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
Participants Printed Name:
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
The purpose of this research is to .
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
- Decreased appetite
- Difficulty sleeping
- Headache, dizziness
- 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 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.
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 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 PIs office).
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 PIs 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 notinclude any part of section 6b unless the research fits the above criteria.
Example Statement of Use of Private Health Information
Health information about you will be collected if you choose to be part of this research study. Health information is protected by law, as explained in the (location/institution) Privacy Notice. If you have not received this notice, please request a copy from the investigator. At (location/institution) your information will only be used or shared as explained and authorized in this consent form or when required by law. It is possible that some of the other people or groups who receive your health information may not be required by Federal privacy laws to protect your information and may share it without your permission.
To participate in this research you must allow the study team to use your health information. If you do not want us to use your protected health information, you may not participate in this study. (When specific therapy is only available through the research, include the following sentence.)The research-related therapy is investigational; therefore, it is not available unless you allow the use of your health information that is collected during this research study.
(For blinded studies) People usually have a right to access their medical records. However, while the research is in progress, you may not be allowed to see or copy certain information that is related to this research study. This is only for the period of the research. You will be allowed to see that information when the entire research project is complete.
Your permission for the use, retention, and sharing of your identifiable health information will (Describe the date or event that will trigger the expiration of this authorization, e.g., expire upon completion of the research study or expire when FDA approval of the study drug is obtained or will continue for the period of time necessary for the preparation of a related followup research study or continue indefinitely or will continue until the NCCIH notifies the investigator that the information is no longer needed. ). At that time the research information not already in your medical record will be destroyed (or will be retained until ___ in order to ___ or information identifying you will be removed from such research results at (location/institution)). Any research information in your medical record will be kept indefinitely.
If you choose to participate, you are free to withdraw your permission for the use and sharing of your health information(if applicable, add: and your samples)at any time. You must do this in writing. Write to Dr. India Butler and let (him/her) know that you are withdrawing from the research study. (His/Her) mailing address is(address).
If you withdraw your permission:
- We will no longer use or share medical information about you (if applicable, add the following: or your samples) for this research study, except when the law allows us to do so
- We are unable to take back anything we have already done or any information we have already shared with your permission
- We may continue using and sharing the information obtained prior to your withdrawal if it is necessary for the soundness of the overall research
- We will keep our records of the care that we provided to you as long as the law requires.
The research team may use the following sources of health information:
- (List any and all medical information collected from or about the participant in connection with this research study, e.g., blood and other tissue samples and related tests, your medical history as it relates to the research study, x-rays, MRIs, questionnaires, etc.)
- (Indicate the span of time from which the records are pulled, e.g., since your diabetes was diagnosed, the last 5 years, or only during the time span of the research study.)
Representatives of the following people or groups within (location/institution) may use your health information and share it with other specific groups in connection with this research study.
- The principal investigator,(Principal Investigator)
- The(location/institution)Institutional Review Board
- The(location/institution)Human Subjects Protection Office
- (If using the Investigational Drug Pharmacy) The (location/institution) Pharmacy
- (If applicable) The (location/institution) Financial Analyst for Clinical Research
- (List every other class of persons or groups affiliated with (location/institution) (e.g., the research team, the study coordinators, etc.) who might need to use and/or disclose the participans information in connection with this study.)
The above people or groups may share your health information with the following people or groups outside (location/institution) for their use in connection with this research study. These groups, while monitoring the research study, may also review and/or copy your original (location/institution) records.
- The Office of Human Research Protections in the U. S. Department of Health and Human Services
- (List every other class of persons or group NOT affiliated withyour institution
(e.g. fellow researchers in this study at (list other institutions), outside data analysts appointed for this study, the Data Safety Monitoring Board appointed for this study, the National Institutes of Health, the Food and Drug Administration, etc., to whom the participant s information might be disclosed.)
- (If the study is international) Representatives from regulatory agencies in other countries may also review your research record, including research-related medical reports and information, along with NCCIH and/or the FDA.
Section 7. COSTS FOR PARTICIPATION
This section discusses participants research-related injuries and their compensation. If the participant incurs costs that may result from participation in the research, include a statement describing any additional costs associated with study participation. Include your institutions mandatory wording for treatment and compensation for injury (see below).
Example Costs for Participation Section
(If there is no risk of physical injury to the participant, do not include this section.)
Every effort to prevent injury as a result of your participation will be taken. It is possible, however, that you could develop complications or injuries as a result of participating in this research study. In the event of injury resulting from this research, medical treatment is available but will be provided at the usual charge. It is the policy of this institution to provide neither financial compensation nor free medical treatment for research-related injury.
(Add, as a separate paragraph, one of the following statements regarding payment for direct costs of treating research-related injuries.)
(If the institution will cover all costs of research-related injuries but did not provide consent form wording, include this statement as a separate paragraph.) If complications or injuries occur that are the result of a medication, procedure, or test required for this study, theinstitution (include the names) will reimburse the standard charges for the treatment of these complications or injuries. The compensation described in this section will be the only form of compensation provided to you for complications or injuries related to this study.
(If the (investigator institution) will cover costs of research-related injuries not covered by the participants insurance carrier but did not provide consent form wording, include this statement as a separate paragraph.)If complications or injuries occur that are the result of a medication, procedure, or test required for this study, theinvestigator, (include the name of institution, if appropriate) will reimburse the standard charges for the treatment of these complications or injuries, provided these charges have not been reimbursed by your nongovernmental medical insurance or other third party. The compensation described in this section will be the only form of compensation provided to you for complications or injuries related to this study.
(If the investigator institution has not agreed to cover costs of research-related injuries, include this statement as a separate paragraph.)Costs for the treatment of research-related injuries will be charged to your insurance carrier or to you. Some insurance companies may not cover costs associated with research studies. If for any reason these costs are not covered by your insurance, they will be your responsibility. You will also be responsible for any deductible, co-insurance, and/or co-pay.
(End this section with the following statement.) You will not lose any legal rights by signing this form.
Section 8. COMPENSATION FOR PARTICIPATION
This section is required in all research studies. It should clearly describe any monetary compensation (total amount, average total amount, amount per visit, amount per hour, etc.).
Example of Compensation for Participation Section
You will be given $_____ on each visit to compensate you for time and expenses for participating in this study.
(Add this if participants do not receive any reimbursement for participation.) You will not receive any compensation for being in this research study.
Section 9. RESEARCH FUNDING
This section discloses what grantors, institutions (e.g., NCCIH), or companies are involved in the research through funding or grants (if none, say so). It also includes information about conflicts of interest, including any consultative or financial relationships the investigators may have with NCCIH.
Example Research Funding Section
The institution and investigators are receiving a grant from NCCIH (list any other grantors) to support this research.
(For funding disclosure)The institution will be reimbursed by NCCIH for use of this sites facilities and for the work the research staff does for this research.
Section 10. VOLUNTARY PARTICIPATION
Example Voluntary Participation Section
Taking part in this research study is voluntary. If you choose to take part in this research, your major responsibilities will include (briefly list major responsibilities. NOTE: Do not include this sentence if there are no major responsibilities for the participant). You do not have to participate in this research. If you choose to take part, you have the right to stop at any time. If you decide not to participate or if you decide to stop taking part in the research at a later date, there will be no penalty or loss of benefits to which you are otherwise entitled.
(Optional, if appropriate)Your investigator may take you out of the research study without your permission. Some possible reasons for this are: (list possible reasons, for example: you did not follow the study instructions, etc.). Also, NCCIH may end the research study early. If your participation in the research ends early, you may be asked to visit the investigator for a final visit.
(Optional, if appropriate)(For clinical studies) If you will be participating in another clinical trial at [institution] or elsewhere while in this research, you should discuss the procedures and/or treatments with your physician or the investigators. This precaution is intended to protect you from possible side effects from interactions of research drugs, treatments, or testing.
(Optional, if appropriate)During the course of the research you will be provided with any significant new findings that may affect your willingness to continue participating in this research.
Section 11. CONTACT INFORMATION FOR QUESTIONS OR CONCERNS
This section clarifies the participants right to have questions answered. It also indicates a contact person in case of further questions about the research or to report a research-related injury, along with someone to contact regarding questions about participant rights and privacy issues.
Example Contact Information for Questions or Concerns Section
You have the right to ask any questions you may have about this research. If you have questions, complaints, or concerns or believe you may ha (phone number).
(All informed consent forms should include this paragraph). If you have questions regarding your rights as a research participant or you have concerns or general questions about the research (add the next phrase if using identifiable health information: or about your privacy and the use of your personal health information), contact the research subjects protection advocate in the (location/institution)Subjects Protection Office at (phone number). You may also call this number if you cannot reach the research team or wish to talk to someone else.
For more information about participation in a research study and about your institutional review board (IRB), a group of people who review the research to protect your rights, please visit the (location/institution)IRBs Web site at (Web site). Included on this Web site, under the heading Participant Information, you can access Federal regulations and information about the protection of human research participants. If you do not have access to the Internet, copies of these Federal regulations are available by calling the (location/institution)at (phone number).
SIGNATURE AND CONSENT/PERMISSION TO BE IN THE RESEARCH
This section is required in all informed consent forms. It ensures that the participant has freely chosen to participate in the research and is free to withdraw at any time, without penalty. It also ensures that appropriate staff has thoroughly explained the research to the participant.
Example Signature and Consent/Permission To Be in the Research Section
Before making the decision regarding enrollment in this research, you should have:
- Discussed this study with an investigator
- Reviewed the information in this form
- Had the opportunity to ask any questions you may have.
Your signature below means that you have received this information, have asked the questions you currently have about the research, and have received answers to those questions. You will receive a copy of the signed and dated form to keep for future reference.
Participant: By signing this consent form, you indicate that you are voluntarily choosing to take part in this research.
__________________________ __________ ________ ________________________
Signature of Participant Date Time Printed Name
Participants Legally Authorized Representative: By signing below, you indicate that you give permission for the participant to take part in this research.
__________________________ __________ ________ ________________________
Signature of Participants Legally Date Time Printed Name
The signature of the participants legally authorized representative is required for people unable to give consent for themselves.
Description of the Legally Authorized Representatives Authority to Act for Participant
Person Explaining the Research:Your signature below means that you have explained the research to the part