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

Back to Researcher’s Guide

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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What type of research study qualifies for exemption?

Federal regulations allow specific categories of human subjects research to be exempt from continuing IRB review (45 CFR 46.104(d)).  Category 1 applies to research conducted in schools and other education settings.

Research conducted in established or commonly accepted educational settings, that specifically involves normal educational practices, that are not likely to adversely impact students’ opportunity to learn required educational content or the assessment of educators who provide instruction. This includes most research on regular and special education instructional strategies, and research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.

Although the regulations do not address a maximum risk level, it is implicit within the concept of exempt research that there must be very little, if any, associated risk.  Please note that survey research involving children is not exempt, nor is observation of a minor’s public behavior unless the investigator does not participate in the activities being observed. (Institutional Review Board Management and Function, Bankert & Amdur, 2006).

Research exempted as normal educational practice is often conducted in public school settings which may demand that specific steps be followed in order to comply with additional state and federal laws.  Although the definition in the regulations is fairly straightforward, it can create a conflict with other regulations that the IRB is obligated to follow, such as Subpart D of 45 CFR 46, FERPA (Family Educational Rights and Privacy Act), and PPRA (Protection of Pupil Rights Amendment).  Subpart D specifically deals with children as a vulnerable population and most protocols that qualify for normal educational practice deal with children.  If the IRB determines that a research study does not qualify for exempt status, then the extra protections for minors under Subpart D apply.  Additionally, FERPA restricts researchers’ access to student records without prior written permission from parents.  However, within FERPA [20 U.S.C. 1232g(b)(1)(F)], there are conditions under which student records can be disclosed without prior written parental consent if an exception applies: Organizations conducting certain studies for or on behalf of the school to develop, validate, or administer predictive tests; administer student aid programs; or improve instruction. An exception requires a written agreement (contract) to use information from a UConn student’s education record. Contact the Privacy Office at UConn early in the process to ensure requirements are met. All exceptions must be reviewed and approved by UConn’s Privacy Officer, Bruce Gelston. A copy of the written agreement must be submitted to the IRB after executed.

Investigators must contact each institution and follow that institution’s FERPA policy, in addition to the requirements of UConn IRB.  Finally, PPRA outlines 8 categories of protected information for survey responses and requires that parents be afforded the right to inspect surveys before they are given to students (for more information on FERPA and PPRA, see the link at the end of this section).

What is an educational setting?

45 CFR 46 does not specify that normal educational practice takes place in schools only.  The IRB defines an educational setting as any setting where an educational experience takes place.  For example, a public school, an after-school club or program, a Boy or Girl Scout meeting, a professional development seminar for school district personnel, or a postsecondary education setting.

Who are the research participants?

The participants should include those involved in the educational experience, which most likely will include the teacher(s), student(s), and possibly the administrator(s).  Participants that are indirectly involved in the educational experience may be included in the study, but they may not be exempt under normal educational practice, thus requiring additional consent procedures.  For example, interviewing a principal may require that you use a consent form because this occurs outside the classroom and may not be considered normal educational practice.  Participants can include populations with special educational needs, though the IRB will require demonstration of the investigator’s credentials to work with these vulnerable populations as well as clear explanation of any additional procedures to minimize risks specific to working with this population.  For example, if a child is significantly cognitively delayed, obtaining assent may not be appropriate, and the investigator must describe what steps will be taken to ensure that appropriate cues are taken from the child that may indicate an unwillingness to continue with study procedures.

What is normal educational practice?

As noted above, the regulations define normal educational practice as “(i) research on regular and special education instructional strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.”

The IRB considers educational time to be a valuable commodity, and thus, the design of a research study that will be carried out in an educational setting should be developed with this in mind.  At the minimum, the research should not waste student educational time, and may offer benefit to the individual and/or classwide educational experience.  The IRB will consider the proposed methodology for the study in light of both time requirements and likelihood of benefit in order to determine whether it qualifies as normal educational practice.  In all cases, the IRB will need to assess risks to all proposed participants in the study to determine the level of review required.

In some cases, it may be helpful if the PI can provide a letter verifying that the appropriate school administrator (e.g, principal, superintendent, school board) considers the proposed research study to be normal educational practice.  (See Appendix A for an example).

Normal educational practice research that may qualify for exemption

• Development of assessments related to educational activities.  The time commitment required to complete assessments should be described and may not exceed reasonable limits.  The protocol design should clearly describe how results will be shared back with the school staff to assist in their instructional decisions as well as potential risks that might be associated (i.e., Will students’ grades be affected by their scores on the assessments? Will results be shared at the individual student level or in aggregate?  How will the data be used by the school?).
• Research with instructional methods or classroom / school activities which may include pre and post testing, surveys, interviews, and/or observations.  For example, if you are studying a new writing technique and you want to ask the students what they think about the writing technique, this could qualify for exemption.  However, if you want to ask the students questions that are beyond the writing technique, the IRB may approve the study using the expedited review mechanism, because the questions may not qualify as normal educational practice.  In all protocols, it is most helpful to the IRB if you clearly justify the necessity for using the chosen methods for collecting data and specify what data will be collected (via testing or survey instruments, interview questions, and/or observation protocols).
• Collecting data specific to teacher and/or student current knowledge, beliefs, or attitudes towards learning, or data about how these change over time.  These studies may be descriptive in nature and may even be longitudinal.  Interviews, observations, and surveys must include questions and subject matter that fall within the scope of the educational activity being studied.
• Data collection using video or audio recordings, and/or photography may be eligible for exempt status only when the materials are accessible only to the researchers and they are destroyed after coding specific to the proposed research.  Video and audio recording that is intended for other uses, such as presentation at meetings, publication, or education of graduate students, may not be eligible for exempt status.  Please justify the necessity for using these methods for collecting data and specify exactly what will be collected.  If the information collected can identify an individual person (i.e., student, staff member), it may be necessary to document signed consent using a consent form.  In addition, if the materials will be used in a presentation or publication, it may be necessary to obtain specific permission from parents to do so.
• Obtaining samples of student work or scores may be eligible for exemption if FERPA regulations are met.

Examples of research eligible for exemption under normal educational practices in a commonly accepted educational setting:

Example 1 –

A researcher is interested in implementing an elementary school art education curriculum designed to help students develop visual vocabulary.  The curriculum involves asking children to sort cards with reproductions of various Western artists as well as additional related activities.  The basic curriculum has been widely used in school settings for over 15 years.  The researcher is interested in adding some contemporary artists and those from other cultures to examine whether there are any differences in children’s ability to make discriminations based on visual elements.  These additions will not add significant time to the curriculum already being implemented and the assessments used in the study are typical of both length and content of  current classroom assessments.  Results of the study will be shared in aggregate form so that teachers can determine the benefit of including these curriculum modifications in the future.

Example 2 –

A middle school department of science teachers begins using graphic organizers to improve instruction of English language learners.  The school has an existing relationship with the local university to partner on projects of collaborative interest.  Thus, the school contacts researchers to ask for assistance in developing appropriate procedures for evaluating the hypothesized improved instructional practices.  Researchers plan to  use the resulting data in aggregate form for purposes related to presentation and publication as well as providing individual data to teachers to inform their instructional practices.

Examples of research NOT Eligible for exemption under normal educational practices in a commonly accepted educational setting:

Example 3 –

A researcher wants to determine whether providing tangible reinforcement or verbal reinforcement will lead to greater increases in appropriate behavior and decreases in problem behavior for students identified with a serious behavior disorder.  Individual students will be chosen for participation from classrooms of the same grade in consultation with the teachers.  The students will be as closely matched for age and nature of the disorder, and then randomly assigned to an intervention condition. For example, one student will receive tangible reinforcement, one will receive verbal reinforcement, and the third will be the control.

Example 4 –

Researchers are interested in developing a new assessment for math skills that involve both scoring of written prompts as well as responses involving use of manipulatives. It is expected that a new standardized, norm-referenced product will result. According to the school, the planned assessment is aligned with current curriculum and will not require students to respond to questions that would be unfamiliar.  However, the development process entails having students respond to more assessment items than would be expected.  In addition, in order to validate the new assessment, additional tests not currently used in the school will be administered for comparison, thus extending total testing time and number of items beyond what would be considered normal educational practice.

Obtaining Parental Permission and Child Assent

In research with minors, even if a protocol does qualify as normal educational practice, the IRB generally requires that parents be notified about the study via a letter sent home with the students (waiver of parental permission with notification).  In some cases, it may be appropriate for the letter to be generated from an appropriate school official (e.g, principal) in conjunction with the PI (see appendix B for one example).  As noted on the IRB-1 form, to justify waiving parental permission, the IRB must find and document the following:

• The research involves no more than minimal risk to the subjects;
• The research could not practicably be carried out without the requested waiver or alteration;
• If the research involves using identifiable private information or identifiable biospecimens, the research could not practicably be carried out without using such information or biospecimens in an identifiable format;
• The waiver or alteration will not adversely affect the rights and welfare of the subjects; and
• Whenever appropriate, the subjects or legally authorized representatives will be provided with additional pertinent information after participation.

Depending on the nature of the research, it may be appropriate to offer an ‘opt out’ option whereby parents are provided a notification form about the research study which they may sign and return an included ‘opt out’ sheet to indicate that they do not want their child and/or their child’s data to be included in the study.  Note that this type of “passive” consent process still involves waiving parental permission because it is not the equivalent of informed consent.

Non-exempt Studies: Expedited and Full Board Review of Research Conducted in Educational Settings If a research study will be conducted in a classroom setting and it does not qualify for exemption, in most cases, a parental consent form must be used to obtain signed parental permission, and when appropriate, signed assent from the students.   A parental permission form must be used to obtain signed permission from at least one parent.  The signature of both parents is typically required only for those studies determined to be of greater than minimal risk. Depending on the age of the students, a separate assent form written at an age-appropriate level can be used, or for older students, an added signature line on the parental permission form can be used.   Assent must be obtained verbally if signed assent is waived by the IRB.

If the protocol does not qualify for exemption yet it poses minimal risk to participants, it may be eligible for expedited review.  If the study poses greater than minimal risk to the participants, the protocol may be reviewed at a full board meeting.  If a study poses greater than minimal risk to participants, the PI must ensure that the IRB-1 includes a careful consideration of those risks with a detailed plan for managing them.

Suggestions for completing the IRB application for research in educational settings When submitting an application for research in an educational setting, the following information should be included:

• If the researcher(s) is not directly involved in the implementation of the intervention, particular attention must be paid to the description of how the surrogate researchers will be trained in the conduct of human subjects research (obtaining consent, ensuring that those students whose parents do not want them to participate are excluded from the intervention, etc.)   Describe who is responsible for distribution and collection of consent documents.  Describe what plan is in place to monitor and manage data collection.
• Describe the plan for handling a student who wants to withdraw from the study after consent/assent has been obtained;
• Clearly describe the difference(s) between what would typically occur in class and what will occur related to the research (i.e., will all students be involved in the same activities or will there be individual students singled out within a classroom?);
• Coercion and undue influence is difficult to avoid in a classroom setting in which activities are determined and implemented by adults.   Research designs should include strategies to reduce this risk.  For instance, clear procedures should be in place for handling students who are not participating in the study in order to minimize interruption to the typical school day.  Although students are generally obligated to participate in activity designed for the whole class, activities specifically implemented for the research need to be clearly explained and alternatives be provided for those choosing not to participate. Appropriate alternatives should be provided for those who opt out, and must be described in the protocol as well as the consent form.
• The risks and inconveniences should be assessed and clearly described in the protocol and consent.  For instance, in studies involving examination of classroom management techniques, will individual students be singled out for use of specific techniques?  If so, what risks does that present to that child and to the other students (e.g., possibility of increasing in disruptive behaviors)?
• Describe how privacy and confidentiality of all participants (i.e., student, teacher) will be maintained.  For example, will study results be shared back with the school on an individual level or in aggregate?  Will information about teacher performance be shared with school administration?  What risks to participants are presented given how data will be both managed and shared?

 Resources and Links

For more information on FERPA, go to www.ed.gov/policy/gen/guid/fpco/ferpa/index.html.

For more information on PPRA, go to www.ed.gov/policy/gen/guid/fpco/ppra/index.html.

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The  IRB holds the PI responsible for the overall management of an approved  study.  Management of the study  encompasses the ethical, technical, administrative, and fiscal elements of a project.  The PI may delegate certain tasks, but retains ultimate responsibility and accountability.  Principal investigators are required to:

• Ensure the ethical conduct of the research study and protect the rights and welfare of research participants by complying with the IRB approved study protocol, and adhering to all University and State policies, and federal regulations, and applicable guidance,
• Ensure the training requirement for the protection of human participants in research (CITI on-line training modules, www.citiprogram.org) are completed by all personnel working on the study,
• Supervise and ensure that all study personnel receive appropriate training, and conduct the study in accordance with the approved protocol (including approved amendments),
• Guide, mentor and advise student researchers,
• Ensure that all research activities have IRB approval and other approvals required by the institution before human participants are involved, and implement the research activity as it was approved by the IRB,
• Report any real or potential conflicts of interests of the PI or any study personnel in compliance with conflict of interest policies and management plans,
• Obtain informed consent from participants or legally authorized representative before participants are involved in the research, and document consent as approved by the IRB.  A copy of the IRB-approved and validated informed consent document must be used to consent each participant.  Participants must be provided with a copy of the form after it has been signed, unless the IRB has specifically waived this requirement. The consent process must include a discussion of the study between the person obtaining consent and the participants,
• Maintain written records of IRB reviews, decisions, research records and informed consent documents,
• Obtain IRB approval for and notify the sponsor (if applicable) of any proposed change to the research protocol prior to its implementation, except when necessary to eliminate apparent immediate hazards to the participants,
• Obtain re-approval by reporting progress of approved research to the IRB, in the manner prescribed by the IRB,
• Promptly report to the IRB any adverse events, protocol deviations or other unanticipated problems involving risks to participants or others.  PIs should not undertake any action with an external funding agency regarding an unanticipated problem or noncompliance without first contacting the IRB Chair or the DRC to determine the correct course of action,
• Verify that IRB approval has been obtained from all participating institutions in collaborative activities with other institutions, and that continuing review by other institutions is maintained,
• Ensure the privacy of participants is maintained,
• Ensure all data are collected, transmitted and stored according to the IRB’s Data Security Guidance for Human Subjects Research and UConn’s Confidential Data Policy,
• Use the most current version of IRB forms and document templates, which can be downloaded from the IRB website,
• Oversee the budget and expenditures related to the study to ensure that adequate resources are available, including staff, equipment supplies, participant incentives, storage space etc., to conduct the study at the University and any other performance site for which the PI is responsible,
• Provide the IRB with audit or inspection reports or findings issued by regulatory agencies, cooperative research groups, contract research organizations, the sponsor, or the funding agency,
• Maintain, when applicable, accurate records on the receipt, use and disposition of excess drugs/devices,
• Conduct the study in compliance with internal policies and federal regulations including 45 CFR 46 and 21 CFR 50 – Protection of Human Participants, 21 CFR 312 – Investigational New Drug Application and 21 CFR 812 – Investigational Device Exemptions; Good Clinical Practices and, when applicable, 21 CFR 210 – Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs and 21 CFR 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals, and the ethical principles outlined in the Belmont Report,
• Retain research records for 3 years after the study completion date.

Responsibilities of All Key Personnel

The IRB holds all study personnel (including PI and co-investigators) responsible for meeting certain obligations.  Study personnel are required to:

• Fulfill the training requirement for the protection of human participants in research (CITI on-line training modules, www.citiprogram.org), and understand the ethical standards and regulatory requirements governing research activities with human participants,
• Comply with applicable UConn IRB policies and procedures and federal regulations regarding human subjects research,
• Document contact with participants, e.g., obtaining informed consent or informing participants of changes that may affect their willingness to continue participating,
• Provide a thorough explanation of the study in lay terms to the participant during the consent process,
• Provide the participant with an opportunity to ask questions and have them answered when obtaining informed consent and throughout their participation,
• Understand the appropriate use of an investigational intervention (drug or device) as described in the protocol, investigator brochures, product information/drug labeling, and various other available sources such as newsletters, safety alerts, or communications from sponsors,  if applicable,
• Be familiar with and follow the adverse event and protocol deviation reporting requirements.

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When research involves the use of focus groups to obtain data, the participants should be given information before the focus group takes place regarding what the topic is, who the other participants / stakeholders may be, where the group will meet, and how long the session will last.  It is particularly important to inform participants ahead of time when sensitive topics will be discussed (e.g., sexuality, substance abuse).

Informing Participants about Other Participants

In the consent form and during the consent discussion, participants should be informed of who may participate in the focus group.  Ideally this would be done during the recruitment phase, throughout the consent discussion and in the consent form.  A participant may decide that he/she does not want to participate based on the expected other participants in the group.

Example:  A focus group to discuss substance abuse and availability of drugs might possibly include participants who are current and former drugs users and members of law enforcement.  Because of the sensitivity of the topic, participants should be told that it is possible that law enforcement officers may take part in the group.  This must also be clearly stated in the consent form.  However, until the focus group actually takes place, it is not possible to know whether  members of law enforcement will actually be present.  Therefore, before the discussion takes place, members should be informed who is present in the focus group and given a choice as to whether they would still like to participate.

Confidentiality of the Information Shared in Focus Group Settings

In the consent form and during the consent discussion, participants should be informed that the information shared in the focus group session should not be shared with anyone outside of the group, and that the confidentiality of anything they choose to say during the session cannot be guaranteed.  If the focus group is being audiotaped, participants should be instructed to maintain their privacy and confidentiality, and that of the people they talk about, they should not use names.

Informing Participants about the Focus Group Topic

In the consent form and during the consent discussion, participants should be informed of the topic that will be discussed during the focus group session.  The IRB expects the PI to fully disclose the exact nature of the focus group topic area in the consent form and as part of the consent discussion.  However, the cultural context must be taken into consideration when addressing this issue.  The PI must provide a justification for not fully disclosing the topic, such as the one provided in the example below, in the IRB-1 protocol application.  For more information on the use of deception in research, please refer to the Researcher’s Guide on the IRB website.

Example:  A research study being conducted in Nepal involved running a series of focus groups to obtain village residents’ views on sex trafficking.  The PI indicated that it would be counterproductive to explain the exact nature of the focus group topic since sex is considered a taboo subject in the local culture.  The PI felt that by clearly stating sex trafficking as the topic, it would change the dynamics of the group and make the discussion difficult.  The PI further indicated that she felt the topic of sex trade would come up spontaneously in the interview if the indirect prompts were provided.  The IRB agreed to give the PI latitude on this matter, and agreed to allow the purpose of the study and the specific topic to be discussed to be described obliquely in the consent form.  This was acceptable since participants were debriefed at the end of the session, and provided with the specific purpose of the study.

Audio- or Video-recording the Focus Group

In cases where the focus group session will be audio- or video-recorded, the PI must disclose use of recording devices in the consent form and as part of the consent discussion.  When the focus group meets, the PI should again disclose this to each member of the focus group, and ask if they agree to be audio- or video-recorded.  If being recorded is a requirement of participation in the focus group, this must be stated in the consent form.  If a member of the focus group objects to being recorded, the PI can excuse the participant from the group, or agree not to audio- or video-record the session.  Video editing tools that blur or block individual participants may also be used, and described in the protocol application.  Participants should be given the opportunity to withdraw their consent AFTER the focus group session has ended.  All of these specifics regarding video-recording must be clearly stated in the consent form.

Focus Groups Conducted in Developing/Traditional Societies

PIs must use special care in conducting focus group sessions in developing countries and in vulnerable communities.  It is crucial that the PI thoroughly understand the structure of local governments and local communities in order to gain permission from a representative of the community to conduct research.  As a first step, the IRB suggests that the PI obtain permission from the mayor, a tribal elder, or from a tribal council.  In some cultures, it is inappropriate for men and women to be invited to discuss some or all topics in one group.  Sensitivity to and knowledge of local culture must be demonstrated by the PI in the IRB application.  Please refer to the Researcher’s Guide on the IRB website for more information regarding Ethnographic/Naturalistic Research.

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