Consent/Assent Procedures and Instructions

One of the main ethical responsibilities of a Principal Investigator is to ensure that potential participants have been provided with all the information they might reasonably need to know. Any research protocol utilizing human participants requires the informed consent of those participants. Potential participants have the right to know what they are being asked to do prior to voluntary participation, no matter what the nature of the protocol and no matter how innocuous it may seem. The procedure of advising potential participants and obtaining voluntary agreement is known as the informed consent process.

Informed consent is a process that involves providing participants a description of the planned procedure in language appropriate to the level of understanding of the participant(s), and that requests voluntary participation in accordance with the Code of Federal Regulations, 45 CFR 46.116. If this is done, and the participant’s signature is obtained, then legally effective written informed consent has been obtained.

Informed consent process for adult participants

Informed consent process for adult participants

• Identify yourself by name, specify your connection to the University of Florida, and identify your faculty (where applicable).
• Provide a statement that the study involves research, a fair explanation of your research procedures (what you expect the participant to do) and their purposes, including identification of any that are experimental. Include a description of any risks or discomforts to be expected, anticipated benefits including knowledge gained or a statement that there are no immediate benefits expected, and any appropriate alternative procedures that might be advantageous for the participant. Note the amount of time (number of sessions, if more than one) the participant can expect to devote to the protocol.
• Explain how participants’ privacy will be protected. It is not adequate to only state “Data collected will be kept confidential to the extent provided by law”. You must also indicate the steps you will take to protect the participant’s privacy. If identifiers will be replaced with codes, note at what point in the research this will take place and how the linking list, if any, will be kept confidential. Anonymity can be promised only when no personal identifiers are attached to the data.
• If tape recording of participants will be a part of the protocol, inform the potential participant of this as part of the informed consent procedure. Specify whether “audio” or “video” tape will be used, who will have access to the tapes and what the disposition of the tapes will be.
• State whether or not compensation will be awarded. Specify what compensation is offered. When monetary compensation is offered, indicate the amount. If experimental credit to meet a course requirement is to be awarded, indicate the amount of credit offered and the course number. Where extra points or class credit are to be given, indicate the amount of extra credit, total possible points for the course, and the course number.
• Indicate that taking part in this procedure is voluntary. Include a statement that the participant is free to withdraw at any time without penalty. Or, where applicable, make it clear if there are any consequences to the participant for discontinuing. Explain any circumstance under which you, as Principal Investigator, might terminate the individual’s participation (e.g., those not scoring above 50% will not be chosen to continue in this protocol).
• Where questionnaires, surveys or interviews are involved, note that the participant does not have to answer any question s/he does not wish to answer. Do not attach any conditions to the statement (e.g., You do not have to answer any questions that make you uncomfortable). Remember, participation is voluntary, and a participant does not have to be able to provide a reason for not answering a question.
• Offer to answer any inquiries concerning the procedures and provide information that a participant can use to reach you later (i.e., your phone number and/or campus address).
• Include a statement that questions or concerns about the research participants’ rights can be directed to the:
  • Mailing Address: University of Florida- IRB-02 Office, P.O. Box 100173, Gainesville, FL 32610-0173
  • Phone: (352) 273-9600

  If you are injured during this study as a result of the negligence of the principal investigator, the University of Florida, the Board of Regents of the State of Florida and the State of Florida shall be liable only as provided by law. you may seek appropriate compensation for injury by contacting the Insurance Coordinator at 316 Stadium, University of Florida, (352) 392-2556.

  Conclude all written informed consents with the following statement or its equivalent:

  I have read the procedure described above. I voluntarily agree to participate in the procedure, and I have received a copy of this description.

  • Identify yourself by name and provide the title of the protocol on the signature portion of the informed consent form.
  • Provide places for dated signatures of the participant, the Principal Investigator and, where appropriate, a witness for written informed consent.
  • Provide the participant with a duplicate of the informed consent and retain signed copies of informed consent forms for a period of three years beyond completion of data collection.
  • When appropriate, one or more of the following additional elements of information should also be provided to each participant in the informed consent:
    1. A statement that the particular procedure may involve risks to the participant (or to the embryo or fetus, if the participant is or may become pregnant) that are currently unforeseeable;
    2. Anticipated circumstances under which the participant’s participation may be terminated by the investigator without regard to the participant’s consent;
    3. Any costs to the participant that may result from taking part in the research;
    4. The consequences of a participant’s decision to withdraw from the research and procedures for orderly termination of participation by the participant;
    5. A statement that significant new findings developed during the course of the research, that may relate to the participant’s willingness to continue, will be provided to the participant.

  Parental informed consent process

  Parental informed consent process

  When participants are less than age 18, or are considered to be mentally impaired, Federal regulations require written documentation of consent by their parent(s) or guardian(s) prior to the researcher approaching the potential participant. This documentation is typically in the form of a letter to the parent(s). The following information may assist you in preparing that document.

  • • Identify yourself by name, specify your connection to the University of Florida, and identify your faculty supervisor (where applicable).
    • Provide a statement that the study involves research and explain what the participant will be asked to do. Indicate who will administer the procedure (i.e., you, the teacher, your supervisor, a colleague). Make certain that the language is appropriate to the person for whom this document is intended. Avoid technical terms and jargon. Do not assume the parents know about your instrument measures or that they know the difference between a survey, inventory or instrument. At the same time, guard against condescending language.
    • Make note of the approximate amount of time your procedure will take (number of days, minutes, etc.).
    • When the procedure is to take place during school hours, make note of the activity the child will miss in order to take part in the study. Inform the parent(s) if the child will be removed from academic classes and, if so, whether or not the child will be allowed to make up any missed work. Indicate if this procedure is part of the ordinarily scheduled instruction by the teacher.
    • Where applicable, include a statement that participation or non-participation in this study will not affect the child’s grade in any class or status in his/her program.
    • If you will be approaching an intact class or group for participation, indicate what those without permission will be doing while the research procedure is taking place.
    • Include a description of any risks or discomforts to be expected. Note benefits that may result for a child taking part in the study, including knowledge gained. Describe any appropriate alternative procedures that might be advantageous for the participant. If no direct benefits are anticipated, make a statement to that effect.
    • Explain how the child’s name will be protected (anonymous response, coding, etc.) and, if applicable, make a positive statement regarding confidentiality (e.g., Individual student scores will be kept confidential to the extent provided by law through a numerical coding system. Only group scores will be published.) State whether or not data will be shared. If so, indicate specifically what data will be shared, whether group or individual, and with whom (e.g., parent, teacher, school board).
    • Indicate whether or not compensation will be awarded. When monetary compensation is offered, state the amount. If another form of compensation will be offered, be specific (e.g., sticker, pencil). Avoid vague statements such as Children will receive a small prize for participation. When children will be rewarded for returning the informed consent form, include provisions for non-participation in the signature portion similar to the following:
      • [ ] I voluntarily agree to allow my child, ________, to participate in ….
      • [ ] I do not wish for my child, ________, to participate in ….

      Specify that the parent (as well as the child) has the right to withdraw permission for the child’s participation or for the use of the child’s data, at any time, without any penalty or prejudice. Do not place conditions on the right to withdraw (e.g., Your child may stop if she becomes frustrated). Make clear any consequences for the participant’s withdrawing. Explain any circumstance under which you, as Principal Investigator, might terminate the individual’s participation (e.g., Children who do not score above 70% on the pretest will not be included in the experimental session).

      • When questionnaires, surveys or interviews are involved, state that the child does not have to answer any question that s/he does not wish to answer. Do not attach conditions to this statement.
      • If tape recording of participants is a part of the process, include this information as part of the parental informed consent procedure. Specify whether you will audio- or videotape, who will have access to the tapes and what the disposition of the tapes will be.
      • Indicate whether the results of the study will be made available to the parents, teachers, and/or school personnel..
      • Offer to answer questions and provide a means of contact in the body of the informed consent.
      • Include a statement that questions or concerns about the research participants’ rights can be directed to the IRB02 office:
        • Mailing Address: University of Florida- IRB-02 Office, P.O. Box 100173, Gainesville, FL 32610-0173
        • Phone: (352) 273-9600

        I have read the procedure described above. I voluntarily agree to allow my child, _____, to participate in Dr. _____’s (title or brief description here) study, and I have received a copy of this description.

        • Provide a signature line labeled Parent / Guardian and a place for the date. The Board also requires a second signature line labeled 2nd Parent / Witness with a place for the date. This is to accommodate parents with court-appointed joint custody. Because it is not your responsibility to become knowledgeable as to which children require joint permission, if a consent form is returned with only one parental signature, you may assume this child’s parents do not fall into that category. Federal Regulations require the signature of both parents under the following circumstances: when research involves greater than minimal risk with no prospect of direct benefit to individual participants, but is likely to yield generalizable knowledge about the participant’s disorder or condition; or when research, otherwise not approvable, presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children.
        • Provide the participant’s parent(s) with a duplicate of the informed consent document and retain signed copies of consent forms for a period of three years beyond completion of data collection.
        • When appropriate, one or more of the following additional elements of information should also be provided in the parental informed consent:
          1. (1) a statement that the particular procedure may involve risks to the participant (or to the embryo or fetus, if the participant is or may become pregnant) that are currently unforeseeable;
          2. (2) anticipated circumstances under which the participant’s participation may be terminated by the investigator without regard to the participant’s consent;
          3. (3) any costs to the participant that may result from taking part in the research;
          4. (4) the consequences of a participant’s decision to withdraw from the research and procedures for orderly termination of participation by the participant;
          5. (5) a statement that significant new findings developed during the course of the research that may relate to the participant’s willingness to continue will be provided to the participant; and
          6. (6) the approximate number of participants involved in the study.

        Assent Signatures

        Assent

        Assent is an individual’s voluntary, affirmative agreement to participate in research. A participant’s failure to object cannot be construed as assent. Assent of minor participants is required in addition to written consent of their parent(s). A verbal assent script is required as part of the IRB02 submission whenever minor participants are involved. Assent scripts should be brief, to the point, and at a language level appropriate to the participant. Include the following elements in assent scripts:

        • Identify yourself and your connection to the University of Florida.
        • Explain what you are asking the child to do. Indicate that the child can stop at any time and, where applicable, that s/he does not have to answer any questions, and that participation or non-participation will not affect his/her grades.
        • Conclude with a question about the child’s willingness to participate, to which the child can respond either positively or negatively.

        Helpful Hints

        • Note that OHRP (the Federal Office for Human Research Protections) requires that written informed consent documents have an expiration date affixed by the IRB02 at the time of approval.
          • The IRB02 may make a determination to waive the requirement for the investigator to obtain a signed consent form for some or all participants as outlined in 46 CFR 46.117(c). In cases where the IRB02 determines that written documentation of consent may be waived and that consent may be obtained orally, a written version of the process to be delivered orally to the participant must be included in the protocol.
          • In accordance with the American Psychological Association guidelines, individuals taking part in research should be referred to as “research participants,” not as “subjects”.
          • No informed consent, whether oral or written, may include any exculpatory language through which the participant or the representative is made to waive or appear to waive any of the participant’s legal rights, or releases or appears to release the investigator, the sponsor, the institution or its agents from liability for negligence.
          • Make every effort to keep informed consent brief and to the point. In most cases, informed consent should be written in the second person (i.e., you, your), with the exception of the signature portion.
          • When duplicate copies are to be used, divide the information portion of the written consent from the signature section with a solid line. When a “tear-off portion” is to be used for the signature section, a dotted line is suggested. Written informed consent forms should be kept to one page whenever possible. If more than one typed page is necessary, consider using a smaller type font or two-sided photocopying.
          • Before submitting copies of the consent document to the IRB02, check for spelling, grammatical, and typographical errors.
          • Three copies of the informed consent document are required when a protocol is submitted to the IRB.