1. TOPAZ Elements The Consent Form Texas Southern University
Office of Research

2. Intended Purpose The intended purposes of this session are to provide:
the rationale of the Consent form; and
suggestions for creating the Consent form, ensuring all required elements are present.
Intended Purpose

3. Goals Educate investigators about the Consent form.
Illustrate the elements of the Consent form.
Goals

4. The U. S. Department of Health & Human Services (HHS) 45 CFR §46
The U.S. Department of Health & Human Services (HHS) 45 CFR § states that "no investigator may involve a human being as a subject in research covered by this policy unless the investigator has obtained the legally effective informed consent of the subject or the subject's legally authorized representative". In other words: Informed consent is required because our federal government says so.
Why do Consent?

5. What are the elements of Consent?
Consent forms must, at a minimum, contain or address the following:
a statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures which are experimental;
a description of any reasonably foreseeable risks or discomforts to the subject;
What are the elements of Consent?

6. What are the elements of Consent?
Consent forms must, at a minimum, contain or address the following:
a description of any benefits to the subject or to others which may reasonably be expected from the research;
a disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject;
a statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained;
What are the elements of Consent?

7. What are the elements of Consent?
Consent forms must, at a minimum, contain or address the following:
a statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.
What are the elements of Consent?

8. What are the elements of Consent?
Consent forms must, at a minimum, contain or address the following:
For research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained;
In some instances, additional elements of Consent may be required, and are found on HHS's website at
cfr-46/index.html#46.116
What are the elements of Consent?

9. Consent Form Appearance
The appearance of the Consent form should be professional.
At the top of the form should be your complete first and last name; college/school name, along with the department; and the address assigned by the University
Beneath the investigator's identifying information should be the name of the study, followed by the name of the document.
Consent Form Appearance

10. Consent Form Appearance
This is an example of a Consent form header.
Consent Form Appearance
Investigator's name is in the largest font size.
Notice the hierarchy:
(1) University; (2) college;
(3) department
Investigator's contact data
Study title
Document type
Notice the same font (Times Roman) used, but with varying attributes (all capitals; bold; italic; different font sizes). This helps draw attention to the various parts of the document so the reader won't miss anything.

11. The format of the Consent form is one component of the appearance
The format of the Consent form is one component of the appearance. Consider checking or setting such features as:
margins (left, right, top, bottom (usually 1" for all))
tabs (typically every ½ inch, depending on the text)
indentions (1/4 inch inside of the tab)
headers and footers
The appearance of the Consent form could set the tone as to how seriously your participants believe in your research.
Consent Form Format

12. Not only are the elements of the Consent form important, but also how they are presented. Spelling and grammar are crucial, and again, may make the difference in the participants' willingness to take part in the study. Be sure to check BOTH spelling and grammar. Also, the intention of the Content form may be misconstrued if words are misspelled, or if the grammar is not on par. Something as simple at "not", when it should be "now" could make a difference to the participant.
Consent Form Content

13. Consent Form Elements: Introduction
Which to create first, the Consent form, or the protocol? It does not matter. If the protocol is created first, the statements from the protocol may be copied and pasted into the Consent form. If the Consent form is created first, the elements in the Consent form will determine the responses to be checked in the protocol.
Consent Form Elements: Introduction

14. Consent Form Elements: #1 Research Background
Element: a statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures which are experimental;
Consent Form Elements: #1 Research Background

15. Consent Form Elements: #1 Research Background
Comparison Translation: Protocol → Consent form
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Consent Form Elements: #1 Research Background

16. Consent Form Elements: #1 Research Background
Comparison Translation: Protocol → Consent form
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Consent Form Elements: #1 Research Background

17. Consent Form Elements: #2 Risk
Element: a description of any reasonably foreseeable risks or discomforts to the subject
Consent Form Elements: #2 Risk
Comparison Translation:
Protocol → Consent form

18. Consent Form Elements: #2 Risk
Comparison Translation: Protocol → Consent form
Consent Form Elements: #2 Risk

19. Consent Form Elements: #3 Benefit
Element: a description of any benefits to the subject or to others which may reasonably be expected from the research
Consent Form Elements: #3 Benefit
Comparison Translation:
Protocol → Consent form

20. Consent Form Elements: #4 Alternative Procedures
Element: a disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject;
Consent Form Elements: #4 Alternative Procedures
Contact the advisor for assistance with this element.

21. Consent Form Elements: #5 Record Confidentiality
Element: a statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained
Consent Form Elements: #5 Record Confidentiality
Comparison Translation: Protocol → Consent form

22. Consent Form Elements: #5 Record Confidentiality
Element: a statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained
Consent Form Elements: #5 Record Confidentiality
Comparison Translation: Protocol → Consent form

23. Consent Form Elements: #5 Record Confidentiality
Element: a statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained
Consent Form Elements: #5 Record Confidentiality
Comparison Translation: Protocol → Consent form

24. Consent Form Elements: #5 Record Confidentiality
Element: a statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained
Consent Form Elements: #5 Record Confidentiality
Comparison Translation: Protocol → Consent form

25. Consent Form Elements: #6 Voluntary Participation
Element: a statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled. Note: This element is not addressed in the protocol.
Consent Form Elements: #6 Voluntary Participation

26. Be sure to provide an appropriate closing to the Consent form, which should include:
Thank you to the participant
Investigator contact information
Participant signature line
Participant signature date
Consent Form Closing

27. Consent Form: the Finished Document
When all of the elements are incorporated into the document, the finished Consent form should look like this:
Consent Form: the Finished Document

28. Questions. Contact Ms. Rhonni E
Questions ??? Contact Ms. Rhonni E. Dixon via at More information and tips can be found at the Office of Research's website
THANK YOU!
Thank you!