Full Review

The following suggestions are offered as guidelines. The exact language is the decision of the researcher, but keep in mind that the HSC reviewers must determine if the participants will be giving informed consent. The language must be understood by the participants at whatever cognitive level they fall. The sequential order of the informed consent must follow that listed in Form C.

I, ____________________________________ , hereby willingly consent to
(participant, parent or guardian)
participate in the ________________________________ research project of
                                 (name of study)
_______________________________________________ of Kutztown University.
(name of principal investigator)

We are conducting a study to determine __________________________________.

The study is part of a project for ________________________________________.

In this study you (your child or ward) will be asked to _______________________.

Your (your child's or ward's) participation should take about ____________ minutes.

The only risk to you (your child or ward) include ____________________________.

The benefits to you (your child or ward) include ____________________________.

All information will be handled in a strictly confidential manner, so that no one will be able to identify you (your child or ward) when the results are recorded/reported.

Your (your child's or ward's) participation in the study is totally voluntary and you may withdraw at any time without negative consequences. If you wish to withdraw, simply _____________________________________________________________.

Please feel free to conact _______________________________________.
                                      Name (s), Title (s) of principal researcher (s)

at ____________________________ if you have any questions about the study.
      telephone number (s)

If a treatment proves to be effective and you have not received this treatment, you (your child or ward) will have the opportunity to undergo the treatment under the same conditions as the other group. (Give the conditions such as cost. etc.)

I understand that if anything occurs to me (my child or ward) while participating in this study that is not caused by the treatment or personnel involved, I cannot hold the researchers or institution responsible.

To be completed in the participant's (parent's or legal guardian's) own writing if the participant is defined "at risk".