Unique Entity Identifier	WNTPS995QBM7

F & A Rates

The current F & A rates are listed on the Budgeting and Costing Guide.
Cost/Indirect Cost Rate Agreement
Date of current agreement	September 27, 2024

Assurance and Compliance

AAALAC Accreditation	University of Connecticut, Storrs Site #001348 June 24, 2010
Animal Subjects	D16-00077 (Legacy A3124-01) (May 20, 2020 – February 29, 2024)
Human Subjects – FWA Federalwide Assurance (FWA)	FWA00007125 (Expires May 5, 2027)
IRB Organization Number (IORG #)	0000027 (Expires May 5, 2025)
Misconduct in Science	Filed 10/1990
NRC Broad Scope License	06-01450-47
NRC Plutonium License	SNM-1889
NRC Sealed Sources License	06-01450-48

State of Connecticut Single Audit Report Fiscal 2023

Report of Findings

A Summary Report will be drafted by the IRB Monitor and sent to the PI for his/her review and responses. The report will provide a detailed summary of the audit identifying areas of improvement and recommendations for improvement. The PI and the IRB Monitor will sign the report. A copy of the signed report will be provided to the Director of Research Compliance, the PI, and the IRB Chair. When indicated, the PI will be invited to respond to each indication of non-compliance listed in the summary with a plan of corrective action for each item. This plan will be submitted to the IRB within 2 weeks of the date of the summary.

It is anticipated that in most cases serious violations involving risk of injury to participants will have already been reported to the IRB. However, if an audit demonstrates that a serious violation involving risk of injury to participants has not been reported, it will be reported immediately to the IRB Chair, Director of Research Compliance, and to the Vice President of Research (or his/her designee).

Audit of Informed Consent/Assent Process

Investigators can request an overview of the consent process at any time before or during initiation of a study. During an audit of consent, the IRB Monitor will review:

The timing of recruitment and screening in relation to informed consent.
The appropriateness of the person obtaining consent.
The consent process to meet the needs of vulnerable populations.
Steps to aid participants with barriers to understanding or lack of capacity to consent (language, reading level, etc.)
Steps to see if the participant understands the research purpose, risks, benefits, voluntary participation, withdrawal, confidentiality, costs/compensation, and contacts for questions or injuries.

If you have questions regarding the auditing process or would like to schedule a time to meet with the Post Approval Monitor for an individual or group education session please contact:

Joan Levine, MPH Post Approval Monitor
University of Connecticut
Research Compliance Services
438 Whitney Road Extension, Unit 1246
Storrs, CT 06269-1246
Tel: 860.486.7145
Fax: 860.486.1044
e-mail: joan.levine@uconn.edu

IRB Post Approval Monitoring & Audits

Research Integrity & Compliance Services (RICS) is committed to ensuring that all approved research is conducted in accordance with the IRB approved protocol, federal and state regulations, UConn’s institutional policies, and the ethical principles outlined in the Belmont Report. The primary goal of the Monitoring Program is to provide the most current information to investigators and students through education, training, and monitoring. Working together with Principal Investigators and student researchers, the Monitoring Program will assist with identifying needed areas of education and minimize risks to human subjects. Additionally, monitoring visits help foster communication between researchers and the IRB, and provide targeted education for faculty, staff, and students conducting human subjects research. All studies, including those approved under the Exempt Category, are subject to audit.

For-cause audits will be a priority for the Monitoring Program. However, special emphasis is placed on studies that include vulnerable populations or have activities that may place participants at greater risk than what may be anticipated in ordinary circumstances. Monitoring takes place with an emphasis on quality improvement and providing support for researchers.

Categories of Audits

Routine: The Education & QA/QI Specialist collaborates with the IRB Program Director and IRB Chair to select studies to audit. Selection may include monitoring only certain elements of the research, such as observation of the informed consent process, study procedures, or study records.
Informed consent: This audit is intended to support researchers in conducting the informed consent process. It may include observation of the consent process and/or a thorough review of the process. Monitoring also includes reviewing the process of how Principal Investigators train study personnel on administering consent to participants.
For-cause: Under 45 CFR 46.113 requirements, this review is performed when concerns regarding compliance, protocol adherence, or subject safety are brought to the attention of the IRB or the IRB Education & QA/QI Specialist. This includes a review of all or any related study activities.
Investigator Initiated: A PI may request an on-site review to help keep records and procedures in compliance with federal regulations and institutional policies, or to prepare for an external audit by a sponsor or federal agency.

Audit Notice

Except in cases where the safety of subjects is a concern, or where the IRB specifically requests an unannounced audit, written notification of an audit will be sent from RICS. Depending on the nature of the research study, an IRB member who has experience in the study topic may also be present at the audit. The Investigator will contact the Education & QA/QI Specialist to arrange a visit within the following estimated timeframes:

Routine: At least two weeks’ notice in advance of the initial meeting of the audit.
Informed Consent: At least one week notice in advance of the monitoring.
For-cause: At least twenty-four (24) hours’ notice by a telephone call and email to the PI from the Institutional Official or his/her designee.
Investigator Initiated: A time will be arranged by mutual convenience.

Elements of Audit Review

Before Audit: Investigators will receive a letter informing them that their study has been chosen for an audit. The investigator will then contact the Education & QA/QI Specialist and a time will be scheduled for the audit.

Prior to the audit, the Education & QA/QI Specialist will review the study protocol and all documentation related to the study in the IRB submission including:

Grant Application, if applicable; the grant application may be compared to the IRB approved protocol.
The IRB submission. IRB Meeting issues (quorum, diversity, expertise, conflict of interest); adequacy of review.
IRB submission to determine whether it contains all correspondence/amendments, adverse events, and protocol deviations the investigator submitted.
Whether annual continuing review was completed.
Elements of Informed Consent/Assent documents, as well as review of the required elements of informed consent according to the federal regulations and IRB requirements.
Subsequent publications resulting from IRB approved protocols may also be reviewed.

Investigators can prepare for the audit by reviewing the checklist of questions below. (Please note that not all items on the checklist apply to all research studies)

Preparing for an audit

- Does the researcher have available the most recently approved protocol, consent form, and study documents for review?
- How many participants are currently enrolled? How many have been approved by the IRB?
- Are all key personnel listed on the Appendix A Personnel Form? Are personnel conducting procedures according to their role in the study?
- Have any participants withdrawn/dropped from study? If so, is reason documented?
- Have any adverse events occurred? Were all reported to the IRB?
- Are participants consented with the most recently IRB approved and validated version of the consent form? Have all the consent forms been signed and dated by the participant and the person obtaining consent?
- Have all study measures and procedures been approved by the IRB before implementing?
- Are all advertisements and methods of recruitment IRB approved?
- Are study documents maintained as outlined in the protocol? Are participant ID numbers generated per protocol?
- Have all enrolled participants met eligibility criteria? Is there documentation of eligibility?
- Have there been any protocol deviations? Have they been reported to the IRB?
- Have there been any unanticipated problems with protocol implementation?
- Has participant compensation been documented?
- Have there been any participant complaints?
- Are raw data files organized, complete, and legible?

During the audit, the Education & QA/QI Specialist will briefly meet with the PI to discuss the study and the PI will provide the study files for review. The PI must make available the use of a quiet space to review the study files. The PI or designee who is familiar with the study will be available during the audit in case the Education & QA/QI Specialist has questions. As needed, during the audit, the Education & QA/QI Specialist will provide recommendations and educational support on record retention and documentation, and other compliance related issues. Documents pertaining to research will be held strictly confidential.

Review of Regulatory Compliance may include review of the following:

Roles and responsibilities of investigators and key personnel
Protocol file/regulatory documentation
IRB Documentation
Consent/Assent Forms
Individual participant records to determine if:
- The participants met the inclusion/exclusion criteria for the study
- Study related procedures are performed according to the protocol
- Study related procedures are scheduled and performed per the study time line
- Data are recorded and stored securely as described in the Consent Form
- Adverse events and/or protocol deviations have been reported according to institutional policy
- Payments were made to participants as described in the protocol
- Participant ID numbers are assigned according to the protocol

After the audit is complete, the Education & QA/QI Specialist will meet with the PI (and/or student investigator) and provide a brief summary of findings.

Report of Findings

A report that includes a detailed summary of the audit findings and recommendations for improvement will be sent to the PI within 10 days after the audit has been completed. The PI will be invited to respond to each indication of non-compliance listed in the summary with a plan of corrective action for each item. Findings of non-compliance will be reported to the IRB at its next fully convened meeting.

It is anticipated that in most cases serious violations involving risk of injury to participants will have already been reported to the IRB. However, if an audit demonstrates that a serious violation involving risk of injury to participants has not been reported, it will be reported immediately to the IRB Chair, Director of Research Compliance Services, and to the Vice President for Research (or his/her designee).

Audit of Informed Consent/Assent Process

Investigators can request an overview of the consent process at any time before or during initiation of a study. During an audit of consent, the IRB Education & QA/QI Specialist will review:

The timing of recruitment and screening in relation to informed consent.
The appropriateness of the person obtaining consent.
The consent process to meet the needs of vulnerable populations.
Steps to aid participants with barriers to understanding or lack of capacity to consent (language, reading level, etc.).
Steps to see if the participant understands the research purpose, risks, benefits, voluntary participation, withdrawal, confidentiality, costs/compensation, and contacts for questions or injuries.

If you have questions regarding the auditing process, or would like to schedule a time to meet with the Education & QA/QI Specialist for an individual or group education session, please contact:

Joan Levine, MPH, CIP
Education and QA/QI Specialist
(860) 486-7145
joan.levine@uconn.edu

Human Subjects Protocol Wording Tips

PRISM Toolkit Word List

The full PRISM Readability Toolkit

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Study Design and Scientific Review

The IRB has an ethical obligation to review the design or other aspects of a study that may affect the scientific quality of the protocol. The following sections from internationally recognized ethical guides state that ethical research requires that:

the study is designed to minimize the risks to subjects and
the potential risks of the research are justified by the potential benefits.

The Ethical Codes:

Nuremberg Code (1949)

Several sections including the following address the question.

Point 3. “The experiment should be so designed and based on the results of animal experimentation and a knowledge of the natural history of the disease or other problem under study that the anticipated results will justify the performance of the experiment.”

Declaration of Helsinki (2000)

Several sections including the following address the question.

Section 11. “Medical Research involving human subjects must conform to generally accepted scientific principles and be based on a thorough knowledge of the scientific literature, other relevant sources of information, and adequate laboratory and when appropriate, animal experimentation.”
Section 18. “Medical research involving human subjects should only be conducted if the importance of the objective outweighs the inherent risks and burdens to the subject. This is especially important when the human subjects are healthy volunteers.”
Section 29. “The benefits, risks, burdens, and effectiveness of a new method should be tested against those of the best current prophylactic, diagnostic or therapeutic methods. This does not exclude the use of placebo, or no treatment, in studies where no proven prophylactic, diagnostic or therapeutic method exists.”

Federal Research Regulations

DHHS and corresponding FDA Sections (21 CFR 56.111).

45 CFR 46.111 Criteria for IRB approval of research.

In order to approve research covered by this policy the IRB shall determine that all of the following requirements are satisfied:

Risks to subjects are minimized: (i) By using procedures which are consistent with sound research design and which do not unnecessarily expose subjects to risk, and (ii) whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes.
Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result. In evaluating risks and benefits, the IRB should consider only those risks and benefits that may result from the research (as distinguished from risks and benefits of therapies subjects would receive even if not participating in the research). The IRB should not consider possible long-range effects of applying knowledge gained in the research (for example, the possible effects of the research on public policy) as among those research risks that fall within the purview of its responsibility.

Guidelines

Robert J. Amdur in Ch. 5-2 “Evaluating Study Design and Quality” in IRB Management and Function by Elizabeth A. Bankert and Robert J. Amdur notes the references above and offers the following guidelines to IRBs when evaluating a study’s scientific design and benefit from the perspective of risk to participants.
The IRB should use independent judgment and common sense. For example if the design of a student research project for a course is flawed but creates no effective risk to subjects, there is no ethical basis for the IRB to require revisions for approval. There are only educational reasons to suggest changes.
The IRB should NOT approve a study without requiring revisions if:

revising the design will decrease the risks to participants in a meaningful way without a major compromise to the persuasiveness of the study results; OR
the study design is “so flawed that the value of the study results will be almost zero.” In this case, even though the risks may be low if the potential benefit is zero, the overall risk/benefit ratio would be unacceptable; OR
the study involves a meaningful risk and asks a question that was already answered in earlier research or “not important” to the field of scientific inquiry.

Policies and Procedures

UConn IRB, Submission to the IRB, Scientific Review

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Student-Athletes

Student-athletes, like all students at UConn, are a vulnerable population because of concerns with issues of coercion, undue influence and privacy. However, their involvement in research studies raises special concerns regarding recruitment and compensation for research studies since they are subject to NCAA rules and regulations that are related to their eligibility for participation in athletics.

Recruitment

Any member of the coaching staff, faculty or graduate student researchers are encouraged to contact the IRB office prior to submission of the protocol for advice to minimize the potential for undue influence, coercion, or NCAA compliance concerns. You may be advised to consider using anonymous data collection methods or an independent third party to consent participants or collect data.

If student-athletes are specifically recruited for a research study because of their status as athletes, the researchers must obtain approval from the Athletics Research Committee prior to enrollment. Written documentation of approval from the Athletics Research Committee must be provided to the IRB and indicate that they understand the research, are supportive of student-athlete participation, and, confirm that it will not jeopardize the student-athlete’s NCAA eligibility.

Studies involving student athletes should include safeguards to prevent undue influence and ensure that student athletes do not feel obligated to participate or that their participation will reflect favorably on them. Researchers should be mindful of the circumstances and settings for recruitment and consent, understanding that the presence of teammates, coaches, or athletic staff may influence decision-making. Recruitment and consent plans and materials should make it clear that participation or non-participation will not affect eligibility, playtime, or status as a student athlete. Throughout the research, it should be clear that participants are free to withdraw at any time without facing any negative consequences.

Confidentiality

If results of the research will be shared with the coach or any member of the coaching staff, sports medicine or athletic training staff or any staff person in the Director of Athletics office, the nature of the data being shared must be fully explained in the protocol application. In addition, the student-athletes must be informed of this in the consent form. NCAA rules regarding countable athletically related activities may apply in research that involves the student-athlete engaging in an athletics activity even if no athletics staff member is present. In certain situations, research may not be able to be shared with coaches if providing such information will trigger the activity to become countable. The Athletics Research Committee will advise when such a situation arises.

Compensation to Student-Athletes

Per NCAA Bylaws, a student-athlete may receive compensation from an institution for participating in a research study involving only student-athletes, provided the study is initiated and conducted by a faculty member at a member institution and the study and compensation arrangements are approved by the institutional review board of the faculty member’s institution consistent with policies applicable to other institution-based research studies.

Similarly, student athletes may be paid for their participation in research studies that recruit from the general student body or population as long as they receive the same compensation as other participants and are involved in the same manner.

Updated 8.1.2024

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