Irb Approval Form (Page 2 of 3) in pdf

State any financial obligations that will result from participation.

If there are no financial obligations:

Example:

There is no cost to you to be in this research study.

How will information about you be protected?

If data is collected such that it is anonymous (only if names or other identifying information has not been collected

during the study):

Example:

All data collected in this study is anonymous. This means that no names or identifying information will be

recorded during the study. There is no way to connect your identify with any of your responses.

If data is collected such that it is not anonymous:

Example:

Reasonable steps will be taken to protect your privacy and the confidentiality of your study data.

(Explain procedures for assuring data privacy and confidentiality, such as use of numbered identifiers,

locked files, restricted access, destruction of the data after a specific time period, how long audio or video

tapes will be kept and how they will be disposed of, etc.)

The information from this study may be published in scientific journals or presented at scientific meetings

but your identity will be kept confidential.

What will happen if you decide not to be in this study or if you decide to stop participation during the

study?

Include the following language in all informed consent documents:

Participation in this study is completely voluntary. If you choose to participate, you may stop participation

at any time without penalty and without losing any benefits that are a part of this study.

What should you do if you have questions or concerns about this research study?

For studies that involve no or minimal risk:

If you have any questions or concerns during or after this study, you may contact:

(Give the Principal Investigator’s name and contact information. If the P.I. is a student, the faculty

advisor’s name and contact information must also be provided.)

For studies that involve greater than minimal risk, you must include an explanation as to whether any

compensation or treatments are available, and if so, what they consist of and where more information can be

obtained.

Example (if there will be no compensation for services or treatment):

If you have a problem or experience harm as a direct result of being in this study, you should immediately

contact:

(Give the Principal Investigator’s name and contact information. If the P.I. is a student, the faculty

advisor’s name and contact information should be provided instead.)

If necessary, you can be provided with referral information for appropriate services or treatment.

However, you will not receive any compensation for services or treatment.

Irb Approval Form Page 2