The University of Arizona s1

Delete the red text prior to submitting this form to the IRB.

Sample language is in italics

Required language is in regular text

The University of Arizona Consent to Participate in Research

Study Title:
Principal Investigator:
Sponsor (delete if not sponsored)

This is a consent form for research participation. It contains important information about this study and what to expect if you decide to participate. Please consider the information carefully. Feel free to discuss the study with your friends and family and to ask questions before making your decision whether or not to participate.

Why is this study being done?

Explain the purpose of the study and a statement that the study involves research.

What will happen if I take part in this study?

Explain the procedures to be followed. Specifically identify any procedures that are for research only.

How long will I be in the study?

Explain the expected duration of the subject's participation.

How many people will take part in this study?

Identify the approximate number of subjects you plan to enroll in the study, both total (study-wide) and local (if different).

Can I stop being in the study?

Explain 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.

Your participation is voluntary. You may refuse to participate in this study. If you decide to take part in the study, you may leave the study at any time. No matter what decision you make, there will be no penalty to you and you will not lose any of your usual benefits. Your decision will not affect your future relationship with The University of Arizona. If you are a student or employee at the University of Arizona, your decision will not affect your grades or employment status.

What risks, side effects or discomforts can I expect from being in the study?

Explain any reasonably foreseeable risks or discomforts to the subjects as a result of participation or procedures from the research.

What benefits can I expect from being in the study?

Explain any reasonably expected benefits to subject or others.

You may or may not benefit as a result of participating in this study.

What other choices do I have if I do not take part in the study?

Describe any appropriate alternative procedures or courses of treatment. For some studies, the only alternative would be to not participate:

You may choose not to participate in this study without penalty or loss of benefits to which you are otherwise entitled.

Will my study-related information be kept confidential?

Specify the extent, if any, to which confidentiality of identifiable records will be maintained. Specify the entity(ies) which would potentially have access to research files.

Efforts will be made to keep your study-related information confidential. However, there may be circumstances where this information must be released. For example, personal information regarding your participation in this study may be disclosed if required by state law.

Also, your records may be reviewed by the following groups (identify as appropriate):

· Office for Human Research Protections or other federal, state, or international regulatory agencies

· The University of Arizona Institutional Review Board

· The sponsor supporting the study, their agents or study monitors

· Banner – University Medical Center Tucson (B–UMCT)

Who can answer my questions about the study?

For questions, concerns, or complaints about the study you may contact ______.

For questions about your rights as a participant in this study or to discuss other study-related concerns or complaints with someone who is not part of the research team, you may contact the Human Subjects Protection Program at 520-626-6721 or online at http://rgw.arizona.edu/compliance/human-subjects-protection-program.

If you are injured as a result of participating in this study or for questions about a study-related injury, you may contact ______.

An Institutional Review Board responsible for human subjects research at The University of Arizona reviewed this research project and found it to be acceptable, according to applicable state and federal regulations and University policies designed to protect the rights and welfare of participants in research.

Signing the consent form

I have read (or someone has read to me) this form, and I am aware that I am being asked to participate in a research study. I have had the opportunity to ask questions and have had them answered to my satisfaction. I voluntarily agree to participate in this study.

I am not giving up any legal rights by signing this form. I will be given a copy of this form.

Printed name of subject / Signature of subject
AM/PM
Date and time

When appropriate, one or more of the following elements should also be included in the informed consent. Delete any of the following sections if not applicable to the Human Research.

What happens if I am injured because I took part in this study?

For research involving more than minimal risk, include the following elements:

· An explanation as to whether any compensation is available if injury occurs

· An explanation as to whether any medical treatments are available if injury occurs

· If compensation and/or treatment is available: what comprises that compensation and/or treatment, or where further information may be obtained

A statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant) which are currently unforeseeable.

If you suffer an injury from participating in this study, you should seek treatment. The University of Arizona has no funds set aside for the payment of treatment expenses for this study.

You will be provided with any new information that develops during the course of the research that may affect your decision whether or not to continue participation in the study.

When may participation in the study be stopped?

Under what circumstances the subject's participation may be stopped by the investigator, the consequences of a subject's decision to withdraw from the research, and the procedures for orderly withdrawal of participation by the subject.

What are the costs of taking part in this study?

Any additional costs to the subject from participating in the research (e.g. subject's time, insurance billing, transportation).

Will I be paid for taking part in this study?

Discuss the amount and timing, including a description of any proration, of any compensation (monetary and/or non-monetary).

By law, payments to subjects may be considered taxable income.

Will educational records be accessed?

· Specify the records that may be disclosed;

· State the purpose of the disclosure; and

· Identify the party or class of parties to whom the disclosure may be made.

Education records used by this research project are education records as defined and protected by Family Educational Rights and Privacy Act (FERPA). FERPA is a federal law that protects the privacy of student education records.

Will my data or specimens be stored for future research?

Include a description of what information/specimens will be stored and whom they will be shared with (both internal to the UA or outside the UA). What research may be conducted with these data/specimens - including unspecified future research, genetics, disease specific, etc. The IRB prefers optional opt-in check boxes where subjects can agree to the various levels of research use.

Also include a description of how the information will be protected and stored. Explain if reconsent will be obtained from subjects for specific uses.

Language in this section must match the language in the IRB application.

Will medical records be accessed?

This language is required to obtain authorization from patients for access to Protected Health Information.

For you to be in this research study, we need your permission to collect, use and share health information that identifies you. If you sign this form, we will collect, use and share your health information until the end of this research study, which may be after your direct participation in the research project ends. If you decide not to sign this form, you cannot participate in the research study. Whatever decision you make about this research study will not affect your access to medical care.

Information to be used includes things learned from the procedures described in this consent form. Other information may be collected, including, but not limited to, your name, address, date of birth, and information from your medical records. This may include information about HIV and genetic testing, or treatment for drug or alcohol abuse or mental health problems.

We may use and share your health information with people involved in this research, others who administer, oversee, regulate, pay for or work with us on research, and other external entities who provide services to support the research. In addition, people involved with your future medical treatment (including your insurance plan) may become aware of your participation and of any information added to your medical record as a result of your participation in this study.

We will use and disclose your information only as described in this form and in the relevant Notice of Privacy Practices provided by the individual or entity who holds your medical records and/or other related information; however, people outside the University of Arizona who receive your information may not be covered by this promise or the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) or other applicable federal and state laws. We try to make sure that everyone who needs to see your information keeps it confidential, but we cannot guarantee this.

You can cancel your permission to use and disclose your information at any time by contacting the Principal Investigator of this study in writing. Please include the study number and your contact information. The Principal Investigator’s name, address, phone and fax information are on page [insert page number] of this form. Please note that we may continue to use and share the information we have already collected about you, but we won’t collect any further information about you for the research study.

If you have any questions, please ask the Investigator. The Investigator will give you a signed copy of this form.

Optional language to include:

Your health information may also be useful for other studies. We can only use the health information collected for this research study again if the [IRB] gives us permission. The [IRB] may ask us to talk to you again before using or sharing the health information collected for this research study for other research purposes. However, if we meet certain requirements established by law, the [IRB] may also let us use and share your health information collected for this research study for additional research without talking to you again.

Additional language that may be necessary to include. Delete any of the following sections if not applicable to the Human Research.

For clinical trials, include the following information in the consent form:

· The probability for random assignment to each treatment

· The subject’s responsibilities

· When there is no intended clinical benefit to the subject, a statement to this effect

· No statements of unproven claims of effectiveness or certainty of benefit, either implicit or explicit

· A statement that monitors, auditors, IRB, and regulatory authorities will be granted direct access to the subject’s original medical records for verification of clinical trial procedures and data, without violating the confidentiality of the subject, to the extent permitted by applicable laws and regulations and that, by signing the consent document, the subject or LAR is authorizing such access

· Assurance that the subject’s identity will remain confidential if the trial results are published,

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 this Web site at any time

If using services from the Banner – University Medical Center Tucson, include this language under 'Will my study-related information be kept confidential?':

[Language if using services from the Banner – University Medical Center Tucson]

Banner – University Medical Center Tucson (B–UMCT) has an electronic medical record system. Medical services and test results completed by B–UMCT for this research project will be placed in your medical record (such as blood draws, CT scans, and MRIs). If you do not have a B–UMCT medical record one will be created for you. It is necessary to create a medical record for services completed by B–UMCT so that B–UMCT can appropriately bill for the service. Therefore, people involved with your future care and insurance may become aware of your participation and of any information added to your medical record as a result of your participation in this study.

Your medical record will be flagged to note that you are in a research study. You will also have a research record that is separate from your medical record. Your research record may contain additional information that is not included in your medical record.

[Alternative confidentiality statement for studies involving healthy volunteers who do not have a previous relationship with B–UMCT]

Participation in research involves some loss of privacy. We will do our best to make sure that information about you is kept confidential, but we cannot guarantee total privacy. If you do not have a Banner – University Medical Center Tucson (B–UMCT) medical record, one will be created for you. Your test results will be added to the B–UMCT medical record. It is necessary to create a medical record for services completed by B–UMCT so that B–UMCT can appropriately bill for the service. Therefore, people involved with your future care and insurance may become aware of your participation and of the results of your scan. Your personal information may be given out if required by law.