developing an informed consent document

This template for developing an informed consent document to use in your research study is meant to provide structure and guidance to the process, not to serve as your exact informed consent document. Please remember to consult your institution and institutional review board (IRB) for specific consent requirements, instructions, and templates.

For the purposes of this document, guidelines within the template will be provided in italics. If this document is used to develop your informed consent form, please remember to delete the italicized instructions and insert your specific information.

Place the version number and date on the bottom of each page, as such:

Version 1 (Please change version number with each amendment.)
Month Day, Year

When making changes to an approved and “final” protocol over time, please provide at the front of the protocol a summary of the changes, including the exact words that are changed, the location in the protocol, the date the modification was approved by the appropriate committee, and the date it became effective.

INFORMED CONSENT FORM

Florida State College at Jacksonville

Title of Project: A Phase II, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of TJ301 (FE 999301) Administered Intravenously in Patients with Active Ulcerative Colitis

Principal Investigator: India Butler

Other Investigators: Kaytlynn Williams, Connell King Nkongla Nosheu, Shaqurria Horne

Participant’s Printed Name:

INTRODUCTORY PARAGRAPH

Example Introductory Paragraph

We invite you to take part in a research study A Phase II, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of TJ301 (FE 999301) Administered Intravenously in Patients with Active Ulcerative Colitis atFlorida State College at Jacksonvillewhich seeks to identify a more effective means of treating Active Ulcerative Colitis.

Taking part in this study is entirely voluntary. We urge you discuss any questions about this study with our staff members. Talk to your family and friends about it and take your time to make your decision. If you decide to participate, you must sign this form to show that you want to take part.

Section 1. PURPOSE OF THE RESEARCH

This section is required in all consent forms. It focuses on explaining to the participant why they were asked to participate in the study and the purpose of the research study.

Example 1: Purpose of the Research

You are being offered the opportunity to take part in this research study because (state why the individual was selected, e.g., condition, age, or healthy volunteer). This research study is being done to find out….

OR

The purpose of this research is to ….

OR

The purpose of this research study is to obtain information on the safety and effectiveness of (name of drug, device, etc.) Approximately (number) people will take part in this research (nationwide or worldwide) and about (number) people are expected to take part at (location/institution).

Section 2. PROCEDURES

This section is required in all consent forms. It outlines the procedures of the study and explains exactly what will happen to the individual should they choose to take part in the study. It should clearly identify what parts of the procedure, if any, are experimental.

Section 3. TIME DURATON OF THE PROCEDURES AND STUDY

This section is required in all informed consent forms. The purpose of this section is to clearly outline the time commitment a participant is committing to in choosing to take part in the study.

Example of a Time Duration Section

If you agree to take part in this study, your involvement will last approximately (give length of time of participation). You will be asked to return to the clinic (number) times. Each clinic visit will take approximately (number) minutes.

Section 4. DISCOMFORTS AND RISKS

This section is required in all informed consent forms. For certain research studies, it may suffice to say that there are no know risks associated with the research. However, in most studies, this section will outline in lay terms what risks or discomforts may be associated with each procedures or drug administered. List by regimen the physical and nonphysical risks of participating in the study in percentages and numbers whenever possible. Nonphysical risks may include such things as the inability to work, potential anxiety related to the sensitive nature of the questions asked, etc. List the known human experiences related to the treatment and procedures involved, including bruising or discomfort from blood draws, as well as any relevant animal data. Highlight or otherwise identify side effects that may be irreversible, long-term, or life threatening. The use of lists or a table format is recommended.

Example of a Discomforts and Risks Section for a Drug Study

While on the study, you are at risk for the following side effects. Most of them are listed below but they will vary from person to person. Drugs will be given to make some of the side effects less serious and uncomfortable. Many side effects go away after the drug is stopped but, in some cases, the side effects may be serious and/or lasting.

Drug XYZ Side Effects

More likely

  • Decreased appetite
  • Difficulty sleeping
  • Headache, dizziness

Less likely

  • Hallucinations or delusions
  • Nausea and/or vomiting

(The following text should be added for trials with a placebo arm.)

If you are in the treatment group that receives placebo (inactive substance) your symptoms or condition may worsen or not improve.

Other Possible Risks Associated With Participating in This Study

  • Venipuncture: The risks of drawing blood include temporary discomfort from the needle stick, bruising, bleeding, and, rarely, infection.
  • Subcutaneous injections: Injections to the skin may be less convenient than some other forms of treatment, such as oral medications. In addition, injections may cause momentary discomfort and other local symptoms, such as bleeding, bruising, and, rarely, infection.

(Also, if applicable, the following should be added.)

There also may be other side effects or discomforts that we cannot predict, especially to a fetus or embryo. Because the drugs in this study may affect an unborn baby, you should not become pregnant or father a baby while on this study. Your doctor will discuss this with you. You should not breast-feed a baby while on this study.

Section 5. POTENTIAL BENEFITS

This section must be in all informed consent forms. However, the way it is included may vary depending on the type of research. The purpose of this section is to describe the benefits of participating for the subject and for others. The following should be included in this section:

  • This section should address two parts: 1) potential benefits to the participant, and 2) potential benefits to others. The two ideas can be integrated, but for the purposes of the example below, they have been separated into two subsections.
  • NOTE: Payment given to the subject for participation in the study is not a benefit; it is a compensation for the subject’s time and any expenses incurred as a result of participation in the study and should not be included in this section.

Example of Possible Benefits Section

Possible Benefits to the Participant

(For clinical research studies where direct benefit is possible) The possible benefit you may experience from the (drug, device, or procedure) described in this research includes (list any benefits that may be reasonably expected). However, there is no guarantee that you will benefit from being in this research.

(For research with no direct benefit) You will not benefit from taking part in this research study.

Possible Benefits to Others

(Address potential benefits to others) The results of this research may guide the future treatment of….

OR

Medical science may gain further understanding of….

Section 6. STATEMENT OF CONFIDENTIALITY

This section is required in all informed consent forms. This section must outline how all confidential information and or materials will be treated, stored, and maintained and for what lengths of time, as well as how materials will be disposed of at the end of the study period. Privacy and confidentiality measures must be addressed in this section.

This section must also include a statement containing the following language:

A description of this clinical trial will be available on http:///www.ClinicalTrials.gov, as required by U.S. law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search the Web site at any time.

6.1 Privacy and Confidentiality Measures

Example Statement of Confidentiality

Your research records that are reviewed, stored, and analyzed at (location/institution) will be kept in a secured area in (list where records are stored). (Include the following if specimens are collected for research purposes)Your samples collected for research purposes will be labeled with (list all that apply: a code number, your initials, etc.) and will be stored (list where the samples will be stored and how they are secured).

(For research records/samples that are sent outside your institution, describe methods that will be used to ensure confidentiality. If records and specimens are sent to different entities or labeled differently, describe their confidentiality measures separately.) For research records (and specimens) sent to (outside entity), you will not be identified by name, Social Security number, address, or phone number. The records (and specimens) may include (list all that apply: a code number, your initials, date of birth, etc.). The list that matches your name with the code number will be kept in a locked file in (note location, such as PI’s office).

OR

For research records (and specimens) sent to (outside entity), you will be identified by (list all that apply: name, Social Security number, address, phone number, date of birth, any other direct personal identifier or code number, etc.). The list that matches your name with the code number will be kept in a locked file in (note location, such as PI’s office).

(Remember to include separate descriptions for records and specimens if they are labeled differently, stored differently, or sent to separate entities.)

The following statement is considered mandatory for all research studies:

In the event of any publication or presentation resulting from the research, no personally identifiable information will be shared.

The following statement is for those studies that do not include section 6.2.

We will keep your participation in this research study confidential to the extent permitted by law. However, it is possible that other people may become aware of your participation in this study. For example, the following people or groups may inspect and copy records pertaining to this research:

  • The Office of Human Research Protections in the U. S. Department of Health and Human Services (for drug/device studies, add the U.S. Food and Drug Administration) The (location/institution) Institutional Review Board (a committee that reviews and approves research studies)
  • The (location/institution) Human Subjects Protection Office
  • The National Institutes of Health, the study sponsor.

Some of these records could contain information that personally identifies you. Reasonable efforts will be made to keep the personal information in your research record private and confidential but absolute confidentiality cannot be guaranteed.

6.2 The Use of Private Health Information

Section 6b is mandatory if the research creates, obtains, uses, and/or discloses identifiablehealth information about the research participants. The 18 identifiers are listed under HIPAA regulations. Do not include any part of section 6b unless the research fits the above criteria.

Example Statement of Use of Private Health Information

No Comment.