Claim Substantiation Informed Consent - RIPT


AGREEMENT TO BE IN A RESEARCH STUDY

STUDY TITLE: Evaluation of the Skin Care Formulas for Allergy Potential

PROTOCOL: Repeat Insult Patch Test

RESEARCH STUDY INVESTIGATOR: William Christopfe l

24-HOUR TELEPHONE: 651-340-4975         

INTRODUCTION

Before agreeing to participate in this research study, it is important that you read and understand the following explanation of the study and procedures.  This statement describes the purpose, procedures, benefits, risks, discomforts and precautions of the study.  It also describes the alternative procedures that are available to you and your right to withdraw from the study at any time.  No guarantees or assurances can be made as to the results of the study.

The investigator is being paid by the sponsor (the company paying for this study) to conduct this research study.

You must be honest with the investigator about your health history or you may harm yourself by participating in this study.

BACKGROUND

You have been invited to participate in a research study designed to measure the allergy potential of topical skin care products.

You must be at least 18 and less than 70 years old, in good general health, and willing to follow study guidelines including medication restrictions during the study.  Your skin type must meet the study requirements.  You will be required to show identification before enrollment.  Due to equipment limitations, your weight cannot exceed 300lbs.  You cannot participate in this study if any of the following are true:

  • You have a history of allergic or abnormal skin responses.
  • You have a sensitivity or allergy to cosmetic products, toiletries, sunscreens and/or topical drugs
  • You have significant past or current medical history of systemic illness that may increase your risk of study participation or that may affect the results of the study, including but not limited to <> a history of cancer, lupus and uncontrolled diabetes, thyroid conditions, or hypertension
  • You have any previous or present skin condition such severe acne (pimples), psoriasis, eczema, skin cancer, abnormal moles or any other condition that might increase the risk of your participation in this study.
  • You have recently used any medicine that may make you more sensitive to allergy medicines, pain relief medicines or medicines for skin conditions. (This will be explained to you by the investigator or study technician and you will be shown a list of these medicines.)
  • You have participated in any other clinical research study in the past 2 months.
  • You have allergy or sensitivity to latex
  • You are pregnant or planning on becoming pregnant while enrolled in the study or if you are currently nursing a child.

A list of prohibited medications will be provided to you.

NUMBER OF SUBJECTS

Up to 200 subjects may be required to complete these procedures for each test product.

DURATION OF STUDY AND PROCEDURES

Induction Phase

A small sample of the product is applied to the target area of the back. For semi-occlusive or occlusive patching, hypoallergenic patches are applied over the product. The patch is removed after 24-hrs, and the skin responses are read after 48 hrs. This sequence is repeated nine times, applying product to the exact same area. Any visible irritation is recorded.

Test material(s) will be placed on a 2cm Bandage or equivalent coverings. The patch(es) will be applied to the subject’s back between the scapulae and waist, or to the inner forearm.

Challenge Phase

After a rest period of 10 to 21 days, a patch is applied to a different area in order to challenge for sensitization.

The challenge patch(es) are applied to previously unpatched (virgin) sites, adjacent to the original induction patch sites. The challenge sites are scored 24 to 48 hours after application.

PHOTOGRAPHS

We may obtain photographs of treated sites on your back at some visits.  You will not be identifiable in any of the photographs and the photographs will be used only for scientific purposes, and possibly for research publications.  These photographs will be obtained using a digital camera and only the test area will be included.  You will be given the opportunity to view your photographs.

POSSIBLE SIDE EFFECTS AND RISKS

If you do not understand what any of these side effects mean, please ask the investigator or study staff to explain these terms to you. 

Because the study products are investigational, all the side effects may not be known.  There may be rare and unknown side effects. Some of these may be life threatening.

You must tell the investigator or study staff about all side effects that you have. If you are not honest about your side effects, you may harm yourself by staying in this study.

UNFORESEEN RISKS

There may be rare and unknown side effects. Some of these may be life threatening. 

Risks to the fetus (unborn child) are unknown.  If you are pregnant or planning on becoming pregnant you must not participate.  The study may involve currently unforeseeable risks to breastfed babies. If you are breastfeeding a child, you should not participate in the study.

IN CASE OF STUDY RELATED INJURY

In the unlikely event that medical treatment is required as a result of this study, it will be provided by the study sponsor at no cost to you.  No other compensation is offered in the event of a research-related injury.  You will not lose any of your legal rights as a research subject by signing this consent form.

ALTERNATIVE TO PARTICIPATING IN THE STUDY

This research study is for research purposes only.  The only alternative is not to participate in this study.

NEW FINDINGS

Any new important information which is discovered during the study and which may influence your willingness to continue participation in the study will be made available to you.

BENEFITS

You will receive no direct benefit from this study.  The knowledge gained from this study will contribute to the development of more effective sunscreens.

COMPENSATION FOR PARTICIPATION

You will receive a payment of _____ for completing the study.  If you do not complete the study, you will be paid the following for each visit you complete: __________.  Payments are made by check upon completion of the study.

CONFIDENTIALITY

Your medical records are confidential except as required by law.  The study staff, the study sponsor or designee, IRB and other regulatory agencies including the Food and Drug Administration (FDA) may review records of your study participation.  However, confidentiality of any information you provide will be maintained to the maximum extent possible.

The data from this study may be submitted to a government website designed to provide information about clinical trials.  If submitted, a description of this clinical trial may be available on 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 website at any time.

The Institutional Review Board (IRB), and accrediting agencies may inspect and copy your records, which may have your name on them.  Therefore, total confidentiality cannot be guaranteed.  If the study results are presented at meetings or printed in publications, your name will not be used.

You have the right to see your study records and you may withdraw your permission to collect and share your personal information pertaining to this study at any time.  Personal information collected before you withdrew your permission may continue to be shared as part of this study.  If you withdraw your permission allowing the collection and sharing of your personal information you will no longer be able to participate in this study.  You may withdraw your permission to collect and share personal information by sending a written request to:

CONTACT INFORMATION

If you have questions, concerns, or complaints about this study or to report a study related injury, contact the study investigator or study staff at:

651-340-4975

If you are unable to reach anyone at the number(s) listed above and you require immediate (life threatening) medical attention, please go to the nearest emergency room.

If you do not want to talk to the investigator or study staff, if you have concerns or complaints about the research, or to ask questions about your rights as a study subject you may contact the IRB.  IRB policy indicates that all concerns/complaints are to be submitted in writing for review at a convened IRB meeting to:

 Mailing Address:            and            Email Address:

William Christopfel

Bell Clinical Services

2950 Lexington Ave. S.

Eagan, MN 55121

w.christopfel@bellintlabs.com

If you are unable to provide your concerns/complaints in writing or if this is an emergency situation regarding subject safety, contact our office at:

IRB has approved the information in this consent form and has given approval for the investigator to do the study. This does not mean IRB has approved your being in the study.  You must consider the information in this consent form for yourself and decide if you want to be in this study.

VOLUNTARY PARTICIPATION AND WITHDRAWAL

Your participation in this study is entirely voluntary.  You may decide not to participate or you may withdraw from the study at any time without any effect on your future medical care.  Your refusal to participate or your withdrawal from the study will cause no penalty or loss of benefits to which you are entitled.  If you choose to withdraw from the study, you will be asked to state your reason for withdrawal and to have any procedures or examinations that the investigator feels are in your best interest.

Your participation in this study may be ended without your consent by the investigator, the sponsor, IRB, or the FDA at any time for the following reasons: if the study appears to be medically harmful to you, if you fail to follow directions for participating in the study, if we discover that you do not meet study requirements, if the study is stopped or for other administrative reasons.

AGREEMENT TO BE IN THE STUDY

This consent form contains important information to help you decide if you want to be in the study.  If you have any questions that are not answered in this consent form, ask one of the study staff.

Please answer YES or NO to the following questions:

  1. Is this document in a language you understand?                   
  1. Do you understand the information in this consent form?                   
  1. Have you been given enough time to ask questions and talk about the study?               
  1. Have all of your questions been answered to your satisfaction?                   
  1. Do you think you received enough information about the study?                   
  1. Do you volunteer to be in this study of your own free will and without being

pressured by the investigator or study staff?                        

  1. Do you know that you can leave the study at any time without giving

     a reason and without affecting your health care?                            

  1. Do you know that your health records from this study may be reviewed by the

sponsor company and by government authorities?                         

  1. Do you know that you cannot be in another study while you are in this study?               

IF YOU ANSWERED “NO” TO ANY OF THE ABOVE QUESTIONS,

OR YOU ARE UNABLE TO ANSWER ANY OF THE ABOVE QUESTIONS,

YOU SHOULD NOT SIGN THIS CONSENT FORM.

I HAVE CAREFULLY READ AND UNDERSTAND THIS INFORMED CONSENT

CONSENT

A signed and dated copy of this consent form will be given to me.  The test has been explained to my satisfaction and I agree to participate as described.  I have been given the opportunity to discuss all aspects of this study and to ask questions.  I am at least 18 years old, in good health, and freely give my informed consent to serve a subject in this study. 

I understand that the product I am testing is proprietary and highly confidential.  I agree that I will not disclose or describe this product to anyone who is not an employee of.  I also agree that if, as part of the testing procedure, I am required to take the product out of the building for use, I will not give it or show it to any friend, family member or acquaintance.  I will not use the product, or any information I received about the product, for any purpose other than my participation in the current testing process.

SIGNATURE: ________________________________________ DATE: __________

Name: ____________________________________________________

Address: __________________________________________________

City/State/Zip: _____________________________________________

Home Telephone: ___________________________________________

Cellular Telephone: __________________________________________