Special Population Requirements


Children


Consent / assent issues

Parental/Guardian Consent
The informed consent must clearly explain what is required of child as well as what is asked of the parent. The document should also clearly state if there is to be future contact with the family or if there will be any observations or interactions with the child while the parent is not present.
Child Assent
Since children cannot give legal consent to participate in research, we speak of parents giving consent, but their children give their assent, where appropriate. Children can only be approached for assent after parental consent has been given. The assent is usually a scripted interaction, though with older minors it can be a document. The assent must be in age-appropriate language, explaining that their parents have consented to have them participate, but they do not have to participate if they don’t want to. If appropriate, the assent should state that the research study is not school and will not affect grades or teacher interaction. The assent should state if they will miss any activities from the regular school day, and how that will be made up. The script should also clearly state what the child is being asked to do, where, for how long, and with whom, and the nature of any compensation; explain that they can stop participating at any time and still receive part of that compensation for their time; and the extent that their responses will be confidential.
Group Assent
The IRB discourages group assenting procedures (asking children in a classroom setting to raise their hand if they do/do not wish to participate). This creates social pressure that may sway judgment. If at possible, it is preferable to ask children in a one-on-one setting or devise a system of passing out papers and having the child decide and covertly mark the paper individually.
Opt-Out Consents
The IRB does not approve “opt out” “consent” procedures. IRB does not recognize “passive consent” as such; you’re requesting a waiver of (parental) consent.
Waiver or Parental Consent
The IRB can waive parental consent under current regulations ( under 45CFR, both 46.408(b) / 46.116(d)), if the study is minimal risk, not practicable without the waiver, and waiver won’t affect the participants’ risk or rights, and if appropriate efforts are made to inform the parents about the work. Arguments that these conditions are met should be included in the protocol submission. The IRB tends to be very conservative in approving this unless the survey is benign and anonymous. If this consent method is sought, the researchers much also submit a letter from the school indicating their approval for the procedure in the absence of parental consent.

Asking children to evaluate their peers or family

  • Some studies are interested in peer social interactions, resulting in a need to have identified children evaluate other identified children, for example to correlate what one says about oneself to others’ views of them. This creates some difficulty, however, because the the named classmates are participants in the research, as the regulations [45 CFR 46.102(f)(2)] define human subject as a person “about whom an investigator obtains identifiable private information.” The consequence is that researchers will need to get parental consent and child assent both for children who are evaluating others and those classmates who are being evaluated.
    • If the evaluation of others is intended only to inform you about the views of the respondents, then there may be no need to obtain/maintain identifiers for the classmates. If that’s the case, the procedures to keep any information about those who are being evaluated anonymous should be made clear in the protocol and consent forms.
  • See Special Populations: Classrooms and Students for more information about classroom studies.
  • When researchers wish to ask children about their family environment or the behaviors that they witness from their family members, the family members are similarly participants in the study. In such cases, there may be significant risks to the family members if information about financial status, emotional well-being, illegal behaviors or other sensitive topics were disclosed. Their consent must be sought, or the researcher needs to explain why their consent should be waived.

Asking parents / guardians / teachers to report on the behavior of children

  • As when children are asked to report on the behavior of peers and parents (see above), assent may be needed from the true subjects of the study, in this case, the children, when parents are being asked to report about their child’s behavior. This requirement is particularly important when the child can be identified, and the topics are sensitive ones. The IRB will consider the particular circumstances to determine if assent is needed in all such third-party interviews.

Mandatory reporting of abuse

  • If the researcher or their staff obtains credible evidence that a child being evaluated for research purposes shows signs of abuse, it is mandated by state law that the researcher must report that information to the Florida Abuse Hotline. Research that, because of the topics explored (for example, parental discipline) or because of the population to be studied (for example, children with mood disorders or other at-risk groups), is more likely to uncover evidence of abuse, the consent and/or assent scripts should state explicitly that any evidence of abuse must be reported to a state hotline.
  • This is the web page detailing the use of the abuse hotline, 1-800-96-ABUSE. http://www.dcf.state.fl.us/abuse/

Asking children for information about behavior unknown to parents / illegal behavior

  • Some studies ask children about behavior unknown to the parents; this often concerns sensitive areas such as drug use, sexual practices, or criminal behaviors. It is not necessary that this information be shared with the parents, and often it is critical that it be withheld from parents. However, researchers must let parents and children know in the informed consent that they will ask about certain behaviors, and that the parents will not be able to find out their children’s answers.
  • If this information could be brought into a court of law or otherwise disclosed, the data should have potential identifiers as soon as possible, either when collected, or when coded, so that it cannot be connected to participants. (These include direct identifiers like social security numbers, drivers license numbers, etc., as well as indirect information that could uniquely identify a person, such as a combination of demographic and descriptive information). A Certificate of Confidentiality may provide further protection from such disclosure. For more information, see Special Populations: Illegal Behavior.

Children who are not under their parents’ care (wards of the state, foster children, etc)

  • Consent and assent must still be obtained when studying children who are not under their parents’ care.
    • It is the researchers’ responsibility to determine who is legally responsible for the participant (who could consent to have medical treatment done to the children?).
    • Information about who is legal guardian for the group of interest, and the source for this information, should be included in the protocol.
  • It is important to note that children may have been removed from the care of their parents for a reason that makes them particularly vulnerable, such as abuse/neglect. How this vulnerable population will be protected must also be addressed in the protocol.

Children with compromised mental/communicative capacities

  • See the section on Special Populations: Compromised Mental/Communication Capacity.

Sample assent scripts

[Older Children]
Hello [child’s name]. My name is [examiner’s name] and I am a student at the University of Florida. I am trying to learn about how students think, learn, and behave in school. I will be working with several students at [name of school or after-school program]. If you decide to participate, you will be asked to do a series of activities, including some reading, writing, and math activities, and answering some questions about your feelings and emotions. We will spend about an hour and a half working in a group with other students and we will spend another hour and a half working on tasks individually. There are no known risks to participation, and most students actually enjoy the tests. You do not have to be in this study if you don’t want to and you can quit the study at any time. Other than the researchers, no one will know your answers, including your teachers or your classmates. If you don’t like a question, you don’t have to answer it and, if you ask, your answers will not be used in the study. I also want you to know that whatever you decide, this will not affect your grades in class. Your [parent / guardian] said it would be OK for you to participate. Would you be willing to participate in this study?
[Younger Children]
Hi, my name is [examiner’s name], and I’m from the University. I’d like to tell you a few little stories and ask you some questions about them. Your [teacher / mom] said it was OK. We’ll do it in the conference room, and it takes about 15 minutes. Would you like to come do this?



Classrooms and Students


In a large university such as UF, the classroom is the site of many research activities, both when students are being trained in the research procedures and methods in the behavioral and social sciences, and when investigators are interested in research questions where students are the appropriate population.

Class Projects

  • Class projects do not need to be reviewed by the IRB if they are class projects within University of Florida classes, conducted only for instructional purposes, and there are no plans to use the research to”add to generalized knowledge,” such as presenting the results at a conference, publishing them, posting them to a publicly available website, etc.
  • Any class studies where there is a possibility that the results may be presented/published outside of the class should be reviewed and approved by the IRB and have proper consent/assent procedures.
  • Class projects may involve participants other than the students in that class; nonetheless, if the purpose of the project is strictly instructional, it does not qualify as “research” for regulatory purposes, and does not need to be reviewed by the IRB. Of course, professional and academic ethical guidelines should be followed for such activities, and the instructor is responsible for ethical oversight of their students’ projects.

Consenting minors (including college students who are younger than 18 years)

  • See section on Special Populations: Children
  • College students younger than 18 are minors, and parental consent as well as the student’s assent is necessary. When studying a college student population it is the responsibility of the researcher to ask the age of the college student and NOT TEST or COLLECT DATA FROM students that are younger than 18 years.
  • If a college classroom population is being tested that includes students younger than 18 years, and extra credit is being offered as compensation, then an equivalent alternative non-research opportunity must be available to those who are under 18.

If Observing Students’ Behavior In Classroom Setting Or Having Participants Fill Out Surveys In A Classroom Setting

  • All consents and assents must include what activities students may do during testing time if they do not wish to participate in the classroom testing.
  • If participants you are observing in the classroom might be stigmatized by being singled out for observation, appropriate precautions must be made so that the other students will not know who is being observed and why. Similar precautions must be taken if select students are being removed from the classroom for some special status or if surveys are being filled out by a whole class that only will be appropriate for a subset of participants to fully fill out. Details must be provided in the protocol about how this stigma will be avoided.
  • Given the sensitive nature of some surveys, participants may be afraid that their answers will be viewed by other students or tracked back to them. Having the survey be anonymous and providing each participant with a unmarked closeable envelope in which the surveys can be placed prior to handing them to the researcher or advisor may decrease this risk. Providing adequate spacing between students during data collection may be essential to ensure confidentiality in these situations.

Offering extra credit as compensation for participation

  • If compensation is extra credit, those participants who do not wish to participate in research must be given a time/effort equivalent academic extra credit opportunity so that they can feel free not to participate, but still get benefits available to those who can/want to participate in research. This alternative activity must be described in detail in the protocol submission as well as in the consent form/assent script.
  • Extra credit for participation must be limited to no greater than the equivalent of 2% of the student’s overall grade in the course to minimize any risk of coercion via “undue compensation.”

Accessing academic records

  • Explicit permission must be obtained to access confidential academic records. The researcher must detail in the consent/parent consent to access exactly what records will be seen and when. If the participant is a minor, but child is old enough to understand what these records are and how their release may affect them, this aspect of the research must also be assented to by the children.
  • Records can not be accessed unless it is expressly consented to, even if some member of the research group would otherwise have access to these records for non-research purposes.

Students taken out of the classroom setting for testing

  • If any participants are going to be taken away from classroom activities for this research, the consent forms and assent script must include information about what classroom activities will be missed by the participants when they are removed from the classroom for testing. If students are to miss some classroom material, it must be detailed how it is that they will make up this material.
  • If only a subset of students will be removed from the class to be tested (for example, those with reading difficulties), it must be detailed in the protocol what procedures will be used to prevent these participants from being stigmatized by the other students who notice that the child is being removed because they are of a special population.

Evaluating Educational Programs/Educational Tools

  • It’s not uncommon for us to receive protocols that have a mix of what’s called “program evaluation/quality assurance” aspects, such as examining a standard part of the curriculum or new method of educating. This may or may not require IRB approval. It is for the IRB to decide if the project is exempt from research. See Types of Protocol Review for more information about this determination.
  • The following questions are relevant to the IRB’s review, and must be addressed in detail in any protocol studying educational methods:
  • Will students be learning something different than the regular standard educational practice?
  • Are there plans to publish or present the evaluation of this new educational procedure at a conference or publish it such that it can be accessed by other educators, researchers, or the public at large?
  • Additionally, if the new educational program requires some action of the teachers or access to schools, it is necessary to have an informed consent for the teachers and the principals listing what expected of them and also what expected of the children.

Classroom Observation

  • Common issues and considerations for protocols that observe students in classroom settings include the following:
  • Is it public? As with publicly accessible websites and “chatrooms,” there is some controversy about what constitutes “public behavior,” and what a person might have a “reasonable expectation of privacy” about.
  • Data will be collected on which students? Are some singled out, because of teacher selection or other criteria?
  • Is consent necessary for all students about whom data is recorded, even if identifiers are not recorded?
  • Teacher consent may also be necessary.
  • Each of these issues must be addressed by researchers submitting a protocol of this nature.

Wanting to test students in a class where a researcher is teacher/supervisor/teacher’s aide, etc

  • Though it may be convenient, there are many reasons NOT to test one’s own class.
    • In fact, unless there is a compelling reason other than convenience to test one’s own class, it is highly encouraged to test another teacher’s class to prevent some of the problems of potential coercion.
    • The idea of “coercion” is that students may feel obliged to participate, even if there is no direct “compulsion” to do so. This is a specific instance of a general problem that occurs when researchers are in some supervisory capacity regarding their targeted participants.
    • Often two professors will swap classes so to not be testing their own students, who may feel pressured to participate.
  • If for some reason it is essential to test own students, it sometimes can be done. However, the reason why it must be one’s own class must be argued in the protocol.
    • When this is allowed, special procedures must be in place to prevent coercion.
    • Generally, this is managed by preventing instructor/supervisor knowledge of who has and has not consented to participate in the study.
    • For the same reason that we ask investigators collecting data from their own classes that they be blind to who has been / will be participating until the final exams are graded.
    • Specifically, the researchers must explain how they will be blind to who has agreed to participate until after grades are finalized – or alternatively, how grades are determined “mechanistically” (e.g., objective tests) and the instructor is not making any judgments regarding grades. There is more of a problem if there is a “subjective” component to grading that could be influenced, even slightly, by the instructor’s knowledge of who has and has not agreed to participate.
    • The procedure for doing this must be detailed in both the protocol and the consent forms.
      • In these cases, there are often ways to arrange things to avoid the potential for coerciveness, for example, by having everyone do some activity or exercise as part of the regular class; then after final grades are determined, ask students if their data can be used for research purposes.
      • In other cases, when this is not practicable, the instructor can have the research component conducted by an assistant, and the instructor remains blind as to who has and has not participated.
      • It’s also helpful if it can be confirmed that there is no “subjective” component to the grade that could be so influenced.

Use of materials that have already been collected for non-research purposes

  • These documents, such as class assignments/papers/etc, can be examined for research. However, these materials need to be those that were gathered for purposes other than for the research study.
      • The researcher must explain that prior purpose in the protocol submission and who is offering the data and how it will be transferred to the researcher.
        • If at all possible, the data need to be processed before they are given to the researcher such that all identifiers have been removed. Any identifier is something that could be tracked identity back, for example birth date within a classroom full of people could be an identifier.

    Use of UF ID’s or Gatorlink information for Identifiers with University of Florida Students

        • Gatorlink signon and passwords BOTH should not be requested since that allows access to many of the students’ UF computer records/ functions. Researchers may never ask for participants’ gatorlink password.
        • UFID can be used as identifiers for research, and may be useful as thus if extra credit is being assigned as compensation for participation.
          • However, collection of UFID is an identifier and should not be stored on data that is being kept confidential.

    Opt Out (Passive) Consent In Schools/Classroom Settings

      • We don’t approve “opt out” “consent” forms. IRB doesn’t recognize “passive consent” as such; you’re requesting waiver of consent/parental consent.
      • The regulations allow for waiver of parental consent/consent for minimal risk research under appropriate conditions, i.e., that the research has potential benefit but could not be practically carried out without the waiver.
        • We tend to be very conservative in approving this, but have approved this in the some cases where the potential benefit is very high or the survey is benign and anonymous. If this is to take place in a school, there needs to be a letter submitted along with the protocol indicating the school principal’s approval for the procedure in the absence of parental consent.


Compromised Mental/Communication Capacity


Consent/Assent Issues

Two crucial issues when a researcher wishes to collect data from cognitively challenged participants are (a) legal consent and (b) communication about the research with the participant.

  • It is the researcher’s responsibility to determine if the participant themselves can legally consent. If not, it is the researcher’s responsibility to find out who can legally consent, and seek that person’s signed consent.
  • Regardless of whether the participants may legally consent for themselves, if it is judged that the participant is capable of understanding what is being asked of them, then it is the researcher’s responsibility to make a consent/assent process that will be optimally understood by the participant.
  • As with any consent/assent process, the protocol must detail how all efforts will be made to have the participant understand who the experimenter is and how they can withdraw their consent if desired.
  • Also, in cases of those who are communicatively challenged, the protocol needs to detail how the researcher will determine that the participant wants to stop participating. The researcher may, for example, include consulting with the participants’ regular caregivers on how the participant might express when they wish to withdraw from an activity.

Safety issues

  • Some special populations may pose a risk to themselves, those around them, or those working on the study. This is especially true of violent or self-injurious individuals.
    • It is imperative that the protocol describe the experience and credentials of those working with the population, so that the IRB can judge if the study will be carried out by those who have the skills to minimize the risk of injury, and to respond effectively to potentially harmful events.
  • There are also certain behavioral interventions with mentally challenged violent individuals where the researchers must first determine what is rewarding unwanted behavior (commonly called functional analysis). If this unwanted behavior is violent to the self or others, the protocol must include details about how the functional analysis will be set up so to decrease risk of injury, when functional analysis will be stopped, and when/how intervention will take place to stop self harm or harm of others.
  • All of this information should also be included in consent documents of the participants to the legal guardian.


Deception Required Protocols


When is deception allowed?

  • Many research questions in social and behavioral science cannot be answered if participants are fully aware of the question being asked, since their behavior will often be changed by that knowledge. In some cases, we might not describe the procedure as active deception, so much as lack of full disclosure of the nature or purpose of what is being studied. For example, we may be interested in how a participant’s mood affects their cognitive performance, or social interactions. On the other hand, some studies may require active deception, for example by providing participants bogus feedback about their performance, attitudes or aptitudes, or by staging certain kinds of interactions between them and others who are covert confederates of the researcher.
  • Broadly, the regulations allow for studies that involve deception, despite the fact it appears to go against the fundamental principle of informed consent. As with any research, the IRB must weigh the potential benefits of any knowledge gained from the research, against the costs and potential harm of the deception. It must be demonstrated that the research could not be practicably carried out without the deception.
  • In assessing potential harm, we consider the potential for stress and discomfort that the deception might involve, as well as the duration of that stress – how long is the delay before the true nature of the study is disclosed?

What should consent include?

  • In studies that require deception the consent form should tell as much true information as possible about the protocol. Aspects of the protocol that are not disclosed should be omitted or be covered in larger/blanket statements. The consent form should not be an instrument of deception. A second “experiment information” sheet of some sort would be more appropriate for manipulations of the participant rather than the consent form itself, which still serves to tell the participant who is conducting the research, what they will be doing, how to contact the experimenters and IRB etc.
  • Many descriptors of the study may be possible in the informed consent document, giving the participants some true idea of what sorts of experiences they will have in the research, without exposing the manipulation of interest. Usually the consent/assent forms include something descriptive about the study, possibly not the title of the protocol, but usually something vague.

When is debriefing necessary?

  • Debriefing is necessary any time that the full and true purpose of the experiment can not be disclosed at the beginning of the study.
  • This necessitates a full disclosure of the true manipulations taking place and the true and full purpose of the experiment, an opportunity for the participant to ask questions to the researchers, and a formal debriefing form explaining the manipulations and containing signatures lines and an area where participants again consent in writing to include their data in the study.
    • Specifically, the form must contain BOTH a place where the participant signs saying that they received the debriefing and a line where they initial to say YES or NO that they will still allow their data to be used in the study now that they know the full purpose of the study.

What should debriefing procedures / debriefing form be like?

  • Must happen in a way that all participants are aware of the full true purpose of the study and none left undebriefed. This most commonly means that participants are debriefed after the testing session ends but before they leave the experimenter’s presence.
  • Participants must then be told the purpose of the study, and also be presented with a form that explains this. The participant then reads and signs the debriefing form to say they have read it. However, there is a separate part of the form saying if they ARE or ARE NOT willing to have their data included. If the do not respond to that second question, or respond NO, then their data is NOT included. There cannot be “passive re-consent;” if researchers do not get a definite response, that they cannot use that participant’s data.
  • The form should not only include an explanation of the deception in the current study, but also a brief explanation about why deception must take place in social and behavioral research more generally.
  • An example debriefing form is provided below.

Sample Debriefing Form

  1. Sometimes in research it is necessary not to tell the participants the hypothesis. We can’t always tell people about the purpose of the experiment because:
    1. It might affect our results–If we tell people the purpose of the experiment or how we predict people will act in the experiment, they may deliberately do whatever it is they think we want them to do, just to help us out and give us the results that they think we want. Or, it is also possible that the opposite might occur. That is, if we tell people our predictions; they might deliberately act in the opposite direction to show us that we can’t figure them out. Either way, we would not have a very good indication of how they would act in situation in everyday life.
    2. Do you understand why sometimes we cannot reveal the full purpose of the experiment at the onset?
    3. In the study today, you completed a number of questionnaires and did a number of other tasks. Do you have any idea what we were really looking for in this study? Do you have any idea what we were hypothesizing in this study? Please list any ideas on the form we have given you. Please also write anything you think about what the study was actually about?
  2. Now I would like to tell you the purpose of this study.
    1. What we are most interested in is whether the presence of other people affects goal setting. We predict that the presence of other people will affect the goals people set. Is this what you thought we were interested in? When did you think this?
      1. For the Control Condition: Today, you were in the control condition, which means you were engaging in the goal setting task without any observation by another person. What do you think that we predict you would do?
      2. For the Important Other Condition: Today, you were in the ‘important other condition’, which means you were engaging in the last trial of the goal setting task while being observed by a visiting faculty member from another University. The person who observed the study today is actually not a faculty member; he is an undergraduate research assistant in our lab. Did you believe that the person watching was a faculty member? If not, what made you doubt he was a faculty member? What do you think that we predict you would do?
      3. For the Peer Condition: Today you were in the ‘peer condition’ which means you were engaging in the last trial of the goal setting task while being observed by a fellow student also participating in the study. The person also participating in this study is actually not another participant; he is an undergraduate research assistant in out lab. Did you believe that he was actually a fellow participant? If not, what made you doubt he was a fellow participant? What do you think that we predict you would do?
    2. There are three conditions to our study: people who set goals alone, people who set goals with an important other, and people who set goals with a peer. We are interested in if different audiences lead to people setting different goals. We are also interested in how the performance of the person relates to the goals they have set.
      1. For the Important Other Condition: Did you feel that the presence of the observer made you set a different goal? If so, how was that goal different from previous goals and why do you think you set a different goal? If not, Why not? Did you think the goal you set affected your performance? Why or Why not?
      2. For the Peer Condition: Did you feel that the presence of the observer made you set a different goal? If so, how was that goal different from previous goals and why do you think you set a different goal? If not, Why not? Did you think the goal you set affected your performance? Why or Why not?
    3. We are not really interested in your performance on this task or your perceptions of the University. We are more interested in how the presence of other people affected your goal setting.
      1. For the Important Other Condition: We tried very hard to make you believe that you were being observed by a faculty member. We tried also to stress the idea that the faculty member valued and was impressed by high-scoring students. If there was anything that you did not believe about this, please let me know now. Also, let me know if there is anything you think would make the study more realistic.
      2. For the Peer Condition: We tried very hard to make you believe that you were being observed by a fellow participant. We tried also to stress the idea that the participants did not like or value high-scoring students. If there was anything that you did not believe about this, please let me know now. Also, let me know if there is anything you think would make the study more realistic.
  3. Obviously, if we tell people outright what we are studying, it might affect their behavior. Thus we had to conceal the real purpose of the experiment until now. Do you understand now why I didn’t tell you the real purpose of the experiment at the outset? Do you have any questions
  4. There are some final things I need to talk to you about.
    1. We have lots of people participating in this study or similar studies both during this semester and across the next few semesters. The success of this study requires that the people who participate have no idea in advance what the study is about and that we are really interested in whether the audience affects the goals people set. What this means is that I need you not to say anything about the study to anyone else. Why?
      1. If you talk to others about the purpose of the study it would be the same as I told them at the beginning all about the purpose of the study. Their responses wouldn’t be spontaneous and natural. So you discuss this study with others, we wouldn’t have enough valid data to draw any conclusions about how people naturally behave in this situation. In short, the study would be wasted; your time would be wasted and our time would be wasted.
      2. We want everyone to get some educational value out of being in this experiment and so I am telling you what our true hypothesis was. However, if you tell someone else what happened and they or a friend of theirs participates in this study, then they won’t get the same experience from this experiment that you do. Part of your requirement is based on learning a deeper understanding of how research is done and the importance of aspects of research (like deception and debriefing, like this one), if a person enters the study knowing the true hypothesis, he or she would be robbed of this aspect.
      3. You may wonder what difference it makes to tell a friend or roommate or boyfriend or girlfriend because they will never be in the study. But they may say something to someone else who will be in the study. Or they may be in the study or a similar study down the road. I realize you may have an urge to tell people about what happened in this experiment. However, I am going to ask you to keep what happened and the purpose of the experiment secret.
      4. In short what this means, is after you leave this door I am asking you to not discuss the details of this experiment. We have, in the past, overheard students talking around campus, in the building, waiting for a T.A, or in the Reitz Union talking about studies. Keep in mind one reason we ask you not to tell anyone, is you never know who else is hearing you.
    2. If anybody asks you about the experiment, just tell them that it was an experiment on how people make first impressions. Don’t make a big mystery about the study. Just say that you were in such and such experiment and that you are not at liberty to discuss the nature of the experiment.
  5. I hope you see why it is important not to tell anyone the purpose of the experiment.
    1. We have tried to make this experiment as interesting as possible for you. Please resist any temptation to talk about this experiment.
    2. So will you promise not to say anything about the experiment?
  6. Do you have any questions? Comments? Suggestions?

I have read aloud and discussed all of these points with the participant and allowed her/him to ask questions.

_____________________                    ___________

Researcher                                              Date

I have had all the points on this form explained to me, and I had the opportunity to ask questions about the true purpose and experimental manipulations that took place in this study.

_____________________                    ___________

Participant                                              Date

Research participant,

Now that you have learned the true and full purpose of the current study and know about the actual manipulations that took place as part of this study, will wish to have your data to be included in this research project?

Please Sign Only One Of The Lines Below

YES, I DO want my data to be included in this study

_____________________                    ___________

Participant                                                 Date

OR

NO, I DO NOT want my data to be included in this study

_____________________                    ___________

Participant                                                 Date



E-Mail and Web-Based Research


The number of research projects being implemented in part or wholly through the Internet has mushroomed in recent years. The most common concerns about web-based research for the IRB are recruitment and consent, and protection of confidentiality of the participants’ identity and/or responses. There are also concerns about studies of interactions between individuals that are occurring naturally on the web, in chat rooms, bulletin boards, and other virtual communities.

Web/e-mail consent forms

  • Web consent forms should follow exactly the same format as a standard informed consent, except there should be a button to click for “I accept” with a statement that clicking this button means the person agrees to participate in the study as described, and the program will proceed with the study presentation. We don’t require electronic signatures in such cases. It’s helpful if possible to allow for the participant to print a copy of the consent document locally for their records.
  • If recruitment is done via the web/email, but the study itself is done elsewhere (in person, by phone, or regular mail), the consent forms can allow for the participant to either email back saying that they consent, or make a response directly via the web page, which can be recorded for the investigator by the program.

Confidentiality, and Anonymous On-Line Surveys

  • Many studies are making use of third-party software to implement online surveys and other forms of data collection. In cases where sensitive information is being obtained from individuals, the protocol should be explicit about what software system or vendor is being used to implement the study (e.g., Survey Monkey), and explain that system’s privacy protections. For example, are IP addresses of respondents collected, then destroyed, or not monitored at all?
  • It is often the case that data saved on vendor’s servers is not as secure as you might hope, or they might claim. Data should be removed from the vendor’s server as soon after collection as possible; if there is some need to maintain the data on the remote server, this should be explained in the protocol.
  • On-line surveys can be administered anonymously given that the following precautions are taken:
    • Confirm that the service provider for the web-based survey does not, or cannot, collect IP addresses of respondents in any way that could be connected with their participation or their data.
    • No questions asking for identifying information, including e-mail address, should be sought in any of the online surveys.
    • Ensure that any code connecting responses at multiple occasions is participant generated and not traceable back to the participant. These can be unique, and easily and reliably generated by participants, and usually involve some combination of parts of family first names, letters of hometowns, etc.



Illegal Behavior


General concerns when collecting data about illegal behavior

  • Any research that is gathering data on participants who are engaging in illegal behavior puts those participants at risk of being discovered and perpetrator and facing legal repercussions. This is most certainly true if the data collected details illegal behavior. However, it is also true if the data collected is not about the illegal behavior per se, but that the population of interest is those who engage in illegal behavior.
  • A number of illegal behaviors are often not recognized as such by researchers, but these behaviors raise the same concerns as any other illegal behavior. These include: underage drinking, underage smoking, and sexual behavior that, because of the age of the participants, is illegal.
  • Even though the researchers and the University of Florida do not condone any illegal behavior, it is the researchers’ and IRB’s responsibility to determine how to study this population to offer them and/or society some benefit, while protecting these participants from the risk of negative repercussions of participation in research.
  • Generally, participants can be protected from later having the data collected used against them when subpoenaed in court by one of two strategies discussed further on this page.
    • Having no identifiers linked with the data
    • Obtaining a federal exception from having data obtainable by courts of law, a Certificate of Confidentiality

Truly anonymous data collection

One method for managing data that is collected from participants who are engaging in illegal behavior is to collect the data completely anonymously. This is a case where the requirement for a signature on the informed consent document can be waived by the board. No information that could identify the participants, directly or indirectly, should be recorded. This data includes but is not limited to: photographs, video, voice, or unique personal information (such as name, birthdays, address, etc). Depending on the population being studied, certain demographic information, alone or in combination with other facts about a person, could easily lead to their identification (for example, a sex offender’s race, age, and specific crime, in a particular county). The guidelines for HIPAA compliance include a list of such potential identifiers.

Use of non-identifying codes to track anonymous participants across time/sessions

  • In some cases a group of participants are examined at multiple points, and the research design necessitates tracking of participants from one time point to the next.
  • In these cases, the IRB suggests having participants generate an identifying number that they can remember, but that you could not trace them back to. Subject-generated codes can be unique, and easily and reliably generated by participants, and usually involve some combination of parts of family first names, letters of hometowns, etc.

Certificate of Confidentiality

  • Some research designs necessitate collection of identifying information. In order to decrease the risk to participants, there is a federal mechanism for preventing the data from being subpoenaed by a court of law. This mechanism is a Certificate of Confidentiality, which may be provided by NIH.
  • It is the researchers’ responsibility to apply for this certificate and to then furnish it to the IRB board along with their protocol. If the researchers wish, they may first submit their protocol and their intent to apply for a Certificate of Confidentiality to the board.
  • For more information on a certificate of confidentiality, click here. Please read the information carefully and note that there may be a substantial wait to obtaining this certificate. The delay should be inquired about to the granting agency. The IRB has no knowledge or control over the granting of these certificates.



Inclusion of Women and Minorities in Study Populations


In the IRB02′s analysis of the balance between the risks and benefits within a protocol, an evaluation of the quality of the research is a key factor. In order for research to have the optimal societal benefit, it must sample a population representing the population at large so that the findings are valuable as generalizable to the population at large.

NIH has specific recommends concerning the proper representation of women and minorities in research studies:

  • Special emphasis should be placed on the need for inclusion of minorities and women in studies of diseases, disorders, and conditions which disproportionately affect them.
  • If one gender and/or minorities are excluded or are inadequately represented in this research, particularly in proposed population-based studies, a clear compelling rationale for exclusion or inadequate representation should be provided.
  • Composition of study population must be described in terms of gender and racial/ethnic group, together with a rationale for its choice.
  • Gender and racial/ethnic issues should be addressed when developing a research protocol and sample size appropriate for the scientific objectives of the study.
  • Protocols must employ a study design with gender and/or minority representation (by age distribution, risk factors, incidence/prevalence, etc.) appropriate to the scientific objectives of the research.
  • It is not a requirement for the study design to provide statistical power to answer the questions posed for men and women and racial/ethnic groups separately, however, whenever there are scientific reasons to anticipate differences between men and women, and racial/ethnic groups, with regard to the hypothesis under investigation you should include an evaluation of these gender and minority group differences in the proposed study.
  • If adequate inclusion of one gender and/or minorities is impossible or inappropriate with respect to the purpose of the research because of the health of the subjects, or other reasons, or if they are the only study population available, or if there is a disproportionate representation of one gender or minority/majority group, the rationale for the study population must be well explained and justified.


Non-English Speaking Populations and International Research Projects


A wide range of protocols involve potential participants whose primary language is not English, or who do not speak English at all. Such protocols obviously are common in disciplines such as Anthropology and Sociology, but with the increasingly international character of the research enterprise at modern universities, studies with non-English speaking populations are being submitted by disciplines ranging from Forest Resources and Conservation, Food Science and Human Nutrition,and Youth and Community Services, to the Digital Worlds Institute and Linguistics. These projects commonly, but not exclusively, take place in other countries.

Informed Consent for Non-English Speaking Populations

  • It is the responsibility of the principal investigator to insure that the information provided during the consent process is comprehensible to the potential participants. If there are non-English speaking participants to be recruited, the consent documents – including both written consent forms and oral consent and assent (for children) scripts – should be submitted both in English, and in the language of the target population. The investigator should document the qualifications of the translator, whether themselves or another person, in that language. Are they native speakers or the language? If not, what sort of training have they had? Since the goal of these scripts is effective communication, it’s important that the translator have extensive conversational experience in the target language, and not just “academic” training.
  • It is helpful, particularly for protocols that may involve more than minimal risk, to have the consent documents “back-translated” into English, so we can assess whether essential information has been accurately communicated in the target language.
  • One element of informed consent which may need modification with participants in these studies is the contact information for the Investigator or the UFIRB. Participants may not have access to or experience with phones or email, for example; or it may be impracticable to have them phone an international number to contact a supervisor or the IRB office. In such cases, the PI should explain how participants will be provided with appropriate contacts for any questions about the research, or their rights as participants. In some instances it would be helpful to have a member of the local community act as a liaison in this capacity.
  • If the research itself involves direct interactions with participants, it is important that the individuals who will be interacting with participants in these studies be fluent in that language, whether it is merely to be ready to answer questions that might arise during the consent phase, or to conduct in-depth interviews. The investigator should explain in the protocol who will be interacting with participants, and again describe their qualifications and experience in that language and culture.

Literacy and informed consent

  • Particularly in certain international settings, potential participants may be illiterate. Obviously, neither a written informed consent document nor signed documentation of consent makes sense in such cases. Oral consent scripts, with a waiver of documentation of informed consent (i.e. signed consent) may be proposed under these circumstances.

Review of research activities by other countries and communities.

  • In addition to review by the UFIRB, research projects to be conducted in other countries may require approval by various agencies from those countries. This may involve anything from informal approval from the local community, to more formal review by regional or national bodies analogous to the IRB. It is the responsibility of the investigator to determine the appropriate mechanisms for such local review and consent, and to include a description of those mechanisms, and a statement of how they will be implemented before the start of any data collection.
  • The OHRP recently established a database of contacts for exploring the requirements for international research in many countries. If your research involves work in one of those countries, this is a good place to begin learning about human research protections in those communities. Although currently the bulk of the focus of those protections concern biomedical issues such as drugs and biological specimens, there is a growing interest aspects of research protections more appropriate to social and behavioral science research activities.

Cultural considerations in research and informed consent

  • It is not uncommon for expectations and concepts about research to be different among different cultures and communities. This may be especially true among non-English speaking populations in foreign countries.
  • These cultural differences can mean a reluctance to sign any form, which can be seen as a potential threat in cultures where signatures are not the norm for economic or contractual social agreements. It is appropriate in such cases for the researcher to request a waiver of the requirement for signed documentation of consent, and obtain oral consent for participation.
  • Similarly, participant attributes that may define your target population – or that are disclosed as part of your research – a disorder, disease, ethnic or religious identification, sexual orientation, and the like, may be benign in our culture, but stigmatizing and potentially very harmful in another culture. In such cases, any additional steps that will taken to protect the privacy of individuals or the confidentiality of this information, both during recruitment and in other phases of the research, should be explicitly described.
  • In general, you should explain in the protocol (a) how you will be able to identify such cross-cultural issues in your work (have you become familiar with the conventions or that culture? Do you have a local collaborator who is sensitive to these kinds of issues?), (b) any potential for such problems in your project, and (c) the steps that will been taken to minimize any additional risks that these may create.
  • A helpful resource for thinking about these kinds of issues is the American Anthropological Association’s statement about ethnographic research and IRBs.



Patients


Should this protocol be reviewed by the BioMedical IRB (IRB01) or NonMedical IRB (IRB02)?

  • Protocols have to be reviewed by IRB01 (Biomedical IRB) if HIPAA protection of private health information is triggered. This threshold is fairly low if the research is being conducted either by a person under a HIPAA “covered entity” (Shands/UF Health Science Center).
    • For example, if the researcher within the HIPAA covered entity is collecting/recording HIPAA-sensitive information.and participants are going to be screened/selected for participation based on their medical records, this triggers the need for HIPAA compliance.
    • Also, if the researcher within the HIPAA covered entity is collecting data that is protected health information, this also triggers the need for HIPAA compliance.
  • The threshold for triggering HIPAA is significantly higher (more liberal) with investigators outside of the covered entity (the Health Center and affiliated programs and colleges) in our “hybrid institution,” but when that threshold is passed, these protocols then have to be reviewed by IRB01.
    • This threshold is reached if waivers to access medical records are involved. This requires HIPAA compliance in management of these records.
  • Testing a patient population does not necessarily mean that the protocol must go to IRB01, if the research is a behavioral and psychophysiological exploration of aspects of a patient population.
    • In a few cases, these protocols may be reviewed by IRB02 (non-medical IRB), but the board may seek the expert views of someone knowledgeable of the population and the issues of concern surrounding that group, so to determine if the population is at any specific risk or if the procedure is safe.
    • If the manipulation of interest has to do with treatment of the disorder, the research may be referred to IRB01, which contains individuals whose medical/physiological knowledge is better suited to judge safety/risks/benefits for participant populations or certain manipulations of treatment/diet/physical exercise etc.
  • Protocols that are commonly reviewed by IRB01 include treatment studies and pharmacological interventions.



Prisoners


Why are prisoners a “special population?”

One of the three “subparts” of the federal code that focus on particular populations of subjects that may be especially vulnerable as research participants concern prisoners (Subpart C, 45 CFR 46.301-306). In the past, prisoners were sometimes seen as a convenient population for conducting all kinds of research where their ability to refuse to participate was compromised. The regulations are intended to afford these individuals “additional DHHS protections” because of this potential and historical vulnerability.

Scope of the definition of “prisoner.”

46.303(c) defines “prisoner” as

[A]ny individual involuntarily confined or detained in a penal institution. The term is intended to encompass individuals sentenced to such an institution under a criminal or civil statute, individuals detained in other facilities by virtue of statutes or commitment procedures which provide alternatives to criminal prosecution or incarceration in a penal institution, and individuals detained pending arraignment, trial, or sentencing.

The “residential” nature of the detention is critical; for example, someone ordered to a residential substance-abuse treatment program as an alternative to prison would be considered a prisoner, but those ordered to a similar treatment program but residing in the community would not be considered prisoners. Similarly, probationers are not considered prisoners, even if they are required to wear monitoring devices (although OHRP recognizes there may be special circumstances in that case that must be considered). Residents of a psychiatric facility who were ordered there as an alternative to imprisonment would be prisoners, but those committed involuntarily through civil action because of the risk they pose to themselves or others, would not be prisoners.

Special protections for prisoners

Research involving prisoners as subjects is constrained in several ways:

  • The IRB review process must include a prisoner or prisoner representative. (46.304(b)). The IRB02 has two such members who can act in this role.
  • Special attention is paid to the compensation, or any “advantages” being offered for participation, to avoid potentially coercive incentives, such as access to special facilities, medical care, special consideration for parole, or earnings (46.305)(a)(2).
  • The selection of prisoners should be “fair to all prisoners” and, unless otherwise approved, be done on a random basis from among potential participants. Selection and special privileges have been issues, for example, in recent “faith-based” rehabilitation programs.
  • Approvable research topics is restricted to those that directly concern prisoners; these are specified as (a) the causes, effects, and processes of incarceration, (b) prisoners as incarcerated persons, or prisons “as institutional structures;” (c) those that concern “conditions particularly affecting prisoners,” such as drug addiction or sexual assaults; or (d) those concerning practices that may improve the health or well-being of the prisoners. [46.306]. The first two of these categories must be minimal risk to be approved.
  • The exemptions that otherwise could be applied to protocols, thus waiving the review process, do not apply to studies involving prisoners (see 46.101(i), footnote 1).

Expedited review of studies involving prisoners.

Research with prisoners as subjects does not necessarily have to be reviewed by the convened Board, but can be given expedited review. However, given the additional protections and constraints on such research, it is much more likely that the full Board will be asked to consider the protocol.

For more information about prisoner research, see the regulations and FAQ’s regarding prisoners at the OHRP website.