Essentials of Informed Consent

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

Involvement: Identify the investigator, faculty sponsor (if relevant), and any funding or sponsoring organizations. Identify Methodist University as the responsible institution or as one of the responsible institutions.

Overview: 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. It might be helpful to ask yourself what information you would need to have as a naive potential subject in order to feel that you could make such 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 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.

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

Miscellaneous: Include the following statement: “This project has been approved by the Methodist University Institutional Review Board for the Protection of Human and animal subjects (Phone: 910.480.8494).”

Sample Informed Consent Language

COVID-19 Informed Consent

INFORMED CONSENT

for a Research Study entitled

“Title of Your Study”

You are invited to participate in a research study to ____(purpose and objectives)____.  The study is being conducted by _(your name, title)_, under the direction of ___(advisor, title)__ in the Methodist University Department of ___________.  You were selected as a possible participant because you are ___________________ and are age 18 or older.
What will be involved if you participate?  If you decide to participate in this research study, you will be asked to ______________.  Your total time commitment will be approximately _____________.
Are there any risks or discomforts?  The risks associated with participating in this study are ___________.  To minimize these risks, we will _________.  Additionally, this research is taking place during the COVID19 pandemic. All study procedures will be completed with national, state, and local safety procedures in mind. (If medical treatment may be necessary, add the following:) You are responsible for any costs associated with medical treatment.
Are there any benefits to yourself or others?  If you participate in this study, you can expect to ________________.  We/I cannot promise you that you will receive any or all of the benefits described.
 Will you receive compensation for participating?  To thank you for your time you will be offered __________________.
Are there any costs?  If you decide to participate, you will ____________.
If you change your mind about participating, you can withdraw at any time during the study.  Your participation is completely voluntary.  If you choose to withdraw, your data can be withdrawn as long as it is identifiable.   Your decision about whether or not to participate or to stop participating will not jeopardize your future relations with Methodist University, the Department of _____________ or _________________.
 Participant’s initials ______                                                             Page 1 of 2
Your privacy will be protected.  Any information obtained in connection with this study will remain anonymous (or confidential).  Information obtained through your participation may be ____________(e.g. used to fulfill an educational requirement, published in a professional journal, presented at a professional meeting, etc….)
If you have questions about this study, please ask them now or contact ___________________ at  _____________________ or _________________ at ___________________.  A copy of this document will be given to you to keep.
If you have questions about your rights as a research participant, you may contact the Methodist University Institutional Review Board by phone (910)-480-8494 or e-mail at irb@methodist.edu.
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.
_____________________________      ______________________________

Participant’s signature             Date        Investigator obtaining consent    Date

 

_____________________________     ______________________________

Printed Name                                         Printed Name

                                                               ______________________________

                                                               Co-Investigator                        Date

 

______________________________

Printed Name


Regular Informed Consent

You are invited to participate in a research study about ____________________________.

This study is being conducted by ______________________________ with the assistance of ______________ (Faculty Supervisor) from the Department of ________________________ at Methodist University.   The objective of this study is to ____________________________________________.

You were selected as a possible participant in this study because you are ____________________________________________________________________________

There are no known risks if you decide to participate in this research study. There are no costs to you for participating in the study. The information you provide will be used in my work __________________________________. The questionnaire will take about _____ minutes of time to complete. The information collected may not benefit you directly, but the information learned in this study should provide more general benefits.

This survey is anonymous / confidential (Need to discuss with supervisor). (If anonymous may add statement.) We will not collect IP addresses and the information is encrypted; however we cannot guarantee absolute anonymity over the internet. No one will be able to identify you or your answers, and no one will know whether or not you participated in the study. If you begin the survey your responses are automatically entered into the database and will be included in our data. Should the data be published, no individual information will be disclosed. Our Institutional Review Board may inspect these records.

Your participation in this study is voluntary. By clicking on this link ___________  and completing the survey, you are voluntarily agreeing to participate. You are free to decline to answer any particular question you do not wish to answer for any reason.

If you have any questions about the study, please contact (Faculty Sponsor) ______________ at (910) ___________ or by e-mail _____________

If you have any questions about your rights as a research participant or if you feel you’ve been placed at risk, you may contact the Methodist University Institutional Review Board (IRB) by mail at Methodist University, Institutional Review Board, by phone at (910) 480-8494, or by e-mail at irb@methodist.edu.