Informed Consent Guidelines

Title: Show the heading of "Informed Consent Form." You may want to add the full title of the project.

Overview/Description: Invite subjects to participate and tell them the purposes of the study. Give a brief description of the procedures to be used and the time required, providing enough detail to enable subjects to make an informed decision.

Risks and benefits: Describe any reasonable foreseeable risks or discomforts associated with the study. If there are no known risks, this should be stated. Also, give a description of the likely benefits to subjects or to others.

Compensation: Provide a statement of any compensation available to subjects, along with information on how it can be obtained.

Handling discomfort or injury: If appropriate, tell subjects what treatment will be available and how it can be obtained.

Confidentiality: Specify the procedure for maintaining the confidentiality of records that identify subjects.

For more information: Tell subjects how to obtain more information about the project.

Voluntary participation: Explicitly state that the subject may refuse to participate or may withdraw for any reason without penalty. Describe the procedures for both electing to participate and for declining, along with a statement regarding the disposition of data which may have already been collected from subjects who later elect to withdraw.

Right to Withdraw: Include a statement "the subject may withdraw at any time without penalty."

Signature: Provide a space for signatures indicating consent, and remember to include a second copy for the subject to keep when obtaining consent.

Witness: Have signature for a witness to the consent process.

Include the following statement: This project has been approved by the East Stroudsburg University of Pennsylvania Institutional Review Board for the Protection of Human Subjects. Provide the contact information of the IRB Chair.