Informed Consent Form for Research Being Conducted Under the Auspices of the University

The University of Tulsa Institutional Review Informed Consent Form and Instructions

~ GENERAL INSTRUCTIONS FOR THE INFORMED CONSENT FORMS ~

 ALWAYS get your IRB application documents from the Human Protections Webpage, so you are sure that you are using the most updated version of each form. New/corrected form versions will be uploaded often. DO NOT use a form template that you’ve saved or from a previous IRB application submission. Here is the link to that webpage: http://www.utulsa.edu/research/Office-of-Research-and-Sponsored-Programs/Research- Integrity-Compliance-and-Certification/Protection-of-Human-Subjects%20-%20IRB.aspx

 You have several types of Informed Consent Forms to choose from. Select the Informed Consent Form(s) appropriate for your study. Then DO NOT alter the format of the form.

 Please follow the blue, italicized and/or bracketed [ ] instructions after the title headings of each section on all the Informed Consent forms. Once you type in the necessary information, you can delete ONLY the blue, italicized and/or bracketed [ ] instructions at the top of each section.

 Any language that is NOT blue, italicized and/or bracketed is REQUIRED language and needs to remain in that section. Your instructions will be only to add any additional language if needed.

 Write clearly and concisely and keep this form to one page whenever possible. Tailor the language/vocabulary to your subject pool, using lay language that your subject pool will understand. If your subject pool is the general adult public, use language/vocabulary around an 8th grade reading level. Write in conversational language in the 2nd person as if talking directly to your subject (“you” are being asked to… “your” responses…)

 Use the “Pre-Approved Language Library & Additional Consent Requests for Informed Consent Forms” to find pre-approved statements or additional consent requests to copy and paste into your Informed Consent Forms in the appropriate sections, whenever possible. Your study may require a combination of several of these statements in one or more sections. This IRB resource will be continually updated & added on to, so always check the website and use the latest version. You can find this resource at: http://www.utulsa.edu/research/Office-of-Research-and-Sponsored- Programs/Research-Integrity-Compliance-and-Certification/Protection-of-Human-Subjects%20- %20IRB.aspx

 DO NOT delete entire sections of the Informed Consent Form unless instructions explicitly state that you may delete the section, if not applicable to your study : *[This section can be deleted if not applicable to your study]

If you have any questions completing the IRB documents or to submit your completed IRB protocol documents, contact: Carmen Schaar-Walden Coordinator of Research Compliance Office of Research and Sponsored Programs McClure Hall, Room 205-C 918-631-3310

v2015 [email protected]

INFORMED CONSENT FORM FOR RESEARCH BEING CONDUCTED UNDER THE AUSPICES OF THE UNIVERSITY OF TULSA

INTRODUCTION: This study is entitled, “[Insert the title of the study]”. The person(s) directing this project is (are) [Insert name(s) and title(s) of the researcher(s)]. [If a faculty sponsor is involved, insert faculty sponsor name and title]. This document defines the terms and conditions for consenting to participate in this study.

DESCRIPTION OF THE STUDY: [Insert a brief explanation about the study and of what a subject can expect if they choose to participate in this study to include: number of sessions/appointments; expected duration of time for each session/appointment]

POTENTIAL RISKS OF PARTICIPATION: [Insert a brief description of any potential risks to participants.]

ANTICIPATED BENEFITS OF PARTICIPATION: [Insert a brief description of any direct or indirect benefits to the participants or to society. DO NOT include any compensation or extra credit here.]

CONDITIONS OF PARTICIPATION: [In addition to the mandatory language in this section, add any additional selection criteria in this section, to include: age, gender, health conditions, etc…at the beginning of this section] Participation is voluntary. Refusal to participate will involve no penalty or loss of benefits to which you are otherwise entitled. Furthermore, you may discontinue participation at any time without penalty or loss of benefits to which the participant is otherwise entitled.

CONFIDENTIALITY: [This information should be the same/similar to the Confidentiality section of the application form. - briefly explain whether subjects will be identifiable to the researcher(s) or have any way to link individual responses back to the subjects; explain if you will need to create a link between subjects and their responses and how it will be secured; include details on how all data will be secured (where? how long? who has access?) and if later destroyed, include an approximate destroy date. If study is conducted electronically (web, disks, files) address how confidentiality or anonymity will be maintained & describe in detail the 3rd party service administering the study and their security/protects that are set up by that entity. Will the project publications allow identification of individual subjects?]

*[This section can be deleted if not applicable to your study] COMPENSATION FOR INJURY: [For research involving more than minimal risk, explain whether or not any compensation or medical treatment is available if injury occurs. If compensation or treatment will be provided, describe the nature of the compensation and/or treatment. If no compensation will be available, make that clear in this section. Explain how the subject can obtain additional information if necessary.]

*[This section can be deleted if not applicable to your study] INCENTIVES/PAYMENTS: [If course extra credit is being offered, please include any non-research extra credit option available. If this is part explain any incentives/payments that are provided in increments and what criteria these increments are based on. Also explain if participants still receive these incentives/payments if they withdraw early and if they will receive a portion of the incentive/payment for what they’ve completed before they withdrew. If there is raffle/lottery incentive, please include your justification why a raffle/lottery is being requested instead of a universal incentive and you must state the estimated odds of winning on this application and the Informed Consent Form.] [For some protocols, compensation such as payment, gifts or extra credit may be offered. Please include that information. PLEASE NOTE : The TU Controller’s Office requires identifying information to issue checks of any dollar amount or to track payment via cash or gift certificates over $25 to payees. [In those cases, the Confidentiality section of the consent form must inform participants that they will be asked to provide their Name, Address and Social Security Number to receive compensation] This information will be provided to the Controller’s Office at the time of payment (payment/compensation is made via a check) or at the end of the year with the link between the particular project and the participant removed.

v2015 CONTACTS FOR QUESTIONS ABOUT THE STUDY: Participants may contact [Insert name of the PI and contact email address and phone number and (if applicable) add Faculty Mentor name and email address] with questions about the study.

For inquires about rights as a research participant, contact Carmen Schaar-Walden, Coordinator of Research Compliance, Office of Research, The University of Tulsa at 918-631-3310 or via e-mail at [email protected].

PARTICIPANT ASSURANCE: I have read and understand the terms and conditions of this study and I hereby agree to participate in the above-described research study. I understand my participation is voluntary and that I may withdraw at any time without penalty.

______Signature of Participant Date