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/

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.

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.

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

1. Click My Human Subjects.
2. Click Search For.
3. Enter your search criteria.
4. Click the Open/Locate button.
5. 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.

Addresses

Official Address

For all proposals, applications and communications

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)

Award Checks

Payable to: University of Connecticut

Mailed to: University of Connecticut

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

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:

1. Roles and responsibilities of investigators and key personnel
2. Protocol file/regulatory documentation
3. IRB Documentation
4. Consent/Assent Forms
5. 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

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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:

1. the study is designed to minimize the risks to subjects and
2. 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:

1. 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.
2. 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, 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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General Recruitment

Advertisements and recruitment material are considered an extension of the informed consent and participant selection process.  As such, recruitment of participants into a study may not begin prior to IRB approval.  The IRB must approve all recruitment methods and material (flyers, letters, brochures, e-mail advertisements, radio announcements, etc.) prior to use.  Materials must also be submitted for review and re-approval at the time of continuing review.  The content of recruitment materials and the method for communicating it cannot create undue influence or contain misleading or exculpatory language.

The following are examples of common recruitment methods for human research studies.  All recruitment methods must be described in the protocol application.

• Use advertisements, notices, and/or media to recruit subjects.  Examples include flyers posted in public settings, newspaper ads, and radio and television advertisements.
• Direct recruitment of participants unknown to the researchers.  Examples include random digit dialing, approaching people in public settings, snowball sampling, use of social networks, and Craigslist.
• Maintain a separate IRB-approved recruitment protocol to develop a database of potential participants (preparatory to research).  The participants/patients provide consent ahead of time to be contacted for future research studies.  Researchers contact patients about participation in IRB-approved studies in accordance with the signed consent.
• Provide colleagues with an IRB-approved Introduction letter describing the study.  This letter would explain the purpose and procedures of the study and inform individuals how to contact the research team.  Researchers are prohibited from having access to participant/patient names, addresses, or phone numbers; interested individuals must initiate contact.
• Send an IRB-approved letter to certain individuals asking for referrals of eligible participants interested in the study.  The researchers may provide the referring individual with IRB-approved recruitment material for the study to give to potential participants.  If interested, the participant contacts the researchers for additional information.
• Approach your own students or employees.  This method raises ethical concerns because individuals may have difficulty saying no to an authority figure.  For strategies to minimize undue influence, refer to the IRB policies and procedures regarding Review of Studies Involving Vulnerable Populations.

For studies that involve recruitment of patients from a medical practice or other treatment facility, it is not acceptable for investigators not affiliated with that practice or facility to directly recruit patients. The initial contact must be initiated by the physician or an employee of the practice or facility. Recruitment can take the form of a flyer posted in the waiting area or handed to potential participants by a physician or employee of the practice or facility. Due to HIPAA regulations, medical practices or treatment facilities may not give out telephone numbers or addresses of their patients.

If applicable to the study design, or required by a funding agency, the PI is responsible for tracking the ethnicity or race of participants who are recruited into studies.  In such cases, investigators should ask participants to self-identify at the time of consent.

Advertisements

Advertisements should contain information that provides enough detail to allow the prospective participant to determine his/her eligibility and interest.  Visual effects that may create undue influence cannot be used, for example, placing the phrase “GET PAID $100!!!” in all capital letters or an extra large font while the rest of the ad is in lower case or a smaller font is not acceptable.

Generally, the elements of any advertisement to recruit participants should be limited to the following:

• the name of the PI and UConn Storrs department affiliation;
• an accurate description of the condition under study and/or the research purpose, e.g., “low fat vs. low carb diets for weight loss,” or “acculturation of Cuban immigrants;”
• in summary form, the key eligibility criteria that will be used to admit (or exclude) participants into the study, e.g., acceptable age range or unacceptable physical limitations;
• a straightforward and truthful description of the benefits, if any, to the participant from participating in the study, e.g., “free health screening;”
• if applicable, a statement that compensation is available or a statement of how much compensation is available, e.g., “Participants may receive up to $100;”
• the amount / length of time or other commitment required of the participants;
• the location of the research and contact information for obtaining additional information.

Advertisements must display the IRB validation stamp, unless an exception has been granted by the IRB.  If it is not feasible to make copies of the validated version, it is acceptable to use the exact wording of the validation stamp: “UConn IRB, Approval On (date), Approved until (date), Approved by (initials).”

Recruitment information sent by email to listservs, Craigslist, etc. must include the following statement, “This research study was approved by the UConn IRB, Protocol # __________.”

Advertisements cannot incorporate elements that:

• state or imply a certainty of favorable outcome or other benefit beyond what is in the informed consent form;
• Use catchy words like “free” or “exciting.”
• For FDA regulated research studies (new drugs/devices) or studies on nutritional supplements:
  • make claims that the supplement, drug, device or biologic is safe or effective for the purpose under investigation or that the supplement, drug, device or biologic is known to be equivalent or superior to any other supplement drug, device or biologic;
  • use terms such as “new treatment,” “new supplement” or “new medication” without identifying it as investigational.

Refer to the FDA’s regulations concerning the promotion of investigational drugs (21 CFR 312.7(a)) and of investigational devices (21 CFR 812(7)) for additional information.

Recruitment/Advertising Tips and Suggestions

• Understand the target population.  What media does the population read or view?  Where do they go for information?
• Make concerted efforts to recruit participants from minority and under-represented groups.  Describe those efforts in the protocol application.
• Spend the time to make the recruitment flyers easy to read and understand.  Advertisements must be written using lay language, at an 8th grade reading level (similar to the level used popular magazines and newspapers) that is appropriate for the participant population.  You should select a font style and size that is easy to read such as Times Roman , Arial, or Garamond.

A sample, recruitment flyer template is available for your reference.

Source material for this policy guidance was provided by the University of California – Irvine IRB.  The UConn IRB gratefully acknowledges this support.

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The UConn IRB agrees that oral history interviews are not designed to contribute to generalizable knowledge and are therefore not subject to IRB review.

The revisions to the Common Rule that went into effect in January 2019 deem the following activities not to be research under the regulations:

1. Scholarly and journalistic activities (g., oral history, journalism, biography, literary criticism, legal research, and historical scholarship), including the collection and use of information, that focus directly on the specific individuals about whom the information is collected.

2. Public health surveillance activities, including the collection and testing of information or biospecimens, conducted, supported, requested, ordered, required, or authorized by a public health authority. Such activities are limited to those necessary to allow a public health authority to identify, monitor, assess, or investigate potential public health signals, onsets of disease outbreaks, or conditions of public health importance (including trends, signals, risk factors, patterns in diseases, or increases in injuries from using consumer products). Such activities include those associated with providing timely situational awareness and priority setting during the course of an event or crisis that threatens public health (including natural or man-made disasters).

3. Collection and analysis of information, biospecimens, or records by or for a criminal justice agency for activities authorized by law or court order solely for criminal justice or criminal investigative purposes.

4. Authorized operational activities (as determined by each agency) in support of intelligence, homeland security, defense, or other national security missions.

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The Office for Human Research Protections (OHRP) protects the rights, welfare, and well-being of subjects involved in research conducted or supported by the Department of Health and Human Services (HHS) and helps ensure that such research is carried out in accordance with the regulations described at 45 CFR 46.

As noted in the UConn IRB Policy and Procedures, all research involving human participants conducted by the faculty, students, and staff of UConn, or research conducted using UConn facilities, is conducted in accordance with federal regulations, regardless of funding source.  Because UConn is engaged in human subjects research that may be conducted or supported by an agency of the U.S. Department of Health and Human Services, UConn has an OHRP approved Federalwide Assurance (FWA).  This FWA is our contract with OHRP whereby the University agrees to conduct all human subjects research in compliance with the HHS regulations.  The UConn Storrs FWA number is 00007125.

If you go to the OHRP website you’ll see that OHRP is comprised of five divisions – Compliance, Education, Policy and Oversight, Secretary’s Advisory Committee, and International Research.  The three most relevant divisions to researchers are the Compliance, Education and International Divisions.

The Compliance division is essentially the auditing arm of OHRP.  If it becomes necessary for the IRB to report unanticipated problems, serious or continuing noncompliance, protocol deviations, suspensions or terminations, the Compliance division reviews the report and the corrective actions.  The Compliance division then determines what, if any, additional action needs to be taken to protect human research subjects.  The Compliance division may also audit the Office of Research Compliance and the UConn IRB with regard to institutional compliance with 45 CFR 46.  As indicated on the OHRP website, the division “evaluates all written substantive allegations or indications of noncompliance with the HHS regulations. If complaints or concerns arise regarding an institution’s human subject protection practices, OHRP opens a formal evaluation and, if necessary, requires corrective action by the institution.”  Any findings of noncompliance are issued in the form of determination letters.  OHRP maintains a list of determinations of institutional noncompliance.  You can access the list here – http://www.hhs.gov/ohrp/compliance-and-reporting/index.html.  You will note that institutional noncompliance covers a wide range of IRB procedures involving: initial and continuing review, expedited review, informed consent, IRB membership, and IRB documentation.

The Education division is responsible for a number of initiatives including: (1) Responding to requests for clarification and guidance regarding ethical issues in biomedical and behavioral research involving human subjects and (2) Developing and conducting quality improvement activities to improve human research protection programs.  The Education division developed the IRB Guidebook (http://www.hhs.gov/ohrp/education-and-outreach/archived-materials/) as well as the Human Subjects Regulation Decision Charts (http://www.hhs.gov/ohrp/policy/checklists/decisioncharts.html) which are helpful in determining whether or not the research activity requires IRB review and, if so, what level of review is required.

The International Division provides quality improvement consultation and research ethics training to domestic and foreign institutions involved in international biomedical and behavioral research.  It maintains a compilation of human subjects protections laws, regulations and guidelines governing human subjects research around the world.

March 2009

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