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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Ethnographic research presents special challenges to investigators as it can be difficult to accurately describe the nature of the ethnographic research within the confines of the IRB-1 or IRB-5 protocol application forms.  Therefore, we have created a separate form for submission of qualitative or ethnographic research, the IRB-9 form.  The IRB appreciates that ethnographic research has the following special characteristics (Arwood, T., and McGough, H., 2007 PRIM&R SBER Conference):

• It is experiential
• It is interactive
• It is not easily bounded by time and place
• It is often exploratory
• It morphs easily and often (new questions emerge during research)
• The boundaries between normal activities and communication and data collection are blurred

In order for the IRB to understand these special characteristics and the nature and scope of a particular ethnographic research project, the following issues should be addressed in the IRB application form, if applicable to the research.

Participant Population

• The kinds of people who will be involved in the research should be described.  If there are different groups or categories of people, the groups and the approximate number of participants in each group anticipated to be enrolled must be described.  If an exact number of people to be enrolled are unknown, a range should be provided.  An amendment should be submitted to the IRB when/if actual numbers exceed those estimates.

Description of Procedures

• The length of time to be spent at the field site(s) should be described.  If unsure, an approximate length of time should be provided (e.g., one year, two summer months, etc.).  An amendment should be submitted to the IRB when/if actual dates exceed those estimates.
• The research techniques that will be used to conduct the research (such as participant observation, interviews, focus groups, use of public, private governmental or other records, administration of test, etc.) should be described.  The topics or research domains to be covered as well as what will be observed (such as individual behaviors, community rituals, societal norms, etc.) should be described.  This will help the IRB get a sense of what will be learned from and about the participants in the research.
• Explain how the maximum number of participants is determined or what criteria will be used to determine when data collection is completed.

The research site(s) or location(s):

• Explain where the research will be conducted and explain why this particular research setting was chosen.
• Has the researcher conducted research at this site or with the population previously?  If so, briefly describe the topics and duration of your previous research.
• Is local governmental or community permission to conduct research required at any of the sites?  If so, explain how you will obtain this permission.  If there is formal documentation of this permission, attach it to the application form or indicate when it will be received and forward to the IRB.
• Will you work with local collaborators (interviewers, interpreters, translators, guides, etc.)?  If so, please explain who these collaborators are and how they will be involved in the research.  Will they need to obtain local ethics committee approval for their role in the study?
• Many countries have the expectation that foreign scholars will collaborate with local scholars and institutions.  Explain whether this applies to your research and if local IRB or other type of ethical review board approval will be obtained.

 Risks and Inconveniences

Risk of harm in ethnographic research is usually limited to what may result from invasion of privacy, stigmatization, or breach of confidentiality.  Harm may happen to individuals and to the groups or communities to which they belong.

• Identify the risks of harm that may result from this research.
• Describe the steps you will take to minimize the risks of harm.  If harm occurs, what plans do you have to manage it?
• If there are different risks of harm for different groups of participants, please identify the risks for each group.  Sometimes this cannot be known in advance of entering the field.  If unanticipated problems occurrence research has begun, the incidents must be reported to the IRB.  When appropriate, the study can be modified to address any issues that arise.

 Benefits

• Is it possible that individuals who take part in your research can reliably expect a direct benefit from taking part?  If yes, describe.
• Describe the anticipated benefits of this research for the community you will study, for your profession, or for society in general.

Confidentiality

• Describe how you will find out how people in this setting feel about the fact that you will write articles about them.  Will you consult with the people from whom you collected data before you publish?
• Are any portions of the research material you may collect not publicly available and expected by community standards to be private?  If yes, describe the materials that are private and explain (1) how you will store the private information or materials while you are in the field so that the confidentiality of the data is protected; (2) explain how you will store the private information or materials after you leave the field so that confidentiality is protected; (3) explain whether you will retain information that could lead to identification of the research site and explain any negative consequences this could have; (4) explain if you will record any direct participant identifiers (such as names or contact information) that could be linked to the private research material.
• If you will record identifiers (# 4 above) explain why and describe how you will protect against disclosure of this information or explain why this is not necessary.  If you will retain the identifiers linked to the data, explain (1) how long the identifiers will be kept, (2) how confidentiality will be maintained during this period, (3) who will have access to data (such as sponsors, advisors, government agencies, etc.).  In each case, explain whether they will have access to study data with identifiers or only to coded data with no access to the identifying study code.  If identifiers will be maintained indefinitely, explain why.  For example, do you intend to re-contact participants or communicate with them over a long period of time, or is the data identifiable by its nature (recordings, genealogies, etc.).  Explain how you will protect the data from a breach of confidentiality or why this is not necessary.
• If you will retain data that may place participants at risk for criminal or civil liability or be damaging to their financial standing, employability or reputation, please explain.  It may be advisable to obtain a federal Certificate of Confidentiality.
• The IRB acknowledges that sometimes it is not possible or desirable to maintain anonymity.  For example, when a researcher works with a small group of people only found in a particular region with whom others have worked.  In order to advance ethnographic knowledge about the group, their identity must be made known.

Sometimes individuals or whole communities do not want to remain anonymous.  If this is the case, please describe why.  If there are differences in the community about this, describe how this will be handled.

Consent Procedures/Process

• Explain how you will introduce yourself as a researcher to potential participants.  If you already know them, please explain the circumstances.
• How will you inform people about your research and obtain their consent to participate?  If you plan to use an oral consent process and to work informed consent procedures into your introduction to a group, or the beginning of an interview, please provide a general script or a list of points you will cover.
• Describe how people in this setting let you know if they don’t want to talk with you.
• Identify who is responsible for giving consent in the research setting (for instance, if a tribal council or community leader provides consent for the entire group).  Sometimes the consent process can be multi-layered in community settings.  Be sure to describe what the full process is in the setting in which the research will take place.
• Describe how you will handle situations in which group consent is provided, but individuals to not want to participate and vice versa.

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The importance of accurate documentation to the quality of medical care given to patients is unquestioned. It is such an accepted element of patient risk reduction in hospitals and in court rooms that the corresponding maxim is: “If it’s not written down, it didn’t happen.” NYU Medical Center website reminds its employees that in addition to its importance in providing a chronological description of patient care, and communication to other health professionals, “proper documentation also facilitates:

• If an adverse event occurs, you will have a record of what transpired prior to and of the incident.
• Appropriate compliance and quality review evaluations.
• Collection of data that may be used for research and education.”

These concerns also apply to research with human subjects, whether it is conducted in a hospital setting where the chart is a legal document or elsewhere.  It is common sense that accurately recording information is essential for providing accurate research data.

 Basic Principles of Documentation

• Entries need to be legible.  If your handwriting is not readable, PRINT.
• Date and sign or initial each entry you make at the end of the entry/page.
• Document immediately after you complete a procedure; details never so clear later on.
• Write complete entries; use standardized abbreviations only.
• Don’t document something for someone else.
• Don’t sign a document for someone else.
• Maintain the confidentiality of the record you are creating. Re-file subject files; don’t leave them open in common rooms where casual observers like other graduate students may view them.   Don’t discuss subject information outside the research team.

 

Making Corrections

Mistakes happen; if you make a mistake, correct it right away.

Do:

• Draw a single line through the incorrect entry:     120/80     error   120/60 CAM / *5/21/07 (*if a different date.) So that you can still read it.
• Write “error” immediately after it and initial it.
• *Preferably, you realized your mistake right away and are correcting it the same day. If not, you should also include the date you are making the correction.

Do not:

• Scribble over the entire original entry so that it is impossible to read.
• The implication may be made that you wanted to hide something.
• Do not alter or go back and correct entries. The more corrections in a record the less reliable a record appears to be; the more time that goes by the less reliable a correction appears to be.

Back to Researcher’s Guide

The IRB recognizes that the uses of deception or incomplete disclosure in research are valuable research techniques.  However, the use of such techniques raises  special issues that the IRB will review closely.  Deception occurs when participants are  deliberately given false information about some aspect of the research.  Incomplete disclosure occurs when  participants are not given information about the real purpose or the nature of  the research.

Justifying the Use of Deception in the IRB-1 Protocol Application

Federal regulations prohibit the use of  deceptive techniques that place participants at greater than minimal risk.  An investigator proposing to use deception or  incomplete disclosure should justify its use in the IRB-1 protocol  application.  Address the following when preparing  the IRB-1:

• In the procedures section, justify use of deception and explain why deception is necessary to achieve the goals of the study.  Explain if alternative methods not involving use of deception were considered and why these methods are not  being used (Sloan & Hull, 2006).
• In the procedures section, explain the process to debrief participants.  Explain when participants will be debriefed and who will debrief them. Provide copies of the debriefing statement that will be given to participants and the script that will be used by the researchers to orally explain the study (see below for guidance regarding the debriefing).
• In the risk section, explain if use of deception is likely to cause the participant psychological discomfort (i.e., stress, loss of self-esteem, embarrassment) while the deception is taking place.  Explain how this risk will be minimized during the experiment and after the experiment is complete (i.e. full debriefing)  (Sloan & Hull, 2006).
• Complete the waiver of consent section.  When participants are not given complete information about the study in the consent document, the IRB must waive certain required elements of the consent process (i.e. an explanation of the purpose of the research, a description of the procedures involved, etc.).  See below for additional information.

Informed Consent  Requirements with Use of Deception in Research

Potential participants should be advised in the consent form that the information they are given is not complete and that they will be debriefed after the research procedures are completed.  Address the following when preparing the consent form/information sheet:

• In the “Why is this study being done?” section, provide a truthful and accurate  explanation of the purpose of the study to the extent possible, without priming participants or by giving too much of the study away.
• Include the following statement in the “What will I be asked to do?” section, “Some research requires that the full purpose of the study not be explained before you participate.  We will give you a full explanation at the end of the study.”  Please note:  the last sentence can be further customized to say, “We will give you a full explanation as soon as you complete the study.”

Debriefing  Requirements for Use of Deception in Research

The debriefing is an essential part of the informed consent  process and is mandatory when the research study involves use of  deception. The debriefing provides  participants with a full explanation of the hypothesis being tested, procedures  to deceive participants and the reason(s) why it was necessary to deceive  them. It should also include other  relevant background information pertaining to the study (see below).

The Federal Debriefing Requirement

When required elements of informed consent are waived or altered by the IRB, in accordance with criteria provided in the regulations,  participants must be debriefed at the end of the study, when appropriate.  When a research study involves use of  deception, the IRB must find that:

• the research involves no more than minimal risk to participants;
• 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 participants; and
• whenever appropriate, the participants will be provided with additional pertinent information after participation.

As indicated above, the debriefing must occur “when appropriate.”  It may be inappropriate when:  Debriefing regarding the deception may cause more harm than the deception itself.   For example, if a student is selected for participation in a study based  upon certain physical characteristics (i.e., weight), it might not be  appropriate for the debriefing to describe that aspect of the selection  process.

The timing of the debriefing is also an  important consideration.  Generally, the  IRB expects that participants will be debriefed immediately following their  participation in the study.  However, it is possible that an immediate debriefing may compromise study results.  Participants who have completed the study  might tell others about it.  If they have been debriefed and have been debriefed may share that information with  prospective participants, thus compromising the scientific  validity of the study.  The IRB  recommends the use of the following strategies to handle this situation.

If participant names and contact information are collected as part of study procedures, debriefing information can be sent when the study is completed via mail, email or by phone.

If participant names and contact information are not collected researchers can:

• Give participants a URL where they can get debriefing information and a date upon which it will be available.
• Have each participant address an envelope to themselves before they leave the study session and send them debriefing information when the research is completed.

In most cases, the IRB expects that participants will be  given a debriefing statement to take with them after the study is complete and  after participants have been given an oral debriefing (script) immediately  following completion of the study.  Both  the debriefing statement and the debriefing script must be reviewed and  approved by the IRB.

The process to debrief participants must be explained in the  IRB-1 protocol.  Address the  following elements:

• Indicate who will debrief participants.  The IRB expects that this person is a member of the research team, someone knowledgeable about the research and the deception.  If the research is student directed  (i.e. related to graduate studies, master’s thesis or doctoral dissertation), the IRB expects that the student researcher will debrief participants.
• Indicate when participants will be debriefed. Again, the IRB generally expects that participants will be immediately debriefed after they complete the study.  Any delay in debriefing must be explained and justified.
• Provide a rationale for any elements of the deception that will not be revealed to participants.

At a minimum, the debriefing statement must include the  following:

• Label the form as “Debriefing Statement”
• Study title
• PI name and contact information for follow-up questions
• Student researcher’s name and contact information, if applicable, for follow-up questions.
• Thank participants for taking the time to participate in the study
• Explain what was being studied (i.e., purpose, hypothesis, aim).  Use lay terms and avoid use of jargon.
• Explain how participants were deceived
• Explain why deception was necessary in order to carry out the research
• Explain how the results of the deception will be evaluated
• If the study involves use of audio or video-recording an individual participant, give the participant an opportunity to withdraw his/her consent for use of the recordings and, potentially, withdraw from the study all together, after the true purpose of the study is revealed.The IRB suggests that participants be given at least 48 hours to make this decision and provide contact information for whom participants should contact regarding their withdrawal from the study.  This option must be given to  participants even if they were video or audio-recorded during a focus group or during an experiment involving other participants.  If a participant decides to withdraw, the PI must use video editing tools to make an individual who withdraws unidentifiable.  If tools are not available, the PI cannot use the video or audio recording.

Consider adding the following, additional elements, to the  debriefing statement:

• Provide references/website for further reading on the topic
• Emphasize that it was the not the gullibility of the participant but rather the skill of the experimenter that is responsible for the success of the deception (Sloan & Hull, 2006).
• If the study did not involve use of audio or video recording but involves sensitive topics, it may be appropriate to give participants an opportunity to withdraw their consent to participate.

In addition to the elements included in the debriefing statement,  consider adding the following elements to the oral debriefing that takes place after the participant has completed the study:

• Relate the research to something participants may have learned in class (methods or theory)
• Explain anticipated or observed results so far
• Offer to provide them with the study results

Debriefing as an  Educational Tool

Finally, the IRB suggests that the debriefing also be used  as an educational tool, even when the study does not involve use of  deception.  Participants should be given  a simple, clear and informative explanation of the rationale for the design of  the study and the methods used.  Ask for  and answer participant’s questions.

Sloan, L and Hull,  J.  2006.   Deception of Research Subjects 2nd Edition.  In E. A Bankert and R. J. Amdur (Eds.), Institutional Review Board Management and  Function (210-215).  Sudbury,  Massachusetts:   Jones and Bartlett  Publishers.

Source material for this policy guidance was provided by the  Duke University IRB and the Stanford University Psychology Department.  The UConn IRB gratefully acknowledges this  support.

January 2009

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For more information on Informed Consent see IRB Policies and Procedures.

“Informed consent is more than just providing a prospective participant with a form to sign.  Informed consent is a process” that  stems from the requirement for Respect for Persons one of the three most important  principles of conducting research with human participants. (See the Belmont Report: Respect for Persons).   The informed consent process is an interaction between the prospective participant and the Principal Investigator, student  investigator or other designated qualified, key personnel (hereafter referred  to as the “PI”). During the process, the research study is explained to the  participant so that the participant can make an informed decision about whether  or not to participate in the research study.   This common sense process involves having a conversation with the  prospective participants to ensure that the participant understands the research study and the reasons why the study is being conducted as well as the risks and benefits of the research. The conversation must allow the participant sufficient time to ask questions and to consider whether to participate in the  study.  This conversation must also take  place in a setting that affords a sufficient level of privacy for the  participant.  The informed consent  process is most often documented by the use of an IRB approved and validated informed  consent form.  The person obtaining consent must be trained in human subject protection, have an in-depth knowledge about the research study and be able to answer all questions posed by the participant.

Before beginning the conversation, the PI should discuss with the participant whether any special provisions will be needed for the consent process to take place.   For example, hearing impaired individuals may want a sign language interpreter present or individuals with dyslexia may prefer to have the document read to them.   The informed consent process should also be specific to each participant  population and must take into consideration the participant’s native language, level of education, and maturity.  Non-English speakers, educationally  disadvantaged and minors are among the populations considered to be vulnerable.  The IRB will look to see that the PI has taken this  into consideration throughout the consent process.

Informed consent is an on-going process and this is particularly important for longitudinal studies.  The PI should be available to answer participants questions at all times.  In certain circumstances, it may be appropriate to remind participants of the purpose of the study and to remind them of the study procedures that will take place in the future.  For example, longitudinal studies that require completion of multiple assessments over several weeks or several months should be accompanied by a brief informed consent document, not necessarily one that must be signed, to explain the research and the study procedures that must be completed at the point in time the assessment is to be completed.

The informed consent process should also take place in person.  The IRB may, for extenuating circumstances or minimal risk studies, consider the possibility of obtaining consent by phone or fax.

When Consent Must be Obtained

Consent must be obtained prior to any involvement of the participant in a study. All consent forms must include instructions for the participants as to whom to contact  regarding research related questions, the PI/research team members, research related injuries (if applicable) and how to contact the IRB regarding their  rights as a research participant.

In general, participants must consent to any screening procedures as well as to participation in the study.  The PI may choose to use two different forms or to use one form that includes both phases.  Participants are considered enrolled at the time of signing the consent form.   Participants must be informed that they may be withdrawn if it is determined that they do not meet inclusion criteria.  Participants who did not meet the screening criteria are to be reported as withdrawals from the study at the time of continuation.  Note that there are certain exceptions to obtaining consent prior to screening.  Please contact the IRB Office for more information.

Consent from individuals other than the participant may need to be obtained if investigators seek information about people who are not principals to the research  (“secondary participants”).  These people could be members of the principal participant’s family, friends, sexual  partners, co-workers, etc.  Such individuals may be participants in their own right, even if the investigator  never has any contact with the individual.   The federal regulations define a human participant not only as someone with whom the investigator interacts,  but also as someone about whom the  investigator seeks information.

Requirements of Informed Consent

As explained in the federal law that governs research with human participants, the informed consent process and document must contain certain required elements.  Most of the elements involve basic, common sense information – information that most people would want to know in any situation before deciding to participate.  Consider the  following scenario involving a decision to go to see a movie.  It begins with your friend inviting you out for the night.  The purpose of going out would be to see a movie.  Your  friend will naturally explain the procedures for the evening; suggesting  the name and location of the movie and the time to leave so you will be able to go out to dinner but make it to the movie in time to see the previews. You may be hesitant about going out because you have had a tense day at work and you consider that one of the benefits of going out would be a relaxing evening.  Even if the evening is relaxing, you consider that a possible inconvenience (or risk) may be giving up the time to do something else.  Of course, the deal is even sweeter when your friend insists on paying for the movie so that you don’t have to worry about any economic considerations for the evening.  After weighing the fun you’ll have going to the movie versus staying home or doing something else, you decide to go to see the movie.  You have made a voluntary decision to go to see the movie.  Of course, this example is not research but it illustrates that the elements of the informed consent process are really  common sense and that providing these elements for consideration enable people to make an informed decision about whether or not to participate.  For a complete explanation of the required elements of the informed consent process refer to the informed consent document templates   and the IRB Policies and Procedures document.

Standard Consent and Documentation

The informed consent process is most often documented by use of an IRB approved, validated consent form.  Consent must be obtained from individuals who are at least 18 years old (or who, under their state’s laws are  emancipated individuals) and who are competent to give informed consent.  The PI must make a practical assessment of the participant’s capacity to understand the research, weigh the risks and benefits and make an informed decision about whether to participate.

Consent will most often be documented using a full length standard signed consent form that lists the required elements of consent.  The participant (or the participant’s legally authorized  representative) and person obtaining the consent (PI or delegate) must sign and date the form prior to study participation.  The PI must provide the participant (or the  participant’s legally authorized representative) with a copy of the signed and dated document.

When it is feasible, the PI or his/her delegate must sign and date the form in the presence of the participant. Written consent may not be necessary or appropriate in certain studies, such as surveys, interviews and other minimal risk research or in research where the participants are to remain anonymous. In these cases, the investigator should prepare an Information Sheet appropriate for the study.  An Information Sheet is similar to a consent form; it contains the same required elements but omits the signature section.

The IRB has prepared a number of informed  consent templates.  The templates should be used; however, the IRB will consider alternative formats (e.g. letter format) on a case-by-case  basis.  The PI must explain why the templates are not feasible for this research in the documentation of consent section of the IRB-1 or in the informed consent section of the IRB-5.  The templates also provide guidance and suggested language that may be used to inform participants about the research  study, the requirements for participation and the participants’ rights and  responsibilities.

1.) The consent document must be written with language that is understandable 2.) It should include plain conversational language, at an 8th grade reading level, similar to the level used in popular magazines and newspapers to the participant  population. 3.) Jargon and field specific terms should be avoided or if unavoidable must be defined. 4.) It must also be written in the second person  (e.g., you are invited to participate, your child will be assigned, etc.).  The IRB has tips on writing for lay audiences and Microsoft Word has a tool to assess readability.  The consent document should be prepared with a font that is easy to read such as Times Roman, Arial, or Garamond and use a font size no smaller than 12 point. Instructions that accompany the informed consent templates also have additional suggestions for  preparing the consent form.

Waiver of Consent or Alteration to Elements of Consent

In some circumstances, the IRB may waive or alter some or all of the elements of informed consent. A waiver or alteration of consent may be granted by the IRB when certain regulatory criteria under 45 CFR 46.116 are met.

The IRB must find and document the following:

1. The research involves no more than minimal risk to the subjects;
2. The research could not practicably be carried out without the requested waiver or alteration;
3. 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;
4. The waiver or alteration will not adversely affect the rights and welfare of the subjects; and
5. Whenever appropriate, the subjects or legally authorized representatives will be provided with additional pertinent information after participation.

In all cases the IRB is required to find and document justification for any alteration to the requirements of consent.

Assessment of Participant’s Understanding of the Research and Consent Process

As described earlier, the PI must make a practical assessment of the participant’s capacity to understand the consent discussion in order to be certain that the participant can give informed consent.  This must be done in all circumstances even for minimal risk studies with participants who are not considered to be vulnerable.  Such an assessment is also useful in order to gauge whether the participant may be able to understand and carry out the research procedures.  The PI can facilitate this process by asking the participant open-ended questions that ask for explanations rather than closed ended answers that can be answered by a “yes” or “no” answer. For example: “Please tell me in your own words what we’re going to ask you to do?” vs. “Do you understand the procedures?”

Informed Consent Requirements with Use of Deception in Research

The use of  deception in research (e.g., participants are initially misinformed  deliberately for purposes of the study) raises special issues that the IRB will  review closely.  One consideration is  whether the deception is necessary.  A PI proposing to use deception must justify its use in the procedures section of  the IRB-1.  Federal regulations prohibit the use of deceptive techniques that place participants at greater than minimal risk.  The IRB may modify the informed consent process for research involving deception when participants are not placed at risk.  However, potential participants should be advised in the consent form that the information they are given is not complete and that they will be debriefed after the research  procedures are completed.

The  debriefing should include a detailed description of the ways in which deception was used and the reason why deception was necessary in order to carry out the  research. The investigator is responsible for ensuring that the participant leaves the research setting with an accurate understanding of the purpose of  the research and why deception was used.  The debriefing process, including any written materials, should be provided to the IRB as a part of submitted protocols.  The following statement, or some similar statement, must appear in every consent form/information sheet for studies involving deception:

“Research designs often require that  the full intent of the study not be explained prior to participation. Although we have described the general nature of the tasks that you will be asked to  perform, the full intent of the study will not be explained to you until after the completion of the study. At that time, we will provide you with a full  debriefing which will include an explanation of the hypothesis that was tested  and other relevant background information pertaining to the study. You will  also be given an opportunity to ask any questions you might have about the  hypothesis and the procedures used in the study.”

Requirement for Witness Signature on the Consent Form

It is  possible to conduct an oral presentation of informed consent information in  conjunction with providing 1) a short form written consent document stating that the elements of informed consent have been presented orally and 2) a written summary of what is presented orally.   This procedure is most often used when a witness to the informed consent process may be required for certain vulnerable populations (i.e. educationally disadvantaged, illiterate or non-English speaking individuals or when the study is complex in nature.  For example, the IRB may require that the entire consent process be witnessed by a research  participant advocate, a representative of the IRB, research study personnel, a primary caregiver or other appropriate individual.

Consent of Participants Not Fluent in English

For participants not fluent in English, the consent process and document as well as study related documents (e.g., survey instrument, medical release forms) must  be presented in a language (preferably native) understandable to them.  If it is expected that participants who do not speak English will be enrolled in a study, translated documents should be made available.  The IRB must review and approve all foreign language versions of the consent documents.  The IRB recommends the use of one of two methods for translation.  If one of the two recommended methods is not feasible, the IRB will accept certification from the  PI that he/she or a member of the research staff translated the document and that the translation is accurate.  This should be explained in the documentation of consent section of the IRB-1.

The informed consent process must also be conducted in a language understandable to the participant and may therefore require the use of a translator or sign language  interpreter.  In most cases, the translator may be a family member or friend of the participant, an employee of  the institution or may be hired by the PI.  The IRB will determine whether a professional translator is required on a case-by-case basis.

Re-Consenting Participants

Common sense and IRB requirements dictate that participants must be reconsented if there have been developments that may affect a participant’s willingness to  continue to participate.  To continue the movie analogy given above, such developments may be a discovery that the movie  may be scarier for the participant than anticipated or that the movie is sold out and another must be selected.   Re-consent more commonly occurs in biomedical studies, but may occur in social and behavioral research in cases where participants in an on-going study are asked to provide consent for their data to be used for another research purpose or in cases where the PI has a need to retain data (de-identified) indefinitely.  In most cases, re-consent can take place at the participant’s next regularly scheduled visit.  In some circumstances, depending upon the level of risk and the nature of the information to be conveyed to participants,  the PI or the IRB may require that participants need to be contacted  immediately.

It should be noted that minor participants who are actively participating in a research study when they research the age of majority should be re-consented as adults  at their next regularly scheduled visit.

Assent from Children or Decisionally Impaired Individuals

In the State of Connecticut only individuals who are 18 years old (the age of majority, Conn.  Gen. Stats.  §1-1d) or older, may  legally consent to participate in research.   This legal authority may be withheld from some classes of individuals  with limited decision-making or cognitive ability.  Further, some individuals voluntarily give over this authority to another through a power of attorney or a health care proxy.  Individuals who do not have the  authority to consent to participate in research must still provide their “assent,”  which may be in writing, oral or in some circumstances, by action or behavior,  e.g., with very young children.

Assent is a knowledgeable agreement to participate in the project.  It differs from “consent” which is recognized as being granted from an individual with the legal authority to do so.   Children cannot legally give consent; however, they can provide assent.  Adequate provisions should be made for soliciting the independent, non-coerced assent from children or  cognitively impaired persons who are capable of a knowledgeable agreement.  In cases where assent is obtained from a child or cognitively impaired  participant, permission must also be obtained from parents or legally authorized representatives.  In accordance with the ethical principal of respect for persons, if the person from whom assent is sought refuses, the person should not be enrolled, even if  the parents or legally authorized representatives give permission.  Alternatively, if the person from whom assent is sought agrees to participate, the person may not be enrolled if the parents  or legally authorized representatives do not give permission.  In rare circumstances, depending on the nature of the study and the age and circumstances of the child or decisionally impaired person, the IRB may waive the requirement for permission from parents  or legally authorized representatives.

The IRB will determine whether one or both parents must sign a parental permission  form.  The IRB may find that permission  from one parent (or legally authorized representative) is sufficient for research involving no greater than minimal risk or for research involving greater than minimal risk but holding out the prospect of direct benefit to the  participant.

As a general guideline, if the participant is 12 years of age or older, the child signs and dates an assent signature line on the parental permission form and a parent or  guardian signs the same form.  Note that the language used to describe the consent form has changed.  Parents give their permission, not their consent, for their child to participate.   In certain circumstances, the PI may propose or the IRB may require that a separate assent statement is necessary.   For example, the PI may wish to reinforce the voluntary nature of participation and the nature of the study with minor participants in studies taking place at a school where the parents have already given permission of the minor participant to participate in the study.

If a separate assent form is required, both the form and the assent discussion with the participant should be in a language especially tailored for participant, i.e., age appropriate and should describe the following:

• Explain why the study is being conducted;
• Describe what will happen and for how long or how often;
• State it is up to the child/individual to participate and that it is okay to say no;
• Explain if it will hurt and for how long and how often;
• Say what the child’s/individual’s other choices are;
• Describe any good things that might happen;
• Say whether there is any compensation for participating; and,
• Ask for questions.

The assent form should be limited to one page.   Illustrations might be helpful and larger type makes it easier for some  individuals to read.  In studies involving older children or adolescents it may be possible for the child to read and indicate their written assent on the assent form.

If the child is between 7-12 years of age, and the study is a therapeutic trial, the parent signs the parental permission form and the child participant does not have to sign.  If the study is not a therapeutic trial, the parents or guardians sign the parental permission form and the participant signs an assent statement that is either included at the end of the parental permission form after the signature lines or as a separate document.

If the child is less than 7 years of age, the parent or guardian signs the parental permission form, the participant signs nothing.   No written assent statement is required; however, the PI should provide a script that will be followed to describe the study to participants.  However, the PI or person obtaining consent must document in the study record that the child was willing to participate.

Considerations for Informed Consent for International Research

Field research done outside of the United States, especially in non-western societies or places where the participants do not speak English, poses some problems in obtaining written documentation of informed consent.  In these situations, it is sometimes  impossible, for a variety of reasons, to obtain written consent.  If that is the case, the PI must provide the IRB with a statement of the reasons why it should waive written consent, and also provide an acceptable alternative method of obtaining oral consent, which is appropriate to both the participants and their culture (refer to  Ethnographic Research section).

If the participants may be economically or educationally disadvantaged, the investigator should pay particular attention to these issues and ensure that  appropriate safeguards have been implemented.

Informed Consent Requirements for Research with a Certificate of Confidentiality

A certificate of confidentially protects the participant’s confidentiality by protecting identifiable research records from subpoena.  The  certificate goes beyond the consent form in ensuring confidentiality and  anonymity.  Without the certificate,  researchers can be required by a court-ordered subpoena to disclose research results (often as part of a criminal investigation of the participants).  Regardless of a study’s funding source or whether it is funded, Certificates of Confidentiality are issued by the National Institutes of Health (NIH) and other Department of Health and Human Services  (HHS) agencies. They allow the investigator and others who have access to research records to refuse to disclose identifying information on research participants in civil, criminal, administrative, legislative, or other  proceedings, whether federal, state, or local.

The IRB has prepared language to explain Certificate of Confidentiality requirements in the consent form. Either this or similar language must be used when the PI obtains a Certificate of  Confidentiality.

Back to Researcher’s Guide

Federal regulations for human subjects research require Institutional Review Boards (IRBs) to determine that adequate provisions to protect the privacy of subjects and the confidentiality of data are in place and that researchers include adequate provisions for monitoring the data collected to ensure the safety of subjects in their research plan. This page will help investigators plan for the collection, transmission, and storage of research data in a secure manner consistent with University policies and federal regulations. Methods for working with research data often evolve over time given rapid changes to technology. As a result, periodic updates will be made to this page. Researchers are encouraged to reference this page as information is often updated to reflect new technology and security parameters.

The Principal Investigator is responsible for all aspects of research, including the collection, transmission, storage, backup, and security of data and ensuring those listed as key personnel are informed and trained on the procedures related to data security. Research team meetings should include documentation of training and discussion about the safeguards in place to protect research data.  This is particularly important should a breach occur or loss or theft of a device that stores identifiable data. These occurrences must be immediately communicated to the IRB, Information Technology Services (ITS), or UConn’s Privacy Office. To assist researchers with documenting these procedures and for the IRB to review and make appropriate determinations, all human subjects research submissions must include  a completed Data Security Assessment Form. Any changes regarding the use of technology in research must be submitted to the IRB (via an amendment to an approved protocol) for approval prior to implementation of the changes.

The informed consent form must include information regarding any terms of service or end user agreement for technologies used in the research as well as information about whether a vendor has access to a participant’s contact list or other information on their device, ability to track location, and whether there is a possibility that any participant data will be used for marketing or other activities or sold to a third party.

Questions related to the security or allowable use of software for the collection, transmission, and storage of research data can be directed to UConn’s Information Security Office security@uconn.edu.

Definitions

Anonymous Data: Records including tissue and samples that do not have a code assigned that would permit the data to be traced back to an individual. This includes any information that was recorded or collected without any of the 18 identifiers as defined by HIPAA. Note that IP addresses are considered by the University and some international standards to be identifiable even though the address is linked to the computer and not specifically to the individual.

Confidential data under UConn policy is data that is regulated by Federal or State laws including but not limited to Family Rights and Privacy Act (FERPA), Health Insurance Portability and Accountability Act (HIPAA), or the Children’s Online Privacy Protection Act (COPPA). Sensitive data include information related to alcohol or drug use, traumatic experiences, child/elder abuse, or illegal behavior, or where disclosure outside of the research study has the potential to place participants at risk of criminal or civil liability or be damaging to their financial standing, employability, educational advancement, or reputation.

De-identified Data: Data that are stripped of all identifying information and there is no way the data could be linked back to an individual through a key or other coding method. Best practice when de-identifying data is to use the safe harbor method where all HIPAA identifiers are removed.

Coded Data: Data, including tissue and samples are coded when a link or key to the code exists, such as a number, letter, symbol, pseudonym, or any combination, that is linked to an individual participant’s identifiers. The code should not include information related to an individual, such as initials or date of birth.

Protected Health Information(PHI): Individually identifiable health information, held or maintained by a covered entity or its business associates acting for the covered entity, that is transmitted or maintained in any form or medium (including the individually identifiable health information of non-U.S. citizens). This includes identifiable demographic and other information relating to the past, present, or future physical or mental health or condition of an individual, or the provision or payment of health care to an individual that is created or received by a health care provider, health plan, employer, or health care clearinghouse. For purposes of the Privacy Rule, genetic information is considered to be health information.”  UConn is designated as a Hybrid Entity under HIPAA. Under the Hybrid status, UConn’s Speech & Hearing Clinic is a covered Entity. Please contact UConn’s Privacy webpage for more information regarding HIPAA.

Private Information: includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information that has been provided for specific purposes by an individual and that the individual can reasonably expect will not be made public (e.g., a medical record).

Identifiable Private Information: is private information for which the identity of the subject is or may readily be ascertained by the investigator or associated with the information. An identifiable biospecimen is a biospecimen for which the identity of the subject is or may readily be ascertained by the investigator or associated with the biospecimen.

Data Collection and Storage:

All University owned computers and laptops must have encryption enabled by default and must be used for all storage of UConn Confidential Data or identifiable participant data and comply with UConn’s Confidential Data Policy. Research data may be stored on UConn secure drives, such as P and R, or the use of university authorized cloud services, such as UConn Office 365 (e.g. OneDrive/SharePoint).

University devices must be used when research involves collection or storage of photographic images or voice recordings of research participants, and data protected under HIPAA and FERPA. At times, researchers purchase cell phones and other devices to be used by the research team. Personal devices, such as laptops, cell phones, or digital recorders that are owned by the researcher or member of the study team are not an acceptable method to collect identifiable or UConn Confidential data due to inherent risk of loss of confidentiality. If it is not possible to use a university device, the consent form must reference loss of confidentiality as a risk to research participants. Data should be held on personal devices only for the time necessary to be promptly moved to a secure university managed location. A personal device, such as a cell phone may be used for appointment reminders, as long as personal identifiers are not paired with other identifiable information. Personal laptops may be used for storing public data. All personal devices must be password protected. ITS recommends using university applications and sponsored software for identifiable data collection because there are secure controls in place to help minimize risk.

When using wearable devices, such as an activity trackers,  a smartwatch, voice recording devices, location trackers, or other technology to collect research data, information must be included in the informed consent form that states participants will be required to download and agree to terms of service or other agreements applicable to the app if the participant is using their own device and not one provided to them by the researchers.  If an app meets the regulatory definition of a mobile medical application as defined by the FDA, additional regulatory determinations may need to be made depending on its intended use.

Transmission of Research Data:

UConn does not recommend the transmission of identifiable datasets by email due to the inherent risk of compromise. When emailing data that do not contain any personal identifiers, include [encrypt] in the subject line of an email when sending from a university email account. If emails are compromised, this could place data at risk and result in loss of confidentiality for research participants. Identifiable data should be transmitted via a secure service, such as Office365, FileLocker, a secure website, or by using secure protocols, such as a File Transfer Protocol (FTPS). Filelocker is an encrypted web-based application that is used to provide short term secure storage and encrypted transport of files both across campus and anywhere with web access. The level of security should be appropriate to the risk.

Informed Consent:

Human subjects regulations allow researchers to obtain written consent in an electronic format. The Office for Human Research Protections (OHRP) and the U.S. Food and Drug Administration (FDA) issued guidance for obtaining informed consent electronically. Electronic informed consent (eIC) should be easy to navigate, allowing the user to proceed forward or backward within the system and stop and continue at a later time. If the consent process takes place remotely and is not personally witnessed by study personnel, the electronic system must include a method to ensure that the person electronically signing the informed consent is the subject who will be participating in the research or the subject’s legally authorized representative (LAR) (see 21 CFR 11.100 (b)). Examples may include verification of a state issued ID or other documents, use of personal questions, biometric or visual methods. At UConn, an example is the use of the NetID and password.   However, minimal risk social behavioral research may not warrant such verification. FDA-regulated clinical investigations must comply with criteria under 21 CFR part 11. For this type of research, the electronic system must capture and record the date the subject or LAR provided consent and a copy of the informed consent must be provided to the person signing the form. Consent forms that include a hand-written signature may be returned via fax or postal mail.

For anonymous internet-based surveys or for research that the IRB grants a waiver of signed consent, include “I agree” or “I do not agree” check boxes on the information sheet or consent form for participants to click to indicate their active choice of whether or not they consent to participate. Please be sure to use the most updated forms found on the IRB’s Forms & Templates page. These forms are periodically updated and include other applicable required statements.

Web Conferencing for Collecting Research Data

The use of web conferencing to conduct research interviews and/or to collect research data has increased significantly. To comply with UConn ITS guidelines and policies, researchers should use UConn approved software or services when conducting these activities. This guidance has been developed in conjunction with Research Compliance Services (RCS) and UConn’s ITS Security to assist researchers in understanding what platforms may be appropriate.

The nature of the data dictates which platforms may be appropriate. For example, investigators who will collect identifiable sensitive data (e.g. personal health information, illegal behaviors, substance use, etc.) that could place research participants at risk if disclosed may use Microsoft Teams or WebEx to conduct remote research interviews. Investigators collecting research data that is not sensitive may also use Google Hangouts/Meet when conducting research interviews remotely. In all cases, researchers must ensure their data collection activities are properly secured against outside (non-invited) guests. Most platforms provide specific controls to help prevent inappropriate access; for example, please visit online instructions for WebEx. When using software that is not secured or sponsored by university ITS, the consent form must include loss of confidentiality and possibility of data mining as risks.

Other web-based software may be allowable on a case-by-case basis, but must first be cleared through ITS and/or Procurement. Some web conference software allows the researcher to record sessions, share screens, and automatically transcribe the recording. When recording sessions, researchers are asked to ensure that the recordings are stored in one of the following ways: on a University secure server, UConn’s version of Office 365, NetApp, or SharePoint.

Internet Based Research

Computer and Internet-based methods for collecting, storing, and transmitting data in research involving human participants are increasing in use and constantly evolving. As new methods are developed and used by researchers, they present new challenges to the protection of research participants. The IRB reviews computer and Internet-based research protocols using the same considerations and standards of approval of research under human subjects regulations and UConn policies.

Internet-based survey instruments should be formatted in a way that will allow participants to skip questions if they wish or provide a response such as “I choose not to answer.” If all of the questions in a survey require a response, then the Information Sheet or consent form must include a statement about this requirement. Also, at the end of the survey, there should be two buttons: one to allow participants to discard the data and the other to submit it for inclusion in the study.

Computer-and internet-based procedures for advertising and recruiting potential study participants (e.g., social media, internet advertising, e-mail solicitation, banner ads) must follow the IRB guidelines for recruitment that apply to any traditional media, such as newspapers and bulletin boards. All advertising and recruitment material must be reviewed and approved by the IRB prior to implementation.

Investigators are advised to review the University’s policy on Use of Official Email Lists prior to soliciting participants by email. If you plan on using LISTSERVs at UConn, please contact list moderators for individual list policies regarding solicitations for research.

Online data collection software:

The UConn Office of Institutional Research & Effectiveness (OIRE) has obtained a license from Qualtrics as an on-line data collection tool. Qualtrics is available to all faculty members, students, and staff with a UConn Net ID and password.

Research Electronic Data Capture (REDCap) is also available to UConn researchers for a fee. REDCap is a secure web application for building and managing online survey databases.

The use of on-line survey software should be administered by a professionally trained person with knowledge in computer and internet security. Access to the data housed in the survey software must only be limited to key project personnel.

The informed consent form must include what individuals have access to the data (e.g., survey software panel personnel) and must state how data will be collected, transmitted stored.

Both Qualtrics or REDCap may be configured to allow use of a mouse or finder to obtain a written signature.

For international research, investigators are cautioned that encryption standards vary from country to country and that there are legal restrictions regarding the export of certain encryption software outside US boundaries. Similarly, data privacy regulations vary between states. Investigators are responsible for understanding the data privacy laws where data collection occurs under their protocol.

Data Storage/Disposal:

If a server is used for data storage, personal identifying information should be kept separate from the data. It is recommended that competent data destruction services be used to ensure that no data can be recovered from obsolete electronic media. Researchers must adhere to the UConn Information Security Office’s Confidential Data Security Standard Policy, and Data Storage Guidelines. As a reminder, federal regulations require human subjects records be retained for at least 3 years after completion of the research.

Children’s Online Privacy Protection Act (COPPA)

Researchers working with children online are subject to COPPA in addition to human subjects regulations. Researchers are prohibited from collecting personal information from a child without posting notices about how the information will be used and without getting “verifiable parental consent”. For minimal risk research written permission may be obtained by paper, mail, or fax. If the research is more than minimal risk, parental permission should be obtained in a face-to-face meeting.

The Protection of Pupil Rights Amendment (PPRA)

PPRA, 34 CFR Part 98, is a Federal law governed by the Department of Education that 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. The law requires schools to obtain written consent from parents before minor students are required to in any U.S. Department of Education funded survey, analyses, or evaluation collects information in the following areas: Political affiliations; mental and psychological problems potentially embarrassing to the student and his/her family;  Sex behavior and attitudes; Illegal, anti-social, self-incriminating and demeaning behavior; Critical appraisals of other individuals with whom respondents have close family relationships; Legally recognized privileged or analogous relationships, such as those of lawyers, physicians, and ministers; Religious practices, affiliations, or beliefs of the student or student’s parent*; or income (other than that required by law to determine eligibility for participation in a program or for receiving financial assistance under such program.)

Source material for this policy guidance was provided by the Pennsylvania State University and the University of Georgia IRBs. The UConn IRB gratefully acknowledges this support.

Additional Resources:

UConn Security Policy Manual.pdf

UConn Password Standards

Information Security Office Security Tips

Information Security Office Confidential Data Handling Suggestions

February 2021

Back to Researcher’s Guide

Investigators seeking funding from the National Institutes of Health (NIH) must also satisfy the NIH training requirement before an approved study may be initiated. For more information on the NIH training requirements, go to the following FAQ webpage: http://grants.nih.gov/grants/policy/hs_educ_faq.htm.

To access the training directly and for more information on training requirements, go to NIH Office of Extramural Research.

When Sponsored Program Services (SPS) has set up a new award account, the Department will receive an email with the account number and Subrecipient institution named on the project. The Department will then follow these instructions:

1. Submit a requisition in KFS.

• If the vendor (Subrecipient) is not available in KFS, obtain a completed and signed Form W-9 from the vendor and create the new vendor through KFS.  When you submit the Subaward Agreement, notify SPS that you have initiated the new vendor setup.

2. Download the UConn Research Subaward Agreement.

a. Enter the following information in these fields on page 1:

• • Prime Award No.
  • Awarding Agency
  • Subrecipient Name
  • Amount Funded This Action
  • Est. Total (if incrementally funded)
  • Subaward Period of Performance dates
  • Estimated Project Period dates (if incrementally funded)
  • Project Title

Please note: SPS will fill in the Subaward No. using the PO number generated in KFS.

b. On Attachment 3A, fill in the Principal Investigator contact information.

c. Completed all of the necessary information and save the file using the following convention: subrecipient name_KFS#.

3. E-mail the following to subawards@uconn.edu with the Subrecipient name and KFS number in the subject line.

a. Subaward Agreement
b. Scope of Work and Budget documents
c. Subrecipient contact information (name and e-mail)

4. SPS will confirm receipt and send the Department a final draft to review before sending the Subaward Agreement out for Subrecipient signature.

Amendments

Amendments will be used to make any necessary changes to the Agreement. Amendments will also now be used instead of Release of Funds letters to notify Subrecipients that funding for subsequent years of a project is available.  SPS will draft and send the Amendment to the Subrecipient and encumber the funds in KFS by amending the PO.

Please email Amendment requests to subawards@uconn.edu and provide any necessary information such as funding amount and budget period.

 

The use of material transfer agreements (MTAs) is widespread in today’s research and development environment. Biological materials, such as reagents, cell lines, plasmids, and vectors are the most frequently transferred materials, but MTAs may also be used for other types of materials, such as chemical compounds.

Sponsored Program Services – Contracts Team reviews and approves all MTAs for incoming materials. For these MTAs, complete the Cell-Line Biological Materials Registration or the Human Embryonic Stem Cell Registration form, as applicable. Submit the completed form with the MTA and any pertinent approvals to spscontracts@uconn.edu.

Technology Commercialization Services creates and processes all MTAs that cover transfers of research materials outside of UConn, to both non-profit and for-profit institutions.  Please submit requests and questions to Ana Fidantsef, PhD at ana.fidantsef@uconn.edu.

 

Team	Schools / Colleges	Departments
Team   1: Khalid Jabarkahil Beverly Dauphinais Shelby Corbin	Agriculture, Health and Natural Resources	All
	Business	All
	CT Small Business Development Center	All
	Graduate School	All
	Institute for Student Success	All
	Law School	All
	Vice President for Global Affairs	All
	Vice President for Research	Center for Environmental Sciences & Engineering and CT National Estuarine Research Reserve
Team   2: Meg Niewinski Lori Abell Carleen Wells	CLAS	All (except Marine Sciences)
	Fine Arts	All
	Public Safety	All
	Stamford Regional Campus	All
	Torrington Regional Campus	All
	Vice President for Research	Institution for Collaboration on Health, Intervention and Policy
Team   3 Khalid Jabarkhail Jennifer McNeal Deborah Ives	CLAS	Marine Sciences
	Division of Health Services	Student Health Services
	Education	All
	Nursing	All
	Pharmacy	All
	Social Work	All
	University Libraries	Library Dodd Center
	Vice President for Research	National Undersea Research  Center and Connecticut Sea Grant
Team   4: Daniela Parciasepe Christie Rodgers Sally Parker	CT Transportation Institute	All
	Engineering	All
	Office of the Provost	Institute of Materials Science

 

Grant-funded research collaborations usually involve issuing a Subaward to the collaborating institution.  Subaward agreements are used to issue grant funds to Subrecipients.  A contractor PO should be used to contract for consulting services.  All grant-funded Subaward agreements must be reviewed by the Sponsored Programs Service (SPS) and the Principal Investigator (PI) before they are sent to Subrecipient for execution.  All grant-funded Contractor agreements for consulting services must be reviewed by Procurement Services and the PI before they are sent to the Contractor for execution.

Subrecipient versus Contractor

In determining whether an agreement between the issuing entity and another non-Federal entity is classified as a subrecipient or a contractor, the substance of the relationship is more important than the form of the agreement.  All of the characteristics listed below may not be present in all cases, and the issuing entity must use judgment in classifying each agreement appropriately.

 

Definitions from Uniform Guidance (2 CFR, PART 200)

Subrecipients – Per §200.93 a subrecipient is a non-Federal entity that receives a subaward from a pass-through entity to carry out part of a Federal program; but does not include an individual that is a beneficiary of such program. A subrecipient may also be a recipient of other Federal awards directly from a Federal awarding agency. In general, a subrecipient relationship with UConn will include the following characteristics (per §200.330):

• Has its performance measured in relation to whether objectives of a Federal program were met
• Has responsibility for programmatic decision making
• Is responsible for adherence to applicable Federal program requirements specified in the Federal award
• In accordance with its agreement, uses the Federal funds to carry out a program for a public purpose specified in authorizing statute, as opposed to providing goods or services for the benefit of the pass-through entity.

Contractor – Per §200.22 a contract means a legal instrument by which a non-Federal entity purchases property or services needed (i.e. like a vendor) to carry out the project or program under a Federal award. In general, the contractor relationship with UConn will include the following characteristics (per §200.330):

• Provides the goods and services within normal business operations
• Provides similar goods or services to many different purchasers
• Normally operates in a competitive environment
• Provides goods or services that are ancillary to the operation of the Federal program
• Is not subject to compliance requirements of the Federal program as a result of the agreement, though similar requirements may apply for other reasons.

Assistance

Subaward agreement requests must be submitted to subawards@uconn.edu. 

Contractor Agreement requests must be submitted to Procurement Services.  The Hiring of a Consultant form can be found at the following website: https://purchasing.procurement.uconn.edu/procurement_forms/

UConn

• UConn Health – Human Subjects Protection Office
• UConn ClinicalTrials.gov
• Office of University Compliance
• UConn Qualtrics Online Survey Information
• Policy on the Security Requirements for Protecting University Data at Rest
• UConn Family Educational Rights and Privacy Act (FERPA)
• UConn Health Insurance Portability & Accountability Act (HIPAA)
• UConn REDCap

Connecticut Educational Institutions

• Central Connecticut State University IRB
• Eastern Connecticut State University IRB
• Southern Connecticut State University IRB
• Hartford Public Schools
• New Haven Public Schools
• The University of Hartford IRB
• Yale University IRBs

State of Connecticut

• Department of Developmental Services
• Department of Mental Health and Addiction Services (DHMAS)
• Department of Public Health Human Investigations Committee
  • Department of Public Health Genomics
• Connecticut Office of Early Childhood
• Department of Correction Organizational Development Unit (includes Research and Evaluation)

Greater Hartford Area Hospitals and Medical Centers

• Hartford Hospital IRB
• St. Francis Hospital and Medical Center IRB
• Connecticut Children’s Medical Center IRB
• The Hospital of Central Connecticut IRB

The Jackson Laboratory

• Institutional Review Board

Federal Government

• Office for Human Research Protections (OHRP)
  • OHRP Human Subject Regulations Decision Charts
  • 45CFR46 (2018 Requirements)
  • OHRP International Standards and National Policies
  • OHRP IRB Guidebook
• U.S. Food and Drug Administration (Guidance for IRBs, etc.)
  • 21 CFR Parts 50 and 56
  • FDA Investigator Responsibilities – Protecting the Rights, Safety, and Welfare of Study Subjects 
  • Frequently Asked Questions on Botanical Drug Product Development (Addresses Dietary Supplements and INDs)
  • Development & Approval Process (Drugs)
  • Information Sheet Guidances for Institutional Review Boards, Clinical Investigators, and Sponsors.
  • Medical Devices
  • Mobile Medical Applications
  • Informed Consent Guidance for IRBs, Clinical Investigators and Sponsors
• Department of Health and Human Services – HIPAA
• National Institutes of Health (NIH) Office of Research Integrity (ORI) Research Involving Human Subjects
  • NIH Certificates of Confidentiality Kiosk
  • NIMH Human Subject Research Issues
  • NIH Scientific Data Sharing
• ClinicalTrials.gov
• Department of Energy – Human Subjects Protection Program
• NASA Human Research Program
• National Science Foundation (NSF)
• U.S. Department of Education Protection of Human Subjects in Research
  • Family Policy Compliance Office (FPCO) – Information about FERPA and PPRA
• U.S. Department of Energy Human Subject Protection Program
• U.S. Department of Veterans Affairs Program for Research Integrity Development & Education (PRIDE)
• Walter Reed Army Institute of Research Human Subject Protection Branch (HSPB)
• Department of the Navy – Human Research Protection Program
• National Institute of Justice – Human Subjects and Privacy Protection
• Department of Education
  • Protection of Human Subjects
  • Us Department of Education (FERPA)
  • Protection of Pupil Rights Amendment (PPRA)

Training for Research with Human Participants

• Collaborative IRB Training Initiative (CITI)

IRB Professional Organizations/Forums/Accreditation

• Public Responsibility in Medicine and Research (PRIM&R)
• Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP)
• IRB Discussion and News Forum

IRB/Bioethics

• The Hastings Center
• DHHS – Office of Research Integrity

International Research Ethics Guidelines

• Council for  International Organizations of Medical Sciences (CIOMS) International Ethical  Guidelines for Biomedical Research Involving Human Subjects
• Nuffield Council on  Bioethics (UK)
• World Health Organization (WHO) Ethics Publications
• Listing of  International Bioethics Organizations
• General Data Protection Regulation (GDPR)

Recruitment

• ResearchMatch at UConn – Information about UConn and UConn Health’s participation in Research Match.
• ResearchMatch – National volunteer registry used by over 120 institutions to match volunteers with active research studies.

Resources

• The Center for Health Studies – Project to Review and Improve Study Materials (PRISM)
• The Researcher’s Guide provides investigators and students with information that will be helpful for meeting the standards set by the UConn IRB policies and by the Federal Regulations for the protection of human subjects in research.
  • Download the entire Researcher’s Guide

  Or go to each section in the guide:

  • Secondary Data Analysis
    Guidance on analysis of existing data sets.
  • Data Security and Internet-Based Research
    Protecting and securing data on devices and during transmission over the internet.  Conducting research on the web.
  • Closure of Human Subjects Research Studies
    Guidance on study closure procedures, record retention, and adverse events learned after study closure
  • Consent Process
    Informed consent is more than the form.
  • Deception/Debriefing
    Guidance for use of deception in research and debriefing requirements.
  • Documentation
    Good research documentation habits are essential to reliable research data.
  • Does Evaluation Require IRB Review?
    The decision about whether review is required should be made in concert with the IRB.
  • Ethnographic/Naturalistic Research
    Guidelines for submission of ethnographic/naturalistic research protocols.
  • Focus Groups
    Guidance on when research involves focus groups to obtain data.
  • Investigator Responsibilities
    Your part in the compliance partnership.
  • Normal Educational Practice
    What type of educational research may or may not qualify for review under the exempt criteria?
  • OHRP Guidance
    A brief introduction to the Federal office that oversees research with human participants.
  • Oral Histories
    When are oral histories “human subject research” under the federal rules definition?
  • PI Mentoring of Student Researchers Conducting Research with Human Participants
    Guidance regarding the importance of mentoring student researchers and the responsibilities of mentorship.
  • Recruitment and Advertising Guidance
    Guidance for recruitment and advertising, including a recruitment flyer template.
  • Student Athlete Involvement in Research Studies
    Guidance regarding recruitment and compensation.
  • Study Design and Scientific Review
    How design is related to participant protection.
  • Wording Tips
    Need to simplify language for participants?
    • Download the PRISM Toolkit Word List
    • Download the full PRISM Readability Toolkit

Animal Care Services (NetID restricted link)  provides animal husbandry and veterinary care for vertebrate animals housed at the Storrs Campus, excluding the farm animals under the supervision of the Department of Animal Science. ACS veterinarians have University-wide responsibilities for assisting faculty and the IACUC in protocol review, facility inspections, and training. The Animal Care and Use Program is accredited by AAALAC International.

For further information, please contact acsinfo@uconn.edu.