ALWAYS PREPARE THE INFORMED CONSENT DOCUMENT ON YOUR TSU DEPARTMENTAL LETTERHEAD

(This example is provided only as a guide in preparing a formal Informed Consent document. You are reminded to consider the particular requirements of your project when preparing the Informed Consent document. Investigators are expected to use formal (signed) Informed Consent when reasonable. Exceptions to the use of signed consent must be approved by the IRB.)

INFORMED CONSENT

for a Research Study Entitled

Title of project

You are invited to participate in a research study (describe purpose). This study is being conducted by (investigator's name and title if applicable, specify “under the supervision of faculty advisor’s name and title”). We (I) hope to learn (objective). You were selected as a possible participant because (why - this should be consistent with the criteria stated in the Subject Population section of the protocol).

If you decide to participate, we (I) will (describe procedures to be followed, including how long they will take, frequency of participant's participation, and approximately how long total participation will require).

(Describe reasonable risks or discomforts associated with participation and explain procedures you will use to reduce or eliminate risks/discomforts.) (Describe reasonable benefits to participants and provide a statement regarding realistic benefits to persons other than participants. If possible benefits are described, you must add the following statement:) We (I) cannot promise you that you will receive any or all of the benefits described. (If the participant will receive compensation, describe the amount and nature. Avoid references such as wages, payment, etc. which might imply an employer/ employee relationship. If medical treatment for physical injuries is available, state the extent treatment will be provided and where it will be carried out. If medical treatment will be provided at the participant's expense, so state. If extra credit is involved, state amount and provisions for credit accrual. If there is a possibility of additional expenses to the participant because of participation, describe it.)

(Describe appropriate alternative procedures that might be advantageous to the participant, if any, and any procedures which are experimental. If any standard treatment is being withheld, the following statement must be added: This is a RESEARCH project not a treatment for your condition.)

Any information obtained in connection with this study and that can be identified with you will remain confidential (or anonymous, depending upon the specific conditions of data collection). (Explain how data will be kept confidential). Information collected through your participation may be (e.g., used to fulfill an educational requirement (....), published in a professional journal, and/or presented at a professional meeting, etc.) If so, none of your identifiable information will be included.

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Participant’s Initials

(required for all non-signature pages)

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(If data will be confidential [directly identifiable or through code lists] participants should be informed that the information will be protected and when all identifying data [or codes] will be destroyed. Participants must also be informed that they may withdraw from participation at any time, without penalty, and that they may withdraw any data which has been collected about themselves, as long as that data is identifiable.)

Your decision whether or not to participate will not jeopardize your future relations with Tennessee State University University or (name of your department) (and name of cooperating institution or agency, if any).

If you have any questions we (or I) invite you to ask them now. If you have questions later, (provide the name, telephone number and e-mail address of investigator and faculty advisor) will be happy to answer them. You will be provided a copy of this form to keep.

For more information regarding your rights as a research participant you may contact the Chair of the Tennessee State University Institutional Review Board, Dr. Monique McCallister, by phone (615) 963-7619 or e-mail at .

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HAVING READ THE INFORMATION PROVIDED, YOU MUST DECIDE WHETHER OR NOT YOU WISH TO PARTICIPATE IN THIS RESEARCH STUDY. YOUR SIGNATURE INDICATES YOUR WILLINGNESS TO PARTICIPATE.

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Participant's signature Date Investigator's signature Date

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Print Name Print Name

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Parent’s or Guardian Signature Date Coinvestigator's signature Date

(if appropriate) (if appropriate)

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Print Name Print Name

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