Informed Consent

All research requires informed consent. Voluntary participation and informed consent are at the very core of what the IRB committee is reviewing.

 The “informed consent” for participants at least 18 years of age should contain the following information:

  • A statement that the study involves research
  • An explanation of the purposes of the research
  • The name of PI
  • The contact information for PI
  • The name of faculty sponsor
  • The contact information for faculty sponsor
  • The expected duration of the subject's participation
  • A description of the procedures to be followed
  • A description of any risks or discomforts to the subject
  • A description of any benefits to the subject
  • A statement describing the extent to which confidentiality of records identifying the subject will be maintained
  • A statement of how data will be stored, destroyed, etc.
  • 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
  • The contact info for the IRB committee for more info (irb@webster.edu)

When a researcher is using an anonymous questionnaire, the requirements of informed consent may be fulfilled by providing an “information sheet” as the first page of the survey.

Following the above information, implied consent for online data collection is usually completed with a statement such as, “I am at least 18 years of age and I agree to participate in the research described above” or “By continuing with this survey, you affirm that you are at least 18 years old and you agree to participate in this research.”


Generic Informed Consent Letter

The following is an example of a letter of informed consent. Be aware that this is just a starting point, your particular research methodology may require additional information be provided to participant.

Notes:

1. Items in bold regular type may be used verbatim.
2. Items in plain regular type are descriptions of sections to be provided by the researcher.
3. Items in italic type give two options; choose one.


A. Sample Text

Consent Form: [Study Title]

I am conducting research on [topic/title of study].  I am investigating this because [purpose].  If you decide to do this, (you)/(your child)will be asked to [Describe ways in which human subjects will be involved, including length of time (e.g.: two hours over a three week period)].

[If participation involves any discomfort or risk, describe in lay language.   If physical injury might result, describe, and include the following:] [Emergency medical treatment within the limits of that normally offered by the University Health Center (telephone 968-6922) will be provided for physical injuries occurring on the Webster University main campus.  The care that can be provided is nurse-directed care during office hours of 8:30-4:30 Monday - Friday from late August through early May.  If an injury/illness requires care beyond the capabilities of the nurse on staff, the individual will be referred to other resources such as a hospital emergency room.  No other medical treatment or financial compensation for injury from participation in this project is available.]

[Describe procedures for anonymity/confidentiality in lay language.]

If (you take)/(your child takes) part in this project [Describe benefits to subjects or others in lay language].  Taking part in this project is entirely up to you, and no one will hold it against (you)/(your child) if you decide not to do it.  If(you do)/(your child does) take part, (you)/(he or she) may stop at any time without penalty.  In addition, you may ask to have your data withdrawn from the study after the research has been conducted.

If you want to know more about this research project, please contact me at [phone # & email address, include adviser's name, phone number, and email address if appropriate]. This project has been approved by the Institutional Review Board at Webster University [and the specific site(s) if appropriate]. Information on Webster University policy and procedure for research involving humans can be obtained from the Institutional Review Board, email irb@webster.edu.

You will get a copy of this consent form.

Sincerely,

[Name, title]


B. Consent Statement(s)

I agree to (take part)/(let my child take part) in this project.  I know what (I)/(he or she) will have to do and that (I)/(he or she) can stop at any time.

________________________________      _____________

Signature                                                      Date


C.   Audio/Videotape Consent Addition

What follows is a consent statement for research designs utilizing audio and/or videotaping. This is to be used instead of section "B" above in the event the researcher is taping the participant.

I agree to (audio)/(video) taping at _____________ on __________.

__________________________      ______________

Signature                                            Date

I have been told that I have the right to (hear)/(see) the (audio)/(video)tapes before they are used. I have decided that I:

______ want to (hear)/(see) the tapes

______ do not want to (hear)/(see) the tapes

Sign below if you do not want to (hear)/(see) the tapes. If you want to (hear)/(see) the tapes, you will be asked to sign after (hearing)/(seeing) them.


[Researchers' names] and other researchers approved by Webster University may use the tapes made of (me)/(my child). The original tapes or copies may be used for (check all that apply):


______ this research project

______ teacher education

______ presentation at professional meetings

______________________    _________    _______________________

Signature                               Date                    Address