Elements of Informed Consent and Sample Consent Letter

  1. Types of Consent:

    1. Signed parent consent (active): The researcher must have a signed parent permission slip for each student who is involved. This situation will occur when (a) using Special Education students, (b) in the opinion of the ERC, the researcher is asking questions that infringe on family privacy, (c) the researcher is videotaping or photographing subjects, or (d) the researcher so requests. These letters may be distributed by first class mail or, upon consent of the school, could be hand carried by students.
    2. Informed parent consent (passive): The researcher must adequately inform each parent of the research activities, but only obtain parent signatures for those students whose parents do not want them to participate. (Rarely used).
    3. No parent permission: The research activities are initiated/sponsored by the MMSD and/or the research activities are considered part of the normal instructional process.
  2. Providing basic elements of informed consent
    1. Unless otherwise authorized by the ERC, researchers, at a minimum, shall provide the following information to each subject:
      1. A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures that are experimental;
      2. A description of any reasonably foreseeable risks or discomforts to the subject;
      3. A description of any benefits to the subject or to others that may be reasonably be expected from the research;
      4. A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained;
      5. A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.
      6. If applicable, a statement informing parents that video and/or audio taping of students will take place and a place on the consent form for parents to give active consent to the recordings.  Typically this is done with a check box or boxes and relevant language contained in the consent form signed by the parent.  (The consent letter must also clearly state what measures will be taken by the researcher if the image or voice of a student without consent is captured by a recording device.)
      7. If the research protocol includes a survey instrument administered to students, consent forms must clearly state that parents have the right to preview the survey before they provide consent.  The consent form must also state how the parent may preview the survey. Providing the preview is the responsibility of the researcher; MMSD will not provide copies of these surveys to parents.
      8. The name, address, phone number and institutional affiliation of the researcher, including the principal investigator's contact information if the researcher is a student; and,
      9. A statement indicating IRB contact information.
    2. When research involves more than minimal risk, an explanation about whether there is compensation available and an explanation about whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained must be included.

 

Sample Consent Letter

(Must be on Sponsoring Institution's Letterhead)

Date

Dear Parents,

We would like to include your child in a research project on the development of language comprehension skills in children and teenagers. This study will be conducted by researchers from (name of Sponsoring Institution).

Each student will participate in four sessions. All sessions will be held in a room in your child's school during non-instructional hours (e.g. before or after school, lunch, recess, etc.). The four sessions will be held on different days. Each session will last between 25 and 35 minutes. Each session will involve either audio or video taping your child engaged in language development activities.

To help us in our research, we also would like permission to ask your child's teacher for information from your child's school records. This information will consist of scores from standardized cognitive tests, information about possible problems in hearing, vision, and physical mobility, and information about the causes of your child's learning difficulties (e.g., whether these problems are due to Down's syndrome).

It would be helpful if you could complete the brief questionnaire entitled Family Background, which is attached. Completion of this questionnaire is optional. If you would like, you child can participate in the project even if you do not complete the questionnaire.

Only the researchers will have access to the information collected in this project, which will be kept in locked storage at the university for a period of seven years following the completion of the research. Neither your name nor your child's name will appear in any reports of this research. You have a right to review a copy of any survey, questionnaire, checklist, etc. being administered to your child.

Participation in this project is voluntary and involves no unusual risks to you or your child. You may rescind your permission at any time with no negative consequences. Your child can refuse to participate or withdraw from the project at any time with no negative consequences (e.g. their grades, right to receive services, etc.).

Your child's participation in the project will help us develop better methods of identifying and treating language comprehension problems that may hinder a child's academic progress.

If you agree to let your child participate, please indicate this decision on the following page and mail that back to us in the postage-paid envelope provided. A detailed description of the project is attached in case you need more information before deciding. If you complete the Family Background questionnaire, please include it in the postage-paid envelope as well. If you have any questions about this research or would like to review the (survey, questionnaire, checklist, etc.) prior to providing consent, please feel free to contact me at XXX-XXXX or my supervising professor (insert Professor's name here), at XXX-XXXX. If you have questions about your or your child's rights as a research subject, you may contact the (Name of Sponsoring Institution) Institutional Research Board at XXX-XXXX.

Sincerely,

(Researcher's Name)


Please indicate below your decisions regarding the various parts of this research project:

I give my permission for the items checked "Yes" below:
__________________________________________(Parent/Guardian printed name)
__________________________________________(Parent/Guardian signature)
____________________Date
  Yes         No
______ ______ My child's participation in this research project.
______ ______ Interviewing my child's teacher.
______ ______ Obtaining information from my child's school records.
______ ______ Videotaping of my child.
______ ______ Audiotaping of my child.

Please return this page in the postage paid envelope.