Sample Informed Consent Form s1

SAMPLE INFORMED CONSENT FORM

Title: Title of research as it appears on the application for human research health sciences form and protocol

Sponsor: Name of Study Sponsor Address of Study Sponsor Phone number of Study Sponsor

Principal Investigator: Name of Principal Investigator Address of Principal Investigator Phone number of Principal Investigator 24 hour phone number

The following persons are sub-investigators for this research study: List all sub-investigators

You have been asked to participate in a research study. This form is designed to give you information about this research study. The principal investigator or person authorized to obtain your consent will tell you about the study and answer any of your questions. If you have any questions about this research study or an injury related to this research study you should contact (principal investigator) at (phone number). If you have any questions about your rights as a human research subject please contact the Director of Patient Advocacy at Abington Memorial Hospital at 215-481-2209.

Purpose of this research study

Disclosure of any funds received by the investigator and disclosure of any type of payment or reimbursement to the subject

Subjects expected duration in this study and the total number of research subjects to be enrolled in this study

Describe all procedures of this research study and specify any procedures which are experimental

Provide a statement of where materials (such as: tissue, blood, etc.) derived from the subject are to be sent and stored

Potential risks or discomforts to the subject

Disclosure of any cost to the subject include the following language:

You may contact a financial counselor to assist you with this process through Abington Memorial Hospital Patient Service Center at 215-481-5777.

Statement that the particular treatment or procedure may involve risks to the embryo or fetus if the subject is to become pregnant, the method of birth control recommended and any pregnancy testing required prior to subject entering onto this study, suggested language follows:

Version date: Patient’s initials______Revision date: Page 1 of 4 Due to the effect of this drug/device, there could by serious harm to unborn children (or children who are breast-feeding) and it could also jeopardize the health of the mother. In addition, it is possible that harmful side effects that are not yet known could occur to both the mother and unborn or breast-feeding child. For this reason, if you are pregnant, you will inform the investigator and will be given a serum pregnancy test prior to entry into the study. You also understand that you will practice a medically accepted method of birth control (such as:…) during your participation in the study. Further, you understand that while you are taking this drug/device you should not become pregnant, and if you do become pregnant, you must discontinue the drug/device and consider termination of the pregnancy. If male contraception methods or warnings are warranted, the appropriate information must be provided in this section as well.

Potential health benefits to the subject or to others which may reasonably be expected

Disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject

Anticipated circumstances under which the subject’s participation may be terminated by the investigator

Consequences of the subject’s decision to withdraw and procedures for orderly termination of participation by the subject

Statement that significant new findings developed during the course of the research, which may relate to the subject’s willingness to continue participation will be provided to the subject

Statement that there will be no waiver of Subject’s legal rights or release of investigator, sponsor, or institution from negligence

Statement describing the extent to which confidentiality of records identifying the subject are to be kept

Compensation for research related injury if any and an explanation as to whether any medical treatments are available and what they consist of if injury occurs, include the following language:

In the event of any physical injury resulting from the research procedures, medical treatment will be provided without cost to you, but financial compensation is not otherwise available from Abington Memorial Hospital. If the injury is related to the investigational product/procedure, the Sponsor may reimburse for medical expenses incurred by you as a result of participation in the study.

You or your third Party payor, if any, may be billed for medical expenses associated with this study only if they are deemed medically necessary and if such expenses would have been incurred independent of the study.

If you suffer a physical injury or illness that is deemed to be unrelated to the research procedure, medical treatment will be provided to you and you and your third party will be billed for medical expenses associated with treatment provided.

Text for a subject receiving payment for study participation over $600.00 per year section: You may receive up to (insert dollar amount or compensation) for taking part in this study. This amount may be taxable and will be reported to the Internal Revenue Service (IRS).

Sample text for video tape section:

of 4 To assist with accurate recording of participant responses, interviews may be recorded on a video recording device. Participants have the right to refuse to allow such taping without penalty. Please select one of the following options.

□ I consent to the use of video recording.

□ I do not consent to the use of video recording.

______Signature Date

Sample text for audio tape section: To assist with accurate recording of participant responses, interviews may be recorded on an audio recording device. Participants have the right to refuse to allow such taping without penalty. Please select one of the following options.

□ I consent to the use of audio recording.

□ I do not consent to the use of audio recording.

Sample text for photograph section: □ I hereby give my permission to take photographs as deemed advisable for diagnostic, educational, or research purposes to enhance the medical record. I further authorize the use of such audio-visual material (video tape, audio tape, photographs) for teaching purposes or to illustrate scientific papers or lectures at any time hereafter without inspection or approval, on my part, of the finished product or the specific use to which this material may be applied. I hereby consent to any or all of the above procedures.

□ I hereby give my permission to take photographs as deemed advisable for my medical record or diagnostic purposes only

□ I do not give my permission to take photographs

All of your questions have been answered and this informed consent has been explained to you in a language understandable to you.

You understand that your participation is voluntary refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and you may stop participating in this study at any time without penalty or loss of benefits, to which you are entitled. You will contact (principal investigator) for procedures to follow prior to ending your participation.

You will receive a copy of this informed consent form.

of 4 The following persons are authorized to obtain my consent: List all (principal investigator, sub- investigators, research coordinators)

Subject signature Date

(or authorized representative signature) Date

Witness Date

Authorized person obtaining consent Date

Principal Investigator Date

______Translator (when applicable) Date