TITLE:

The exact title of the research should appear at the top of the form, followed by the CPHS HSC #.

INVITATION TO TAKE PART:

You are being invited to take part in a research project called, "_________" conducted by __________________.

Explain to the potential subject that:
"Your decision to take part is voluntary and you may refuse to take part, or choose to stop taking part, at any time. A decision not to take part, or to stop being a part of the research project will not change the services that are available to you from (physician, hospital, service agency, etc.) or (your grades, employment)".

"You may refuse to answer any questions asked or written on any forms"

"This research project has been reviewed by the Committee for the Protection of Human Subjects (CPHS) of the University of Texas Health Science Center at Houston as HSC-(fill in with assigned CPHS HSC#)."

DESCRIPTION OF RESEARCH:

PURPOSE: Why this research is being done:

• Succinctly explain the research WITHOUT medical terms or other scientific jargon.
• Identify investigational drugs/devices.

PROCEDURE: What to expect as a subject:

• Describe the procedures so that the potential subject will know exactly what will happen and the time period.
• Do not detail procedures conducted as part of standard treatment. Clarify how research procedures differ from standard treatment.
• Clearly state the use of experimental drugs, devices, treatment, etc.
• For venipunctures for blood samples - "you will have about (state in tsp., tbls., or oz.) of blood drawn from a vein in your arm (state frequency). The total amount of blood withdrawn during your participation will be about (state in tsp., tbls., or oz.)."

TIME COMMITMENT:

How much time we ask of you:

• Give the amount of time which the subject will be asked to devote to the study, including follow-up.
• Contrast the time requirement with that required for standard care, if applicable.

BENEFITS:

Possible benefits to you:

Describe potential benefits to the subject and to society in general. If drugs, laboratory examinations or other procedures are provided free to the subject, indicate whether these will be available when the study ends.

** HOWEVER ** Do NOT put the free provision of these drugs, laboratory examinations or other procedures to the subject in this "Benefits" sections, that information belongs in the "Cost, Reimbursement, and Compensation" section. Only indicate if the drugs, laboratory examinations or other procedures will still be available to the subject after the end of the study.

Or, "you may receive no direct benefit from being in this study; however, your taking part may help patients get better care in the future".

RISKS AND/OR DISCOMFORTS:

Possible risks, discomforts, or inconveniences to you:

Explain only the risks, discomforts, or inconveniences derived from the research itself.

List possible physical, psychological, legal or social risks or possible risks from loss of confidentiality that may arise from taking part in the study.

ALTERNATIVES:

Alternatives to being in the study:

"You may select other options than being in this research study. They are __. Dr. ______ (PI's name) will discuss these alternatives with you".

If no other alternative is available, this should be stated. For instance, it may be stated, "The only alternative is not to take part in this study."

STUDY WITHDRAWAL:

How taking part in the research study may be stopped:

Describe the circumstances under which the investigator may stop a subject's involvement without regard to the subject's wishes; e.g. evidence of drug allergy; inability of subject to maintain appointments; noncompliance with protocol; evidence of potential danger to subject.

If an immediate halt to the research may cause injury, explain the procedure for subject withdrawal.

IN CASE OF INJURY:

If an injury is caused by the research:

When an injury (physical or otherwise) is possible instruct the subject to report injury to the principal investigator (name and 24 hour telephone number) and to the Committee for the Protection of Human Subjects at (713) 500-7943.

Describe provisions made for compensation or provision of treatment; and, if there is no provision, it is mandatory to add the following statement:

"If you suffer any injury as a result of taking part in this research study, please understand that nothing has been arranged to provide free treatment of the injury or any other type of payment. However, all needed facilities, emergency treatment and professional services will be available to you, just as they are to the community in general. You should report any injury to Dr. _____________ at (list principal investigator's name and phone number here) and to the Committee for the Protection of Human Subjects at (713) 500-7943. You will not give up any of your legal rights by signing this consent form."

The costs for care of a research-related injury when a subject is enrolled in a study sponsored by a pharmaceutical company, MUST be covered by the company. The contract concluded by the university, the investigator and the sponsor will include such language. The following is mandatory "in case of injury" language for pharmaceutical company sponsored protocols:

"If you suffer any injury as a result of taking part in this research study the sponsor of this study, (enter sponsor's name), will pay for reasonable and necessary medical expenses if the injury is a direct result of taking the study medicine or undergoing study procedures, and not due to the natural course of any underlying disease or treatment process. You should report any such injury to (put the principal investigator's name and phone number here) and to the Committee for the Protection of Human Subjects at 713-500-7943. You will not give up any of your legal rights by signing this consent form."

COSTS, REIMBURSEMENT, AND COMPENSATION:

List any free services/drugs, etc. which the subject will receive, clarifying how long this will be available to the subject.

Inform subjects of any additional costs they may incur.
Describe reimbursement for expense, parking, babysitting, etc.

Describe any compensation for taking part. If compensation is dependent upon completing certain portions of the study, give the schedule of payment.

This section should include:

"If you received a bill that you believe is related to your taking part in this research study, please contact ______________ (list contact name and number here) with questions."

CONFIDENTIALITY:

This section should state how the subject's confidentiality will be maintained:

"You will not be personally identified in any reports or publications that may result from this study. Any personal information about you that is gathered during this study will remain confidential to every extent of the law. A special number will be used to identify you in the study and only the investigator will know your name. There is either a separate section in this consent form or a separate authorization form that you will be asked to sign which details the use and disclosure of your protected health information."

Please Note: There is a difference in the confidentiality statement on informed consent forms for those protocols which are "sensitive", those that are non-sensitive, and those that are subject to FDA review:

Sensitive protocols are those in which the research and/or medical records would likely contain information dealing with matters which the subjects would not wish to have known by others, e.g. drug use, sexual history, etc. Personal identifiers must be masked when the study sponsor is monitoring records for sensitive protocols, but can be seen (not copied) for non-sensitive protocols.

Committee approved language for sensitive and non-sensitive protocols that are subject to FDA review is as follows:

Non-sensitive protocol: Please understand that representatives of the FDA, the Committee for the Protection of Human Subjects, and the sponsor of this research may review your research and/or medical records for the purposes of verifying research data, and will see personal identifiers. However, identifying information will not appear on records retained by the sponsor. You will not be personally identified in any reports or publications that may result from this study. There is either a separate section in this consent form or a separate authorization form that you will be asked to sign which details the use and disclosure of your protected health information.

NEW INFORMATION:

When applicable, add a statement that significant new findings developed during the course of the research which might relate to the subject's willingness to continue participation would be provided to the subject.

QUESTIONS:

State that the principal investigator will be glad to answer any further questions at any time. State that the subjects can contact the investigator to discuss problems, voice concerns, obtain information, and offer input in addition to asking questions about the research. Include the principal investigator's name and phone number (a 24 hour phone number is essential for any drug or device study).

SIGNATURES:

The consent document should be concluded as follows:

"Sign below only if you understand the information given to you about the research and choose to take part. Make sure that any questions have been answered and that you understand the study. If you have any questions or concerns about your rights as a research subject, call the Committee for the Protection of Human Subjects at (713) 500-7943. You may also call the Committee to discuss problems, concerns, and questions; obtain information about the research; and offer input about current or past participation in a research study. If you decide to take part in this research study, a copy of this signed consent form will be given to you."

Provide spaces for:

• Printed name of subject
• Subject signature, date, AND TIME (of signature -- this is a new requirement)
• If appropriate, parent/guardian/next of kin signature and date
• Printed name of individual obtaining consent/assent/permission
• Signature of individual obtaining consent/assent/permission and date

CPHS STATEMENT:

This study (HSC-__-__-___) has been reviewed by the Committee for the Protection of Human Subjects (CPHS) of the University of Texas Health Science Center at Houston. For any questions about research subject's rights, or to report a research-related injury, call the CPHS at (713) 500-7943.